Psoriatic Arthritis
Conditions
Brief summary
The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who have an inadequate response or are intolerant to biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.
Interventions
Tablets administered orally once daily with or without food.
DRUGFilgotinib
Tablets will be administered orally once daily with or without food.
Sponsors
Galapagos NV
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female participants who are 18-75 years of age (19-75 years of age at sites in Republic of Korea, 20-75 years of age at sites in Japan and Taiwan), on the day of signing initial informed consent * Meet Classification Criteria for Psoriatic Arthritis (CASPAR) * Have a history consistent with Psoriatic Arthritis (PsA) ≥ 6 months at Screening * Have active PsA defined as ≥ 3 swollen joints (from a 66 swollen joint count \[SJC\]) and ≥ 3 tender joints (from a 68 tender joint count \[TJC\]) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1 * Must have a documented history or active signs of at least one of the following at Screening * Plaque psoriasis * Nail changes attributed to psoriasis * Have had inadequate response (lack of efficacy after ≥ 12 week duration of therapy) or intolerance to at least one and not more than 3 biologic DMARDs (bioDMARD) administered for the treatment of PsA or psoriasis, as per local guidelines / standard of care * Prior to the first dose of study drug on Day 1, treatment with bioDMARD(s) should have been discontinued Key
Exclusion criteria
* Prior exposure to a janus kinase (JAK) inhibitor \> 2 doses * Any active / recent infection * Any chronic and / or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make a individual unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement * Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of investigator NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA * Any history of an inflammatory arthropathy with onset before age of 16 years old * Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the individual by participating in the study, (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator * Pregnancy or nursing females * Active drug or alcohol abuse, as per judgement of investigator Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 | Week 12 | ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain), and high-sensitivity C-reactive protein (hsCRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16 | Baseline, 4, and 16 weeks | PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; leeds enthesitis index (LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; Tender dactylitis count (TDC) \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; C-reactive protein (CRP). The score of PASDAS ranges from 0-10, lower scores indicates better function. A negative change from baseline indicates improvement. |
| Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Weeks 20, 24, 28, 36, and 48 | MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to 100 (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 for participants with enthesitis at baseline. |
| Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Weeks 4, 8, 12, and 16 | VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 with participants with enthesitis at baseline. |
| Change From Baseline in PASDAS at Week 48 | Baseline, Week 48 | PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; leeds enthesitis index (LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; Tender dactylitis count (TDC) \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; C-reactive protein (CRP). The score of PASDAS ranges from 0-10, lower scores indicates better function. A negative change from baseline indicates improvement. |
| Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Weeks 20, 24, 28, 36, and 48 | VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 with participants with enthesitis at baseline. |
| Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. A negative change from baseline indicates improvement. |
| Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. A negative change from baseline indicates improvement. |
| Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Baseline, 2, 4, 8, 12, and 16 weeks | The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement. |
| Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Baseline, 18, 20, 24, 28, 36, and 48 weeks | The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement. |
| Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Baseline, 4, 8, 12, and 16 weeks | mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (\>30 onycholysis together with oil-drop dyschromia, \>50 pitting, \>50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement. |
| Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Baseline, 20, 24, 28, 36, and 48 weeks | mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (\>30 onycholysis together with oil-drop dyschromia, \>50 pitting, \>50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement. |
| Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Baseline, 4, 8, 12, and 16 weeks | Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement. |
| Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Baseline, 20, 24, 28, 36, and 48 weeks | Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement. |
| Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16 | Baseline, 4, and 16 weeks | The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. The 12 NRS is focused on pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment, social life, and depression. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement. |
| Change From Baseline in PsAID-12 Score at Week 48 | Baseline, Week 48 | The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. The 12 NRS is focused on pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment, social life, and depression. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement. |
| Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16 | Weeks 4 and 16 | PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2. |
| Percentage of Participants With PASDAS LDA at Week 48 | Week 48 | PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2. |
| Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16 | Weeks 4 and 16 | PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9. |
| Percentage of Participants Who Achieved PASDAS Remission at Week 48 | Week 48 | PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9. |
| Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement. |
| Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement. |
| Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement. |
| Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | The DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. |
| Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Baseline, 18, 20, 24, 28, 36, 48 and 60 weeks | The DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. |
| Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) ≤ 3.2. |
| Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) ≤ 3.2. |
| Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) remission is defined as DAS28 (CRP) \< 2.6. |
| Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) remission is defined as DAS28 (CRP) \< 2.6. |
| Time to Achieve DAS28(CRP) LDA | Approximately 16 weeks | The DAS28 (CRP) is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28 (CRP) ≤ 3.2. Time to achieve DAS28(CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28(CRP) LDA. |
| Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA LDA is defined as DAPSA ≤ 14. |
| Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA LDA is defined as DAPSA ≤ 14. |
| Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA remission is defined as DAPSA ≤ 4. |
| Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA remission is defined as DAPSA ≤ 4. |
| Time to Achieve DAPSA LDA | Approximately 16 weeks | DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA LDA is defined as DAPSA ≤ 14. Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA. If the DAPSA LDA is not achieved during main study phase, the time to achieve DAPSA LDA will be censored at the last non-missing DAPSA LDA assessment date during main study phase. If the component scores of DAPSA LDA are at different dates for a visit, the latest date will be used for the derivation of time to achieve DAPSA LDA. |
| Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Weeks 2, 4, 8, 12, and 16 | The PsARC response was defined as improvement in at least 2 of the following 4 criteria; ≥ 30% decrease in SJC66, ≥ 30% decrease in TJC68, ≥ 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), ≥ 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity) and with at least one of the 2 joint criteria, with no deterioration in any other criteria. |
| Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Weeks 18, 20, 24, 28, 36, 48, and 60 | The PsARC response was defined as improvement in at least 2 of the following 4 criteria; ≥ 30% decrease in SJC66, ≥ 30% decrease in TJC68, ≥ 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), ≥ 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity) and with at least one of the 2 joint criteria, with no deterioration in any other criteria. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Baseline, 4, 8, 12, and 16 weeks | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Baseline, 20, 24, 28, 36, and 48 weeks | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement. |
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 4, 8, 12, and 16 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 20, 24, 28, 36, and 48 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 4, 8, 12, and 16 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 20, 24, 28, 36, and 48 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 4, 8, 12, and 16 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 20, 24, 28, 36, and 48 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 4, 8, 12, and 16 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Weeks 20, 24, 28, 36, and 48 | PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease. |
| Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Baseline, 4, 8, 12, and 16 weeks | The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. A negative change from baseline indicates improvement. |
| Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Baseline, 20, 24, 28, 36, and 48 weeks | The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. A negative change from baseline indicates improvement. |
| Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Baseline, 4, 8, 12, and 16 weeks | LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. LDI measures the ratio of the circumference of affected digit to circumference of digit on contralateral hand or foot using a Leeds Dactylometer. LDI score is calculated based on circumference of the dactylitic finger/toe (mm), circumference of the contralateral digit (mm), tenderness score (0 = no tenderness, 1 = tender). Tenderness of affected digits is assessed on a scale from 0 (no tenderness) to 3 (tender and withdrawn). A higher LDI indicates worse dactylitis. Negative change from baseline indicates improvement. |
| Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Baseline, 20, 24, 28, 36, and 48 weeks | LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. LDI measures the ratio of the circumference of affected digit to circumference of digit on contralateral hand or foot using a Leeds Dactylometer. LDI score is calculated based on the circumference of the dactylitic finger/toe (mm), circumference of contralateral digit (mm), tenderness score (0 = no tenderness, 1 = tender). Tenderness of affected digits is assessed on a scale from 0 (no tenderness) to 3 (tender and withdrawn). A higher LDI indicates worse dactylitis. Negative change from baseline indicates improvement. |
| Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Baseline, 4, 8, 12, and 16 weeks | Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score \>0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement. |
| Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Weeks 4, 8, 12, and 16 | MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to 100 (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 for participants with enthesitis at baseline. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Baseline, 2, 4, 8, 12, and 16 weeks | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. A negative change from baseline indicates improvement (less disability). |
| Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. A negative change from baseline indicates improvement (less disability). |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16 | Baseline, 4, and 16 weeks | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate less fatigue. Positive change in value indicates improvement (no or less severity of fatigue). |
| Change From Baseline in FACIT-Fatigue Scale Score at Week 48 | Baseline, Week 48 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate better quality of life. Positive change in value indicates improvement (no or less severity of fatigue). |
| Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16 | Baseline, 4, and 16 weeks | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicated improvement (better health status). |
| Change From Baseline in MCS of the SF-36v2 at Week 48 | Baseline, Week 48 | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicated improvement (better health status). |
| Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16 | Baseline, 4, and 16 weeks | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicates improvement (better health status). |
| Change From Baseline in PCS of the SF-36v2 at Week 48 | Baseline, Week 48 | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicates improvement (better health status). |
| Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Baseline, 20, 24, 28, 36, and 48 weeks | Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score \>0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement. |
Countries
Australia, Belgium, Canada, Czechia, Hungary, Japan, Poland, South Korea, Spain, Taiwan, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States, Europe, Canada, Australia, and Asia. The first participant was screened on 13 November 2019. The last study visit occurred on 18 March 2021.
Pre-assignment details
170 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Filgotinib 200 mg (Main Study) Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks. | 36 |
| Filgotinib 100 mg (Main Study) Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for 16 weeks. | 34 |
| Placebo (Main Study) PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for 16 weeks. | 36 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| LTE Phase (After Week 16 to Week 63) | Adverse Event | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| LTE Phase (After Week 16 to Week 63) | Study Terminated by Sponsor | 0 | 0 | 0 | 17 | 19 | 10 | 8 |
| Main Study (Up to 16 Weeks) | Adverse Event | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Main Study (Up to 16 Weeks) | Investigator's Discretion | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Main Study (Up to 16 Weeks) | Study Terminated by Sponsor | 14 | 13 | 14 | 0 | 0 | 0 | 0 |
| Main Study (Up to 16 Weeks) | Withdrew Consent | 2 | 1 | 3 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Filgotinib 200 mg (Main Study) | Filgotinib 100 mg (Main Study) | Total | Placebo (Main Study) |
|---|---|---|---|---|
| 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) | 5.2 score on a scale STANDARD_DEVIATION 1.94 | 5.1 score on a scale STANDARD_DEVIATION 2.33 | 5.0 score on a scale STANDARD_DEVIATION 2.11 | 4.8 score on a scale STANDARD_DEVIATION 2.1 |
| 36-item Short-Form Version 2 (SF-36v2) Mental Component Summary (MCS) | 45.8 score on a scale STANDARD_DEVIATION 11.97 | 48.1 score on a scale STANDARD_DEVIATION 8.79 | 47.9 score on a scale STANDARD_DEVIATION 11.15 | 49.8 score on a scale STANDARD_DEVIATION 12.2 |
| 36-item Short-Form Version 2 (SF-36v2) Physical Component Summary (PCS) | 33.7 score on a scale STANDARD_DEVIATION 8.13 | 35.5 score on a scale STANDARD_DEVIATION 9.41 | 34.9 score on a scale STANDARD_DEVIATION 8.83 | 35.7 score on a scale STANDARD_DEVIATION 9.05 |
| Age, Continuous | 56 years STANDARD_DEVIATION 10.5 | 54 years STANDARD_DEVIATION 9.3 | 55 years STANDARD_DEVIATION 10.1 | 54 years STANDARD_DEVIATION 10.5 |
| Disease Activity in Psoriatic Arthritis (DAPSA) | 45.9 score on a scale STANDARD_DEVIATION 22.64 | 42.8 score on a scale STANDARD_DEVIATION 22.05 | 44.0 score on a scale STANDARD_DEVIATION 22.49 | 43.1 score on a scale STANDARD_DEVIATION 23.26 |
| Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) | 4.8 score on a scale STANDARD_DEVIATION 0.98 | 4.8 score on a scale STANDARD_DEVIATION 0.97 | 4.8 score on a scale STANDARD_DEVIATION 0.97 | 4.8 score on a scale STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 31 Participants | 101 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue | 25.9 score on a scale STANDARD_DEVIATION 12.98 | 30.9 score on a scale STANDARD_DEVIATION 10.08 | 29.2 score on a scale STANDARD_DEVIATION 11.48 | 31.0 score on a scale STANDARD_DEVIATION 10.66 |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) | 1.24 score on a scale STANDARD_DEVIATION 0.637 | 1.03 score on a scale STANDARD_DEVIATION 0.612 | 1.14 score on a scale STANDARD_DEVIATION 0.603 | 1.13 score on a scale STANDARD_DEVIATION 0.557 |
| Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment | 61 score on a scale STANDARD_DEVIATION 19.3 | 56 score on a scale STANDARD_DEVIATION 23.3 | 58 score on a scale STANDARD_DEVIATION 21.9 | 57 score on a scale STANDARD_DEVIATION 23.4 |
| High-Sensitivity C- Reactive Protein (hsCRP) | 8.03 milligrams per liter (mg/L) STANDARD_DEVIATION 18.347 | 7.58 milligrams per liter (mg/L) STANDARD_DEVIATION 10.361 | 7.94 milligrams per liter (mg/L) STANDARD_DEVIATION 14.149 | 8.20 milligrams per liter (mg/L) STANDARD_DEVIATION 12.707 |
| Leeds Dactylitis Index (LDI) | 54.8 score on a scale STANDARD_DEVIATION 83.24 | 21.9 score on a scale STANDARD_DEVIATION 26.26 | 38.4 score on a scale STANDARD_DEVIATION 61.55 | 22.1 score on a scale STANDARD_DEVIATION 12.91 |
| Leeds Enthesitis Index (LEI) | 2 score on a scale STANDARD_DEVIATION 1.7 | 2 score on a scale STANDARD_DEVIATION 1.6 | 2 score on a scale STANDARD_DEVIATION 1.5 | 1 score on a scale STANDARD_DEVIATION 1.2 |
| Modified Nail Psoriasis Severity Index (mNAPSI) | 11 score on a scale STANDARD_DEVIATION 9.7 | 15 score on a scale STANDARD_DEVIATION 21.4 | 12 score on a scale STANDARD_DEVIATION 13.8 | 10 score on a scale STANDARD_DEVIATION 7.1 |
| Patient's Global Assessment of Disease Activity (PGADA) | 56 score on a scale STANDARD_DEVIATION 22.4 | 55 score on a scale STANDARD_DEVIATION 24.7 | 55 score on a scale STANDARD_DEVIATION 22.6 | 53 score on a scale STANDARD_DEVIATION 21.1 |
| Physician's Global Assessment of Disease Activity (PhGADA) | 63 score on a scale STANDARD_DEVIATION 13.8 | 63 score on a scale STANDARD_DEVIATION 14 | 62 score on a scale STANDARD_DEVIATION 14.1 | 59 score on a scale STANDARD_DEVIATION 14.5 |
| Physician's Global Assessment of Psoriasis (PhGAP) | 2.7 score on a scale STANDARD_DEVIATION 0.79 | 2.8 score on a scale STANDARD_DEVIATION 0.95 | 2.8 score on a scale STANDARD_DEVIATION 0.84 | 2.9 score on a scale STANDARD_DEVIATION 0.81 |
| Psoriasis Area and Severity Index (PASI) | 8.5 score on a scale STANDARD_DEVIATION 6.54 | 9.6 score on a scale STANDARD_DEVIATION 6.43 | 9.1 score on a scale STANDARD_DEVIATION 6.29 | 9.1 score on a scale STANDARD_DEVIATION 6.25 |
| Psoriatic Arthritis Disease Activity Score (PASDAS) | 5.9 score on a scale STANDARD_DEVIATION 0.97 | 5.7 score on a scale STANDARD_DEVIATION 1.07 | 5.7 score on a scale STANDARD_DEVIATION 0.99 | 5.6 score on a scale STANDARD_DEVIATION 0.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 32 Participants | 101 Participants | 34 Participants |
| Region of Enrollment Australia | 1 participants | 0 participants | 2 participants | 1 participants |
| Region of Enrollment Canada | 2 participants | 1 participants | 3 participants | 0 participants |
| Region of Enrollment Czechia | 2 participants | 2 participants | 6 participants | 2 participants |
| Region of Enrollment Hungary | 1 participants | 0 participants | 2 participants | 1 participants |
| Region of Enrollment Japan | 1 participants | 1 participants | 2 participants | 0 participants |
| Region of Enrollment Poland | 9 participants | 9 participants | 27 participants | 9 participants |
| Region of Enrollment South Korea | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Spain | 4 participants | 6 participants | 17 participants | 7 participants |
| Region of Enrollment Taiwan | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 16 participants | 15 participants | 45 participants | 14 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 45 Participants | 18 Participants |
| Sex: Female, Male Male | 24 Participants | 19 Participants | 61 Participants | 18 Participants |
| Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | 4 score on a scale STANDARD_DEVIATION 3.8 | 6 score on a scale STANDARD_DEVIATION 4.4 | 5 score on a scale STANDARD_DEVIATION 3.7 | 4 score on a scale STANDARD_DEVIATION 2.8 |
| Swollen Joint Count Based on 66 Joints (SJC66) | 11 swollen joint count STANDARD_DEVIATION 6.7 | 10 swollen joint count STANDARD_DEVIATION 8.7 | 10 swollen joint count STANDARD_DEVIATION 8.1 | 10 swollen joint count STANDARD_DEVIATION 8.9 |
| Tender Dactylitis Count (TDC) | 3 tender dactylitis count STANDARD_DEVIATION 4.9 | 1 tender dactylitis count STANDARD_DEVIATION 0.6 | 2 tender dactylitis count STANDARD_DEVIATION 3.6 | 1 tender dactylitis count STANDARD_DEVIATION 0.9 |
| Tender Joint Count Based on 68 Joints (TJC68) | 23 tender joint count STANDARD_DEVIATION 17.2 | 21 tender joint count STANDARD_DEVIATION 14.6 | 22 tender joint count STANDARD_DEVIATION 15.6 | 22 tender joint count STANDARD_DEVIATION 15.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 | 0 / 36 | 0 / 18 | 0 / 20 | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 7 / 36 | 4 / 34 | 9 / 36 | 10 / 18 | 7 / 20 | 5 / 10 | 2 / 8 |
| serious Total, serious adverse events | 1 / 36 | 1 / 34 | 0 / 36 | 1 / 18 | 1 / 20 | 0 / 10 | 2 / 8 |
Outcome results
Primary
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain), and high-sensitivity C-reactive protein (hsCRP).
Time frame: Week 12
Population: Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 | 60.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 | 35.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 | 33.1 percentage of participants |
p-value: 0.02295% CI: [4.3, 49.6]Multiple imputation method
p-value: 0.8995% CI: [-20.5, 25]Multiple imputation method
Secondary
Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. The 12 NRS is focused on pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment, social life, and depression. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement.
Time frame: Baseline, 4, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16 | Change from Baseline at Week 4 | -0.97 score on a scale | Standard Deviation 1.876 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16 | Change from Baseline at Week 16 | -1.58 score on a scale | Standard Deviation 2.263 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16 | Change from Baseline at Week 4 | -0.66 score on a scale | Standard Deviation 1.492 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16 | Change from Baseline at Week 16 | -1.04 score on a scale | Standard Deviation 1.802 |
| Placebo (Main Study) | Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16 | Change from Baseline at Week 4 | -0.49 score on a scale | Standard Deviation 1.139 |
| Placebo (Main Study) | Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16 | Change from Baseline at Week 16 | -0.38 score on a scale | Standard Deviation 1.543 |
Secondary
Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60
SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -10 swollen joint count | Standard Deviation 7.7 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -13 swollen joint count | Standard Deviation 9.5 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -14 swollen joint count | Standard Deviation 7.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -11 swollen joint count | Standard Deviation 9.5 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -21 swollen joint count | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -10 swollen joint count | Standard Deviation 9.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -14 swollen joint count | Standard Deviation 7.8 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -7 swollen joint count | Standard Deviation 4.1 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -6 swollen joint count | Standard Deviation 4.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -6 swollen joint count | Standard Deviation 4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -7 swollen joint count | Standard Deviation 4.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -2 swollen joint count | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -6 swollen joint count | Standard Deviation 6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -8 swollen joint count | Standard Deviation 7.6 |
| Placebo (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | 0 swollen joint count | Standard Deviation 0.5 |
| Placebo (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -3 swollen joint count | Standard Deviation 3.2 |
| Placebo (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -3 swollen joint count | Standard Deviation 4.2 |
| Placebo (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -2 swollen joint count | Standard Deviation 4.1 |
| Placebo (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -2 swollen joint count | Standard Deviation 3.3 |
| Placebo (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -6 swollen joint count | Standard Deviation 8.9 |
| Placebo (Main Study) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -5 swollen joint count | Standard Deviation 2.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -1 swollen joint count | Standard Deviation 2.1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | 2 swollen joint count | Standard Deviation 7.1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | 2 swollen joint count | Standard Deviation 4.9 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | 2 swollen joint count | Standard Deviation 6.6 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -1 swollen joint count | Standard Deviation 2.6 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -1 swollen joint count | Standard Deviation 3.4 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | 2 swollen joint count | Standard Deviation 6.9 |
Secondary
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -8 swollen joint count | Standard Deviation 8.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -7 swollen joint count | Standard Deviation 8.5 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -3 swollen joint count | Standard Deviation 7.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -6 swollen joint count | Standard Deviation 7.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -7 swollen joint count | Standard Deviation 7.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -4 swollen joint count | Standard Deviation 5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -3 swollen joint count | Standard Deviation 5.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -3 swollen joint count | Standard Deviation 4.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -4 swollen joint count | Standard Deviation 7.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -6 swollen joint count | Standard Deviation 6.9 |
| Placebo (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -5 swollen joint count | Standard Deviation 6.1 |
| Placebo (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -4 swollen joint count | Standard Deviation 5.9 |
| Placebo (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | 0 swollen joint count | Standard Deviation 6.5 |
| Placebo (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -4 swollen joint count | Standard Deviation 6.3 |
| Placebo (Main Study) | Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -3 swollen joint count | Standard Deviation 6 |
Secondary
Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -27.0 score on a scale | Standard Deviation 22.87 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -40.5 score on a scale | Standard Deviation 31.97 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -44.9 score on a scale | Standard Deviation 27.81 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -32.1 score on a scale | Standard Deviation 29.72 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -86.2 score on a scale | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -28.8 score on a scale | Standard Deviation 37.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -37.3 score on a scale | Standard Deviation 26.49 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -28.5 score on a scale | Standard Deviation 20.68 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -24.1 score on a scale | Standard Deviation 20.79 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -22.1 score on a scale | Standard Deviation 18.37 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -23.6 score on a scale | Standard Deviation 18.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -18.5 score on a scale | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -20.5 score on a scale | Standard Deviation 15.12 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -23.5 score on a scale | Standard Deviation 18.8 |
| Placebo (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -3.0 score on a scale | Standard Deviation 7.61 |
| Placebo (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -9.3 score on a scale | Standard Deviation 9.1 |
| Placebo (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -9.6 score on a scale | Standard Deviation 11.79 |
| Placebo (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -6.9 score on a scale | Standard Deviation 6.51 |
| Placebo (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -1.3 score on a scale | Standard Deviation 10.75 |
| Placebo (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -16.3 score on a scale | Standard Deviation 21 |
| Placebo (Main Study) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -12.9 score on a scale | Standard Deviation 11.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -5.4 score on a scale | Standard Deviation 15.02 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | 1.8 score on a scale | Standard Deviation 23.75 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -2.3 score on a scale | Standard Deviation 17.56 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | 1.1 score on a scale | Standard Deviation 16.48 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -5.3 score on a scale | Standard Deviation 9.72 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -9.9 score on a scale | Standard Deviation 13.51 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -5.3 score on a scale | Standard Deviation 20.48 |
Secondary
Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60
The DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48 and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 28 | -2.1 score on a scale | Standard Deviation 1.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 24 | -1.8 score on a scale | Standard Deviation 1.75 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 36 | -2.9 score on a scale | Standard Deviation 1.38 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 18 | -2.1 score on a scale | Standard Deviation 1.37 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 20 | -1.9 score on a scale | Standard Deviation 1.34 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 60 | -4.9 score on a scale | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 48 | -2.7 score on a scale | Standard Deviation 1.37 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 18 | -1.8 score on a scale | Standard Deviation 0.84 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 28 | -2.2 score on a scale | Standard Deviation 0.84 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 60 | -0.4 score on a scale | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 36 | -2.1 score on a scale | Standard Deviation 1 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 48 | -2.2 score on a scale | Standard Deviation 0.93 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 24 | -1.9 score on a scale | Standard Deviation 1.13 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 20 | -1.7 score on a scale | Standard Deviation 0.9 |
| Placebo (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 60 | -0.7 score on a scale | Standard Deviation 0.14 |
| Placebo (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 36 | -0.6 score on a scale | Standard Deviation 1.3 |
| Placebo (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 18 | -0.9 score on a scale | Standard Deviation 0.7 |
| Placebo (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 20 | -1.1 score on a scale | Standard Deviation 0.71 |
| Placebo (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 28 | -0.9 score on a scale | Standard Deviation 0.73 |
| Placebo (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 48 | -1.3 score on a scale | Standard Deviation 0.67 |
| Placebo (Main Study) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 24 | -0.8 score on a scale | Standard Deviation 0.66 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 24 | -0.7 score on a scale | Standard Deviation 1.37 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 18 | -0.4 score on a scale | Standard Deviation 0.92 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 60 | 0.1 score on a scale | Standard Deviation 2.61 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 48 | 0.5 score on a scale | Standard Deviation 1.62 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 20 | -0.2 score on a scale | Standard Deviation 1.34 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 28 | -0.5 score on a scale | Standard Deviation 1.79 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60 | Change from Baseline at Week 36 | -0.5 score on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -25.2 score on a scale | Standard Deviation 24.43 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -22.0 score on a scale | Standard Deviation 21.73 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -11.6 score on a scale | Standard Deviation 19.12 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -15.1 score on a scale | Standard Deviation 18.48 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -26.3 score on a scale | Standard Deviation 23.48 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -14.4 score on a scale | Standard Deviation 14.96 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -9.4 score on a scale | Standard Deviation 14.11 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -11.5 score on a scale | Standard Deviation 12.53 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -15.8 score on a scale | Standard Deviation 19.32 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -19.4 score on a scale | Standard Deviation 18.13 |
| Placebo (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -16.6 score on a scale | Standard Deviation 15.61 |
| Placebo (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -14.9 score on a scale | Standard Deviation 16.43 |
| Placebo (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -2.9 score on a scale | Standard Deviation 16.01 |
| Placebo (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -14.4 score on a scale | Standard Deviation 20.15 |
| Placebo (Main Study) | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -8.0 score on a scale | Standard Deviation 19.32 |
Secondary
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
The DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -1.0 score on a scale | Standard Deviation 1.09 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -1.7 score on a scale | Standard Deviation 1.35 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -1.5 score on a scale | Standard Deviation 1.18 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -1.2 score on a scale | Standard Deviation 1.18 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -1.8 score on a scale | Standard Deviation 1.37 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -1.1 score on a scale | Standard Deviation 0.99 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -1.3 score on a scale | Standard Deviation 1.21 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -0.7 score on a scale | Standard Deviation 0.78 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -1.3 score on a scale | Standard Deviation 1.04 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -0.7 score on a scale | Standard Deviation 0.69 |
| Placebo (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -1.0 score on a scale | Standard Deviation 1.26 |
| Placebo (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -1.0 score on a scale | Standard Deviation 1.1 |
| Placebo (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -0.2 score on a scale | Standard Deviation 0.7 |
| Placebo (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -0.7 score on a scale | Standard Deviation 1.18 |
| Placebo (Main Study) | Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -1.1 score on a scale | Standard Deviation 1.41 |
Secondary
Change From Baseline in FACIT-Fatigue Scale Score at Week 48
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate better quality of life. Positive change in value indicates improvement (no or less severity of fatigue).
Time frame: Baseline, Week 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in FACIT-Fatigue Scale Score at Week 48 | 6.9 score on a scale | Standard Deviation 11.27 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in FACIT-Fatigue Scale Score at Week 48 | 4.4 score on a scale | Standard Deviation 11.76 |
| Placebo (Main Study) | Change From Baseline in FACIT-Fatigue Scale Score at Week 48 | 5.1 score on a scale | Standard Deviation 9.09 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in FACIT-Fatigue Scale Score at Week 48 | 3.0 score on a scale | Standard Deviation 7.63 |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate less fatigue. Positive change in value indicates improvement (no or less severity of fatigue).
Time frame: Baseline, 4, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16 | Change from Baseline at Week 4 | 4.8 score on a scale | Standard Deviation 6.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16 | Change from Baseline at Week 16 | 6.9 score on a scale | Standard Deviation 11.56 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16 | Change from Baseline at Week 4 | 2.3 score on a scale | Standard Deviation 5.94 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16 | Change from Baseline at Week 16 | 1.9 score on a scale | Standard Deviation 7.93 |
| Placebo (Main Study) | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16 | Change from Baseline at Week 4 | 2.5 score on a scale | Standard Deviation 8.23 |
| Placebo (Main Study) | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16 | Change from Baseline at Week 16 | 0.6 score on a scale | Standard Deviation 11.14 |
Comparison: Week 4p-value: 0.4395% CI: [-1.9, 4.5]MMRM
Comparison: Week 4p-value: 0.8195% CI: [-3.6, 2.9]MMRM
Comparison: Week 16p-value: 0.0495% CI: [0.2, 9.9]MMRM
Comparison: Week 16p-value: 0.5895% CI: [-3.4, 6.1]MMRM
Secondary
Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. A negative change from baseline indicates improvement (less disability).
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -0.42 score on a scale | Standard Deviation 0.403 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -0.38 score on a scale | Standard Deviation 0.468 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -0.21 score on a scale | Standard Deviation 0.431 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -0.23 score on a scale | Standard Deviation 0.43 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -0.41 score on a scale | Standard Deviation 0.346 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | 0.00 score on a scale | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -0.36 score on a scale | Standard Deviation 0.345 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -0.30 score on a scale | Standard Deviation 0.546 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -0.25 score on a scale | Standard Deviation 0.428 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -0.29 score on a scale | Standard Deviation 0.417 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -0.14 score on a scale | Standard Deviation 0.573 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -0.09 score on a scale | Standard Deviation 0.481 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -0.25 score on a scale | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -0.33 score on a scale | Standard Deviation 0.485 |
| Placebo (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -0.28 score on a scale | Standard Deviation 0.558 |
| Placebo (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -0.29 score on a scale | Standard Deviation 0.672 |
| Placebo (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -0.63 score on a scale | Standard Deviation 0.685 |
| Placebo (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -0.25 score on a scale | Standard Deviation 0.777 |
| Placebo (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -0.38 score on a scale | Standard Deviation 0 |
| Placebo (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -0.44 score on a scale | Standard Deviation 0.725 |
| Placebo (Main Study) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -0.11 score on a scale | Standard Deviation 0.254 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -0.19 score on a scale | Standard Deviation 0.265 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -0.11 score on a scale | Standard Deviation 0.168 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -0.02 score on a scale | Standard Deviation 0.356 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -0.02 score on a scale | Standard Deviation 0.156 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -0.20 score on a scale | Standard Deviation 0.259 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -0.04 score on a scale | Standard Deviation 0.191 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -0.13 score on a scale | Standard Deviation 0.234 |
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. A negative change from baseline indicates improvement (less disability).
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -0.38 score on a scale | Standard Deviation 0.506 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -0.29 score on a scale | Standard Deviation 0.412 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -0.13 score on a scale | Standard Deviation 0.343 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -0.16 score on a scale | Standard Deviation 0.32 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -0.38 score on a scale | Standard Deviation 0.489 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -0.07 score on a scale | Standard Deviation 0.471 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -0.04 score on a scale | Standard Deviation 0.277 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -0.06 score on a scale | Standard Deviation 0.364 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -0.15 score on a scale | Standard Deviation 0.401 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -0.09 score on a scale | Standard Deviation 0.456 |
| Placebo (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -0.08 score on a scale | Standard Deviation 0.328 |
| Placebo (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -0.14 score on a scale | Standard Deviation 0.342 |
| Placebo (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -0.03 score on a scale | Standard Deviation 0.228 |
| Placebo (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -0.10 score on a scale | Standard Deviation 0.337 |
| Placebo (Main Study) | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -0.07 score on a scale | Standard Deviation 0.273 |
Comparison: Week 2p-value: 0.1995% CI: [-0.22, 0.04]MMRM
Comparison: Week 2p-value: 0.8495% CI: [-0.15, 0.12]MMRM
Comparison: Week 4p-value: 0.395% CI: [-0.22, 0.07]MMRM
Comparison: Week 4p-value: 0.8995% CI: [-0.14, 0.16]MMRM
Comparison: Week 8p-value: 0.06495% CI: [-0.37, 0.01]MMRM
Comparison: Week 8p-value: 0.8895% CI: [-0.17, 0.2]MMRM
Comparison: Week 12p-value: 0.02395% CI: [-0.43, -0.03]MMRM
Comparison: Week 12p-value: 0.7595% CI: [-0.23, 0.17]MMRM
Comparison: Week 16p-value: 0.00595% CI: [-0.51, -0.1]MMRM
Comparison: Week 16p-value: 0.5495% CI: [-0.27, 0.14]MMRM
Secondary
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60
HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -26 score on a scale | Standard Deviation 26.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -30 score on a scale | Standard Deviation 22.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -27 score on a scale | Standard Deviation 23.7 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -13 score on a scale | Standard Deviation 30.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -22 score on a scale | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -18 score on a scale | Standard Deviation 30 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -23 score on a scale | Standard Deviation 20.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -23 score on a scale | Standard Deviation 28 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -19 score on a scale | Standard Deviation 26.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -25 score on a scale | Standard Deviation 29.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -24 score on a scale | Standard Deviation 23.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -35 score on a scale | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -18 score on a scale | Standard Deviation 24.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -13 score on a scale | Standard Deviation 24.7 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -21 score on a scale | Standard Deviation 25 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -18 score on a scale | Standard Deviation 25.5 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -19 score on a scale | Standard Deviation 24.5 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -17 score on a scale | Standard Deviation 22 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -2 score on a scale | Standard Deviation 25.4 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -24 score on a scale | Standard Deviation 23.6 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -20 score on a scale | Standard Deviation 28.3 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -12 score on a scale | Standard Deviation 12.7 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -23 score on a scale | Standard Deviation 2.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -8 score on a scale | Standard Deviation 5.5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -7 score on a scale | Standard Deviation 23.5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -7 score on a scale | Standard Deviation 8.5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -17 score on a scale | Standard Deviation 8.4 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -21 score on a scale | Standard Deviation 4.2 |
Secondary
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -10 score on a scale | Standard Deviation 23 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -24 score on a scale | Standard Deviation 30 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -10 score on a scale | Standard Deviation 20.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -17 score on a scale | Standard Deviation 22.7 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -22 score on a scale | Standard Deviation 26.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -8 score on a scale | Standard Deviation 21.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -12 score on a scale | Standard Deviation 22.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -13 score on a scale | Standard Deviation 21.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -4 score on a scale | Standard Deviation 17 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -3 score on a scale | Standard Deviation 12 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -6 score on a scale | Standard Deviation 23.5 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -4 score on a scale | Standard Deviation 14.7 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -8 score on a scale | Standard Deviation 19.1 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -12 score on a scale | Standard Deviation 20 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -6 score on a scale | Standard Deviation 21.9 |
Secondary
Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -4.57 mg/L | Standard Deviation 12.585 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -4.96 mg/L | Standard Deviation 13.906 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -5.21 mg/L | Standard Deviation 16.03 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -4.42 mg/L | Standard Deviation 10.769 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -4.01 mg/L | Standard Deviation 6.669 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -2.43 mg/L | Standard Deviation 6.248 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | 0.53 mg/L | Standard Deviation 14.972 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -1.20 mg/L | Standard Deviation 6.309 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -0.05 mg/L | Standard Deviation 7.21 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -1.68 mg/L | Standard Deviation 5.085 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -0.37 mg/L | Standard Deviation 13.337 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | 0.56 mg/L | Standard Deviation 8.836 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -1.35 mg/L | Standard Deviation 11.841 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -1.09 mg/L | Standard Deviation 11.687 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | 0.05 mg/L | Standard Deviation 5.566 |
Secondary
Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60
The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -1.49 mg/L | Standard Deviation 5.017 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -0.68 mg/L | Standard Deviation 4.04 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -3.31 mg/L | Standard Deviation 5.963 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | 1.56 mg/L | Standard Deviation 6.011 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -3.10 mg/L | Standard Deviation 5.507 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -1.84 mg/L | Standard Deviation 6.262 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -1.65 mg/L | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -0.92 mg/L | Standard Deviation 5.46 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -2.21 mg/L | Standard Deviation 4.515 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -0.70 mg/L | Standard Deviation 4.064 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -1.36 mg/L | Standard Deviation 4.214 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -0.84 mg/L | Standard Deviation 7.796 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -12.32 mg/L | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | 0.07 mg/L | Standard Deviation 6.378 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -2.08 mg/L | Standard Deviation 2.353 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | 2.39 mg/L | Standard Deviation 4.851 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -1.01 mg/L | Standard Deviation 5.187 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | 2.24 mg/L | Standard Deviation 7.159 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -3.83 mg/L | Standard Deviation 6.244 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -1.92 mg/L | Standard Deviation 1.217 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -3.54 mg/L | Standard Deviation 6.98 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -1.68 mg/L | Standard Deviation 1.992 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -2.73 mg/L | Standard Deviation 0.827 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -2.33 mg/L | Standard Deviation 2.777 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -2.49 mg/L | Standard Deviation 3.285 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -3.05 mg/L | Standard Deviation 2.871 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -1.72 mg/L | Standard Deviation 4.828 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -2.38 mg/L | Standard Deviation 1.959 |
Secondary
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -24 score on a scale | Standard Deviation 32.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -20 score on a scale | Standard Deviation 28.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -13 score on a scale | Standard Deviation 24.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -9 score on a scale | Standard Deviation 27.2 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -21 score on a scale | Standard Deviation 30.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -7 score on a scale | Standard Deviation 21.9 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -7 score on a scale | Standard Deviation 18.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -8 score on a scale | Standard Deviation 19.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -11 score on a scale | Standard Deviation 19.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -13 score on a scale | Standard Deviation 24.2 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -5 score on a scale | Standard Deviation 25.7 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -8 score on a scale | Standard Deviation 23.2 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -4 score on a scale | Standard Deviation 21.6 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -11 score on a scale | Standard Deviation 23 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -9 score on a scale | Standard Deviation 20.6 |
Secondary
Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60
PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -24 score on a scale | Standard Deviation 26.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -31 score on a scale | Standard Deviation 17 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -26 score on a scale | Standard Deviation 27.5 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -16 score on a scale | Standard Deviation 30 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -32 score on a scale | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -12 score on a scale | Standard Deviation 30.2 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -19 score on a scale | Standard Deviation 27.9 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -23 score on a scale | Standard Deviation 27.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -24 score on a scale | Standard Deviation 30.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -28 score on a scale | Standard Deviation 34.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -21 score on a scale | Standard Deviation 30.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -10 score on a scale | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -18 score on a scale | Standard Deviation 31 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -20 score on a scale | Standard Deviation 25.4 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -10 score on a scale | Standard Deviation 34 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -13 score on a scale | Standard Deviation 16.4 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -15 score on a scale | Standard Deviation 25.3 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -19 score on a scale | Standard Deviation 26.4 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | 11 score on a scale | Standard Deviation 34.9 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -18 score on a scale | Standard Deviation 21.6 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -14 score on a scale | Standard Deviation 18.4 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -18 score on a scale | Standard Deviation 9.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -6 score on a scale | Standard Deviation 12 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -6 score on a scale | Standard Deviation 5.1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -9 score on a scale | Standard Deviation 25.1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -11 score on a scale | Standard Deviation 21.5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -24 score on a scale | Standard Deviation 8.6 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -21 score on a scale | Standard Deviation 9.5 |
Secondary
Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60
PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -47 score on a scale | Standard Deviation 19.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -36 score on a scale | Standard Deviation 24 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -77 score on a scale | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -40 score on a scale | Standard Deviation 24.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -46 score on a scale | Standard Deviation 23.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -32 score on a scale | Standard Deviation 28.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -43 score on a scale | Standard Deviation 16.8 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -31 score on a scale | Standard Deviation 12.9 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -37 score on a scale | Standard Deviation 13.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -35 score on a scale | Standard Deviation 14.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -33 score on a scale | — |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -29 score on a scale | Standard Deviation 15.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -29 score on a scale | Standard Deviation 15.1 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -29 score on a scale | Standard Deviation 17.7 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -27 score on a scale | Standard Deviation 19.1 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -7 score on a scale | Standard Deviation 14 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -14 score on a scale | Standard Deviation 11.9 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -21 score on a scale | Standard Deviation 15 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -20 score on a scale | Standard Deviation 13.1 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -25 score on a scale | Standard Deviation 4 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -18 score on a scale | Standard Deviation 13.4 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -8 score on a scale | Standard Deviation 5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -16 score on a scale | Standard Deviation 4.2 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -1 score on a scale | Standard Deviation 2.3 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -7 score on a scale | Standard Deviation 8.9 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -6 score on a scale | Standard Deviation 10.7 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -8 score on a scale | Standard Deviation 7.2 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -3 score on a scale | Standard Deviation 22.3 |
Secondary
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -34 score on a scale | Standard Deviation 21.2 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -31 score on a scale | Standard Deviation 22.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -14 score on a scale | Standard Deviation 21.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -20 score on a scale | Standard Deviation 21.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -35 score on a scale | Standard Deviation 24.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -24 score on a scale | Standard Deviation 14.1 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -16 score on a scale | Standard Deviation 14.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -19 score on a scale | Standard Deviation 15.8 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -25 score on a scale | Standard Deviation 17.9 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -27 score on a scale | Standard Deviation 20.3 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -18 score on a scale | Standard Deviation 20.9 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -15 score on a scale | Standard Deviation 19.5 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -8 score on a scale | Standard Deviation 16 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -17 score on a scale | Standard Deviation 20.1 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -12 score on a scale | Standard Deviation 18.5 |
Secondary
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -12 tender joint count | Standard Deviation 15.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -10 tender joint count | Standard Deviation 13.2 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -6 tender joint count | Standard Deviation 10.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -7 tender joint count | Standard Deviation 10.7 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -13 tender joint count | Standard Deviation 15.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -8 tender joint count | Standard Deviation 11.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -5 tender joint count | Standard Deviation 12.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -7 tender joint count | Standard Deviation 10.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -10 tender joint count | Standard Deviation 12.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -11 tender joint count | Standard Deviation 12.5 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 16 | -10 tender joint count | Standard Deviation 10.7 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 12 | -9 tender joint count | Standard Deviation 10.7 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 2 | -2 tender joint count | Standard Deviation 11.9 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 8 | -8 tender joint count | Standard Deviation 13.2 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16 | Change from Baseline at Week 4 | -4 tender joint count | Standard Deviation 13.9 |
Secondary
Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60
TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -60 tender joint count | — |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -16 tender joint count | Standard Deviation 25.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -22 tender joint count | Standard Deviation 21.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -18 tender joint count | Standard Deviation 18.7 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -25 tender joint count | Standard Deviation 19.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -21 tender joint count | Standard Deviation 20 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -12 tender joint count | Standard Deviation 14.8 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -14 tender joint count | Standard Deviation 14.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -13 tender joint count | Standard Deviation 12.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -10 tender joint count | Standard Deviation 12.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -11 tender joint count | Standard Deviation 12 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -12 tender joint count | Standard Deviation 9.9 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -17 tender joint count | Standard Deviation 14.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -11 tender joint count | — |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -4 tender joint count | Standard Deviation 4.6 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | -4 tender joint count | Standard Deviation 5.7 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -1 tender joint count | Standard Deviation 2.3 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | 0 tender joint count | Standard Deviation 1.3 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | 0 tender joint count | Standard Deviation 1.9 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -6 tender joint count | Standard Deviation 9.9 |
| Placebo (Main Study) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | -5 tender joint count | Standard Deviation 3.5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 24 | -1 tender joint count | Standard Deviation 12.1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 60 | 3 tender joint count | Standard Deviation 17.7 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 48 | -3 tender joint count | Standard Deviation 14 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 20 | 1 tender joint count | Standard Deviation 8.9 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 18 | -2 tender joint count | Standard Deviation 6.4 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 36 | -5 tender joint count | Standard Deviation 10.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60 | Change from Baseline at Week 28 | -2 tender joint count | Standard Deviation 13.4 |
Secondary
Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline
LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. LDI measures the ratio of the circumference of affected digit to circumference of digit on contralateral hand or foot using a Leeds Dactylometer. LDI score is calculated based on the circumference of the dactylitic finger/toe (mm), circumference of contralateral digit (mm), tenderness score (0 = no tenderness, 1 = tender). Tenderness of affected digits is assessed on a scale from 0 (no tenderness) to 3 (tender and withdrawn). A higher LDI indicates worse dactylitis. Negative change from baseline indicates improvement.
Time frame: Baseline, 20, 24, 28, 36, and 48 weeks
Population: Participants in the FAS with dactylitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | -123.4 score on a scale | Standard Deviation 145.68 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | -94.2 score on a scale | Standard Deviation 125.41 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | -123.4 score on a scale | Standard Deviation 145.68 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | -164.6 score on a scale | Standard Deviation 147.22 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | -79.5 score on a scale | Standard Deviation 120.99 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | -11.8 score on a scale | Standard Deviation 1.64 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | -11.8 score on a scale | Standard Deviation 1.64 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | -11.8 score on a scale | Standard Deviation 1.64 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | -13.0 score on a scale | Standard Deviation 2.37 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | -9.7 score on a scale | Standard Deviation 6.78 |
| Placebo (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | 0.0 score on a scale | Standard Deviation 0 |
| Placebo (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | 0.0 score on a scale | Standard Deviation 0 |
| Placebo (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | 0.0 score on a scale | Standard Deviation 0 |
| Placebo (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | 0.0 score on a scale | — |
| Placebo (Main Study) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | 0.0 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | 0.0 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | 0.0 score on a scale | Standard Deviation 0 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | 0.0 score on a scale | Standard Deviation 0 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | 0.0 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | 0.0 score on a scale | — |
Secondary
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. LDI measures the ratio of the circumference of affected digit to circumference of digit on contralateral hand or foot using a Leeds Dactylometer. LDI score is calculated based on circumference of the dactylitic finger/toe (mm), circumference of the contralateral digit (mm), tenderness score (0 = no tenderness, 1 = tender). Tenderness of affected digits is assessed on a scale from 0 (no tenderness) to 3 (tender and withdrawn). A higher LDI indicates worse dactylitis. Negative change from baseline indicates improvement.
Time frame: Baseline, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with dactylitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 4 | -18.8 score on a scale | Standard Deviation 48.27 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 8 | -45.4 score on a scale | Standard Deviation 88.15 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 12 | -49.8 score on a scale | Standard Deviation 85.77 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 16 | -42.1 score on a scale | Standard Deviation 95.15 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 16 | -11.7 score on a scale | Standard Deviation 6.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 4 | -5.3 score on a scale | Standard Deviation 15.36 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 12 | -11.8 score on a scale | Standard Deviation 11.82 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 8 | -14.4 score on a scale | Standard Deviation 26.14 |
| Placebo (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 16 | -16.2 score on a scale | Standard Deviation 15.04 |
| Placebo (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 8 | 23.3 score on a scale | Standard Deviation 129.9 |
| Placebo (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 12 | -15.8 score on a scale | Standard Deviation 15.82 |
| Placebo (Main Study) | Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 4 | 13.1 score on a scale | Standard Deviation 70.34 |
Secondary
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement.
Time frame: Baseline, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with enthesitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 4 | 0 score on a scale | Standard Deviation 1.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 8 | -1 score on a scale | Standard Deviation 2.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 12 | -1 score on a scale | Standard Deviation 2.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 16 | -1 score on a scale | Standard Deviation 2.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 16 | -1 score on a scale | Standard Deviation 1.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 4 | -1 score on a scale | Standard Deviation 1.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 12 | 0 score on a scale | Standard Deviation 1.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 8 | 0 score on a scale | Standard Deviation 1.4 |
| Placebo (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 16 | 0 score on a scale | Standard Deviation 1.4 |
| Placebo (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 8 | 0 score on a scale | Standard Deviation 1.6 |
| Placebo (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 12 | 0 score on a scale | Standard Deviation 1.5 |
| Placebo (Main Study) | Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 4 | 0 score on a scale | Standard Deviation 1.9 |
Comparison: Week 4p-value: 0.2495% CI: [-1, 0]MMRM
Comparison: Week 4p-value: 0.2295% CI: [-1, 0]MMRM
Comparison: Week 8p-value: 0.4395% CI: [-1, 1]MMRM
Comparison: Week 8p-value: 0.795% CI: [-1, 1]MMRM
Comparison: Week 12p-value: 0.195% CI: [-2, 0]MMRM
Comparison: Week 12p-value: 0.995% CI: [-1, 1]MMRM
Comparison: Week 16p-value: 0.8895% CI: [-1, 1]MMRM
Comparison: Week 16p-value: 0.8995% CI: [-1, 1]MMRM
Secondary
Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline
Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement.
Time frame: Baseline, 20, 24, 28, 36, and 48 weeks
Population: Participants in the FAS with enthesitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | -2 score on a scale | Standard Deviation 1.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | -1 score on a scale | Standard Deviation 2 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | -3 score on a scale | Standard Deviation 1.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | -2 score on a scale | Standard Deviation 1.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | -2 score on a scale | Standard Deviation 2.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | -1 score on a scale | Standard Deviation 2.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | -2 score on a scale | Standard Deviation 2.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | -2 score on a scale | Standard Deviation 2.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | 0 score on a scale | Standard Deviation 1.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | -1 score on a scale | Standard Deviation 1.6 |
| Placebo (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | -1 score on a scale | Standard Deviation 1 |
| Placebo (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | 0 score on a scale | Standard Deviation 1.3 |
| Placebo (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | 0 score on a scale | Standard Deviation 0.8 |
| Placebo (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | 0 score on a scale | Standard Deviation 2.1 |
| Placebo (Main Study) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | -1 score on a scale | Standard Deviation 1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | 0 score on a scale | Standard Deviation 1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | 0 score on a scale | Standard Deviation 0.4 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | 0 score on a scale | Standard Deviation 1.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | 0 score on a scale | Standard Deviation 0.5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | 1 score on a scale | Standard Deviation 1.3 |
Secondary
Change From Baseline in MCS of the SF-36v2 at Week 48
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicated improvement (better health status).
Time frame: Baseline, Week 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in MCS of the SF-36v2 at Week 48 | 2.3 score on a scale | Standard Deviation 10.55 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in MCS of the SF-36v2 at Week 48 | 1.5 score on a scale | Standard Deviation 8.74 |
| Placebo (Main Study) | Change From Baseline in MCS of the SF-36v2 at Week 48 | -0.5 score on a scale | Standard Deviation 4.13 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in MCS of the SF-36v2 at Week 48 | -1.4 score on a scale | Standard Deviation 7.51 |
Secondary
Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicated improvement (better health status).
Time frame: Baseline, 4, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16 | Change from Baseline at Week 4 | 1.4 score on a scale | Standard Deviation 7.91 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16 | Change from Baseline at Week 16 | 3.3 score on a scale | Standard Deviation 9.84 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16 | Change from Baseline at Week 4 | 1.0 score on a scale | Standard Deviation 5.07 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16 | Change from Baseline at Week 16 | 1.8 score on a scale | Standard Deviation 8.12 |
| Placebo (Main Study) | Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16 | Change from Baseline at Week 4 | -0.2 score on a scale | Standard Deviation 8.48 |
| Placebo (Main Study) | Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16 | Change from Baseline at Week 16 | 0.7 score on a scale | Standard Deviation 9.43 |
Secondary
Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline
mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (\>30 onycholysis together with oil-drop dyschromia, \>50 pitting, \>50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement.
Time frame: Baseline, 20, 24, 28, 36, and 48 weeks
Population: Participants in the FAS with psoriatic nail involvement at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 28 | -13 score on a scale | Standard Deviation 15.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 36 | -13 score on a scale | Standard Deviation 15.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 20 | -11 score on a scale | Standard Deviation 12.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 24 | -10 score on a scale | Standard Deviation 11.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 48 | -9 score on a scale | Standard Deviation 16.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 28 | -5 score on a scale | Standard Deviation 11.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 36 | -6 score on a scale | Standard Deviation 8.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 24 | -4 score on a scale | Standard Deviation 7.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 20 | -5 score on a scale | Standard Deviation 10.1 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 48 | -3 score on a scale | Standard Deviation 5 |
| Placebo (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 28 | -3 score on a scale | Standard Deviation 4.9 |
| Placebo (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 20 | -1 score on a scale | Standard Deviation 4.8 |
| Placebo (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 24 | -2 score on a scale | Standard Deviation 4 |
| Placebo (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 36 | 2 score on a scale | Standard Deviation 2.1 |
| Placebo (Main Study) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 48 | 1 score on a scale | Standard Deviation 5.6 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 36 | -2 score on a scale | Standard Deviation 1.2 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 24 | -1 score on a scale | Standard Deviation 1.4 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 20 | -3 score on a scale | Standard Deviation 5.5 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 28 | -3 score on a scale | Standard Deviation 2.3 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 48 | -8 score on a scale | Standard Deviation 10.6 |
Secondary
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (\>30 onycholysis together with oil-drop dyschromia, \>50 pitting, \>50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement.
Time frame: Baseline, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with psoriatic nail involvement at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 4 | -6 score on a scale | Standard Deviation 7.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 8 | -7 score on a scale | Standard Deviation 9.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 12 | -7 score on a scale | Standard Deviation 8.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 16 | -8 score on a scale | Standard Deviation 9.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 16 | -6 score on a scale | Standard Deviation 9.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 4 | -4 score on a scale | Standard Deviation 8.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 12 | -4 score on a scale | Standard Deviation 11.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 8 | -5 score on a scale | Standard Deviation 11.1 |
| Placebo (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 16 | -2 score on a scale | Standard Deviation 8.3 |
| Placebo (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 8 | 0 score on a scale | Standard Deviation 11.2 |
| Placebo (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 12 | 1 score on a scale | Standard Deviation 14 |
| Placebo (Main Study) | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline | Change from Baseline at Week 4 | 0 score on a scale | Standard Deviation 9.7 |
Secondary
Change From Baseline in PASDAS at Week 48
PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; leeds enthesitis index (LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; Tender dactylitis count (TDC) \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; C-reactive protein (CRP). The score of PASDAS ranges from 0-10, lower scores indicates better function. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in PASDAS at Week 48 | -3.3 score on a scale | Standard Deviation 1.69 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PASDAS at Week 48 | -2.0 score on a scale | Standard Deviation 1.35 |
| Placebo (Main Study) | Change From Baseline in PASDAS at Week 48 | -1.7 score on a scale | Standard Deviation 0.57 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PASDAS at Week 48 | 0.0 score on a scale | Standard Deviation 0.3 |
Secondary
Change From Baseline in PCS of the SF-36v2 at Week 48
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicates improvement (better health status).
Time frame: Baseline, Week 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in PCS of the SF-36v2 at Week 48 | 1.7 score on a scale | Standard Deviation 7.27 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PCS of the SF-36v2 at Week 48 | 3.2 score on a scale | Standard Deviation 7.54 |
| Placebo (Main Study) | Change From Baseline in PCS of the SF-36v2 at Week 48 | 3.8 score on a scale | Standard Deviation 8.51 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PCS of the SF-36v2 at Week 48 | -1.9 score on a scale | Standard Deviation 4.74 |
Secondary
Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement.
Time frame: Baseline, 18, 20, 24, 28, 36, and 48 weeks
Population: Participants in the FAS with psoriasis covering \>=3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 18 | -2 score on a scale | Standard Deviation 1.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | -1 score on a scale | Standard Deviation 0.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | -2 score on a scale | Standard Deviation 1.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -1 score on a scale | Standard Deviation 0.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | -2 score on a scale | Standard Deviation 0.6 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | -1 score on a scale | Standard Deviation 1 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | 0 score on a scale | Standard Deviation 0.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -1 score on a scale | Standard Deviation 0.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 18 | -1 score on a scale | Standard Deviation 0.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | 0 score on a scale | Standard Deviation 0.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | 0 score on a scale | Standard Deviation 0.9 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | 0 score on a scale | Standard Deviation 0.5 |
| Placebo (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | -1 score on a scale | Standard Deviation 0.8 |
| Placebo (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | -2 score on a scale | Standard Deviation 0.8 |
| Placebo (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -1 score on a scale | Standard Deviation 1.2 |
| Placebo (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | -1 score on a scale | Standard Deviation 0.8 |
| Placebo (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | -1 score on a scale | Standard Deviation 0.8 |
| Placebo (Main Study) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 18 | -1 score on a scale | Standard Deviation 0.6 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | 0 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | 0 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | 0 score on a scale | Standard Deviation 0 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -1 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 18 | 0 score on a scale | Standard Deviation 0 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | -1 score on a scale | Standard Deviation 0.7 |
Secondary
Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicates improvement (better health status).
Time frame: Baseline, 4, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16 | Change from Baseline at Week 4 | 2.1 score on a scale | Standard Deviation 4.95 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16 | Change from Baseline at Week 16 | 4.6 score on a scale | Standard Deviation 6.43 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16 | Change from Baseline at Week 4 | 2.2 score on a scale | Standard Deviation 3.92 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16 | Change from Baseline at Week 16 | 2.6 score on a scale | Standard Deviation 5.8 |
| Placebo (Main Study) | Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16 | Change from Baseline at Week 4 | 0.8 score on a scale | Standard Deviation 5.61 |
| Placebo (Main Study) | Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16 | Change from Baseline at Week 16 | 0.6 score on a scale | Standard Deviation 5.95 |
Comparison: Week 4p-value: 0.495% CI: [-1.2, 3.1]MMRM
Comparison: Week 4p-value: 0.2895% CI: [-1, 3.4]MMRM
Comparison: Week 16p-value: 0.01195% CI: [0.9, 6.7]MMRM
Comparison: Week 16p-value: 0.1495% CI: [-0.7, 5]MMRM
Secondary
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement.
Time frame: Baseline, 2, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with psoriasis covering \>=3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 12 | -1 score on a scale | Standard Deviation 1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 8 | -1 score on a scale | Standard Deviation 0.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 2 | -1 score on a scale | Standard Deviation 0.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 16 | -2 score on a scale | Standard Deviation 1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 4 | -1 score on a scale | Standard Deviation 1.1 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 4 | 0 score on a scale | Standard Deviation 0.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 2 | 0 score on a scale | Standard Deviation 0.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 8 | 0 score on a scale | Standard Deviation 0.8 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 12 | -1 score on a scale | Standard Deviation 0.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 16 | 0 score on a scale | Standard Deviation 0.7 |
| Placebo (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 16 | 0 score on a scale | Standard Deviation 0.9 |
| Placebo (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 12 | -1 score on a scale | Standard Deviation 0.8 |
| Placebo (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 2 | 0 score on a scale | Standard Deviation 0.9 |
| Placebo (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 8 | -1 score on a scale | Standard Deviation 1.1 |
| Placebo (Main Study) | Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline | Change from Baseline at Week 4 | 0 score on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in PsAID-12 Score at Week 48
The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. The 12 NRS is focused on pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment, social life, and depression. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in PsAID-12 Score at Week 48 | -1.04 score on a scale | Standard Deviation 2.441 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in PsAID-12 Score at Week 48 | -1.44 score on a scale | Standard Deviation 2.396 |
| Placebo (Main Study) | Change From Baseline in PsAID-12 Score at Week 48 | -1.59 score on a scale | Standard Deviation 1.807 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in PsAID-12 Score at Week 48 | 0.39 score on a scale | Standard Deviation 1.123 |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement.
Time frame: Baseline, 20, 24, 28, 36, and 48 weeks
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | -2.3 score on a scale | Standard Deviation 2.34 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | -2.9 score on a scale | Standard Deviation 3.25 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | -1.7 score on a scale | Standard Deviation 1.54 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -2.5 score on a scale | Standard Deviation 2.37 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | -0.4 score on a scale | Standard Deviation 7.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -4.4 score on a scale | Standard Deviation 3.65 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | -1.0 score on a scale | Standard Deviation 4.68 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | -2.9 score on a scale | Standard Deviation 3.83 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | -2.6 score on a scale | Standard Deviation 3.06 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | -2.0 score on a scale | Standard Deviation 3.77 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | -2.0 score on a scale | Standard Deviation 2.21 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | -2.9 score on a scale | Standard Deviation 2.45 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -2.0 score on a scale | Standard Deviation 2.62 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | -2.4 score on a scale | Standard Deviation 2.3 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | -1.8 score on a scale | Standard Deviation 1.41 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 36 | -3.8 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 24 | -1.9 score on a scale | Standard Deviation 2.69 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 20 | -1.3 score on a scale | Standard Deviation 1.84 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 28 | -4.0 score on a scale | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 48 | -2.6 score on a scale | — |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement.
Time frame: Baseline, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 16 | -5.5 score on a scale | Standard Deviation 6.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 8 | -3.6 score on a scale | Standard Deviation 4.82 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 4 | -1.8 score on a scale | Standard Deviation 2.79 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 12 | -4.5 score on a scale | Standard Deviation 6.79 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 16 | -1.0 score on a scale | Standard Deviation 7.34 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 12 | -2.3 score on a scale | Standard Deviation 5.28 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 8 | -1.7 score on a scale | Standard Deviation 5.27 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 4 | -2.0 score on a scale | Standard Deviation 3.7 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 12 | -4.9 score on a scale | Standard Deviation 7.1 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 8 | -4.3 score on a scale | Standard Deviation 6.3 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 4 | -1.5 score on a scale | Standard Deviation 7.87 |
| Placebo (Main Study) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Change from Baseline at Week 16 | -5.4 score on a scale | Standard Deviation 6.1 |
Secondary
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; leeds enthesitis index (LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; Tender dactylitis count (TDC) \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; C-reactive protein (CRP). The score of PASDAS ranges from 0-10, lower scores indicates better function. A negative change from baseline indicates improvement.
Time frame: Baseline, 4, and 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16 | Change from Baseline at Week 4 | -1.2 score on a scale | Standard Deviation 1.34 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16 | Change from Baseline at Week 16 | -2.1 score on a scale | Standard Deviation 1.73 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16 | Change from Baseline at Week 4 | -0.8 score on a scale | Standard Deviation 0.73 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16 | Change from Baseline at Week 16 | -1.4 score on a scale | Standard Deviation 1.19 |
| Placebo (Main Study) | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16 | Change from Baseline at Week 4 | -0.6 score on a scale | Standard Deviation 0.96 |
| Placebo (Main Study) | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16 | Change from Baseline at Week 16 | -0.9 score on a scale | Standard Deviation 1.08 |
Secondary
Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline
The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. A negative change from baseline indicates improvement.
Time frame: Baseline, 20, 24, 28, 36, and 48 weeks
Population: Participants in the FAS with enthesitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | -4 score on a scale | Standard Deviation 5.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | -3 score on a scale | Standard Deviation 5.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | -6 score on a scale | Standard Deviation 5.3 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | -3 score on a scale | Standard Deviation 6.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | -3 score on a scale | Standard Deviation 5.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | -5 score on a scale | Standard Deviation 5.4 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | -5 score on a scale | Standard Deviation 5.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | -6 score on a scale | Standard Deviation 5.8 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | -3 score on a scale | Standard Deviation 4.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | -4 score on a scale | Standard Deviation 3.6 |
| Placebo (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | 0 score on a scale | Standard Deviation 1.7 |
| Placebo (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | 0 score on a scale | Standard Deviation 2.4 |
| Placebo (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | 0 score on a scale | Standard Deviation 0.4 |
| Placebo (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | 0 score on a scale | Standard Deviation 2.1 |
| Placebo (Main Study) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | -1 score on a scale | Standard Deviation 1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 36 | 1 score on a scale | Standard Deviation 1.7 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 24 | -1 score on a scale | Standard Deviation 0.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 20 | 0 score on a scale | Standard Deviation 1.1 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 28 | 0 score on a scale | Standard Deviation 0.8 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline | Change from Baseline at Week 48 | 0 score on a scale | Standard Deviation 2 |
Secondary
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. A negative change from baseline indicates improvement.
Time frame: Baseline, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with enthesitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 4 | -2 score on a scale | Standard Deviation 3.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 8 | -2 score on a scale | Standard Deviation 4.9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 12 | -2 score on a scale | Standard Deviation 5.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 16 | -2 score on a scale | Standard Deviation 5.6 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 16 | -3 score on a scale | Standard Deviation 2.9 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 4 | -2 score on a scale | Standard Deviation 2.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 12 | -3 score on a scale | Standard Deviation 3.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 8 | -2 score on a scale | Standard Deviation 3.2 |
| Placebo (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 16 | -2 score on a scale | Standard Deviation 2.2 |
| Placebo (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 8 | -1 score on a scale | Standard Deviation 1.9 |
| Placebo (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 12 | -1 score on a scale | Standard Deviation 2.8 |
| Placebo (Main Study) | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline | Change from Baseline at Week 4 | 0 score on a scale | Standard Deviation 2.7 |
Secondary
Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline
Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score \>0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement.
Time frame: Baseline, 20, 24, 28, 36, and 48 weeks
Population: Participants in the FAS with dactylitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | -7 tender dactylitis count | Standard Deviation 8.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | -6 tender dactylitis count | Standard Deviation 7.4 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | -7 tender dactylitis count | Standard Deviation 8.8 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | -10 tender dactylitis count | Standard Deviation 9 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | -5 tender dactylitis count | Standard Deviation 7.2 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | -1 tender dactylitis count | Standard Deviation 0 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | -1 tender dactylitis count | Standard Deviation 0 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | -1 tender dactylitis count | Standard Deviation 0 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | -1 tender dactylitis count | Standard Deviation 0 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | -1 tender dactylitis count | Standard Deviation 0.5 |
| Placebo (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | 0 tender dactylitis count | Standard Deviation 0 |
| Placebo (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | 0 tender dactylitis count | Standard Deviation 0 |
| Placebo (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | 0 tender dactylitis count | Standard Deviation 0 |
| Placebo (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | 0 tender dactylitis count | — |
| Placebo (Main Study) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | 0 tender dactylitis count | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 36 | 0 tender dactylitis count | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 24 | 0 tender dactylitis count | Standard Deviation 0 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 20 | 0 tender dactylitis count | Standard Deviation 0 |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 28 | 0 tender dactylitis count | — |
| Filgotinib 100 mg From Placebo (LTE) | Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline | Change from Baseline at Week 48 | 0 tender dactylitis count | — |
Secondary
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score \>0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement.
Time frame: Baseline, 4, 8, 12, and 16 weeks
Population: Participants in the FAS with dactylitis at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 4 | -1 tender dactylitis count | Standard Deviation 2.2 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 8 | -3 tender dactylitis count | Standard Deviation 5.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 12 | -3 tender dactylitis count | Standard Deviation 5.1 |
| Filgotinib 200 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 16 | -3 tender dactylitis count | Standard Deviation 5.3 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 16 | -1 tender dactylitis count | Standard Deviation 0.5 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 4 | 1 tender dactylitis count | Standard Deviation 2.7 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 12 | -1 tender dactylitis count | Standard Deviation 0.8 |
| Filgotinib 100 mg (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 8 | 1 tender dactylitis count | Standard Deviation 3.7 |
| Placebo (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 16 | -1 tender dactylitis count | Standard Deviation 0.8 |
| Placebo (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 8 | 1 tender dactylitis count | Standard Deviation 7.1 |
| Placebo (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 12 | -1 tender dactylitis count | Standard Deviation 1 |
| Placebo (Main Study) | Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline | Change from Baseline at Week 4 | 0 tender dactylitis count | Standard Deviation 3.1 |
Secondary
Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 66.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 30.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 40.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 37.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 50.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 38.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 18.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 11.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 40.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 22.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 21.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 56.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 28.6 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 66.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 25.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 11.1 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 8.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 15.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 36.4 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 43.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 18.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 8.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 8.8 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 2.8 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 8.6 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 3.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 9.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 17.6 percentage of participants |
Comparison: Week 2p-value: 0.3195% CI: [-7.8, 19.8]Regression, Logistic
Comparison: Week 2p-value: 0.4895% CI: [-11.1, 5.5]Regression, Logistic
Comparison: Week 4p-value: 0.795% CI: [-14.1, 19.2]Regression, Logistic
Comparison: Week 4p-value: 0.1795% CI: [-20.7, 3.6]Regression, Logistic
Comparison: Week 8p-value: 0.3495% CI: [-12.5, 25.6]Regression, Logistic
Comparison: Week 8p-value: 0.9895% CI: [-16.9, 16.4]Regression, Logistic
Comparison: Week 12p-value: 0.07195% CI: [-5.1, 42.5]Regression, Logistic
Comparison: Week 12p-value: 0.2795% CI: [-27.7, 10.1]Regression, Logistic
Comparison: Week 16p-value: 0.00295% CI: [19.5, 62]Regression, Logistic
Comparison: Week 16p-value: 0.08295% CI: [-2.3, 32.6]Regression, Logistic
Secondary
Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in the FAS with the available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 40.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 25.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 33.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 30.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 30.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 37.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 11.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 9.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 25.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 10.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 10.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 11.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in the FAS with the available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 2.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 15.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 2.9 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 12.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 21.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 9.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 2.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 2.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 0 percentage of participants |
Comparison: Week 295% CI: [-5.6, 11.5]
Comparison: Week 295% CI: [-2.9, 2.9]
Comparison: Week 495% CI: [-5.4, 11]
Comparison: Week 495% CI: [-2.9, 2.9]
Comparison: Week 895% CI: [-4.2, 29.5]
Comparison: Week 895% CI: [-11.6, 5.7]
Comparison: Week 1295% CI: [0.2, 36.3]
Comparison: Week 1295% CI: [-9.7, 15.6]
Comparison: Week 1695% CI: [-2, 27]
Comparison: Week 1695% CI: [-3.7, 21.9]
Secondary
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 62.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 66.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 62.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 77.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 46.2 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 46.2 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 100.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 75.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 100.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 50.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 47.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 72.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 50.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 44.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 66.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 100.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 42.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 33.3 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 12.5 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 16.7 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 20.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 50.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 60.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 59.4 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 26.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 31.4 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 56.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 32.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 6.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 29.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 35.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 36.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 30.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 32.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 11.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 39.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 20.6 percentage of participants |
Comparison: Week 2p-value: 0.09895% CI: [-5.5, 36.3]Regression, Logistic
Comparison: Week 2p-value: 0.495% CI: [-21.1, 11]Regression, Logistic
Comparison: Week 4p-value: 0.2695% CI: [-12.6, 34.3]Regression, Logistic
Comparison: Week 4p-value: 0.3995% CI: [-14.6, 32.2]Regression, Logistic
Comparison: Week 8p-value: 0.08895% CI: [-6.9, 46.9]Regression, Logistic
Comparison: Week 8p-value: 0.4995% CI: [-32.9, 18.9]Regression, Logistic
Comparison: Week 12p-value: 0.01995% CI: [2.4, 54.2]Regression, Logistic
Comparison: Week 12p-value: 0.8595% CI: [-22.5, 28.4]Regression, Logistic
Comparison: Week 16p-value: 0.03695% CI: [-0.4, 52.3]Regression, Logistic
Comparison: Week 16p-value: 0.695% CI: [-19.7, 31.8]Regression, Logistic
Secondary
Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA LDA is defined as DAPSA ≤ 14.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 53.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 62.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 66.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 30.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 38.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 62.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 77.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 72.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 75.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 60.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 47.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 100.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 75.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 80.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 71.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 75.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 42.9 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 33.3 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 37.5 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 60.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 50.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA LDA is defined as DAPSA ≤ 14.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 12 | 51.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 8 | 40.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 2 | 17.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 4 | 25.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 16 | 54.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 8 | 29.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 2 | 12.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 4 | 17.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 12 | 41.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 16 | 39.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 16 | 36.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 12 | 32.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 2 | 8.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 8 | 35.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16 | Week 4 | 20.0 percentage of participants |
Comparison: Week 295% CI: [-9.2, 27.8]
Comparison: Week 295% CI: [-13.5, 21]
Comparison: Week 495% CI: [-16.8, 28.2]
Comparison: Week 495% CI: [-23.7, 19]
Comparison: Week 895% CI: [-21.1, 31.8]
Comparison: Week 895% CI: [-31, 19.3]
Comparison: Week 1295% CI: [-7, 45.3]
Comparison: Week 1295% CI: [-16.9, 34.6]
Comparison: Week 1695% CI: [-8.7, 45.6]
Comparison: Week 1695% CI: [-23.4, 29.5]
Secondary
Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA remission is defined as DAPSA ≤ 4.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 46.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 50.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 55.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 23.1 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 30.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 37.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 22.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 18.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 43.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 10.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 15.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 16.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 20.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 28.6 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 25.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 75.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 14.3 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 12.5 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA remission is defined as DAPSA ≤ 4.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 12 | 15.2 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 8 | 9.4 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 2 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 4 | 2.9 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 16 | 16.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 8 | 2.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 2 | 3.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 12 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 16 | 15.2 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 16 | 3.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 12 | 2.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 2 | 2.8 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 8 | 8.8 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16 | Week 4 | 5.7 percentage of participants |
Comparison: Week 295% CI: [-11, 5.4]
Comparison: Week 295% CI: [-10.6, 11.1]
Comparison: Week 495% CI: [-15.2, 9.5]
Comparison: Week 495% CI: [-16.3, 4.9]
Comparison: Week 895% CI: [-16.4, 17.5]
Comparison: Week 895% CI: [-19.9, 8.2]
Comparison: Week 1295% CI: [-4.3, 28.7]
Comparison: Week 1295% CI: [-9.7, 15.6]
Comparison: Week 1695% CI: [-4.2, 30.4]
Comparison: Week 1695% CI: [-4.5, 28.7]
Secondary
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) ≤ 3.2.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 38.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 50.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 75.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 100.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 60.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 77.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 38.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 90.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 88.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 75.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 47.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 66.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 100.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 100.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 71.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 100.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 100.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 62.5 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 71.4 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 37.5 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 40.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) ≤ 3.2.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 12 | 51.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 4 | 40.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 16 | 54.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 8 | 53.1 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 2 | 20.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 4 | 26.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 12 | 41.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 2 | 18.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 16 | 42.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 8 | 38.2 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 16 | 36.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 4 | 20.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 8 | 35.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 12 | 26.5 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16 | Week 2 | 11.1 percentage of participants |
Comparison: Week 295% CI: [-10.4, 29.4]
Comparison: Week 295% CI: [-12.5, 26.7]
Comparison: Week 495% CI: [-3.8, 43.8]
Comparison: Week 495% CI: [-16.3, 29.3]
Comparison: Week 895% CI: [-8.8, 44.5]
Comparison: Week 895% CI: [-22.9, 28.8]
Comparison: Week 1295% CI: [-0.5, 50.6]
Comparison: Week 1295% CI: [-10.5, 39.9]
Comparison: Week 1695% CI: [-8.7, 45.6]
Comparison: Week 1695% CI: [-20.5, 32.6]
Secondary
Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) remission is defined as DAS28 (CRP) \< 2.6.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in FAS with the available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 53.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 38.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 100.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 55.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 30.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 50.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 62.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 55.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 31.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 62.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 50.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 63.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 44.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 62.5 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 75.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 60.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 57.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 100.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 20.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 42.9 percentage of participants |
Secondary
Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) remission is defined as DAS28 (CRP) \< 2.6.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in FAS with the available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 12 | 33.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 2 | 11.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 16 | 38.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 4 | 20.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 8 | 21.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 12 | 32.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 4 | 8.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 2 | 6.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 16 | 24.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 8 | 20.6 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 16 | 21.2 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 8 | 20.6 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 2 | 2.8 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 4 | 14.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16 | Week 12 | 11.8 percentage of participants |
Comparison: Week 295% CI: [-6, 23.9]
Comparison: Week 295% CI: [-9.4, 15.9]
Comparison: Week 495% CI: [-14.7, 26.2]
Comparison: Week 495% CI: [-23.4, 12.4]
Comparison: Week 895% CI: [-21.5, 24.1]
Comparison: Week 895% CI: [-22.2, 22.2]
Comparison: Week 1295% CI: [-0.8, 43.9]
Comparison: Week 1295% CI: [-1.4, 42.6]
Comparison: Week 1695% CI: [-7.7, 42.7]
Comparison: Week 1695% CI: [-20.2, 26.3]
Secondary
Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48
MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to 100 (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 for participants with enthesitis at baseline.
Time frame: Weeks 20, 24, 28, 36, and 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 55.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 38.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 62.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 37.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 30.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 36.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 30.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 11.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 43.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 21.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 40.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 71.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 75.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 20.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 28.6 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 20.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to 100 (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 for participants with enthesitis at baseline.
Time frame: Weeks 4, 8, 12, and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 4 | 5.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 8 | 15.6 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 12 | 21.2 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 16 | 34.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 16 | 24.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 4 | 8.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 12 | 17.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 8 | 11.8 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 16 | 12.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 8 | 14.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 12 | 8.8 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16 | Week 4 | 11.4 percentage of participants |
Comparison: Week 4p-value: 0.3995% CI: [-21.6, 9.9]Regression, Logistic
Comparison: Week 4p-value: 0.6595% CI: [-19.7, 14.5]Regression, Logistic
Comparison: Week 8p-value: 0.86-19.4% CI: [-19.4, 21.3]Regression, Logistic
Comparison: Week 8p-value: 0.795% CI: [-22, 16.1]Regression, Logistic
Comparison: Week 12p-value: 0.1595% CI: [-7.5, 32.3]Regression, Logistic
Comparison: Week 12p-value: 0.395% CI: [-10.1, 27.7]Regression, Logistic
Comparison: Week 16p-value: 0.03595% CI: [-0.7, 45.2]Regression, Logistic
Comparison: Week 16p-value: 0.2295% CI: [-9.3, 33.5]Regression, Logistic
Secondary
Percentage of Participants Who Achieved PASDAS Remission at Week 48
PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.
Time frame: Week 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Week 48 | 25.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Week 48 | 11.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Week 48 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASDAS Remission at Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.
Time frame: Weeks 4 and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16 | Week 4 | 2.9 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16 | Week 16 | 12.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16 | Week 4 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16 | Week 16 | 9.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16 | Week 4 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16 | Week 16 | 0 percentage of participants |
Comparison: Week 495% CI: [-5.6, 11.5]
Comparison: Week 495% CI: [-2.9, 2.9]
Comparison: Week 1695% CI: [-2, 27.8]
Comparison: Week 1695% CI: [-3.7, 21.9]
Secondary
Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease.
Time frame: Weeks 20, 24, 28, 36, and 48
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 16.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 14.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 14.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease.
Time frame: Weeks 20, 24, 28, 36, and 48
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 66.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 83.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 66.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 100.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 57.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 66.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 60.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 60.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 57.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 57.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 66.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 40.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 75.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 75.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 100.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 100.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease.
Time frame: Weeks 20, 24, 28, 36, and 48
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 66.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 50.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 14.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 50.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 40.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 20.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 42.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 42.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 66.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 75.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease.
Time frame: Weeks 20, 24, 28, 36, and 48
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 33.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 16.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 14.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 14.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 25.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 24 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 28 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60
The PsARC response was defined as improvement in at least 2 of the following 4 criteria; ≥ 30% decrease in SJC66, ≥ 30% decrease in TJC68, ≥ 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), ≥ 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity) and with at least one of the 2 joint criteria, with no deterioration in any other criteria.
Time frame: Weeks 18, 20, 24, 28, 36, 48, and 60
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 73.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 87.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 88.9 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 61.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 100.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 53.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 75.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 66.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 63.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 68.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 70.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 100.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 68.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 83.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 42.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 44.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 16.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 25.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 100.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 24 | 16.7 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 60 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 20 | 28.6 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 18 | 28.6 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 36 | 20.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60 | Week 28 | 0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease.
Time frame: Weeks 4, 8, 12, and 16
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 6.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 5.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 0 percentage of participants |
Comparison: Week 495% CI: [-6.7, 6.7]
Comparison: Week 495% CI: [-11.6, 23.3]
Comparison: Week 895% CI: [-12.9, 26.2]
Comparison: Week 895% CI: [-11.8, 23.6]
Comparison: Week 1295% CI: [-6.9, 6.9]
Comparison: Week 1295% CI: [-11.8, 23.6]
Comparison: Week 1695% CI: [-7.1, 7.1]
Comparison: Week 1695% CI: [-11.8, 23.6]
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease.
Time frame: Weeks 4, 8, 12, and 16
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 13.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 40.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 60.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 64.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 35.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 35.3 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 29.4 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 41.2 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 35.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 35.7 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 42.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 13.3 percentage of participants |
Comparison: Week 495% CI: [-31, 31]
Comparison: Week 495% CI: [-12.8, 56.7]
Comparison: Week 895% CI: [-37.9, 46.5]
Comparison: Week 895% CI: [-35.4, 46.3]
Comparison: Week 1295% CI: [-25.6, 59.9]
Comparison: Week 1295% CI: [-53.7, 26.8]
Comparison: Week 1695% CI: [-14.1, 71.2]
Comparison: Week 1695% CI: [-40.8, 39.9]
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease.
Time frame: Weeks 4, 8, 12, and 16
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 13.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 13.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 40.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 42.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 23.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 17.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 17.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 17.6 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 21.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 7.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 21.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 6.7 percentage of participants |
Comparison: Week 4p-value: 0.5595% CI: [-21.3, 34.7]Regression, Logistic
Comparison: Week 4p-value: 0.2495% CI: [-17.4, 39.3]Regression, Logistic
Comparison: Week 8p-value: 0.4795% CI: [-22.6, 35]Regression, Logistic
Comparison: Week 8p-value: 0.2595% CI: [-18.6, 39.6]Regression, Logistic
Comparison: Week 12p-value: 0.4495% CI: [-21.1, 58.3]Regression, Logistic
Comparison: Week 12p-value: 0.6895% CI: [-38.4, 30.8]Regression, Logistic
Comparison: Week 16p-value: 0.3395% CI: [-19.4, 62.2]Regression, Logistic
Comparison: Week 16p-value: 0.9895% CI: [-33.9, 38.1]Regression, Logistic
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease.
Time frame: Weeks 4, 8, 12, and 16
Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 6.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 13.3 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 6.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 28.6 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 11.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 5.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 16 | 7.1 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 8 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 12 | 21.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline | Week 4 | 6.7 percentage of participants |
Comparison: Week 495% CI: [-24.5, 24.5]
Comparison: Week 495% CI: [-23.9, 22.4]
Comparison: Week 895% CI: [-10.8, 37.4]
Comparison: Week 895% CI: [-11.8, 23.6]
Comparison: Week 1295% CI: [-46.6, 17.1]
Comparison: Week 1295% CI: [-46.3, 15.2]
Comparison: Week 1695% CI: [-13, 55.8]
Comparison: Week 1695% CI: [-22.3, 31.5]
Secondary
Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
The PsARC response was defined as improvement in at least 2 of the following 4 criteria; ≥ 30% decrease in SJC66, ≥ 30% decrease in TJC68, ≥ 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), ≥ 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity) and with at least one of the 2 joint criteria, with no deterioration in any other criteria.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 75.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 68.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 32.4 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 41.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 62.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 44.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 21.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 41.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 58.8 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 48.5 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 16 | 42.4 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 12 | 35.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 2 | 13.9 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 8 | 50.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16 | Week 4 | 25.7 percentage of participants |
Comparison: Week 295% CI: [-3.8, 40.7]
Comparison: Week 295% CI: [-13.5, 28.2]
Comparison: Week 495% CI: [-8.5, 40.4]
Comparison: Week 495% CI: [-9.4, 40.3]
Comparison: Week 895% CI: [-7.5, 45]
Comparison: Week 895% CI: [-32.5, 20.7]
Comparison: Week 1295% CI: [15.8, 65.2]
Comparison: Week 1295% CI: [-2.5, 49.5]
Comparison: Week 1695% CI: [-6.8, 46.9]
Comparison: Week 1695% CI: [-21, 33.1]
Secondary
Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 with participants with enthesitis at baseline.
Time frame: Weeks 4, 8, 12, and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 8 | 3.1 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 12 | 3.0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 16 | 3.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 16 | 6.1 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 12 | 5.9 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 8 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 16 | 3.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 8 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 12 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
Comparison: Week 495% CI: [-2.8, 2.8]
Comparison: Week 495% CI: [-2.9, 2.9]
Comparison: Week 895% CI: [-5.9, 12.2]
Comparison: Week 895% CI: [-2.9, 2.9]
Comparison: Week 1295% CI: [-5.8, 11.9]
Comparison: Week 1295% CI: [-5, 16.7]
Comparison: Week 1695% CI: [-11.4, 11.6]
Comparison: Week 1695% CI: [-10, 16.1]
Secondary
Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48
VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 with participants with enthesitis at baseline.
Time frame: Weeks 20, 24, 28, 36, and 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 22.2 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 7.7 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 0 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 12.5 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 7.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 10.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 12.5 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 10.0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 14.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 0 percentage of participants |
| Placebo (Main Study) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 36 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 24 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 20 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 28 | 0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48 | Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants With PASDAS LDA at Week 48
PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.
Time frame: Week 48
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants With PASDAS LDA at Week 48 | 50.0 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants With PASDAS LDA at Week 48 | 33.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants With PASDAS LDA at Week 48 | 50.0 percentage of participants |
| Filgotinib 100 mg From Placebo (LTE) | Percentage of Participants With PASDAS LDA at Week 48 | 0 percentage of participants |
Secondary
Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\]; PhGADA \[using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity)\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; LEI \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; TDC \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.
Time frame: Weeks 4 and 16
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg (Main Study) | Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16 | Week 4 | 8.8 percentage of participants |
| Filgotinib 200 mg (Main Study) | Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16 | Week 16 | 38.7 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16 | Week 4 | 21.2 percentage of participants |
| Filgotinib 100 mg (Main Study) | Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16 | Week 16 | 30.3 percentage of participants |
| Placebo (Main Study) | Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16 | Week 4 | 8.6 percentage of participants |
| Placebo (Main Study) | Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16 | Week 16 | 12.1 percentage of participants |
Comparison: Week 495% CI: [-15.9, 16.5]
Comparison: Week 495% CI: [-7.1, 32.3]
Comparison: Week 1695% CI: [3, 50.2]
Comparison: Week 1695% CI: [-4.1, 40.4]
Secondary
Time to Achieve DAPSA LDA
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. DAPSA LDA is defined as DAPSA ≤ 14. Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA. If the DAPSA LDA is not achieved during main study phase, the time to achieve DAPSA LDA will be censored at the last non-missing DAPSA LDA assessment date during main study phase. If the component scores of DAPSA LDA are at different dates for a visit, the latest date will be used for the derivation of time to achieve DAPSA LDA.
Time frame: Approximately 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Filgotinib 200 mg (Main Study) | Time to Achieve DAPSA LDA | 84 days |
| Filgotinib 100 mg (Main Study) | Time to Achieve DAPSA LDA | NA days |
| Placebo (Main Study) | Time to Achieve DAPSA LDA | NA days |
Secondary
Time to Achieve DAS28(CRP) LDA
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28 (CRP) ≤ 3.2. Time to achieve DAS28(CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28(CRP) LDA.
Time frame: Approximately 16 weeks
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Filgotinib 200 mg (Main Study) | Time to Achieve DAS28(CRP) LDA | 57 days |
| Filgotinib 100 mg (Main Study) | Time to Achieve DAS28(CRP) LDA | NA days |
| Placebo (Main Study) | Time to Achieve DAS28(CRP) LDA | 115 days |