Rheumatoid Arthritis
Conditions
Keywords
Methotrexate, insufficient responders
Brief summary
The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis. Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.
Interventions
DRUGFilgotinib
Administered as Oral Tablets
Sponsors
Gilead Sciences
Galapagos NV
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigator's judgment * Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib Key
Exclusion criteria
* Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason * Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigator's judgment * Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogren's syndrome * Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment-Emergent Adverse Events | From First dose to Week 437 | An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The ACR response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP. |
| Percentage of Participants Achieving ACR50 Response: NRI | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP. |
| Percentage of Participants Achieving ACR50 Response: OC | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP. |
| Percentage of Participants Achieving ACR70 Response: NRI | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP. |
| Percentage of Participants Achieving ACR70 Response: OC | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5.hsCRP. |
| ACR N% Improvement (ACR-N) Response: OC | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | ACR-N was defined as the smallest percentage improvement from core baseline in SJC66, TJC68 and the median of the following 5 items (Pain VAS \[taken from the HAQ-DI\], 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP). It had a range between 0 and 100%. |
| Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The DAS28(CRP) was a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), SGA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP using the formula: DAS28(CRP) = 0.56 \* Square root \[SQRT\] (TJC28) + 0.28 \* SQRT(SJC28) + 0.36 \* Ln(CRP+1) + 0.014 \* SGA + 0.96 and the total possible score ranged from 1 to 9.4. Higher values indicated higher disease activity. A negative change from baseline indicated improvement. |
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The American College of Rheumatology (ACR) response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in swollen joint count 66 (SJC66), and 2) ≥ 20% improvement from baseline in tender joint count 68 (TJC68), and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), 2.Subject's Global Assessment of Disease Activity (SGA) (VAS), 3. Physician's Global Assessment of Disease Activity (PGA) (VAS), 4. Total HAQ-DI score, and 5. High-Sensitivity C- Reactive Protein (hsCRP). |
| Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | The CDAI was the SDAI modified that excluded CRP and consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm). SDAI = TJC + SJC + SGA+ PGA. The CDAI score ranged from 0 to approximately 76. Higher CDAI indicated greater disease activity. A negative change from baseline indicated improvement. |
| Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | DAS28(CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None= Actual DAS28(CRP) ≤ 3.2, \> 3.2 to ≤ 5.1, or \> 5.1 AND Improvement in DAS28(CRP) from baseline ≤ 6.0 or \> 0.6 to ≤ 1.2; Moderate= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline \> 0.6 to ≤ 1.2, Actual DAS28(CRP) \> 3.2 to ≤ 5.1 or \> 5.1 AND Improvement in DAS28(CRP) from baseline \> 1.2, or Actual DAS28(CRP) \> 3.2 to ≤ 5.1 AND Improvement in DAS28(CRP) from baseline \> 0.6 to ≤ 1.2; Good= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline \> 1.2. |
| Percentage of Participants Achieving ACR/EULAR Remission: NRI | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1. |
| Percentage of Participants Achieving ACR/EULAR Remission: OC | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1. |
| Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 | The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components: * Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items). * Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items). These scales were from 0 to 100 with higher scores indicating a better quality of life. |
| Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 | The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components: * Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items). * Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items). These scales were from 0 to 100 with higher scores indicating a better quality of life. |
| Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 | FACIT-Fatigue scale was a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). Negatively stated items were reversed by subtracting the response from 4 before being added to obtain a total score. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating less fatigue. A positive change from baseline indicated better quality of life. |
| Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm), CRP (mg/dL). SDAI = TJC + SJC + SGA + PGA+ CRP. The SDAI score ranged from 0 to approximately 86. Higher SDAI indicated greater disease activity. A negative change from baseline indicated improvement. |
Countries
Argentina, Australia, Belgium, Bulgaria, Chile, Colombia, Czechia, France, Germany, Guatemala, Hungary, Israel, Latvia, Mexico, Moldova, New Zealand, Poland, Romania, Russia, Spain, Ukraine, United States
Participant flow
Recruitment details
Participants with moderately to severely active rheumatoid arthritis were enrolled in this study.
Pre-assignment details
Participants from DARWIN1 or DARWIN2 were rolled over into this extension study. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
Participants by arm
| Arm | Count |
|---|---|
| Filgotinib Darwin 1 Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved. | 497 |
| Filgotinib Darwin 2 Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. | 242 |
| Total | 739 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 165 | 101 |
| Overall Study | Adverse Event and Treatment Failure | 0 | 2 |
| Overall Study | Lost to Follow-up | 12 | 9 |
| Overall Study | Non-compliance with Study Procedures | 2 | 0 |
| Overall Study | Not Defined | 21 | 3 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Sponsor Request | 38 | 15 |
| Overall Study | Treatment Failure | 3 | 2 |
| Overall Study | Use of Non-permitted Concurrent Therapy | 3 | 0 |
| Overall Study | Withdrawal by Subject | 90 | 29 |
Baseline characteristics
| Characteristic | Filgotinib Darwin 2 | Total | Filgotinib Darwin 1 |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 12.2 | 53 years STANDARD_DEVIATION 11.9 | 53 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 85 Participants | 293 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 157 Participants | 446 Participants | 289 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 56 Participants | 175 Participants | 119 Participants |
| Race (NIH/OMB) White | 181 Participants | 555 Participants | 374 Participants |
| Sex: Female, Male Female | 198 Participants | 603 Participants | 405 Participants |
| Sex: Female, Male Male | 44 Participants | 136 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 497 | 8 / 242 |
| other Total, other adverse events | 386 / 497 | 189 / 242 |
| serious Total, serious adverse events | 84 / 497 | 48 / 242 |
Outcome results
Primary
Number of Participants Experiencing Treatment-Emergent Adverse Events
An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date.
Time frame: From First dose to Week 437
Population: Safety Analysis Set. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib Darwin 1 | Number of Participants Experiencing Treatment-Emergent Adverse Events | 453 participants |
| Filgotinib Darwin 2 | Number of Participants Experiencing Treatment-Emergent Adverse Events | 223 participants |
Secondary
ACR N% Improvement (ACR-N) Response: OC
ACR-N was defined as the smallest percentage improvement from core baseline in SJC66, TJC68 and the median of the following 5 items (Pain VAS \[taken from the HAQ-DI\], 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP). It had a range between 0 and 100%.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 96 | 64.8 percentage of improvement | Standard Deviation 28.61 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 204 | 62.3 percentage of improvement | Standard Deviation 28.64 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 384 | 60.0 percentage of improvement | Standard Deviation 30.27 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 216 | 61.6 percentage of improvement | Standard Deviation 29.87 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 108 | 61.2 percentage of improvement | Standard Deviation 30.22 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 228 | 64.2 percentage of improvement | Standard Deviation 27.83 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 36 | 59.8 percentage of improvement | Standard Deviation 29.7 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 240 | 59.8 percentage of improvement | Standard Deviation 28.22 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 120 | 63.4 percentage of improvement | Standard Deviation 29.25 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 252 | 62.4 percentage of improvement | Standard Deviation 28.71 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 60 | 59.9 percentage of improvement | Standard Deviation 29.97 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 264 | 63.4 percentage of improvement | Standard Deviation 29.81 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 132 | 62.3 percentage of improvement | Standard Deviation 29.15 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 276 | 63.3 percentage of improvement | Standard Deviation 28.27 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 24 | 57.9 percentage of improvement | Standard Deviation 29.64 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 288 | 65.1 percentage of improvement | Standard Deviation 29.68 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 144 | 61.7 percentage of improvement | Standard Deviation 28.99 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 300 | 64.9 percentage of improvement | Standard Deviation 30.16 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 72 | 61.4 percentage of improvement | Standard Deviation 28.92 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 312 | 64.8 percentage of improvement | Standard Deviation 29.89 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 156 | 61.5 percentage of improvement | Standard Deviation 28.05 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 324 | 65.9 percentage of improvement | Standard Deviation 27.39 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 48 | 59.6 percentage of improvement | Standard Deviation 30.69 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 336 | 62.7 percentage of improvement | Standard Deviation 29.35 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 168 | 62.8 percentage of improvement | Standard Deviation 29.75 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 348 | 64.8 percentage of improvement | Standard Deviation 29.26 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 84 | 61.6 percentage of improvement | Standard Deviation 29.07 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 360 | 62.7 percentage of improvement | Standard Deviation 29.81 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 372 | 64.2 percentage of improvement | Standard Deviation 28.58 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 180 | 63.2 percentage of improvement | Standard Deviation 28.29 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 12 | 56.3 percentage of improvement | Standard Deviation 28.43 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 396 | 61.5 percentage of improvement | Standard Deviation 31.34 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 192 | 60.4 percentage of improvement | Standard Deviation 29.15 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Week 408 | 65.9 percentage of improvement | Standard Deviation 41.08 |
| Filgotinib Darwin 1 | ACR N% Improvement (ACR-N) Response: OC | Extension Baseline | 48.1 percentage of improvement | Standard Deviation 30.29 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 408 | 35.4 percentage of improvement | Standard Deviation 50.04 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Extension Baseline | 46.3 percentage of improvement | Standard Deviation 27.77 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 12 | 56.3 percentage of improvement | Standard Deviation 27.13 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 24 | 60.8 percentage of improvement | Standard Deviation 27.76 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 36 | 60.7 percentage of improvement | Standard Deviation 27.95 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 360 | 61.2 percentage of improvement | Standard Deviation 28.32 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 48 | 58.9 percentage of improvement | Standard Deviation 28.65 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 60 | 60.1 percentage of improvement | Standard Deviation 28.43 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 72 | 59.0 percentage of improvement | Standard Deviation 28.47 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 84 | 63.6 percentage of improvement | Standard Deviation 26.74 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 96 | 61.2 percentage of improvement | Standard Deviation 26.87 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 108 | 60.9 percentage of improvement | Standard Deviation 28.69 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 120 | 61.1 percentage of improvement | Standard Deviation 28.72 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 132 | 61.3 percentage of improvement | Standard Deviation 28.52 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 144 | 60.8 percentage of improvement | Standard Deviation 29.12 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 156 | 58.0 percentage of improvement | Standard Deviation 27.7 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 168 | 56.9 percentage of improvement | Standard Deviation 30.25 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 180 | 59.9 percentage of improvement | Standard Deviation 29.79 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 192 | 61.5 percentage of improvement | Standard Deviation 27.3 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 204 | 61.9 percentage of improvement | Standard Deviation 26.79 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 216 | 61.4 percentage of improvement | Standard Deviation 26.86 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 228 | 63.0 percentage of improvement | Standard Deviation 26.45 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 240 | 60.6 percentage of improvement | Standard Deviation 28.48 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 252 | 62.5 percentage of improvement | Standard Deviation 26.24 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 264 | 64.4 percentage of improvement | Standard Deviation 27.05 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 276 | 65.9 percentage of improvement | Standard Deviation 25.42 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 288 | 63.0 percentage of improvement | Standard Deviation 29.82 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 300 | 61.9 percentage of improvement | Standard Deviation 27.14 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 312 | 59.9 percentage of improvement | Standard Deviation 30.37 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 324 | 61.2 percentage of improvement | Standard Deviation 30.98 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 336 | 59.8 percentage of improvement | Standard Deviation 28.9 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 348 | 62.8 percentage of improvement | Standard Deviation 28.29 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 372 | 64.6 percentage of improvement | Standard Deviation 29.43 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 384 | 62.9 percentage of improvement | Standard Deviation 30.43 |
| Filgotinib Darwin 2 | ACR N% Improvement (ACR-N) Response: OC | Week 396 | 64.7 percentage of improvement | Standard Deviation 28.98 |
Secondary
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
The CDAI was the SDAI modified that excluded CRP and consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm). SDAI = TJC + SJC + SGA+ PGA. The CDAI score ranged from 0 to approximately 76. Higher CDAI indicated greater disease activity. A negative change from baseline indicated improvement.
Time frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 120 | -34.5 score on a scale | Standard Deviation 12.7 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 252 | -35.3 score on a scale | Standard Deviation 11.94 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 96 | -34.6 score on a scale | Standard Deviation 12.76 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 264 | -35.6 score on a scale | Standard Deviation 12.15 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 132 | -34.1 score on a scale | Standard Deviation 12.82 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 276 | -35.9 score on a scale | Standard Deviation 11.38 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 12 | -31.8 score on a scale | Standard Deviation 13.45 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 288 | -35.4 score on a scale | Standard Deviation 12.28 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 24 | -32.4 score on a scale | Standard Deviation 13.63 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 300 | -35.8 score on a scale | Standard Deviation 12.84 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 168 | -34.1 score on a scale | Standard Deviation 13.64 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 312 | -35.5 score on a scale | Standard Deviation 13.1 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 324 | -35.8 score on a scale | Standard Deviation 12.3 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 144 | -34.1 score on a scale | Standard Deviation 12.63 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 336 | -35.0 score on a scale | Standard Deviation 11.76 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 156 | -34.0 score on a scale | Standard Deviation 12.74 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 348 | -35.3 score on a scale | Standard Deviation 11.7 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 192 | -33.9 score on a scale | Standard Deviation 12.1 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 360 | -35.5 score on a scale | Standard Deviation 12 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 372 | -35.4 score on a scale | Standard Deviation 12.46 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 180 | -34.5 score on a scale | Standard Deviation 12.1 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 384 | -34.8 score on a scale | Standard Deviation 11.82 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 204 | -34.2 score on a scale | Standard Deviation 12.26 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 396 | -34.7 score on a scale | Standard Deviation 13.28 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 48 | -33.1 score on a scale | Standard Deviation 13.79 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 408 | -39.2 score on a scale | Standard Deviation 12.87 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 216 | -34.5 score on a scale | Standard Deviation 12.18 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 36 | -33.0 score on a scale | Standard Deviation 13.44 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 84 | -33.9 score on a scale | Standard Deviation 12.82 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 60 | -33.7 score on a scale | Standard Deviation 12.97 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 228 | -35.2 score on a scale | Standard Deviation 11.69 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 72 | -33.8 score on a scale | Standard Deviation 12.73 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 108 | -34.3 score on a scale | Standard Deviation 12.96 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 240 | -34.3 score on a scale | Standard Deviation 11.99 |
| Filgotinib Darwin 1 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Extension Baseline | -28.8 score on a scale | Standard Deviation 14.58 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 96 | -34.7 score on a scale | Standard Deviation 12.56 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Extension Baseline | -28.0 score on a scale | Standard Deviation 13.68 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 12 | -32.4 score on a scale | Standard Deviation 12.76 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 24 | -32.9 score on a scale | Standard Deviation 13.79 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 36 | -33.8 score on a scale | Standard Deviation 12.51 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 108 | -34.5 score on a scale | Standard Deviation 12.92 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 132 | -34.7 score on a scale | Standard Deviation 13.07 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 312 | -35.5 score on a scale | Standard Deviation 14.4 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 360 | -34.0 score on a scale | Standard Deviation 11.54 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 120 | -35.2 score on a scale | Standard Deviation 11.87 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 144 | -34.9 score on a scale | Standard Deviation 12.12 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 156 | -34.8 score on a scale | Standard Deviation 13.29 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 168 | -34.8 score on a scale | Standard Deviation 12.55 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 180 | -34.8 score on a scale | Standard Deviation 12.39 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 192 | -35.9 score on a scale | Standard Deviation 12.65 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 204 | -36.3 score on a scale | Standard Deviation 12.79 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 216 | -36.0 score on a scale | Standard Deviation 13 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 228 | -35.8 score on a scale | Standard Deviation 11.98 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 240 | -35.2 score on a scale | Standard Deviation 13.27 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 252 | -36.4 score on a scale | Standard Deviation 13.55 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 264 | -36.9 score on a scale | Standard Deviation 13.53 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 276 | -36.4 score on a scale | Standard Deviation 12.84 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 288 | -36.5 score on a scale | Standard Deviation 13.47 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 300 | -35.7 score on a scale | Standard Deviation 14.29 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 324 | -36.0 score on a scale | Standard Deviation 14.37 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 336 | -34.2 score on a scale | Standard Deviation 13.32 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 348 | -34.8 score on a scale | Standard Deviation 11.73 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 372 | -33.9 score on a scale | Standard Deviation 12.73 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 384 | -32.6 score on a scale | Standard Deviation 13.11 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 396 | -34.2 score on a scale | Standard Deviation 12.55 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 408 | -34.9 score on a scale | Standard Deviation 6.36 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 48 | -34.1 score on a scale | Standard Deviation 13.18 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 60 | -34.2 score on a scale | Standard Deviation 12.22 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 72 | -34.4 score on a scale | Standard Deviation 12.57 |
| Filgotinib Darwin 2 | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | Change from Core Baseline at Week 84 | -35.2 score on a scale | Standard Deviation 12.31 |
Secondary
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
The DAS28(CRP) was a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), SGA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP using the formula: DAS28(CRP) = 0.56 \* Square root \[SQRT\] (TJC28) + 0.28 \* SQRT(SJC28) + 0.36 \* Ln(CRP+1) + 0.014 \* SGA + 0.96 and the total possible score ranged from 1 to 9.4. Higher values indicated higher disease activity. A negative change from baseline indicated improvement.
Time frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 288 | -3.5 score on a scale | Standard Deviation 1.22 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 156 | -3.4 score on a scale | Standard Deviation 1.22 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 192 | -3.3 score on a scale | Standard Deviation 1.16 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 276 | -3.5 score on a scale | Standard Deviation 1.1 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 300 | -3.6 score on a scale | Standard Deviation 1.19 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 336 | -3.5 score on a scale | Standard Deviation 1.17 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 384 | -3.4 score on a scale | Standard Deviation 1.24 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 12 | -3.1 score on a scale | Standard Deviation 1.28 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 24 | -3.2 score on a scale | Standard Deviation 1.29 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 36 | -3.3 score on a scale | Standard Deviation 1.28 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 48 | -3.3 score on a scale | Standard Deviation 1.32 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 60 | -3.3 score on a scale | Standard Deviation 1.22 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 72 | -3.3 score on a scale | Standard Deviation 1.23 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 84 | -3.4 score on a scale | Standard Deviation 1.21 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 96 | -3.4 score on a scale | Standard Deviation 1.22 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 108 | -3.4 score on a scale | Standard Deviation 1.22 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 120 | -3.4 score on a scale | Standard Deviation 1.2 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 132 | -3.3 score on a scale | Standard Deviation 1.21 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 144 | -3.4 score on a scale | Standard Deviation 1.19 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 168 | -3.4 score on a scale | Standard Deviation 1.27 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 180 | -3.4 score on a scale | Standard Deviation 1.12 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 204 | -3.4 score on a scale | Standard Deviation 1.16 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 216 | -3.4 score on a scale | Standard Deviation 1.16 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 228 | -3.5 score on a scale | Standard Deviation 1.12 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 240 | -3.4 score on a scale | Standard Deviation 1.13 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 252 | -3.5 score on a scale | Standard Deviation 1.11 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 264 | -3.5 score on a scale | Standard Deviation 1.19 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Extension Baseline | -2.7 score on a scale | Standard Deviation 1.4 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 312 | -3.5 score on a scale | Standard Deviation 1.27 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 324 | -3.6 score on a scale | Standard Deviation 1.14 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 348 | -3.5 score on a scale | Standard Deviation 1.2 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 360 | -3.6 score on a scale | Standard Deviation 1.21 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 372 | -3.6 score on a scale | Standard Deviation 1.18 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 396 | -3.5 score on a scale | Standard Deviation 1.38 |
| Filgotinib Darwin 1 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 408 | -3.8 score on a scale | Standard Deviation 0.97 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 360 | -3.4 score on a scale | Standard Deviation 1.13 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 12 | -3.1 score on a scale | Standard Deviation 1.22 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 96 | -3.4 score on a scale | Standard Deviation 1.13 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 144 | -3.4 score on a scale | Standard Deviation 1.15 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 168 | -3.4 score on a scale | Standard Deviation 1.2 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 156 | -3.4 score on a scale | Standard Deviation 1.28 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 204 | -3.5 score on a scale | Standard Deviation 1.06 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 300 | -3.5 score on a scale | Standard Deviation 1.23 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 276 | -3.6 score on a scale | Standard Deviation 1.17 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 288 | -3.6 score on a scale | Standard Deviation 1.28 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 396 | -3.8 score on a scale | Standard Deviation 1.12 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 180 | -3.4 score on a scale | Standard Deviation 1.21 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 336 | -3.4 score on a scale | Standard Deviation 1.16 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 192 | -3.5 score on a scale | Standard Deviation 1.13 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Extension Baseline | -2.6 score on a scale | Standard Deviation 1.28 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 312 | -3.4 score on a scale | Standard Deviation 1.3 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 372 | -3.6 score on a scale | Standard Deviation 1.26 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 24 | -3.2 score on a scale | Standard Deviation 1.33 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 216 | -3.5 score on a scale | Standard Deviation 1.15 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 36 | -3.3 score on a scale | Standard Deviation 1.22 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 324 | -3.5 score on a scale | Standard Deviation 1.24 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 48 | -3.3 score on a scale | Standard Deviation 1.26 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 228 | -3.5 score on a scale | Standard Deviation 1.09 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 60 | -3.4 score on a scale | Standard Deviation 1.17 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 384 | -3.5 score on a scale | Standard Deviation 1.26 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 72 | -3.4 score on a scale | Standard Deviation 1.21 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 240 | -3.4 score on a scale | Standard Deviation 1.19 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 84 | -3.5 score on a scale | Standard Deviation 1.09 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 348 | -3.6 score on a scale | Standard Deviation 1.14 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 252 | -3.6 score on a scale | Standard Deviation 1.24 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 108 | -3.3 score on a scale | Standard Deviation 1.21 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 408 | -2.8 score on a scale | Standard Deviation 0.25 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 120 | -3.5 score on a scale | Standard Deviation 1.14 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 264 | -3.6 score on a scale | Standard Deviation 1.2 |
| Filgotinib Darwin 2 | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | Change from Core Baseline at Week 132 | -3.5 score on a scale | Standard Deviation 1.26 |
Secondary
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components: * Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items). * Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items). These scales were from 0 to 100 with higher scores indicating a better quality of life.
Time frame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 48 | 6.2 score on a scale | Standard Deviation 10.52 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 240 | 6.5 score on a scale | Standard Deviation 11.11 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 144 | 6.2 score on a scale | Standard Deviation 10.72 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 288 | 7.3 score on a scale | Standard Deviation 11.49 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 96 | 6.5 score on a scale | Standard Deviation 10.54 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 336 | 6.7 score on a scale | Standard Deviation 10.49 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 192 | 6.1 score on a scale | Standard Deviation 11.47 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 384 | 6.3 score on a scale | Standard Deviation 11.23 |
| Filgotinib Darwin 1 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Extension Baseline | 6.1 score on a scale | Standard Deviation 9.67 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 384 | 8.0 score on a scale | Standard Deviation 10.98 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Extension Baseline | 7.1 score on a scale | Standard Deviation 10.01 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 48 | 6.8 score on a scale | Standard Deviation 10.84 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 96 | 6.7 score on a scale | Standard Deviation 10.33 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 144 | 6.6 score on a scale | Standard Deviation 10.86 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 192 | 7.5 score on a scale | Standard Deviation 11.6 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 240 | 7.7 score on a scale | Standard Deviation 11.66 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 288 | 8.2 score on a scale | Standard Deviation 11.2 |
| Filgotinib Darwin 2 | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | Change from Core Baseline at Week 336 | 6.6 score on a scale | Standard Deviation 13.65 |
Secondary
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components: * Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items). * Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items). These scales were from 0 to 100 with higher scores indicating a better quality of life.
Time frame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 48 | 11.3 score on a scale | Standard Deviation 9.45 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 240 | 10.9 score on a scale | Standard Deviation 9.58 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 144 | 11.8 score on a scale | Standard Deviation 9.86 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 288 | 13.0 score on a scale | Standard Deviation 10.71 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 96 | 12.2 score on a scale | Standard Deviation 9.7 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 336 | 12.8 score on a scale | Standard Deviation 10.12 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 192 | 11.2 score on a scale | Standard Deviation 9.21 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 384 | 11.5 score on a scale | Standard Deviation 9.97 |
| Filgotinib Darwin 1 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Extension Baseline | 9.2 score on a scale | Standard Deviation 9.11 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 384 | 11.7 score on a scale | Standard Deviation 8 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Extension Baseline | 9.5 score on a scale | Standard Deviation 8.85 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 48 | 11.5 score on a scale | Standard Deviation 8.74 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 96 | 11.8 score on a scale | Standard Deviation 8.87 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 144 | 12.2 score on a scale | Standard Deviation 9.21 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 192 | 11.0 score on a scale | Standard Deviation 9.4 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 240 | 11.4 score on a scale | Standard Deviation 9.29 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 288 | 13.1 score on a scale | Standard Deviation 9.5 |
| Filgotinib Darwin 2 | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | Change from Core Baseline at Week 336 | 12.0 score on a scale | Standard Deviation 8.79 |
Secondary
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
FACIT-Fatigue scale was a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). Negatively stated items were reversed by subtracting the response from 4 before being added to obtain a total score. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating less fatigue. A positive change from baseline indicated better quality of life.
Time frame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Extension Baseline | 10.7 score on a scale | Standard Deviation 11.06 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 144 | 12.3 score on a scale | Standard Deviation 11.31 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 336 | 13.2 score on a scale | Standard Deviation 12.18 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 48 | 11.6 score on a scale | Standard Deviation 11.16 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 96 | 12.0 score on a scale | Standard Deviation 11.59 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 192 | 11.7 score on a scale | Standard Deviation 11.63 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 240 | 11.5 score on a scale | Standard Deviation 11.52 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 288 | 13.4 score on a scale | Standard Deviation 13.21 |
| Filgotinib Darwin 1 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 384 | 12.6 score on a scale | Standard Deviation 13.35 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 288 | 15.0 score on a scale | Standard Deviation 12.03 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 96 | 12.9 score on a scale | Standard Deviation 10.97 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 192 | 12.8 score on a scale | Standard Deviation 11.96 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 336 | 13.8 score on a scale | Standard Deviation 12.29 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Extension Baseline | 12.1 score on a scale | Standard Deviation 10.71 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 240 | 12.5 score on a scale | Standard Deviation 11.74 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 48 | 12.7 score on a scale | Standard Deviation 11.62 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 384 | 13.9 score on a scale | Standard Deviation 10.76 |
| Filgotinib Darwin 2 | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | Change from Core Baseline at Week 144 | 13.2 score on a scale | Standard Deviation 11.92 |
Secondary
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm), CRP (mg/dL). SDAI = TJC + SJC + SGA + PGA+ CRP. The SDAI score ranged from 0 to approximately 86. Higher SDAI indicated greater disease activity. A negative change from baseline indicated improvement.
Time frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 144 | -35.7 score on a scale | Standard Deviation 13.15 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 60 | -35.3 score on a scale | Standard Deviation 13.57 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 216 | -36.1 score on a scale | Standard Deviation 12.92 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 72 | -35.4 score on a scale | Standard Deviation 13.38 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 168 | -35.8 score on a scale | Standard Deviation 14.18 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 84 | -35.6 score on a scale | Standard Deviation 13.38 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 312 | -37.1 score on a scale | Standard Deviation 13.71 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 96 | -36.2 score on a scale | Standard Deviation 13.31 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 108 | -36.0 score on a scale | Standard Deviation 13.56 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 120 | -36.1 score on a scale | Standard Deviation 13.28 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 240 | -35.9 score on a scale | Standard Deviation 12.69 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 132 | -35.6 score on a scale | Standard Deviation 13.38 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 48 | -34.7 score on a scale | Standard Deviation 14.38 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 156 | -35.5 score on a scale | Standard Deviation 13.36 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 360 | -37.4 score on a scale | Standard Deviation 12.83 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 180 | -36.2 score on a scale | Standard Deviation 12.72 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 252 | -37.2 score on a scale | Standard Deviation 12.63 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 204 | -35.8 score on a scale | Standard Deviation 12.78 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 228 | -36.8 score on a scale | Standard Deviation 12.38 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 276 | -37.5 score on a scale | Standard Deviation 12.18 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 288 | -37.0 score on a scale | Standard Deviation 13.22 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Extension Baseline | -30.2 score on a scale | Standard Deviation 15.49 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 300 | -37.5 score on a scale | Standard Deviation 13.55 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 324 | -37.7 score on a scale | Standard Deviation 13.06 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 192 | -35.5 score on a scale | Standard Deviation 12.74 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 336 | -36.7 score on a scale | Standard Deviation 12.52 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 348 | -37.0 score on a scale | Standard Deviation 12.53 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 12 | -33.4 score on a scale | Standard Deviation 14.16 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 372 | -37.3 score on a scale | Standard Deviation 12.68 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 24 | -34.0 score on a scale | Standard Deviation 14.19 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 384 | -36.5 score on a scale | Standard Deviation 12.64 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 264 | -37.3 score on a scale | Standard Deviation 12.98 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 396 | -36.3 score on a scale | Standard Deviation 14.32 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 36 | -34.7 score on a scale | Standard Deviation 13.98 |
| Filgotinib Darwin 1 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 408 | -40.4 score on a scale | Standard Deviation 12.91 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 108 | -36.6 score on a scale | Standard Deviation 13.65 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 36 | -35.9 score on a scale | Standard Deviation 13.42 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 96 | -36.8 score on a scale | Standard Deviation 13.47 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 132 | -36.9 score on a scale | Standard Deviation 14.25 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 168 | -36.9 score on a scale | Standard Deviation 13.84 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 180 | -36.9 score on a scale | Standard Deviation 13.33 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 204 | -38.5 score on a scale | Standard Deviation 13.72 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 216 | -38.0 score on a scale | Standard Deviation 13.85 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 228 | -37.9 score on a scale | Standard Deviation 12.87 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 240 | -37.1 score on a scale | Standard Deviation 14.38 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 252 | -38.6 score on a scale | Standard Deviation 14.85 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 264 | -39.2 score on a scale | Standard Deviation 14.59 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 276 | -38.6 score on a scale | Standard Deviation 13.98 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 300 | -38.0 score on a scale | Standard Deviation 15.38 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 312 | -37.7 score on a scale | Standard Deviation 15.54 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 336 | -36.6 score on a scale | Standard Deviation 14.36 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 348 | -37.2 score on a scale | Standard Deviation 13.02 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 408 | -35.6 score on a scale | Standard Deviation 5.98 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Extension Baseline | -29.8 score on a scale | Standard Deviation 14.27 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 24 | -35.0 score on a scale | Standard Deviation 14.65 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 48 | -36.2 score on a scale | Standard Deviation 14.08 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 60 | -36.3 score on a scale | Standard Deviation 12.85 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 72 | -36.7 score on a scale | Standard Deviation 13.41 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 84 | -37.3 score on a scale | Standard Deviation 13.12 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 12 | -34.1 score on a scale | Standard Deviation 13.79 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 120 | -37.4 score on a scale | Standard Deviation 12.9 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 144 | -36.9 score on a scale | Standard Deviation 13.12 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 156 | -36.9 score on a scale | Standard Deviation 14.46 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 192 | -38.2 score on a scale | Standard Deviation 13.66 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 288 | -38.6 score on a scale | Standard Deviation 15.09 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 324 | -38.1 score on a scale | Standard Deviation 15.56 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 360 | -36.3 score on a scale | Standard Deviation 13.05 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 372 | -37.8 score on a scale | Standard Deviation 13.64 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 384 | -36.5 score on a scale | Standard Deviation 14.58 |
| Filgotinib Darwin 2 | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | Change from Core Baseline at Week 396 | -39.5 score on a scale | Standard Deviation 13.5 |
Secondary
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
The ACR response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 108 | 86.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 216 | 86.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 60 | 84.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 228 | 89.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 120 | 85.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 240 | 88.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 36 | 86.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 252 | 89.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 132 | 88.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 264 | 86.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 72 | 87.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 276 | 91.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 144 | 86.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 288 | 87.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 24 | 84.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 300 | 88.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 156 | 87.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 312 | 88.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 84 | 87.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 324 | 89.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 168 | 87.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 336 | 88.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 48 | 84.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 348 | 87.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 180 | 89.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 360 | 86.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 96 | 89.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 372 | 89.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 192 | 87.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 384 | 85.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 12 | 86.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 396 | 85.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 204 | 89.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 408 | 66.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Extension Baseline | 77.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 408 | 50.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Extension Baseline | 79.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 12 | 87.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 24 | 89.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 36 | 89.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 48 | 86.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 60 | 90.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 72 | 87.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 84 | 91.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 96 | 91.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 108 | 89.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 120 | 91.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 132 | 92.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 144 | 89.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 156 | 89.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 168 | 84.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 180 | 88.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 192 | 88.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 204 | 91.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 216 | 93.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 228 | 92.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 240 | 89.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 252 | 91.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 264 | 90.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 276 | 93.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 288 | 85.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 300 | 91.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 312 | 87.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 324 | 86.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 336 | 88.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 348 | 91.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 360 | 88.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 372 | 85.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 384 | 84.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | Week 396 | 92.0 percentage of participants |
Secondary
Percentage of Participants Achieving ACR50 Response: NRI
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 108 | 49.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 216 | 36.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 60 | 53.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 228 | 38.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 120 | 48.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 240 | 34.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 36 | 58.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 252 | 32.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 132 | 47.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 264 | 30.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 72 | 53.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 276 | 29.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 144 | 46.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 288 | 29.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 24 | 56.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 300 | 29.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 156 | 42.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 312 | 29.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 84 | 52.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 324 | 30.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 168 | 43.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 336 | 27.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 48 | 55.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 348 | 27.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 180 | 42.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 360 | 24.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 96 | 55.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 372 | 23.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 192 | 38.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 384 | 21.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 12 | 60.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 396 | 19.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 204 | 37.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Week 408 | 0.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: NRI | Extension Baseline | 48.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 408 | 0.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Extension Baseline | 45.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 12 | 61.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 24 | 60.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 36 | 60.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 48 | 53.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 60 | 51.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 72 | 47.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 84 | 51.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 96 | 47.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 108 | 43.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 120 | 43.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 132 | 42.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 144 | 43.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 156 | 35.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 168 | 34.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 180 | 38.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 192 | 37.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 204 | 38.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 216 | 35.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 228 | 34.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 240 | 33.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 252 | 32.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 264 | 33.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 276 | 36.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 288 | 33.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 300 | 28.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 312 | 26.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 324 | 28.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 336 | 25.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 348 | 26.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 360 | 24.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 372 | 24.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 384 | 21.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: NRI | Week 396 | 20.7 percentage of participants |
Secondary
Percentage of Participants Achieving ACR50 Response: OC
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 96 | 73.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 216 | 68.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 48 | 65.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 228 | 72.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 108 | 68.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 240 | 66.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 24 | 64.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 252 | 68.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 120 | 72.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 264 | 66.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 60 | 67.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 276 | 68.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 144 | 71.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 288 | 70.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 12 | 62.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 300 | 72.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 156 | 72.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 312 | 69.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 72 | 68.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 324 | 72.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 168 | 73.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 336 | 70.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 36 | 67.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 348 | 71.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 180 | 72.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 360 | 67.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 84 | 69.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 372 | 70.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 192 | 67.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 384 | 64.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Extension Baseline | 49.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 396 | 65.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 204 | 69.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 408 | 66.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR50 Response: OC | Week 132 | 71.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 408 | 50.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 132 | 66.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Extension Baseline | 46.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 12 | 64.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 24 | 69.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 36 | 71.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 48 | 65.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 60 | 66.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 72 | 65.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 84 | 73.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 96 | 69.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 108 | 66.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 120 | 67.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 144 | 67.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 156 | 63.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 168 | 60.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 180 | 67.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 192 | 67.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 204 | 69.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 216 | 64.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 228 | 66.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 240 | 69.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 252 | 71.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 264 | 74.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 276 | 76.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 288 | 73.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 300 | 66.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 312 | 64.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 324 | 65.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 336 | 63.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 348 | 69.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 360 | 67.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 372 | 71.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 384 | 65.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR50 Response: OC | Week 396 | 64.9 percentage of participants |
Secondary
Percentage of Participants Achieving ACR70 Response: NRI
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 36 | 40.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 204 | 26.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 12 | 36.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 216 | 26.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 108 | 35.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 228 | 27.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 48 | 39.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 240 | 21.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 120 | 36.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 252 | 21.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Extension Baseline | 30.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 264 | 23.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 132 | 32.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 276 | 21.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 288 | 22.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 60 | 36.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 300 | 22.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 144 | 31.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 312 | 23.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 24 | 37.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 324 | 21.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 156 | 26.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 336 | 20.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 348 | 19.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 72 | 38.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 360 | 17.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 168 | 30.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 372 | 16.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 96 | 39.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 384 | 14.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 180 | 30.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 396 | 14.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 84 | 36.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 408 | 0.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: NRI | Week 192 | 26.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 408 | 0.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 336 | 17.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Extension Baseline | 23.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 12 | 36.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 24 | 39.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 36 | 37.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 48 | 36.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 60 | 34.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 72 | 30.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 84 | 34.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 96 | 28.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 108 | 29.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 120 | 31.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 132 | 29.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 144 | 28.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 156 | 22.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 168 | 24.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 180 | 25.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 192 | 25.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 204 | 24.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 216 | 23.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 228 | 24.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 240 | 21.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 252 | 20.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 264 | 22.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 288 | 24.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 300 | 19.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 312 | 19.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 324 | 21.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 348 | 19.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 360 | 16.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 372 | 17.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 384 | 14.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 396 | 14.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: NRI | Week 276 | 24.8 percentage of participants |
Secondary
Percentage of Participants Achieving ACR70 Response: OC
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5.hsCRP.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 300 | 55.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 120 | 53.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 12 | 37.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 132 | 48.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 216 | 49.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 144 | 48.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 24 | 42.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 156 | 45.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 348 | 51.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 168 | 51.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 36 | 46.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 180 | 52.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 264 | 50.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 192 | 46.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 48 | 46.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 204 | 49.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 360 | 49.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 228 | 50.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 60 | 45.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 252 | 46.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 396 | 49.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 276 | 48.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 72 | 48.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 288 | 52.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 408 | 66.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 312 | 55.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 84 | 48.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 324 | 52.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 336 | 51.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 240 | 42.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 96 | 52.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 372 | 49.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Extension Baseline | 30.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 384 | 45.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR70 Response: OC | Week 108 | 49.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 384 | 45.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 204 | 45.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 228 | 46.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 252 | 45.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 288 | 54.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 324 | 49.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 348 | 50.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 408 | 50.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Extension Baseline | 23.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 12 | 38.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 24 | 45.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 36 | 44.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 48 | 44.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 60 | 44.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 72 | 42.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 84 | 48.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 96 | 41.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 108 | 45.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 120 | 47.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 132 | 46.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 144 | 44.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 156 | 40.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 168 | 42.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 180 | 44.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 192 | 45.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 216 | 42.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 240 | 43.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 264 | 51.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 276 | 53.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 300 | 45.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 312 | 47.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 336 | 44.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 360 | 44.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 372 | 50.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR70 Response: OC | Week 396 | 45.5 percentage of participants |
Secondary
Percentage of Participants Achieving ACR/EULAR Remission: NRI
A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 12 | 13.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 180 | 10.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 72 | 15.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 192 | 10.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 324 | 9.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 204 | 11.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 84 | 15.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 216 | 11.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 24 | 14.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 228 | 11.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 108 | 14.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 240 | 8.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 96 | 18.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 252 | 7.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 120 | 12.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 264 | 11.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 36 | 15.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 276 | 8.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 132 | 12.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 288 | 10.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Extension Baseline | 10.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 300 | 10.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 144 | 10.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 348 | 9.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 48 | 17.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 360 | 9.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 156 | 10.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 372 | 8.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 336 | 8.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 384 | 6.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 60 | 15.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 396 | 7.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 168 | 13.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 408 | 0.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 312 | 10.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 408 | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 312 | 7.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 324 | 10.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 84 | 12.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Extension Baseline | 7.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 12 | 11.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 24 | 15.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 36 | 14.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 48 | 14.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 60 | 12.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 72 | 12.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 96 | 11.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 108 | 10.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 120 | 13.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 132 | 12.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 144 | 9.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 300 | 8.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 156 | 8.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 168 | 7.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 180 | 11.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 192 | 10.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 204 | 9.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 216 | 7.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 228 | 9.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 240 | 7.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 252 | 7.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 264 | 7.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 276 | 9.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 288 | 9.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 336 | 7.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 348 | 9.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 360 | 6.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 372 | 6.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 384 | 4.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: NRI | Week 396 | 5.4 percentage of participants |
Secondary
Percentage of Participants Achieving ACR/EULAR Remission: OC
A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1.
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 108 | 20.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 216 | 21.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 60 | 19.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 228 | 22.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 120 | 17.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 240 | 16.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 36 | 17.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 252 | 16.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 132 | 17.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 264 | 24.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 72 | 19.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 276 | 20.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 144 | 15.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 288 | 23.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 24 | 16.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 300 | 26.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 156 | 18.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 312 | 24.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 84 | 19.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 324 | 22.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 168 | 23.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 336 | 21.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 48 | 20.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 348 | 23.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 180 | 17.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 360 | 24.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 96 | 24.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 372 | 24.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 192 | 17.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 384 | 20.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 12 | 13.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 396 | 25.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 204 | 19.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 408 | 66.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Extension Baseline | 10.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 408 | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Extension Baseline | 7.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 12 | 11.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 24 | 17.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 36 | 17.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 48 | 16.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 60 | 15.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 72 | 16.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 84 | 17.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 96 | 16.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 108 | 16.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 120 | 20.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 132 | 19.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 144 | 15.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 156 | 14.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 168 | 13.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 180 | 18.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 192 | 18.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 204 | 17.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 216 | 14.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 228 | 18.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 240 | 14.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 252 | 16.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 264 | 16.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 276 | 20.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 288 | 21.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 300 | 19.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 312 | 18.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 324 | 23.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 336 | 18.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 348 | 23.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 360 | 16.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 372 | 18.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 384 | 12.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving ACR/EULAR Remission: OC | Week 396 | 16.3 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
The American College of Rheumatology (ACR) response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in swollen joint count 66 (SJC66), and 2) ≥ 20% improvement from baseline in tender joint count 68 (TJC68), and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), 2.Subject's Global Assessment of Disease Activity (SGA) (VAS), 3. Physician's Global Assessment of Disease Activity (PGA) (VAS), 4. Total HAQ-DI score, and 5. High-Sensitivity C- Reactive Protein (hsCRP).
Time frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: The Full Analysis Set (FAS) included all participants who enrolled in the extension study and received at least one dose of study drug.~NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 108 | 61.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 216 | 45.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 60 | 67.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 228 | 47.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 120 | 57.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 240 | 45.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 36 | 75.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 252 | 42.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 132 | 59.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 264 | 39.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 72 | 68.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 276 | 39.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 144 | 56.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 288 | 36.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 24 | 75.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 300 | 35.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 156 | 50.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 312 | 36.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 84 | 65.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 324 | 36.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 168 | 52.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 336 | 34.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 48 | 71.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 348 | 33.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 180 | 52.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 360 | 31.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 96 | 68.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 372 | 30.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 192 | 49.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 384 | 28.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 12 | 83.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 396 | 26.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 204 | 48.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 408 | 0.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Extension Baseline | 76.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 408 | 0.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Extension Baseline | 77.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 12 | 83.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 24 | 77.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 36 | 75.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 48 | 71.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 60 | 69.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 72 | 62.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 84 | 64.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 96 | 61.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 108 | 58.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 120 | 59.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 132 | 57.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 144 | 57.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 156 | 50.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 168 | 47.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 180 | 51.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 192 | 48.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 204 | 50.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 216 | 50.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 228 | 48.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 240 | 43.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 252 | 42.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 264 | 40.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 276 | 44.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 288 | 38.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 300 | 39.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 312 | 36.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 324 | 37.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 336 | 35.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 348 | 34.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 360 | 31.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 372 | 28.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 384 | 27.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | Week 396 | 28.5 percentage of participants |
Secondary
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
DAS28(CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None= Actual DAS28(CRP) ≤ 3.2, \> 3.2 to ≤ 5.1, or \> 5.1 AND Improvement in DAS28(CRP) from baseline ≤ 6.0 or \> 0.6 to ≤ 1.2; Moderate= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline \> 0.6 to ≤ 1.2, Actual DAS28(CRP) \> 3.2 to ≤ 5.1 or \> 5.1 AND Improvement in DAS28(CRP) from baseline \> 1.2, or Actual DAS28(CRP) \> 3.2 to ≤ 5.1 AND Improvement in DAS28(CRP) from baseline \> 0.6 to ≤ 1.2; Good= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline \> 1.2.
Time frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 312: Good | 75.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 408: Good | 100.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Extension Baseline: Good | 46.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Extension Baseline: Moderate | 43.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Extension Baseline: None | 10.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 12: Good | 59.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 12: Moderate | 35.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 12: None | 5.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 24: Good | 65.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 24: Moderate | 29.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 24: None | 5.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 36: Good | 66.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 36: Moderate | 29.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 36: None | 3.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 48: Good | 67.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 48: Moderate | 27.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 48: None | 4.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 60: Good | 67.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 60: Moderate | 29.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 60: None | 2.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 72: Good | 70.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 72: Moderate | 26.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 72: None | 2.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 84: Good | 70.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 84: Moderate | 27.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 84: None | 2.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 96: Good | 72.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 96: Moderate | 25.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 96: None | 1.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 108: Good | 74.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 108: Moderate | 23.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 108: None | 2.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 120: Good | 74.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 120: Moderate | 23.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 120: None | 1.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 132: Good | 69.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 132: Moderate | 28.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 144: Good | 72.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 144: Moderate | 25.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 144: None | 1.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 156: Good | 69.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 156: Moderate | 28.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 156: None | 2.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 168: Good | 73.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 168: Moderate | 23.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 168: None | 3.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 180: Good | 74.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 180: Moderate | 25.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 180: None | 0.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 192: Good | 71.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 192: Moderate | 26.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 192: None | 2.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 204: Good | 73.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 204: Moderate | 23.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 204: None | 2.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 216: Good | 72.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 216: Moderate | 26.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 216: None | 1.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 228: Good | 76.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 228: Moderate | 23.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 228: None | 0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 240: Good | 73.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 240: Moderate | 26.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 240: None | 0.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 252: Good | 74.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 252: Moderate | 24.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 252: None | 1.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 264: Good | 74.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 264: Moderate | 24.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 264: None | 1.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 276: Good | 74.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 276: Moderate | 25.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 276: None | 0.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 288: Good | 73.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 288: Moderate | 24.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 288: None | 1.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 300: Good | 74.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 300: Moderate | 23.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 300: None | 1.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 132: None | 2.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 312: Moderate | 22.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 312: None | 1.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 324: Good | 75.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 324: Moderate | 21.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 324: None | 2.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 336: Good | 74.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 336: Moderate | 24.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 336: None | 1.0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 348: Good | 76.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 348: Moderate | 21.5 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 348: None | 1.6 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 360: Good | 73.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 360: Moderate | 23.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 360: None | 2.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 372: Good | 76.8 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 372: Moderate | 21.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 372: None | 1.9 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 384: Good | 70.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 384: Moderate | 28.4 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 384: None | 1.3 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 396: Good | 73.2 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 396: Moderate | 21.7 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 396: None | 5.1 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 408: Moderate | 0 percentage of participants |
| Filgotinib Darwin 1 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 408: None | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 312: Good | 66.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 204: Moderate | 22.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 384: None | 1.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Extension Baseline: Good | 41.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 204: None | 1.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Extension Baseline: Moderate | 48.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 312: Moderate | 32.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Extension Baseline: None | 9.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 216: Good | 69.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 12: Good | 60.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 360: None | 2.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 12: Moderate | 34.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 216: Moderate | 28.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 12: None | 4.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 312: None | 1.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 24: Good | 65.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 216: None | 1.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 24: Moderate | 28.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 408: Good | 50.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 24: None | 5.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 228: Good | 70.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 36: Good | 66.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 324: Good | 71.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 36: Moderate | 30.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 228: Moderate | 29.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 36: None | 3.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 372: Good | 77.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 48: Good | 68.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 228: None | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 48: Moderate | 27.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 324: Moderate | 26.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 48: None | 4.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 240: Good | 63.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 60: Good | 64.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 396: Good | 81.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 60: Moderate | 34.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 240: Moderate | 36.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 60: None | 1.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 324: None | 1.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 72: Good | 65.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 240: None | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 72: Moderate | 32.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 372: Moderate | 18.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 72: None | 1.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 252: Good | 73.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 84: Good | 69.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 336: Good | 71.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 84: Moderate | 29.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 252: Moderate | 25.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 84: None | 1.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 408: None | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 96: Good | 69.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 252: None | 0.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 96: Moderate | 27.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 336: Moderate | 26.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 96: None | 3.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 264: Good | 75.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 108: Good | 66.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 372: None | 4.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 108: Moderate | 29.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 264: Moderate | 22.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 108: None | 3.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 336: None | 2.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 120: Good | 67.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 264: None | 1.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 120: Moderate | 29.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 396: Moderate | 19.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 120: None | 2.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 276: Good | 70.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 132: Good | 69.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 348: Good | 78.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 132: Moderate | 27.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 132: None | 2.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 276: Moderate | 28.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 144: Good | 65.6 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 384: Good | 78.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 144: Moderate | 33.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 276: None | 1.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 144: None | 1.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 348: Moderate | 20.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 156: Good | 64.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 288: Good | 73.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 156: Moderate | 30.9 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 408: Moderate | 50.0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 156: None | 4.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 288: Moderate | 24.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 168: Good | 68.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 348: None | 1.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 168: Moderate | 29.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 288: None | 2.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 168: None | 2.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 384: Moderate | 20.3 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 180: Good | 68.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 300: Good | 74.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 180: Moderate | 28.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 360: Good | 73.2 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 180: None | 2.8 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 300: Moderate | 25.5 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 192: Good | 71.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 396: None | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 192: Moderate | 28.1 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 300: None | 0 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 192: None | 0.7 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 360: Moderate | 24.4 percentage of participants |
| Filgotinib Darwin 2 | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | Week 204: Good | 76.3 percentage of participants |