Psoriatic Arthritis
Conditions
Keywords
Biologic-Naive, BMS-986165, Deucravacitinib, Disease-modifying Anti-rheumatic Drugs, DMARDs, Joint Disease, Psoriatic Arthritis, PsA
Brief summary
The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening. * Meets the Classification Criteria for Psoriatic Arthritis at Screening. * Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening. * Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1. * Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening. * ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading. * Must have completed the week 52 treatment for the optional open-label long-term extension period.
Exclusion criteria
* Nonplaque psoriasis at screening or day 1. * Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis. * History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease). * Active fibromyalgia. * Received an approved or investigational biologic therapy for the treatment of PsA or PsO. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ACR 20 Response at Week 16 | Week 16 | The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | Baseline and Week 16 | DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \>5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16 | Baseline and Week 16 | HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement. |
| Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 16 | PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method. |
| Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16 | Baseline and Week 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement. |
| Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | Week 16 | Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. |
| Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | Week 16 | Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count \<= 1 2. Swollen joint count \<=1 3. Psoriasis Area and Severity Index (PASI) \<= 1 or body surface area (BSA) \<= 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain \<= 15 5. Patient Global Assessment of PsA disease activity \<= 20 6. HAQ-DI \<= 0.5 7. Tender enthesial points \<= 1 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16 | Baseline and Week 16 | FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement. |
| Percentage of Participants Meeting Dactylitis Resolution at Week 16 | Week 16 | Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count =\> 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor. |
| Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16 | Baseline and Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. Change from baseline reflects progression or improvement; a decrease suggests reduced damage or improvement. |
| Percentage of Participants With ACR 20 Response up to Week 16 | Week 2, 4, 8, 12, and 16 | The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method. |
| Percentage of Participants With ACR 50 Response up to Week 16 | Week 2, 4, 8, 12, and 16 | The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method. |
| Percentage of Participants With ACR 70 Response up to Week 16 | Week 2, 4, 8, 12, and 16 | The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Baseline and Week 2, 4, 8, 12, and 16 | HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement. |
| Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Baseline and Week 2, 4, 8, 12, and 16 | HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Clinically meaningful improvement was defined as ≥0.35improvement from baseline. |
| Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4, 8, 12 and 16 | PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method. |
| Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4, 8, 12 and 16 | PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method. |
| Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4, 8, 12 and 16 | PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method. |
| Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement. |
| Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 4, 8, 12 and 16 | Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. |
| Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 4, 8, 12 and 16 | Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right \\\[R\\\]/left \\\[L\\\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. |
| Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 4, 8, 12, and 16 | Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count \<= 1 2. Swollen joint count \<=1 3. Psoriasis Area and Severity Index (PASI) \<= 1 or body surface area (BSA) \<= 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain \<= 15 5. Patient Global Assessment of PsA disease activity \<= 20 6. HAQ-DI \<= 0.5 7. Tender enthesial points \<= 1 |
| Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Baseline and Week 2, 4, 8, 12 and 16 | FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement. |
| Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 4, 8, 12 and 16 | Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count =\> 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor. |
| Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Baseline and Week 2, 4, 8, 12 and 16 | The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement. |
| Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Baseline and Week 2, 4, 8, 12 and 16 | The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \\\[cm\\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. The DAPSA score ranges from 0 to 154, with a higher score indicating more disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement. |
| Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Baseline and Week 2, 4, 8, 12 and 16 | The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \\\[cm\\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. |
| Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Baseline and Week 2, 4, 8, 12 and 16 | The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \\\[cm\\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. A score 0 signifies remission. |
| Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 2, 4, 8, 12 and 16 | The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. |
| Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Baseline and Week 2, 4, 8, 12 and 16 | DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \\\< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \\\>5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement. |
| Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 2, 4, 8, 12 and 16 | DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \\\< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \\\>5.1=high disease activity. |
| Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 2, 4, 8, 12 and 16 | DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \\\< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \\\>5.1=high disease activity. |
| Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 | Baseline and Week 4, 12 and 16 | The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement. |
| Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Baseline and Week 4, 8, 12 and 16 | Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement. |
| Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 2, 4, 8, 12 and 16 | The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of ≥ 30% in tender joint counts; 2) Decrease of ≥ 30% in swollen joint counts; 3) Decrease of ≥ 20% in Physician Global Assessment of PsA; 4) Decrease of ≥ 20% in Participant's Global Assessment of Disease Activity |
| Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 2, 4, 8, 12 and 16 | BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5 |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0 at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0.5 at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= Smallest Detectable Change (SDC) at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96\* standard deviation of the paired differences of change from baseline/ square root of (2\*k); k is the number of reviewers and is default to 2 in this study. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0 at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0.5 at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= SDC at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96\* standard deviation of the paired differences of change from baseline/ square root of (2\*k); k is the number of reviewers and is default to 2 in this study. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0 at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0.5 at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= SDC at Week 16 | Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96\* standard deviation of the paired differences of change from baseline/ square root of (2\*k); k is the number of reviewers and is default to 2 in this study. |
| Change From Baseline in PsA-modified SvdH Erosion Scores Response at Week 16 | Baseline and Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Change From Baseline in PsA-modified SvdH JSN Scores Response at Week 16 | Baseline and Week 16 | The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. |
| Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical sub component is one of the 4 subscales of PCS. The physical subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 physical sub-component indicates an improvement. |
| Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The role activity sub component is one of the 4 subscales of PCS. The role activity subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 role activity indicates an improvement. |
| Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The bodily pain sub component is one of the 4 subscales of PCS. The bodily pain subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 bodily pain subcomponent indicates an improvement. |
| Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The general health perceptions sub component is one of the 4 subscales of PCS. The general health perceptions subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 general health perceptions subcomponent indicates an improvement. |
| Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The vitality subcomponent is one of the 4 subscales of MCS. The vitality subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 vitality subcomponent indicates an improvement. |
| Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The social subcomponent is one of the 4 subscales of MCS. The social subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 social subcomponent indicates an improvement. |
| Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental health subcomponent is one of the 4 subscales of MCS. The mental health subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 mental health subcomponent indicates an improvement. |
| Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 | Baseline and Week 4, 12 and 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The emotional problem subcomponent is one of the 4 subscales of MCS. The emotional problem subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 emotional problems subcomponent indicates an improvement. |
| Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | Baseline and week 16 | WPAI contains 4 subcomponents - absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. Each subcomponent score ranges from 0 to 100, with higher numbers indicating worse outcome. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement. |
| Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Baseline and week 4 and 16 | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement. |
| Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 | Baseline and week 4, 12, and 16 | The Patient-Reported Outcome Measures Information System Sleep Disturbance assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement. |
Countries
Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Czechia, Finland, France, Hungary, Ireland, Italy, Mexico, Poland, Romania, Russia, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period. | 336 |
| Placebo-Controlled Period - Placebo Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period. | 334 |
| Total | 670 |
Baseline characteristics
| Characteristic | Placebo-Controlled Period - Deucravacitinib 6 mg QD | Total | Placebo-Controlled Period - Placebo |
|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 12.52 | 52.0 years STANDARD_DEVIATION 12.41 | 52.3 years STANDARD_DEVIATION 12.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 101 Participants | 195 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 165 Participants | 330 Participants | 165 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 70 Participants | 145 Participants | 75 Participants |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 17 Participants | 36 Participants | 19 Participants |
| Race/Ethnicity, Customized ASIAN OTHER | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized CHINESE | 24 Participants | 38 Participants | 14 Participants |
| Race/Ethnicity, Customized OTHER | 27 Participants | 48 Participants | 21 Participants |
| Race/Ethnicity, Customized WHITE | 263 Participants | 542 Participants | 279 Participants |
| Sex: Female, Male Female | 164 Participants | 334 Participants | 170 Participants |
| Sex: Female, Male Male | 172 Participants | 336 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 336 | 0 / 334 | 0 / 309 | 0 / 306 |
| other Total, other adverse events | 39 / 332 | 32 / 333 | 68 / 309 | 67 / 306 |
| serious Total, serious adverse events | 6 / 332 | 8 / 333 | 21 / 309 | 17 / 306 |
Outcome results
Primary
Percentage of Participants With ACR 20 Response at Week 16
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 16
Population: Randomized population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 20 Response at Week 16 | 54.2 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 20 Response at Week 16 | 34.1 percentage of participants |
p-value: <0.000195% CI: [1.67, 3.13]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \\\[cm\\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. The DAPSA score ranges from 0 to 154, with a higher score indicating more disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
Time frame: Baseline and Week 2, 4, 8, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 4 | -12.5643 Score on a Scale | Standard Deviation 14.38734 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 12 | -19.8346 Score on a Scale | Standard Deviation 17.22613 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 8 | -16.6770 Score on a Scale | Standard Deviation 16.71038 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 16 | -20.7263 Score on a Scale | Standard Deviation 18.08249 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 2 | -7.6211 Score on a Scale | Standard Deviation 13.23221 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 16 | -13.4075 Score on a Scale | Standard Deviation 17.31116 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 2 | -7.0045 Score on a Scale | Standard Deviation 11.71166 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 4 | -10.1201 Score on a Scale | Standard Deviation 13.64766 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 8 | -12.3610 Score on a Scale | Standard Deviation 15.70632 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 | Week 12 | -13.2671 Score on a Scale | Standard Deviation 17.41524 |
Secondary
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \>5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Time frame: Baseline and Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | -1.4106 Score on a Scale | Standard Deviation 1.13277 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | -0.8902 Score on a Scale | Standard Deviation 1.1075 |
p-value: <0.000195% CI: [-0.6709, -0.3392]ANCOVA
Secondary
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \\\< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \\\>5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Time frame: Baseline and Week 2, 4, 8, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 4 | -0.7655 Score on a Scale | Standard Deviation 0.90092 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 12 | -1.3360 Score on a Scale | Standard Deviation 1.13745 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 8 | -1.0820 Score on a Scale | Standard Deviation 1.02041 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 16 | -1.4106 Score on a Scale | Standard Deviation 1.13277 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 2 | -0.4028 Score on a Scale | Standard Deviation 0.77126 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 16 | -0.8902 Score on a Scale | Standard Deviation 1.1075 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 2 | -0.4006 Score on a Scale | Standard Deviation 0.70508 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 4 | -0.6468 Score on a Scale | Standard Deviation 0.82146 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 8 | -0.7727 Score on a Scale | Standard Deviation 0.99752 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 | Week 12 | -0.8450 Score on a Scale | Standard Deviation 1.09776 |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = not at all to 4 = very much. Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Time frame: Baseline and Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16 | 4.9 Score on a Scale | Standard Deviation 8.84 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16 | 2.2 Score on a Scale | Standard Deviation 8.81 |
p-value: <0.000195% CI: [1.4, 3.9]ANCOVA
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = not at all to 4 = very much. Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Time frame: Baseline and Week 2, 4, 8, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 4 | 2.5 Score on a Scale | Standard Deviation 7.48 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 12 | 4.3 Score on a Scale | Standard Deviation 8.98 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 8 | 4.5 Score on a Scale | Standard Deviation 8.68 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 16 | 4.9 Score on a Scale | Standard Deviation 8.84 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 2 | 2.2 Score on a Scale | Standard Deviation 7.31 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 16 | 2.2 Score on a Scale | Standard Deviation 8.81 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 2 | 2.3 Score on a Scale | Standard Deviation 6.52 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 4 | 2.3 Score on a Scale | Standard Deviation 7.67 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 8 | 2.8 Score on a Scale | Standard Deviation 9.64 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 | Week 12 | 1.8 Score on a Scale | Standard Deviation 8.97 |
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing no difficulty, 1 representing some difficulty, 2 representing much difficulty, and 3 representing unable to do. increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Time frame: Baseline and Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16 | -0.4103 Score on a Scale | Standard Deviation 0.52303 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16 | -0.2118 Score on a Scale | Standard Deviation 0.51583 |
p-value: <0.000195% CI: [-0.2442, -0.0933]ANCOVA
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing no difficulty, 1 representing some difficulty, 2 representing much difficulty, and 3 representing unable to do. increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Time frame: Baseline and Week 2, 4, 8, 12, and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 4 (n=325, 326) | -0.2412 Score on a Scale | Standard Deviation 0.43862 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 12 (n= 326, 327) | -0.3589 Score on a Scale | Standard Deviation 0.49384 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 8 (n=327, 326) | -0.3119 Score on a Scale | Standard Deviation 0.50219 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 16 (n=326, 327) | -0.4103 Score on a Scale | Standard Deviation 0.52303 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 2 (n=324, 323) | -0.1655 Score on a Scale | Standard Deviation 0.37744 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 16 (n=326, 327) | -0.2118 Score on a Scale | Standard Deviation 0.51583 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 2 (n=324, 323) | -0.1250 Score on a Scale | Standard Deviation 0.38243 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 4 (n=325, 326) | -0.1614 Score on a Scale | Standard Deviation 0.39402 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 8 (n=327, 326) | -0.1963 Score on a Scale | Standard Deviation 0.47057 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 | Week 12 (n= 326, 327) | -0.1957 Score on a Scale | Standard Deviation 0.5308 |
Secondary
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16
Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Time frame: Baseline and Week 4, 8, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 4 | -1.2 Score on a Scale | Standard Deviation 1.81 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 8 | -1.7 Score on a Scale | Standard Deviation 2.09 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 12 | -2.1 Score on a Scale | Standard Deviation 2.16 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 16 | -2.2 Score on a Scale | Standard Deviation 2.22 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 16 | -1.3 Score on a Scale | Standard Deviation 1.96 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 4 | -0.8 Score on a Scale | Standard Deviation 1.61 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 12 | -1.3 Score on a Scale | Standard Deviation 2.01 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 | Week 8 | -1.2 Score on a Scale | Standard Deviation 1.89 |
Secondary
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16
The Patient-Reported Outcome Measures Information System Sleep Disturbance assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = not at all to 5 = very much with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Time frame: Baseline and week 4, 12, and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 | Week 4 | -1.48 Score on a Scale | Standard Deviation 6.489 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 | Week 12 | -2.46 Score on a Scale | Standard Deviation 8.196 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 | Week 16 | -3.15 Score on a Scale | Standard Deviation 7.761 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 | Week 4 | -1.09 Score on a Scale | Standard Deviation 6.413 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 | Week 12 | -0.88 Score on a Scale | Standard Deviation 8.177 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 | Week 16 | -1.59 Score on a Scale | Standard Deviation 7.645 |
Secondary
Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. Change from baseline reflects progression or improvement; a decrease suggests reduced damage or improvement.
Time frame: Baseline and Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16 | 0.3980 Score on a Scale | Standard Deviation 2.00852 |
| Placebo-Controlled Period - Placebo | Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16 | 0.5757 Score on a Scale | Standard Deviation 2.73874 |
p-value: 0.719495% CI: [-0.7114, 1.0306]ANCOVA
Secondary
Change From Baseline in PsA-modified SvdH Erosion Scores Response at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Baseline and Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in PsA-modified SvdH Erosion Scores Response at Week 16 | 0.32 Score on a Scale | Standard Deviation 1.417 |
| Placebo-Controlled Period - Placebo | Change From Baseline in PsA-modified SvdH Erosion Scores Response at Week 16 | 0.37 Score on a Scale | Standard Deviation 1.326 |
Secondary
Change From Baseline in PsA-modified SvdH JSN Scores Response at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Baseline and Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in PsA-modified SvdH JSN Scores Response at Week 16 | 0.09 Score on a Scale | Standard Deviation 0.703 |
| Placebo-Controlled Period - Placebo | Change From Baseline in PsA-modified SvdH JSN Scores Response at Week 16 | 0.14 Score on a Scale | Standard Deviation 0.485 |
Secondary
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16
The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 | Week 4 | -1.0405 Score on a Scale | Standard Deviation 1.03004 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 | Week 12 | -1.7675 Score on a Scale | Standard Deviation 1.37563 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 | Week 16 | -1.9064 Score on a Scale | Standard Deviation 1.45258 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 | Week 4 | -0.8258 Score on a Scale | Standard Deviation 0.97038 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 | Week 12 | -1.0780 Score on a Scale | Standard Deviation 1.33036 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 | Week 16 | -1.1026 Score on a Scale | Standard Deviation 1.31166 |
Secondary
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16
The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement.
Time frame: Baseline and Week 2, 4, 8, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 4 | -1.164 Score on a Scale | Standard Deviation 1.5433 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 12 | -1.761 Score on a Scale | Standard Deviation 2.0074 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 8 | -1.545 Score on a Scale | Standard Deviation 1.9037 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 16 | -1.851 Score on a Scale | Standard Deviation 2.044 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 2 | -0.807 Score on a Scale | Standard Deviation 1.3327 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 16 | -1.015 Score on a Scale | Standard Deviation 1.9955 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 2 | -0.652 Score on a Scale | Standard Deviation 1.2524 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 4 | -0.836 Score on a Scale | Standard Deviation 1.558 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 8 | -0.991 Score on a Scale | Standard Deviation 1.9281 |
| Placebo-Controlled Period - Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 | Week 12 | -0.883 Score on a Scale | Standard Deviation 1.9677 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The bodily pain sub component is one of the 4 subscales of PCS. The bodily pain subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 bodily pain subcomponent indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 | Week 4 | 10.0 Score on a Scale | Standard Deviation 16.52 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 | Week 12 | 16.6 Score on a Scale | Standard Deviation 20.96 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 | Week 16 | 18.2 Score on a Scale | Standard Deviation 21.83 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 | Week 4 | 8.5 Score on a Scale | Standard Deviation 15.47 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 | Week 12 | 9.4 Score on a Scale | Standard Deviation 19.66 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 | Week 16 | 10.0 Score on a Scale | Standard Deviation 18.85 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The emotional problem subcomponent is one of the 4 subscales of MCS. The emotional problem subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 emotional problems subcomponent indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 | Week 4 | 2.718 Score on a Scale | Standard Deviation 20.1133 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 | Week 12 | 5.846 Score on a Scale | Standard Deviation 21.407 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 | Week 16 | 7.438 Score on a Scale | Standard Deviation 22.6517 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 | Week 4 | 2.128 Score on a Scale | Standard Deviation 20.1154 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 | Week 12 | 0.718 Score on a Scale | Standard Deviation 21.0925 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 | Week 16 | 2.370 Score on a Scale | Standard Deviation 21.4931 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The general health perceptions sub component is one of the 4 subscales of PCS. The general health perceptions subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 general health perceptions subcomponent indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 | Week 4 | 6.1 Score on a Scale | Standard Deviation 12.95 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 | Week 12 | 8.4 Score on a Scale | Standard Deviation 15.13 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 | Week 16 | 8.9 Score on a Scale | Standard Deviation 16 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 | Week 4 | 5.1 Score on a Scale | Standard Deviation 13.35 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 | Week 12 | 4.8 Score on a Scale | Standard Deviation 15.02 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 | Week 16 | 4.6 Score on a Scale | Standard Deviation 14.85 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 | Week 4 | 0.814 Score on a Scale | Standard Deviation 7.5082 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 | Week 12 | 2.056 Score on a Scale | Standard Deviation 8.4206 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 | Week 16 | 2.588 Score on a Scale | Standard Deviation 8.3442 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 | Week 4 | 0.634 Score on a Scale | Standard Deviation 7.3796 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 | Week 12 | 0.034 Score on a Scale | Standard Deviation 8.3926 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 | Week 16 | 0.358 Score on a Scale | Standard Deviation 8.1559 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental health subcomponent is one of the 4 subscales of MCS. The mental health subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 mental health subcomponent indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 | Week 4 | 2.1 Score on a Scale | Standard Deviation 14.17 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 | Week 12 | 4.9 Score on a Scale | Standard Deviation 16.41 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 | Week 16 | 5.5 Score on a Scale | Standard Deviation 15.98 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 | Week 4 | 2.2 Score on a Scale | Standard Deviation 13.99 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 | Week 12 | 1.4 Score on a Scale | Standard Deviation 16.38 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 | Week 16 | 1.5 Score on a Scale | Standard Deviation 15.78 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Time frame: Baseline and Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16 | 6.410 Score on a Scale | Standard Deviation 8.2883 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16 | 3.847 Score on a Scale | Standard Deviation 7.2929 |
p-value: <0.000195% CI: [3.481, 9.781]ANCOVA
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 | Week 4 | 3.760 Score on a Scale | Standard Deviation 6.2768 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 | Week 12 | 6.021 Score on a Scale | Standard Deviation 7.5809 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 | Week 16 | 6.410 Score on a Scale | Standard Deviation 8.2883 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 | Week 4 | 3.326 Score on a Scale | Standard Deviation 5.7315 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 | Week 12 | 3.916 Score on a Scale | Standard Deviation 7.6614 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 | Week 16 | 3.847 Score on a Scale | Standard Deviation 7.2929 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical sub component is one of the 4 subscales of PCS. The physical subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 physical sub-component indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 | Week 4 | 7.923 Score on a Scale | Standard Deviation 17.9483 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 | Week 12 | 13.615 Score on a Scale | Standard Deviation 20.5725 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 | Week 16 | 15.414 Score on a Scale | Standard Deviation 22.393 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 | Week 4 | 6.908 Score on a Scale | Standard Deviation 17.0306 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 | Week 12 | 7.784 Score on a Scale | Standard Deviation 22.4709 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 | Week 16 | 8.226 Score on a Scale | Standard Deviation 22.1449 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The role activity sub component is one of the 4 subscales of PCS. The role activity subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 role activity indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 | Week 4 | 6.962 Score on a Scale | Standard Deviation 20.6963 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 | Week 12 | 13.096 Score on a Scale | Standard Deviation 22.7372 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 | Week 16 | 13.152 Score on a Scale | Standard Deviation 23.637 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 | Week 4 | 7.058 Score on a Scale | Standard Deviation 18.7454 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 | Week 12 | 8.365 Score on a Scale | Standard Deviation 21.1286 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 | Week 16 | 7.913 Score on a Scale | Standard Deviation 20.8035 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The social subcomponent is one of the 4 subscales of MCS. The social subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 social subcomponent indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 | Week 4 | 6.69 Score on a Scale | Standard Deviation 20.61 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 | Week 12 | 11.96 Score on a Scale | Standard Deviation 23.99 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 | Week 16 | 13.80 Score on a Scale | Standard Deviation 22.96 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 | Week 4 | 4.62 Score on a Scale | Standard Deviation 20.737 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 | Week 12 | 4.88 Score on a Scale | Standard Deviation 22.539 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 | Week 16 | 4.74 Score on a Scale | Standard Deviation 23.303 |
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The vitality subcomponent is one of the 4 subscales of MCS. The vitality subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 vitality subcomponent indicates an improvement.
Time frame: Baseline and Week 4, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 | Week 4 | 4.558 Score on a Scale | Standard Deviation 14.6829 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 | Week 12 | 8.442 Score on a Scale | Standard Deviation 17.9283 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 | Week 16 | 9.682 Score on a Scale | Standard Deviation 16.4474 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 | Week 4 | 4.327 Score on a Scale | Standard Deviation 14.3971 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 | Week 12 | 4.308 Score on a Scale | Standard Deviation 17.6763 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 | Week 16 | 4.893 Score on a Scale | Standard Deviation 17.5265 |
Secondary
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Time frame: Baseline and week 4 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Utility Score (Week 4) | 0.1006 Score on a Scale | Standard Deviation 0.1947 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Utility Score (Week 16) | 0.1630 Score on a Scale | Standard Deviation 0.23696 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Mobility (Week 4) | -0.3 Score on a Scale | Standard Deviation 0.77 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Mobility (Week 16) | -0.5 Score on a Scale | Standard Deviation 0.88 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Self-Care (Week 4) | -0.3 Score on a Scale | Standard Deviation 0.81 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Self-Care (Week 16) | -0.5 Score on a Scale | Standard Deviation 0.9 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Usual Activities (Week 4) | -0.3 Score on a Scale | Standard Deviation 0.83 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Usual Activities (Week 16) | -0.5 Score on a Scale | Standard Deviation 0.92 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Pain/Discomfort (Week 4) | -0.4 Score on a Scale | Standard Deviation 0.77 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Pain/Discomfort (Week 16) | -0.6 Score on a Scale | Standard Deviation 0.93 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Anxiety/Depression (Week 4) | -0.2 Score on a Scale | Standard Deviation 0.74 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Anxiety/Depression (Week 16) | -0.3 Score on a Scale | Standard Deviation 0.84 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Anxiety/Depression (Week 4) | -0.1 Score on a Scale | Standard Deviation 0.79 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Utility Score (Week 4) | 0.0694 Score on a Scale | Standard Deviation 0.19282 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Usual Activities (Week 4) | -0.3 Score on a Scale | Standard Deviation 0.71 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Utility Score (Week 16) | 0.0721 Score on a Scale | Standard Deviation 0.23083 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Pain/Discomfort (Week 16) | -0.3 Score on a Scale | Standard Deviation 0.92 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Mobility (Week 4) | -0.3 Score on a Scale | Standard Deviation 0.8 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Usual Activities (Week 16) | -0.3 Score on a Scale | Standard Deviation 0.78 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Mobility (Week 16) | -0.3 Score on a Scale | Standard Deviation 0.92 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Anxiety/Depression (Week 16) | -0.1 Score on a Scale | Standard Deviation 0.91 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Self-Care (Week 4) | -0.2 Score on a Scale | Standard Deviation 0.78 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Pain/Discomfort (Week 4) | -0.3 Score on a Scale | Standard Deviation 0.81 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 | Self-Care (Week 16) | -0.1 Score on a Scale | Standard Deviation 0.86 |
Secondary
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16
WPAI contains 4 subcomponents - absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. Each subcomponent score ranges from 0 to 100, with higher numbers indicating worse outcome. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Time frame: Baseline and week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | WPAI Absenteeism | -3.30 Score on a Scale | Standard Deviation 20.777 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | WPAI Presenteeism | -13.76 Score on a Scale | Standard Deviation 23.299 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | Work Productivity | -13.33 Score on a Scale | Standard Deviation 24.053 |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | WPAI Activity Impairment | -15.20 Score on a Scale | Standard Deviation 25.466 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | WPAI Activity Impairment | -9.69 Score on a Scale | Standard Deviation 23.855 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | WPAI Absenteeism | 1.23 Score on a Scale | Standard Deviation 19.389 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | Work Productivity | -6.80 Score on a Scale | Standard Deviation 21.526 |
| Placebo-Controlled Period - Placebo | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 | WPAI Presenteeism | -6.91 Score on a Scale | Standard Deviation 20.332 |
Secondary
Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16
BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Time frame: Week 2, 4, 8, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed. with spondylitis in addition to peripheral joint involvement as their presentation of PsA were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 4 | 10.9 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 12 | 25.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 8 | 18.2 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 16 | 25.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 2 | 7.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 16 | 14.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 2 | 6.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 4 | 16.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 8 | 14.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 | Week 12 | 16.3 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count \<= 1 2. Swollen joint count \<=1 3. Psoriasis Area and Severity Index (PASI) \<= 1 or body surface area (BSA) \<= 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain \<= 15 5. Patient Global Assessment of PsA disease activity \<= 20 6. HAQ-DI \<= 0.5 7. Tender enthesial points \<= 1
Time frame: Week 16
Population: Randomized population. Only participants with available data at the timepoint were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | 19.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | 10.2 percentage of participants |
p-value: 0.001295% CI: [1.33, 3.26]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16
Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count \<= 1 2. Swollen joint count \<=1 3. Psoriasis Area and Severity Index (PASI) \<= 1 or body surface area (BSA) \<= 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain \<= 15 5. Patient Global Assessment of PsA disease activity \<= 20 6. HAQ-DI \<= 0.5 7. Tender enthesial points \<= 1
Time frame: Week 4, 8, 12, and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 4 | 6.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 8 | 10.1 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 12 | 14.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 16 | 19.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 16 | 10.2 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 4 | 3.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 12 | 7.2 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 | Week 8 | 6.6 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16
The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: Week 2, 4, 8, 12 and 16
Population: Randomized population. Only participants with a baseline PGA-F score of ≥3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 4 | 12.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 8 | 19.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 12 | 16.9 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 16 | 23.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 16 | 14.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 4 | 6.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 12 | 21.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 | Week 8 | 16.4 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0.5 at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0.5 at Week 16 | 64.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0.5 at Week 16 | 62.9 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0 at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Week 16
Population: Randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0 at Week 16 | 60.4 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0 at Week 16 | 56.6 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= SDC at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96\* standard deviation of the paired differences of change from baseline/ square root of (2\*k); k is the number of reviewers and is default to 2 in this study.
Time frame: Week 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= SDC at Week 16 | 66.7 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= SDC at Week 16 | 66.8 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0.5 at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Week 16
Population: Randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0.5 at Week 16 | 70.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0.5 at Week 16 | 68.9 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0 at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Week 16
Population: Randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0 at Week 16 | 67.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0 at Week 16 | 64.4 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= SDC at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96\* standard deviation of the paired differences of change from baseline/ square root of (2\*k); k is the number of reviewers and is default to 2 in this study.
Time frame: Week 16
Population: Randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= SDC at Week 16 | 70.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= SDC at Week 16 | 68.9 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0.5 at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Week 16
Population: Randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0.5 at Week 16 | 62.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0.5 at Week 16 | 60.5 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0 at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Time frame: Week 16
Population: Randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0 at Week 16 | 59.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0 at Week 16 | 53.9 percentage of participants |
Secondary
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= Smallest Detectable Change (SDC) at Week 16
The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96\* standard deviation of the paired differences of change from baseline/ square root of (2\*k); k is the number of reviewers and is default to 2 in this study.
Time frame: Week 16
Population: Randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= Smallest Detectable Change (SDC) at Week 16 | 67.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= Smallest Detectable Change (SDC) at Week 16 | 66.2 percentage of participants |
Secondary
Percentage of Participants Meeting Dactylitis Resolution at Week 16
Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count =\> 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Time frame: Week 16
Population: Randomized population. Only participants with tender dactylitis count \>=1 at baseline were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Dactylitis Resolution at Week 16 | 59.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Dactylitis Resolution at Week 16 | 43.5 percentage of participants |
p-value: 0.02795% CI: [1.07, 3.03]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Meeting Dactylitis Resolution up to Week 16
Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count =\> 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Time frame: Week 4, 8, 12 and 16
Population: Randomized population. Only participants with tender dactylitis count \>=1 at baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 4 | 36.4 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 8 | 44.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 12 | 54.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 16 | 59.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 16 | 43.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 4 | 33.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 12 | 48.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Dactylitis Resolution up to Week 16 | Week 8 | 43.5 percentage of participants |
Secondary
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \\\< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \\\>5.1=high disease activity.
Time frame: Week 2, 4, 8, 12 and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 4 | 8.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 12 | 20.8 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 8 | 14.9 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 16 | 22.3 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 2 | 2.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 16 | 13.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 2 | 2.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 4 | 5.4 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 8 | 8.7 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 | Week 12 | 9.0 percentage of participants |
Secondary
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \\\< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \\\>5.1=high disease activity.
Time frame: Week 2, 4, 8, 12 and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 4 | 9.8 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 12 | 14.3 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 8 | 11.3 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 16 | 15.2 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 2 | 5.4 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 16 | 8.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 2 | 4.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 4 | 6.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 8 | 9.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 | Week 12 | 11.7 percentage of participants |
Secondary
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Time frame: Week 16
Population: Randomized population with Enthesitis at Baseline by LEI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | 48.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | 46.1 percentage of participants |
p-value: 0.569995% CI: [0.74, 1.75]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16
Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Time frame: Week 4, 8, 12 and 16
Population: Randomized population with Enthesitis at Baseline by LEI
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 4 | 31.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 8 | 44.4 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 12 | 47.2 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 16 | 48.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 16 | 46.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 4 | 32.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 12 | 50.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 | Week 8 | 47.9 percentage of participants |
Secondary
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16
Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right \\\[R\\\]/left \\\[L\\\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.
Time frame: Week 4, 8, 12 and 16
Population: Randomized population with Enthesitis at Baseline by SPARCC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 4 | 19.4 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 8 | 34.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 12 | 36.6 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 16 | 45.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 16 | 34.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 4 | 25.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 12 | 34.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 | Week 8 | 30.8 percentage of participants |
Secondary
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 4, 8, 12 and 16
Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4 | 1.9 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 8 | 8.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 12 | 11.1 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 16 | 14.2 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 16 | 1.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4 | 1.2 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 12 | 1.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 8 | 0.6 percentage of participants |
Secondary
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 16
Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | 51.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | 7.1 percentage of participants |
p-value: <0.000195% CI: [7.19, 27.59]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 4, 8, 12 and 16
Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4 | 11.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 8 | 31.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 12 | 42.6 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 16 | 51.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 16 | 7.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4 | 6.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 12 | 8.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 8 | 10.0 percentage of participants |
Secondary
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 4, 8, 12 and 16
Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4 | 4.3 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 8 | 14.8 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 12 | 20.4 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 16 | 25.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 16 | 1.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 4 | 1.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 12 | 3.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline | Week 8 | 1.8 percentage of participants |
Secondary
Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing no difficulty, 1 representing some difficulty, 2 representing much difficulty, and 3 representing unable to do. increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Clinically meaningful improvement was defined as ≥0.35improvement from baseline.
Time frame: Baseline and Week 2, 4, 8, 12, and 16
Population: Randomized population. Only participants with a HAQ-DI score ≥0.35 at Baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 4 | 41.4 Percentage of Participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 12 | 49.7 Percentage of Participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 8 | 45.5 Percentage of Participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 16 | 51.3 Percentage of Participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 2 | 28.0 Percentage of Participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 16 | 38.8 Percentage of Participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 2 | 28.0 Percentage of Participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 4 | 30.9 Percentage of Participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 8 | 34.2 Percentage of Participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline | Week 12 | 39.7 Percentage of Participants |
Secondary
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \\\[cm\\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. A score 0 signifies remission.
Time frame: Baseline and Week 2, 4, 8, 12 and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 4 | 1.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 12 | 5.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 8 | 3.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 16 | 8.6 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 2 | 0.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 16 | 2.7 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 2 | 0.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 4 | 0.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 8 | 1.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 | Week 12 | 1.8 percentage of participants |
Secondary
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \\\[cm\\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Time frame: Baseline and Week 2, 4, 8, 12 and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 4 | 13.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 12 | 28.9 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 8 | 21.4 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 16 | 26.2 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 2 | 6.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 16 | 18.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 2 | 4.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 4 | 9.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 8 | 16.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 | Week 12 | 17.4 percentage of participants |
Secondary
Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of ≥ 30% in tender joint counts; 2) Decrease of ≥ 30% in swollen joint counts; 3) Decrease of ≥ 20% in Physician Global Assessment of PsA; 4) Decrease of ≥ 20% in Participant's Global Assessment of Disease Activity
Time frame: Week 2, 4, 8, 12 and 16
Population: Randomized population. Only participants with data available at the timepoint were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 4 | 47.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 12 | 55.4 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 8 | 51.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 16 | 62.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 2 | 25.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 16 | 40.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 2 | 21.9 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 4 | 31.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 8 | 41.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 | Week 12 | 39.8 percentage of participants |
Secondary
Percentage of Participants With ACR 20 Response up to Week 16
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 2, 4, 8, 12, and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 20 Response up to Week 16 | Week 12 | 49.1 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 20 Response up to Week 16 | Week 2 | 14.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 20 Response up to Week 16 | Week 4 | 31.5 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 20 Response up to Week 16 | Week 8 | 42.6 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 20 Response up to Week 16 | Week 16 | 54.2 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 20 Response up to Week 16 | Week 16 | 34.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 20 Response up to Week 16 | Week 8 | 30.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 20 Response up to Week 16 | Week 2 | 13.8 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 20 Response up to Week 16 | Week 12 | 31.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 20 Response up to Week 16 | Week 4 | 19.5 percentage of participants |
Secondary
Percentage of Participants With ACR 50 Response up to Week 16
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 2, 4, 8, 12, and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 50 Response up to Week 16 | Week 4 | 7.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 50 Response up to Week 16 | Week 12 | 22.6 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 50 Response up to Week 16 | Week 8 | 17.0 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 50 Response up to Week 16 | Week 16 | 24.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 50 Response up to Week 16 | Week 2 | 2.1 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 50 Response up to Week 16 | Week 16 | 13.5 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 50 Response up to Week 16 | Week 2 | 1.2 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 50 Response up to Week 16 | Week 4 | 3.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 50 Response up to Week 16 | Week 8 | 9.6 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 50 Response up to Week 16 | Week 12 | 10.8 percentage of participants |
Secondary
Percentage of Participants With ACR 70 Response up to Week 16
The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Time frame: Week 2, 4, 8, 12, and 16
Population: Randomized population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 70 Response up to Week 16 | Week 4 | 1.8 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 70 Response up to Week 16 | Week 12 | 7.4 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 70 Response up to Week 16 | Week 8 | 5.7 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 70 Response up to Week 16 | Week 16 | 11.6 percentage of participants |
| Placebo-Controlled Period - Deucravacitinib 6 mg QD | Percentage of Participants With ACR 70 Response up to Week 16 | Week 2 | 0.3 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 70 Response up to Week 16 | Week 16 | 5.4 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 70 Response up to Week 16 | Week 2 | 0.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 70 Response up to Week 16 | Week 4 | 0.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 70 Response up to Week 16 | Week 8 | 3.0 percentage of participants |
| Placebo-Controlled Period - Placebo | Percentage of Participants With ACR 70 Response up to Week 16 | Week 12 | 3.6 percentage of participants |