Psoriatic Arthritis
Conditions
Keywords
Psoriatic arthritis, PsA, Deucravacitinib, BMS-986165, Apremilast, Otezla
Brief summary
The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.
Interventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening * Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria 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 * 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 |
|---|---|---|
| Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | Week 16 | The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | Baseline, 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 Quiestionnaire - Disability Index (HAQ-DI) at Week 16 | Baseline, 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. |
| Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | 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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. |
| Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16 | Baseline, Week 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component 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. |
| Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | Week 16 | Number 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. |
| Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | Week 16 | Number 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, 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. |
| Number of Participants Meeting Dactylitis Resolution at Week 16 | Week 16 | Number 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. |
| Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16 | Week 16 | The American College of Rheumatology (ACR) 50 is defined as 50% improvement over baseline in tender (68) and swollen (66) joint counts and a 50% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. |
| Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16 | Week 16 | The American College of Rheumatology (ACR) 70 is defined as 70% improvement over baseline in tender (68) and swollen (66) joint counts and a 70% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Baseline, Weeks 2, 4, 8, 12, 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. |
| Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16 | Week 16 | Number of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score 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. |
| Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Weeks 4, 8, 12, 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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. |
| Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Weeks 4, 8, 12, 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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. |
| Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Weeks 4, 8, 12, 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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. |
| Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score | Baseline, Weeks 4, 12, 16 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component 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. |
| Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Weeks 4, 8, 12, 16 | Number 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. |
| Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Weeks 4, 8, 12, 16 | Number 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. |
| Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Weeks 4, 8, 12, 16 | Number 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 | Baseline, Weeks 4, 12, 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 better 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 | Baseline, Weeks 2, 4, 8, 12, 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. |
| Number of Participants Meeting Dactylitis Resolution | Weeks 4, 8, 12, 16 | Number 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 | Baseline, Weeks 2, 4, 8, 12, 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 | Baseline, Weeks 2, 4, 8, 12, 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. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement. |
| Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Weeks 2, 4, 8, 12, 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. |
| Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Weeks 2, 4, 8, 12, 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. |
| Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Weeks 4, 8, 12, 16 | 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 (DAS) 28 C-reactive Protein (CRP) Score | Baseline, Weeks 2, 4, 8, 12, 16 | The DAS28-CRP is a composite outcome measure that assesses: 1) 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; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 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. |
| Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Weeks 2, 4, 8, 12, 16 | The DAS28-CRP is a composite outcome measure that assesses: 1) 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; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity. |
| Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Weeks 2, 4, 8, 12, 16 | The DAS28-CRP is a composite outcome measure that assesses: 1) 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; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity. |
| Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) | Baseline, Weeks 4, 12, 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) | Baseline, Weeks 4, 8, 12, 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. |
| Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Weeks 2, 4, 8, 12, 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 |
| Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Weeks 2, 4, 8, 12, 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 |
| Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Baseline, Week 16 | The WPAI is a 6-item questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. 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 | Baseline, Weeks 4, 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) | Baseline, Weeks 4, 12, 16 | The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b 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, Belgium, Canada, China, Colombia, Czechia, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Taiwan, United Kingdom, United States
Contacts
Bristol-Myers Squibb
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deucravacitinib Deucravacitinib 6 mg daily | 312 |
| Placebo Placebo daily | 312 |
| Apremilast Apremilast 30 mg twice daily | 105 |
| Total | 729 |
Baseline characteristics
| Characteristic | Deucravacitinib | Placebo | Apremilast | Total |
|---|---|---|---|---|
| Age, Continuous | 48.7 Years STANDARD_DEVIATION 11.73 | 49.3 Years STANDARD_DEVIATION 12.18 | 49.1 Years STANDARD_DEVIATION 13.47 | 49.0 Years STANDARD_DEVIATION 12.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 50 Participants | 16 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants | 200 Participants | 64 Participants | 459 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 63 Participants | 62 Participants | 25 Participants | 150 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants | 7 Participants | 4 Participants | 24 Participants |
| Race (NIH/OMB) Asian | 54 Participants | 45 Participants | 28 Participants | 127 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 19 Participants | 8 Participants | 49 Participants |
| Race (NIH/OMB) White | 223 Participants | 240 Participants | 65 Participants | 528 Participants |
| Sex: Female, Male Female | 153 Participants | 168 Participants | 56 Participants | 377 Participants |
| Sex: Female, Male Male | 159 Participants | 144 Participants | 49 Participants | 352 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 312 | 1 / 312 | 0 / 105 | 0 / 292 | 1 / 292 | 0 / 90 | 0 / 245 | 1 / 254 | 0 / 70 |
| other Total, other adverse events | 89 / 312 | 93 / 311 | 39 / 105 | 90 / 292 | 106 / 292 | 32 / 90 | 58 / 245 | 61 / 254 | 23 / 70 |
| serious Total, serious adverse events | 6 / 312 | 3 / 311 | 4 / 105 | 12 / 292 | 13 / 292 | 6 / 90 | 16 / 245 | 13 / 254 | 6 / 70 |
Outcome results
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Time frame: Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | 169 Participants |
| Placebo | Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | 123 Participants |
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
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. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAPSA baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 8 | -13.5855 Score on a scale | Standard Deviation 14.33402 |
| Deucravacitinib | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 12 | -15.7385 Score on a scale | Standard Deviation 16.02197 |
| Deucravacitinib | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 16 | -17.5225 Score on a scale | Standard Deviation 16.66002 |
| Deucravacitinib | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 2 | -4.9619 Score on a scale | Standard Deviation 12.27319 |
| Deucravacitinib | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 4 | -9.0129 Score on a scale | Standard Deviation 11.93271 |
| Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 4 | -8.2813 Score on a scale | Standard Deviation 12.79788 |
| Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 8 | -10.7292 Score on a scale | Standard Deviation 16.10715 |
| Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 2 | -5.9569 Score on a scale | Standard Deviation 12.24097 |
| Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 12 | -11.8980 Score on a scale | Standard Deviation 16.33187 |
| Placebo | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score | Week 16 | -12.1547 Score on a scale | Standard Deviation 17.74566 |
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, Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deucravacitinib | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | -1.3133 score on a scale | Standard Deviation 1.1742 |
| Placebo | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | -0.9095 score on a scale | Standard Deviation 1.1047 |
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
The DAS28-CRP is a composite outcome measure that assesses: 1) 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; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 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, Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 2 | -0.3226 Score on a scale | Standard Deviation 0.74392 |
| Deucravacitinib | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 12 | -1.1279 Score on a scale | Standard Deviation 1.14379 |
| Deucravacitinib | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 16 | -1.3133 Score on a scale | Standard Deviation 1.1742 |
| Deucravacitinib | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 4 | -0.6292 Score on a scale | Standard Deviation 0.84069 |
| Deucravacitinib | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 8 | -0.9992 Score on a scale | Standard Deviation 1.0175 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 8 | -0.7579 Score on a scale | Standard Deviation 0.99991 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 2 | -0.4044 Score on a scale | Standard Deviation 0.70334 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 4 | -0.5888 Score on a scale | Standard Deviation 0.75652 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 16 | -0.9095 Score on a scale | Standard Deviation 1.1047 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score | Week 12 | -0.8826 Score on a scale | Standard Deviation 1.03604 |
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
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, Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 4 | 1.3 Score on a scale | Standard Deviation 6.7 |
| Deucravacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 12 | 2.2 Score on a scale | Standard Deviation 8.4 |
| Deucravacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 8 | 2.9 Score on a scale | Standard Deviation 7.53 |
| Deucravacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 16 | 2.6 Score on a scale | Standard Deviation 8.17 |
| Deucravacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 2 | 0.8 Score on a scale | Standard Deviation 6.6 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 16 | 1.9 Score on a scale | Standard Deviation 8.54 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 2 | 1.5 Score on a scale | Standard Deviation 6.52 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 4 | 1.6 Score on a scale | Standard Deviation 6.95 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 8 | 1.9 Score on a scale | Standard Deviation 8.54 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Week 12 | 2.0 Score on a scale | Standard Deviation 8.91 |
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, Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deucravacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16 | 2.6 Score on a scale | Standard Deviation 8.17 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16 | 1.9 Score on a scale | Standard Deviation 8.54 |
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
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, Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 4 | -0.1547 score on a scale | Standard Deviation 0.41308 |
| Deucravacitinib | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 12 | -0.2544 score on a scale | Standard Deviation 0.45565 |
| Deucravacitinib | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 8 | -0.2301 score on a scale | Standard Deviation 0.44365 |
| Deucravacitinib | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 16 | -0.3103 score on a scale | Standard Deviation 0.46159 |
| Deucravacitinib | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 2 | -0.0546 score on a scale | Standard Deviation 0.38637 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 16 | -0.2219 score on a scale | Standard Deviation 0.46858 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 2 | -0.1335 score on a scale | Standard Deviation 0.34583 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 4 | -0.1760 score on a scale | Standard Deviation 0.40042 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 8 | -0.1964 score on a scale | Standard Deviation 0.43603 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | Week 12 | -0.2236 score on a scale | Standard Deviation 0.46098 |
Change From Baseline in Health Assessment Quiestionnaire - 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, Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deucravacitinib | Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16 | -0.3103 score on a scale | Standard Deviation 0.46159 |
| Placebo | Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16 | -0.2219 score on a scale | Standard Deviation 0.46858 |
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
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, Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with mCPDAI baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 12 | -1.6 Score on a scale | Standard Deviation 1.8 |
| Deucravacitinib | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 8 | -1.3 Score on a scale | Standard Deviation 1.71 |
| Deucravacitinib | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 16 | -1.8 Score on a scale | Standard Deviation 1.97 |
| Deucravacitinib | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 4 | -0.8 Score on a scale | Standard Deviation 1.57 |
| Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 16 | -1.2 Score on a scale | Standard Deviation 2.02 |
| Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 8 | -0.9 Score on a scale | Standard Deviation 1.86 |
| Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 12 | -1.0 Score on a scale | Standard Deviation 1.87 |
| Placebo | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) | Week 4 | -0.7 Score on a scale | Standard Deviation 1.76 |
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b 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, Weeks 4, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PROMIS baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) | Week 4 | -1.35 Score on a scale | Standard Deviation 6.958 |
| Deucravacitinib | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) | Week 12 | -1.76 Score on a scale | Standard Deviation 7.945 |
| Deucravacitinib | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) | Week 16 | -2.21 Score on a scale | Standard Deviation 7.447 |
| Placebo | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) | Week 4 | -1.41 Score on a scale | Standard Deviation 6.156 |
| Placebo | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) | Week 12 | -1.48 Score on a scale | Standard Deviation 7.145 |
| Placebo | Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) | Week 16 | -1.53 Score on a scale | Standard Deviation 7.134 |
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
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, Weeks 4, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PASDAS baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) | Week 4 | -0.8037 Score on a scale | Standard Deviation 0.90993 |
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) | Week 12 | -1.5273 Score on a scale | Standard Deviation 1.27441 |
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) | Week 16 | -1.7047 Score on a scale | Standard Deviation 1.32902 |
| Placebo | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) | Week 4 | -0.7690 Score on a scale | Standard Deviation 0.90884 |
| Placebo | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) | Week 12 | -1.0137 Score on a scale | Standard Deviation 1.174 |
| Placebo | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) | Week 16 | -1.1434 Score on a scale | Standard Deviation 1.26434 |
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
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, Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 2 | -0.658 Score on a scale | Standard Deviation 1.3895 |
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 4 | -0.986 Score on a scale | Standard Deviation 1.5902 |
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 12 | -1.511 Score on a scale | Standard Deviation 1.9314 |
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 8 | -1.419 Score on a scale | Standard Deviation 1.7445 |
| Deucravacitinib | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 16 | -1.729 Score on a scale | Standard Deviation 2.015 |
| Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 16 | -0.968 Score on a scale | Standard Deviation 1.9075 |
| Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 8 | -0.849 Score on a scale | Standard Deviation 1.8018 |
| Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 2 | -0.590 Score on a scale | Standard Deviation 1.2369 |
| Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 12 | -0.937 Score on a scale | Standard Deviation 1.9126 |
| Placebo | Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score | Week 4 | -0.761 Score on a scale | Standard Deviation 1.5206 |
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
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 better 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, Weeks 4, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 MCS baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score | Week 4 | 0.195 Score on a scale | Standard Deviation 7.7026 |
| Deucravacitinib | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score | Week 12 | 1.245 Score on a scale | Standard Deviation 8.6442 |
| Deucravacitinib | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score | Week 16 | 1.009 Score on a scale | Standard Deviation 9.774 |
| Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score | Week 16 | -0.438 Score on a scale | Standard Deviation 9.3388 |
| Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score | Week 4 | 0.300 Score on a scale | Standard Deviation 7.7067 |
| Placebo | Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score | Week 12 | 0.123 Score on a scale | Standard Deviation 9.1804 |
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component 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, Weeks 4, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score | Week 4 | 3.364 Score on a scale | Standard Deviation 5.8439 |
| Deucravacitinib | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score | Week 12 | 5.419 Score on a scale | Standard Deviation 7.1066 |
| Deucravacitinib | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score | Week 16 | 6.194 Score on a scale | Standard Deviation 7.464 |
| Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score | Week 4 | 2.771 Score on a scale | Standard Deviation 5.8897 |
| Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score | Week 12 | 3.578 Score on a scale | Standard Deviation 6.7537 |
| Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score | Week 16 | 4.262 Score on a scale | Standard Deviation 7.0328 |
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component 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, Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deucravacitinib | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16 | 6.194 Score on a scale | Standard Deviation 7.464 |
| Placebo | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16 | 4.262 Score on a scale | Standard Deviation 7.0328 |
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
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, Weeks 4, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with EQ-5D-5L baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Utility Score | 0.0990 Score on a scale | Standard Deviation 0.21113 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Utility Score | 0.0505 Score on a scale | Standard Deviation 0.17658 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Mobility | -0.2 Score on a scale | Standard Deviation 0.74 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Mobility | -0.3 Score on a scale | Standard Deviation 0.92 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Self-Care | -0.1 Score on a scale | Standard Deviation 0.73 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Self-Care | -0.2 Score on a scale | Standard Deviation 0.83 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Usual Activities | -0.1 Score on a scale | Standard Deviation 0.76 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Usual Activities | -0.3 Score on a scale | Standard Deviation 0.84 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Pain/Discomfort | -0.3 Score on a scale | Standard Deviation 0.75 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Pain/Discomfort | -0.5 Score on a scale | Standard Deviation 0.89 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Anxiety/Depression | -0.1 Score on a scale | Standard Deviation 0.76 |
| Deucravacitinib | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Anxiety/Depression | -0.1 Score on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Anxiety/Depression | -0.1 Score on a scale | Standard Deviation 0.78 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Utility Score | 0.0770 Score on a scale | Standard Deviation 0.22126 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Anxiety/Depression | 0.0 Score on a scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Usual Activities | -0.2 Score on a scale | Standard Deviation 0.73 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Pain/Discomfort | -0.4 Score on a scale | Standard Deviation 0.93 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Mobility | -0.2 Score on a scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Usual Activities | -0.3 Score on a scale | Standard Deviation 0.83 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Mobility | -0.3 Score on a scale | Standard Deviation 0.87 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Utility Score | 0.0655 Score on a scale | Standard Deviation 0.1908 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Self-Care | -0.2 Score on a scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 4 Pain/Discomfort | -0.3 Score on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents | Week 16 Self-Care | -0.2 Score on a scale | Standard Deviation 0.81 |
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
The WPAI is a 6-item questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Time frame: Baseline, Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with WPAI baseline and post-baseline measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Presenteeism | -13.97 Score on a scale | Standard Deviation 23.38 |
| Deucravacitinib | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Activity Impairment | -15.72 Score on a scale | Standard Deviation 25.226 |
| Deucravacitinib | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Absenteeism | -0.59 Score on a scale | Standard Deviation 21.406 |
| Deucravacitinib | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Work Productivity | -13.71 Score on a scale | Standard Deviation 24.087 |
| Placebo | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Activity Impairment | -8.16 Score on a scale | Standard Deviation 24.178 |
| Placebo | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Presenteeism | -5.96 Score on a scale | Standard Deviation 22.238 |
| Placebo | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Work Productivity | -5.79 Score on a scale | Standard Deviation 23.951 |
| Placebo | Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16 | Absenteeism | 1.56 Score on a scale | Standard Deviation 22.108 |
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
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: Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with spondylitis in addition to peripheral joint involvement as their presentation of PsA
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 4 | 6 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 12 | 11 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 8 | 12 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 16 | 17 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 2 | 2 Participants |
| Placebo | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 16 | 4 Participants |
| Placebo | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 2 | 1 Participants |
| Placebo | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 4 | 1 Participants |
| Placebo | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 8 | 5 Participants |
| Placebo | Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score | Week 12 | 4 Participants |
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Number 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: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 4 | 19 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 8 | 35 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 12 | 56 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 16 | 80 Participants |
| Placebo | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 16 | 46 Participants |
| Placebo | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 4 | 16 Participants |
| Placebo | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 12 | 24 Participants |
| Placebo | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) | Week 8 | 28 Participants |
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
Number 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: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | 80 Participants |
| Placebo | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | 46 Participants |
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
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: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with a baseline PGA-F score of \>= 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 4 | 10 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 8 | 13 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 12 | 16 Participants |
| Deucravacitinib | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 16 | 17 Participants |
| Placebo | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 16 | 15 Participants |
| Placebo | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 4 | 10 Participants |
| Placebo | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 12 | 11 Participants |
| Placebo | Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 | Week 8 | 13 Participants |
Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
The American College of Rheumatology (ACR) 50 is defined as 50% improvement over baseline in tender (68) and swollen (66) joint counts and a 50% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Time frame: Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16 | 90 Participants |
| Placebo | Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16 | 51 Participants |
Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
The American College of Rheumatology (ACR) 70 is defined as 70% improvement over baseline in tender (68) and swollen (66) joint counts and a 70% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Time frame: Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16 | 33 Participants |
| Placebo | Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16 | 17 Participants |
Number of Participants Meeting Dactylitis Resolution
Number 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: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count \>=1 at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Dactylitis Resolution | Week 4 | 24 Participants |
| Deucravacitinib | Number of Participants Meeting Dactylitis Resolution | Week 8 | 31 Participants |
| Deucravacitinib | Number of Participants Meeting Dactylitis Resolution | Week 12 | 39 Participants |
| Deucravacitinib | Number of Participants Meeting Dactylitis Resolution | Week 16 | 43 Participants |
| Placebo | Number of Participants Meeting Dactylitis Resolution | Week 16 | 36 Participants |
| Placebo | Number of Participants Meeting Dactylitis Resolution | Week 4 | 30 Participants |
| Placebo | Number of Participants Meeting Dactylitis Resolution | Week 12 | 29 Participants |
| Placebo | Number of Participants Meeting Dactylitis Resolution | Week 8 | 27 Participants |
Number of Participants Meeting Dactylitis Resolution at Week 16
Number 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: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count \>=1 at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Meeting Dactylitis Resolution at Week 16 | 43 Participants |
| Placebo | Number of Participants Meeting Dactylitis Resolution at Week 16 | 36 Participants |
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Number 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: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 4 | 45 Participants |
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 8 | 70 Participants |
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 12 | 74 Participants |
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 16 | 74 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 16 | 66 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 4 | 55 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 12 | 58 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) | Week 8 | 54 Participants |
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
Number 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: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | 74 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | 66 Participants |
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Number 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: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by SPARCC
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 4 | 53 Participants |
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 8 | 73 Participants |
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 12 | 75 Participants |
| Deucravacitinib | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 16 | 86 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 16 | 75 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 4 | 55 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 12 | 66 Participants |
| Placebo | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) | Week 8 | 55 Participants |
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Time frame: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 4 | 2 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 8 | 6 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 12 | 17 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 16 | 24 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 16 | 8 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 4 | 0 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 12 | 9 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100) | Week 8 | 3 Participants |
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Time frame: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 4 | 14 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 8 | 26 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 12 | 45 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 16 | 63 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 16 | 23 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 4 | 10 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 12 | 22 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) | Week 8 | 19 Participants |
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at 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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Time frame: Week 16
Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | 63 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | 23 Participants |
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Time frame: Weeks 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 4 | 4 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 8 | 10 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 12 | 31 Participants |
| Deucravacitinib | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 16 | 41 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 16 | 13 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 4 | 3 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 12 | 15 Participants |
| Placebo | Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90) | Week 8 | 7 Participants |
Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
Number of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score 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.
Time frame: Week 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib | Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16 | 131 Participants |
| Placebo | Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16 | 118 Participants |
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
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: Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 12 | 20 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 4 | 2 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 8 | 12 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 2 | 1 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 16 | 30 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 2 | 1 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 8 | 4 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 16 | 9 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 4 | 1 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission | Week 12 | 8 Participants |
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
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: Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 8 | 69 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 12 | 95 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 4 | 44 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 16 | 104 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 2 | 25 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 16 | 78 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 2 | 18 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 8 | 55 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 4 | 42 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response | Week 12 | 66 Participants |
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
The DAS28-CRP is a composite outcome measure that assesses: 1) 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; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity.
Time frame: Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 12 | 64 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 16 | 84 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 2 | 13 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 4 | 27 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 8 | 57 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 8 | 31 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 4 | 14 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 16 | 44 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 12 | 35 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission | Week 2 | 7 Participants |
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
The DAS28-CRP is a composite outcome measure that assesses: 1) 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; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity.
Time frame: Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 16 | 56 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 4 | 39 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 8 | 35 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 12 | 54 Participants |
| Deucravacitinib | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 2 | 23 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 16 | 43 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 12 | 39 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 4 | 31 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 2 | 19 Participants |
| Placebo | Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response | Week 8 | 32 Participants |
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
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: Weeks 2, 4, 8, 12, 16
Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Deucravacitinib | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 12 | 176 Participants |
| Deucravacitinib | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 16 | 187 Participants |
| Deucravacitinib | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 2 | 71 Participants |
| Deucravacitinib | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 8 | 163 Participants |
| Deucravacitinib | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 4 | 128 Participants |
| Placebo | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 4 | 98 Participants |
| Placebo | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 12 | 122 Participants |
| Placebo | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 8 | 126 Participants |
| Placebo | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 16 | 138 Participants |
| Placebo | Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) | Week 2 | 69 Participants |