Trial Outcomes & Findings for A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs (NCT NCT04908202)

NCT ID: NCT04908202

Last Updated: 2025-10-24

Results Overview

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 670 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2025-10-24

Participant Flow

Participant milestones

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Active Treatment Period - Deucravacitinib 6 mg QD Participants earlier randomized to Deucravacitinib 6 mg QD arm in Placebo-Controlled period continued to receive 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD Participants earlier randomized to Placebo arm in Placebo-Controlled period received 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.
Pre-Treatment Period STARTED	336	334	0	0
Pre-Treatment Period COMPLETED	332	333	0	0
Pre-Treatment Period NOT COMPLETED	4	1	0	0
Placebo-Controlled Treatment Period STARTED	332	333	0	0
Placebo-Controlled Treatment Period COMPLETED	309	306	0	0
Placebo-Controlled Treatment Period NOT COMPLETED	23	27	0	0
Active Treatment Period STARTED	0	0	309	306
Active Treatment Period COMPLETED	0	0	168	160
Active Treatment Period NOT COMPLETED	0	0	141	146

Reasons for withdrawal

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Active Treatment Period - Deucravacitinib 6 mg QD Participants earlier randomized to Deucravacitinib 6 mg QD arm in Placebo-Controlled period continued to receive 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD Participants earlier randomized to Placebo arm in Placebo-Controlled period received 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.
Pre-Treatment Period OTHER REASONS	3	1	0	0
Pre-Treatment Period PARTICIPANT WITHDREW CONSENT	1	0	0	0
Placebo-Controlled Treatment Period Lack of Efficacy	1	2	0	0
Placebo-Controlled Treatment Period Adverse Event	8	6	0	0
Placebo-Controlled Treatment Period PARTICIPANT REQUEST TO DISCONTINUE STUDY TREATMENT	2	3	0	0
Placebo-Controlled Treatment Period PARTICIPANT WITHDREW CONSENT	4	10	0	0
Placebo-Controlled Treatment Period Lost to Follow-up	0	1	0	0
Placebo-Controlled Treatment Period ADMINISTRATIVE REASONS BY SPONSOR	0	1	0	0
Placebo-Controlled Treatment Period Other reasons	8	4	0	0
Active Treatment Period OTHER REASONS	0	0	1	3
Active Treatment Period Lack of Efficacy	0	0	4	5
Active Treatment Period Adverse Event	0	0	5	8
Active Treatment Period PARTICIPANT REQUEST TO DISCONTINUE STUDY TREATMENT	0	0	2	2
Active Treatment Period PARTICIPANT WITHDREW CONSENT	0	0	8	11
Active Treatment Period Lost to Follow-up	0	0	2	2
Active Treatment Period POOR/NON-COMPLIANCE	0	0	1	0
Active Treatment Period ADMINISTRATIVE REASONS BY SPONSOR	0	0	1	1
Active Treatment Period ONGOING Treatment	0	0	117	114

Baseline Characteristics

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Baseline characteristics by cohort

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Total n=670 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 12.52 • n=5 Participants	52.3 years STANDARD_DEVIATION 12.32 • n=7 Participants	52.0 years STANDARD_DEVIATION 12.41 • n=5 Participants
Sex: Female, Male Female	164 Participants n=5 Participants	170 Participants n=7 Participants	334 Participants n=5 Participants
Sex: Female, Male Male	172 Participants n=5 Participants	164 Participants n=7 Participants	336 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	101 Participants n=5 Participants	94 Participants n=7 Participants	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	165 Participants n=5 Participants	165 Participants n=7 Participants	330 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	70 Participants n=5 Participants	75 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	263 Participants n=5 Participants	279 Participants n=7 Participants	542 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized OTHER	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized CHINESE	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN OTHER	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Randomized population

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants With ACR 20 Response at Week 16	54.2 percentage of participants Interval 48.7 to 59.6	34.1 percentage of participants Interval 29.1 to 39.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=317 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=317 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16	-1.4106 Score on a Scale Standard Deviation 1.13277	-0.8902 Score on a Scale Standard Deviation 1.10750

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16	-0.4103 Score on a Scale Standard Deviation 0.52303	-0.2118 Score on a Scale Standard Deviation 0.51583

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=162 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=170 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline	51.9 percentage of participants Interval 43.9 to 59.8	7.1 percentage of participants Interval 3.7 to 12.0

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16	6.410 Score on a Scale Standard Deviation 8.2883	3.847 Score on a Scale Standard Deviation 7.2929

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population with Enthesitis at Baseline by LEI

Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=178 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=167 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16	48.3 percentage of participants Interval 40.8 to 55.9	46.1 percentage of participants Interval 38.4 to 54.0

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population. Only participants with available data at the timepoint were analyzed.

Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:

1. Tender joint count <= 1

2. Swollen joint count <=1

3. Psoriasis Area and Severity Index (PASI) <= 1 or body surface area (BSA) <= 3%

4. Patient assessment of psoriatic arthiritis (PsA) pain <= 15

5. Patient Global Assessment of PsA disease activity <= 20

6. HAQ-DI <= 0.5

7. Tender enthesial points <= 1

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16	19.0 percentage of participants Interval 15.0 to 23.7	10.2 percentage of participants Interval 7.2 to 13.9

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16	4.9 Score on a Scale Standard Deviation 8.84	2.2 Score on a Scale Standard Deviation 8.81

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population. Only participants with tender dactylitis count \>=1 at baseline were included in the analysis.

Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count => 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=132 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=108 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Dactylitis Resolution at Week 16	59.1 percentage of participants Interval 50.2 to 67.6	43.5 percentage of participants Interval 34.0 to 53.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. Change from baseline reflects progression or improvement; a decrease suggests reduced damage or improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=245 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=251 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16	0.3980 Score on a Scale Standard Deviation 2.00852	0.5757 Score on a Scale Standard Deviation 2.73874

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, and 16

Population: Randomized population.

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants With ACR 20 Response up to Week 16 Week 4	31.5 percentage of participants Interval 26.6 to 36.8	19.5 percentage of participants Interval 15.4 to 24.1
Percentage of Participants With ACR 20 Response up to Week 16 Week 2	14.0 percentage of participants Interval 10.5 to 18.2	13.8 percentage of participants Interval 10.3 to 17.9
Percentage of Participants With ACR 20 Response up to Week 16 Week 8	42.6 percentage of participants Interval 37.2 to 48.0	30.5 percentage of participants Interval 25.6 to 35.8
Percentage of Participants With ACR 20 Response up to Week 16 Week 12	49.1 percentage of participants Interval 43.6 to 54.6	31.1 percentage of participants Interval 26.2 to 36.4
Percentage of Participants With ACR 20 Response up to Week 16 Week 16	54.2 percentage of participants Interval 48.7 to 59.6	34.1 percentage of participants Interval 29.1 to 39.5

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, and 16

Population: Randomized population.

The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants With ACR 50 Response up to Week 16 Week 2	2.1 percentage of participants Interval 0.8 to 4.2	1.2 percentage of participants Interval 0.3 to 3.0
Percentage of Participants With ACR 50 Response up to Week 16 Week 4	7.7 percentage of participants Interval 5.1 to 11.1	3.6 percentage of participants Interval 1.9 to 6.2
Percentage of Participants With ACR 50 Response up to Week 16 Week 8	17.0 percentage of participants Interval 13.1 to 21.4	9.6 percentage of participants Interval 6.6 to 13.3
Percentage of Participants With ACR 50 Response up to Week 16 Week 12	22.6 percentage of participants Interval 18.3 to 27.5	10.8 percentage of participants Interval 7.7 to 14.6
Percentage of Participants With ACR 50 Response up to Week 16 Week 16	24.7 percentage of participants Interval 20.2 to 29.7	13.5 percentage of participants Interval 10.0 to 17.6

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, and 16

Population: Randomized population.

The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants With ACR 70 Response up to Week 16 Week 16	11.6 percentage of participants Interval 8.4 to 15.5	5.4 percentage of participants Interval 3.2 to 8.4
Percentage of Participants With ACR 70 Response up to Week 16 Week 2	0.3 percentage of participants Interval 0.0 to 1.6	0.0 percentage of participants Interval 0.0 to 1.1
Percentage of Participants With ACR 70 Response up to Week 16 Week 4	1.8 percentage of participants Interval 0.7 to 3.8	0.0 percentage of participants Interval 0.0 to 1.1
Percentage of Participants With ACR 70 Response up to Week 16 Week 8	5.7 percentage of participants Interval 3.4 to 8.7	3.0 percentage of participants Interval 1.4 to 5.4
Percentage of Participants With ACR 70 Response up to Week 16 Week 12	7.4 percentage of participants Interval 4.9 to 10.8	3.6 percentage of participants Interval 1.9 to 6.2

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12, and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Week 12 (n= 326, 327)	-0.3589 Score on a Scale Standard Deviation 0.49384	-0.1957 Score on a Scale Standard Deviation 0.53080
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Week 2 (n=324, 323)	-0.1655 Score on a Scale Standard Deviation 0.37744	-0.1250 Score on a Scale Standard Deviation 0.38243
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Week 4 (n=325, 326)	-0.2412 Score on a Scale Standard Deviation 0.43862	-0.1614 Score on a Scale Standard Deviation 0.39402
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Week 8 (n=327, 326)	-0.3119 Score on a Scale Standard Deviation 0.50219	-0.1963 Score on a Scale Standard Deviation 0.47057
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Week 16 (n=326, 327)	-0.4103 Score on a Scale Standard Deviation 0.52303	-0.2118 Score on a Scale Standard Deviation 0.51583

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12, and 16

Population: Randomized population. Only participants with a HAQ-DI score ≥0.35 at Baseline were included in the analysis.

HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Clinically meaningful improvement was defined as ≥0.35improvement from baseline.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=314 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=307 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline Week 2	28.0 Percentage of Participants Interval 23.1 to 33.3	28.0 Percentage of Participants Interval 23.1 to 33.4
Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline Week 4	41.4 Percentage of Participants Interval 35.9 to 47.1	30.9 Percentage of Participants Interval 25.8 to 36.4
Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline Week 8	45.5 Percentage of Participants Interval 39.9 to 51.2	34.2 Percentage of Participants Interval 28.9 to 39.8
Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline Week 12	49.7 Percentage of Participants Interval 44.0 to 55.4	39.7 Percentage of Participants Interval 34.2 to 45.5
Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline Week 16	51.3 Percentage of Participants Interval 45.6 to 56.9	38.8 Percentage of Participants Interval 33.3 to 44.5

SECONDARY outcome

Timeframe: Week 4, 8, 12 and 16

Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=162 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=170 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 4	11.7 percentage of participants Interval 7.2 to 17.7	6.5 percentage of participants Interval 3.3 to 11.3
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 8	31.5 percentage of participants Interval 24.4 to 39.2	10.0 percentage of participants Interval 5.9 to 15.5
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 12	42.6 percentage of participants Interval 34.9 to 50.6	8.8 percentage of participants Interval 5.0 to 14.1
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 16	51.9 percentage of participants Interval 43.9 to 59.8	7.1 percentage of participants Interval 3.7 to 12.0

SECONDARY outcome

Timeframe: Week 4, 8, 12 and 16

Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=162 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=170 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 4	4.3 percentage of participants Interval 1.8 to 8.7	1.8 percentage of participants Interval 0.4 to 5.1
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 8	14.8 percentage of participants Interval 9.7 to 21.2	1.8 percentage of participants Interval 0.4 to 5.1
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 16	25.3 percentage of participants Interval 18.8 to 32.7	1.8 percentage of participants Interval 0.4 to 5.1
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 12	20.4 percentage of participants Interval 14.5 to 27.4	3.5 percentage of participants Interval 1.3 to 7.5

SECONDARY outcome

Timeframe: Week 4, 8, 12 and 16

Population: Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=162 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=170 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 4	1.9 percentage of participants Interval 0.4 to 5.3	1.2 percentage of participants Interval 0.1 to 4.2
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 8	8.0 percentage of participants Interval 4.3 to 13.3	0.6 percentage of participants Interval 0.0 to 3.2
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 12	11.1 percentage of participants Interval 6.7 to 17.0	1.8 percentage of participants Interval 0.4 to 5.1
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline Week 16	14.2 percentage of participants Interval 9.2 to 20.5	1.8 percentage of participants Interval 0.4 to 5.1

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 Week 4	3.760 Score on a Scale Standard Deviation 6.2768	3.326 Score on a Scale Standard Deviation 5.7315
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 Week 12	6.021 Score on a Scale Standard Deviation 7.5809	3.916 Score on a Scale Standard Deviation 7.6614
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16 Week 16	6.410 Score on a Scale Standard Deviation 8.2883	3.847 Score on a Scale Standard Deviation 7.2929

SECONDARY outcome

Timeframe: Week 4, 8, 12 and 16

Population: Randomized population with Enthesitis at Baseline by LEI

Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=178 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=167 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 Week 8	44.4 percentage of participants Interval 37.0 to 52.0	47.9 percentage of participants Interval 40.1 to 55.8
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 Week 4	31.5 percentage of participants Interval 24.7 to 38.8	32.9 percentage of participants Interval 25.9 to 40.6
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 Week 12	47.2 percentage of participants Interval 39.7 to 54.8	50.3 percentage of participants Interval 42.5 to 58.1
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16 Week 16	48.3 percentage of participants Interval 40.8 to 55.9	46.1 percentage of participants Interval 38.4 to 54.0

SECONDARY outcome

Timeframe: Week 4, 8, 12 and 16

Population: Randomized population with Enthesitis at Baseline by SPARCC

Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right \[R\]/left \[L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=216 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=211 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 Week 4	19.4 percentage of participants Interval 14.4 to 25.4	25.6 percentage of participants Interval 19.8 to 32.0
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 Week 8	34.7 percentage of participants Interval 28.4 to 41.5	30.8 percentage of participants Interval 24.6 to 37.5
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 Week 12	36.6 percentage of participants Interval 30.1 to 43.4	34.6 percentage of participants Interval 28.2 to 41.4
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16 Week 16	45.8 percentage of participants Interval 39.1 to 52.7	34.1 percentage of participants Interval 27.8 to 40.9

SECONDARY outcome

Timeframe: Week 4, 8, 12, and 16

Population: Randomized population.

Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:

1. Tender joint count <= 1

2. Swollen joint count <=1

3. Psoriasis Area and Severity Index (PASI) <= 1 or body surface area (BSA) <= 3%

4. Patient assessment of psoriatic arthiritis (PsA) pain <= 15

5. Patient Global Assessment of PsA disease activity <= 20

6. HAQ-DI <= 0.5

7. Tender enthesial points <= 1

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 Week 4	6.0 percentage of participants Interval 3.7 to 9.0	3.0 percentage of participants Interval 1.4 to 5.4
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 Week 12	14.0 percentage of participants Interval 10.5 to 18.2	7.2 percentage of participants Interval 4.7 to 10.5
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 Week 8	10.1 percentage of participants Interval 7.1 to 13.9	6.6 percentage of participants Interval 4.2 to 9.8
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16 Week 16	19.0 percentage of participants Interval 15.0 to 23.7	10.2 percentage of participants Interval 7.2 to 13.9

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 Week 4	0.814 Score on a Scale Standard Deviation 7.5082	0.634 Score on a Scale Standard Deviation 7.3796
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 Week 12	2.056 Score on a Scale Standard Deviation 8.4206	0.034 Score on a Scale Standard Deviation 8.3926
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16 Week 16	2.588 Score on a Scale Standard Deviation 8.3442	0.358 Score on a Scale Standard Deviation 8.1559

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 Week 4	2.5 Score on a Scale Standard Deviation 7.48	2.3 Score on a Scale Standard Deviation 7.67
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 Week 2	2.2 Score on a Scale Standard Deviation 7.31	2.3 Score on a Scale Standard Deviation 6.52
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 Week 8	4.5 Score on a Scale Standard Deviation 8.68	2.8 Score on a Scale Standard Deviation 9.64
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 Week 12	4.3 Score on a Scale Standard Deviation 8.98	1.8 Score on a Scale Standard Deviation 8.97
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16 Week 16	4.9 Score on a Scale Standard Deviation 8.84	2.2 Score on a Scale Standard Deviation 8.81

SECONDARY outcome

Timeframe: Week 4, 8, 12 and 16

Population: Randomized population. Only participants with tender dactylitis count \>=1 at baseline were included in the analysis.

Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count => 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=132 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=108 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Dactylitis Resolution up to Week 16 Week 4	36.4 percentage of participants Interval 28.2 to 45.2	33.3 percentage of participants Interval 24.6 to 43.1
Percentage of Participants Meeting Dactylitis Resolution up to Week 16 Week 8	44.7 percentage of participants Interval 36.0 to 53.6	43.5 percentage of participants Interval 34.0 to 53.4
Percentage of Participants Meeting Dactylitis Resolution up to Week 16 Week 12	54.5 percentage of participants Interval 45.7 to 63.2	48.1 percentage of participants Interval 38.4 to 58.0
Percentage of Participants Meeting Dactylitis Resolution up to Week 16 Week 16	59.1 percentage of participants Interval 50.2 to 67.6	43.5 percentage of participants Interval 34.0 to 53.4

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 Week 2	-0.807 Score on a Scale Standard Deviation 1.3327	-0.652 Score on a Scale Standard Deviation 1.2524
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 Week 4	-1.164 Score on a Scale Standard Deviation 1.5433	-0.836 Score on a Scale Standard Deviation 1.5580
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 Week 8	-1.545 Score on a Scale Standard Deviation 1.9037	-0.991 Score on a Scale Standard Deviation 1.9281
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 Week 12	-1.761 Score on a Scale Standard Deviation 2.0074	-0.883 Score on a Scale Standard Deviation 1.9677
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16 Week 16	-1.851 Score on a Scale Standard Deviation 2.0440	-1.015 Score on a Scale Standard Deviation 1.9955

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. The DAPSA score ranges from 0 to 154, with a higher score indicating more disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=325 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=323 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 Week 12	-19.8346 Score on a Scale Standard Deviation 17.22613	-13.2671 Score on a Scale Standard Deviation 17.41524
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 Week 2	-7.6211 Score on a Scale Standard Deviation 13.23221	-7.0045 Score on a Scale Standard Deviation 11.71166
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 Week 4	-12.5643 Score on a Scale Standard Deviation 14.38734	-10.1201 Score on a Scale Standard Deviation 13.64766
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 Week 8	-16.6770 Score on a Scale Standard Deviation 16.71038	-12.3610 Score on a Scale Standard Deviation 15.70632
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16 Week 16	-20.7263 Score on a Scale Standard Deviation 18.08249	-13.4075 Score on a Scale Standard Deviation 17.31116

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12 and 16

Population: Randomized population.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 Week 2	6.5 percentage of participants Interval 4.1 to 9.7	4.5 percentage of participants Interval 2.5 to 7.3
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 Week 4	13.7 percentage of participants Interval 10.2 to 17.8	9.9 percentage of participants Interval 6.9 to 13.6
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 Week 8	21.4 percentage of participants Interval 17.2 to 26.2	16.5 percentage of participants Interval 12.7 to 20.9
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 Week 12	28.9 percentage of participants Interval 24.1 to 34.0	17.4 percentage of participants Interval 13.5 to 21.9
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16 Week 16	26.2 percentage of participants Interval 21.6 to 31.2	18.9 percentage of participants Interval 14.8 to 23.5

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12 and 16

Population: Randomized population.

The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. A score 0 signifies remission.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 Week 4	1.5 percentage of participants Interval 0.5 to 3.4	0.6 percentage of participants Interval 0.1 to 2.1
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 Week 16	8.6 percentage of participants Interval 5.9 to 12.2	2.7 percentage of participants Interval 1.2 to 5.1
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 Week 2	0.3 percentage of participants Interval 0.0 to 1.6	0.0 percentage of participants Interval 0.0 to 1.1
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 Week 8	3.0 percentage of participants Interval 1.4 to 5.4	1.8 percentage of participants Interval 0.7 to 3.9
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16 Week 12	5.7 percentage of participants Interval 3.4 to 8.7	1.8 percentage of participants Interval 0.7 to 3.9

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12 and 16

Population: Randomized population. Only participants with a baseline PGA-F score of ≥3

The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=71 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=61 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 Week 8	19.7 percentage of participants Interval 11.2 to 30.9	16.4 percentage of participants Interval 8.2 to 28.1
Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 Week 4	12.7 percentage of participants Interval 6.0 to 22.7	6.6 percentage of participants Interval 1.8 to 15.9
Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 Week 12	16.9 percentage of participants Interval 9.0 to 27.7	21.3 percentage of participants Interval 11.9 to 33.7
Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16 Week 16	23.9 percentage of participants Interval 14.6 to 35.5	14.8 percentage of participants Interval 7.0 to 26.2

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=325 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=323 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 Week 2	-0.4028 Score on a Scale Standard Deviation 0.77126	-0.4006 Score on a Scale Standard Deviation 0.70508
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 Week 12	-1.3360 Score on a Scale Standard Deviation 1.13745	-0.8450 Score on a Scale Standard Deviation 1.09776
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 Week 16	-1.4106 Score on a Scale Standard Deviation 1.13277	-0.8902 Score on a Scale Standard Deviation 1.10750
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 Week 4	-0.7655 Score on a Scale Standard Deviation 0.90092	-0.6468 Score on a Scale Standard Deviation 0.82146
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16 Week 8	-1.0820 Score on a Scale Standard Deviation 1.02041	-0.7727 Score on a Scale Standard Deviation 0.99752

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12 and 16

Population: Randomized population.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 Week 2	5.4 percentage of participants Interval 3.2 to 8.3	4.8 percentage of participants Interval 2.8 to 7.7
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 Week 4	9.8 percentage of participants Interval 6.9 to 13.5	6.0 percentage of participants Interval 3.7 to 9.1
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 Week 8	11.3 percentage of participants Interval 8.1 to 15.2	9.3 percentage of participants Interval 6.4 to 12.9
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 Week 12	14.3 percentage of participants Interval 10.7 to 18.5	11.7 percentage of participants Interval 8.4 to 15.6
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16 Week 16	15.2 percentage of participants Interval 11.5 to 19.5	8.1 percentage of participants Interval 5.4 to 11.5

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12 and 16

Population: Randomized population.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 Week 2	2.1 percentage of participants Interval 0.8 to 4.2	2.1 percentage of participants Interval 0.8 to 4.3
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 Week 4	8.0 percentage of participants Interval 5.4 to 11.5	5.4 percentage of participants Interval 3.2 to 8.4
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 Week 8	14.9 percentage of participants Interval 11.3 to 19.1	8.7 percentage of participants Interval 5.9 to 12.2
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 Week 12	20.8 percentage of participants Interval 16.6 to 25.6	9.0 percentage of participants Interval 6.1 to 12.6
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16 Week 16	22.3 percentage of participants Interval 18.0 to 27.2	13.8 percentage of participants Interval 10.3 to 17.9

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=317 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=316 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 Week 4	-1.0405 Score on a Scale Standard Deviation 1.03004	-0.8258 Score on a Scale Standard Deviation 0.97038
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 Week 12	-1.7675 Score on a Scale Standard Deviation 1.37563	-1.0780 Score on a Scale Standard Deviation 1.33036
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16 Week 16	-1.9064 Score on a Scale Standard Deviation 1.45258	-1.1026 Score on a Scale Standard Deviation 1.31166

SECONDARY outcome

Timeframe: Baseline and Week 4, 8, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=325 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 Week 12	-2.1 Score on a Scale Standard Deviation 2.16	-1.3 Score on a Scale Standard Deviation 2.01
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 Week 4	-1.2 Score on a Scale Standard Deviation 1.81	-0.8 Score on a Scale Standard Deviation 1.61
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 Week 8	-1.7 Score on a Scale Standard Deviation 2.09	-1.2 Score on a Scale Standard Deviation 1.89
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16 Week 16	-2.2 Score on a Scale Standard Deviation 2.22	-1.3 Score on a Scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 Week 2	25.9 percentage of participants Interval 21.3 to 30.9	21.9 percentage of participants Interval 17.5 to 26.7
Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 Week 4	47.0 percentage of participants Interval 41.6 to 52.5	31.1 percentage of participants Interval 26.2 to 36.4
Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 Week 8	51.5 percentage of participants Interval 46.0 to 56.9	41.3 percentage of participants Interval 36.0 to 46.8
Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 Week 12	55.4 percentage of participants Interval 49.9 to 60.8	39.8 percentage of participants Interval 34.5 to 45.3
Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16 Week 16	62.5 percentage of participants Interval 57.1 to 67.7	40.1 percentage of participants Interval 34.8 to 45.6

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed. with spondylitis in addition to peripheral joint involvement as their presentation of PsA were included in the analysis.

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

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=55 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=49 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 Week 12	25.5 percentage of participants Interval 14.7 to 39.0	16.3 percentage of participants Interval 7.3 to 29.7
Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 Week 16	25.5 percentage of participants Interval 14.7 to 39.0	14.3 percentage of participants Interval 5.9 to 27.2
Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 Week 2	7.3 percentage of participants Interval 2.0 to 17.6	6.1 percentage of participants Interval 1.3 to 16.9
Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 Week 4	10.9 percentage of participants Interval 4.1 to 22.2	16.3 percentage of participants Interval 7.3 to 29.7
Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16 Week 8	18.2 percentage of participants Interval 9.1 to 30.9	14.3 percentage of participants Interval 5.9 to 27.2

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0 at Week 16	59.5 percentage of participants Interval 54.1 to 64.8	53.9 percentage of participants Interval 48.4 to 59.3

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0.5 at Week 16	62.8 percentage of participants Interval 57.4 to 68.0	60.5 percentage of participants Interval 55.0 to 65.8

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96* standard deviation of the paired differences of change from baseline/ square root of (2*k); k is the number of reviewers and is default to 2 in this study.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= Smallest Detectable Change (SDC) at Week 16	67.6 percentage of participants Interval 62.3 to 72.5	66.2 percentage of participants Interval 60.8 to 71.2

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0 at Week 16	60.4 percentage of participants Interval 55.0 to 65.7	56.6 percentage of participants Interval 51.1 to 62.0

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0.5 at Week 16	64.3 percentage of participants Interval 58.9 to 69.4	62.9 percentage of participants Interval 57.4 to 68.1

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96* standard deviation of the paired differences of change from baseline/ square root of (2*k); k is the number of reviewers and is default to 2 in this study.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= SDC at Week 16	66.7 percentage of participants Interval 61.3 to 71.7	66.8 percentage of participants Interval 61.4 to 71.8

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0 at Week 16	67.6 percentage of participants Interval 62.3 to 72.5	64.4 percentage of participants Interval 59.0 to 69.5

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0.5 at Week 16	70.5 percentage of participants Interval 65.3 to 75.4	68.9 percentage of participants Interval 63.6 to 73.8

SECONDARY outcome

Timeframe: Week 16

Population: Randomized population.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96* standard deviation of the paired differences of change from baseline/ square root of (2*k); k is the number of reviewers and is default to 2 in this study.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=336 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=334 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= SDC at Week 16	70.5 percentage of participants Interval 65.3 to 75.4	68.9 percentage of participants Interval 63.6 to 73.8

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=245 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=251 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in PsA-modified SvdH Erosion Scores Response at Week 16	0.32 Score on a Scale Standard Deviation 1.417	0.37 Score on a Scale Standard Deviation 1.326

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=245 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=251 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in PsA-modified SvdH JSN Scores Response at Week 16	0.09 Score on a Scale Standard Deviation 0.703	0.14 Score on a Scale Standard Deviation 0.485

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical sub component is one of the 4 subscales of PCS. The physical subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 physical sub-component indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 Week 4	7.923 Score on a Scale Standard Deviation 17.9483	6.908 Score on a Scale Standard Deviation 17.0306
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 Week 12	13.615 Score on a Scale Standard Deviation 20.5725	7.784 Score on a Scale Standard Deviation 22.4709
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16 Week 16	15.414 Score on a Scale Standard Deviation 22.3930	8.226 Score on a Scale Standard Deviation 22.1449

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The role activity sub component is one of the 4 subscales of PCS. The role activity subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 role activity indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 Week 16	13.152 Score on a Scale Standard Deviation 23.6370	7.913 Score on a Scale Standard Deviation 20.8035
Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 Week 4	6.962 Score on a Scale Standard Deviation 20.6963	7.058 Score on a Scale Standard Deviation 18.7454
Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16 Week 12	13.096 Score on a Scale Standard Deviation 22.7372	8.365 Score on a Scale Standard Deviation 21.1286

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The bodily pain sub component is one of the 4 subscales of PCS. The bodily pain subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 bodily pain subcomponent indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 Week 4	10.0 Score on a Scale Standard Deviation 16.52	8.5 Score on a Scale Standard Deviation 15.47
Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 Week 12	16.6 Score on a Scale Standard Deviation 20.96	9.4 Score on a Scale Standard Deviation 19.66
Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16 Week 16	18.2 Score on a Scale Standard Deviation 21.83	10.0 Score on a Scale Standard Deviation 18.85

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The general health perceptions sub component is one of the 4 subscales of PCS. The general health perceptions subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 general health perceptions subcomponent indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 Week 12	8.4 Score on a Scale Standard Deviation 15.13	4.8 Score on a Scale Standard Deviation 15.02
Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 Week 4	6.1 Score on a Scale Standard Deviation 12.95	5.1 Score on a Scale Standard Deviation 13.35
Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16 Week 16	8.9 Score on a Scale Standard Deviation 16.00	4.6 Score on a Scale Standard Deviation 14.85

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The vitality subcomponent is one of the 4 subscales of MCS. The vitality subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 vitality subcomponent indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 Week 4	4.558 Score on a Scale Standard Deviation 14.6829	4.327 Score on a Scale Standard Deviation 14.3971
Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 Week 12	8.442 Score on a Scale Standard Deviation 17.9283	4.308 Score on a Scale Standard Deviation 17.6763
Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16 Week 16	9.682 Score on a Scale Standard Deviation 16.4474	4.893 Score on a Scale Standard Deviation 17.5265

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The social subcomponent is one of the 4 subscales of MCS. The social subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 social subcomponent indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 Week 16	13.80 Score on a Scale Standard Deviation 22.960	4.74 Score on a Scale Standard Deviation 23.303
Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 Week 4	6.69 Score on a Scale Standard Deviation 20.610	4.62 Score on a Scale Standard Deviation 20.737
Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16 Week 12	11.96 Score on a Scale Standard Deviation 23.990	4.88 Score on a Scale Standard Deviation 22.539

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental health subcomponent is one of the 4 subscales of MCS. The mental health subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 mental health subcomponent indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 Week 4	2.1 Score on a Scale Standard Deviation 14.17	2.2 Score on a Scale Standard Deviation 13.99
Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 Week 12	4.9 Score on a Scale Standard Deviation 16.41	1.4 Score on a Scale Standard Deviation 16.38
Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16 Week 16	5.5 Score on a Scale Standard Deviation 15.98	1.5 Score on a Scale Standard Deviation 15.78

SECONDARY outcome

Timeframe: Baseline and Week 4, 12 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The emotional problem subcomponent is one of the 4 subscales of MCS. The emotional problem subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 emotional problems subcomponent indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=327 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 Week 4	2.718 Score on a Scale Standard Deviation 20.1133	2.128 Score on a Scale Standard Deviation 20.1154
Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 Week 12	5.846 Score on a Scale Standard Deviation 21.4070	0.718 Score on a Scale Standard Deviation 21.0925
Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16 Week 16	7.438 Score on a Scale Standard Deviation 22.6517	2.370 Score on a Scale Standard Deviation 21.4931

SECONDARY outcome

Timeframe: Baseline and week 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

WPAI contains 4 subcomponents - absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. Each subcomponent score ranges from 0 to 100, with higher numbers indicating worse outcome. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=325 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=325 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 WPAI Absenteeism	-3.30 Score on a Scale Standard Deviation 20.777	1.23 Score on a Scale Standard Deviation 19.389
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 WPAI Presenteeism	-13.76 Score on a Scale Standard Deviation 23.299	-6.91 Score on a Scale Standard Deviation 20.332
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 Work Productivity	-13.33 Score on a Scale Standard Deviation 24.053	-6.80 Score on a Scale Standard Deviation 21.526
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16 WPAI Activity Impairment	-15.20 Score on a Scale Standard Deviation 25.466	-9.69 Score on a Scale Standard Deviation 23.855

SECONDARY outcome

Timeframe: Baseline and week 4 and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

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.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=325 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=325 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Utility Score (Week 4)	0.1006 Score on a Scale Standard Deviation 0.19470	0.0694 Score on a Scale Standard Deviation 0.19282
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Anxiety/Depression (Week 16)	-0.3 Score on a Scale Standard Deviation 0.84	-0.1 Score on a Scale Standard Deviation 0.91
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Usual Activities (Week 16)	-0.5 Score on a Scale Standard Deviation 0.92	-0.3 Score on a Scale Standard Deviation 0.78
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Pain/Discomfort (Week 4)	-0.4 Score on a Scale Standard Deviation 0.77	-0.3 Score on a Scale Standard Deviation 0.81
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Pain/Discomfort (Week 16)	-0.6 Score on a Scale Standard Deviation 0.93	-0.3 Score on a Scale Standard Deviation 0.92
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Anxiety/Depression (Week 4)	-0.2 Score on a Scale Standard Deviation 0.74	-0.1 Score on a Scale Standard Deviation 0.79
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Utility Score (Week 16)	0.1630 Score on a Scale Standard Deviation 0.23696	0.0721 Score on a Scale Standard Deviation 0.23083
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Mobility (Week 4)	-0.3 Score on a Scale Standard Deviation 0.77	-0.3 Score on a Scale Standard Deviation 0.80
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Mobility (Week 16)	-0.5 Score on a Scale Standard Deviation 0.88	-0.3 Score on a Scale Standard Deviation 0.92
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Self-Care (Week 4)	-0.3 Score on a Scale Standard Deviation 0.81	-0.2 Score on a Scale Standard Deviation 0.78
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Self-Care (Week 16)	-0.5 Score on a Scale Standard Deviation 0.90	-0.1 Score on a Scale Standard Deviation 0.86
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16 Usual Activities (Week 4)	-0.3 Score on a Scale Standard Deviation 0.83	-0.3 Score on a Scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline and week 4, 12, and 16

Population: Randomized population. Only participants with data available at the timepoint were analyzed.

The Patient-Reported Outcome Measures Information System Sleep Disturbance assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.

Outcome measures

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=326 Participants Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 Week 4	-1.48 Score on a Scale Standard Deviation 6.489	-1.09 Score on a Scale Standard Deviation 6.413
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 Week 12	-2.46 Score on a Scale Standard Deviation 8.196	-0.88 Score on a Scale Standard Deviation 8.177
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16 Week 16	-3.15 Score on a Scale Standard Deviation 7.761	-1.59 Score on a Scale Standard Deviation 7.645

Adverse Events

Placebo-Controlled Period - Deucravacitinib 6 mg QD

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo-Controlled Period - Placebo

Serious events: 8 serious events

Other events: 32 other events

Deaths: 0 deaths

Active Treatment Period - Deucravacitinib 6 mg QD

Serious events: 21 serious events

Other events: 68 other events

Deaths: 0 deaths

Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD

Serious events: 17 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=332 participants at risk Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=333 participants at risk Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Active Treatment Period - Deucravacitinib 6 mg QD n=309 participants at risk Participants earlier randomized to Deucravacitinib 6 mg QD arm in Placebo-Controlled period continued to receive 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD n=306 participants at risk Participants earlier randomized to Placebo arm in Placebo-Controlled period received 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Cardiac disorders Angina unstable	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Cardiac disorders Atrial fibrillation	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Cardiac disorders Myocardial infarction	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Cardiac disorders Sinus node dysfunction	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Eye disorders Iridocyclitis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Gastrointestinal disorders Hiatus hernia	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Gastrointestinal disorders Inguinal hernia	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Hepatobiliary disorders Cholelithiasis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Immune system disorders Drug hypersensitivity	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Appendicitis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Bronchitis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations COVID-19 pneumonia	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Cellulitis	0.30% 1/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Erysipelas	0.30% 1/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Hepatitis infectious mononucleosis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Herpes zoster disseminated	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Oral candidiasis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Pneumonia	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Renal cyst infection	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Respiratory tract infection	0.30% 1/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Soft tissue infection	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Urinary tract infection	0.30% 1/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Vulval cellulitis	0.30% 1/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Wrist fracture	0.30% 1/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Investigations Blood glucose increased	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.65% 2/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Nervous system disorders Cerebral haemorrhage	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Nervous system disorders Embolic stroke	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Nervous system disorders Migraine	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Nervous system disorders Transient ischaemic attack	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Psychiatric disorders Hallucination	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Psychiatric disorders Major depression	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Psychiatric disorders Psychotic disorder	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.33% 1/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Reproductive system and breast disorders Vaginal haematoma	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.30% 1/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Vascular disorders Hypertension	0.00% 0/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.32% 1/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	0.00% 0/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.

Other adverse events

Measure	Placebo-Controlled Period - Deucravacitinib 6 mg QD n=332 participants at risk Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered 6 mg of deucravacitinib tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Placebo-Controlled Period - Placebo n=333 participants at risk Participants with Active Psoriatic Arthritis who are naive to biologic disease anti-rheumatic drugs were administered placebo tablet orally once daily (QD) from Week 1 till Week 16 during Placebo-Controlled treatment period.	Active Treatment Period - Deucravacitinib 6 mg QD n=309 participants at risk Participants earlier randomized to Deucravacitinib 6 mg QD arm in Placebo-Controlled period continued to receive 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD n=306 participants at risk Participants earlier randomized to Placebo arm in Placebo-Controlled period received 6 mg deucravacitinib tablet orally QD till Week 52 during Active Treatment period.
Infections and infestations Nasopharyngitis	3.9% 13/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	3.6% 12/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	7.8% 24/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	8.5% 26/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Infections and infestations Upper respiratory tract infection	5.1% 17/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	3.0% 10/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	10.4% 32/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	10.8% 33/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.
Vascular disorders Hypertension	3.0% 10/332 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	3.0% 10/333 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	5.8% 18/309 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.	4.6% 14/306 • All-cause mortality and Adverse events were collected from first dose (Day 1) and up to 30 days after the last dose of treatment in the study (up to approximately 164 weeks) All-cause mortality was collected for all the randomized participants and adverse events were collected for all the treated participants.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
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