Trial Outcomes & Findings for A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (NCT NCT03675308)

Last Updated: 2025-08-05

Results Overview

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

964 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2025-08-05

Participant Flow

Participants were enrolled at 186 sites in 38 countries globally. The study includes a 24-week double-blind placebo-controlled treatment period (Period 1) and an ongoing 184-week open-label treatment period (Period 2). Results are reported for Period 1 which was from 25 March 2019 to 8 October 2020.

Participants were randomized equally (1:1 ratio) to receive double-blind treatment with risankizumab 150 mg or matched placebo for 24 weeks. Randomization was stratified by extent of psoriasis (≥ 3% body surface area \[BSA\] or \< 3% BSA), current conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) use (0 vs ≥ 1), presence of dactylitis (yes vs no), and presence of enthesitis (yes vs no) at Baseline.

Participant milestones

Participant milestones
Measure	Placebo Participants randomized to receive placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Study STARTED	481	483
Overall Study COMPLETED	467	473
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants randomized to receive placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	6	4
Overall Study Lost to Follow-up	3	0
Overall Study Lack of Efficacy	1	1
Overall Study Coronavirus Disease-2019 (COVID-19) Logistical Restrictions	1	2
Overall Study Other	0	1

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=481 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=483 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Total n=964 Participants Total of all reporting groups
Age, Continuous	51.2 years STANDARD_DEVIATION 12.10 • n=481 Participants	51.3 years STANDARD_DEVIATION 12.21 • n=483 Participants	51.3 years STANDARD_DEVIATION 12.15 • n=964 Participants
Age, Customized < 65 years	408 Participants n=481 Participants	414 Participants n=483 Participants	822 Participants n=964 Participants
Age, Customized ≥ 65 years	73 Participants n=481 Participants	69 Participants n=483 Participants	142 Participants n=964 Participants
Sex: Female, Male Female	247 Participants n=481 Participants	231 Participants n=483 Participants	478 Participants n=964 Participants
Sex: Female, Male Male	234 Participants n=481 Participants	252 Participants n=483 Participants	486 Participants n=964 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	92 Participants n=481 Participants	93 Participants n=483 Participants	185 Participants n=964 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	389 Participants n=481 Participants	390 Participants n=483 Participants	779 Participants n=964 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=481 Participants	0 Participants n=483 Participants	0 Participants n=964 Participants
Race/Ethnicity, Customized White	451 Participants n=481 Participants	454 Participants n=483 Participants	905 Participants n=964 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=481 Participants	4 Participants n=483 Participants	6 Participants n=964 Participants
Race/Ethnicity, Customized Asian	22 Participants n=481 Participants	13 Participants n=483 Participants	35 Participants n=964 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=481 Participants	3 Participants n=483 Participants	4 Participants n=964 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=481 Participants	1 Participants n=483 Participants	1 Participants n=964 Participants
Race/Ethnicity, Customized Multiple	5 Participants n=481 Participants	8 Participants n=483 Participants	13 Participants n=964 Participants
Current Use of csDMARD Yes	364 Participants n=481 Participants	366 Participants n=483 Participants	730 Participants n=964 Participants
Current Use of csDMARD No	117 Participants n=481 Participants	117 Participants n=483 Participants	234 Participants n=964 Participants
Extent of Psoriasis < 3% BSA	209 Participants n=481 Participants	210 Participants n=483 Participants	419 Participants n=964 Participants
Extent of Psoriasis ≥ 3% BSA	272 Participants n=481 Participants	273 Participants n=483 Participants	545 Participants n=964 Participants
Presence of Dactylitis Yes	147 Participants n=481 Participants	148 Participants n=483 Participants	295 Participants n=964 Participants
Presence of Dactylitis No	334 Participants n=481 Participants	335 Participants n=483 Participants	669 Participants n=964 Participants
Presence of Enthesitis Yes	290 Participants n=481 Participants	297 Participants n=483 Participants	587 Participants n=964 Participants
Presence of Enthesitis No	191 Participants n=481 Participants	186 Participants n=483 Participants	377 Participants n=964 Participants
Tender Joint Count	20.5 joints STANDARD_DEVIATION 12.79 • n=481 Participants	20.8 joints STANDARD_DEVIATION 14.05 • n=483 Participants	20.6 joints STANDARD_DEVIATION 13.43 • n=964 Participants
Swollen Joint Count	12.2 joints STANDARD_DEVIATION 8.02 • n=481 Participants	12.1 joints STANDARD_DEVIATION 7.80 • n=483 Participants	12.2 joints STANDARD_DEVIATION 7.91 • n=964 Participants
Patient's Assessment of Pain	57.1 mm STANDARD_DEVIATION 22.61 • n=479 Participants • Participants with available data	57.1 mm STANDARD_DEVIATION 22.57 • n=482 Participants • Participants with available data	57.1 mm STANDARD_DEVIATION 22.58 • n=961 Participants • Participants with available data
Patient's Global Assessment of Disease Activity	57.4 mm STANDARD_DEVIATION 22.06 • n=479 Participants • Participants with availabe data	57.9 mm STANDARD_DEVIATION 21.75 • n=482 Participants • Participants with availabe data	57.6 mm STANDARD_DEVIATION 21.89 • n=961 Participants • Participants with availabe data
Physician's Global Assessment of Disease Activity	62.4 mm STANDARD_DEVIATION 16.99 • n=461 Participants • Participants with available data	61.3 mm STANDARD_DEVIATION 17.64 • n=466 Participants • Participants with available data	61.8 mm STANDARD_DEVIATION 17.32 • n=927 Participants • Participants with available data
Health Assessment Questionnaire Disability Index (HAQ-DI)	1.17 score on a scale STANDARD_DEVIATION 0.651 • n=479 Participants • Participants with available data	1.15 score on a scale STANDARD_DEVIATION 0.664 • n=482 Participants • Participants with available data	1.16 score on a scale STANDARD_DEVIATION 0.658 • n=961 Participants • Participants with available data
High-sensitivity C-reactive Protein (hsCRP) Level	11.33 mg/L STANDARD_DEVIATION 14.122 • n=481 Participants	11.88 mg/L STANDARD_DEVIATION 15.933 • n=483 Participants	11.60 mg/L STANDARD_DEVIATION 15.051 • n=964 Participants
Psoriasis Area Severity Index (PASI) Score	10.04 score on a scale STANDARD_DEVIATION 10.436 • n=271 Participants • Participants with psoriasis BSA involvement ≥ 3% at Baseline	10.89 score on a scale STANDARD_DEVIATION 10.052 • n=273 Participants • Participants with psoriasis BSA involvement ≥ 3% at Baseline	10.47 score on a scale STANDARD_DEVIATION 10.244 • n=544 Participants • Participants with psoriasis BSA involvement ≥ 3% at Baseline
Modified Nail Psoriasis Severity Index (mNAPSI) Score	16.56 score on a scale STANDARD_DEVIATION 16.045 • n=338 Participants • Participants with psoriatic nail disease at Baseline	18.13 score on a scale STANDARD_DEVIATION 16.443 • n=309 Participants • Participants with psoriatic nail disease at Baseline	17.31 score on a scale STANDARD_DEVIATION 16.243 • n=647 Participants • Participants with psoriatic nail disease at Baseline
Physician Global Assessment of Fingernail Psoriasis Score (PGA-F)	2.0 score on a scale STANDARD_DEVIATION 1.00 • n=338 Participants • Participants with psoriatic nail disease at Baseline	2.1 score on a scale STANDARD_DEVIATION 1.04 • n=309 Participants • Participants with psoriatic nail disease at Baseline	2.0 score on a scale STANDARD_DEVIATION 1.02 • n=647 Participants • Participants with psoriatic nail disease at Baseline
Short-Form 36 (SF-36) Physical Component Summary (PCS) Score	35.15 score on a scale STANDARD_DEVIATION 7.692 • n=477 Participants • Participants with available data	35.24 score on a scale STANDARD_DEVIATION 8.094 • n=482 Participants • Participants with available data	35.20 score on a scale STANDARD_DEVIATION 7.893 • n=959 Participants • Participants with available data
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score	29.3 score on a scale STANDARD_DEVIATION 11.23 • n=477 Participants • Participants with available data	29.4 score on a scale STANDARD_DEVIATION 11.28 • n=482 Participants • Participants with available data	29.4 score on a scale STANDARD_DEVIATION 11.25 • n=959 Participants • Participants with available data

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=481 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=483 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24	33.5 percentage of participants Interval 29.3 to 37.8	57.3 percentage of participants Interval 52.9 to 61.8

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis (PsA) use that could meaningfully impact efficacy assessment, was used.

The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=479 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=482 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24	-0.11 score on a scale Interval -0.16 to -0.06	-0.31 score on a scale Interval -0.36 to -0.27

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score.

Outcome measures

Outcome measures
Measure	Placebo n=272 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=273 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24	9.9 percentage of participants Interval 6.4 to 13.5	52.3 percentage of participants Interval 46.4 to 58.3

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=481 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=483 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants With an ACR20 Response at Week 16	33.4 percentage of participants Interval 28.9 to 37.9	56.3 percentage of participants Interval 51.7 to 60.8

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

A participant was classified as achieving MDA if 5 of the following 7 criteria were met: * Tender joint count (out of 68 joints) ≤ 1 * Swollen joint count (out of 66 joints) ≤ 1 * PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3% * Patient's assessment of pain ≤ 15 (VAS from 0 to 100) * Patient's Global Assessment of disease activity ≤ 20 (VAS from 0 to 100) * HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3) * Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, for an overall score range from 0 to 6)

Outcome measures

Outcome measures
Measure	Placebo n=481 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=483 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24	10.2 percentage of participants Interval 7.5 to 12.9	25.0 percentage of participants Interval 21.2 to 28.9

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set with nail psoriasis at Baseline; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used.

The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (\>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (\> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (\>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=338 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=309 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24	-5.57 score on a scale Interval -6.7 to -4.44	-9.76 score on a scale Interval -10.95 to -8.58

SECONDARY outcome

Timeframe: Baseline and Week 24

The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=338 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=309 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)	-0.4 score on a scale Interval -0.5 to -0.3	-0.8 score on a scale Interval -1.0 to -0.7

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set participants with a Baseline LEI \> 0; Includes pooled data from KEEPsAKE 1 (this study) and the companion study M15-998 (NCT03671148; KEEPsAKE2). Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0. LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst). To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).

Outcome measures

Outcome measures
Measure	Placebo n=448 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=444 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants With Resolution of Enthesitis at Week 24	34.8 percentage of participants Interval 30.4 to 39.2	48.4 percentage of participants Interval 43.8 to 53.1

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set participants with a Baseline LDI \> 0; Includes pooled data from KEEPsAKE 1 (this study) and the companion study M15-998 (NCT03671148; KEEPsAKE2). Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0. LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used. Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=188 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants With Resolution of Dactylitis at Week 24	51.0 percentage of participants Interval 44.1 to 57.8	68.1 percentage of participants Interval 61.4 to 74.7

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or who were rescued prior to Week 24.

The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers. Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst). Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst). Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN. The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst).

Outcome measures

Outcome measures
Measure	Placebo n=457 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=458 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24	0.32 score on a scale Interval 0.11 to 0.53	0.23 score on a scale Interval 0.02 to 0.44

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used.

The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=477 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=482 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24	3.20 score on a scale Interval 2.5 to 3.89	6.52 score on a scale Interval 5.83 to 7.2

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; a mixed effect model repeat measurement analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis (PsA) use that could meaningfully impact efficacy assessment, was used.

The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=477 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=482 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24	3.9 score on a scale Interval 3.1 to 4.7	6.5 score on a scale Interval 5.6 to 7.3

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Outcome measures
Measure	Placebo n=481 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=483 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24	11.3 percentage of participants Interval 8.4 to 14.1	33.4 percentage of participants Interval 29.2 to 37.7

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Outcome measures
Measure	Placebo n=481 Participants Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=483 Participants Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24	4.7 percentage of participants Interval 2.8 to 6.7	15.3 percentage of participants Interval 12.0 to 18.5

Adverse Events

Placebo

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Risankizumab

Serious events: 12 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=481 participants at risk Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.	Risankizumab n=483 participants at risk Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Blood and lymphatic system disorders ANAEMIA	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Blood and lymphatic system disorders BLOOD LOSS ANAEMIA	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Cardiac disorders ANGINA UNSTABLE	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Ear and labyrinth disorders VERTIGO	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Gastrointestinal disorders COLITIS	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Gastrointestinal disorders DUODENAL ULCER	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Infections and infestations APPENDICITIS PERFORATED	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Infections and infestations CELLULITIS	0.21% 1/481 • Number of events 2 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Infections and infestations COMPLICATED APPENDICITIS	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Infections and infestations DYSENTERY	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Infections and infestations GASTROENTERITIS	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Infections and infestations ORAL BACTERIAL INFECTION	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Infections and infestations PNEUMONIA	0.42% 2/481 • Number of events 2 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Infections and infestations PNEUMONIA VIRAL	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Infections and infestations UROSEPSIS	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Musculoskeletal and connective tissue disorders PSORIATIC ARTHROPATHY	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Psychiatric disorders DEPRESSION	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Renal and urinary disorders URETEROCELE	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.00% 0/481 • From first dose of study drug to Week 24	0.21% 1/483 • Number of events 1 • From first dose of study drug to Week 24
Skin and subcutaneous tissue disorders PSORIASIS	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24
Skin and subcutaneous tissue disorders PUSTULAR PSORIASIS	0.21% 1/481 • Number of events 1 • From first dose of study drug to Week 24	0.00% 0/483 • From first dose of study drug to Week 24