Trial Outcomes & Findings for A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (NCT NCT03671148)
NCT ID: NCT03671148
Last Updated: 2025-08-29
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).
ACTIVE_NOT_RECRUITING
PHASE3
444 participants
Baseline and Week 24
2025-08-29
Participant Flow
Participants were enrolled at 99 sites in Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, New Zealand, Poland, Portugal, South Africa, Spain, Sweden, United Kingdom, and the US including Puerto Rico. 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 07 March 2019 to 22 June 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 current conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) use (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% body surface area \[BSA\] or \< 3% BSA) at Baseline.
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
|
220
|
224
|
|
Overall Study
Received Study Drug
|
219
|
224
|
|
Overall Study
COMPLETED
|
199
|
215
|
|
Overall Study
NOT COMPLETED
|
21
|
9
|
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
|
8
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
7
|
2
|
|
Overall Study
COVID-19 Logistical Restrictions
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Incomplete Randomization Visit
|
1
|
0
|
Baseline Characteristics
participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 Participants
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Total
n=443 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 12.64 • n=219 Participants
|
53.1 years
STANDARD_DEVIATION 12.53 • n=224 Participants
|
52.9 years
STANDARD_DEVIATION 12.57 • n=443 Participants
|
|
Age, Customized
< 65 years
|
176 Participants
n=219 Participants
|
178 Participants
n=224 Participants
|
354 Participants
n=443 Participants
|
|
Age, Customized
≥ 65 years
|
43 Participants
n=219 Participants
|
46 Participants
n=224 Participants
|
89 Participants
n=443 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=219 Participants
|
124 Participants
n=224 Participants
|
244 Participants
n=443 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=219 Participants
|
100 Participants
n=224 Participants
|
199 Participants
n=443 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=219 Participants
|
42 Participants
n=224 Participants
|
85 Participants
n=443 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
176 Participants
n=219 Participants
|
182 Participants
n=224 Participants
|
358 Participants
n=443 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=219 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=443 Participants
|
|
Race/Ethnicity, Customized
White
|
210 Participants
n=219 Participants
|
218 Participants
n=224 Participants
|
428 Participants
n=443 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=219 Participants
|
2 Participants
n=224 Participants
|
5 Participants
n=443 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=219 Participants
|
2 Participants
n=224 Participants
|
5 Participants
n=443 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
3 Participants
n=219 Participants
|
2 Participants
n=224 Participants
|
5 Participants
n=443 Participants
|
|
Current Use of Conventional Synthetic Disease-modifying Anti-rheumatic Drug (csDMARD)
Yes
|
129 Participants
n=219 Participants
|
141 Participants
n=224 Participants
|
270 Participants
n=443 Participants
|
|
Current Use of Conventional Synthetic Disease-modifying Anti-rheumatic Drug (csDMARD)
No
|
90 Participants
n=219 Participants
|
83 Participants
n=224 Participants
|
173 Participants
n=443 Participants
|
|
Number of Prior Biologic Therapies
0 prior biologics
|
118 Participants
n=219 Participants
|
119 Participants
n=224 Participants
|
237 Participants
n=443 Participants
|
|
Number of Prior Biologic Therapies
≥ 1 prior biologic
|
101 Participants
n=219 Participants
|
105 Participants
n=224 Participants
|
206 Participants
n=443 Participants
|
|
Extent of Psoriasis
< 3%
|
100 Participants
n=219 Participants
|
101 Participants
n=224 Participants
|
201 Participants
n=443 Participants
|
|
Extent of Psoriasis
≥ 3%
|
119 Participants
n=219 Participants
|
123 Participants
n=224 Participants
|
242 Participants
n=443 Participants
|
|
Tender Joint Count
|
22.3 joints
STANDARD_DEVIATION 13.80 • n=219 Participants
|
22.8 joints
STANDARD_DEVIATION 14.90 • n=224 Participants
|
22.6 joints
STANDARD_DEVIATION 14.35 • n=443 Participants
|
|
Swollen Joint Count
|
13.6 joints
STANDARD_DEVIATION 8.98 • n=219 Participants
|
13.0 joints
STANDARD_DEVIATION 8.73 • n=224 Participants
|
13.3 joints
STANDARD_DEVIATION 8.85 • n=443 Participants
|
|
Patient's Assessment of Pain
|
57.0 score on a scale
STANDARD_DEVIATION 23.09 • n=219 Participants
|
55.0 score on a scale
STANDARD_DEVIATION 23.52 • n=224 Participants
|
56.0 score on a scale
STANDARD_DEVIATION 23.30 • n=443 Participants
|
|
Patient's Global Assessment of Disease Activity
|
56.2 score on a scale
STANDARD_DEVIATION 22.98 • n=219 Participants
|
56.2 score on a scale
STANDARD_DEVIATION 21.79 • n=224 Participants
|
56.2 score on a scale
STANDARD_DEVIATION 22.36 • n=443 Participants
|
|
Physician's Global Assessment of Disease Activity
|
60.7 score on a scale
STANDARD_DEVIATION 16.36 • n=213 Participants • participants with available data
|
63.0 score on a scale
STANDARD_DEVIATION 17.01 • n=219 Participants • participants with available data
|
61.9 score on a scale
STANDARD_DEVIATION 16.71 • n=432 Participants • participants with available data
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.13 score on a scale
STANDARD_DEVIATION 0.626 • n=219 Participants
|
1.10 score on a scale
STANDARD_DEVIATION 0.618 • n=224 Participants
|
1.12 score on a scale
STANDARD_DEVIATION 0.621 • n=443 Participants
|
|
High-sensitivity C-reactive Protein (hsCRP)
|
8.16 mg/L
STANDARD_DEVIATION 17.120 • n=219 Participants
|
7.45 mg/L
STANDARD_DEVIATION 10.937 • n=224 Participants
|
7.80 mg/L
STANDARD_DEVIATION 14.319 • n=443 Participants
|
|
Psoriasis Area Severity Index (PASI) Score
|
8.35 score on a scale
STANDARD_DEVIATION 9.942 • n=119 Participants • Participants with psoriasis BSA involvement ≥ 3% at Baseline
|
7.74 score on a scale
STANDARD_DEVIATION 6.698 • n=123 Participants • Participants with psoriasis BSA involvement ≥ 3% at Baseline
|
8.04 score on a scale
STANDARD_DEVIATION 8.438 • n=242 Participants • Participants with psoriasis BSA involvement ≥ 3% at Baseline
|
|
Short-Form 36 (SF-36) Physical Component Summary (PCS) Score
|
35.16 score on a scale
STANDARD_DEVIATION 9.070 • n=219 Participants
|
35.61 score on a scale
STANDARD_DEVIATION 8.766 • n=224 Participants
|
35.39 score on a scale
STANDARD_DEVIATION 8.910 • n=443 Participants
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
|
27.7 score on a scale
STANDARD_DEVIATION 12.71 • n=219 Participants
|
28.2 score on a scale
STANDARD_DEVIATION 11.49 • n=224 Participants
|
28.0 score on a scale
STANDARD_DEVIATION 12.10 • n=443 Participants
|
|
Presence of Enthesitis
Yes
|
158 Participants
n=219 Participants
|
147 Participants
n=224 Participants
|
305 Participants
n=443 Participants
|
|
Presence of Enthesitis
No
|
61 Participants
n=219 Participants
|
77 Participants
n=224 Participants
|
138 Participants
n=443 Participants
|
|
Presence of Dactylitis
Yes
|
57 Participants
n=219 Participants
|
40 Participants
n=224 Participants
|
97 Participants
n=443 Participants
|
|
Presence of Dactylitis
No
|
160 Participants
n=219 Participants
|
184 Participants
n=224 Participants
|
344 Participants
n=443 Participants
|
|
Presence of Dactylitis
Missing
|
2 Participants
n=219 Participants
|
0 Participants
n=224 Participants
|
2 Participants
n=443 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
26.5 percentage of participants
Interval 20.7 to 32.4
|
51.3 percentage of participants
Interval 44.8 to 57.9
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
-0.05 score on a scale
Interval -0.12 to 0.02
|
-0.22 score on a scale
Interval -0.28 to -0.15
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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
| Measure |
Placebo
n=119 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=123 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
|
10.2 percentage of participants
Interval 4.7 to 15.6
|
55.0 percentage of participants
Interval 46.2 to 63.9
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: 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 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).
Outcome measures
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
25.3 percentage of participants
Interval 19.4 to 31.2
|
48.3 percentage of participants
Interval 41.7 to 54.8
|
SECONDARY outcome
Timeframe: Week 24Population: 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
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
11.4 percentage of participants
Interval 7.2 to 15.6
|
25.6 percentage of participants
Interval 19.9 to 31.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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 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
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
2.01 score on a scale
Interval 0.94 to 3.08
|
5.87 score on a scale
Interval 4.86 to 6.88
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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 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
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
2.6 score on a scale
Interval 1.4 to 3.9
|
4.9 score on a scale
Interval 3.7 to 6.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
9.3 percentage of participants
Interval 5.4 to 13.2
|
26.3 percentage of participants
Interval 20.3 to 32.3
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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
| Measure |
Placebo
n=219 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=224 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
|
5.9 percentage of participants
Interval 2.7 to 9.0
|
12.0 percentage of participants
Interval 7.7 to 16.3
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set participants with a Baseline LEI \> 0; 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).
Outcome measures
| Measure |
Placebo
n=158 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=147 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
|
30.4 percentage of participants
Interval 23.2 to 37.6
|
42.9 percentage of participants
Interval 34.9 to 50.9
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set participants with a Baseline LDI \> 0; 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. The 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.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab
n=40 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
|
42.1 percentage of participants
Interval 29.3 to 54.9
|
72.5 percentage of participants
Interval 58.7 to 86.3
|
Adverse Events
Placebo
Risankizumab 150 mg
Serious adverse events
| Measure |
Placebo
n=219 participants at risk
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab 150 mg
n=224 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
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Infections and infestations
ABSCESS
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Infections and infestations
ERYSIPELAS
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Infections and infestations
GASTROENTERITIS
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 2 • From first dose of study drug to Week 24
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Nervous system disorders
MYELOPATHY
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.46%
1/219 • Number of events 1 • From first dose of study drug to Week 24
|
0.00%
0/224 • From first dose of study drug to Week 24
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.00%
0/219 • From first dose of study drug to Week 24
|
0.45%
1/224 • Number of events 1 • From first dose of study drug to Week 24
|
Other adverse events
| Measure |
Placebo
n=219 participants at risk
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
Risankizumab 150 mg
n=224 participants at risk
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
|
|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.0%
11/219 • Number of events 13 • From first dose of study drug to Week 24
|
7.6%
17/224 • Number of events 17 • From first dose of study drug to Week 24
|
Additional Information
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