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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) (KEEPsAKE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671148
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriatic Arthritis (PsA)
Interventions Biological: Placebo
Biological: Risankizumab
Enrollment 444
Recruitment Details

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.

Pre-assignment Details 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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description Participants randomized to receive placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Period Title: Overall Study
Started 220 224
Received Study Drug 219 224
Completed [1] 199 215
Not Completed 21 9
Reason Not Completed
Adverse Event             3             2
Withdrawal by Subject             8             2
Lost to Follow-up             1             2
Lack of Efficacy             7             2
COVID-19 Logistical Restrictions             0             1
Other             1             0
Incomplete Randomization Visit             1             0
[1]
Completed Period 1 Study Participation
Arm/Group Title Placebo Risankizumab Total
Hide Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Total of all reporting groups
Overall Number of Baseline Participants 219 224 443
Hide Baseline Analysis Population Description
The full analysis set included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 219 participants 224 participants 443 participants
52.7  (12.64) 53.1  (12.53) 52.9  (12.57)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
< 65 years
176
  80.4%
178
  79.5%
354
  79.9%
≥ 65 years
43
  19.6%
46
  20.5%
89
  20.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
Female
120
  54.8%
124
  55.4%
244
  55.1%
Male
99
  45.2%
100
  44.6%
199
  44.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
Hispanic or Latino
43
  19.6%
42
  18.8%
85
  19.2%
Not Hispanic or Latino
176
  80.4%
182
  81.3%
358
  80.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
White
210
  95.9%
218
  97.3%
428
  96.6%
Black or African American
3
   1.4%
2
   0.9%
5
   1.1%
Asian
3
   1.4%
2
   0.9%
5
   1.1%
Multiple
3
   1.4%
2
   0.9%
5
   1.1%
Current Use of Conventional Synthetic Disease-modifying Anti-rheumatic Drug (csDMARD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
Yes
129
  58.9%
141
  62.9%
270
  60.9%
No
90
  41.1%
83
  37.1%
173
  39.1%
Number of Prior Biologic Therapies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
0 prior biologics
118
  53.9%
119
  53.1%
237
  53.5%
≥ 1 prior biologic
101
  46.1%
105
  46.9%
206
  46.5%
Extent of Psoriasis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
< 3%
100
  45.7%
101
  45.1%
201
  45.4%
≥ 3%
119
  54.3%
123
  54.9%
242
  54.6%
[1]
Measure Description: The extent of psoriasis was measured by the physician as the total body surface area (BSA) involved with psoriasis. For purposes of clinical estimation, the total surface of the participant's palm and five digits was assumed to be approximately equivalent to 1% of BSA.
Tender Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 219 participants 224 participants 443 participants
22.3  (13.80) 22.8  (14.90) 22.6  (14.35)
[1]
Measure Description: A total of 68 joints were assessed for the presence or absence of tenderness by pressure manipulation on physical examination.
Swollen Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 219 participants 224 participants 443 participants
13.6  (8.98) 13.0  (8.73) 13.3  (8.85)
[1]
Measure Description: A total of 66 joints were assessed for the presence or absence of swelling by directed physical examination.
Patient's Assessment of Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 219 participants 224 participants 443 participants
57.0  (23.09) 55.0  (23.52) 56.0  (23.30)
[1]
Measure Description: Participants were asked to indicate the severity of their arthritis pain within the previous 24 hours using a horizontal 100 mm visual analog scale (VAS), ranging from 0 (no pain) to 100 (severe pain).
Patient's Global Assessment of Disease Activity   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 219 participants 224 participants 443 participants
56.2  (22.98) 56.2  (21.79) 56.2  (22.36)
[1]
Measure Description: Participants were asked to rate their current psoriatic arthritis disease activity within the past 24 hours on a horizontal 100 mm VAS ranging from 0 (very well) to 100 (very poor).
Physician's Global Assessment of Disease Activity   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 213 participants 219 participants 432 participants
60.7  (16.36) 63.0  (17.01) 61.9  (16.71)
[1]
Measure Description: The physician rated the participant's current global psoriatic arthritis disease activity in the past 24 hours (independently from the participant's assessment) on a 100 mm horizontal VAS ranging from 0 (very well) to 100 (very poorly).
[2]
Measure Analysis Population Description: participants with available data
Health Assessment Questionnaire - Disability Index (HAQ-DI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 219 participants 224 participants 443 participants
1.13  (0.626) 1.10  (0.618) 1.12  (0.621)
[1]
Measure Description:

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.

High-sensitivity C-reactive Protein (hsCRP)  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 219 participants 224 participants 443 participants
8.16  (17.120) 7.45  (10.937) 7.80  (14.319)
Psoriasis Area Severity Index (PASI) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 119 participants 123 participants 242 participants
8.35  (9.942) 7.74  (6.698) 8.04  (8.438)
[1]
Measure Description: 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, and desquamation 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).
[2]
Measure Analysis Population Description: Participants with psoriasis BSA involvement ≥ 3% at Baseline
Short-Form 36 (SF-36) Physical Component Summary (PCS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 219 participants 224 participants 443 participants
35.16  (9.070) 35.61  (8.766) 35.39  (8.910)
[1]
Measure Description:

The 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 PCS ranges from 0 to 100, with a normative mean value of 50; higher scores are associated with less disability.

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 219 participants 224 participants 443 participants
27.7  (12.71) 28.2  (11.49) 28.0  (12.10)
[1]
Measure Description: 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, functional fatigue, emotional fatigue, and social consequences of fatigue. 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 items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue.
Presence of Enthesitis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
Yes
158
  72.1%
147
  65.6%
305
  68.8%
No
61
  27.9%
77
  34.4%
138
  31.2%
[1]
Measure Description:

Enthesitis is inflammation of the entheses, the specific point where tendons or ligaments attach to bone. The Leeds enthesitis index (LEI) is a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus left and right, Achilles tendon insertion left and right and medial condyle femur left and right. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6.

Presence of enthesitis is defined as an LEI > 0.

Presence of Dactylitis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 224 participants 443 participants
Yes
57
  26.0%
40
  17.9%
97
  21.9%
No
160
  73.1%
184
  82.1%
344
  77.7%
Missing
2
   0.9%
0
   0.0%
2
   0.5%
[1]
Measure Description: Dactylitis is characterized by swelling of the fingers or toes. The Leeds dactylitis index (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). Scores for each digit are summed for the total LDI. The presence of dactylitis is defined as LDI > 0.
1.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Hide Description

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).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.5
(20.7 to 32.4)
51.3
(44.8 to 57.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of current use of csDMARD (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% BSA or < 3% BSA) at Baseline.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 24.5
Confidence Interval (2-Sided) 95%
15.9 to 33.0
Estimation Comments Response Rate Difference = Risankizumab - Placebo
2.Secondary Outcome
Title Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
Hide Description

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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-0.05
(-0.12 to 0.02)
-0.22
(-0.28 to -0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.
Method Mixed Effect Model Repeated Measurement
Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.26 to -0.07
Estimation Comments Difference = Risankizumab - Placebo
3.Secondary Outcome
Title Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
Hide Description

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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 119 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.2
(4.7 to 15.6)
55.0
(46.2 to 63.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 44.3
Confidence Interval (2-Sided) 95%
33.9 to 54.6
Estimation Comments Response Rate Difference = Risankizumab - Placebo
4.Secondary Outcome
Title Percentage of Participants With an ACR20 Response at Week 16
Hide Description

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).
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.3
(19.4 to 31.2)
48.3
(41.7 to 54.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 22.6
Confidence Interval (2-Sided) 95%
13.9 to 31.2
Estimation Comments Response Rate Difference = Risankizumab - Placebo
5.Secondary Outcome
Title Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Hide Description

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)
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.4
(7.2 to 15.6)
25.6
(19.9 to 31.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 14.0
Confidence Interval (2-Sided) 95%
7.0 to 21.0
Estimation Comments Response Rate Difference = Risankizumab - Placebo
6.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Hide Description

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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
2.01
(0.94 to 3.08)
5.87
(4.86 to 6.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.
Method Mixed Effect Model Repeated Measurement
Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.86
Confidence Interval (2-Sided) 95%
2.41 to 5.31
Estimation Comments Difference = Risankizumab - Placebo
7.Secondary Outcome
Title Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
Hide Description 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.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
2.6
(1.4 to 3.9)
4.9
(3.7 to 6.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.
Method Mixed Effect Model Repeated Measurement
Comments MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
0.6 to 3.9
Estimation Comments Difference = Risankizumab - Placebo
8.Secondary Outcome
Title Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
Hide Description

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).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.3
(5.4 to 13.2)
26.3
(20.3 to 32.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 16.6
Confidence Interval (2-Sided) 95%
9.7 to 23.6
Estimation Comments Response Rate Difference = Risankizumab - Placebo
9.Secondary Outcome
Title Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
Hide Description

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).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 219 224
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.9
(2.7 to 9.0)
12.0
(7.7 to 16.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
0.8 to 11.3
Estimation Comments Response Rate Difference = Risankizumab - Placebo
10.Secondary Outcome
Title Percentage of Participants With Resolution of Enthesitis at Week 24
Hide Description

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).

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 158 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.4
(23.2 to 37.6)
42.9
(34.9 to 50.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 13.8
Confidence Interval (2-Sided) 95%
3.5 to 24.2
Estimation Comments Response Rate Difference = Risankizumab - Placebo
11.Secondary Outcome
Title Percentage of Participants With Resolution of Dactylitis at Week 24
Hide Description

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.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Risankizumab
Hide Arm/Group Description:
Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
Overall Number of Participants Analyzed 57 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.1
(29.3 to 54.9)
72.5
(58.7 to 86.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.
Method of Estimation Estimation Parameter Response Rate Difference
Estimated Value 38.8
Confidence Interval (2-Sided) 95%
22.9 to 54.8
Estimation Comments Response Rate Difference = Risankizumab - Placebo
Time Frame From first dose of study drug to Week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Risankizumab 150 mg
Hide Arm/Group Description Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
All-Cause Mortality
Placebo Risankizumab 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/219 (0.00%)      0/224 (0.00%)    
Hide Serious Adverse Events
Placebo Risankizumab 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/219 (5.48%)      9/224 (4.02%)    
Blood and lymphatic system disorders     
ANAEMIA  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Cardiac disorders     
CARDIAC FAILURE CONGESTIVE  1  1/219 (0.46%)  1 0/224 (0.00%)  0
CORONARY ARTERY DISEASE  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Gastrointestinal disorders     
UMBILICAL HERNIA  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Infections and infestations     
ABSCESS  1  0/219 (0.00%)  0 1/224 (0.45%)  1
CELLULITIS  1  0/219 (0.00%)  0 1/224 (0.45%)  1
ERYSIPELAS  1  1/219 (0.46%)  1 0/224 (0.00%)  0
GASTROENTERITIS  1  1/219 (0.46%)  1 0/224 (0.00%)  0
GASTROENTERITIS VIRAL  1  0/219 (0.00%)  0 1/224 (0.45%)  1
POSTOPERATIVE ABSCESS  1  1/219 (0.46%)  1 0/224 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  1/219 (0.46%)  1 0/224 (0.00%)  0
URINARY TRACT INFECTION  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Injury, poisoning and procedural complications     
FEMUR FRACTURE  1  1/219 (0.46%)  1 0/224 (0.00%)  0
HIP FRACTURE  1  0/219 (0.00%)  0 1/224 (0.45%)  1
TOXICITY TO VARIOUS AGENTS  1  0/219 (0.00%)  0 1/224 (0.45%)  2
Metabolism and nutrition disorders     
DIABETES MELLITUS  1  0/219 (0.00%)  0 1/224 (0.45%)  1
Musculoskeletal and connective tissue disorders     
INTERVERTEBRAL DISC DEGENERATION  1  0/219 (0.00%)  0 1/224 (0.45%)  1
NECK PAIN  1  1/219 (0.46%)  1 0/224 (0.00%)  0
OSTEOARTHRITIS  1  0/219 (0.00%)  0 1/224 (0.45%)  1
PSORIATIC ARTHROPATHY  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  0/219 (0.00%)  0 1/224 (0.45%)  1
MYELOPATHY  1  0/219 (0.00%)  0 1/224 (0.45%)  1
Psychiatric disorders     
SUICIDE ATTEMPT  1  0/219 (0.00%)  0 1/224 (0.45%)  1
Renal and urinary disorders     
NEPHROLITHIASIS  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Reproductive system and breast disorders     
METRORRHAGIA  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ASTHMA  1  1/219 (0.46%)  1 0/224 (0.00%)  0
Skin and subcutaneous tissue disorders     
ACNE  1  0/219 (0.00%)  0 1/224 (0.45%)  1
Surgical and medical procedures     
HIP ARTHROPLASTY  1  0/219 (0.00%)  0 1/224 (0.45%)  1
1
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Risankizumab 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/219 (5.02%)      17/224 (7.59%)    
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION  1  11/219 (5.02%)  13 17/224 (7.59%)  17
1
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03671148    
Other Study ID Numbers: M15-998
2017-002464-40 ( EudraCT Number )
First Submitted: September 12, 2018
First Posted: September 14, 2018
Results First Submitted: February 1, 2022
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022