Risankizumab Well Tolerated, Shows Improvements in Symptoms of Psoriatic Arthritis

Hands with PsA
Hands of person with psoriatic arthritis.
Researchers reported integrated results from 24-week, phase 3 randomized clinical trials on the safety and efficacy of risankizumab in patients with active psoriatic arthritis.

The following article is a part of conference coverage from the American College of Rheumatology (ACR) Convergence 2021, being held virtually from November 3 to 10, 2021. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the ACR Convergence 2021.


Risankizumab was found to be effective and safe in the treatment of active psoriatic arthritis (PsA), according to trial data presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 3 to 10, 2021. Compared with placebo, risankizumab was associated with greater improvements in signs and symptoms of PsA among patients with previous inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR) or biologic therapies (bio-IR).

Interleukin (IL)-23 inhibitor risankizumab is currently under investigation for the treatment of PsA in adults.

In the current analysis, the researchers pooled data from 2 double-blind, phase 3 randomized controlled trials of risankizumab vs placebo for PsA treatment (KEEPSAKE 1 and 2). The trials enrolled adults with active PsA, active plaque psoriasis, and nail psoriasis who had at least 5 swollen joints and at least 5 tender joints and were csDMARD-IR and bio-IR. In each study, patients were randomly assigned 1:1 to receive blinded subcutaneous risankizumab 150 mg or placebo at weeks 0, 4, and 16.

The primary endpoint was the percentage of patients achieving 20% improvement in the ACR score (ACR20) by week 24. Safety was assessed during both the trials.

The pooled cohort included 1407 patients, among whom 1354 (688 in the risankizumab group and 666 in the placebo group) completed the 24-week assessment. Baseline demographic and clinical characteristics were comparable between groups.

At week 24, the percentage of patients achieving ACR20 was 55.5% in the pooled risankizumab group and 31.3% in the pooled placebo group (difference, 24.0; 95% CI, 19.0-29.0; P <.001).

The risankizumab vs placebo group also had greater improvements in all secondary outcomes, including Health Assessment Questionnaire-Disability Index score and Functional Assessment of Chronic Illness Therapy-Fatigue score.

Risankizumab was well tolerated, with no new safety signals observed during the 24-week period.

These data support the use of risankizumab in the treatment of PsA in patients who are csDMARD-IR or bio-IR.

Disclosure: This research was supported by AbbVie. Please see the original reference for a full list of authors’ disclosures


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Ostor A, Papp K, Moreno M, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week integrated results from 2 phase 3, randomized, double-blind clinical trials for csDMARD-IR and bio-IR patients. Presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 0453.