Risankizumab Shown Effective With No Increase in Adverse Events vs Placebo in PsA

Risankizumab showed superior efficacy across multiple outcomes compared with a placebo, with no significant increase in adverse events in patients with psoriatic arthritis (PsA).

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The FDA approved risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, in March 2019 for the treatment PsA in adults.

Researchers explained that the cause of PsA is unknown and that current treatments may not be sufficiently effective. Therefore, they conducted a meta analysis of double-blind, randomized, placebo-controlled trials, with the aim of evaluating the effectiveness and safety of risankizumab.

The study is published in Rheumatology and Therapy.

“Risankizumab, as an IL-23 inhibitor, exhibits significant efficacy and a favorable safety profile in treating PsA,” wrote the researchers of the study. “These findings provide substantial support for the inclusion of risankizumab as a highly effective treatment option for PsA, offering valuable guidance to clinicians and patients in their therapeutic decision-making process.”

The researchers conducted a database search from January 1, 1950, to October 1, 2023, using the terms “Psoriatic arthritis,” “Risankizumab,” and related free words. Although no restrictions were used regarding gender, age, race, or publication timeframe, inclusion criteria required the studies have a placebo or historical control group. Additionally, animal experiments, letters, comments, and editorials were excluded from the analysis.

A total of 238 studies were initially identified, and 10 studies were included in the meta analysis. Three of the studies evaluated the safety of risankizumab. All studies were randomized controlled trials published between 2021 and 2023.

Six studies of 5038 patients with PsA treated with either risankizumab or placebo were included in the analysis.

The results of the analysis showed significant efficacy of risankizumab compared with placebo in various evaluation indicators, with a significantly higher American College of Rheumatology-20 (ACR20) response rate (RR) than the placebo group (RR, 1.76; 95% CI, 1.57-1.98; P < .001). Patients treated with risankizumab also demonstrated significantly higher minimal disease activity than patients in the placebo group (RR, 1.83; 95% CI, 1.05-3.18; P < .05).

The risankizumab group also exhibited improvement in the Short Form 36 Questionnaire (SF-36) score (SMD 0.51, 95% CI 0.33-0.69, P < 0.001), as well as a significantly lower Health Assessment Questionnaire Disability Index score (−0.27, 95% CI, −0.37 to −0.17; P < .001) and higher Functional Assessment of Chronic Illness Therapy-Fatigue score (0.27; 95% CI, 0.20-0.35, P < .001) compared with the placebo group. Furthermore, patients in the risankizumab group had a significantly lower Psoriasis Area and Severity Index score (−6.12; 95% CI,−10.02 to 2.23, P < 0.001).

No significant differences were identified in the incidence of serious adverse events between the risankizumab and placebo groups.

The researchers acknowledged some limitations to their study, including that PsA is a complex disease and may not be captured by only assessing the specific test and questionnaire score values that were used in the analysis. Additionally, the analysis only includes up to 24 weeks of data from clinical trials, so it could not estimate the long-term effectiveness in trials or real-world clinical settings. Furthermore, the study was limited only to published articles in English and Chinese databases.

Despite these limitations, the researchers believe the study shows substantial support for the inclusion of risankizumab as an effective and safe treatment for patients with PsA.

“The results of this meta-analysis provide robust evidence for the efficacy and clinical benefits of risankizumab in PsA treatment,” wrote the researchers. “The significant improvements observed in ACR20 response rates and other key secondary endpoints, such as enthesitis, dactylitis, cutaneous psoriasis, and nail disease, highlight the therapeutic benefits of risankizumab.”

Reference

Su QY, Zhou HN, Xia GM, et al. Efficacy and safety of risankizumab in patients with psoriatic arthritis: A systematic review and meta-analysis of randomized controlled trials. Rheumatol Ther. Published online February 1, 2024. doi:10.1007/s40744-024-00638-5