Risankizumab Shows Efficacy in Patients With Active Psoriatic Arthritis Through 52 Weeks

In a recent study, risankizumab showed greater efficacy in patients with active psoriatic arthritis (PsA) compared with placebo up to week 52 across different patient demographics and disease characteristics.

Doctor at appointment shows patient printed fragment of examination, where joint disease is recorded | shidlovski - stock.adobe.com

The post hoc analysis is published in the Journal of Dermatological Treatment.

“Among all subgroups, numerically higher response rates were achieved in patients randomized to receive risankizumab relative to those patients who received placebo at week 24 across disease domains, including rigorous skin response criteria, composite measures to assess overall disease activity, and PsA-related signs and symptoms,” the researchers wrote. “Furthermore, patients randomized to receive continued risankizumab treatment achieved sustained response rates through 52 weeks.”

The analysis follows KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) phase 3 trial designs, in which risankizumab demonstrated greater efficacy compared with placebo in patents with PsA. Patients enrolled in these studies were aged 18 years and older, had a confirmed clinical diagnosis of PsA and active disease, had an inadequate response or intolerance to conventional synthetic disease-modifying, anti-rheumatic drugs, and/or had an inadequate response or intolerance to 1 or 2 biologic therapies.

In the current analysis, the researchers evaluated efficacy outcomes at weeks 24 and 52 by baseline demographics and clinical characteristics, including 20% or greater, 50%, and 70% improvement in American College of Rheumatology (ACR20/50/70) response criteria, 90% or greater improvement in Psoriasis Area Severity Index (PASI), Minimal Disease Activity (MDA) status, Low Disease Activity (LDA) status, and minimal clinically important difference in pain.

A total of 1408 patients were initially randomized to receive either risankizumab 150mg or placebo, of whom 1354 continued into the open-label periods, and 1235 were still ongoing treatment at the time of the data cutoff date on April 19, 2021.

Baseline demographics and clinical characteristics of patients were generally well-balanced between groups.

At week 24, higher ACR20 response rates were observed in patients who received risankizumab (46.3% to 60.1%) compared with patients who received placebo (15.5% to 36.2%), regardless of subgroups. Additionally, consistent proportions of patients who received risankizumab achieved ACR20 (48.6% to 75.8%) at week 52, while those initially randomized to placebo who switched to risankizumab experienced an improvement from week 24 (43.7% to 63.9%), regardless of subgroups.

The researchers also noted similar trends for other efficacy measures for rigorous skin response criteria, composite measures of overall disease activity, and PsA-related symptoms.

Study limitations included a relatively small sample size and that further evidence-based on real-world patient data may be needed to confirm if the findings from this study are applicable to the general population.

Despite these limitations, the researchers believe the study finds risankizumab to exhibit superior efficacy compared with placebo at week 24 with sustained or improved efficacy up to week 52 across different patient subgroups.

“Patients treated with risankizumab throughout the study achieved generally consistent efficacy, regardless of patient demographic, disease characteristics, and prior/concomitant treatment exposure,” wrote the researchers. “At week 52, patients who switched from placebo to risankizumab also achieved similar response rates as those who were treated with risankizumab from baseline through week 52 with similar improved efficacy across subgroups.”

Reference

Merola JF, Armstrong A, Khattri S, et al. Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: A post hoc integrated analysis of the Phase 3 Keepsake 1 and keepsake 2 randomized controlled trials. Journal of Dermatological Treatment. 2024;35(1). doi:10.1080/09546634.2024.2342383