KEEPsAKE 2 Trial Tests Long-Term Efficacy of Risankizumab for Active PsA

Risankizumab demonstrated robust and durable efficacy through 52 weeks of treatment among patients with active psoriatic arthritis (PsA) who had inadequate response or intolerance to biologic or conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy. Researchers published findings in the journal Rheumatology.

The study was a 52-week follow-up analysis of the ongoing phase 3 KEEPsAKE 2 clinical trial, which randomized patients with active PsA who had a poor response to 1 or 2 biologic therapies or 1 or more csDMARDs to subcutaneous risankizumab 150 mg or placebo at weeks 0, 4, and 16. Patients who received placebo switched to risankizumab at week 24. As of week 28, all participants received 150 mg every 12 weeks.

The proportion of patients achieving at least 20% improvement in American College of Rheumatology criteria (ACR20) at week 24 was 51.3% with risankizumab and 26.5% with placebo, according to the study. At week 52, ACR20 was achieved by 58.5% of patients originally randomized to risankizumab and 55.7% of patients who switched from placebo to risankizumab. Other PsA sign and symptom measures, as well as health-related quality of life and fatigue, showed similar efficacy trends through week 52.

“Notably, efficacy was maintained with administration of risankizumab every 12 weeks, while similar interleukin-23 inhibitors are administered every 8 weeks,” researchers wrote. “By the long-term data cut-off (19 April 2021), 84.8% of patients randomized to receive continuous risankizumab continued in the study.”

Risankizumab was generally well tolerated, with stable rates of serious and treatment-emergent adverse events leading to discontinuation through week 52. The analysis identified no new safety signals.

“As anticipated, patients initially randomized to receive placebo and then switched to risankizumab at week 24 experienced a similar trajectory of improvements in the signs and symptoms of PsA from week 24 through week 52,” researchers reported.

Reference
Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology. 2023;62(6):2122-2129. doi: 10.1093/rheumatology/keac605