Efficacy, Safety of Risankizumab for Treatment of Active Psoriatic Arthritis

Risankizumab, a humanized monoclonal antibody, was well-tolerated and had long-term efficacy for the treatment of active psoriatic arthritis (PsA) at week 52 in patients who previously had inadequate response or tolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), according to a follow-up analysis of an ongoing phase 3 study.

KEEPsAKE 1 is a double-blind, placebo-controlled study in which patients were randomly assigned to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4, and 16 and were monitored until week 24. An open-label extension period continued from week 24 through week 208, with all continuing patients to receive open-label risankizumab 150 mg every 12 weeks.

A total of 57.3% of patients treated with risankizumab (n = 483) achieved 20% or greater improvement in the American College of Rheumatology criteria (ACR20) at week 24, whereas 33.5% of patients treated with placebo (n = 481) achieved this improvement.

Of the 97.5% of patients who continued with the extension period, 70.0% of patients who were randomized to receive risankizumab and 63.0% of patients who were switched from placebo to risankizumab following week 24 achieved ACR20 at week 52. Other efficacy measures, such as nail outcomes and health-related quality of life, had similar results for the two groups. The treatment was well-tolerated through 52 weeks, with a consistent safety profile from week 24 through week 52.

The authors note that the homogenous study population may limit the generalizability of the study results. The elimination of the placebo group after week 24 may also impact long-term efficacy and safety results. 

“This study supports the use of risankizumab in patients with active PsA who have inadequate response, intolerance, or contraindication to csDMARDs,” the researchers concluded. “…KEEPsAKE 1 remains ongoing and will allow further assessment of long-term efficacy and safety in PsA.”

Reference:

Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology. 2023;62(6):2113-2121. doi:10.11093/rheumatology/keac607.