FDA Approves Risankizumab-rzaa for Adult Patients With Active Psoriatic Arthritis

The Food and Drug Administration recently announced approval of risankizumab-rzaa, an IL-23 inhibitor, for the treatment of active psoriatic arthritis in adult patients.

Risankizumab-rzaa is indicated for active psoriatic arthritis, including disease states that were intolerant to biologic therapy with or without nonbiologic disease-modifying antirheumatic drugs in adults with moderate-to-severe plaque psoriasis.

The approval was granted based on efficacy and safety data from the KEEPsAKE-1 and KEEPsAKE-2 multicenter, randomized, double-blind, placebo-controlled phase 3 studies. Both studies showed that risankizumab-rzaa demonstrated improvements in ACR50 and ACR70 responses compared to placebo at week 24.

The phase 3 studies also found that the safety profile observed in patients with psoriatic arthritis treated with risankizumab-rzaa is consistent with the safety profile in patients with plaque psoriasis.

Reference:
U.S. FDA approves second indication for SKYRIZI® (risankizumab-rzaa) to treat adults with active psoriatic srthritis. Press Release. Abbvie; January 21, 2022. Accessed January 24, 2022. https://www.prnewswire.com/news-releases/us-fda-approves-second-indication-for-skyrizi-risankizumab-rzaa-to-treat-adults-with-active-psoriatic-arthritis-301466021.html