FDA Approves New Treatment Option for Patients With Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (skyrizi) for the treatment of active psoriatic arthritis (PsA) in adults.

Previously approved in 2019 for the treatment of moderate to severe plaque psoriasis, this is the second indication for risankizumab-rzaa. Risankizumab-rzaa is administered via a single 150-mg injection subcutaneously 4 times per year following the administration of 2 starter doses at weeks 0 and 4. The injection can be administered alone or in combination with disease-modifying antirheumatic drugs (DMARDs).

This approval was based on the results from the KEEPsAKE-1 and KEEPsAKE-2 randomized, placebo-controlled studies. These studies evaluated the safety and efficacy of this medication in individuals with active PsA who have had an inadequate response with DMARDs and/or biologic therapy. Compared with placebo, risankizumab-rzaa met the primary endpoint of ACR20 and resulted in significant improvements for PsA symptoms such as painful joints, dactylitis, and enthesitis.

Associated serious adverse events include allergic reactions and infections. Upper respiratory infections, fatigue, fungal skin infections, headache, and injection site reactions are among the most common adverse events.

—Leigh Precopio

Reference:

US FDA approves second indication for skyrizi (risankizumab-rzaa) to treat adults with active psoriatic arthritis. News release. AbbVie; January 21, 2022. Accessed January 24, 2022. https://news.abbvie.com/news/press-releases/us-fda-approves-second-indication-for-skyrizi-risankizumab-rzaa-to-treat-adults-with-active-psoriatic-arthritis.htm