Risankizumab Submitted for Regulatory Approval to FDA, EMA for Psoriatic Arthritis

April 7, 2021
Morgan Petronelli, Associate Editor

AbbVie announces the submission of regulatory filings for risankizumab to the FDA and EMA seeking approval for the drug as a treatment for psoriatic arthritis.

AbbVie Inc. announced the application submissions for regulatory approval of risankizumab (Skyrizi, AbbVie) to the FDA and EMA for the treatment of psoriatic arthritis (PsA) in adults, according to a press release announcing the filings.1

Risankizumab, an interleukin (IL)-23 inhibitor that works by binding to the p19 subunit of IL-23, is thought to be associated with various chronic immune-mediated diseases such as psoriasis.

Most recently, risankizumab 150 mg was FDA-approved in April 2019 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.1 The approved dose of 150 mg consists of two 75 mg subcutaneous injections administered at week 0,4 and then subsequently every 12 weeks.

The filings are supported by positive data from two phase 3 trials (KEEPsAKE-1, NCT03675308; KEEPsAKE-2, NCT03671148). Both trials are multicenter, double-blind, randomized, placebo-controlled and investigating the efficacy and safety of risankizumab in adult patients with active PsA.

KEEPsAKE-1 observed risankizumab in PsA patients who had an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD). Meanwhile, KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs.

Both studies had a primary endpoint of achievement of an American college of Rheumatology (ACR) 20 response at week 24. Secondary endpoints included a change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI), and of achievement of a Psoriasis Area and Severity Index (PASI) score of 90 and minimal disease activity (MDA) at week 24. The studies are ongoing, with the long-term extension remaining blinded to investigate the long-term safety, tolerability, and efficacy of risankizumab in patients who have completed the placebo-controlled period.

Results of the studies showed risankizumab demonstrated significant improvements in disease, skin clearance, and physical function at week 24 when compared to placebo.1 Significantly more patients treated with risankizumab achieved the primary endpoint of ACR20 response at week 24 vs placebo in both studies.

Additionally, the safety profile of risankizumab in the studies was consistent with the safety profile of risankizumab in plaque psoriasis, with no new safety risks observed, according to the release.

"Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome,” said Michael Severino, MD, vice chairman and president of AbbVie. “Despite advancements, many patients cannot find relief from the signs and symptoms of this disease. We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals."

Risankizumab is currently undergoing various phase 3 trials investigating the drug as a treatment for psoriasis, Crohn's disease, ulcerative colitis and PsA.1

References:

1. Abbvie submits regulatory applications for skyrizi® (Risankizumab) in psoriatic arthritis to fda and ema. AbbVie Inc. Accessed April 7, 2021. https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-applications-for-skyrizi-risankizumab-in-psoriatic-arthritis-to-fda-and-ema-301264138.html