AbbVie submitted an application to the FDA for the use of risankizumab-rzaa, 150 mg (Skyrizi) in adults with active psoriatic arthritis.
AbbVie has submitted an application seeking FDA approval for risankizumab-rzaa, 150 mg (Skyrizi) for the treatment of adults with active psoriatic arthritis.
Risankizumab-rzaa, an interleukin-23 inhibitor, was previously approved in 2019 for the treatment of moderate to severe plaque psoriasis.
The application submission is supported by data from the phase 3 KEEPsAKE-1 and KEEPsAKE-2 trials, which evaluated risankizumab-rzaa in adults with active psoriatic arthritis, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs.
For the studies, patients were randomized to risankizumab-rzaa 150 mg or placebo followed by risankizumab-rzaa at week 24. Patients randomized to risankizumab-rzaa received 4 maintenance doses a year, following 2 initiation doses.
According to the results, risankizumab-rzaa demonstrated significant improvement in disease activity (as measured by ACR20 response and minimal disease activity), skin clearance (as measured by at least a 90% improvement in Psoriasis Area Severity Index) and physical function (as measured by the Health Assessment Questionnaire Disability Index) at week 24 versus placebo.
Overall, more patients treated with risankizumb-rzaa achieved the primary end point of ACR20 response at week 24 versus placebo. Additionally, no new safety risks for risankizumab-rzaa were observed in the studies.
“Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome,” Michael Severino, MD, vice chairman and president of AbbVie, said in a statement. “We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals.”