AbbVie has submitted a Biologics License Application to the Food and Drug Administration (FDA) for risankizumab-rzaa for the treatment of adults with active psoriatic arthritis.

The application is supported by 2 pivotal phase 3 studies, KEEPsAKE-1 (ClinicalTrials.gov: NCT03675308) and KEEPsAKE-2 (ClinicalTrials.gov: NCTHAHA03671148), which compared the efficacy and safety of risankizumab to placebo in adults with active psoriatic arthritis who had an inadequate response or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). The primary endpoint for both studies was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 24.

Results from KEEPsAKE-1 and KEEPsAKE-2 showed that 57% and 51% of patients, respectively, treated with risankizumab 150mg achieved ACR20 at week 24 compared with 34% and 27% of patients who received placebo (P <.001). Risankizumab was also associated with improvements in skin clearance, physical function, and minimal disease activity at week 24. The safety profile of risankizumab was generally consistent with that observed in previous studies.

Risankizumab, an interleukin-23 antagonist, is currently marketed under the trade name Skyrizi® and is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 


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References

1.    AbbVie submits regulatory applications for Skyrizi® (risankizumab) in psoriatic arthritis to FDA and EMA. [press release]. North Chicago, IL: AbbVie; April 7, 2021. 

2.    Risankizumab (Skyrizi®) phase 3 results demonstrate improvements in disease activity across joint and skin symptoms among psoriatic arthritis patients. [press release]. North Chicago, IL: AbbVie; January 5, 2021.