AbbVie Inc. (NYSE: ABBV) announced Tuesday that SKYRIZI™ met both primary and all ranked secondary endpoints, which includes superiority at week 52, versus Cosentyx® in a head-to-head Phase 3 study. SKYRIZI showed significantly higher rates of skin clearance compared to Cosentyx, meeting the primary endpoint of superiority with at least a 90 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) at week 52. Of patients treated with SKYRIZI, 87 percent achieved PASI 90 compared to 57 percent of Cosentyx-treated patients at 52 weeks (p<0.001). At week 16, SKYRIZI also met the other primary endpoint of non-inferiority to Cosentyx with 74 percent of SKYRIZI patients achieving PASI 90 compared to 66 percent of Cosentyx patients.
Michael Severino, M.D., vice chairman and president of AbbVie explained that, "In this study, SKYRIZI showed superior efficacy compared to Cosentyx in helping patients achieve and maintain high levels of skin clearance at week 52… Head-to-head data like these are crucial to help patients and their doctors make informed treatment decisions. We are pleased to add these results to the growing body of evidence supporting SKYRIZI as a differentiated treatment option for adults living with psoriasis."
According to AbbVie, the current safety data available demonstrated that the safety profile of SKYRIZI was consistent with that observed in previously reported studies, and that no new safety signals observed through week 52. The rates of adverse events (AEs) were comparable between SKYRIZI and Cosentyx. The most common after effects (AEs) that were observed are nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhea. The rate of serious AEs were 5.5 percent in the SKYRIZI group and 3.7 percent in the Cosentyx group. Adverse events leading to discontinuation of the study drug were 1.2 percent in the SKYRIZI group and 4.9 percent in the Cosentyx group. There were no deaths in either treatment group.
SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.