AbbVie, a research-based global biopharmaceutical company, announces new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI (risankizumab-rzaa) to COSENTYX (secukinumab) at week 52.
Particularly, 66 percent of psoriasis patients receiving SKYRIZI achieved completely clear skin—100 percent clearance in the Psoriasis Area and Severity Index (PASI 100)—versus 40 percent of patients receiving COSENTYX at week 52 (p<0.001).
These new head-to-head results from the IMMerge Phase 3b open-label study were shared today during an online late-breaking presentation by the American Academy of Dermatology (AAD). AbbVie previously announced top-line results from this study in January.
“I’ve seen first-hand how achieving and maintaining completely clear skin can have an incredibly positive impact on the lives of my psoriasis patients,” said chief investigator Richard B. Warren, MD, PhD, professor and honorary consultant dermatologist at the Dermatology Centre Salford Royal NHS Foundation Trust, University of Manchester. “These new data are critical as they underscore that complete skin clearance is a realistic treatment goal for people living with psoriasis.”
SKYRIZI met both PASI 90 primary endpoints of non-inferiority to COSENTYX at week 16 and superiority to COSENTYX at week 52. At week 16, 74 percent of SKYRIZI-treated patients achieved PASI 90 compared to 66 percent of COSENTYX-treated patients. Of patients treated with SKYRIZI, 87 percent achieved PASI 90 at week 52 compared to 57 percent of patients treated with COSENTYX (p<0.001).
Additional results demonstrated a significantly higher proportion of patients treated with SKYRIZI achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) compared to those treated with COSENTYX at week 52 (88 percent versus 58 percent, respectively, p<0.001).
Current safety data available demonstrated that the safety profile of SKYRIZI was consistent with that seen in previously reported studies, with no new safety signals observed through week 52. The rates of adverse events (AEs) were comparable between SKYRIZI and COSENTYX. The most common AEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhea.
The rates 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 is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
[Source(s): AbbVie, PR Newswire]