AbbVie published Phase 3 clinical trials of Skyrizi in Crohn's Disease.
AbbVie announced that The Lancet had published the induction and maintenance programs of Skyrizi in patients with Crohn's disease- ADVANCE, MOTIVATE (induction studies), and FORTIFY (maintenance study).
ADVANCE and MOTIVATE were Phase 3, placebo-controlled induction studies. The ADVANCE trial included patients who had an inadequate response to biologics or conventional therapy; MOTIVATE trial included patients who had an inadequate response to biologics. All the primary endpoints were met in both trials.
In the ADVANCE trial, CDAI clinical remission rate for risankizumab 600 mg was 45%, and risankizumab 1,200 mg was 42%, versus 25% with placebo. The endoscopic response rate with risankizumab 600 mg was 40%, risankizumab 1,200 mg was 32%, versus 12% with placebo.
In MOTIVATE trial, CDAI clinical remission rate for risankizumab 600 mg was 42%, and risankizumab 1,200 mg was 40%, versus 20% with placebo. The endoscopic response rate with risankizumab 600 mg was 29%, risankizumab 1,200 mg was 34%, versus 11% with placebo.
BMS MS product Zeposia is approved for UC in EU
Zeposia (ozanimod) is approved in Europe for moderate to severe ulcerative colitis in adults. The drug is indicated for treating patients who had an inadequate response to conventional therapy or biologics.
The approval is based on the Phase 3 True North trial, a placebo-controlled trial that evaluated the efficacy of Zeposia versus placebo in adult patients with moderately to severe ulcerative colitis. Nearly 30% of the patients failed or were intolerant to TNF blockers.
In the induction phase, at week 10, the trial met the primary endpoint (18% versus 6%), and the secondary endpoints
At week 52, the primary endpoint of clinical remission was met (37% versus 19%), and the secondary endpoints
Zeposia is a sphingosine-1 phosphate receptor modulator, which Celgene developed.