AbbVie’s Skyrizi (risankizumab) Meet Primary and Secondary Endpoints in P-III (SEQUENCE) Head-to-Head Study for Crohn's Disease
Shots:
- The P-III trial evaluating risankizumab (600mg, IV induction at 0, 4 & 8wk. and 360mg, SC at 12wk. & q8w) vs ustekinumab (IV dose at week 0 and 90mg, SC, q8w) in 527 patients who have failed one or more anti-TNFs
- The results showed that risankizumab met both 1EPs of non-inferiority for clinical remission (CDAI) at 24wk. (remission rates were 59% vs 40%) and superiority of endoscopic remission (SES-CD ≤4 and at 2-point reduction over baseline and no sub-score ≥1 in any individual component) at 48wk. (remission rates were 32% vs 16%)
- All 2EPs achieved statistical significance for superiority over ustekinumab. The safety profile was consistent with the known safety profile of risankizumab with no new safety risks
Ref: PR newswire | Image: AbbVie
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
