AbbVie Reports Head-To-Head P-III Study (SEQUENCE) of Skyrizi (risankizumab) for Crohn's Disease
Shots:
- The P-III study evaluating risankizumab (600mg, IV at 0, 4 & 8wk. and 360mg, SC at 12wk. and q8w) vs ustekinumab (IV dose at week 0 & 90mg, SC, q8w)
- The trial met both 1EPs of non-inferiority for clinical remission (CDAI) at 24wk. (59% vs 40%) and superiority of endoscopic remission (32% vs 16%) at 48wk. & also showed superiority for all ranked 2EPs incl. achievement of clinical remission (61% vs 41%) at 48wk., endoscopic response (45% vs 22%) at 48wk. and (45% vs 26%) at 24wk., steroid-free endoscopic remission (31% vs 15%) & clinical remission (61% vs 40%) at 48wk.
- The safety results were consistent with the overall safety profile of risankizumab with no new safety risks. Risankizumab was approved for CD, PsA & PsO and is being evaluated for mod. to sev. UC
Ref: AbbVie | Image: AbbVie
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