The approval was based on the data from the 3 P-III clinical studies (ADVANCE/MOTIVATE induction & FORTIFY maintenance) evaluating the safety, efficacy & tolerability of Skyrizi vs PBO as induction (600-1200mg) & maintenance (180-360mg) therapy in patients with moderately/severely active Crohn’s disease
The patients treated with Skyrizi (600mg, IV) in the induction trials depicted a clinical remission of (43% & 35%) & an endoscopic response in (40% & 29%) @12wks vs (22% & 19%) & (12% & 11%) in PBO whereas those treated with Skyrizi (360mg, SC) in the maintenance trial depicted a clinical remission of 52% & an endoscopic response of 47% @52wks. vs 40% & 22% in PBO
The induction trials showed mucosal healing & endoscopic remission in (21% & 14%) & (24% & 19%) of patients @12wks. vs (8% & 4%) & (9% & 4%) in PBO whereas for that in the maintenance trial the number was 31% & 39% vs 10% & 13% @52wks.
Ref: AbbVie | Image: AbbVie