AbbVie’s Rinvoq (upadacitinib) Receives the US FDA’s Approval for the Treatment of Adults with Moderately to Severely Active Crohn's Disease
- The approval was based on 3 P-III trials incl. (U-EXCEED & U-EXCEL) induction studies & (U-ENDURE) maintenance study to evaluate upadacitinib (45mg, qd) as IT & (15/30mg, qd) as MT vs PBO
- The results showed that more patients achieved the co-1EPs in both studies treated with Rinvoq 45mg @12wk. and (15 & 30mg) @52wks. demonstrated an endoscopic response (34% & 46% vs 3% & 13%) in 2 induction studies & (28% & 41% vs 7%) in the maintenance study; clinical remission (36% & 46% vs 18% & 23%) & (42% & 55% vs 14%), respectively
- In the 2EPs from the IT & MT, corticosteroid-free clinical remission (30% & 40% vs 11% & 13%) & (42% & 53% vs 14%), a greater proportion of patients achieved clinical response @2wk. The safety profile was consistent with the known safety profile of Rinvoq
Ref: AbbVie | Image: AbbVie
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