The P-III (U-ENDURE) study evaluate upadacitinib (15/30mg, qd) vs PBO as maintenance therapy in 673 patients with CD with inadequate response or who were intolerant to a conventional or biologic therapy
The results showed that patients achieved clinical remission per CDAI @52wk. (37% & 48% vs 15%); clinical remission per SF/AP (36% & 46% vs 14%); endoscopic response (28% & 40% vs 7%); endoscopic remission (19% & 29% vs 5%) & corticosteroid-free clinical remission/CDAI & SF/AP
The safety results were consistent with the P-III induction studies, no new safety risks with no thrombotic events & no deaths were reported. Future regulatory filings will contain the results of the (U-ENDURE), (EXCEED) & (U-EXCEL) studies
Ref: PRNewswire | Image: AbbVie
