Positive Phase III results for Rinvoq in Crohn's disease

US pharma major AbbVie (NYSE: ABBV) yesterday announced positive top-line results from U-ENDURE, its Phase III maintenance study evaluating the JAK inhibitor Rinvoq (upadacitinib) in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to a conventional or biologic therapy.

The results showed that more patients treated with either dose of upadacitinib (15mg or 30mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo. Use of upadacitinib in Crohn's disease has not been evaluated by health authorities. Results from the U-ENDURE maintenance study, in addition to results from the U-EXCEED and U-EXCEL induction studies, will be included in future regulatory submissions.

In the U-ENDURE maintenance study, patients from U-EXCEED and U-EXCEL who responded to 12 weeks of upadacitinib 45mg oral induction treatment were re-randomized to receive upadacitinib 15mg, upadacitinib 30mg, or placebo. Clinical remission was defined by the Crohn's Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).