Policy & Regulation
AbbVie's upadacitinib (RINVOQ(R)) Achieved Clinical Remission and Endoscopic Response at One Year in Phase 3 Maintenance Study in Patients with Crohn's Disease
12 May 2022 -

US-based biopharmaceutical company AbbVie announced on Wednesday positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating 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 company said that 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.

The U-ENDURE study is a Phase 3, multicentre, randomised, double-blind, placebo-controlled maintenance and long-term study designed to evaluate the efficacy and safety of upadacitinib 15mg and 30mg in adults with moderate to severe Crohn's disease. U-ENDURE enrolled patients who responded to 12 weeks of induction treatment from the U-EXCEED and U-EXCEL studies. 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-randomised 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).

'We are deeply committed to supporting Crohn's disease patients who continue to live with challenging symptoms that impact their daily lives,' said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. 'These results represent important progress as we work to bring new treatment options to patients with inflammatory bowel disease.'

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea and abdominal pain.

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