Phase III trial reveals positive results for Crohn’s disease treatment
pharmafile | May 12, 2022 | News story | Business Services |
AbbVie has announced positive topline results from U-ENDURE, its Phase III maintenance study, evaluating upadacitinib in adult patients with Crohn’s disease.
The trial analysed adults 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.
A significantly higher proportion of patients who received upadacitinib achieved clinical remission, compared to the placebo group.
“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, MD, senior vice president, Research and Development, CSO, AbbVie. “These results represent important progress as we work to bring new treatment options to patients with inflammatory bowel disease.”
“Symptomatic relief as well as healing of the intestinal mucosa in Crohn’s disease are important long-term treatment targets which may be associated with slowing disease progression and better quality of life for patients,” said Julian Panes, Emeritus Professor of Medicine and the Chief of the IBD Unit at Hospital Clínic de Barcelona and lead study investigator. “These results are encouraging, and would be particularly important for patients who have not found relief with other conventional or biologic treatment options.”
The use of upadacitinib in Crohn’s disease has not yet been evaluated by health authorities. Results from the U-ENDURE maintenance study will be included in future regulatory submissions.
Lina Adams
