AbbVie's Upadacitinib Shows Clinical Response In Crohn's Disease Maintenance Study At One Year

AbbVie Inc ABBV announced topline results from U-ENDURE Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease.
The trial included patients who had an inadequate response or were intolerant to conventional or biologic therapy.
A significantly higher proportion of patients who received upadacitinib 15 mg or 30 mg achieved clinical remission (37% and 48%) versus 15% in the placebo group.
Results also showed that 36% and 46% of patients who received upadacitinib 15 mg and 30 mg, respectively, achieved clinical remission at week 52 compared to 14% in the placebo group.
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At week 52, 28% and 40% of patients who received upadacitinib 15 mg and 30 mg, respectively, achieved endoscopic response compared to 7% on the placebo.
In addition, 19% and 29% of patients who received upadacitinib 15 mg and 30 mg achieved endoscopic remission, respectively, compared to 5% on the placebo.
A significantly higher proportion of patients on upadacitinib achieved corticosteroid-free clinical remission than placebo at week 52.
The safety results of upadacitinib were generally consistent with the safety profile observed in the Phase 3 induction studies in Crohn's disease. No deaths were reported throughout the study, and no new safety risks were identified.
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