AbbVie’s risankizumab meets Phase 3 endpoints in ulcerative colitis

AbbVie announced positive top-line results from its Phase 3 maintenance study showing risankizumab 180 mg or 360 mg subcutaneous achieved the primary endpoint of clinical remission at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis. A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved clinical remission at week 52: 40% and 38%, respectively, compared to 25% in the induction-only control group. 51% of patients treated with risankizumab 180 mg and 48% of patients treated with risankizumab 360 mg achieved endoscopic improvement at week 52 vs 32% of patients in the induction-only control group. Significantly more patients treated with risankizumab 180 mg and 360 mg achieved histologic endoscopic mucosal improvement at week 52 compared to those treated with induction only: 43% and 42%, respectively, vs 23%. A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved steroid-free clinical remission compared to the induction-only control group at week 52. in the 52-week, double-blind, placebo-controlled COMMAND study was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed. Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.