Skyrizi met primary and key secondary endpoints in 52-week phase III maintenance study in ulcerative colitis patients- AbbVie.

In the COMMAND maintenance study, patients from the Phase IIb/III INSPIRE study who responded to induction treatment were re-randomized to receive risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab treatment (risankizumab intravenous [IV] induction-only control group). Approximately 75% of patients previously failed at least one advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) for 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 (p<0.01).></0.01).>

In COMMAND , 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 (p<0.001). additionally, 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% (p><0.001). 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 (40% and 37%, respectively, vs 25%; p><0.01).></0.01).></0.001).></0.001).>

"These positive results suggest that risankizumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that disrupt their daily lives," said Stefan Schreiber, M.D., director of department of internal medicine I, University Hospital Schleswig-Holstein, Germany, COMMAND study investigator. "Risankizumab's achievement of a broad range of difficult-to-reach endpoints encompassing endoscopic-histologic outcomes and many others represents important progress toward addressing the need for additional treatment options for patients with ulcerative colitis."

The safety profile of risankizumab 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. The most common adverse events observed in the risankizumab groups were colitis ulcerative, COVID-19, nasopharyngitis and arthralgia. Serious adverse events occurred in 5.2% and 5.1% of patients in the risankizumab 180 mg and 360 mg groups compared to 8.2% of patients in the control group. There was one death in the 360 mg group due to adenocarcinoma assessed as unrelated to study drug. There were no adjudicated major adverse cardiac events (MACE) and no adjudicated anaphylactic reaction events.

Full results from the COMMAND study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. Risankizumab (Skyrizi) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.