Lilly’s Omvoh shows sustained 4-year efficacy in ulcerative colitis

Lilly's Omvoh is the first and only IL-23p19 antagonist to show four years of sustained, corticosteroid-free comprehensive patient outcomes in ulcerative colitis

New data from Eli Lilly and Company showed Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active ulcerative colitis (UC) achieve sustained, long-term outcomes through four years.

The results were seen across multiple symptomatic, clinical, endoscopic, histologic and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy (27%).

These data are the final results from the LUCENT-3 Phase 3 open-label extension study and will be presented at United European Gastroenterology (UEG) Week, taking place Oct. 4-7 in Berlin.

"Helping people with ulcerative colitis achieve long-term comprehensive disease control is a major goal for gastroenterologists, as it has remained out of reach for many patients," said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "These long-term findings reinforce mirikizumab as a highly effective biologic for UC management, showing sustained clinical, endoscopic and steroid-free remission over four years, and improvement in bowel urgency, which can present a significant burden on patients' lives."

The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.

"With these results, Omvoh continues to set a high standard as the first and only IL-23p19 with evidence of sustained efficacy and consistent safety in ulcerative colitis over four years," said Mark Genovese, M.D., senior vice president of Lilly Immunology development.

"Lilly is shaping the future of IBD care to make life better for patients by redefining what's possible in terms of steroid-free, long-lasting, comprehensive disease control, including durable clinical and endo-histologic remission and relief of disruptive symptoms like bowel urgency."

Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 44 countries around the world.