Eli Lilly’s ulcerative colitis (UC) treatment, Omvoh (mirikizumab), has shown sustained positive outcomes in patients with moderately to severely active UC four years after the initiation of treatment.
Bruce Sands, a professor of medicine and chief of the Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai said: “Helping people with UC achieve long-term comprehensive disease control is a major goal for gastroenterologists, as it has remained out of reach for many patients,”
“These long-term findings reinforce Omvoh 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 data represent the final results from the phase 3 open-label extension study, LUCENT-3, which assessed patients over a four-year treatment period, including those who achieved clinical remission after one year in the preceding LUCENT-2 phase 3 study.
Positive outcomes were observed across multiple symptomatic, clinical and quality-of-life measures. Among participants, 78% achieved corticosteroid-free clinical remission, with 78% maintaining long-term remission and 90% demonstrating remission on the Inflammatory Bowel Disease (IBD) Questionnaire. The long-term safety profile of Omvoh remained consistent with earlier findings.
“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, senior vice president of Lilly Immunology development.
Omvoh works by selectively targeting and inhibiting the IL-23 pathway which, if over-activated, can become inflamed and contribute to the pathogenesis of inflammatory bowel disease (IBD).
Lilly is conducting additional studies to evaluate the efficacy of Omvoh in UC, including trials in paediatric populations and combination therapy studies.