Eli Lilly's Omvoh (mirikizumab) has shown promising long-term efficacy and safety in patients with ulcerative colitis (UC) and Crohn's disease (CD), according to data presented at the American College of Gastroenterology Annual Meeting. The Phase III trials, LUCENT-3 and VIVID-2, demonstrated sustained remission and symptom improvement over multiple years, offering hope for patients seeking lasting relief from these chronic inflammatory conditions.
Sustained Remission in Ulcerative Colitis
The LUCENT-3 trial, an open-label extension of the LUCENT-1 and LUCENT-2 trials, evaluated the long-term efficacy and safety of Omvoh in UC patients for up to three years. Patients who achieved clinical remission with Omvoh after one year in the LUCENT-2 trial maintained impressive results over the extended period. Specifically, 81% maintained long-term clinical remission, 82% achieved long-term endoscopic remission, and 72% experienced mucosal healing. Furthermore, 79% achieved corticosteroid-free clinical remission, and patients showed sustained, clinically meaningful improvements in bowel urgency, with a symptom score decrease of -4.72.
The study included patients who had previously failed to respond to TNF inhibitors, tofacitinib, or other biologic therapies, highlighting Omvoh's potential as a valuable option for those with refractory disease. The safety profile remained consistent with previous observations, with 7.4% of patients experiencing serious adverse events (AEs) and 5.3% discontinuing treatment due to AEs.
Long-Term Efficacy in Crohn's Disease
The VIVID-2 trial, a long-term extension of the SERENITY and VIVID-1 trials, assessed the efficacy and safety of Omvoh in CD patients for up to five years. Results showed that patients with moderately to severely active CD who were administered Omvoh maintained high rates of clinical and endoscopic remission over time. An observed case analysis revealed that 96% of patients achieved clinical response as per the Crohn's Disease Activity Index (CDAI), 87% were in clinical remission as measured by CDAI, 76% achieved endoscopic response, and 54% achieved endoscopic remission.
Similar to the UC study, the long-term safety profile of Omvoh in CD patients was consistent with previous findings, with 8.5% of patients reporting a serious AE and 1.9% discontinuing treatment due to an AE.
Expert Commentary
"Despite continued advances, people living with ulcerative colitis and Crohn's disease are still seeking treatments that can address difficult-to-manage symptoms such as bowel urgency and provide lasting results over time," said Dr. Bruce Sands, MD, MS, 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 multi-year data show mirikizumab is a targeted therapy that can provide intestinal healing over time and improvement in key symptoms that matter most to patients."
About Mirikizumab
Mirikizumab, marketed as Omvoh, is an interleukin-23p19 (IL-23p19) antagonist that selectively binds to the p19 subunit of IL-23, thereby interfering with its interaction with the IL-23 receptor. It was approved in October 2023 as the first and only IL-23p19 antagonist indicated for the treatment of adults with moderately to severely active UC.
