Eli Lilly and Company reports 4-year LUCENT-3 data showing 63.5% sustained disease clearance with Omvoh (mirikizumab-mrkz) in ulcerative colitis, with consistent long-term safety.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
Eli Lilly and Company has reported new long‑term data for Omvoh (mirikizumab‑mrkz), demonstrating sustained disease control in adults with moderately to severely active ulcerative colitis (UC). The findings come from the LUCENT‑3 (NCT03519945) open‑label extension study and will be presented at Digestive Disease Week.
Among patients who achieved disease clearance after one year of treatment, 63.5% maintained that level of remission through four years of continued therapy. Disease clearance was defined as the combined achievement of symptomatic, endoscopic, and histologic remission.
The analysis included patients who initially reached clinical remission during the LUCENT‑2 maintenance study (NCT03524092) and subsequently entered LUCENT‑3 for long‑term follow‑up.
Importantly, the reported durability reflects outcomes in this responder population rather than the overall treated cohort. Lilly noted that these findings represent the first time an interleukin‑23p19 (IL‑23p19) inhibitor has demonstrated sustained disease clearance over four years in UC.
Safety outcomes remained consistent with previous studies. In patients continuing into LUCENT‑3, 12% reported a serious adverse event and 7% discontinued treatment due to adverse events. Common adverse reactions observed across LUCENT‑1 and LUCENT‑2 included upper respiratory tract infections, injection‑site reactions, arthralgia, rash, headache, and herpes viral infections. No new safety signals were identified, and the long‑term safety profile remained consistent with the known profile of Omvoh.
Mirikizumab selectively targets the p19 subunit of interleukin‑23, a cytokine involved in driving intestinal inflammation. By inhibiting this pathway, the therapy reduces inflammatory activity associated with ulcerative colitis and other inflammatory bowel diseases.
Omvoh is approved for the treatment of moderately to severely active UC and Crohn’s disease in adults in multiple regions globally, including the United States, where it is available as a single‑injection maintenance regimen for UC.
Lilly is also advancing combination strategies to enhance treatment outcomes. Ongoing studies include mirikizumab in combination with eltrekibart (NCT06598943) and zotemtegrast (NCT07186101), as well as the COMMIT‑UC (NCT06937086) and COMMIT‑CD (NCT06937099) trials evaluating its use alongside incretin‑based therapies in patients with inflammatory bowel disease and metabolic comorbidities. Pediatric studies in UC (NCT05784246) and Crohn’s disease (NCT05509777) are also underway.
Jean‑Frédéric Colombel, M.D., of the Icahn School of Medicine at Mount Sinai, stated that sustained disease clearance at this duration has not previously been demonstrated for IL‑23p19 therapies in UC, highlighting the potential to influence long‑term disease progression.
Overall, these findings support mirikizumab as a durable treatment option and reinforce the growing role of targeted biologic therapies in managing chronic inflammatory bowel diseases.
References
About the Writer
Dr.Preethi Putti, PharmD is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.