Lilly’s Omvoh delivers first ever four-year disease clearance data for an IL-23p19 therapy in ulcerative colitis

Eli Lilly has recently presented new long-term data showing that Omvoh (mirikizumab-mrkz) achieved durable disease clearance through four years of continuous treatment in patients with moderately to severely active ulcerative colitis, marking the first time any IL-23p19 inhibitor has demonstrated this level of sustained remission over that timeframe.

The data come from the LUCENT-3 open-label extension study and were presented at Digestive Disease Week. Among patients who achieved disease clearance at one year, 63.5% sustained it at four years. Even at the most stringent measure, requiring endoscopic normalisation alongside symptomatic and histologic remission, 61.3% of patients who achieved it at one year maintained it through four years.

Disease clearance is a high clinical bar, requiring the simultaneous achievement of symptomatic, endoscopic and histologic remission. Real-world studies have associated it with reduced rates of hospitalisation and surgery, making durability at this composite endpoint particularly meaningful for long-term patient outcomes.

Adrienne Brown, Lilly’s Executive Vice President and President of Lilly Immunology, framed the results as raising the standard for what patients should expect from treatment: “Ulcerative colitis is a lifelong disease, and every person living with the condition deserves a treatment that can deliver strong and durable disease control, not just symptom relief. Disease clearance sets that bar higher, and these data show Omvoh-treated patients achieved and sustained it over four years with consistent monthly dosing.”

Jean-Frédéric Colombel, Director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, highlighted the significance of the composite endpoint approach: “What makes these data so compelling is that they go beyond individual measures of improvement to show that patients treated with Omvoh achieved disease clearance, with simultaneous symptomatic, endoscopic and histologic remission, maintained over four years. For a progressive disease like ulcerative colitis, that level of durable remission has the potential to change the long-term course of the disease for patients.”

The long-term safety profile was consistent with the known profile of Omvoh, with no new safety signals observed. Among patients who completed one year of blinded maintenance therapy and continued into LUCENT-3, 12% reported a serious adverse event and 7% discontinued due to an adverse event. One UC-related hospitalisation and zero UC-related surgeries were reported across the three-year extension period.

Lilly is continuing to build on this foundation through a pipeline of combination approaches in ulcerative colitis and Crohn’s disease. These include studies pairing mirikizumab with eltrekibart, a monoclonal antibody targeting neutrophil-driven inflammation, and with zotemtegrast, an oral integrin inhibitor. The COMMIT-UC and COMMIT-CD trials are also investigating mirikizumab alongside incretin-based therapy in patients with inflammatory bowel disease who also have obesity or overweight. Paediatric trials are ongoing in both indications.

Omvoh is approved for moderately to severely active ulcerative colitis and Crohn’s disease in adults across 47 countries. In the US, it is also approved for a single-injection maintenance regimen in ulcerative colitis.

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