Lilly’s Omvoh is the first IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years

New long-term data from Eli Lilly show that patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) achieved lasting disease clearance across four years of continuous treatment. In the LUCENT-3 open-label extension study, 63.5% of patients who had reached disease clearance at the one-year mark went on to sustain it at four years. These results, presented at Digestive Disease Week, mark the first time an IL-23p19 inhibitor has shown durable disease clearance over four years in UC patients.

Disease clearance refers to the simultaneous achievement of symptomatic, endoscopic and histologic remission, and represents a high clinical bar. Real-world studies have linked disease clearance to lower rates of hospitalisation and surgery. While previously published four-year Omvoh data highlighted strong individual outcomes, this new analysis goes further by assessing those outcomes together as a composite endpoint.

“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,” said Adrienne Brown, executive vice president and president of Lilly Immunology. “Disease clearance sets that bar higher, and these data show Omvoh-treated patients achieved and sustained it over four years with consistent monthly dosing.”

Durable disease clearance in ulcerative colitis

Disease clearance was assessed among patients who had achieved clinical remission with Omvoh at one year in the LUCENT-2 maintenance study before continuing treatment in LUCENT-3. The analysis showed that 63.5% of patients who reached disease clearance at one year maintained it through four years. Even at the most stringent threshold, which required endoscopic normalisation alongside symptomatic and histologic remission, 61.3% of patients who achieved it at one year continued to meet that standard at four years.

“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,” said Jean-Frédéric Colombel, director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai. “Until now, disease clearance has not been demonstrated for this length of time for any IL-23p19 therapy in ulcerative colitis. 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.”

These findings add to the expanding body of long-term evidence for Omvoh in inflammatory bowel disease, building on previously reported four-year results in UC and three-year results in Crohn’s disease, including reductions in serious disease-related complications. During the three-year extension in LUCENT-3, one UC-related hospitalisation and zero UC-related surgeries were recorded among Omvoh-treated patients.

The long-term safety profile in patients with moderately to severely active UC remained consistent with Omvoh’s established profile, with no new safety signals identified. Among patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued into LUCENT-3, 12% reported a serious adverse event and 7% discontinued treatment due to an adverse event. The most commonly reported adverse reactions associated with Omvoh treatment included upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.

Lilly continues to push forward the standard of care in gastroenterology through the next wave of immunology innovation, encompassing combination approaches, novel mechanisms and the potential of incretins. In UC, the company is pursuing combination studies of mirikizumab aimed at delivering strong induction efficacy while sustaining long-term remission and a favourable safety profile. These include studies with eltrekibart, a monoclonal antibody targeting neutrophil-driven inflammation, and zotemtegrast, an oral integrin inhibitor. Separate trials are also investigating mirikizumab alongside an incretin-based therapy in adults with UC or Crohn’s disease who are overweight or obese with at least one additional weight-related condition. Trials in paediatric patients are additionally ongoing in both UC and Crohn’s disease.

Omvoh has received regulatory approval for the treatment of moderately to severely active UC and Crohn’s disease in adults across 47 countries. In the US, Omvoh is also approved for a single-injection maintenance regimen in UC.

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Related Topics and Keywords

IL-23p19, Lilly's Omvoh™, ulcerative colitis