INDIANAPOLIS – New long-term data from Eli Lilly and Co. show patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) achieved durable disease clearance through four years of continuous treatment. In the LUCENT-3 open-label extension study, 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years. These results will be presented at Digestive Disease Week (DDW) and represent the first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance through four years in people with UC.
Disease clearance is the simultaneous achievement of symptomatic, endoscopic and histologic remission. In real-world studies, achieving disease clearance has been associated with reduced rates of hospitalizations and surgery.2-3 While previously reported four-year Omvoh data showed durable individual outcomes, this new analysis goes further by evaluating those outcomes together as a composite endpoint, reflecting a higher clinical bar.
“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.”
Disease clearance was evaluated among patients who achieved clinical remission with Omvoh at one year in the LUCENT-2 maintenance study and continued treatment in LUCENT-3, an open-label extension study. This analysis, which was not pre-specified, showed 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years.* Even at the most stringent measure — requiring endoscopic normalization in addition to symptomatic and histologic remission — 61.3% of patients who achieved it at one year maintained it through 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 Dr. 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 expand the growing body of long-term data on Omvoh in inflammatory bowel disease (IBD), building on previously disclosed four-year results in UC and three-year results in Crohn’s disease, including reduction of serious disease-related complications. In LUCENT-3, one UC-related hospitalization and zero UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension.
The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.5 The most common adverse reactions (reported in at least 2% of subjects at a higher frequency than placebo) associated with Omvoh treatment in LUCENT-1 and -2 were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.
Lilly continues to advance the standard of care in gastroenterology through the next wave of immunology innovation, including combination approaches, novel mechanisms and the potential of incretins. In UC, Lilly is pursuing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor. The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn’s disease and obesity or overweight with at least one additional weight-related comorbid condition. In addition, trials of mirikizumab in pediatric patients are ongoing in UC (NCT05784246) and Crohn’s disease (NCT05509777).
Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn’s disease in adults and has been approved in 47 countries around the world. In the U.S., Omvoh is also approved for a single-injection maintenance regimen in UC.
