New long-term data from Eli Lilly and Company 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 percent 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 that an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance through 4 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 hospitalisations and surgery. 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.

Adrienne Brown, Executive Vice President and President, Lilly Immunology, said, "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."

Disease clearance was evaluated among patients who achieved clinical remission with Omvoh at 1 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 percent of Omvoh-treated patients who achieved disease clearance at one year sustained it at 4 years. Even at the most stringent measure—requiring endoscopic normalisation in addition to symptomatic and histologic remission—61.3 percent of patients who achieved it at 1 year maintained it through 4 years.

Jean-Frédéric Colombel, M.D., Director, Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine, Mount Sinai, said, "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. 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 hospitalisation 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 1 year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12 percent reported a serious adverse event, while seven percent discontinued treatment due to an adverse event. The most common adverse reactions (reported in at least two percent 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.