Omvoh achieves steroid-free disease control at one year in ulcerative colitis and Crohn’s disease – Eli Lilly

New data analyses from Eli Lilly and Company show patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease treated with Omvoh (mirikizumab-mrkz) achieved multiple treatment goals simultaneously at one year, as measured by comprehensive disease control in UC and corticosteroid-free deep remission in Crohn’s disease.

These multidimensional outcomes were observed even in patients with prior biologic failure, a population often facing greater treatment challenges. More than one-third of patients in the UC analysis and nearly half of patients in the Crohn’s disease analysis had previously experienced biologic treatment failure. Furthermore, patients who achieved these endpoints were more likely to also achieve remission on the Inflammatory Bowel Disease Questionnaire (IBDQ), a validated patient-reported measure of health-related quality of life. Together, these findings reflect an evolution of treatment goals in inflammatory bowel disease (IBD), looking across symptoms, inflammation and impact of disease on daily life to support a more holistic, patient-centered approach that goes beyond clinical remission. These post-hoc data from the LUCENT and VIVID programs will be presented at United European Gastroenterology (UEG) Week 2026.

“Treatment in inflammatory bowel disease is often measured one endpoint at a time. These new data show that patients treated with Omvoh achieved multiple treatment goals simultaneously at one year, including those with prior biologic failure, and were more likely to report better quality of life,” said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. “These findings reinforce the impact that Omvoh can have for people living with ulcerative colitis and Crohn’s disease and show that a higher bar for disease control is achievable.”

A comprehensive approach to IBD management considers multiple dimensions of disease, including the symptoms patients experience, what clinicians can objectively measure and how disease affects daily life. In previously published real-world studies, improvements across multiple dimensions of disease have been associated with a lower risk of flares, steroid use, hospitalization and surgery over time.

“Inflammatory bowel disease is complex, and understanding treatment impact requires a broader view than any single endpoint can provide. These endpoints reflect a meaningful shift in how we define treatment success,” said Stefan Schreiber, M.D., University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel. “Across the LUCENT and VIVID programs, Omvoh-treated patients achieved multidimensional treatment outcomes, including comprehensive disease control in ulcerative colitis and corticosteroid-free deep remission in Crohn’s disease. Importantly, these outcomes were also observed in patients with prior biologic failure.”

Comprehensive disease control with Omvoh in ulcerative colitis
Comprehensive disease control is a novel composite outcome, informed by an international expert consensus, that combines clinical remission, no corticosteroid use for at least 12 weeks before Week 52, histologic remission and fecal calprotectin ≤250 μg/g. Omvoh is the first IL-23p19 inhibitor evaluated for comprehensive disease control in UC, reflecting an evolving approach to treatment goals that goes beyond individual measures of disease activity for people living with UC.

Comprehensive disease control was evaluated in a post hoc analysis at one year in patients with UC who responded to Omvoh at Week 12 in the LUCENT-1 induction study and were re-randomized in LUCENT-2 to continue Omvoh or receive placebo. More than one-third of patients (35.3%) had previously experienced biologic treatment failure.

At one year:

• i) 27.7% of patients treated with Omvoh achieved comprehensive disease control compared with 14% receiving placebo.
• ii) Among patients with prior biologic failure, 23.4% of those treated with Omvoh achieved comprehensive disease control compared with 9.4% receiving placebo.
• iii) Among Omvoh-treated patients, 91.1% of those who achieved comprehensive disease control also achieved IBDQ remission, compared with 65.2% of those who did not achieve comprehensive disease control.
• iv) Omvoh-treated patients who achieved comprehensive disease control were also more likely to report no to minimal bowel urgency (bowel urgency remission) and greater improvements in work productivity than those who did not achieve comprehensive disease control.

Corticosteroid-free deep remission with Omvoh in Crohn’s disease
Corticosteroid-free deep remission was evaluated in a post hoc analysis at one year in patients with Crohn’s disease in VIVID-1. Nearly half of patients (48.6%) had previously experienced biologic treatment failure. Corticosteroid-free deep remission is a composite outcome that combines clinical remission (as measured by the Crohn’s Disease Activity Index), endoscopic remission and no corticosteroid use for at least 12 weeks before Week 52.

At one year:

• i) 20.4% of patients receiving Omvoh achieved corticosteroid-free deep remission compared with 2% receiving placebo.
• ii) Among patients with prior biologic failure, 15.7% of those treated with Omvoh achieved corticosteroid-free deep remission compared with none of those receiving placebo.
• iii) Among Omvoh-treated patients, 88.1% of those who achieved corticosteroid-free deep remission also achieved IBDQ remission, compared with 51% of those who did not achieve corticosteroid-free deep remission.

The safety findings observed in the Phase 3 LUCENT and VIVID clinical trial programs have been reported previously. The most common adverse reactions associated with Omvoh treatment in LUCENT-1 and -2 (reported in at least 2% of subjects at a higher frequency than placebo) were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection. In VIVID-1, the most common adverse reactions associated with Omvoh treatment (reported in at least 5% of subjects at a higher frequency than placebo) were upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests.

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. Omvoh is also approved as a single-injection maintenance regimen for adults with UC in several countries around the world, including the U.S., EU, Canada and Japan.

About the LUCENT Clinical Trial Program
Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed a biologic or Janus kinase inhibitor (JAKi). The randomized, double-blind, placebo-controlled LUCENT-1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT-2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT-1.

About the VIVID Clinical Trial Program
VIVID-1 was a Phase 3 randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn’s disease. Patients randomized to Omvoh received Omvoh 900 mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8, followed by a maintenance dose of 300 mg by subcutaneous injection (SC) at Week 12 and then every four weeks (Q4W) for 40 weeks.