Lilly’s Omvoh achieved composite disease control in ulcerative colitis and corticosteroid-free deep remission in Crohn’s disease at one year, including after biologic failure.
Written By: Saniya Katakdhond, PharmD
Reviewed By: Pharmacally Editorial Team
Eli Lilly reported new post-hoc analyses from its Phase 3 LUCENT and VIVID clinical programmes evaluating Omvoh (mirikizumab-mrkz), an interleukin-23p19 (IL-23p19) antagonist, in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease. The analyses assessed composite outcomes that combine multiple measures of disease activity rather than relying on clinical remission alone.
The findings included patients with prior biologic treatment failure, who can face additional treatment challenges. Patients achieving these composite endpoints were also more likely to report remission on the Inflammatory Bowel Disease Questionnaire (IBDQ), a validated measure of health-related quality of life. However, both analyses were post hoc, and the associations do not establish that achieving composite remission directly caused improvements in quality of life.
Comprehensive Disease Control in Ulcerative Colitis
The LUCENT-2 (NCT03524092) analysis evaluated comprehensive disease control at one year among patients who responded to Omvoh induction treatment at Week 12 in LUCENT-1 (NCT03518086) and were subsequently re-randomised to continue Omvoh or receive placebo in LUCENT-2. The composite endpoint combined clinical remission, histologic remission, faecal calprotectin levels of 250 μg/g or lower, and no corticosteroid use for at least 12 weeks before Week 52.
Overall, 27.7% of patients continuing Omvoh achieved comprehensive disease control, compared with 14% receiving placebo. Among patients with prior biologic treatment failure, the respective rates were 23.4% and 9.4%. Prior biologic failure had occurred in 35.3% of patients included in the UC analysis.
Quality-of-life outcomes also favoured patients achieving the composite endpoint. Among Omvoh-treated patients, 91.1% of those reaching comprehensive disease control achieved IBDQ remission, compared with 65.2% of those who did not. Patients achieving the endpoint were also more likely to report no to minimal bowel urgency and greater improvements in work productivity.
These findings suggest that combining symptomatic, histologic and biomarker measures may identify treatment responses that clinical remission alone does not fully capture. However, the results apply to the selected maintenance population that had already responded to Omvoh induction, rather than all patients initiating treatment.
Corticosteroid-Free Deep Remission in Crohn’s Disease
In VIVID-1 (NCT03926130) corticosteroid-free deep remission required clinical remission measured using the Crohn’s Disease Activity Index, endoscopic remission and no corticosteroid use for at least 12 weeks before Week 52.
At one year, 20.4% of patients receiving Omvoh achieved corticosteroid-free deep remission, compared with 2% receiving placebo. Among patients with prior biologic treatment failure, 15.7% of Omvoh-treated patients reached this endpoint, compared with none receiving placebo. Nearly half of patients in the Crohn’s disease analysis, 48.6%, had previously experienced biologic treatment failure.
IBDQ remission was achieved by 88.1% of Omvoh-treated patients who reached corticosteroid-free deep remission, compared with 51% of those who did not.
The findings indicate that deeper disease control and better patient-reported health status were associated in this analysis. Nevertheless, the results do not establish causality, and the placebo-group findings should be interpreted within the trial’s analysis methods.
Safety and Clinical Context
The safety findings from the LUCENT and VIVID programmes were reported previously. In LUCENT-1 and LUCENT-2, the most common adverse reactions occurring 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, adverse reactions meeting the corresponding threshold of at least 5% included upper respiratory tract infections, injection-site reactions, headache, arthralgia and elevated liver tests.
Omvoh is approved for adults with moderately to severely active UC and Crohn’s disease. Lilly reported that the new post-hoc analyses would be presented at United European Gastroenterology (UEG) Week 2026.
Clinical Interpretation
The analyses highlight a broader approach to inflammatory bowel disease management, integrating symptoms, endoscopic and histologic findings, biomarkers and corticosteroid use. The observed differences in composite outcomes, including among patients with prior biologic failure, support further consideration of multidimensional treatment goals.
However, the UC and Crohn’s disease endpoints differ and should not be compared directly. The post-hoc findings also do not establish long-term benefits such as reduced hospitalisation or surgery. Further evidence is needed to determine how these composite measures may inform treatment decisions and long-term outcomes.
References
New composite outcomes data show patients treated with Lilly’s Omvoh achieved comprehensive corticosteroid-free disease control in ulcerative colitis and corticosteroid-free deep remission in Crohn’s disease at one year, Eli Lilly and Company, October 15, 2026.
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1), ClinicalTrials.gov ID NCT03518086
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2), ClinicalTrials.gov ID NCT03524092
A Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (VIVID-1), ClinicalTrials.gov ID NCT03926130
About the Writer
Saniya Sanjay Katakdhond (Linkedin) is a Doctor of Pharmacy professional with hands-on experience in patient case review, clinical documentation, medical record analysis, and patient care.
Her hospital experience has strengthened her understanding of clinical conditions, treatment approaches, and multidisciplinary healthcare practices.
With ICH-GCP certification and a research-oriented approach, she brings clinical insight and attention to detail to healthcare content development.
As a healthcare writer, Saniya focuses on translating clinical knowledge and patient-care experience into clear, accurate, and evidence-informed medical content.