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News|Articles|October 15, 2026

Lilly's Mirikizumab (Omvoh) Hits New IBD Remission Goals

Key Takeaways

  • Lilly's mirikizumab (Omvoh) helped 27.7% of ulcerative colitis patients achieve comprehensive disease control at one year, versus 14% with placebo.
  • In Crohn's disease, 20.4% of mirikizumab-treated patients achieved corticosteroid-free deep remission at one year, versus 2% with placebo.
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Mirikizumab (Omvoh) achieved comprehensive disease control in 27.7% of UC patients and deep remission in 20.4% with Crohn disease at 1 year.

Eli Lilly and Company (Lilly) shared new post hoc analyses showing that mirikizumab-mrkz (Omvoh) helped patients with ulcerative colitis (UC) and Crohn disease achieve multiple treatment goals simultaneously at one year, including those with prior biologic treatment failure.¹ In an October 15, 2026 announcement, the phase 3 LUCENT-2 trial, 27.7% of mirikizumab-treated patients with UC achieved comprehensive disease control, a novel composite outcome combining symptomatic, endoscopic, and histologic remission with biomarker normalization and no corticosteroid use, compared with 14% receiving placebo.¹ Mirikizumab is the first IL-23p19 inhibitor evaluated for comprehensive disease control in UC, a composite outcome informed by international expert consensus.¹

Key facts

  • Drug: Mirikizumab-mrkz (Omvoh); Eli Lilly and Company
  • Class: Interleukin-23p19 (IL-23p19) antagonist
  • Indications studied: Moderately to severely active ulcerative colitis (LUCENT-2) and Crohn disease (VIVID-1)
  • UC outcome: Comprehensive disease control in 27.7% (mirikizumab) vs 14% (placebo) at one year
  • Crohn’s disease outcome: Corticosteroid-free deep remission in 20.4% (mirikizumab) vs 2% (placebo) at one year
  • Prior biologic failure subgroup: 23.4% vs 9.4% (UC); 15.7% vs 0% (Crohn disease)
  • Current approval: Moderately to severely active UC and Crohn disease in 47 countries
  • Presentation: ACG 2026 (UC analysis) and UEG Week 2026 (Crohn disease analysis)

In the phase 3 VIVID-1 trial, 20.4% of mirikizumab-treated patients with Crohn disease achieved corticosteroid-free deep remission, a composite of clinical and endoscopic remission with no corticosteroid use, compared with 2% receiving placebo.¹ “Treatment in inflammatory bowel disease is often measured one endpoint at a time,” said Anabela Cardoso, MD, senior vice president, Lilly Immunology Medical Affairs, in a company press release.¹ “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.”

How did mirikizumab perform among patients with prior biologic treatment failure?

More than one-third (35.3%) of the UC analysis population and nearly half (48.6%) of the Crohn disease analysis population had previously failed a biologic.¹ Among UC patients with prior biologic failure, 23.4% receiving mirikizumab achieved comprehensive disease control versus 9.4% receiving placebo. Among Crohn disease patients with prior biologic treatment failure, 15.7% receiving mirikizumab achieved corticosteroid-free deep remission versus none receiving placebo.¹

“These endpoints reflect a meaningful shift in how we define treatment success. Across the LUCENT and VIVID programs, Omvoh-treated patients achieved multidimensional treatment outcomes...importantly, these outcomes were also observed in patients with prior biologic failure,” said Stefan Schreiber, MD, of University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel, in the release.¹

How do these composite outcomes relate to quality of life?

Patients who achieved comprehensive disease control or corticosteroid-free deep remission were more likely to also achieve remission on the Inflammatory Bowel Disease Questionnaire (IBDQ), a validated quality-of-life measure: 91.1% of mirikizumab-treated UC patients who achieved comprehensive disease control also achieved IBDQ remission, versus 65.2% of those who did not, and 88.1% of mirikizumab-treated Crohn disease patients who achieved corticosteroid-free deep remission also achieved IBDQ remission, versus 51% of those who did not.¹

Mirikizumab-treated UC patients who achieved comprehensive disease control were also more likely to report no to minimal bowel urgency and greater improvements in work productivity than those who did not.¹ Comprehensive disease control is informed by an international Delphi consensus among inflammatory bowel disease (IBD) experts, and in prior published research, histologic remission specifically has been independently linked to lower rates of relapse, hospitalization, and surgery in IBD.²,³

What are the limitations?

These are post hoc analyses of previously reported LUCENT and VIVID trial data, not pre-specified primary endpoints, and the comparisons by biologic-failure status are not from a randomized subgroup design.¹ Mirikizumab is already approved for both UC and Crohn disease in 47 countries, including a single-injection maintenance option for UC approved in the United States, the European Union, Canada, and Japan.⁴ These new composite-outcome data describe how an already-approved treatment performs against a higher bar, not a new indication or approval.¹

The release does not report statistical significance testing for the composite-outcome percentages themselves.¹ Lilly is also studying mirikizumab in combination with other mechanisms, including an anti-neutrophil monoclonal antibody and an oral integrin inhibitor in UC, and is running dedicated trials combining mirikizumab with an incretin-based therapy in patients who have inflammatory bowel disease along with obesity or overweight.¹

References

  1. Eli Lilly and Company. New composite outcomes data show patients treated with Lilly’s Omvoh (mirikizumab-mrkz) achieved comprehensive corticosteroid-free disease control in ulcerative colitis and corticosteroid-free deep remission in Crohn’s disease at one year. Press release. Published October 15, 2026. Accessed October 15, 2026. https://investor.lilly.com/news-releases/news-release-details/new-composite-outcomes-data-show-patients-treated-lillys-omvoh
  2. Schreiber S, Danese S, Dignass A, et al. Defining comprehensive disease control for use as a treatment target for ulcerative colitis in clinical practice: International Delphi consensus recommendations. J Crohns Colitis. 2024;18(1):91-105. doi:10.1093/ecco-jcc/jjad130
  3. Shehab M, Al Akram S, Hassan A, Alrashed F, Jairath V, Bessissow T. Histological disease activity as predictor of clinical relapse, hospitalization, and surgery in inflammatory bowel disease: systematic review and meta-analysis. Inflamm Bowel Dis. 2024;30(4):563-572. doi:10.1093/ibd/izad119
  4. Eli Lilly and Company. Lilly’s Omvoh (mirikizumab-mrkz) approved by US FDA with single-injection maintenance regimen for ulcerative colitis. Press release. Published October 27, 2025. Accessed October 15, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-approved-us-fda-single-injection

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