Patients with moderately to severely active ulcerative colitis (UC) or Crohn disease treated with mirikizumab-mrkz (Omvoh; Eli Lilly) were more likely than those receiving placebo to meet several treatment goals at once at 1 year, according to new post hoc analyses of the phase 3 LUCENT and VIVID programs.¹

The benefit extended to patients with prior biologic failure, who made up more than one-third of the UC analysis and nearly half of the Crohn disease analysis. Patients who reached these composite endpoints were also more likely to report remission on the Inflammatory Bowel Disease Questionnaire (IBDQ), a validated quality-of-life measure.¹

Stefan Schreiber, MD, of University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel, Germany, described the endpoints as "a meaningful shift in how we define treatment success.” He noted that inflammatory bowel disease (IBD) is complex enough that no single endpoint captures the full effect of treatment.¹

Comprehensive disease control is a composite target developed through an international modified Delphi consensus of 12 gastroenterologists and 1 patient advocate. The panel aimed to define a patient-centered goal that captures aspects of UC not reflected in traditional trial endpoints.²

In the LUCENT analysis, comprehensive disease control required all of the following at week 52¹:

• Clinical remission by modified Mayo score
• No corticosteroid use for at least 12 weeks before week 52
• Histologic remission
• Fecal calprotectin ≤250 μg/g

According to Lilly, mirikizumab is the first IL-23p19 inhibitor evaluated against this composite outcome in UC.¹

The analysis included patients who responded to mirikizumab during 12 weeks of LUCENT-1 induction and were then re-randomized in LUCENT-2 to continue treatment or switch to placebo. Overall, 35.3% had prior biologic failure.

At 1 year:

• 27.7% of mirikizumab-treated patients achieved comprehensive disease control vs 14% of those receiving placebo
• Among patients with prior biologic failure, rates were 23.4% vs 9.4%, respectively
• Of mirikizumab-treated patients who achieved comprehensive disease control, 91.1% also reached IBDQ remission vs 65.2% of those who did not

Patients who achieved comprehensive disease control were also more likely to report no to minimal bowel urgency and greater gains in work productivity.

In VIVID-1, corticosteroid-free deep remission was defined as clinical remission by Crohn's Disease Activity Index (CDAI <150), endoscopic remission, and no corticosteroid use for at least 12 weeks before week 52. Nearly half of patients (48.6%) had prior biologic failure.

At 1 year:

• 20.4% of mirikizumab-treated patients achieved corticosteroid-free deep remission vs 2% of those receiving placebo.
• Among patients with prior biologic failure, 15.7% of mirikizumab-treated patients reached the endpoint vs none receiving placebo.
• Of mirikizumab-treated patients who achieved deep remission, 88.1% also reached IBDQ remission vs 51% of those who did not.

Placebo-treated participants who did not respond by week 12 switched to mirikizumab and were counted as nonresponders.

The safety profile was consistent with previously reported LUCENT and VIVID data. In the UC trials, the most common adverse reactions included upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. In VIVID-1, they included upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

The prescribing information includes warnings for hypersensitivity reactions, infections, tuberculosis, and hepatotoxicity. Clinicians should screen for tuberculosis before treatment, monitor liver enzymes and bilirubin for at least 24 weeks, and avoid live vaccines in treated patients.

The findings reflect a broader move in IBD care toward treatment targets that combine symptoms, objective markers of inflammation, steroid avoidance, and quality of life.^1,2

Because the analyses were post hoc, the results should be interpreted as exploratory. Mirikizumab is approved in the US for adults with moderately to severely active UC and Crohn disease.¹

The UC analysis was presented at the American College of Gastroenterology 2026 Annual Scientific Meeting, and the Crohn disease analysis is scheduled for United European Gastroenterology (UEG) Week 2026.¹

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. News release. 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