Key Takeaways
- Omvoh demonstrated sustained steroid-free remission through three years in Crohn’s disease patients.
- Over 90% of patients maintained clinical and corticosteroid-free remission long term.
- Around 80% of patients reported improvement in bowel urgency, a key disruptive symptom.
- Long-term data suggest potential reduction in serious complications such as hospitalizations and surgery.
Written By: Samiksha Jadhav, BPharm and Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Eli Lilly and Company announced new long-term data showing Omvoh (mirikizumab-mrkz), the first and only IL-23p19 inhibitor with strong, durable efficacy over four years in ulcerative colitis (UC) and three years in Crohn’s disease. These findings from the Phase 3 VIVID-2 (NCT04232553) open-label extension study were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO) in Stockholm.
Additional post hoc analyses from VIVID-1 (Crohn’s) (NCT03926130) and LUCENT-3 (NCT03519945) (UC) highlighted minimal hospitalizations and surgeries in Omvoh-treated patients across both major inflammatory bowel disease (IBD) types.
Adrienne Brown, executive vice president and president of Lilly Immunology, emphasized that many IBD patients fail to achieve lasting remission, leaving them at risk of serious complications. She stated that Omvoh’s three-year data demonstrate durable remission and fewer severe outcomes, highlighting its potential to modify disease progression.
Long-Term Efficacy in Crohn’s Disease (VIVID-2 Open-Label Extension)
In VIVID-2, patients from the Phase 3 VIVID-1 trial who achieved endoscopic response at one year with Omvoh maintained durable efficacy through three years (152 weeks) of continuous treatment. Key results among these endoscopic responders:
Endpoint | Result at 152 Weeks |
Clinical remission | 92.4% |
Corticosteroid-free clinical remission | 91.2% |
≥3-point reduction on Urgency Numeric Rating Scale (UNRS) | 82.1% |
UNRS ≤2 | 71.7% |
Sustained inflammation control was evident via continued decreases in biomarkers (C-reactive protein and fecal calprotectin) up to three years
Edward Barnes, M.D., MPH, Associate Professor of Medicine at the University of North Carolina at Chapel Hill, noted that uncontrolled Crohn’s disease leads to persistent flares and disruptive symptoms. He highlighted that over 90% of patients maintained steroid-free remission for three years with Omvoh, with 80% experiencing relief from bowel urgency, reinforcing confidence in its durability.
The long-term safety profile in moderately to severely active Crohn’s disease aligned with Omvoh’s known profile. Common adverse events (≥5% from end of year 1 to year 3) included COVID-19, nasopharyngitis, and upper respiratory tract infection.
Reduced Disease Complications Across IBD (VIVID-1 and LUCENT-3)
Omvoh consistently lowered severe IBD-related complications:
- VIVID-1 (Crohn’s, Weeks 0-12): Reduced hospitalizations/surgeries by nearly half vs. placebo (16.9 vs. 30.9 per 100 patient-years).
- VIVID-1 (Crohn’s, Weeks 12-52): Reduced by nearly 70% vs. placebo responders (4.5 vs. 14.0 per 100 patient-years).
- LUCENT-3 (UC, 3-Year Extension): One UC-related hospitalization (0.1 per 100 patient-years); no UC-related surgeries (0 per 100 patient-years)
These build on prior UC four-year and Crohn’s two-year data.
VIVID and LUCENT Trials
VIVID Program (Crohn’s): VIVID-1 was a 52-week, randomized, double-blind, placebo-controlled Phase 3 trial in adults with moderately to severely active Crohn’s disease. Omvoh dosing: 900 mg IV at weeks 0, 4, 8; then 300 mg SC at week 12 and Q4W for 40 weeks. VIVID-2 completers (including week-52 endoscopy) assessed long-term clinical remission (CDAI) and endoscopic response at week 52 of VIVID-2 (104 weeks total); safety from first VIVID-2 dose.
LUCENT Program (UC): Two Phase 3 trials (LUCENT-1 induction; LUCENT-2 maintenance) in biologic-naïve and prior-failure patients (corticosteroids, immunomodulators, biologics, or JAKi). LUCENT-3 was a single-arm, open-label extension (up to four years total).
About Omvoh
Omvoh (mirikizumab-mrkz), an IL-23p19 antagonist, treats moderately to severely active UC and Crohn’s disease in adults. It selectively targets the p19 subunit of IL-23, inhibiting a pathway central to IBD pathogenesis. Approved in 47 countries.
Lilly’s Pipeline Advances
Lilly is advancing mirikizumab combinations to boost induction efficacy while maintaining long-term remission and safety. These include UC studies with eltrekibart (targeting neutrophil-driven inflammation; NCT06598943) or LY4268989 (MORF-057, an oral α4β7 integrin inhibitor; NCT07186101), plus COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) evaluating concomitant incretin therapy in overweight/obese UC or Crohn’s patients. Pediatric trials are also ongoing for UC (NCT05784246) and Crohn’s disease (NCT05509777).
References
Patients with Crohn’s disease maintained steroid-free remission for three years with Lilly’s Omvoh (mirikizumab-mrkz), 19 February 2026, Patients with Crohn’s disease maintained steroid-free remission for three years with Lilly’s Omvoh (mirikizumab-mrkz)
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants with Crohn’s Disease (VIVID-2), ClinicalTrials.gov ID NCT04232553, https://clinicaltrials.gov/study/NCT04232553
A Study of Mirikizumab (LY3074828) in Participants with Crohn’s Disease (VIVID-1), ClinicalTrials.gov ID NCT03926130, https://clinicaltrials.gov/study/NCT03926130
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants with Moderately to Severely Active Ulcerative Colitis (LUCENT 3), ClinicalTrials.gov ID NCT03519945, https://clinicaltrials.gov/study/NCT03519945