- More than 90% of mirikizumab-mrkz-treated patients who were in clinical remission at one year sustained it with two years of continuous treatment
- Nearly 90% of patients who achieved endoscopic response at one year sustained it at two years
- Mirikizumab-mrkz is the first IL-23p19 antagonist to demonstrate multi-year, sustained efficacy and safety for both Grohn’s disease and ulcerative colitis
18 February 2025: The latest results of VIVID-2 open-label extension study, had come out showing that the majority of patients with moderately to severely active Crohn’s disease receiving two years of continuous treatment with mirikizumab-mrkz, product of Eli Lilly & Company, achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure. Data from this study was presented at the Crohn’s and Colitis Congress (CCC), held from February 6-8, 2025, in San Francisco.
Mirikizumab-mrkz works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation.
“Many people living with Crohn’s disease has tried available therapies without success or have experienced a loss of efficacy with their treatment,” said Edward Barnes, M.D., MPH, Associate Professor of Medicine in the Division of Gastroenterology & Hepatology, Co-Director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill. “These positive, multi-year data can give health care providers confidence that mirikizumab-mrkz may help their patients achieve and maintain long-term outcomes, including intestinal healing.”
Participants randomized to mirikizumab-mrkz in the Phase 3 VIVID-1 study who achieved endoscopic response after one year of treatment continued mirikizumab-mrkz maintenance treatment in VIVID-2. The following results were achieved based upon observed case analysis after two years of continuous treatment, including one year during VIVID-1:
- Among patients who were in clinical remission at one year in VIVID-1, 92.9% maintained clinical remission at two years as measured by Crohn’s Disease Activity Index (COAi).
- Among patients treated in VIVID-2, 87.6% maintained endoscopic response, defined by visible healing of the intestinal lining and measured by a ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score.
- Among patients who were in endoscopic remission at one year of treatment in VIVID-1, 78.6% maintained endoscopic remission at two years as measured by SES-CD ≤4 and ≥2-point reduction from baseline, with no subscore >1 in any individual variable.1
Additionally:
- Among patients who were not in clinical remission by COAi at one year, 60.8% gained clinical remission during the second year of treatment.
- Among patients who were not in endoscopic remission at one year, 35.4% gained endoscopic remission during the second year of treatment.
In VIVID-2, the long-term safety profile of mirikizumab-mrkz in patients with moderately to severely active Crohn’s disease was generally consistent with the known safety profile of Mirikizumab-mrkz. During the second year of continuous treatment with mirikizumab-mrkz, 6.8% of patients with endoscopic response at one year reported a serious adverse event and 0.8% discontinued treatment due to an adverse event.
“Lilly is setting a high bar for sustained and durable treatment response for patients living with the profound impact of inflammatory bowel disease,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “These results build on the body of evidence that demonstrates mirikizumab-mrkz’s ability to provide early meaningful improvement and long-term disease control with strong clinical, endoscopic and histologic outcomes.”
Mirikizumab-mrkz was approved by the United States Food and Drug Administration (FDA) for the treatment of moderately to severely active Crohn’s disease in adult in January 2025. In December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for mirikizumab-mrkz for the treatment of adults with moderately to severely active Crohn’s disease. Lilly has submitted marketing applications around the globe, including in Canada, Japan and China, with additional global regulatory submissions planned. Mirikizumab-mrkz is also approved in 44 countries for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
Mirikizumab-mrkz is the first and only IL-23p19 antagonist to demonstrate long-term, multi-year, sustained efficacy and safety for both Crohn’s disease and UC.
Mirikizumab-mrkz has additional ongoing trials in Crohn’s disease and UC, including studies to evaluate the long-term efficacy and safety of mirikizumab-mrkz in pediatric patients and adults, and a Phase 4 real world evidence study to evaluate mirikizumab-mrk’s impact in patients with UC in clinical practice.
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’sdisease. Patients randomized to Mirikizumab-mrkz received Mirikizumab-mrkz 900mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8 followed by a maintenance dose of 300mg by subcutaneous injection (SC) at Week 12 and then every 4 weeks (Q4W) for 40 weeks. Participants who completed VIVID-1, including the Week 52 endoscopy, were eligible for VIVID-2. In VIVID-2, the primary objective is to evaluate the long-term effect of Mirikizumab-mrkz in clinical remission by COAi and endoscopic response at Week 52 of treatment in VIVID-2 (totaling 104 weeks of continuous treatment). Safety is being assessed from the first dose in VIVID-2.1
Using a modified non-responder imputation method, among Mirikizumab-mrkz endoscopic responders at year one, 81.8% maintained endoscopic response at two years, 86.9% maintained clinical remission at two years, and 72.5% maintained endoscopic remission at two years.
About Mirikizumab-mrkz
Mirikizumab-mkrz is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults. Mirikizumab-mrkz selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.
