Omvoh Demonstrates Three-Year Steroid-Free Remission in Crohn's Disease Patients
核心洞察
More than 90% of Crohn's disease (搜索) patients who achieved steroid-free remission at one year maintained steroid-free control through three years with Omvoh treatment.
Omvoh-treated patients experienced exceptionally low surgery and hospitalization rates, with nearly 50% reduction in disease-related complications versus placebo in the first 12 weeks.
The IL-23p19 inhibitor stands as the only drug in its class to demonstrate strong and durable efficacy over three years in Crohn's disease (搜索) and four years in ulcerative colitis (搜索).
New long-term data from Eli Lilly's Phase 3 VIVID-2 open-label extension study demonstrate that Omvoh (mirikizumab-mrkz (搜索)) delivered sustained efficacy through three years in adults with moderately to severely active Crohn's disease (搜索). The landmark results, presented at the 21st Congress of the European Crohn's and Colitis Organisation in Stockholm, showed more than 90% of patients who achieved steroid-free remission at one year maintained steroid-free control through three years of treatment.
Sustained Clinical Outcomes and Symptom Relief
Among patients who achieved endoscopic response at one year with Omvoh, 82.8% maintained clinical remission through three years, while 81.1% maintained corticosteroid-free clinical remission. Additionally, 72.7% of patients maintained clinically meaningful improvement in bowel urgency, and 64.0% achieved bowel urgency remission, addressing one of the most disruptive symptoms of Crohn's disease (搜索).
"For people with Crohn's disease (搜索), unpredictable flares and abdominal pain can persist when remission isn't achieved or sustained," said Edward Barnes, M.D. MPH, Associate Professor of Medicine at the University of North Carolina at Chapel Hill. "Seeing more than 90% of patients maintain steroid-free remission through three years on consistent monthly dosing, with 80% also experiencing relief from the disruptive symptoms of bowel urgency, gives providers confidence in Omvoh for outcomes that can last."
Dramatic Reduction in Disease Complications
Complementary data from the VIVID-1 and LUCENT-3 clinical trials revealed exceptionally low rates of severe disease-related complications across both major types of inflammatory bowel disease (搜索). In VIVID-1, Omvoh reduced Crohn's disease (搜索)-related hospitalizations and surgeries by nearly half versus placebo in the first 12 weeks, with incidence rates of 16.9 versus 30.9 per 100 patient-years. The reduction was even more pronounced during weeks 12 to 52, with a nearly 70% decrease in complications (4.5 versus 14.0 per 100 patient-years).
In ulcerative colitis (搜索) patients from LUCENT-3, only one UC-related hospitalization and no UC-related surgeries were reported during the three-year long-term extension, with incidence rates of 0.1 and 0 per 100 patient-years, respectively.
Sustained Inflammatory Control
The three-year data also demonstrated continued improvement in inflammation markers. Patients who achieved endoscopic response at one year experienced sustained decreases in inflammatory biomarkers, including C-reactive protein and fecal calprotectin, up to three years of treatment. This sustained inflammatory control suggests potential for long-term disease modification.
Safety Profile Remains Consistent
The long-term safety profile in patients with moderately to severely active Crohn's disease (搜索) remained consistent with the known safety profile of Omvoh. Common adverse events reported from the end of year one through year three included COVID-19, nasopharyngitis, and upper respiratory tract infection, occurring in at least 5% of patients who achieved endoscopic response at one year.
Unique Position in IL-23 Inhibitor Class
Omvoh now stands as the first and only IL-23p19 inhibitor to demonstrate strong and durable efficacy over four years in ulcerative colitis (搜索) and three years in Crohn's disease (搜索), with proven reduction of disease complications. The drug's consistent monthly dosing regimen provides a simplified treatment approach for patients managing chronic inflammatory bowel disease (搜索).
"Too many people with inflammatory bowel disease (搜索) never achieve lasting remission, leaving them vulnerable to cumulative damage from poorly controlled inflammation that can result in emergency hospitalizations or surgery," said Adrienne Brown, executive vice president and president of Lilly Immunology. "Omvoh is redefining what durable disease control can look like, with long-term data showing patients treated with Omvoh stayed in remission and experienced fewer serious complications over three years, underscoring its potential to alter the course of the disease."
Expanding Research Pipeline
Lilly is advancing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in ulcerative colitis (搜索) with eltrekibart, a monoclonal antibody targeting neutrophil-driven inflammation, and with LY4268989 (搜索) (MORF-057), an oral α4β7 integrin (搜索) inhibitor. The company has also initiated COMMIT-UC and COMMIT-CD trials evaluating mirikizumab used concomitantly with incretin-based therapy in adults with IBD who also have obesity or are overweight with weight-related comorbidities.
Omvoh has received regulatory approvals for treating moderately to severely active ulcerative colitis (搜索) and Crohn's disease (搜索) in adults and has been approved in 47 countries worldwide.