Patients with Crohn’s disease maintained steroid-free remission for three years with Omvoh (mirikizumab-mrkz) – Eli Lilly

New long-term data from Eli Lilly and Company showed Omvoh (mirikizumab-mrkz) delivered durable efficacy through three years in adults with moderately to severely active Crohn’s disease. These data from the Phase III VIVID-2 open-label extension study were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO) in Stockholm. Additional data presented from the Phase III VIVID-1 (Crohn’s disease) and LUCENT-3 (UC) clinical trials showed Omvoh-treated patients experienced minimal hospitalizations and surgeries across both major types of inflammatory bowel disease (IBD). Omvoh is the first and only IL-23p19 inhibitor to show strong and durable efficacy over four years in UC and three years in Crohn’s disease, with proven reduction of disease complications.

“Too many people with inflammatory bowel disease 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.”

Long-Term Remission and Bowel Urgency Improvements in Crohn’s Disease
In VIVID-2, patients who achieved an endoscopic response at one year with Omvoh in the Phase III VIVID-1 clinical trial experienced long-term efficacy, with the majority remaining in clinical and corticosteroid-free remission and sustaining bowel urgency improvements through three years of continuous Omvoh treatment.

“For people with Crohn’s disease, unpredictable flares and abdominal pain can persist when remission isn’t achieved or sustained. Additionally, ongoing symptoms like urgent trips to the bathroom and fatigue can continue to disrupt daily life when the disease is not adequately controlled,” said Edward Barnes, M.D. MPH, Associate Professor of Medicine, 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.”

These new long-term Crohn’s disease data also showed Omvoh-treated patients who achieved endoscopic response at one year experienced sustained improvement in inflammation, as measured by the continued decrease in inflammatory biomarkers (C-reactive protein and fecal calprotectin) up to three years. The long-term safety profile in patients with moderately to severely active Crohn’s disease was consistent with the known safety profile of Omvoh. Common adverse events reported from the end of year one through the end of year three (≥5% of Omvoh-treated patients who achieved endoscopic response at one year) included COVID-19, nasopharyngitis, and upper respiratory tract infection.

Consistently Low Rates of Severe Disease‑Related Complications in IBD
Complementing the three-year Crohn’s disease results, additional post hoc data presented from the VIVID-1 (Crohn’s disease) and LUCENT-3 (UC) clinical trials showed patients treated with Omvoh experienced consistently low rates of severe disease-related complications. In VIVID-1, Omvoh reduced Crohn’s disease-related hospitalizations and/or surgeries by nearly half versus placebo in the first 12 weeks (incidence rate: 16.9 vs. 30.9 per 100 patient-years), and by nearly 70% during weeks 12 to 52 (4.5 vs. 14.0). In LUCENT-3, one UC-related hospitalization and no UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension (incidence rates 0.1 and 0 per 100 patient-years, respectively). Together, these findings expand the growing body of long-term data on Omvoh in IBD, building on previously disclosed two-year results in Crohn’s disease and four-year results in UC.

Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn’s disease in adults and has been approved in 47 countries around the world.

About the VIVID Clinical Trial Program
VIVID-1 was a Phase III randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn’s disease. Patients randomized to Omvoh received Omvoh 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 Omvoh in clinical remission by CDAI 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.

Using a modified non-responder imputation method, among Omvoh endoscopic responders at year one, 82.8% of patients maintained CDAI clinical remission through three years, 81.1% maintained corticosteroid-free clinical remission, 72.7% maintained clinically meaningful improvement in bowel urgency and 64.0% of patients maintained bowel urgency remission.

About the LUCENT Clinical Trial Program
Omvoh was studied in two Phase III clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed biologic or Janus kinase inhibitors (JAKi). The randomized, double‑blind, placebo‑controlled LUCENT‑1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT‑2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT‑1. LUCENT-3, the single-arm long-term Phase III open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of Omvoh in patients with UC for an additional three years of treatment (up to four years total).