Eli Lilly has announced positive long-term data from the Phase III VIVID-1 study, revealing that Omvoh (mirikizumab) achieved a significantly better histologic response at one year compared to Johnson & Johnson’s Stelara (ustekinumab) in patients with Crohn’s disease. These findings support Lilly's efforts to expand Omvoh's label beyond its current approval for ulcerative colitis.
The VIVID-1 trial, a head-to-head study, evaluated the efficacy and safety of Omvoh versus Stelara and placebo over 52 weeks. The results indicated that a greater proportion of patients treated with Omvoh achieved histologic response, as defined by the European Crohn’s and Colitis Organisation (ECCO) criteria, compared to those treated with Stelara. This advantage was maintained even within the subgroup of patients who had active histologic disease at baseline and had experienced failure with at least one prior biologic therapy.
Key Findings from the VIVID-1 Trial
At 52 weeks, 58.2% of patients in the Omvoh group achieved histologic response, compared to 48.8% in the Stelara group. Furthermore, 39.6% of patients treated with Omvoh achieved an endoscopic-histologic response, versus 27.8% in the Stelara group. Lilly reported these effects as “nominally statistically significant.”
Mark Genovese, senior vice president of development at Lilly Immunology, stated that these findings set a higher standard for evaluating long-term treatment response in inflammatory bowel disease, emphasizing more ambitious targets of mucosal healing.
Safety and Tolerability
In terms of safety, the adverse events associated with Omvoh in the VIVID-1 trial were consistent with its established profile in ulcerative colitis. Common side effects included anemia, arthralgia, and upper respiratory tract infections. Notably, serious adverse events were more frequently observed in the placebo group compared to the Omvoh group.
Mechanism of Action and Regulatory Landscape
Omvoh is a humanized IgG4 monoclonal antibody that selectively targets the IL-23 cytokine, inhibiting its interaction with its receptor. This mechanism modulates the differentiation, proliferation, and survival of T cells and innate immune cells, ultimately suppressing mucosal inflammation. Omvoh received FDA approval for treating moderately to severely active ulcerative colitis in October 2023.
Lilly is actively pursuing regulatory approval for Omvoh in Crohn’s disease, submitting data from the VIVID-1 trial to the FDA and other global health authorities. If approved, Omvoh would compete directly with Stelara, a well-established treatment in the inflammatory diseases market, which generated nearly $10.9 billion in sales in 2023.
Competitive Context
Stelara faces increasing competition from biosimilars due to patent expirations. Teva and Alvotech gained FDA approval for their Stelara biosimilar, Selarsdi, for psoriatic arthritis and plaque psoriasis, while Samsung Bioepis received approval for Pyzchiva, a biosimilar that will compete with Stelara in psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Lilly is also investigating Omvoh's potential in pediatric Crohn’s disease and ulcerative colitis through ongoing trials, further expanding its therapeutic scope in inflammatory bowel diseases.
