Lilly reports their new Phase 3 study of mirikizumab data comparing this to ustekinumab for Crohn’s disease

Eli Lilly announce their new data demonstrating more patients with moderately to severely active Crohn’s disease treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. VIVID-1 is the first Phase 3 study for any approved or investigational treatment in Crohn’s disease to report histologic and combined histologic-endoscopic outcomes that were evaluated using a systematic assessment of five bowel segments and strict definitions consistent with the recently published European Crohn’s and Colitis position statement on mucosal histopathology.

Note that: Crohn’s disease inflammation occurs at the cellular level—defined as histologic inflammation—and persists even after treatment with standard of care therapies in up to one-quarter of patients with Crohn’s disease despite evidence of endoscopic mucosal healing.

“Treatment strategies for Crohn’s disease must evolve beyond traditional measures of clinical remission and endoscopy, to the evaluation of depth of intestinal healing by measuring histologic and transmural resolution,” said Fernando Magro, M.D., Ph.D., head of clinical pharmacology at University Hospital São João. “These histologic data build on the growing body of evidence for mirikizumab, which may provide a greater depth of mucosal healing for those living with this chronic, progressive disease.”

The overall safety profile of mirikizumab in patients with moderately to severely active Crohn’s disease was consistent with the known safety profile in patients with ulcerative colitis. The frequency of serious adverse events was greater in placebo than mirikizumab. The most common adverse events were COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis and injection site reactions.

“As the first company to report rigorous histologic and endo-histologic outcomes in Crohn’s disease that align with a recent ECCO position statement, Lilly is setting a higher bar for the evaluation of long-term treatment response in inflammatory bowel disease. This includes more ambitious targets of mucosal healing, which we applied to compare mirikizumab’s histo-endoscopic effect to ustekinumab,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “These data also broaden our understanding of the underlying inflammation that drives Crohn’s disease and may represent a critical step forward in helping health care providers and their patients make more informed choices about treatment.”

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Crohn's disease, elli lilly, lilly pharma, Phase 3 study of mirikizumab, ustekinumab