Over half of Crohn's patients on Lilly's mirikizumab achieved remission in one year, including those with prior biologic failure

In a pivotal Phase 3 VIVID-1 study by Eli Lilly and Company, nearly half of the patients treated with mirikizumab for moderately to severely active Crohn's disease showed significant improvements across multiple clinical and endoscopic endpoints after one year. The findings, presented at Digestive Disease Week® in Washington, D.C., highlight the potential of mirikizumab, particularly for patients with previous biologic treatment failures, a group typically difficult to treat.

Crohn's disease, a chronic inflammatory bowel disorder, can lead to progressive bowel damage, disability, and reduced quality of life if inadequately managed. Standard treatments often fail to provide sustained responses, necessitating new therapeutic options. Mirikizumab, targeting the IL23p19 pathway, has shown promising results in this context.

The study's co-primary endpoints included clinical response and remission rates by patient-reported outcomes (PRO) at Week 12 and Week 52, as well as endoscopic response at Week 52, all showing statistically significant improvements for mirikizumab over placebo. Specifically, 39.3% of biologically naive patients and 36.7% of those with prior biologic treatment failures achieved clinical response and endoscopic response at Week 52, compared to 11.8% and 6.2% in the placebo group, respectively. Furthermore, clinical remission was noted in 54.1% of mirikizumab patients at one year, with 48.4% also achieving endoscopic response.

Dr. Bruce Sands from the Icahn School of Medicine at Mount Sinai emphasized the significance of these results, particularly for patients with previous biologic failures. The consistent efficacy across different patient groups underscores mirikizumab's potential impact on Crohn's disease management.

Mirikizumab demonstrated safety profiles consistent with previous observations in ulcerative colitis trials. Common adverse events included COVID-19, anemia, headache, and upper respiratory infections, with serious adverse incidents being more frequent in the placebo group.

Mirikizumab also showed nominal statistical superiority over ustekinumab, another medication used for Crohn's disease, in terms of combined clinical remission and endoscopic response rates, particularly in patients with previous biologic failures. However, it did not achieve statistical superiority in endoscopic response alone. Notably, biomarkers for inflammation, such as fecal calprotectin and C-reactive protein, were significantly reduced in the mirikizumab group compared to ustekinumab at multiple time points, including Week 52.

Lilly has submitted a supplemental Biologics License Application for mirikizumab to the U.S. FDA and European Medicines Agency, with additional global regulatory submissions planned. The company is also conducting further studies to assess the drug’s efficacy and safety in pediatric Crohn's disease patients and other long-term treatment scenarios.

Dr. Mark Genovese from Lilly highlighted the company's commitment to developing innovative treatments for inflammatory bowel diseases, aiming to improve standard care through continued research and clinical trials.

The VIVID-1 trial involved administering mirikizumab intravenously for the first 12 weeks, followed by subcutaneous injections every four weeks until Week 52. This regimen aimed to maintain high response and remission rates over a substantial period.

As the quest for better treatments for Crohn's disease continues, mirikizumab's promising data may represent a significant step forward, offering hope for patients struggling with this debilitating condition.