Lilly's Mirikizumab Shows Long-Term Efficacy and Safety for Ulcerative Colitis and Crohn's Disease

Eli Lilly and Company has revealed encouraging results from two extensive Phase 3 studies that examined the long-term effects of mirikizumab on patients with inflammatory bowel diseases (IBD), specifically ulcerative colitis (UC) and Crohn’s disease. The findings from these studies, LUCENT-3 and VIVID-2, were presented at the American College of Gastroenterology (ACG) Annual Meeting in Philadelphia.

Mirikizumab, an interleukin-23p19 (IL23p19) antagonist, works by binding to the p19 subunit of IL-23, thereby blocking its interaction with the IL-23 receptor. This action helps in mitigating the inflammatory responses that are pivotal in the progression of UC and Crohn’s disease. Persistent inflammation in these conditions can lead to severe symptoms like bowel urgency, which significantly impair the patients' quality of life.

In the LUCENT-3 study, patients with moderate to severe UC who achieved remission with mirikizumab maintained their remission for up to three years. Remarkably, over 80% of these patients continued to experience relief from disruptive symptoms, including bowel urgency. These results were sustained regardless of prior failure with other treatments such as TNF inhibitors, tofacitinib, or other biologics. The study indicated that mirikizumab was effective in providing long-term outcomes like histologic-endoscopic mucosal remission, a marker of mucosal healing.

Safety data for mirikizumab from the LUCENT-3 study showed that 7.4% of patients reported serious adverse events, and 5.3% discontinued treatment due to adverse events. The adverse effects were consistent with the known safety profile of mirikizumab.

In the VIVID-2 study, which extended over five years, more than 50% of patients with moderate to severe Crohn’s disease sustained long-term endoscopic remission with mirikizumab. The data indicated high rates of clinical and endoscopic remission over the extended period. Despite the long-term use of the drug, the safety profile for Crohn's disease patients remained consistent with the established safety information of mirikizumab. In this study, 8.5% of patients experienced serious adverse events, and 1.9% discontinued treatment due to these events.

Mirikizumab is already approved in the U.S. for treating moderately to severely active UC in adults and is currently under review by the FDA for Crohn's disease. This drug is notable for being the first IL23p19 antagonist to demonstrate multi-year, long-term efficacy in both UC and Crohn's disease.

Dr. Mark Genovese, senior vice president of Lilly Immunology development, emphasized that these findings highlight their commitment to providing long-term solutions for patients with immune system conditions. Dr. Bruce Sands, a professor of medicine and chief of gastroenterology at Mount Sinai, also noted that the multi-year data supports mirikizumab as a targeted therapy that offers sustained intestinal healing and symptom improvement.

Additionally, Lilly is exploring combination treatments involving mirikizumab and other biologics like eltrekibart, as well as ongoing studies with MORF-057, which might further enhance treatment outcomes for individuals with IBD. This research underscores Lilly’s dedication to advancing therapies that significantly improve the lives of people suffering from debilitating conditions.