Lilly’s mirikizumab is the first IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn’s disease
Posted on October 28, 2024
Eli Lilly releases their new results from two, multi-year, Phase 3 studies that showed patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases, ulcerative colitis and Crohn’s disease. Data from the two trials – LUCENT-3 in moderately to severely active UC and VIVID-2 in moderately to severely active Crohn’s disease.
Note that: Mirikizumab is an interleukin-23p19 antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. Inflammation due to the overactivation of the IL-23 pathway plays a critical role in pathogenesis of UC and Crohn’s disease. Inflammation from UC and Crohn’s disease can lead to disruptive symptoms, including bowel urgency, that can result in decreased health-related quality of life and potentially irreversible complications for patients if left untreated. Mirikizumab is approved in the United States for the treatment of moderately to severely active UC in adults and is under review with the U.S. Food and Drug Administration for moderately to severely active Crohn’s disease.
“Mirikizumab is the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both ulcerative colitis and Crohn’s disease,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “This achievement reflects our commitment to help people with immune system conditions sustain long-standing remission and relieve disease burden.”
Long-Term Data in Adults with UC
In LUCENT-3, mirikizumab helped patients with moderately to severely active UC achieve long-term outcomes, including histologic-endoscopic mucosal remission, defined as mucosal healing. Mirikizumab also provided sustained benefit across symptomatic, clinical, endoscopic and histologic endpoints for up to three years, regardless of previous failure to TNF inhibitors, tofacitinib or other biologics. Among those who achieved clinical remission with mirikizumab at one year in the LUCENT-2 study, the following results were achieved based upon observed case analysis after an additional two years of treatment:
- 81% of patients maintained long-term clinical remission
- 82% achieved long-term endoscopic remission
- 72% had mucosal healing
- 79% achieved corticosteroid-free clinical remission
- Patients demonstrated a sustained clinically meaningful improvement in symptom score reduction for bowel urgency
These results were also evaluated using a modified non-responder imputation and are presented in the About the Mirikizumab Ulcerative Colitis Program section below.
Related Topics and Keywords
Crohn's disease, IL23p19, Lilly's mirikizumab, ulcerative colitis, ulcerative colitis and Crohn's disease
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