Bruce Sands, MD: Long-Term Data for Mirikizumab in Ulcerative Colitis, Crohn’s Disease

Findings from a pair of long-term phase 3 studies of mirikizumab are reinforcing the interleukin-23p19 (IL23p19) antagonist’s sustained safety and efficacy for both ulcerative colitis (UC) and Crohn’s disease (CD).

Results from the LUCENT-3 study in UC and the phase 3 VIVID-2 long-term extension study in CD were presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, and highlight stable, long-term remission among patients treated with mirikizumab. Of note, these data make mirikizumab the first and only IL23p13 antagonist to report long-term, multi-year sustained safety and efficacy data for both UC and CD.

“These studies really show that mirikizumab can be used both in Crohn's disease and in ulcerative colitis, and that when patients do initially respond and especially when they remit, they can expect very durable, long-standing responses and remission with excellent safety, Bruce Sands, MD, Dr. Burrill B. Crohn Professor of Medicine at Mount Sinai, explained to HCPLive.

An IL23p19 antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, mirikizumab is approved by the US Food and Drug Administration for the treatment of moderately to severely active UC and is under review for moderately to severely active CD.

LUCENT-3 findings presented at ACG showed that among those who achieved clinical remission with mirikizumab at 1 year in the LUCENT-2 study, after an additional 2 years of treatment, 81% of patients maintained long-term clinical remission, 82% achieved long-term endoscopic remission, and patients demonstrated a sustained clinically meaningful improvement in symptom score reduction for bowel urgency (-4.72). Additionally, 72% of patients had mucosal healing, 79% achieved corticosteroid-free clinical remission.

VIVID-2 long-term extension findings showed high rates of clinical and endoscopic remission over time among patients treated with mirikizumab. Specifically, after an additional 3 years of treatment, 96% of patients had clinical response and 87% were in clinical remission as measured by the Crohn’s Disease Activity Index (CDAI). Investigators also observed endoscopic response among 76% of patients and endoscopic remission among 54% of patients.

“We know that this class of medications is very effective in inflammatory bowel disease. It also has an excellent safety profile, and mirikizumab is one of a number of agents in this class that are making their way forward in IBD,” Sands said.

Editors’ note: Sands has relevant disclosures with AbbVie, Alimentiv, Amgen, Bristol Myers Squibb, AstraZeneca, Ferring, and others.

References

1. ^{Sands BE, D'Haens GR, Clemow D, et al. P4355 - Long-Term Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment: Results From the LUCENT-3 Open-Label Extension Study. Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}
2. ^{Lilly. Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn's disease. October 28, 2024. Accessed October 29, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-first-and-only-il23p19-antagonist-report-long}