Inflamm Bowel Dis. 2024 Dec 5;30(12):2245-2258.doi: 10.1093/ibd/izae024.

Bruce E Sands ¹, Geert D'Haens ², David B Clemow ³, Peter M Irving ⁴, Jordan T Johns ³, Theresa Hunter Gibble ³, Maria T Abreu ⁵, Scott Lee ⁶, Tadakazu Hisamatsu ⁷, Taku Kobayashi ⁸, Marla C Dubinsky ⁹, Severine Vermeire ¹⁰, Corey A Siegel ¹¹, Laurent Peyrin-Biroulet ^12 13 14, Richard E Moses ³, Joe Milata ³, Vipin Arora ³, Remo Panaccione ¹⁵, Axel Dignass ¹⁶

Author information

¹Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

²Amsterdam University Medical Centers, Amsterdam, the Netherlands.

³Eli Lilly and Company, Indianapolis, IN, USA.

⁴Guy's and St. Thomas' NHS Foundation Trust, King's College London, London, United Kingdom.

⁵UHealth Crohn's and Colitis Center, University of Miami Miller School of Medicine, Miami, FL, USA.

⁶Digestive Health Center, University of Washington Medical Center, Seattle, WA, USA.

⁷Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.

⁸Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.

⁹Icahn School of Medicine at Mount Sinai, New York, NY, USA.

¹⁰Department of Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium.

¹¹Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.

¹²Department of Gastroenterology, INFINY Institute, FHU-CURE, French Institute of Health and Medical Research Nutrition-Genetics and Exposure to Environmental Risks Research Unit, Nancy University Hospital, Nancy, France.

¹³Paris IBD Center, Groupe Hospitalier Privé Ambroise Paré-Hartmann, Neuilly-sur-Seine, France.

¹⁴Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, QC, Canada.

¹⁵Inflammatory Bowel Disease Group, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.

¹⁶Department of Medicine I, Agaplesion Markus Krankenhaus, Frankfurt, Germany.

Abstract

Background: Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious in inducing clinical remission at week 12 (W12) and maintaining clinical remission at W52 in patients with moderately to severely active ulcerative colitis. Results are presented from the open-label extension study through W104.

Methods: Clinical, symptomatic, quality-of-life, and adverse event outcomes are reported for mirikizumab induction responders and extended induction responders, including biologic-failed patients, who entered LUCENT-3, with data shown for W52 maintenance responders or remitters. Discontinuations or missing data were handled by nonresponder imputation (NRI), modified NRI (mNRI), and observed case (OC).

Results: Among W52 mirikizumab responders, clinical response at W104 was 74.5%, 87.2%, and 96.7% and clinical remission was 54.0%, 62.8%, and 70.1% for NRI, mNRI, and OC, respectively. Among W52 mirikizumab remitters, clinical response at W104 was 76.6%, 89.0%, and 98.3% and clinical remission was 65.6%, 76.1%, and 84.2%. Using mNRI, remission rates at W104 for W52 clinical remitters were 74.7% corticosteroid-free, 79.5% endoscopic, 63.9% histologic-endoscopic mucosal remission, 85.9% symptomatic, 59.8% bowel urgency, 80.5% Inflammatory Bowel Disease Questionnaire (using NRI), 71.2% histologic-endoscopic mucosal improvement, and 77.5% bowel urgency improvement. Previous biologic-failed vs not-biologic-failed patient data were generally similar. Extended induction mNRI clinical response was 81.9%. Serious adverse events were reported in 5.2% of patients; 2.8% discontinued treatment due to adverse events.

Conclusions: Endoscopic, histologic, symptomatic, and quality-of-life outcomes support the long-term benefit of mirikizumab treatment up to 104 weeks in patients with ulcerative colitis, including biologic-failed patients, with no new safety concerns.