Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.

Autor:	Sands BE; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., D'Haens G; Amsterdam University Medical Centers, Amsterdam, the Netherlands., Clemow DB; Eli Lilly and Company, Indianapolis, IN, USA., Irving PM; Guy's and St. Thomas' NHS Foundation Trust, King's College London, London, United Kingdom., Johns JT; Eli Lilly and Company, Indianapolis, IN, USA., Hunter Gibble T; Eli Lilly and Company, Indianapolis, IN, USA., Abreu MT; UHealth Crohn's and Colitis Center, University of Miami Miller School of Medicine, Miami, FL, USA., Lee S; Digestive Health Center, University of Washington Medical Center, Seattle, WA, USA., Hisamatsu T; Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan., Kobayashi T; Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan., Dubinsky MC; Icahn School of Medicine at Mount Sinai, New York, NY, USA., Vermeire S; Department of Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium., Siegel CA; Dartmouth Hitchcock Medical Center, Lebanon, NH, USA., Peyrin-Biroulet L; Department 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.; Paris IBD Center, Groupe Hospitalier Privé Ambroise Paré-Hartmann, Neuilly-sur-Seine, France.; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, QC, Canada., Moses RE; Eli Lilly and Company, Indianapolis, IN, USA., Milata J; Eli Lilly and Company, Indianapolis, IN, USA., Arora V; Eli Lilly and Company, Indianapolis, IN, USA., Panaccione R; Inflammatory Bowel Disease Group, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada., Dignass A; Department of Medicine I, Agaplesion Markus Krankenhaus, Frankfurt, Germany.
Jazyk:	angličtina
Zdroj:	Inflammatory bowel diseases [Inflamm Bowel Dis] 2024 Dec 05; Vol. 30 (12), pp. 2245-2258.
DOI:	10.1093/ibd/izae024
Abstrakt:	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. (© 2024 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)
Databáze:	MEDLINE
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