作者
William J Sandborn, Brian G Feagan, Douglas C Wolf, Geert D’Haens, Severine Vermeire, Stephen B Hanauer, Subrata Ghosh, Heather Smith, Matthew Cravets, Paul A Frohna, Richard Aranda, Sheila Gujrathi, Allan Olson
发表日期
2016/5/5
期刊
New England Journal of Medicine
卷号
374
期号
18
页码范围
1754-1762
出版商
Massachusetts Medical Society
简介
Background
Ozanimod (RPC1063) is an oral agonist of the sphingosine-1-phosphate receptor subtypes 1 and 5 that induces peripheral lymphocyte sequestration, potentially decreasing the number of activated lymphocytes circulating to the gastrointestinal tract.
Methods
We conducted a double-blind, placebo-controlled phase 2 trial of ozanimod in 197 adults with moderate-to-severe ulcerative colitis. Patients were randomly assigned, in a 1:1:1 ratio, to receive ozanimod at a dose of 0.5 mg or 1 mg or placebo daily for up to 32 weeks. The Mayo Clinic score was used to measure disease activity on a scale from 0 to 12, with higher scores indicating more severe disease; subscores range from 0 to 3, with higher scores indicating more severe disease. The primary outcome was clinical remission (Mayo Clinic score ≤2, with no subscore >1) at 8 weeks.
Results
The primary outcome occurred in 16% of the patients who …
引用总数
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WJ Sandborn, BG Feagan, DC Wolf, G D'Haens… - New England Journal of Medicine, 2016