Efficacy and safety of etrasimod in a phase 2 randomized trial of patients with ulcerative colitis
Gastroenterology Nov 16, 2019
Sandborn WJ, Peyrin-Biroulet L, Zhang J, et al. - Given that etrasimod (APD334) is an oral, selective sphingosine 1-phosphate receptor modulator in immune-mediated inflammatory disorders development, researchers tested the safety and effectiveness of etrasimod in moderately to severely active ulcerative colitis (UC) individuals. For this investigation, they randomly assigned adult outpatients with modified Mayo Clinic scores (MCSs; stool frequency, rectal bleeding, and endoscopy findings) of 4–9, endoscopic subscores of 2 or more, and rectal bleeding subscores of 1 or more to groups given once-daily etrasimod 1 mg (n = 52), etrasimod 2 mg (n = 50), or placebo (n = 54) for 12 weeks. The study was conducted at 87 centers in 17 countries from October 15, 2015, to February 14, 2018. According to this phase 2, proof of concept, double-blind, parallel-group study, etrasimod 2 mg was more effective than placebo in producing clinical and endoscopic improvements in patients with moderately to severely active UC. The majority of adverse events have been mild to moderate. There is a need for further clinical development.
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