William J. Sandborn
PHILADELPHIA – Etrasimod, a selective, oral S1P receptor 1, 4 and 5 modulator, was successful in achieving dose-dependent improvements in clinical response, remission and endoscopic appearance in patients with moderate-to-severe ulcerative colitis, according to research presented at the American College of Gastroenterology Annual Meeting.
“Patients with moderate to severe ulcerative colitis receiving etrasimod 2 mg per day achieve statistically significant and clinical meaningful differences in all primary and secondary endpoints,” William J. Sandborn, MD, of the University of California San Diego, said during his presentation. “Most exploratory endpoints were also significantly improved.”
In the study known as the OASIS trial, Sandborn and colleagues evaluated etrasimod (Arena Pharmaceuticals) in patients with moderate-to-severe UC, defined as a 3-component Mayo Clinic Score between 4 and 9, with an endoscopic subscore of at least 2 and a rectal bleeding subscore of at least 1.
Researchers gave patients a once-daily dose of 1 mg etrasimod (n = 52), 2 mg (n = 50) or placebo (n = 54). The primary endpoint was change from baseline in Mayo Clinic Score. Investigators also explored the proportion of patients with endoscopic remission.
Sandborn and colleagues found that at week 12, patients who were given etrasimod experienced better dose-dependent improvement across all efficacy measures compared with placebo. The 2 mg dosage group experienced improved Mayo Clinic Score (difference, 0.99 points; 90% CI, 0.30-1.68) and endoscopic improvement (41.8% vs. 17.8%; P = .003) compared with placebo.
In studying the drug’s safety, researchers found that more patients in the placebo group (11.1%) experienced adverse events compared with patients in the 1 mg and 2 mg groups (5.8% and 0%, respectively).
“A dose-response relationship was observed in virtually all measures of treatment efficacy,” Sandborn said. “The OASIS trial results for etrasimod in ulcerative colitis support proceeding to a phase 3 clinical development program.” – by Alex Young
: Sandborn WJ, et al. Plenary Session 1A: IBD, Abstract 1. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 5-10, 2018; Philadelphia.
Sandborn reports financial ties to AbbVie, Akros, Allergan, Ambrx Inc., Amgen, Ardelyx, Arena, Atlantic Healthcare Limited, Atlantic Pharmaceuticals, Avaxia, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celgene/Receptos, Conatus, Cosmo Technologies, Escalier Biosciences, Ferring, Ferring Research Institute, Forward Pharma, Galapagos, Genentech, Gilead Sciences, Immune Pharmaceuticals, Index Pharmaceuticals, Janssen, Kyowa Hakko Kirin Pharma, Lilly, MedImmune, Mesoblast, Miraca Life Sciences, Nivalis Therapeutics, Nutrition Science Partners, Opplian Pharma, Otsuka, Palatin, Paul Hastins, Precision IBS, Progenity, Ritter, Robarts Clinical Trials, Salix, Seattle Genetics, Seres Therapeutics, Sigmoid Biotechnologies, Takeda, Theradiag, Theravance, Tigenix, Tillots, UCB Pharma and Vascular Biogenics.