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TOUCHSTONE Trial: Ozanimod Induces Remission in Ulcerative Colitis
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WASHINGTON — A larger dose of 1 mg of ozanimod induced remission of ulcerative colitis by week 8 of a study presented here at Digestive Disease Week 2015.
“Ozanimod 1 mg induced clinical remission at week 8 and all three secondary endpoints were met for ozanimod 1 mg at week 8,” Sandborn said. “A dose response relationship was observed for all primary and key secondary efficacy endpoints.”
William Sandborn
William Sandborn, MD, professor of Medicine at the University California of San Diego, presented data from 57 sites in 13 countries where they recruited adults with moderate-to-severe ulcerative colitis as defined by Mayo score who had been receiving treatment with oral aminosalicytes and/or prednisone.
Patients were randomized into three groups: placebo (n = 65), ozanimod (Receptos) 0.5 mg (n = 65), and ozanimod 1 mg (n = 67), all of which had similarly high rates of compliance and completion, resulting in a 95% rate of completion of the induction period.
The induction period was 1 week dose titration and 8 weeks of full dose treatment, at which time primary endpoints were assessed.
The primary endpoint was clinical remission (Mayo score ≤ 2, no subscore >1) at week 8, at which time, researchers found that 16.4% of patients in the 1 mg group achieved remission, along with 13.8% of those in the 0.5 mg group and 6.2% of those in the placebo group (P = 0.0482 for 1 mg vs. placebo).
In looking at the secondary endpoint of clinical response (reduction in Mayo score of ≥ 3 and ≥ 30% with a decrease in the rectal bleeding score of ≥ 1 or a rectal bleeding score ≤ 0 or 1) at week 8, 56.7%, 53.8% and 36.9% of patients in the 1 mg, 0.5 mg and placebo groups, respectively, showed clinical response (P = 0.0140 for 1 mg vs. placebo). Another secondary endpoint was proportion of patients with mucosal improvement (endoscopy score ≤ 0 or 1) at week 8. Here, they saw 34.3% of those receiving 1 mg (P = 0.0023), 27.7% (P = .0348) of those receiving 0.5 mg and 12.3% of those receiving placebo who met that endpoint.
“There were no notable cardiac, ophthalmologic or infectious treatment-emergent adverse events observed,” Sandborn said.
Additionally, Sandborn showed that they retrospectively applied the definition for clinical remission at week 8 in the now starting phase 3 program. With a definition of rectal bleeding subscore of 0, stool frequency subscore of 1 or less and improvement of 1 or more and an Endo score of 1 or less, 23.3% of those receiving 1 mg, 16.9% of those receiving 0.5 mg and 9.2% of placebo met this endpoint.
“Ozanimod was well tolerated with a favorable risk-benefit profile supporting advancement of this drug into phase 3 in ulcerative colitis,” he concluded. – by Katrina Altersitz
For more information:
Sandborn WS, et al. Abstract 445. Presented at: Digestive Disease Week; May 16-19, 2015; Washington, D.C.
Disclosures: Sandborn reports financial relationships with ActoGeniX NV, Amgen, AM-Pharma BV, Boehringer Ingelheim Inc, Bristol Myers Squibb, Celgene, Cosmo Technologies, Coronado Biosciences, Eisai Medical Research Inc., Elan Pharmaceuticals, Eli Lilly, Ferring Pharmaceuticals, Genentech, Gilead Sciences, GlaxoSmithKline, Ironwood Pharmaceuticals, Janssen, Lexicon Pharmaceuticals, Millennium Pharmaceuticals, Nisshin Kyorin Pharmaceutical Co., Ltd, Novo Nordisk A/S, Orexigen Therapeutics, Inc., Pfizer, Prometheus Laboratories and Receptos.
Editor's note: This article was updated on May 28, 2015, with clarification from the presenter.