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TOUCHSTONE: 2-Year Data Support Phase 3 Trial of Ozanimod in UC
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ORLANDO — Long-term treatment with ozanimod remained safe and well-tolerated with good compliance and durable efficacy at 2 years follow-up among patients with moderate-to-severe ulcerative colitis, according to findings from the TOUCHSTONE extension trial presented here.
“We believe these data provide evidence of the durable efficacy of long-term treatment with ozanimod and we have initiated a phase 3 trial, but it will be a bit until it is complete and data become available,” William J. Sandborn, MD, of the University of California, La Jolla, Calif., said during his presentation.
For the initial TOUCHSTONE trial, Sandborn and colleagues analyzed data from 197 patients with moderate-to-severe ulcerative colitis who were randomly assigned in a 1:1:1 fashion to 0.5 mg daily ozanimod (n=65; RPC1063, Receptos), 1 mg daily ozanimod (n=67) or placebo (n=65). The extension trial included 170 patients assigned 1 mg daily ozanimod, of which 100 patients were followed through 92 weeks.
At baseline, the partial Mayo Score for placebo was 4.6, followed by 4.5 for 0.5 mg ozanimod and 3.3 for 1 mg ozanimod. The Mayo Score significantly improved by week 8, with -2.3 among patients on placebo, -1.9 for 0.5 mg ozanimod and -1.1 for 1 mg ozanimod.
“Partial Mayo Score substantially improved by week 8 in the extension trial, with the greatest improvement reported in patients who had received placebo or ozanimod 0.5 mg in the main trial,” Sandborn said.
At 2 years follow-up, 91% of patients had little or no active disease based upon the physician global assessment (PGA 0 or 1), 97% had little or no blood in their stools (rectal bleeding subscore 0 or 1) and 86% had no blood in the stools (rectal bleeding subscore 0), according to Sandborn.
Ulcerative colitis flare, anemia, nausea, upper respiratory tract infection, nasopharyngitis, back pain, arthralgia, headache, transaminase elevation and hypertension were the most common adverse events associated with ozanimod — reported in 50% of patients. Serious adverse events, including anemia and ulcerative colitis flare, occurred in 11.1% of patients. – by Jennifer Southall
References:
Sandborn WJ, et al. N Engl J Med. 2016;374:1754-1762.
Sandborn WJ, et al. Abstract 14. Presented at: World Congress of Gastroenterology; Oct. 13-18, 2017; Orlando.
Disclosures: Sandborn reports being a consultant for and receiving grant and research funding from Celgene. See the faculty disclosure index on the ACG website for a full list of disclosures.