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TOUCHSTONE: Patients with UC achieve histological improvements with ozanimod

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Patients with moderate to severe ulcerative colitis achieved histologic improvement and histologic remission with 1 mg ozanimod, according to results from the TOUCHSTONE phase 2 clinical trial presented at the European Crohn’s and Colitis Organization’s Congress.

Ozanimod (Celgene) is an investigational, oral, small molecule sphingosine 1-phosphate 1 and 5 receptor modulator in development for inflammatory bowel disease and other immune-inflammatory indications, according to a press release.

William Sandborn

“It’s exciting to observe histologic improvements in patients with ulcerative colitis who were treated with ozanimod. Clinical research suggests that histologic improvements can be linked with improved clinical outcomes in ulcerative colitis,” William Sandborn, MD, professor of medicine, chief of the division of gastroenterology and director of University of California San Diego Inflammatory Bowel Disease Center, said in the press release. “While often more difficult to measure, endpoints such as histologic improvement or remission are emerging as important treatment goals for patients and their physicians.”

Sandborn and colleagues randomly assigned 67 UC patients to receive 1 mg ozanimod, 65 to receive 0.5 mg ozanimod and 65 to receive placebo during the induction period of the TOUCHSTONE trial, after which 103 continued treatment in the maintenance period — which 91 completed. A blinded central pathologist scored biopsies from baseline and weeks 8 and 32, and histologic remission was defined as a Geboes grade of less than two.

The high dose group achieved greater histologic improvement at 8 weeks (P = .0345) and 32 weeks (P = .0033), compared with placebo. The low dose group also achieved greater improvement compared with placebo, but this did not reach statistical significance at either 8 or 32 weeks. At week 8, histologic remission was achieved by 22.4% of the high dose group (P = .0705 vs. placebo), 13.8% of the low dose group (P = .6294 vs. placebo) and 10.8% of the placebo group. At week 32, histologic remission was achieved by 31.3% of the high dose group (P = .0006 vs. placebo), 23.1% of the low dose group (P = .0164 vs. placebo) and 7.7% of the placebo group.

The researchers concluded that patients with moderate to severe UC can achieve clinical, endoscopic and histologic improvements and remission with 32 weeks of treatment with the high dose of ozanimod.

“These data suggest that in addition to benefits we’ve previously seen, oral ozanimod could also help ulcerative colitis patients achieve the important treatment goal of histologic remission,” Scott Smith, president of Celgene Inflammation & Immunology, said in the press release. “We are committed to bringing innovative medicines and different treatment options for patients with inflammatory bowel disease and continue to actively advance the phase 3 clinical program for ozanimod.” – by Adam Leitenberger

Referen ce:

Sandborn W, et al. Abstract DOP052. Presented at: ECCO Congress; March 16-19, 2016. Amsterdam.

Disclosure: Sandborn reports personal fees from Celgene, as well as numerous other financial relationships and patents. Please see the ECCO disclosures database for Sandborn’s and all other researchers’ relevant financial disclosures.