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Ozanimod Shows Long-Term Improvement for UC Patients
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LAS VEGAS — Ozanimod therapy showed long-term efficacy through improved Mayo score, and decreased incidence of rectal bleeding and stool frequency in patients with moderate-to-severe ulcerative colitis, according to data from the TOUCHSTONE trial presented at ACG 2016.
“Long-term treatment with ozanimod continues to be safe and well tolerated with good compliance and evidence of durable efficacy,” William J. Sandborn, MD, professor of medicine, chief of the division of gastroenterology and director of University of California San Diego Inflammatory Bowel Disease Center, said during his presentation.
William Sandborn
Sandborn and colleagues looked at 170 patients from the TOUCHSTONE clinical trial who, at 32 weeks, had relapsed or did not respond to either placebo or 0.5 mg of ozanimod (RPC1063, Receptos) or finished the maintenance treatment with 1 mg of ozanimod. In this open-label extension, all patients received 1 mg of ozanimod for an additional 44 weeks, allowing observation of safety and efficacy for a total of 76 weeks.
At 44 weeks, after all being dosed with 1 mg of ozanimod, all groups showed improvements in partial Mayo Score. The greatest improvement was reported in patients who previously received placebo or ozanimod 0.5 mg. At 44 weeks, researchers observed a difference of –2.6 in the placebo group and –2.7 in the 0.5 mg ozanimod group.
“Patients receiving treatment with ozanimod 1 mg for the first time in the open label extension had a rapid improvement in partial Mayo Score,” Sandborn said during his presentation.
Approximately 91% of patients had little or no active disease based on the physician global assessment at 44 weeks. In addition, 98.4% had little or no blood in their stools.
Serious treatment-emergent adverse events occurred in 9.4% of patients. The most common adverse events during the trial were UC flare, anemia, upper respiratory tract infection, nasal pharyngitis, back pain, arthralgia, headache and elevated alanine aminotransferase or aspartate aminotransferase levels. – by Melinda Stevens
Reference:
Sandborn WJ, et al. Abstract #30. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 14-19, 2016; Las Vegas, NV.
Disclosure: Sandborn reports consulting for AbbVie, Actavis, Amgen, Celgene, Genentech, Jansen, Prometheus Laboratories, Pfizer, Shire, Salix, Takeda and UCB Pharma; and has received grant and research support from AbbVie, Amgen, Celgene, Genentech, Jansen, Prometheus Laboratories, Pfizer and Takeda. Please see the abstract for a list of all other researchers’ relevant financial disclosures.
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