New Analysis Reveals Oral Ozanimod Effect on Cognitive Processing, Relapse Rate in MS

A post hoc analysis of clinical trial data showed oral ozanimod improved cognitive processing speed and reduced annualized relapse rates and MRI lesions in multiple sclerosis.

Ozanimod improved cognitive processing speed and reduced annualized relapse rates (ARRs) and MRI lesions at 12 months in patients with relapsing multiple sclerosis (RMS), according to a new post hoc analysis of clinical trial data.

The results are based on data from the phase 3 SUNBEAM trial and RADIANCE Part B trials, which evaluated the efficacy and safety of ozanimod compared with first-line treatment interferon beta-1a (IFN) (Avonex) in RMS. The findings were presented at ECTRIMS 2018.

RMS is the most common disease course at the time of diagnosis, with approximately 85% of patients initially diagnosed with this form of MS, according to a Celgene press release.

In the SUNBEAM trial, 0.92 mg and 0.46 mg (equivalent to 1 mg and 0.5 mg ozanimod HCl, respectively) doses of oral ozanimod were evaluated in 1346 patients with RMS treated for at least 1 year. At 12 months, clinical benefits were observed with ozanimod versus IFN (difference: 1.6; 95% confidence interval [CI]: 0.62, 2.56 for ozanimod 1 mg and 1.2; 95% CI: 0.19-2.13 for ozanimod 0.5 mg), according to the analysis. More patients demonstrated clinically meaningful improvements in processing speed at month 12 with ozanimod 1 mg versus IFN.

“Slowed cognitive processing, which is common in multiple sclerosis, often impairs quality of life for people living with this chronic condition,” Bruce Cree, MD, PhD, MAS, professor of neurology at the University of California San Francisco (UCSF) Weill Institute for Neurosciences, clinical research director at the UCSF MS center, and an author of both analyses, said in the press release. “The findings from these news analyses suggest that, when compared to interferon, ozanimod has a beneficial effect on processing speed.”

Additionally, a separate post hoc analysis evaluated the effect of ozanimod in patients with early RMS compared with patients with more advanced disease. According to the analysis, lower ARRs were seen in patients with both early and advanced RMS at 12 months with both doses of ozanimod compared with IFN treatment.

The data also showed that ozanimod reduced MRI lesions in both early and more advanced RMS. The mean number of gadolinium-enhancing (GdE) lesions at 12 months in patients with early RMS was 0.263 with ozanimod 1 mg, 0.458 with ozanimod 0.5 mg, and 0.656 with IFN. In patients with more advanced disease, the mean number of GdE lesions was 0.278, 0.323, and 0.915, respectively, according to the release.

The most commonly reported adverse reactions in the trials for ozanimod were upper respiratory tract infections, urinary tract infections, increases of alanine aminotransferase, and increases of gamma-glutamyl transferase.

Oral ozanimod is also currently in development for other immune-inflammatory indications, including for ulcerative colitis and Crohn disease.

Reference

New Analyses from Pivotal Phase 3 Trials of Oral Ozanimod to Be Presented at ECTRIMS 2018 [news release]. Celgene’s website. https://ir.celgene.com/press-releases/press-release-details/2018/New-Analyses-from-Pivotal-Phase-3-Trials-of-Oral-Ozanimod-to-Be-Presented-at-ECTRIMS-2018/default.aspx. Accessed October 15, 2018.