Multiple Sclerosis Drug Shown to Slow Disability Progression

Novartis recently announced findings from the ACROSS study, which explores disability outcomes in patients with relapsing remitting multiple sclerosis treated with Gilenya (fingolimod).

The results of the study suggest that Gilenya treatment can provide long-term control of disability progression, Novartis reported.

Previous studies have also shown that the drug was the most cost-effective first-line disease modifying-therapy. Gilenya had the lowest cost per relapse avoided compared with other first-line disease modifying therapies, due to a decreased number of relapses.

Initially, researchers enrolled 175 patients with relapsing remitting multiple sclerosis in the 10-year observational phase 2 study. These patients were previously enrolled in the phase 2 D2201 study, which evaluated the efficacy, safety, and tolerability of fingolimod in the patients.

Patients who received Gilenya treatment for at least 8 years were put into the continuous treatment group, and those who have received treatment for less than 8 years were put into the non-continuous treatment group, according to Novartis.

The primary objective was to evaluate if continuous treatment resulted in decreased disability progression. Secondary objectives included the proportion of patients with disability progression, time to first use of wheelchair, and patients who developed secondary progressive multiple sclerosis.

Researchers found that the study met its primary endpoint of lower disability progression at 10 years with continuous versus non-continuous treatment with Gilenya (0.55 versus 1.21, respectively).

They also discovered that risks of progressing to secondary progressive multiple sclerosis (MS) decreased by 66.2% in patients taking Gilenya for at least 8 years, Novartis reported. A four-fold delay in time to first use of a wheelchair was also discovered.

Gilenya impacts relapses, MRI lesions, brain volume loss, and disability progression, which have been previously shown in clinical trials and in real-world settings.

It is currently the approved first-line treatment of relapsing multiple sclerosis in adults in the United States. It has also been approved in the European Union for adults with highly-active relapsing remitting multiple sclerosis, according to Novartis.

“Multiple sclerosis is a debilitating, life-long disease, and greatly impacts how individuals are able to go about their daily lives,” said Vasant Narasimhan, global head Drug Development and chief medical officer for Novartis. “The ACROSS data add to our understanding of the long-term use of Gilenya as a highly-effective treatment option for people with relapsing remitting MS.”