Study Shows Benefits of Fingolimod for Relapsing-Remitted Multiple Sclerosis

Various benefits associated with fingolimod (Gilenya) observed for relapsing-remitted multiple sclerosis.

Individual trials have shown various benefits associated with fingolimod (Gilenya) for relapsing-remitted multiple sclerosis (RRMS), but its consistency across studies has not been fully understood.

The impact of fingolimod, an oral pill, for multiple sclerosis has been continuously investigated. One recent study found that the treatment may not be all that beneficial, while a clinical setting trial reaffirmed the belief that it is.

In a presentation showcased at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Center (CMSC) in National Harbor, Maryland, a team of researchers from Seattle, Washington and Basel, Switzerland analyzed the consistency of this treatment over two years.

Two phase III clinical trials, FREEDOMS and FREEDOMS II, evaluated fingolimod 0.5 mg versus placebo for two years. Positive outcomes were observed with the drug for annualized relapse rate (ARR), magnetic resonance imaging (MRI) lesion activity, and brain volume loss (BVL). Significant improvements were also apparent in confirmed disability progression (CDP) among patients with RRMS.

The two studies consisted of 783 patients taking fingolimod 0.5 mg and 773 patients taking a placebo.

There was a 52% reduction in ARR in those who took fingolimod 0.5 mg. In addition, there was a 76% reduction in new and enlarging T2 lesions, 33% reduction in BVL rate, and 39% reduction in the risk of CDP. These treatment outcomes were consistent among both studies.

“Fingolimod was associated with a consistent, significant reduction in disease activity across key measures of inflammatory processes and disease worsening in patients with RRMS,” the researchers concluded.