Fingolimod vs Interferon in Relapsing-Remitting Multiple Sclerosis
An international team of researchers recently reported on the results of the extension of a trial comparing fingolimod and interferon beta-1a in relapsing-remitting multiple sclerosis. Basically, patients fared better when they took fingolimod, but it’s worth examining the details.
Fingolimod (Gilenya; Novartis Pharmaceuticals) is an immunomodulating drug used to help prevent symptoms of relapsing-remitting multiple sclerosis and slow the worsening of disability. It belongs to a drug class known as sphingosine l-phosphate receptor modulators and works by reducing the activation of immune cells that can cause nerve damage
Interferon beta-1a is a type of protein used to treat MS. It is available as Avonex and Refib and works by reducing the number of inflammatory cells that get through the blood brain barrier and modulating the expression of both pro- and anti-inflammatory factors in the brain.
The core phase was called TRANSFORMS (Trial Assessing injectable interferoN vS. FTY720 Oral in RRMS). This was a one-year, phase 3, double-blind, randomized trial that compared fingolimod (0.5 or 1.25 mg once daily) and interferon beta-1a (30 ug via intramuscular injection once a week).
This phase was followed by a long-term (up to 4.5 years) extension. During this phase, all of the patients who had been taking fingolimod continued their original treatment dose (0.5 mg for 356 patients and 1.25 mg for 330). However, those who had been taking interferon beta-1a were switched to fingolimod (0.5 mg for 167 patients, 1.25 mg for 174).
Of the 1,027 patients who entered the extended part of the study, 772 (75.2%) completed it. Here’s what the investigators found concerning the extension phase of the study:
- The annualized relapse rate in individuals who had been taking fingolimod 0.5 mg was significantly lower than in the group that switched to fingolimod, showing a 35 percent reduced risk of relapse
- Among those who switched to fingolimod, there was a 50 percent reduction in the annualized relapse rate, reduced activity on magnetic resonance imaging (MRI), and a lower rate of brain volume loss
- More specifically, among those who switched to fingolimod, the T2 lesion count decreased by 63 percent and stayed low throughout the extension phase
- The percentage of patients who were free of new or newly enlarging T2 lesions was similar between the continuous fingolimod group and those who switched (42% vs 45%, respectively)
- The prevalence of side effects (average) was similar between the continuous fingolimod group and those who switched. Namely, common cold (averaged about 30%), lymphopenia (23%), headache (21%), urinary tract infections (11%), and upper respiratory tract infections (11%).
Overall, the authors concluded that their findings in the extension phase “support a continued effect of long-term fingolimod therapy in maintaining a low rate of disease activity and sustained improved efficacy” among patients who switch from interferon beta-1a to fingolimod. (Note: Eleven of the 12 authors had some type of competing interest, including four who worked for Novartis Pharmaceuticals. See the study for details.)
Cohen JA et al. Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomized TRANSFORMS study. Journal of Neurology, Neurosurgery and Psychiatry 2015 Jun 25