In the absence of a better alternative, subcutaneous
interferon beta is the standard first-line treatment for
relapsing-remitting multiple sclerosis.
Fingolimod, an oral
immunosuppressant that reduces the circulating lymphocyte count, is in the process of receiving marketing authorisation for this use in the European Union. Initial clinical evaluation is based on 2 trials. In a 12-month, comparative, double-blind, randomised trial including 1292 patients daily treatment with oral
fingolimod (0.5 mg or 1.25 mg) modestly prolonged the interval between exacerbations compared to weekly
intramuscular injections of
interferon beta-1a: about one exacerbation prevented every 6 years. No tangible impact on progression of disability was observed. A double-blind placebo-controlled trial that lasted 2 years also showed a statistically significant reduction in the annual frequency of exacerbations. There was no firm evidence that
fingolimod had a tangible effect on progression of disability. An indirect comparison suggests that the impact of
fingolimod on exacerbations is roughly similar to that of
cladribine, another oral
immunosuppressant that received a negative opinion in this indication from the European Medicines Agency. Several short-term adverse effects consistent with the pharmacological action of
fingolimod and the results of animal pharmacology studies were observed in clinical trials, including
infections (especially herpetic), pulmonary disorders, cardiac conduction disorders and macular oedema. A risk of
lymphoma and
heart failure is possible in the longer term. Given the modest gain in efficacy compared with
interferon beta (based on weak supporting evidence) and the major adverse effects of
fingolimod, it is better to continue to use
interferon beta for initial treatment of
relapsing-remitting multiple sclerosis, and to reserve
fingolimod for use in clinical trials in which patients are closely monitored.