Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis

Abstract

This trial showed the superior efficacy of oral fingolimod with respect to relapse rates and MRI outcomes in patients with multiple sclerosis, as compared with intramuscular interferon beta-1a. Longer studies are needed to assess the safety and efficacy of treatment beyond 1 year. (ClinicalTrials.gov number, NCT00340834.)

Neurological safety of fingolimod: An updated review

“…Regarding laboratory test abnormalities, peripheral blood lymphocyte counts were reduced by approximately 75% from baseline after the first month 1, 3, 5. Mean lymphocyte counts began to rise within days of discontinuation, and reached the lower limit of normal by 4–8 weeks 16.…”

“…Because FTY causes a decrease of circulating lymphocytes, patients might be susceptible to serious infections, such as disseminated or central nervous system herpetic infection; indeed, two deaths were reported during the trial period as a result of primary disseminated varicella zoster infection and Herpes simplex encephalitis in the 1.25 mg/day group 5. Upper respiratory infections including nasopharyngitis or pharyngitis occurred in approximately 45% of patients in the Japanese clinical trial 9.…”

“…Macular edema was confirmed in <1% of patients taking the currently approved dose (0.5 mg/day) 1, 5. It was mostly asymptomatic, though some patients complained of blurred vision or reduced visual acuity.…”

“…IFN‐β1a (1‐year TRANSFORMS and extended TRANSFORMS studies) 5, 6. FTY reduced the annualized relapse rate and slowed the progression of neurological disability in patients with relapsing–remitting multiple sclerosis (RRMS).…”

“…FTY reduced the annualized relapse rate and slowed the progression of neurological disability in patients with relapsing–remitting multiple sclerosis (RRMS). Significant and sustained reductions in magnetic resonance imaging (MRI) lesion counts and brain volume loss have been reported in both short‐term3, 5 and long‐term studies 6, 7…”