The efficacy and safety of fingolimod in patients with relapsing multiple sclerosis: a meta-analysis.

AIMS:

The aim of the present meta-analysis was to evaluate the efficacy and safety of fingolimod in patients with relapsing multiple sclerosis (RMS).

METHODS:

PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for relevant studies. Two authors independently selected the studies, assessed the risk of bias, and extracted the data. The meta-analysis was performed in RevMan 5.3 provided by the Cochrane Collaboration.

RESULTS:

Ten studies met the inclusion criteria. In patients with RMS, fingolimod demonstrated a significantly lower annualized relapse rate (ARR) [0.5 mg/d: mean difference (95% confidence interval) = -0.22 (-0.29 to -0.14); 1.25 mg/d: -0.26 (-0.36 to -0.16); 5 mg/d: -0.41 (-0.72 to -0.10)] than placebo. Fingolimod also exhibited a favorable performance on other magnetic resonance imaging (MRI) outcomes and improved the quality of life in patients. No significant difference was noted in the prevalence of adverse events between the fingolimod treatment group and the placebo/disease-modifying therapies (DMTs) groups.

CONCLUSIONS:

Fingolimod may offer benefits for RMS patients and presents an acceptable safety profile.

TRIAL REGISTRATION:

PROSPERO registration number: CRD42019125749. Registered on 17 April 2019.