Incidence of cancer in patients with multiple sclerosis (MS) who were treated with fingolimod: A systematic review and meta-analysis.

BACKGROUND: Fingolimod is a sphingosine-1-phosphate-receptor modulator that is used for the relapsing form of MS. There are controversial reports regarding the incidence of cancer in patients with MS who were treated with fingolimod. Therefore, we designed this systematic review and meta-analysis to estimate the pooled incidence of cancer in patients with MS who were treated with various dose of fingolimod. METHOD: Two expert researchers searched systematically PubMed, Scopus, EMBASE, Web of Science, and google scholar as well as references of the included studies, and conference abstracts which were published up to November 2021. RESULTS: We found 5231 articles by literature search, after deleting duplicates 3070 remained. Thirty-four articles remained for meta-analysis. Totally, 64,135 patients with MS who received fingolimod were enrolled. The total number of patients with cancer was 2561. The pooled incidence of cancer in patients with MS who received fingolimod was 2.02% (95% CI:2.00-3.01%, I2 = 97.8%, P < 0.001). The pooled incidence of cancer in group who received 0.5 mg was 2.01%(95%CI:1.00-2.04%) (I2 = 91.7%, P < 0.001). The pooled incidence of cancer in the group that received 1.25 mg was 3.01%(95%CI:2.02-5.01%) (I2 = 67.5%, P < 0.001). CONCLUSION: The result of this systematic review and meta-analysis shows that the pooled prevalence of cancer in MS patients who received fingolimod was 2%. The risk of cancer is higher in patients with MS who received 1.25 mg fingolimod 1.25 mg than cases who received 0.5 mg.