Interim Report Released on Real-World Safety of Fingolimod for Relapsing MS

An interim 4-year follow-up analysis of fingolimod (Gilenya) found the safety profile of the treatment to be consistent with the results of phase 3 clinical trials, researchers reported at the 68th Annual AAN Meeting.

VANCOUVER, BC—Once-daily fingolimod (0.5mg) is effective after four years of real-world clinical use among patients with relapsing remitting multiple sclerosis (RRMS), and has a safety profile that is “broadly consistent” with that identified in clinical trials, according to an interim analysis from the PANGAEA long-term safety, tolerability, and effectiveness non-interventional study, presented at the 68th Annual AAN Meeting.  

“The results of the four-year interim analysis of PANGAEA support the positive benefit-risk profile fingolimod demonstrated in Phase 3 clinical trials with real-world evidence,” reported Tjalf Ziemssen, MD, PhD, of the Zentrum für klinische Neurowissenschaften Dresden, in Germany, and coauthors, in a poster presentation.

Fingolimod is a sphingosine 1-phosphate receptor modulator which has been approved for the treatment of relapsing MS.

The analysis included follow-up data for up to four years, for 4051 patients of the originally-enrolled 4229 study participants. Mean patient age was 39.4 years-old and mean time since diagnosis at baseline was 8.2 (±6.3) years.

“The safety profile for fingolimod in real life is comparable to that observed in phase 3 clinical trials,” the authors reported. “30.5% of PANGAEA patients experienced no adverse events [AEs] so far; 8.7% of all adverse events were rated as serious.”

Discontinuation rates related to AEs ranged between 11.3% and 14.9%, for years 2 and 3, respectively. Common AEs included reduced lymphocyte counts, elevated liver enzymes, upper respiratory tract infections, and fatigue and depression deemed to be “potentially MS-related.”

Two patients experienced progressive multifocal leukoencephalopathy (PML).