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Interim report into Gilenya safety released (18/04/16)

Once-daily Gilenya therapy 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 American Academy of Neurology meeting.

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

The analysis included follow-up data for up to four years, for 4051 patients of the originally-enrolled 4229 study participants.

“The safety profile for Gilenya in real life is comparable to that observed in Phase III clinical trials,” the authors reported.

“30.5 per cent of PANGAEA patients experienced no adverse events [AEs] so far; 8.7 per cent of all adverse events were rated as serious.”

Discontinuation rates related to AEs ranged between 11.3 per cent and 14.9 per cent, for years two and three, 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).

Source: MPR Copyright © 2016 Haymarket Media, Inc. (18/04/6)