Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Fingolimod in Relapsing-Remitting MS

Assessing efficacy with comorbidities present

Publish date:: January 19, 2016

Fingolimod showed efficacy in reducing relapses comparable to that observed in the phase III trials and was safe and efficacious irrespective of comorbidities and previous treatment. This according to a study of 105 patients with relapsing-remitting multiple sclerosis (RR-MS). Researchers found:

• The annual relapse rate was reduced by 44% vs the year before starting fingolimod.

• The percentage of patients with worsening EDSS decreased.

• Accordingly, the fraction of patients with no evidence of disease activity increased from 11% to 38%.

• Efficacy and safety were comparable between highly active patients or patients with relevant comorbidities and the general population in the study.

Citation: Rasenack M, Rychen J, Andelova M, et al. Efficacy and safety of fingolimod in an unselected patient population. PLoS One. 2016;11(1):e0146190. doi: 10.1371/journal.pone.0146190.

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