CMSC 2012: Fingolimod Significantly Reduces Relapse Rates in MS Patients, Regardless of Duration of or Reasons for Discontinuing Prior Therapy

SAN DIEGO — The once-daily oral multiple sclerosis (MS) drug, fingolimod, reduces annualized relapse rates in patients with MS who achieved unsatisfactory responses when treated with other disease-modifying therapies (DMTs) or who had been treated for an extended period of time, according to research presented at the Fourth Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and America’s Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

Marcelo Kremenchutzky, MD, University of Western Ontario in London, Ontario, Canada, and colleagues conducted a posthoc analysis using data from the FREEDOMS study, a phase 3, randomized, double-blind study involving more than 1,000 patients aged 18 to 55 years with relapsing MS, recent history of relapse, and an expanded disability status scale (EDSS) score less than 5.5. During this two-year study, patients received either fingolimod 0.5 mg/day, fingolimod 1.25 mg/day, or placebo. The objective of this analysis was to evaluate the efficacy of fingolimod based on a patients’ prior DMT.

Here, patients were stratified according to the duration of their prior DMT as treatment-naïve (0 days), 1 year or less, more than 1 year to less than 3 years, or longer than 3 years. Additionally, ARR was analyzed according to whether patients discontinued prior DMT due to adverse events or due to unsatisfactory therapeutic effect.

In the FREEDOMS study, treatment with fingolimod reduced the annualized relapse rate (ARR) by 54% compared with that achieved by placebo-treated patients. Similar results were achieved in this post hoc analysis of patients with different treatment histories. Fingolimod 1.25 mg/day statistically significantly reduced ARR by 50% to 70% for patients in all DMT duration subgroups. Similarly, fingolimod 0.5 mg/day also yielded statistically significant reductions in patient ARR for treatment-naïve patients and for those who received prior treatment for 1 year to less than 3 years.

Compared with placebo, fingolimod 1.25 mg also statistically significantly reduced ARR by 52% in those patients who had discontinued treatment with a prior DMT due to adverse events. Finally, both fingolimod doses reduced ARR by more than 3-fold for MS patients who had discontinued prior DMT due to unsatisfactory therapeutic effect.

“This analysis demonstrates broad clinical efficacy of fingolimod in patients with varying prior therapy histories. Fingolimod reduced relapse rates in patients with unsatisfactory response to other DMTs and in those with long prior treatment durations, providing an alternative therapy option for these patients,” the authors concluded.

This research was supported by Novartis Pharmaceuticals Corp.