Overview:

Gilenya® (fingolimod) is an oral treatment which is thought to work by retaining certain white blood cells (lymphocytes) in the lymph nodes and thus suppressing those cells from crossing the blood brain barrier. However, Gilenya’s exact mechanisms of disease progression reduction are still unknown.  Prescribed for patients with Relapsing Remitting Multiple Sclerosis Gilenya was approved by the Federal Drug Administration in 2010.  Gilenya reduces the frequency of MS relapses by preventing certain immune cells from reaching the central nervous system, where they could potentially attack myelin, the fatty substance that insulates nerves and helps them transmit impulses between the brain and the body.

The Study:

This observational non-randomized study in 105 patients with relapsing remitting multiple sclerosis (RRMS) and measured cytokines in longitudinal serum samples with the goal of measuring continued efficacy of fingolimod.

Results:

Compared to the year before fingolimod start the annualized relapse rate was reduced by 44%. Also, the percentage of patients with a worsening of the Expanded Disability Status Scale (EDSS) decreased. Accordingly, the fraction of patients with no evidence of disease activity (no relapse, stable EDSS, no new active lesions in MRI) increased from 11% to 38%. The efficacy and safety were comparable between highly active patients or patients with relevant comorbidities and our general patient population.

Conclusions:

The efficacy in reducing relapses was comparable to that observed in the phase III trials. In the cohort fingolimod was safe and efficacious irrespective of comorbidities and previous treatment.