Abstract
BackgroundFingolimod is a first in class oral compound approved for the treatment of relapsing-remitting multiple sclerosis (RR-MS). The aim of this study was to evaluate clinical and neuroradiological responses to fingolimod as well as the safety and tolerability in RR-MS patients in clinical practice. In addition, a panel of pro-inflammatory serum cytokines was explored as potential biomarker for treatment response.MethodsWe conducted a retrospective, non-randomized, open-label, observational study in 105 patients with RR-MS and measured cytokines in longitudinal serum samples.ResultsCompared to the year before fingolimod start the annualized relapse rate was reduced by 44%. Also, the percentage of patients with a worsening of the 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.ConclusionsThe efficacy in reducing relapses was comparable to that observed in the phase III trials. In our cohort fingolimod was safe and efficacious irrespective of comorbidities and previous treatment.
Highlights
Fingolimod has been approved as first oral agent for the treatment of relapsing-remitting MS (RR-MS)
Fingolimod is a first in class oral compound approved for the treatment of relapsing-remitting multiple sclerosis (RR-MS)
Addex, Allozyne, Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Biogen Idec, CLC Behring, GeNeuro SA, Genzyme, GlaxoSmithKline, Lilly, Merck Serono, Mitsubishi Pharma, Novartis, Octapharma, Ono Pharma, Praxicon, Roche, Sanofi-aventis, Santhera, Siemens, Teva, and Xenoport. He lectured at medical conferences or in public on various aspects of the diagnosis and management of multiple sclerosis
Summary
Fingolimod has been approved as first oral agent for the treatment of relapsing-remitting MS (RR-MS). It is a sphingosine 1-phosphate (S1P)-receptor modulator which binds to the S1Preceptors and induces their downregulation on the cell surface [1]. Data on disability progression favored fingolimod treated patients. These clinical results were corroborated by MRI data. Fingolimod is a first in class oral compound approved for the treatment of relapsing-remitting multiple sclerosis (RR-MS). The aim of this study was to evaluate clinical and neuroradiological responses to fingolimod as well as the safety and tolerability in RR-MS patients in clinical practice. A panel of pro-inflammatory serum cytokines was explored as potential biomarker for treatment response.
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