title: Efficacy and Safety of Fingolimod in an Unselected Patient Population.
abstract: BACKGROUND
  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. In addition, a panel of pro-inflammatory serum cytokines was explored as potential biomarker for treatment response.
  
  
  METHODS
  We conducted a retrospective, non-randomized, open-label, observational study in 105 patients with RR-MS and measured cytokines in longitudinal serum samples.
  
  
  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 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 our cohort fingolimod was safe and efficacious irrespective of comorbidities and previous treatment.
authors.affiliation: Department of Neurology, University Hospital Basel, Basel, Switzerland.|Department of Biomedicine, University Hospital Basel, Basel, Switzerland.
authors.forename: Maria
authors.initials: M
authors.lastname: Rasenack
authors.affiliation: Department of Neurology, University Hospital Basel, Basel, Switzerland.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rychen
authors.affiliation: Department of Neurology, University Hospital Basel, Basel, Switzerland.|Department of Radiology, Division of Neuroradiology, Basel, Switzerland.
authors.forename: Michaela
authors.initials: M
authors.lastname: Andelova
authors.affiliation: Department of Neurology, University Hospital Basel, Basel, Switzerland.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Naegelin
authors.affiliation: Department of Radiology, Division of Neuroradiology, Basel, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Stippich
authors.affiliation: Department of Neurology, University Hospital Basel, Basel, Switzerland.|Department of Biomedicine, University Hospital Basel, Basel, Switzerland.
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.affiliation: Department of Biomedicine, University Hospital Basel, Basel, Switzerland.
authors.forename: Raija L P
authors.initials: RL
authors.lastname: Lindberg
authors.affiliation: Department of Neurology, DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.
authors.forename: Till
authors.initials: T
authors.lastname: Sprenger
authors.affiliation: Department of Neurology, University Hospital Basel, Basel, Switzerland.|Department of Biomedicine, University Hospital Basel, Basel, Switzerland.
authors.forename: Tobias
authors.initials: T
authors.lastname: Derfuss
mesh_terms: D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D016207:Cytokines / Q000097:blood; D004417:Dyspnea / Q000209:etiology; D004487:Edema / Q000209:etiology; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy / Q000473:pathology*; D012008:Recurrence; D012189:Retrospective Studies
chemical_list: D016207:Cytokines; D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride