title: Experience with fingolimod in clinical practice.
abstract: OBJECTIVE
  To report experience with fingolimod in clinical practice.
  
  
  METHODS
  Patients in an academic medical center who were prescribed fingolimod from October 2010 to August 2011 were identified through the electronic medical record and followed for 12 months after fingolimod initiation. Adverse effects (AEs), clinical measures, MRI data, and quality of life measures were assessed.
  
  
  RESULTS
  Three hundred seventeen patients started fingolimod. Eleven patients were treatment naïve (3.5%) and 76 (24.0%) had remote disease modifying therapy (DMT) use prior to fingolimod. One hundred fifty-one (47.6%) switched because of patient preference and 79 (24.9%) switched because of breakthrough disease. About 11.6% transitioned from natalizumab. Follow-up data were available for 306 patients (96.5%) with mean follow-up time 332 days. Fingolimod was discontinued in 76 of 306 patients (24.8%) at mean 248 days after fingolimod start. Discontinuation most often was due to AEs (n = 40) or breakthrough disease (n = 22). Among patients who started fingolimod with available 12 month follow-up data, 267 (87.3%) remained relapse free and 256 (83.7%) had no relapses or gadolinium enhancement. Time to first relapse occurred at mean 282 days after fingolimod initiation. Quality of life measures remained stable at follow-up.
  
  
  CONCLUSIONS
  Fingolimod was discontinued at a higher rate in clinical practice than in clinical trials. Discontinuation was primarily due to AEs or breakthrough disease. Disease activity was adequately controlled in most patients who started fingolimod. This clinical practice cohort is consistent with efficacy data from phase 3 trials and describes the most common tolerability issues in clinical practice.
authors.affiliation: 1Mellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Carrie M
authors.initials: CM
authors.lastname: Hersh
authors.forename: Claire
authors.initials: C
authors.lastname: Hara-Cleaver
authors.forename: Richard A
authors.initials: RA
authors.lastname: Rudick
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Cohen
authors.forename: Robert A
authors.initials: RA
authors.lastname: Bermel
authors.forename: Daniel
authors.initials: D
authors.lastname: Ontaneda
mesh_terms: D000328:Adult; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects* / Q000494:pharmacology*; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: clinical practice; disease activity; fingolimod; multiple sclerosis; tolerability