title: Use of fingolimod in patients with relapsing remitting multiple sclerosis in Kuwait.
abstract: BACKGROUND
  Post-marketing studies are important to confirm what was established in clinical trials, and to assess the intermediate and long-term efficacy and safety.
  
  
  OBJECTIVE
  To assess efficacy and safety of fingolimod in multiple sclerosis (MS) in Kuwait.
  
  
  METHODS
  We retrospectively evaluated MS patients using the MS registries in 3 MS clinics. Relapsing remitting MS patients according to revised 2010 McDonald criteria who had been treated with fingolimod for at least 12 months were included. Primary endpoint was proportion of relapse-free patients at last follow-up. Secondary endpoints were mean change in EDSS and proportion of patients with MRI activity (gadolinium-enhancing or new/enlarging T2 lesions).
  
  
  RESULTS
  76 patients met the inclusion criteria. Mean age and mean disease duration were 34.43 and 7.82 years respectively. Mean duration of exposure to fingolimod was 18.50 months. Proportion of relapse-free patients was 77.6% at last follow-up. Mean EDSS score significantly improved (2.93 versus 1.95; p<0.0001) while 17.1% of patients continued to have MRI activity versus 77.6% at baseline (p<0.0001). Four patients stopped fingolimod due to disease breakthrough (n=3) and lymphadenitis (n=1).
  
  
  CONCLUSIONS
  Fingolimod is safe and effective in reducing clinical and radiological disease activity in relapsing remitting MS patients. Our results are comparable to reported results of phase III studies.
authors.affiliation: Division of Neurology, Department of Medicine, Amiri Hospital, Sharq, Kuwait; Neurology Clinic, Department of Medicine, Dasman Diabetes Institute, Dasman, Kuwait. Electronic address: alroughani@gmail.com.
authors.forename: R
authors.initials: R
authors.lastname: Alroughani
authors.affiliation: Department of Neurology, Ibn Sina Hospital, Kuwait City, Kuwait; Department of Neurology & Psychiatry, Al-Minia University Hospital, Minia, Egypt.
authors.forename: S F
authors.initials: SF
authors.lastname: Ahmed
authors.affiliation: Neurology Clinic, Department of Medicine, Dasman Diabetes Institute, Dasman, Kuwait.
authors.forename: R
authors.initials: R
authors.lastname: Behbehani
authors.affiliation: Department of Neurology, Ibn Sina Hospital, Kuwait City, Kuwait; Department of Medicine, Kuwait University, Jabriya, Kuwait.
authors.forename: J
authors.initials: J
authors.lastname: Al-Hashel
mesh_terms: D000328:Adult; D001921:Brain / Q000473:pathology*; D015331:Cohort Studies; D005260:Female; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007730:Kuwait; D008279:Magnetic Resonance Imaging; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology; D011409:Propylene Glycols / Q000627:therapeutic use*; D012189:Retrospective Studies; D013110:Sphingosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine
keywords: Fingolimod; Multiple sclerosis; Outcome measures; Treatment