title: Fingolimod Prescribed for the Treatment of Multiple Sclerosis in Patients Younger Than Age 18 Years.
abstract: BACKGROUND
  There have been no clinical trials for approval of medications for treating multiple sclerosis in patients younger than age 18 years. All treatments are based on personal experience and data from open observational studies. Fingolimod is an oral drug for multiple sclerosis that has been shown to be efficient and safe in adults. The aim of our study is to describe patients with multiple sclerosis who started treatment with fingolimod before the age of 18 years.
  
  
  METHODS
  Seventeen patients treated with fingolimod were identified in the Brazilian database of children and adolescents with multiple sclerosis. The average time of use of the drug was 8.6 months.
  
  
  RESULTS
  Fingolimod showed a good safety and efficacy profile in these patients, all of whom had very active multiple sclerosis. After starting treatment with fingolimod, only one patient had a relapse and a new lesion on magnetic resonance imaging. The patients' degree of disability did not progress. No major adverse events were reported in relation to the first dose of the drug, nor in the short- and medium-term treatment. No patient has been followed for longer than 18 months, thus limiting long-term conclusions.
  
  
  CONCLUSIONS
  Off-label use of fingolimod in patients younger than age 18 years may be a good therapeutic option for multiple sclerosis control.
authors.affiliation: Department of Neurology and MS Unit, Universidade Metropolitana de Santos, Santos, SP, Brazil. Electronic address: yara@bsnet.com.br.
authors.forename: Yara Dadalti
authors.initials: YD
authors.lastname: Fragoso
authors.affiliation: Department of Neurology and MS Unit, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Department of Neurology and MS Unit, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
authors.forename: Soniza Vieira
authors.initials: SV
authors.lastname: Alves-Leon
authors.affiliation: Department of Neurology and MS Unit, Universidade de Sao Paulo, Ribeirao Preto, SP, Brazil.
authors.forename: Amilton Antunes
authors.initials: AA
authors.lastname: Barreira
authors.affiliation: Department of Neurology and MS Unit, Hospital das Clinicas, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Dagoberto
authors.initials: D
authors.lastname: Callegaro
authors.affiliation: Department of Neurology and MS Unit, Hospital da Restauracao de Recife, Recife, PE, Brazil.
authors.forename: Maria Lucia
authors.initials: ML
authors.lastname: Brito Ferreira
authors.affiliation: Department of Neurology and MS Unit, Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Finkelsztejn
authors.affiliation: Department of Neurology and MS Unit, Hospital Beneficencia Portuguesa and Hospital Paulistano, Sao Paulo, SP, Brazil.
authors.forename: Sidney
authors.initials: S
authors.lastname: Gomes
authors.affiliation: Department of Neurology and MS Unit, Hospital Regional Hans Dieter Schimidt, Joinville, SC, Brazil.
authors.forename: Marcus Vinicius
authors.initials: MV
authors.lastname: Magno Goncalves
authors.affiliation: Department of Neurology and MS Unit, Hospital da Restauracao de Recife, Recife, PE, Brazil.
authors.forename: Maria Iris
authors.initials: MI
authors.lastname: Moraes Machado
authors.affiliation: Department of Neurology and MS Unit, Universidade de Sao Paulo, Ribeirao Preto, SP, Brazil.
authors.forename: Vanessa Daccach
authors.initials: VD
authors.lastname: Marques
authors.affiliation: Department of Neurology and MS Unit, Universidade Federal Fluminense, Niteroi, RJ, Brazil.
authors.forename: Andre Palma
authors.initials: AP
authors.lastname: Cunha Matta
authors.affiliation: Department of Neurology and MS Unit, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
authors.forename: Regina Maria
authors.initials: RM
authors.lastname: Papais-Alvarenga
authors.affiliation: Department of Neurology and MS Unit, Hospital das Clinicas, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
authors.forename: Samira Luisa
authors.initials: SL
authors.lastname: Apostolos Pereira
authors.affiliation: Department of Neurology and MS Unit, Hospital de Base do Distrito Federal, Brasilia, DF, Brazil.
authors.forename: Carlos Bernardo
authors.initials: CB
authors.lastname: Tauil
mesh_terms: D000293:Adolescent; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D004185:Disability Evaluation; D011307:Drug Prescriptions; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy*
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: adolescents; children; fingolimod; multiple sclerosis