title: Half-dose fingolimod for treating relapsing-remitting multiple sclerosis: Observational study.
abstract: To investigate the efficacy and safety of fingolimod (FTY) 0.5 mg administered every other day (FTY-EOD) compared to every day (FTY-ED) in multiple sclerosis patients.
  
  
  
  Multicentre retrospective observational study. Clinical, laboratory and neuroimaging data were consecutively collected from 60 FTY-EOD and 63 FTY-ED patients. Baseline characteristics were compared using logistic regression. Efficacy in preventing occurrence of relapses and demyelinating lesions was tested using propensity score-adjusted Cox and linear regressions.
  
  
  
  Weight was inversely associated with risk of switch to FTY-EOD because of any reason (odds ratio (OR) = 0.94, 95% confidence interval (95% CI) = 0.89-0.99, p = 0.026), and female sex and lower baseline lymphocyte count were positively associated with switch because of lymphopenia. Compared to FTY-ED patients, FTY-EOD patients were at higher risk of developing relapses (hazard ratio (HR) = 2.98, 95% CI = 1.07-8.27, p  = 0.036) and either relapses or new magnetic resonance imaging (MRI) demyelinating lesions (combined outcome, HR = 2.07, 95% CI = 1.06-4.08, p  = 0.034). Within FTY-EOD, treatment with natalizumab before FTY and lower age were positively associated with risk of developing relapses and combined outcome, respectively (HR = 25.71, 95% CI = 3.03-217.57, p = 0.002 and HR = 0.85, 95% CI = 0.77-0.96, p  = 0.005). FTY-EOD was overall well tolerated.
  
  
  
  Disease reactivation was observed in a significant proportion of patients treated with FTY-EOD. Neurologists should be cautious when reducing FTY administration to every other day, especially in younger patients and those previously treated with natalizumab.
authors.affiliation: Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
authors.forename: Chiara
authors.initials: C
authors.lastname: Zecca
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Arianna
authors.initials: A
authors.lastname: Merlini
authors.affiliation: Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
authors.forename: Giulio
authors.initials: G
authors.lastname: Disanto
authors.affiliation: San Donato Hospital, Milan, Italy.
authors.forename: Mariaemma
authors.initials: M
authors.lastname: Rodegher
authors.affiliation: Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
authors.forename: Letizia
authors.initials: L
authors.lastname: Panicari
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Marzia Anita Lucia
authors.initials: MAL
authors.lastname: Romeo
authors.affiliation: Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
authors.forename: Ursula
authors.initials: U
authors.lastname: Candrian
authors.affiliation: San Donato Hospital, Milan, Italy.
authors.forename: Maria Josè
authors.initials: MJ
authors.lastname: Messina
authors.affiliation: Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Pravatà
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Moiola
authors.affiliation: Multiple Sclerosis Study Center, Gallarate Hospital, Gallarate, Italy.
authors.forename: Catia
authors.initials: C
authors.lastname: Stefanin
authors.affiliation: Multiple Sclerosis Study Center, Gallarate Hospital, Gallarate, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Ghezzi
authors.affiliation: Legnano Hospital, Legnano, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Perrone
authors.affiliation: Department of Neuroscience, University of Catania, Catania, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.affiliation: Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
authors.forename: Claudio
authors.initials: C
authors.lastname: Gobbi
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Martinelli
mesh_terms: D000328:Adult; D000367:Age Factors; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000494:pharmacology*; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D017063:Outcome Assessment, Health Care; D012008:Recurrence; D012189:Retrospective Studies
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: Demyelination; fingolimod; lymphopenia; multiple sclerosis; relapsing-remitting; treatment response