title: Safety and tolerability of fingolimod in patients with relapsing-remitting multiple sclerosis: results of an open-label clinical trial in Italy.
abstract: The safety profile of fingolimod is well established in clinical trials and post-marketing studies. This study aimed to evaluate the safety and tolerability of fingolimod in a cohort of Italian patients with relapsing-remitting multiple sclerosis (RRMS). This is a non-comparative, open-label, multicentre, interventional study conducted in patients with RRMS with no suitable alternative treatment option. Safety and tolerability of fingolimod 0.5 mg were assessed by recording adverse events (AEs) and serious AEs (SAEs). Of the 906 patients enrolled in the study, 91 % of the patients completed the study. AEs and SAEs were reported in 35.4 and 2.9 % of the patients, respectively. Most common AEs reported were headache (4.1 %), influenza (2.1 %), lymphopenia (1.8 %), asthenia (1.8 %) and pyrexia (1.8 %). Increased alanine aminotransferase levels and hypertension were reported as AE in 1.0 and 1.4 % of the patients, respectively. Macular oedema was reported in three patients. These results emphasize the safety of fingolimod in patients representing the real-world clinical practice in the Italian population. Fingolimod was safe and well tolerated in this population, which, compared to those enrolled in pivotal trials in terms of concomitant diseases and used medications, is broader.
  
  
  BACKGROUND
  EudraCT 2011-000770-60.
authors.affiliation: Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy.|IRCCS San Martino-IST, Genova, Italy.|Center of Excellence for Biomedical Research, Genova, Italy.
authors.forename: Alice
authors.initials: A
authors.lastname: Laroni
authors.affiliation: Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Brogi
authors.affiliation: Department of Neurological Sciences, University Federico II, Naples, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Brescia Morra
authors.affiliation: Neurology Unit, S. Giuseppe Hospital, Empoli, Italy.
authors.forename: Leonello
authors.initials: L
authors.lastname: Guidi
authors.affiliation: Department of Neurology, University La Sapienza, Rome, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Pozzilli
authors.affiliation: Department of Neurology, Scientific Institute, INSPE, Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.affiliation: Department of Neuroscience, Imaging and Clinical Sciences, University G. d'Annunzio, Chieti, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lugaresi
authors.affiliation: Novartis Farma, Origgio, Varese, Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Turrini
authors.affiliation: Novartis Farma, Origgio, Varese, Italy.
authors.forename: Debora
authors.initials: D
authors.lastname: Raimondi
authors.affiliation: Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy.|IRCCS San Martino-IST, Genova, Italy.|Center of Excellence for Biomedical Research, Genova, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Uccelli
authors.affiliation: Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy. glmancardi@neurologia.unige.it.|IRCCS San Martino-IST, Genova, Italy. glmancardi@neurologia.unige.it.
authors.forename: Giovanni Luigi
authors.identifier: http://orcid.org/0000-0001-8427-118X
authors.initials: GL
authors.lastname: Mancardi
mesh_terms: D000328:Adult; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D007239:Infections / Q000139:chemically induced; D007558:Italy; D008269:Macular Edema / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: Fingolimod; Relapsing-remitting multiple sclerosis; Safety; Tolerability