title: Relapses in patients treated with fingolimod after previous exposure to natalizumab.
abstract: In post hoc analyses of an open-label, phase 3b study (FIRST), relapse rates during 4 months of fingolimod therapy were compared in patients with and without previous natalizumab exposure. Reductions in the proportion of patients experiencing relapses and annualized relapse rates (ARRs) from years 1 and 1-2 pre-study were evident between months 1 and 2 of fingolimod treatment, and were most pronounced in natalizumab-naïve patients and those who discontinued natalizumab >6 months pre-study. Patients who discontinued natalizumab 3-6 months pre-study had a peak ARR during month 1 of fingolimod treatment, followed by a decrease during months 2-4. These data indicate that fingolimod has the potential to reduce disease reactivation but that timing of treatment initiation may be critical for achieving an optimal effect.
authors.affiliation: University Vita-Salute San Raffaele, San Raffaele Scientific Institute, Italy g.comi@hsr.it.
authors.forename: G
authors.initials: G
authors.lastname: Comi
authors.affiliation: Neurologische Klinik, Universitätsklinikum der Ruhr-Universität, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Gold
authors.affiliation: Novartis Pharma AG, Switzerland.
authors.forename: F
authors.initials: F
authors.lastname: Dahlke
authors.affiliation: Novartis Healthcare Pvt Ltd, India.
authors.forename: A
authors.initials: A
authors.lastname: Sinha
authors.affiliation: Novartis Pharma AG, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: von Rosenstiel
authors.affiliation: Novartis Pharma AG, Switzerland.
authors.forename: D
authors.initials: D
authors.lastname: Tomic
authors.affiliation: Neurology, Departments of Medicine, Clinical Research and Biomedicine, University Hospital, Switzerland.
authors.forename: L
authors.initials: L
authors.lastname: Kappos
mesh_terms: D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D000069442:Natalizumab / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors; D000069442:Natalizumab; D000068876:Fingolimod Hydrochloride
keywords: ARR; FIRST; Fingolimod; multiple sclerosis; natalizumab; relapse control