title: Teriflunomide reduces relapse-related neurological sequelae, hospitalizations and steroid use.
abstract: Multiple sclerosis (MS) relapses impose a substantial clinical and economic burden. Teriflunomide is a new oral disease-modifying therapy approved for the treatment of relapsing MS. We evaluated the effects of teriflunomide treatment on relapse-related neurological sequelae and healthcare resource use in a post hoc analysis of the Phase III TEMSO study. Confirmed relapses associated with neurological sequelae [defined by an increase in Expanded Disability Status Scale/Functional System (sequelae-EDSS/FS) ≥ 30 days post relapse or by the investigator (sequelae-investigator)] were analyzed in the modified intention-to-treat population (n = 1086). Relapses requiring hospitalization or intravenous (IV) corticosteroids, all hospitalizations, emergency medical facility visits (EMFV), and hospitalized nights for relapse were also assessed. Annualized rates were derived using a Poisson model with treatment, baseline EDSS strata, and region as covariates. Risks of sequelae and hospitalization per relapse were calculated as percentages and groups were compared with a χ(2) test. Compared with placebo, teriflunomide reduced annualized rates of relapses with sequelae-EDSS/FS [7 mg by 32 % (p = 0.0019); 14 mg by 36 % (p = 0.0011)] and sequelae-investigator [25 % (p = 0.071); 53 % (p < 0.0001)], relapses leading to hospitalization [36 % (p = 0.015); 59 % (p < 0.0001)], and relapses requiring IV corticosteroids [29 % (p = 0.001); 34 % (p = 0.0003)]. Teriflunomide-treated patients spent fewer nights in hospital for relapse (p < 0.01). Teriflunomide 14 mg also decreased annualized rates of all hospitalizations (p = 0.01) and EMFV (p = 0.004). The impact of teriflunomide on relapse-related neurological sequelae and relapses requiring healthcare resources may translate into reduced healthcare costs.
authors.affiliation: St Michael's Hospital, University of Toronto, Toronto, ON, Canada, OCONNORP@smh.ca.
authors.forename: Paul W
authors.initials: PW
authors.lastname: O'Connor
authors.forename: Fred D
authors.initials: FD
authors.lastname: Lublin
authors.forename: Jerry S
authors.initials: JS
authors.lastname: Wolinsky
authors.forename: Christian
authors.initials: C
authors.lastname: Confavreux
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Mark S
authors.initials: MS
authors.lastname: Freedman
authors.forename: Tomas P
authors.initials: TP
authors.lastname: Olsson
authors.forename: Aaron E
authors.initials: AE
authors.lastname: Miller
authors.forename: Catherine
authors.initials: C
authors.lastname: Dive-Pouletty
authors.forename: Gaëlle
authors.initials: G
authors.lastname: Bégo-Le-Bagousse
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
mesh_terms: D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003437:Crotonates / Q000008:administration & dosage*; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D006885:Hydroxybutyrates; D008137:Longitudinal Studies; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000503:physiopathology* / Q000517:prevention & control*; D009570:Nitriles; D014052:Toluidines / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D003437:Crotonates; D006885:Hydroxybutyrates; D009570:Nitriles; D014052:Toluidines; C527525:teriflunomide