title: Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
abstract: OBJECTIVE
  Early relapse outcomes in long-term stable patients switching from interferon β/glatiramer acetate (IFNβ/GA) to oral therapy are unknown.
  
  
  OBJECTIVE
  The objective of this study was to compare early relapse and progression in multiple sclerosis (MS) patients switching to oral therapy following a period of stable disease on IFNβ/GA, relative to a propensity-matched comparator of patients remaining on IFNβ/GA.
  
  
  METHODS
  The MSBase cohort study is a global, longitudinal registry for MS. Time to first 6-month relapse in previously stable MS patients switching from platform injectables ('switchers') to oral agents were compared with propensity-matched patients remaining on IFNβ/GA ('stayers') using a Cox marginal model.
  
  
  RESULTS
  Three-hundred and ninety-six switchers were successfully matched to 396 stayers on a 1:1 basis. There was no difference in the proportion of patients recording at least one relapse in the first 1-6 months by treatment arm (7.3% switchers, 6.6% stayers; P = 0.675). The mean annualized relapse rate (P = 0.493) and the rate of first 6-month relapse by treatment arm (hazard ratio 1.22, 95% confidence interval 0.70, 2.11) were also comparable. There was no difference in the rate of disability progression by treatment arm (hazard ratio 1.43, 95% confidence interval 0.63, 3.26).
  
  
  CONCLUSIONS
  This is the first study to compare early relapse switch probability in the period immediately following switch to oral treatment in a population previously stable on injectable therapy. There was no evidence of disease reactivation within the first 6 months of switching to oral therapy.
authors.affiliation: Department of Neurology, Royal Melbourne Hospital, Parkville, Vic., Australia.|Department of Medicine (RMH), University of Melbourne, Parkville, Vic., Australia.
authors.forename: T
authors.initials: T
authors.lastname: Spelman
authors.affiliation: Westmead Hospital, Sydney, NSW, Australia.
authors.forename: L
authors.initials: L
authors.lastname: Mekhael
authors.affiliation: Westmead Hospital, Sydney, NSW, Australia.
authors.forename: T
authors.initials: T
authors.lastname: Burke
authors.affiliation: Department of Neurology, Royal Melbourne Hospital, Parkville, Vic., Australia.|Department of Medicine (RMH), University of Melbourne, Parkville, Vic., Australia.
authors.forename: H
authors.initials: H
authors.lastname: Butzkueven
authors.affiliation: Liverpool Hospital, Sydney, NSW, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Hodgkinson
authors.affiliation: Charles University, Prague, Czech Republic.
authors.forename: E
authors.initials: E
authors.lastname: Havrdova
authors.affiliation: Charles University, Prague, Czech Republic.
authors.forename: D
authors.initials: D
authors.lastname: Horakova
authors.affiliation: Hôpital Notre Dame, Montreal, QC, Canada.
authors.forename: P
authors.initials: P
authors.lastname: Duquette
authors.affiliation: Hospital Universitario Virgen Macarena, Sevilla, Spain.
authors.forename: G
authors.initials: G
authors.lastname: Izquierdo
authors.affiliation: Neuro Rive-Sud, Hôpital Charles LeMoyne, Quebec, QC, Canada.
authors.forename: F
authors.initials: F
authors.lastname: Grand'Maison
authors.affiliation: Center de réadaptation déficience physique Chaudière-Appalache, Levis, QC, Canada.
authors.forename: P
authors.initials: P
authors.lastname: Grammond
authors.affiliation: Brain and Mind Research Institute, Sydney, NSW, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Barnett
authors.affiliation: John Hunter Hospital, Newcastle, NSW, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Lechner-Scott
authors.affiliation: Amiri Hospital, Kuwait City, Kuwait.
authors.forename: R
authors.initials: R
authors.lastname: Alroughani
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Trojano
authors.affiliation: MS Center, Department of Neuroscience, Imaging and Clinical Sciences, University 'G. d'Annunzio', Chieti, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Lugaresi
authors.affiliation: Department of Neurosciences, University of Parma, Parma, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Granella
authors.affiliation: Neurology Unit, ASUR Marche - AV3, Macerata, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Pucci
authors.affiliation: Westmead Hospital, Sydney, NSW, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Vucic
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018450:Disease Progression; D005260:Female; D000068717:Glatiramer Acetate / Q000008:administration & dosage* / Q000494:pharmacology; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000494:pharmacology; D016899:Interferon-beta / Q000008:administration & dosage* / Q000494:pharmacology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D012008:Recurrence; D012042:Registries
chemical_list: D007155:Immunologic Factors; D000068717:Glatiramer Acetate; D016899:Interferon-beta
keywords: dimethyl fumarate; fingolimod; multiple sclerosis; progression; relapse; teriflunomide; treatment switching