Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis

T. Spelman, L. Mekhael, T Burke, H. Butzkueven, Suzanne J Hodgkinson, Eva Havrdova, Dana Horakova, Pierre Pascal Duquette, Guillermo Izquierdo, Francois Grand'Maison, Pierre Grammond, M. Barnett, Jeannette Lechner-Scott, Raed A Alroughani, Maria Trojano, Alessandra Lugaresi, Franco Granella, Eugenio Pucci, Steve Vucic, on behalf of the MSBase Study Group

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Background and Purpose: 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). Conclusion: 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.

Original languageEnglish
Pages (from-to)729-736
Number of pages8
JournalEuropean Journal of Neurology
Issue number4
Publication statusPublished - 1 Apr 2016
Externally publishedYes


  • Dimethyl fumarate
  • Fingolimod
  • Multiple sclerosis
  • Progression
  • Relapse
  • Teriflunomide
  • Treatment switching

Cite this

Spelman, T., Mekhael, L., Burke, T., Butzkueven, H., Hodgkinson, S. J., Havrdova, E., Horakova, D., Duquette, P. P., Izquierdo, G., Grand'Maison, F., Grammond, P., Barnett, M., Lechner-Scott, J., Alroughani, R. A., Trojano, M., Lugaresi, A., Granella, F., Pucci, E., Vucic, S., & on behalf of the MSBase Study Group (2016). Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis. European Journal of Neurology, 23(4), 729-736. https://doi.org/10.1111/ene.12929