Multiple Sclerosis Relapses Following Cessation of Fingolimod

Charles B. Malpas, Izanne Roos, Sifat Sharmin, Katherine Buzzard, Olga Skibina, Ludwig Kappos, Francesco Patti, Raed Alroughani, Dana Horakova, Eva Kubala Havrdova, Guillermo Izquierdo, Sara Eichau, Suzanne Hodgkinson, Pierre Grammond, Jeannette Lechner-Scott, Tomas Kalincik, on behalf of the MSBase Study Group

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Background: There is growing interest in the issue of disease reactivation in multiple sclerosis following fingolimod cessation. Relatively little is known about modifiers of the risk of post-cessation relapse, including the delay to commencement of new therapy and prior disease activity. Objective: We aimed to determine the rate of relapse following cessation of fingolimod and to identify predictors of relapse following cessation. Methods: Data were extracted from the MSBase registry in March 2019. Inclusion criteria were (a) clinically definite relapsing multiple sclerosis, (b) treatment with fingolimod for ≥ 12 months, (c) follow-up after cessation for ≥ 12 months, and (d) at least one Expanded Disability Status Scale score recorded in the 12 months before cessation. Results: A total of 685 patients were identified who met criteria. The mean annualised relapse rate was 1.71 (95% CI 1.59, 1.85) in the year prior to fingolimod, 0.50 (95% CI 0.44, 0.55) on fingolimod and 0.43 (95% CI 0.38, 0.49) after fingolimod. Of these, 218 (32%) patients experienced a relapse in the first 12 months. Predictors of a higher relapse rate in the first year were: younger age at fingolimod cessation, higher relapse rate in the year prior to cessation, delaying commencement of new therapy and switching to low-efficacy therapy. Conclusions: Disease reactivation following fingolimod cessation is more common in younger patients, those with greater disease activity prior to cessation and in those who switch to a low-efficacy therapy.

Original languageEnglish
Pages (from-to)355-364
Number of pages10
JournalClinical Drug Investigation
Issue number4
Publication statusPublished - Apr 2022

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