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Severe Exacerbation of Multiple Sclerosis Following Withdrawal of Fingolimod

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Abstract

Background

Fingolimod is an effective therapy for multiple sclerosis (MS). Isolated reports of very aggressive MS rebound after discontinuation of fingolimod are drawing neurologists’ attention to this potentially severe complication of the drug.

Objective

Our objective was to collect literature data on cases of MS rebound following fingolimod withdrawal. In addition, we report six new cases of this adverse event in Brazil.

Methods

We carried out a systematic review of published data on cases of MS rebound after fingolimod was discontinued. In addition, the study reports a retrospective data series of Brazilian patients presenting this rebound reaction.

Results

Twenty papers have been published reporting on 52 patients with severe MS rebound after fingolimod withdrawal. Six new patients are included in the present paper, all of them with aggressive rebound and accumulated disability sequelae.

Conclusion

We recommend gradual discontinuation of fingolimod with replacement by other treatment. The washout period should not exceed 4 weeks.

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Author information

Authors and Affiliations

  1. Universidade Metropolitana de Santos, Santos, SP, Brazil

    Yara D. Fragoso

  2. MS and Headache Research, Santos, SP, Brazil

    Yara D. Fragoso & Gleysson Rosa

  3. Hospital Sirio-Libanes de Sao Paulo, Sao Paulo, SP, Brazil

    Tarso Adoni

  4. Hospital Beneficencia Portuguesa de Sao Paulo, Sao Paulo, SP, Brazil

    Sidney Gomes

  5. Universidade da Regiao de Joinville, Joinville, SC, Brazil

    Marcus V. M. Goncalves & Laura F. Parolin

  6. Metrowest Medical Center, Framingham, MA, USA

    Gleysson Rosa

  7. Universidade Federal Fluminense, Niteroi, RJ, Brazil

    Heloisa H. Ruocco

  8. Universidade Metropolitana de Santos (UNIMES), Avenida Conselheiro Nebias 536, Santos, SP, CEP 11045-002, Brazil

    Yara D. Fragoso

Authors
  1. Yara D. Fragoso
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  2. Tarso Adoni
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  3. Sidney Gomes
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  4. Marcus V. M. Goncalves
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  5. Laura F. Parolin
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  7. Heloisa H. Ruocco
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Corresponding author

Correspondence to Yara D. Fragoso.

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Funding

This study received no public or private funding.

Conflict of interest

Yara D. Fragoso, Tarso Adoni, Sidney Gomes, Marcus V. M. Goncalves, Laura F. Parolin, Gleysson Rosa, and Heloisa H. Ruocco have no conflicts of interest to declare.

Ethical approval

All procedures in this study were in accordance with the 1964 Helsinki Declaration (and its amendments), with the approval of the Ethics Committee at Universidade Metropolitana de Santos, Santos, SP, Brazil. Patients have given written consent for publication of their clinical data and magnetic resonance images.

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Fragoso, Y.D., Adoni, T., Gomes, S. et al. Severe Exacerbation of Multiple Sclerosis Following Withdrawal of Fingolimod. Clin Drug Investig 39, 909–913 (2019). https://doi.org/10.1007/s40261-019-00804-6

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  • DOI: https://doi.org/10.1007/s40261-019-00804-6

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