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Discontinuation of teriflunomide and dimethyl fumarate in a large Italian multicentre population: a 24-month real-world experience

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Abstract

Background

Teriflunomide (TRF) and Dimethyl fumarate (DMF) are licensed drugs for relapsing-remitting Multiple Sclerosis (RRMS).

Objectives

We aimed to compare the rate and the time to discontinuation among persons with RRMS (pwRRMS), newly treated with TRF and DMF.

Materials and methods

A retrospective study on prospectively collected data was performed in nine tertiary MS centers, in Italy. The 24-month discontinuation rate in the two cohorts was the primary study outcome. We also assessed the time to discontinuation and reasons of therapy withdrawn. Discontinuation of TRF and DMF was defined as a gap of treatment ≥ 60 days.

Results

A cohort of 903 pwRRMS (316 on TRF and 587 on DMF) was analyzed. During 24 months of follow-up, pwRRMS on TRF and DMF showed similar discontinuation rates. The analysis of predictors with Cox regression model showed differences between the two groups (p for log-rank test = 0.007); male gender [HR 2.21 (1.00–4.90); p = 0.01] and the number of previous switches [HR 1.47 (1.16–1.86); p = 0.01] were associated with higher hazard of discontinuation in the DMF group.

Conclusions

In a real-world setting, pwRRMS on TRF and DMF had similar discontinuation rates over 24 months. Male pwRRMS on DMF with a previous history of therapeutic failure are at more risk of discontinuation therapy.

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Acknowledgements

Authors are grateful to Gregory Scott, PhD for language editing.

Author information

Authors and Affiliations

  1. Department “G.F. Ingrassia”, MS centre University of Catania, Catania, Italy

    E. D’Amico, A. Zanghì, M. Zappia & F. Patti

  2. Department of Economics, Business and Statistics, University of Palermo, Palermo, Italy

    M. Sciandra

  3. University of Rome “La Sapienza”-S. Andrea Hospital, Rome, Italy

    G. Borriello & C. Pozzilli

  4. Institute Foundation “G. Giglio”, Cefalù, Italy

    G. Callari

  5. University “Federico II”-I Neurologic Clinic, Naples, Italy

    A. Gallo & G. Tedeschi

  6. Policlinico “P. Giaccone”, Palermo, Italy

    G. Salemi

  7. Villa Sofia Cervello Hospital, Palermo, Italy

    S. Cottone

  8. Azienda Ospedaliera Universitaria “G. Martino”, Messina, Italy

    M. Buccafusca

  9. Azienda Ospedaliera Universitaria “Mater Domini”, Catanzaro, Italy

    P. Valentino

  10. Azienda Sanitaria Provinciale U. O. di Neurologia, Cosenza, Italy

    R. B. Bossio

  11. Institute Foundation “G. Giglio “, Cefalù, Italy

    L. M. E. Grimaldi

Authors
  1. E. D’Amico
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  2. A. Zanghì
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  3. M. Sciandra
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  4. G. Borriello
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  5. G. Callari
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  6. A. Gallo
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  7. G. Salemi
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  8. S. Cottone
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  9. M. Buccafusca
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  10. P. Valentino
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  11. R. B. Bossio
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  12. L. M. E. Grimaldi
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  13. C. Pozzilli
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  14. G. Tedeschi
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  15. M. Zappia
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  16. F. Patti
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Corresponding author

Correspondence to F. Patti.

Ethics declarations

Ethical standards

The study has been approved by the local ethics committee (Catania 1) and has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. All persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study have been omitted.

Conflicts of interest

DE received personal fees by Biogen and Sanofi. He also received travel fundings from Bayer Biogen and Merck. ZA received travel fundings from Bayer-Schering and Sanofi Genzyme outside of the submitted work. BG received personal fees by Biogen and Sanofi. She also received travel fundings from Bayer Biogen and Merck. SM has nothing to disclose. CG received personal fees by Biogen and Sanofi. She also received travel fundings from Bayer Biogen and Merck. GA received personal fees by Biogen and Sanofi. He also received travel fundings from Bayer Biogen and Merck. SG received personal fees for speaking activities by Bayer Biogen Merck Novartis and Teva. BM received personal fees by Biogen and Sanofi. She also received travel fundings from Bayer Biogen and Merck. VP received personal fees by Biogen and Sanofi, Novartis and Roche. She also received travel fundings from Bayer Biogen and Merck. BRB served on the advisory board for Almirall and received grant for congresses participation by Sanofi and Merck. DR reports no disclosures. GLME served on the advisory board for Bayer, Biogen Celgene, Merck, Novartis, Roche, Sanofi and Teva. He also received personal fees for speaking activities at congresses or sponsored symposia. PC served on the advisory board for Bayer, Biogen Celgene, Merck, Novartis, Roche, Sanofi and Teva. He also received personal fees for speaking activities at congresses or sponsored symposia. TG served on the advisory board for Bayer, Biogen Celgene, Merck, Novartis, Roche, Sanofi, Teva and Almirall. He also received personal fees for speaking activities at congresses or sponsored symposia. ZM served on the advisory board for Bayer, Biogen Celgene, Merck, Novartis, Roche, Sanofi, Teva and Almirall. He also received personal fees for speaking activities at congresses or sponsored symposia. PF served on the advisory board for Bayer, Biogen Celgene, Merck, Novartis. Roche, Sanofi, Teva and Almirall. He also received personal fees for speaking activities at congresses or sponsored symposia.

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D’Amico, E., Zanghì, A., Sciandra, M. et al. Discontinuation of teriflunomide and dimethyl fumarate in a large Italian multicentre population: a 24-month real-world experience. J Neurol 266, 411–416 (2019). https://doi.org/10.1007/s00415-018-9144-9

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  • DOI: https://doi.org/10.1007/s00415-018-9144-9

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