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Effects of 2-year treatment with dimethyl fumarate on cognition and functional impairment in patients with relapsing remitting multiple sclerosis

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Abstract

Background

A significant proportion of patients with multiple sclerosis (MS) show cognitive impairment.

Objective

To evaluate the effect of 2-year treatment with oral dimethyl fumarate (DMF) on cognition in relapsing remitting MS (RRMS).

Methods

In this prospective single-arm study RRMS patients treated with DMF underwent a wide battery of tests, including an extensive neuropsychological evaluation, clinical and patient-reported outcomes (PROs) and quality of life (QoL). Primary endpoints were the proportion of patients with cognitive impairment at baseline and of patients with cognitive worsening over 2 years.

Results

Overall, 217 patients (74.2% females, mean age 37.3 years) receiving DMF were recruited, and 156 (67.2%) completed the study. Of the 49 patients with cognitive impairment at baseline, 34 had 2-year data: 15 (44.1%) patients worsened and 19 (55.9%) did not. The cognitive impairment index improved in one third of patients at 2 years. Less than 20% of patients had relapses at 2 years (annualized relapse rate: 0.190). Few patients had disability progression. PROs (fatigue, depression, impairment in work/social activities), QoL, and most of neuropsychological tests significantly improved vs. baseline.

Conclusion

The 2-year treatment with DMF was associated with slowing of cognitive impairment and with significant improvements in QoL and psychosocial function.

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Acknowledgments

This study was sponsored by Biogen Italia S.R.L. (Milan, Italy). Writing and editorial support for the preparation of this manuscript was provided by Luca Cantini, M.D., professional medical writer from IQVIA.

Funding

Funding was provided by Biogen.

Author information

Authors and Affiliations

  1. Department NEUROFARBA, University of Florence, Florence, Italy

    Maria Pia Amato & Benedetta Goretti

  2. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy

    Maria Pia Amato

  3. University Federico II Napoli, Naples, Italy

    Vincenzo Brescia Morra

  4. Azienda Ospedaliera di Padova, Padua, Italy

    Paolo Gallo

  5. Centro Sclerosi Multipla, ASST della Valle Olona, Gallarate, Italy

    Mauro Zaffaroni

  6. Ospedale Policlinico Ss. Annunziata di Chieti, Chieti, Italy

    Marco Onofrj

  7. Ospedale Binaghi, Cagliari, Italy

    Eleonora Cocco

  8. Neurological Centre of Latium, Rome, Italy

    Giovanna Borriello

  9. Biogen Italy, Milan, Italy

    Valentina Zipoli

  10. Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy

    Maria Trojano

Authors
  1. Maria Pia Amato
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  2. Benedetta Goretti
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  3. Vincenzo Brescia Morra
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  4. Paolo Gallo
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  7. Eleonora Cocco
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  8. Giovanna Borriello
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  9. Valentina Zipoli
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Corresponding author

Correspondence to Maria Pia Amato.

Ethics declarations

Conflict of interest

VZ: employee of Biogen;

PT and BG: speaker honoraria from Biogen and Teva;

VBM: funding for travel and speaker honoraria and research support from Bayer Schering, Biogen, Merck Serono, and Sanofi-Genzyme;

PG: served on scientific advisory boards of Almirall, Bayer Schering, Biogen Italy, Merck Serono, Novartis, Roche, Sanofi-Aventis, and Teva; received travel funding and/or speaker honoraria from Biogen Italy, Merck Serono, Novartis, Roche, Sanofi-Aventis, and Teva;

MZ: honoraria for consultancy, lecturing, or participation in advisory boards and financial support for attending scientific meetings from Almirall, Biogen, Genzyme, Merck Serono, Novartis, and Teva;

MO, EC, and CP: scientific advisory boards for Actelion, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi, and Teva; consulting and/or speaking fees, research support, and travel grants from Allergan, Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi, and Teva;

MT: served on scientific advisory boards for Biogen, Genzyme, Novartis, and Roche; has received speaker honoraria from Almirall, Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, and Teva; and has received research grants for her institution from Biogen, Merck Serono, and Novartis;

MPA: research grants and speaker honoraria from and member of advisory boards for Biogen, Bayer, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the reference institutional research committee of each participating site and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was signed by all participants prior to any study-related procedure was started. The study protocol was approved by the reference Ethic Committee of each study site.

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Amato, M.P., Goretti, B., Brescia Morra, V. et al. Effects of 2-year treatment with dimethyl fumarate on cognition and functional impairment in patients with relapsing remitting multiple sclerosis. Neurol Sci 41, 3185–3193 (2020). https://doi.org/10.1007/s10072-020-04320-w

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  • DOI: https://doi.org/10.1007/s10072-020-04320-w

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