Effects of 2-year treatment with dimethyl fumarate on cognition and functional impairment in patients with relapsing rem
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ORIGINAL ARTICLE
Effects of 2-year treatment with dimethyl fumarate on cognition and functional impairment in patients with relapsing remitting multiple sclerosis Maria Pia Amato 1,2 & Benedetta Goretti 1 & Vincenzo Brescia Morra 3 & Paolo Gallo 4 & Mauro Zaffaroni 5 & Marco Onofrj 6 & Eleonora Cocco 7 & Giovanna Borriello 8 & Valentina Zipoli 9 & Maria Trojano 10 Received: 23 October 2019 / Accepted: 28 February 2020 # Fondazione Società Italiana di Neurologia 2020
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. Keywords Dimethyl fumarate . Cognition . Relapsing remitting multiple sclerosis
Introduction Neuropsychological studies have documented that 40–65% of patients with multiple sclerosis (MS) show evidence of
cognitive impairment. Functions most often involved are memory, complex attention, information processing speed, and executive functions, whereas language and attention span are relatively preserved [1, 2].
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10072-020-04320-w) contains supplementary material, which is available to authorized users. * Maria Pia Amato [email protected] 1
Department NEUROFARBA, University of Florence, Florence, Italy
2
IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy
3
University Federico II Napoli, Naples, Italy
4
Azienda Ospedaliera di Padova, Padua, Italy
5
Centro Sclerosi Multipla, ASST della Valle Olona, Gallarate, Italy
6
Ospedale Policlinico Ss. Annunziata di Chieti, Chieti, Italy
7
Ospedale Binaghi, Cagliari, Italy
8
Neurological Centre of Latium, Rome, Italy
9
Biogen Italy, Milan, Italy
10
Department of Basic Medical Sciences, Neurosciences and Sense Organs, Unive
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