Maria Pia Amato1,2, Benedetta Goretti3, Vincenzo Brescia Morra4, Paolo Gallo5, Mauro Zaffaroni6, Marco Onofrj7, Eleonora Cocco8, Giovanna Borriello9, Valentina Zipoli10, Maria Trojano11. 1. Department NEUROFARBA, University of Florence, Florence, Italy. mariapia.amato@unifi.it. 2. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy. mariapia.amato@unifi.it. 3. Department NEUROFARBA, University of Florence, Florence, Italy. 4. University Federico II Napoli, Naples, Italy. 5. Azienda Ospedaliera di Padova, Padua, Italy. 6. Centro Sclerosi Multipla, ASST della Valle Olona, Gallarate, Italy. 7. Ospedale Policlinico Ss. Annunziata di Chieti, Chieti, Italy. 8. Ospedale Binaghi, Cagliari, Italy. 9. Neurological Centre of Latium, Rome, Italy. 10. Biogen Italy, Milan, Italy. 11. Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy.
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.
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.
Authors: Gavin Giovannoni; Ralf Gold; Ludwig Kappos; Douglas L Arnold; Amit Bar-Or; Jing L Marantz; Minhua Yang; Andrew Lee Journal: Mult Scler J Exp Transl Clin Date: 2016-02-19