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J Neurol. 2018 Aug;265(8):1850-1859. doi: 10.1007/s00415-018-8916-6. Epub 2018 Jun 14.

Two-year real-life efficacy, tolerability and safety of dimethyl fumarate in an Italian multicentre study.

Author information

1
Inter-department Multiple Sclerosis Research Centre, IRCCS Mondino Mondino, Pavia, Italy. giulia.mallucci@mondino.it.
2
Multiple Sclerosis Study Centre, ASST Valle Olona, Gallarate, VA, Italy.
3
Department of Neurosciences, The Multiple Sclerosis Centre, University Hospital of Padova, Padua, Italy.
4
Department of Neuroimmunology and Neuromuscular Diseases, Neurological Institute C, Besta IRCCS Foundation, Milan, Italy.
5
Regional Multiple Sclerosis Centre, San Luigi Gonzaga Hospital, Orbassano, TO, Italy.
6
SS Malattie Autoimmuni USC Neurologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
7
Multiple Sclerosis Center, IRRCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi, Milan, Italy.
8
Neurological Department, A. Manzoni Hospital, Lecco, Italy.
9
Department of Neuroscience, University of Torino, Turin, Italy.
10
Inter-department Multiple Sclerosis Research Centre, IRCCS Mondino Mondino, Pavia, Italy.
11
Unit of Biostatistics and Clinical Epidemiology, Department of Public Health, University of Pavia, Pavia, Italy.

Abstract

BACKGROUND:

Dimethyl-fumarate (DMF) demonstrated efficacy and safety in relapsing-remitting multiple sclerosis (MS) in randomized clinical trials.

OBJECTIVES:

To track and evaluate post-market DMF profile in real-world setting.

MATERIALS AND METHODS:

Patients receiving DMF referred to Italian MS centres were enrolled and prospectively followed, collecting demographic clinical and radiological data.

RESULTS:

Among the 735 included patients, 45.4% were naïve to disease-modifying therapies, 17.8% switched to DMF because of tolerance, 27.4% switched to DMF because of lack of efficacy, and 9.4% switched to DMF because of safety concerns. Median DMF exposure was 17 months (0-33). DMF reduced the annual relapse rate (ARR) by 63.2%. At 12 and 24 months, 85 and 76% of patients were relapse-free. NEDA-3 status after 12 months of DMF treatment was maintained by 47.5% of patients. 89 and 70% of patients at 12 and 24 months regularly continued DMF. Most frequent adverse events (AEs) were flushing (37.2%) and gastro-enteric AEs (31.1%).

CONCLUSION:

Our post-market study corroborated that DMF is a safe and effective drug. Additionally, the study suggested that naïve patients strongly benefit from DMF and that DMF improved ARR also in patients who were horizontally switched from injectable therapies due to tolerability and efficacy issues.

KEYWORDS:

DMF; Dimethyl fumarate; MS; Multiple sclerosis; Real-life study; Real-world study

PMID:
29948245
DOI:
10.1007/s00415-018-8916-6
[Indexed for MEDLINE]

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