Two-year real-life efficacy, tolerability and safety of dimethyl fumarate in an Italian multicentre study
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Dimethyl-fumarate (DMF) demonstrated efficacy and safety in relapsing–remitting multiple sclerosis (MS) in randomized clinical trials.
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.
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%).
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.
KeywordsReal-life study Dimethyl fumarate DMF Multiple sclerosis MS Real-world study
Compliance with ethical standards
Conflicts of interest
G. Mallucci received support to travel to scientific meetings from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, and Teva; received speaker honoraria from Biogen Idec and served on the scientific advisory board for Genzyme and Merck Serono. P. Annovazzi received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Almirall, Mylan, Roche and Novartis. S.Miante received a travel grant form Biogen Idec, Novartis, Sanofi-Aventis and Teva. V. Torri-Clerici acted as an Advisory Board member of Merck Serono, Novartis and Genzyme, and received funding for travelling and honoraria for speaking or writing or consultancy from Biogen Idec, Merck, Teva, Novartis, Genzyme, and Almirall. She received support for research project by Almirall and is involved as principal investigator in clinical trials for Novartis and Merck. M. Matta has nothing to disclose. S. La Gioia received grants from Biogen for travel and congress participation. R. Cavarretta has nothing to disclose. V. Mantero has nothing to disclose. G. Costantini has nothing to disclose. V. D’Ambrosio has nothing to disclose. M. Zaffaroni received honoraria for consultancy and participation in advisory boards or travel grants from Genzyme, Biogen Idec, Merck Serono, Sanofi-Aventis, Teva, and Novartis. A. Ghezzi has served on scientific advisory boards for Merck Serono, Biogen Idec and Teva Pharmaceutical Industries Ltd; has received speaker honoraria from Merck Serono, Biogen Idec, Bayer Schering Pharma Novartis, and Serono Symposia International; served as a consultant for Novartis; and receives research support from Sanofi-Aventis, Biogen Idec and Merck Serono. P. Perini has received funding for travel and speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Aventis, and Bayer Schering Pharma and has been a consultant for Merck Serono, Biogen Idec and Teva. S. Rossi acted as an Advisory Board member of Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Genzyme, and received funding for travelling and honoraria for speaking or writing from Biogen Idec, Merck Serono, Teva, Novartis, Bayer Schering, Genzyme, Almirall. She received support for research project by Teva, Merck Serono and Bayer Schering and is involved as principal investigator in clinical trials for Teva and Roche. A. Bertolotto served on the scientific advisory boards of Almirall, Bayer, BiogenIdec, and Genzyme; received speaker honoraria from BiogenIdec, Genzyme, Novartis, and Teva; his institution has received grant support from Bayer, BiogenIdec, Merck, Novartis, Teva, the Italian Multiple Sclerosis Society, Fondazione Ricerca Biomedica ONLUS, and San Luigi ONLUS; received speaker honoraria from BiogenIdec, Genzyme, Novartis, Sanofi-Aventis, and Teva; is on the editorial board of Multiple Sclerosis International, Progress in Neuroscience, Dataset Papers in Neuroscience, Journal of Multiple Sclerosis, Neurology and Therapy, and Multiple Sclerosis and Demyelinating Disorders; and received research support from Regione Piemonte, Italian Multiple Sclerosis Society, Associazione Ricerca Biomedica ONLUS, and San Luigi ONLUS. MR Rottoli has nothing to disclose. M. Rovaris received compensation from Biogen Italy, Teva Pharmaceuticals, Novartis, and Genzyme for speaking and consultant fees. Dr. Rovaris received financial support for research activities from Teva Pharmaceuticals and Merck Serono. R. Balgera has nothing to disclose. P. Cavalla acted as an Advisory Board member of Merck Serono and Genzyme, and received funding for travelling and honoraria for speaking or consultancy from Biogen Idec, Merck Serono, Teva, Novartis, Genzyme and Almirall. She is involved as principal investigator in clinical trials for Novartis, Biogen and Genzyme. C. Montomoli received teaching grants from Biogen Idec and Merck Serono. R. Bergamaschi received research grants from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis and Teva received lecture honoraria from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva; and received support to travel to scientific meetings from Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva.
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