PMID- 29948245
OWN - NLM
STAT- MEDLINE
DCOM- 20181030
LR  - 20181114
IS  - 1432-1459 (Electronic)
IS  - 0340-5354 (Linking)
VI  - 265
IP  - 8
DP  - 2018 Aug
TI  - Two-year real-life efficacy, tolerability and safety of dimethyl fumarate in an 
      Italian multicentre study.
PG  - 1850-1859
LID - 10.1007/s00415-018-8916-6 [doi]
AB  - 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 naive 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 naive 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.
FAU - Mallucci, Giulia
AU  - Mallucci G
AUID- ORCID: 0000-0002-0031-9594
AD  - Inter-department Multiple Sclerosis Research Centre, IRCCS Mondino Mondino, 
      Pavia, Italy. giulia.mallucci@mondino.it.
FAU - Annovazzi, P
AU  - Annovazzi P
AD  - Multiple Sclerosis Study Centre, ASST Valle Olona, Gallarate, VA, Italy.
FAU - Miante, S
AU  - Miante S
AD  - Department of Neurosciences, The Multiple Sclerosis Centre, University Hospital 
      of Padova, Padua, Italy.
FAU - Torri-Clerici, V
AU  - Torri-Clerici V
AD  - Department of Neuroimmunology and Neuromuscular Diseases, Neurological Institute 
      C, Besta IRCCS Foundation, Milan, Italy.
FAU - Matta, M
AU  - Matta M
AD  - Regional Multiple Sclerosis Centre, San Luigi Gonzaga Hospital, Orbassano, TO, 
      Italy.
FAU - La Gioia, S
AU  - La Gioia S
AD  - SS Malattie Autoimmuni USC Neurologia, Azienda Ospedaliera Papa Giovanni XXIII, 
      Bergamo, Italy.
FAU - Cavarretta, R
AU  - Cavarretta R
AD  - Multiple Sclerosis Center, IRRCS Santa Maria Nascente, Fondazione Don Carlo 
      Gnocchi, Milan, Italy.
FAU - Mantero, V
AU  - Mantero V
AD  - Neurological Department, A. Manzoni Hospital, Lecco, Italy.
FAU - Costantini, G
AU  - Costantini G
AD  - Department of Neuroscience, University of Torino, Turin, Italy.
FAU - D'Ambrosio, V
AU  - D'Ambrosio V
AD  - Inter-department Multiple Sclerosis Research Centre, IRCCS Mondino Mondino, 
      Pavia, Italy.
FAU - Zaffaroni, M
AU  - Zaffaroni M
AD  - Multiple Sclerosis Study Centre, ASST Valle Olona, Gallarate, VA, Italy.
FAU - Ghezzi, A
AU  - Ghezzi A
AD  - Multiple Sclerosis Study Centre, ASST Valle Olona, Gallarate, VA, Italy.
FAU - Perini, P
AU  - Perini P
AD  - Department of Neurosciences, The Multiple Sclerosis Centre, University Hospital 
      of Padova, Padua, Italy.
FAU - Rossi, S
AU  - Rossi S
AD  - Department of Neuroimmunology and Neuromuscular Diseases, Neurological Institute 
      C, Besta IRCCS Foundation, Milan, Italy.
FAU - Bertolotto, A
AU  - Bertolotto A
AD  - Regional Multiple Sclerosis Centre, San Luigi Gonzaga Hospital, Orbassano, TO, 
      Italy.
FAU - Rottoli, M R
AU  - Rottoli MR
AD  - SS Malattie Autoimmuni USC Neurologia, Azienda Ospedaliera Papa Giovanni XXIII, 
      Bergamo, Italy.
FAU - Rovaris, M
AU  - Rovaris M
AD  - Multiple Sclerosis Center, IRRCS Santa Maria Nascente, Fondazione Don Carlo 
      Gnocchi, Milan, Italy.
FAU - Balgera, R
AU  - Balgera R
AD  - Neurological Department, A. Manzoni Hospital, Lecco, Italy.
FAU - Cavalla, P
AU  - Cavalla P
AD  - Department of Neuroscience, University of Torino, Turin, Italy.
FAU - Montomoli, C
AU  - Montomoli C
AD  - Unit of Biostatistics and Clinical Epidemiology, Department of Public Health, 
      University of Pavia, Pavia, Italy.
FAU - Bergamaschi, R
AU  - Bergamaschi R
AD  - Inter-department Multiple Sclerosis Research Centre, IRCCS Mondino Mondino, 
      Pavia, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20180614
PL  - Germany
TA  - J Neurol
JT  - Journal of neurology
JID - 0423161
RN  - 0 (Immunosuppressive Agents)
RN  - FO2303MNI2 (Dimethyl Fumarate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Dimethyl Fumarate/*adverse effects/*therapeutic use
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/*therapeutic use
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/drug therapy
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - DMF
OT  - Dimethyl fumarate
OT  - MS
OT  - Multiple sclerosis
OT  - Real-life study
OT  - Real-world study
EDAT- 2018/06/28 06:00
MHDA- 2018/10/31 06:00
CRDT- 2018/06/28 06:00
PHST- 2018/02/07 00:00 [received]
PHST- 2018/05/23 00:00 [accepted]
PHST- 2018/05/22 00:00 [revised]
PHST- 2018/06/28 06:00 [pubmed]
PHST- 2018/10/31 06:00 [medline]
PHST- 2018/06/28 06:00 [entrez]
AID - 10.1007/s00415-018-8916-6 [pii]
AID - 10.1007/s00415-018-8916-6 [doi]
PST - ppublish
SO  - J Neurol. 2018 Aug;265(8):1850-1859. doi: 10.1007/s00415-018-8916-6. Epub 2018 
      Jun 14.