Two-year real-life efficacy, tolerability and safety of dimethyl fumarate in an Italian multicentre study.
J Neurol
; 265(8): 1850-1859, 2018 Aug.
Article
in En
| MEDLINE
| ID: mdl-29948245
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 ANDMETHODS:
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Dimethyl Fumarate
/
Immunosuppressive Agents
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Year:
2018
Type:
Article