| Title |
Safety and Efficacy of Dimethyl Fumarate in Multiple Sclerosis: An Italian, Multicenter, Real-World Study
|
|---|---|
| Published in |
CNS Drugs, July 2018
|
| DOI | 10.1007/s40263-018-0543-3 |
| Pubmed ID | |
| Authors |
Massimiliano Mirabella, Luca Prosperini, Matteo Lucchini, Laura Boffa, Giovanna Borriello, Maria Chiara Buscarinu, Diego Centonze, Antonio Cortese, Chiara De Fino, Laura De Giglio, Giorgia Elia, Roberta Fantozzi, Elisabetta Ferraro, Ada Francia, Simona Galgani, Claudio Gasperini, Shalom Haggiag, Doriana Landi, Girolama Alessandra Marfia, Enrico Millefiorini, Fabrizia Monteleone, Viviana Nociti, Marco Salvetti, Eleonora Sgarlata, Carlo Pozzilli |
| Abstract |
Two phase III trials have demonstrated the clinical and radiological efficacy of delayed-release dimethyl fumarate (DMF) in relapsing-remitting multiple sclerosis (RRMS). However, data on its safety and effectiveness in real-world practice are still limited. The aim of our study was to explore the safety and tolerability profile of DMF in RRMS. We also tried to identify individual variables associated with better clinical and radiological outcomes. We collected the clinical and magnetic resonance imaging (MRI) data of patients with RRMS who started DMF between 2012 and 2017 in seven MS clinics in central Italy. We first evaluated DMF discontinuation rates and the incidence of adverse events and side effects. We then assessed the annualized relapse rate (ARR), the number of patients with clinical relapses or disability worsening and the presence of radiological activity. Third, we investigated which baseline variables were associated with clinical and radiological outcomes. We collected data for 1089 patients with a mean on-treatment follow-up of 17 ± 8 months; 331 (30.4%) of these patients were treatment naïve. In total, 210 (19.5%) patients discontinued DMF mainly because of poor tolerability (n = 103) and disease activity (n = 63), and 166 (16.5%) patients presented with lymphopenia. The ARR reduced from 0.55 to 0.13. Mean change in Expanded Disability Status Scale (EDSS) score was 0.08 ± 0.44 per year. The occurrence of clinical and/or radiological activity during follow-up was associated with younger age [hazard ratio (HR) 0.97; p < 0.001], higher EDSS score (HR 1.18; p < 0.001), greater number of Gd-enhancing lesions at baseline scan (HR 1.14; p = 0.003) and prior exposure to MS treatments (HR 1.43; p = 0.02). This post-marketing data confirms the short-term safety, tolerability and effectiveness of DMF, supporting its use as an early treatment in MS. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Spain | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 58 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 58 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 8 | 14% |
| Student > Bachelor | 7 | 12% |
| Other | 5 | 9% |
| Researcher | 3 | 5% |
| Student > Postgraduate | 3 | 5% |
| Other | 10 | 17% |
| Unknown | 22 | 38% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 17 | 29% |
| Neuroscience | 6 | 10% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 5% |
| Agricultural and Biological Sciences | 2 | 3% |
| Nursing and Health Professions | 1 | 2% |
| Other | 3 | 5% |
| Unknown | 26 | 45% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 20 July 2018.
All research outputs
#20,527,576
of 23,096,849 outputs
Outputs from CNS Drugs
#1,239
of 1,317 outputs
Outputs of similar age
#287,707
of 329,171 outputs
Outputs of similar age from CNS Drugs
#25
of 26 outputs
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