Category: Professional Posters
Purpose: Multiple sclerosis is a demyelinating, degenerative and autoimmune disorder of the central nervous system. Dimethyl fumarate has emerged as an alternative for adult patients with relapsing-remitting multiple sclerosis (RRMS). Preclinical studies indicate that dimethyl fumarate pharmacodynamic responses appear to be primarily mediated through activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway. Dimethyl fumarate has been shown to up regulate Nrf2-dependent antioxidant genes in patients. The main objectives of our study is to describe the use and safety of dimethyl fumarate in a tertiary hospital.
Methods: Observational study of patients treated with dimethyl fumarate was carried out from October 2015 to June 2017 at a reference hospital in the Northwest of Spain. Data sources: electronic medical records (IANUS®) and prescription program (Silicon®). A statistical analysis was performed using the STATA® 15 software. Variables collected: sex, age, Expanded Disability Status Scale (EDSS) score, previous treatment, posology, duration of treatment, adverse events (AE) and discontinuation causes.
Results: 51 patients (78% women). Age (mean): 43.4±9.9 years old. EDSS Score (mean): 1.75±1.30. Among the included patients, 22 (39.3%) were treatment naïve, 16 (31.2%) had only received previous therapy and 13 (25.5%) received dimethyl fumarate as the third or fourth line. Regarding previous therapy, most patients had been treated with immunomodulatory drugs (6 interferon-β 1b, 13 interferon-β 1a, 6 glatiramer acetate), two patients with fingolimod and one patient with natalizumab. The change from previous therapy to dimethyl fumarate was motivated by AE (16 patients) and due to lack of efficacy (8 patients). Posology: 5/56 patients required a slower dose increase, after this period, all patient received the maintenance dose of 240mg twice a day. During the study period, 17 patients (35.7%) permanently discontinued treatment with dimethyl fumarate. In 11 cases (30.4%) the suspension was motivated by AEs (7/11 gastrointestinal disorders, 2/11 persistent lymphopenia, 1/11 headache, 1/11 recurrent urinary tract infections). 4 patients (20%) stopped treatment due to disease progression and the presence of relapses and 2 patients (20%) due to pregnancy planning.
Conclusion: Dimethyl fumarate is proposed as a safe therapy for the treatment of RRMS. Nevertheless, future studies are necessary to detect less frequent AEs, or those occurring with long-term dimethyl fumarate treatment.