Observational studyJournal of neurology2020
Tolerability and safety of dimethyl fumarate in relapsing multiple sclerosis: a prospective observational multicenter study in a real-life Spanish population.
Observational study in Journal of neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
15 citing papers in PubMed, 26 citations in OpenAlex.
- A Randomised, Double-Blind Study Comparing the Gastrointestinal Tolerability of Tegomil Fumarate Versus Dimethyl Fumarate in Healthy Volunteers.Neurology and therapy · 2026Article
- Descriptive Analysis of Patients Treated with Diroximel Fumarate and Dimethyl Fumarate-A Real-Life Experience.Journal of personalized medicine · 2024Article
- Clinical effectiveness of dimethyl fumarate in multiple sclerosis patients from Argentina.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Article
- Case report: Primary cytomegalovirus infection in a patient with late onset multiple sclerosis treated with dimethyl fumarate.Frontiers in neurology · 2024Article
- Dimethyl Fumarate and Intestine: From Main Suspect to Potential Ally against Gut Disorders.International journal of molecular sciences · 2023Review
- Review
- COVID-19 in multiple sclerosis patients treated with dimethyl fumarate.Journal of neurology · 2021Article
- The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review.CNS drugs · 2021Review
- Potential risk of disease modifying therapies on neoplasm development and coadjutant factors in multiple sclerosis outpatients.Scientific reports · 2021Article
- Predictors of lymphocyte count recovery after dimethyl fumarate-induced lymphopenia in people with multiple sclerosis.Journal of neurology · 2021Article
- COVID-19 in dimethyl fumarate-treated patients with multiple sclerosis.Journal of neurology · 2021Article
- Monomethyl Fumarate (MMF, Bafiertam) for the Treatment of Relapsing Forms of Multiple Sclerosis (MS).Neurology international · 2021Review
- Effectiveness of Dimethyl Fumarate in Real-World Clinical Practice and Strategy to Minimize Adverse Effects and Use of Healthcare Resources.Patient preference and adherence · 2021Article
- Three-Year Effectiveness of Dimethyl Fumarate in Multiple Sclerosis: A Prospective Multicenter Real-World Study.CNS drugs · 2020Observational
- Effectiveness and safety of dimethyl fumarate in progressive multiple sclerosis.Multiple sclerosis journal - experimental, translational and clinicalArticle
Corrections and comments
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Authors and funding
26 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDimethyl fumarate (DMF) tolerability and safety in multiple sclerosis (MS) has been analyzed in randomized clinical trials. Real-life studies are needed to assess possible harms of this therapy in a wider MS population.
objectiveTo evaluate DMF tolerability, safety and persistence in MS in a real-world setting.
methodsWe conducted a multicenter prospective study of patients who started DMF, attended in 16 public hospitals of Spain. A specific database was elaborated to collect data on most frequent adverse events (AE). Regression models were used to analyze the effect of demographic and clinical characteristics on risk of AEs and DMF discontinuation.
resultsWe collected data of 886 patients (2681 patients/years-exposition) with median 39.5 (IQR 23, 51.5) months on DMF exposure; 25.3% were treatment naïve and 74.7% switched to DMF from other disease-modifying therapies. DMF was discontinued in 29.9% of patients, in 13.2% due to AEs and in 13.5% to inefficacy. AEs were experienced by 71.2%, being flushing the most frequent (44.1%), 5.4% developed grade III lymphopenia, without cases of grade IV. Females showed a higher risk of flushing and gastroenteric symptoms (OR 1.49, p = 0.011; OR 1.69, p = 0.001, respectively); lymphopenia was associated with older age (OR 1.04, p < 0.001), and a higher EDSS with lymphopenia (OR 1.10, p = 0.035) and DMF withdrawal (HR 1.43, p = 0.012). No safety problems were reported.
conclusionsOur findings confirm good tolerability and safety of DMF in real-world setting and suggest that women have an increased risk of AEs and higher baseline disability involves greater risk of drug discontinuation.
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