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Real-Word Effectiveness and Safety of Dimethyl Fumarate in a Multiple Sclerosis Portuguese Population

2020Journal article Open access
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dc.contributor.authorBarros, A
dc.contributor.authorSequeira, J
dc.contributor.authorSousa, A
dc.contributor.authorParra, J
dc.contributor.authorBrum, M
dc.contributor.authorPedrosa, R
dc.contributor.authorCapela, C
dc.date.accessioned2022-04-29T14:56:13Z
dc.date.available2022-04-29T14:56:13Z
dc.date.issued2020
dc.description.abstractObjectives: The aim of this study was to evaluate postmarketing dimethyl fumarate (DMF) safety and effectiveness in a real-world population with relapsing-remitting multiple sclerosis (RRMS). Methods: This was a retrospective, single-center study with RRMS patients treated with DMF. Demographic, clinical, and imagiological characteristics were analyzed, including annualized relapse rate (ARR), Expanded Disability Status Scale, "No Evidence of Disease Activity 3," previous treatment, adverse events, treatment duration, and reason for discontinuation. We investigated which baseline variables were associated with clinical and radiological outcomes. Results: We included 176 patients (70.4% females) with a median on-treatment follow-up time of 25.5 months. In total, 139 patients received prior disease-modifying therapies, and 37 were treatment-naive. Annualized relapse rate decreased by 77.1% in the total population (P < 0.001) and also decreased in the naive, tolerability switch, and efficacy switch groups by 95.8%, 56.7%, and 76.6% (P < 0.001). No Evidence of Disease Activity 3 status after 12 months of DMF treatment was maintained in 69.2% patients. Thirty patients (17%) discontinued treatment because of adverse drug reactions, and 21 (11.9%) because of lack of effectiveness. The occurrence of first relapse during follow-up was associated with higher ARR in the year before DMF start (hazard ratio, 4.833; P < 0.001) and prior exposure to multiple sclerosis treatments (tolerability and efficacy switchers). Conclusions: In this real-world audit, DMF appeared to be effective and safe for RRMS. Additionally, the study suggested that naive patients strongly benefit from DMF, and DMF also improves ARR in patients who switched from injectable therapies due to tolerability and efficacy issues.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationClin Neuropharmacol. May/Jun 2020;43(3):55-60.pt_PT
dc.identifier.doi10.1097/WNF.0000000000000391.pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/4059
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherLippincott. Williams & Wilkinspt_PT
dc.subjectCHLC NEUpt_PT
dc.subjectAdultpt_PT
dc.subjectAgedpt_PT
dc.subjectFemalept_PT
dc.subjectMalept_PT
dc.subjectHumanspt_PT
dc.subjectMiddle Agedpt_PT
dc.subjectDimethyl Fumarate / adverse effects*pt_PT
dc.subjectDimethyl Fumarate / therapeutic use*pt_PT
dc.subjectImmunosuppressive Agents / adverse effects*pt_PT
dc.subjectImmunosuppressive Agents / therapeutic use*pt_PT
dc.subjectMultiple Sclerosis, Relapsing-Remitting / drug therapy*pt_PT
dc.subjectPortugalpt_PT
dc.subjectRecurrencept_PT
dc.subjectRetrospective Studiespt_PT
dc.subjectTreatment Outcomept_PT
dc.titleReal-Word Effectiveness and Safety of Dimethyl Fumarate in a Multiple Sclerosis Portuguese Populationpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage60pt_PT
oaire.citation.startPage55pt_PT
oaire.citation.titleClinical Neuropharmacologypt_PT
oaire.citation.volume43pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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