Publication
Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC.
| dc.contributor.author | Berger, T | |
| dc.contributor.author | Brochet, B | |
| dc.contributor.author | Brambilla, L | |
| dc.contributor.author | Giacomini, PS | |
| dc.contributor.author | Montalbán, X | |
| dc.contributor.author | Salgado, Salgado, AV, e outros | |
| dc.date.accessioned | 2020-01-31T14:31:12Z | |
| dc.date.available | 2020-01-31T14:31:12Z | |
| dc.date.issued | 2019 | |
| dc.description | Ensaio clínico PROTEC, Protocolo nº 109MS408 | |
| dc.description.abstract | Abstract BACKGROUND: Patient-reported outcomes (PRO) and clinical outcomes give a broad assessment of relapsing-remitting multiple sclerosis (RRMS) disease. OBJECTIVE: The aim is to evaluate the effectiveness of delayed-release dimethyl fumarate (DMF) on disease activity and PROs in patients with RRMS in the clinic. METHODS: PROTEC, a phase 4, open-label, 12-month observational study, assessed annualized relapse rate (ARR), proportion of patients relapsed, and changes in PROs. Newly diagnosed and early MS (≤3.5 EDSS and ≤1 relapse in the prior year) patient subgroups were evaluated. RESULTS: Unadjusted ARR at 12 months post-DMF versus 12 months before DMF initiation was 75% lower (0.161 vs. 0.643, p < 0.0001) overall (n = 1105) and 84%, 77%, and 71% lower in newly diagnosed, ≤3.5 EDSS, and ≤1 relapse subgroups, respectively. Overall, 88% of patients were relapse-free 12 months after DMF initiation (84%, newly diagnosed; 88%, ≤3.5 EDSS; 88%, ≤1 relapse). PRO measures for fatigue, treatment satisfaction, daily living, and work improved significantly over 12 months of DMF versus baseline. CONCLUSION: At 12 months after versus 12 months before DMF initiation, ARR was significantly lower, the majority of patients were relapse-free, and multiple PRO measures showed improvement (overall and for subgroups), suggesting that DMF is effective based on clinical outcomes and from a patient perspective.Clinical trial: A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes (PROTEC), NCT01930708, | pt_PT |
| dc.description.version | info:eu-repo/semantics/publishedVersion | pt_PT |
| dc.identifier.citation | Mult Scler J Exp Transl Clin. 2019 Dec 2;5(4):2055217319887191. | pt_PT |
| dc.identifier.doi | 10.1177/2055217319887191 | pt_PT |
| dc.identifier.issn | 2055-2173 | |
| dc.identifier.uri | http://hdl.handle.net/10400.10/2389 | |
| dc.language.iso | eng | pt_PT |
| dc.peerreviewed | yes | pt_PT |
| dc.publisher | SAGE Publications | pt_PT |
| dc.relation.publisherversion | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6891011/pdf/10.1177_2055217319887191.pdf | pt_PT |
| dc.subject | Multiple sclerosis | pt_PT |
| dc.subject | Dimethyl fumarate | pt_PT |
| dc.subject | Activities of daily living | pt_PT |
| dc.title | Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC. | pt_PT |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.conferencePlace | Thousand Oaks, CA | pt_PT |
| oaire.citation.title | Multiple Sclerosis Journal - Experimental, Translational and Clinical | pt_PT |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | article | pt_PT |