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.
Dimethyl fumarate
activities of daily living
multiple sclerosis
patient-reported outcome measures
quality of life
relapsing–remitting
treatment outcomes
Journal
Multiple sclerosis journal - experimental, translational and clinical
ISSN: 2055-2173
Titre abrégé: Mult Scler J Exp Transl Clin
Pays: United States
ID NLM: 101668877
Informations de publication
Date de publication:
Historique:
received:
26
04
2019
revised:
11
09
2019
accepted:
19
09
2019
entrez:
14
12
2019
pubmed:
14
12
2019
medline:
14
12
2019
Statut:
epublish
Résumé
Patient-reported outcomes (PRO) and clinical outcomes give a broad assessment of relapsing-remitting multiple sclerosis (RRMS) disease. 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. 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. Unadjusted ARR at 12 months post-DMF versus 12 months before DMF initiation was 75% lower (0.161 vs. 0.643, 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.
Sections du résumé
BACKGROUND
BACKGROUND
Patient-reported outcomes (PRO) and clinical outcomes give a broad assessment of relapsing-remitting multiple sclerosis (RRMS) disease.
OBJECTIVE
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
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
RESULTS
Unadjusted ARR at 12 months post-DMF versus 12 months before DMF initiation was 75% lower (0.161 vs. 0.643,
CONCLUSION
CONCLUSIONS
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.
Identifiants
pubmed: 31832225
doi: 10.1177/2055217319887191
pii: 10.1177_2055217319887191
pmc: PMC6891011
doi:
Banques de données
ClinicalTrials.gov
['NCT01930708']
Types de publication
Journal Article
Langues
eng
Pagination
2055217319887191Commentaires et corrections
Type : ErratumIn
Informations de copyright
© The Author(s) 2019.
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