Effect of delayed-release dimethyl fumarate on no evidence of disease activity in relapsing-remitting multiple sclerosis: integrated analysis of the phase III DEFINE and CONFIRM studies
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie
PubMed
28328179
PubMed Central
PMC5413827
DOI
10.1111/ene.13272
Knihovny.cz E-zdroje
- Klíčová slova
- clinical relapse, dimethyl fumarate, disability progression, disease monitoring, magnetic resonance imaging, no evidence of disease activity, relapsing-remitting multiple sclerosis,
- MeSH
- dimethyl fumarát aplikace a dávkování farmakologie MeSH
- dospělí MeSH
- glatiramer acetát aplikace a dávkování farmakologie MeSH
- imunosupresiva aplikace a dávkování farmakologie MeSH
- léky s prodlouženým účinkem MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonanční tomografie metody MeSH
- progrese nemoci * MeSH
- recidiva MeSH
- relabující-remitující roztroušená skleróza diagnostické zobrazování farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- dimethyl fumarát MeSH
- glatiramer acetát MeSH
- imunosupresiva MeSH
- léky s prodlouženým účinkem MeSH
BACKGROUND AND PURPOSE: Significant effects on clinical/neuroradiological disease activity have been reported in patients with relapsing-remitting multiple sclerosis treated with delayed-release dimethyl fumarate (DMF) in phase III DEFINE/CONFIRM trials. We conducted a post hoc analysis of integrated data from DEFINE/CONFIRM to evaluate the effect of DMF on achieving no evidence of disease activity (NEDA) in patients with relapsing-remitting multiple sclerosis. METHODS: The analysis included patients randomized to DMF 240 mg twice daily, placebo or glatiramer acetate (CONFIRM only) for ≤2 years. A time-to-event method was used to estimate the percentage of patients achieving NEDA. Clinical NEDA (no relapses/no 12-week confirmed disability progression) was analysed in the intention-to-treat (ITT) population. Neuroradiological (no new/newly enlarging T2 hyperintense lesions/no gadolinium-enhancing lesions) and overall NEDA (clinical and neuroradiological NEDA) were analysed in the magnetic resonance imaging (MRI) cohort. RESULTS: The ITT and MRI populations comprised 1540 and 692 patients, respectively. The percentage of patients with clinical NEDA (ITT population) and neuroradiological NEDA (MRI cohort) was higher with DMF versus placebo over 2 years [clinical NEDA: 38.9% relative reduction; hazard ratio (HR), 0.61; 95% confidence interval (CI), 0.52-0.72; P < 0.0001; neuroradiological NEDA: 40.0% relative reduction; HR, 0.60; 95% CI, 0.49-0.73; P < 0.0001]. The percentage of patients achieving overall NEDA (MRI cohort) was also higher with DMF (26%) versus placebo (12%) over 2 years, with a relative risk reduction of 42.7% (HR, 0.57; 95% CI, 0.48-0.69; P < 0.0001). CONCLUSIONS: A significantly higher percentage of patients treated with DMF achieved NEDA status over 2 years compared with placebo.
Department of Neurology 1st Faculty of Medicine Charles University Prague Czech Republic
Mellen Center for Multiple Sclerosis Treatment and Research Cleveland Clinic Cleveland OH USA
Multiple Sclerosis Program Baylor Institute for Immunology Research Dallas TX USA
Neurologic Clinic and Policlinic University Hospital Basel Switzerland
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