Delayed-release Dimethyl Fumarate demonstrates sustained efficacy over nine years in newly diagnosed patients with relapsing-remitting multiple Sclerosis - 27/03/19
, Catherine Miller 6Résumé |
Introduction |
DMF demonstrated strong efficacy and a favourable benefit-risk profile in RRMS patients in Phase 3 studies (DEFINE/CONFIRM), which is sustained in the extension study, ENDORSE.
Objectives |
To evaluate efficacy in newly diagnosed patients with RRMS treated with DMF for ∼9 years.
Patients and methods |
An integrated analysis of newly diagnosed patients who continued after 2 years onto the ENDORSE study assessed annualised relapse rate (ARR) and EDSS score. Results are reported for patients treated with DMF 240mg BID: placebo (PBO)/DMF (PBO for Years 0–2/DMF for Years 3–9) or continuous (DMF/DMF) treatment.
Results |
The observed proportion of patients with EDSS≤3.5 was 129/139 (93%) and 65/72 (90%) at Year 2, and 50/54 (93%) and 26/28 (93%) at Year 9 for DMF/DMF and PBO/DMF, respectively. For PBO/DMF, adjusted ARR (95% CI) was 0.25 (0.18–0.37) for Years 0–2 (PBO) and 0,09 (0,06–0.14) for Years 3–9 (DMF).
Discussion |
NA.
Conclusion |
The majority of patients remaining on study maintained walking abilities (EDSS≤3.5) over 9 years and ARR remained low.
Le texte complet de cet article est disponible en PDF.Keywords : Efficacité à long terme, ENDORSE, Dimethyl fumarate (DMF)
Plan
Vol 175 - N° S1
P. S101 - avril 2019 Retour au numéro
Article précédent
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