Delayed-release Dimethyl Fumarate demonstrates sustained efficacy over nine years in newly diagnosed patients with relapsing-remitting multiple Sclerosis

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 240 mg 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.