010 Safety and efficacy of long-term dimethyl fumarate treatment. Issue 6 (27th May 2022) - Gold, Ralf
Abstract : Introduction: ENDORSE (NCT00835770 ) evaluated the safety and efficacy of dimethyl fumarate (DMF) treatment for ≥10 years (Y) in relapsing-remitting MS (RRMS) patients. Methods: Patients treated continuously with DMF 240 mg BID in DEFINE/CONFIRM and ENDORSE were assessed for relapse, confirmed disability progression (CDP), serious adverse events (SAEs), and patient- reported outcomes (PROs): (36-item short form health survey [SF-36]; 5-dimension QoL [EQ-5D]). Results: Of 618 patients treated for ≥10Y, 38%(192/501) were continuously-treated BID. Mean (SD) age 41.6 (8.7) Y; 68% female. Most (51%[98/192]) patients remained relapse-free or had ≤1 relapse, 73%(141/192); median time-to-first-relapse was 58 weeks. Mean baseline (SD) EDSS score was 2.24 (1.18); patients with EDSS ≤3.5: Y2 89%(164/184), Y8 80%(148/184), Y10 79%(146/184). From Y0–10, 64%(122/191) patients had no CDP. Seventy-seven (40%) patients experienced SAEs; primarily MS relapse 18%(34/192) or infections 6%(12/192). From Y0–10, serious infection incidence did not increase and SF-36 and EQ-5D remained stable. Conclusions: Patients continuously treated with DMF BID for ≥10Y had low incidence of relapses; the pro- portion of patients with EDSS ≤3.5, patients with CDP, PROs, and incidence of serious infections remained stable over 10Y reinforcing the safety and efficacy of long-term DMF treatment for RRMS patients. Support: Biogen; disclosures detailed on poster. g.giovannoni@qmul.ac.uk