Clinical effectiveness of dimethyl fumarate in multiple sclerosis patients from Argentina.

Background: We assessed the effectiveness, safety and patient-reported outcomes (PROs) of dimethyl fumarate (DMF) in real-world clinical practice in patients with multiple sclerosis (PwMS) from Argentina.
Methods: We conducted a multicenter ambispective cohort study in Argentina between September 2020 and March 2023. Changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, magnetic resonance imaging (MRI), no evidence of disease activity (NEDA), PROs (depression, anxiety, fatigue, burden of treatment and quality of life), and safety data were collected at clinical visits performed every 6 months for at least 24 months.
Results: We included 161 PwMS (64% female). DMF treatment was associated with a significant reduction in ARR from baseline after 24 months of treatment (from 0.87 to 0.23, p < 0.001). Disability progression was observed in 27.9% vs. 9.3% pre- and post-DMF, and disability improvement was found in 13% of patients from baseline to month 24. MRI activity was significantly reduced compared with baseline. Fatigue, depression, and quality of life scores were significantly improved from baseline to 24 months. Flushing was the most frequent adverse event reported in 19.2%. No significant reduction was observed in the hospitalization rate pre- and post-DMF (19.8% vs. 5.6%, p = 0.32). During follow-up, 135 (83%) patients were relapse-free, 110 (68.3%) were MRI free activity (Gad + lesion) and 108 (67%) reached NEDA.
Conclusions: DMF significantly reduced disease activity in PwMS from Argentina with a good safety profile in real-world settings. A significant impact on the quality of life during follow-up was found.
Competing Interests: Declarations Ethics approval and consent to participate This study was approved by the ethics committee of each participating center. Informed consent A written or verbal informed consent for the use of the anonymized data for research objectives was obtained from all participants before data collection. Conflict of interest Edgar Carnero Contentti has received reimbursement for developing educational presentations, educational and research grants, consultation fees and travel stipends from Bayer Pharmaceuticals Corp., Merck, Roche, Novartis, Raffo, Amgen, TEVA, Biogen, Genzyme Corp, Biosidus, AstraZeneca, LACTRIMS, Harvard Medical School (Postgraduate Medical Education), The Guthy-Jackson Charitable Foundation and The Sumaira Foundation. Ricardo Alonso has received reimbursement for research grants and travel stipends from Merck, Biogen and Genzyme. Marcos Burgos has received reimbursement for developing educational presentations, consultations fees, clinical trials fees and travel stipends from Biogen, Genzyme, Merck, Novartis, Teva, Tuteur. Liliana Patrucco has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Darío Tavolini has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Edgardo Cristiano has received reimbursement for developing educational presentations and travel/accommodations stipends from Merck-Serono Argentina, Biogen-Idec Argentina, Genzyme Argentina, Bayer Inc., Novartis Argentina and TEVA-Tuteur Argentina. Juan I. Rojas has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis, Roche and MSIF. Berenice Silva has received reimbursement for developing educational presentations, educational and research grants, consultation fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Pablo Lopez has received reimbursement for research grants and travel stipends from Merck, Biogen and Genzyme. Verónica Tkachuk has received reimbursement for developing educational presentations, consultations fees, clinical trials fees and travel stipends from Biogen, Genzyme, Merck, Novartis, Teva, Tuteur. Carolina Mainella has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen and Merck. Geraldine Luetic has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Emanuel Silva, Felisa Leguizamon, Santiago Tizio, Marina Alonso Serena has nothing disclose.
(© 2024. Fondazione Società Italiana di Neurologia.)