Recently published findings from the ENDORSE study provide 5 years of randomized safety and efficacy data for two doses of dimethyl fumarate (DMF) in multiple sclerosis. The report complements results from the pivotal CONFIRM and DEFINE trials; however, postmarketing data from clinical practice is needed to complete the risk–benefit profile of DMF.
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Gold, R. et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N. Engl. J. Med. 367, 1098–1107 (2012).
Fox, R. J. et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N. Engl. J. Med. 367, 1087–1097 (2012).
Ralf Gold, Douglas, L. Arnold, Amit Bar-Or et al. Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE, a randomized extension study. Mult. Scler. http://dx.doi.org/10.1177/1352458516649037 (2016).
Tecfidera® Package Insert [online] (Biogen Idec, 2015).
[no authors listed.] TECFIDERA: summary of product characteristics. European Medicines Agency http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002601/WC500162069.pdf.
Nast, A. et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris--Update 2015--Short version--EDF in cooperation with EADV and IPC. J. Eur. Acad. Dermatol. Venereol. 29, 2277–2294 (2015).
Brennan, M. S. et al. Dimethyl fumarate and monoethyl fumarate exhibit differential effects on KEAP1, NRF2 activation, and glutathione depletion in vitro. 10, e0120254 PLoS ONE (2015).
Bartsch, T. et al. Progressive neurologic dysfunction in a psoriasis patient treated with dimethyl fumarate. Ann. Neurol. 78, 501–514 (2015).
Khatri, B. O. et al. The effect of dimethyl fumarate (Tecfidera) on lymphocyte counts: a potential contributor to progressive multifocal leukoencephalopathy risk. Mult. Scler. Relat. Disord. 4, 377–379 (2015).
Rosenkranz, T., Novas, M. & Terborg, C. PML in a patient with lymphocytopenia treated with dimethyl fumarate. N. Engl. J. Med. 372, 1476–1478 (2015).
J.S.-G. has received compensation for consulting services and speaking honoraria from Biogen-Idec, Merck-Serono, Novartis and Teva. M.T. has received compensation for consulting services and speaking honoraria from Almirall, Bayer-Schering, Biogen-Idec, Genzyme, Merck-Serono, Novartis, Roche, Sanofi and Teva.
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Tintoré, M., Sastre-Garriga, J. Dimethyl fumarate is coming of age. Nat Rev Neurol 12, 436–437 (2016). https://doi.org/10.1038/nrneurol.2016.106
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