803
Views
27
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

Dimethyl fumarate for treating relapsing multiple sclerosis

, MD FRCPC FACP FAAN (Emeritus Professor of Neurology) , , MD (Assistant Professor) (Fellow in Multiple Sclerosis) (Assistant Professor) (Fellow in Multiple Sclerosis) & , MD (Professor of Clinical Neurology)

Bibliography

  • Schumacher GA, Beebe G, Kibler RF, et al. Problems of experimental trials of therapy in multiple sclerosis: report by the panel on the evaluation of experimental trials of therapy in multiple sclerosis. Ann N Y Acad Sci 1965;123:552-68
  • Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med 2000;343:938-52
  • Ascherio A, Munger KL, Luenemann JD. The initiation and prevention of multiple sclerosis. Nat Rev Neurol 2012;8:202-612
  • Hauser SL, Chan JR, Oksenberg JR. Multiple sclerosis: prospects and promise. Ann Neurol 2013;74:317-27
  • The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. 1. Clinical results of a multicenter, randomized, double blind, placebo-controlled trial. Neurology 1993;43:655-61
  • Paty DW, Li DK; the UBC MS/MRI Group and the IFN Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Neurology 1993;42:662-7
  • Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39:285-94
  • Rudick RA, Goodkin DE, Jacobs LD, et al. Impact of interferon beta-1a on Neurologic disability in relapsing multiple sclerosis. Neurology 1997;49:358-63
  • Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology 1995;45:1268-76
  • Johnson KP, Brooks BR, Ford CC, et al. Sustained clinical benefits of glatiramer acetate (Copaxone) in multiple sclerosis patients observed for 6 years. Mult Scler 2000;6:255-66
  • PRISMS (Prevention of Relapses and Disability by Interferon b-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomized double-blind placebo-controlled study of interferon b-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498-504
  • Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon ß-1a treatment regimens in MS: the EVIDENCE Trial. Neurology 2002;59:1496-506
  • Immunex Corp. Briefing document on mitoxantrone (Novantrone) for treatment of multiple sclerosis: on file with the FDA. Available from: www.fda.gov/ohrms/dockets/ac/00/backbgrd/3582b1k.pdf [Accessed 30 July 2014]
  • Hartung HP, Gonsette R, Koenig N, et al. Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomized, multicenter trial. Lancet 2002;360:21018-2025
  • Polman CH, O’Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing remitting multiple sclerosis. N Engl J Med 2006;334:899-910
  • Rudick RA, Stuart WH, Calabrese PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 2006;354:911-23
  • Kappos L, Radue EW, O’Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401
  • Khatri B, Barkhof F, Comi G, et al. Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study. Lancet Neurol 2011;10:520-9
  • O’Connor PW, Li D, Freedman MS, et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology 2006;66:894-900
  • O’Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011;365(14):1293-303
  • Fox RJ, Miller DH, Phillips T, et al. Placebo-controlled Phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97
  • Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;d367:1098-107
  • Ropper AH. The “Poison Chair” treatment for multiple sclerosis. N Engl J Med 2012;367:1149-50
  • Gold R. PML with novel immunotherapies: is there light at the end of the tunnel? Mult Scler 2014;20(S1):32; PS6.abstract
  • Ermis U, Weis J, Schultz JB. PML in a patient treated with fumaric acid. N Engl J Med 2013;368:1657-8
  • Van Oosten BW, Killestein J, Barkof F, et al. PML in a patient treated with dimethyl fumarate from a compounding pharmacy. N Engl J Med 2013;368:1658-9
  • Molloy ES, Calabrese LH. Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: evolving role of biologic therapies. Arthritis Rheum 2012;64:3043-51
  • Sweeetser MT, Dawson KT, Bozic C. Manufacturer’s response to case reports of PML. N Engl J Med 2013;368:1659-61
  • Mrowietz U, Reich K. Case reports of PML in patients treated for psoriasis. N Engl J Med 2013;368:1080-1
  • Stoppe M, Thoma E, Liebert UG, et al. Cerebellar manifestations of PML under fumarate and after efalizumab treatment of psoriasis. J Neurol 2014;261(5):1021-4
  • Mohrregh-Kaiabani D, Linker RA, Gold R, Stangel M. Fumaric acid and its esters: an emerging treatment for multiple sclerosis. Curr Neuropharmacol 2009;7:60-4
  • Krebs/ Citric acid cycle. Available from: www.youtube.com/watch?v=juM2ROSLWfw [Accessed 13 September 2014] Online review
  • Ormerod AD, Mrowietz U. Fumaric acid esters, their place in the treatment of psoriasis. Br J Dermatol 2004;150:630-2
  • Schimrigk S, Brune N, Hellwig K, et al. Oral fumaric acid esters for the treatment of active multiple sclerosis: an open-label baseline-controlled pilot trial. Eur J Neurol 2006;13:604-10
  • Wierincka A, Breve J, Mercier D, et al. Detoxification enzyme inducers modify cytokine production in rat mixed glial cells. J Neuroimmunol 2005;166:132-43
  • Arnold HM, Huang C, Huang R, et al. Neuroprotective effects of BG-12 on malonate-induced striatal lesion volume in Sprague-Dawley rat brain [Poster P02-121]. Presented at American Academy of Neurology 64th Annual Meeting; 21 – 28 April 2012; New Orleans LA
  • Nguyen T, Nioi P, Pickett CB. The Nrft2-antioxidant response element signaling pathway and its activation by oxidative stress. J Biol Chem 2009;284:13291-5
  • Linker RA, Lee D-H, Ryan S, et al. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway. Brain 2011;134:678-92
  • Lee DH, Gold R, Linker RA. Mechanisms of oxidative damage in multiple sclerosis and neurodegenerative diseases: therapeutic modulation with fumaric acid esters. Int J Med Sci 2012;13(9):11783-803
  • Scannevin RH, Huang BB, Tedictty S, et al. BG-12 (Dimethyl fumarate) in neuroprotective in the murine cuprizone/rapamycin model of demyelination and neurodegeneration [Poster P05.164]. Programme of the 64th American Academy of Neurology Annual Meeting; 21 – 28 April 2012; New Orleans LA
  • Litjens NHR, Rademaker M, Ravensbergen B, et al. Monomethylfumarate affects polarization of monocyte-derived dendritic cells resulting in down-regulated Th1 lymphocyte responses. Eur J Immunol 2004;34:565-75
  • Ghoreschi K, Bruck J, Kellerer C, et al. Fumarates improve psoriasis and multiple sclerosis by inducing type II dendritic cells. J Exp Med 2011;208(11):2291-303
  • Peng H, Guerau-de-Arellano M, Mehta VB, et al. Dimethyl fumarate inhibits dendritic cell maturation via nuclear factor κB (NF-κB) and extracellular signal-regulated kinase 1 and 2 (ERK 1/2) and mitogen stress-activated kinase 1 and 2 (1/2) signaling. J Biol Chem 2012;287:28017-26
  • Schilling S, Goelz S, Linker R, et al. Fumaric acid esters are effective in chronic experimental autoimmune encephalomyelitis and suppress macrophage infiltration. Clin Exp Immunol 2006;145:101-7
  • Wilms H, Sievers J, Rickert U, et al. Dimethylfumarate inhibits microglial and astrocytic inflammation by suppressing the synthesis of nitric oxide, IL-1β TNF-α, and IL-6 in an in-vitro model of brain inflammation. J Neuroinflammation 2010;7:30
  • Schmidt MM, Dringen R. Fumaric acid diesters deprive cultured primary astrocytes rapidly of glutathione. Neurochem Int 2010;57:460-7
  • Gold R, Linker RA, Stangel M. Fumaric acid and its esters: an emerging treatment for multiple sclerosis with antioxidative mechanism of action. Clin Immunol 2010;142:44-8
  • Bacharach-Buhles M, Pawlak FM, Matthes U, et al. Fumaric acid esters (FAEs) suppress CD 15 and ODP 4-positive cells in psoriasis. Acta Derm Venereol Suppl (Stockh) 1994;186:79-82
  • Chen H, Assmann JC, Krenz A, et al. Hydroxycarboxylic acid receptor 2 mediates dimethyl fumarate’s protective effect in EAE. J Clin Invest 2014;124:2188-92
  • Biogen Idec BG-12 Investigators. Brochure: IB_V7_MS_Final_30_April_2012.pdf. Available from: www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000PharmR.pdf [Accessed 30 July 2014]
  • Ransahoff RM, Brown MA. Innate immunity in the central nervous system. J Clin Invest 2012;122:1154-71
  • Belazzi A, Nardis C, Anzivino E, et al. Human polyomavirus JC reactivation and pathogenic mechanisms of progressive multifocal leukoencephalopathy and cancer in the era of monoclonal antibody therapies. J Neurovirol 2012;18:1-11
  • Fox RJ, Miller DH, Phillips JT, et al. Clinical efficacy of BG-12 (Dimethyl fumarate) in relapsing-remitting multiple sclerosis (RRMS): an integrated analysis of the phase3 DEFINE and CONFIRM Studies [Poster 07.097]. Programme of the American Academy of Neurology Annual Meeting; 21 – 28 April 2012; New Orleans, LA; 2013
  • Kansanen E, Kuosmanen SM, Leinonen H, Levonen A-L. The Keap1-Nrf2 pathway: mechanisms of activation and dysregulation in cancer. Redox Biol 2013;1:45-9
  • Kappos L, Gold R, Miller DH, et al. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicenter, randomised, double-blind, placebo-controlled phase IIb study. Lancet 2008;372:1483-72
  • Biogen-Idec Exhibit presentation at American Academy of Neurology 66th Annual Meeting; 26 April – 3 May 2014; Philadelphia, PA
  • Kappos L, Gold R, Arnold DL, et al. Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: the DEFINE Study. Mult Scler 2014;20:240-52
  • PRISMS-4: long-term efficacy of interferon-β-1a in relapsing MS. Neurology 2001;58:1628-36
  • Mikol DD, Barkhof M, Change P, et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the Rebif vs. glatiramer acetate in relapsing MS disease [REGARD] study): a multicenter, randomised, parallel, open-label trial. Lancet Neurol 2008;7:903-14
  • O’Connor P, Filippi M, Arnason B, et al. 250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective randomised, muticentre study. Lancet Neurol 2009;8:889-97
  • Bosca I, Pascual AM, Casanova B, et al. Four new cases of therapy-related acute promyelocytic leukemia after mitoxantrone. Neurology 2008;71:457-8
  • Kiesseler BC, Jeffrey DR. Chemotherapeutics in the treatment of multiple sclerosis. Ther Adv Neurol Disord 2010;3(5):277-91
  • Clifford DB, De Luca A, Simpson DM, et al. Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases. Lancet Neurol 2010;4):438-46
  • Bloomgren G, Richman S, Hotermans C, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med 2012;366:1870-80
  • Available from: http://www.fda.gov/Drugs/DrugSafety/ucm366529.htm [Accessed 13 September 2014]
  • Putzki N, Clifford DB, Bischof D, et al. Characteristics of PML cases in multiple sclerosis patients switching to fingolimod from natalizumab. Mult Scler 2014;20(S1):43; ECTRIMS2014 Abstr.FC3

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.