Pharmacology and clinical efficacy of dimethyl fumarate (BG-12) for treatment of relapsing–remitting multiple sclerosis

References

• WeinshenkerBGThe natural history of multiple sclerosisNeurol Clin1995131191467739500
   PubMed Web of Science ®Google Scholar
• MurrayTJDiagnosis and treatment of multiple sclerosisBMJ200633252552716513709
   PubMed Web of Science ®Google Scholar
• CompstonAColesAMultiple sclerosisLancet20083721502151718970977
   PubMed Web of Science ®Google Scholar
• WeinshenkerBGBassBRiceGPThe natural history of multiple sclerosis: a geographically based study. I. Clinical course and disabilityBrain1989112Pt 11331462917275
   PubMed Web of Science ®Google Scholar
• TrojanoMPellegriniFFuianiANew natural history of interferon-beta-treated relapsing multiple sclerosisAnn Neurol200761430030617444502
   PubMed Web of Science ®Google Scholar
• BergamaschiRQuagliniSTavazziEImmunomodulatory therapies delay disease progression in multiple sclerosisMult Scler Epub May 31, 2012
   Google Scholar
• BatoulisHAddicksKKuertenSEmerging concepts in autoimmune encephalomyelitis beyond the CD4/T(H)1 paradigmAnn Anat2010192417919320692821
   PubMed Web of Science ®Google Scholar
• FrohmanEMRackeMKRaineCSMultiple sclerosis-the plaque and its pathogenesisN Engl J Med200635494295516510748
   PubMed Web of Science ®Google Scholar
• PetersonLKFujinamiRSInflammation, demyelination, neurodegeneration and neuroprotection in the pathogenesis of multiple sclerosisJ Neuroimmunol2007184374417196667
   PubMed Web of Science ®Google Scholar
• WitteMEBøLRodenburgRJEnhanced number and activity of mitochondria in multiple sclerosis lesionsJ Pathol200921919320419591199
   PubMed Web of Science ®Google Scholar
• HendriksJJAAlblasJVan der PolSMvan TolEADijkstraCDde VriesHEFlavonoids influence monocytic GTPase activity and are protective in experimental allergic encephalitisJ Exp Med20042001667167215611292
   PubMed Web of Science ®Google Scholar
• VladimirovaOO’ConnorJCahillAAlderHButunoiCKalmanBOxidative damage to DNA in plaques of MS brainsMult Scler199844134189839301
   PubMedGoogle Scholar
• MillerDHThompsonAJMorrisseySPHigh dose steroids in acute relapses of multiple sclerosis: MRI evidence for a possible mechanism of therapeutic effectJ Neurol Neurosurg Psychiatry19925564504531619410
   PubMed Web of Science ®Google Scholar
• GalloPChiusoleMSanzariMEffect of high-dose steroid therapy on T-cell subpopulations. A longitudinal study in MS patientsActa Neurol Scand1994892951018191883
   PubMed Web of Science ®Google Scholar
• GoodkinDEInterferon beta-1bLancet1994344105710607934448
   PubMed Web of Science ®Google Scholar
• SchwidSRPanitchHSFull results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a for relapsing multiple sclerosisClin Ther2007292031204818035202
   PubMed Web of Science ®Google Scholar
• JohnsonKPBrooksBRCohenJACopolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study GroupNeurology199545126812767617181
   PubMed Web of Science ®Google Scholar
• HartungHPGonsettRKönigNMitoxantrone in Multiple Sclerosis Study Group (MIMS)Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind randomized multicenter trialLancet20023602018202512504397
   PubMed Web of Science ®Google Scholar
• MartinelliVCoccoECapraRItalian Mitoxantrone GroupAcute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantroneNeurology2011771887189522076543
   PubMed Web of Science ®Google Scholar
• PolmanCHO’ConnorPWHavrdovaEAFFIRM InvestigatorsA randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosisN Engl J Med200635489991016510744
   PubMed Web of Science ®Google Scholar
• BloomgrenGRichmanSHotermansCRisk of natalizumab-associated progressive multifocal leukoencephalopathyN Engl J Med20123661870188022591293
   PubMed Web of Science ®Google Scholar
• KapposLRadueEWO’ConnorPFREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosisN Engl J Med2010362538740120089952
   PubMed Web of Science ®Google Scholar
• CohenJABarkhofFComiGTRANSFORMS Study GroupOral fingolimod or intramuscular interferon for relapsing multiple sclerosisN Engl J Med201036240241520089954
   PubMed Web of Science ®Google Scholar
• RíoJComabellaMMontalbanXPredicting responders to therapies for multiple sclerosisNat Rev Neurol2009555356019794514
   PubMed Web of Science ®Google Scholar
• SchweckendiekW[Treatment of psoriasis vulgaris]Med Monatsschr195913103104 German13643669
   PubMedGoogle Scholar
• MrowietzUChristophersEAltmeyerPTreatment of severe psoriasis with fumaric acid esters: scientific background and guidelines for therapeutic use. The German Fumaric Acid Ester Consensus ConferenceBr J Dermatol199914142442910584060
   PubMed Web of Science ®Google Scholar
• MrowietzURostami-YazdiMNeureitherMReichK[15 years of fumaderm: fumaric acid esters for the systemic treatment of moderately severe and severe psoriasis vulgaris]J Dtsch Dermatol Ges20097Suppl 2S3S16 German19522921
   PubMed Web of Science ®Google Scholar
• WerdenbergDJoshiRWolfframSMerkleHPLangguthPPresystemic metabolism and intestinal absorption of antipsoriatic fumaric acid estersBiopharm Drug Dispos20032425927312973823
   PubMed Web of Science ®Google Scholar
• LitjensNHBurggraafJvan StrijenEPharmacokinetics of oral fumarates in healthy subjectsBr J Clin Pharmacol20045842943215373936
   PubMed Web of Science ®Google Scholar
• NibberingPHThioBZomerdijkTPBezemerACBeijersbergenRLvan FurthREffects of monomethylfumarate on human granulocytesJ Invest Dermatol199310137428392528
   PubMed Web of Science ®Google Scholar
• LinkerRALeeDHRyanSFumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathwayBrain201113467869221354971
   PubMed Web of Science ®Google Scholar
• ScannevinRHChollateSJungMYFumarates promote cytoprotection of central nervous system cells against oxidative stress via the nuclear factor (erythroid-derived 2)-like 2 pathwayJ Pharmacol Exp Ther201234127428422267202
   PubMed Web of Science ®Google Scholar
• LeeDHGoldRLinkerRAMechanisms of oxidative damage in multiple sclerosis and neurodegenerative diseases: therapeutic modulation via fumaric acid estersInt J Mol Sci2012139117831180323109883
   PubMed Web of Science ®Google Scholar
• AltmeyerPHartwigRMatthesU[Efficacy and safety profile of fumaric acid esters in oral long-term therapy with severe treatment refractory psoriasis vulgaris. A study of 83 patients]Hautarzt199647190196 German8647701
   PubMed Web of Science ®Google Scholar
• TreumerFZhuKGläserRMrowietzUDimethylfumarate is a potent inducer of apoptosis in human T cellsJ Invest Dermatol20031211383138814675187
   PubMed Web of Science ®Google Scholar
• de JongRBezemerACZomerdijkTPvan de Pouw-KraanTOttenhoffTHNibberingPHSelective stimulation of T helper 2 cytokine responses by the anti-psoriasis agent monomethylfumarateEur J Immunol199626206720748814248
   PubMed Web of Science ®Google Scholar
• LitjensNHRademakerMRavensbergenBMonomethylfumarate affects polarization of monocyte-derived dendritic cells resulting in down-regulated Th1 lymphocyte responsesEur J Immunol20043456557514768062
   PubMed Web of Science ®Google Scholar
• AsadullahKSchmidHFriedrichMInfluence of monomethylfumarate on monocytic cytokine formation – explanation for adverse and therapeutic effects in psoriasis?Arch Dermatol Res19972896236309444385
   PubMed Web of Science ®Google Scholar
• VandermeerenMJanssensSBorgersMGeysenJDimethylfumarate is an inhibitor of cytokine-induced E-selectin, VCAM-1, and ICAM-1 expression in human endothelial cellsBiochem Biophys Res Commun199723419239168952
   PubMed Web of Science ®Google Scholar
• MrowietzUAsadullahKDimethylfumarate for psoriasis: more than a dietary curiosityTrends Mol Med200511434815649822
   PubMed Web of Science ®Google Scholar
• SchillingSGoelzSLinkerRLuehderFGoldRFumaric acid esters are effective in chronic experimental autoimmune encephalomyelitis and suppress macrophage infiltrationClin Exp Immunol200614510110716792679
   PubMed Web of Science ®Google Scholar
• SchimrigkSBruneNHellwigKOral fumaric acid esters for the treatment of active multiple sclerosis: an open-label, baseline-controlled pilot studyEur J Neurol20061360461016796584
   PubMed Web of Science ®Google Scholar
• KapposLGoldRMillerDHBG-12 Phase IIb Study InvestigatorsEfficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo controlled phase IIb studyLancet20083721463147218970976
   PubMed Web of Science ®Google Scholar
• MacManusDGMillerDHKapposLBG-12 reduces evolution of new enhancing lesions to T1-hypointense lesions in patients with multiple sclerosisJ Neurol201125844945520963434
   PubMed Web of Science ®Google Scholar
• GoldRKapposLArnoldDLDEFINE Study InvestigatorsPlacebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosisN Engl J Med2012367121098110722992073
   PubMed Web of Science ®Google Scholar
• FoxRJMillerDHPhillipsJTCONFIRM Study InvestigatorsPlacebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosisN Engl J Med2012367121087109722992072
   PubMed Web of Science ®Google Scholar
• HoefnagelJJThioHBWillemzeRBouwes BavinckJNLong-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasisBr J Dermatol200314936336912932244
   PubMed Web of Science ®Google Scholar
• ErmisUWeisJSchulzJBPML in a patient treated with fumaric acidN Engl J Med20133681657165823614603
   PubMed Web of Science ®Google Scholar
• van OostenBWKillesteinJBarkhofFPolmanCHWattjesMPPML in a patient treated with dimethyl fumarate from a compounding pharmacyN Engl J Med20133681658165923614604
   PubMed Web of Science ®Google Scholar
• SweetserMTDawsonKTBozicCManufacturer’s response to case reports of PMLN Engl J Med20133681659166123614605
   PubMed Web of Science ®Google Scholar
• SchwabNUlzheimerJCFoxRJFatal PML associated with efalizumab therapy: insights into integrin aLβ2 in JC virus controlNeurology20127845846722302546
   PubMed Web of Science ®Google Scholar
• PhillipsJTFoxRSelmajKSafety and tolerability of oral BG-12 (dimethyl fumarate) in relapsing–remitting multiple sclerosis (RRMS): interim results from ENDORSE Extension Study (P01.162)Neurology201380Meeting Abstracts 1P01.162
   Google Scholar
• US Food Drug AdministrationFDA approves new multiple sclerosis treatment: Tecfidera [press release]Silver Spring, MD: US Food and Drug Administration3272013 [updated March 28, 2013]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAn-nouncements/ucm345528.htmAccessed August 19, 2013
   Google Scholar
• Tecfidera [webpage on the Internet]London, UKEuropean Medicines Agency2013 [updated March 22, 2013]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002601/smops/Positive/human_smop_000498.jsp&mid=WC0b01ac058001d127Accessed August 19, 2013
   Google Scholar
• O’ConnorPJSWolinskyConfavreuxCTEMSO Trial GroupRandomized trial of oral teriflunomide for relapsing multiple sclerosisN Engl J Med2011365141293130321991951
   PubMedGoogle Scholar
• VermerschPCzlonkowskaAGrimaldiLMfor the TENERE Trial GroupTeriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trialMult Scler11212013 [Epub ahead of print]
   Google Scholar
• ComiGJefferyDKapposLALLEGRO Study GroupPlacebo-controlled trial of oral laquinimod for multiple sclerosisN Engl J Med2012366111000100922417253
   PubMed Web of Science ®Google Scholar
• VollmerTSoelberg SorensenPArnoldDon behalf of the BRAVO Study GroupA placebo-controlled and active comparator phase III trial (BRAVO) for relapsing-remitting multiple sclerosis5th Joint triennial congress of the European and Americas Committees for Treatment and Research in Multiple SclerosisAmsterdam, the NetherlandsOctober 19–22 2011
   Google Scholar