Advances in the treatment of relapsing—remitting multiple sclerosis — critical appraisal of fingolimod

References

• AlonsoAHernánMATemporal trends in the incidence of multiple sclerosis: a systematic reviewNeurology20087112913518606967
   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
• ConfavreuxCVukusicSNatural history of multiple sclerosis: a unifying conceptBrain200612960661616415308
   PubMed Web of Science ®Google Scholar
• LassmannHBruckWLucchinettiCFThe immunopathology of multiple sclerosis: an overviewBrain Pathol20071721021817388952
   PubMed Web of Science ®Google Scholar
• FrohmanEMRackeMKRaineCSMultiple sclerosis – the plaque and its pathogenesisN Engl J Med200635494295516510748
   PubMed Web of Science ®Google Scholar
• PozzilliCSchweikertBEcariUBetaPlus Study groupSupportive strategies to improve adherence to IFN beta-1b in multiple sclerosis – results of the βPlus observational cohort studyJ Neurol Sci201130712012621636099
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration FDA approves first oral drug to reduce MS relapses [press release]Silver Spring MD, USAFDA9222010 Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226755.htmAccessed November 19, 2012
   Google Scholar
• Therapeutic Goods AdministrationAustralian Public Assessment Report for Cladribine TabletsWoden, ACT, AustraliaTGA 2011 Available from: http://www.tga.gov.au/pdf/auspar/auspar-movectro.pdfAccessed November 19, 2012
   Google Scholar
• GiovannoniGComiGCookSA placebo controlled trial of oral cladribine for relapsing multiple sclerosisN Engl J Med201036241642620089960
   PubMed Web of Science ®Google Scholar
• CookSVermerschPComiGSafety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (Cladribine Tablets Treating Multiple Sclerosis Orally) studyMult Scler20111757859321228029
   PubMed Web of Science ®Google Scholar
• LukashevMZengWRyanSActivation of Nrf 2 and modulation of disease progression in EAE models by BG00012 (dimethyl fumarate) suggests a novel mechanism of action combining anti-inflammatory and neuroprotective modalitiesMult Scler200713S149
   PubMed Web of Science ®Google Scholar
• KapposLGoldRMillerDHEfficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicenter, randomized, double-blind, placebo controlled phase IIb studyLancet20083721463147218970976
   PubMed Web of Science ®Google Scholar
• GoldRKapposLBar-OrAClinical efficacy of BG-12, an oral therapy, in relapsing–remitting multiple sclerosis: data from the phase 3 DEFINE trialMult Scler J20111795
   Google Scholar
• ArnoldDGoldRBar-OrAEfficacy on MRI endpoints of BG-12, an oral therapy, in relapsing–remitting multiple sclerosis: data from the phase 3 DEFINE trialMult Scler J201117P813
   Google Scholar
• FoxRMillerDPhillipsJTClinical efficacy of BG-12 in relapsing-remitting multiple sclerosis (RRMS): data from the phase 3 CONFIRM studyNeurology201278S01.00
   Google Scholar
• WarnkeCMeyer zu HörsteGHartungHPStüveOKieseierBCReview of teriflunomide and its potential in the treatment of multiple sclerosisNeuropsychiatr Dis Treat2009533334019557143
   PubMed Web of Science ®Google Scholar
• KornTToykaKHartungHPJungSSuppression of experimental autoimmune neuritis by leflunomideBrain20011241791180211522581
   PubMed Web of Science ®Google Scholar
• MerrilJEHanakSPuSFteriflunomide reduces behavioral, electrophysiological, and histopathological deficits in the Dark Agouti rat model of experimental autoimmune encephalomyelitisJ Neurol20092568910319169851
   PubMed Web of Science ®Google Scholar
• O’ConnorPWLiDFreedmannMSA phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapsesNeurology20066689490016567708
   PubMed Web of Science ®Google Scholar
• ConfavreuxCLiDKFreedmanMSLong-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 yearsMult Scler2012181278128922307384
   PubMed Web of Science ®Google Scholar
• O’ConnorPWolinskyJSConfavreuxCRandomized trial of oral teriflunomide for relapsing multiple sclerosisN Engl J Med20113651293130321991951
   PubMed Web of Science ®Google Scholar
• YangJSXuLYXiaoBGHedlundGLinkHLaquinimod (ABR-215062) suppresses the development of experimental autoimmune encephalomyelitis, the Th1/Th2 balance and induces the Th3 cytokine TGFβ in Lewis ratsJ Neuroimmunol20041563915465591
   PubMed Web of Science ®Google Scholar
• ComiGPulizziARovarisMEffect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb studyLancet20083712085209218572078
   PubMed Web of Science ®Google Scholar
• ComiGJefferyDKapposLPlacebo-controlled trial of oral laquinimod for multiple sclerosisN Engl J Med20123661000100922417253
   PubMed Web of Science ®Google Scholar
• VollmerTComiGSorensenPSClinical efficacy of laquinimod for the treatment of multiple sclerosis; pooled analyses from the ALLEGRO and BRAVO phase III trialsNeurology201278S01.007
   Google Scholar
• BrinkmannVFTY720 (fingolimod) in multiple sclerosis: therapeutic effects in the immune and the central nervous systemBr J Pharmacol20091581173118219814729
   PubMed Web of Science ®Google Scholar
• FosterCAHowardLMSchweitzerABrain penetration of the oral immunomodulatory drug FTY720 and its phosphorylation in the central nervous system during experimental autoimmune encepha-lomyelitis: consequences for mode of action in multiple sclerosisJ Pharmacol Exp Ther200732346947517682127
   PubMed Web of Science ®Google Scholar
• SalvadoriMBuddeKCharpentierBFTY720 versus MMF with cyclosporine in de novo renal transplantation: a 1-year, randomized controlled trial in Europe and AustralasiaAm J Transplant200662912292117061999
   PubMed Web of Science ®Google Scholar
• FujitaTInoueKYamamotoSFungal metabolites. Part 11. A potent immunosuppressive activity found in Isaria sinclairii metaboliteJ Antibiot (Tokyo)1994472082158150717
   PubMed Web of Science ®Google Scholar
• ChunJHartungH PMechanism of action of oral fingolimod (FTY720) in multiple sclerosisClin Neuropharmacol1994339110120061941
   PubMed Web of Science ®Google Scholar
• TakabeKPaughSWMilstienSSpiegelS“Inside-out” signaling of sphingosine-1-phosphate: therapeutic targetsPharmacol Rev20086018119518552276
   PubMed Web of Science ®Google Scholar
• SanchezTHlaTStructural and functional characteristics of S1P receptorsJ Cell Biochem20049291392215258915
   PubMed Web of Science ®Google Scholar
• DevKKMullershausenFMattesHBrain sphingosine-1-phosphate receptors: implication for FTY720 in the treatment of multiple sclerosisPharmacol Ther2008117779317961662
   PubMed Web of Science ®Google Scholar
• BrinkmannVSphingosine 1-phosphate receptors in health and disease: mechanistic insights from gene deletion studies and reverse pharmacologyPharmacol Ther20071158410517561264
   PubMed Web of Science ®Google Scholar
• SchwabSRCysterJGFinding a way out: lymphocyte egress from lymphoid organsNat Immunol200781295130118026082
   PubMed Web of Science ®Google Scholar
• IshiiIFukushimaNYeXChunJLysophospholipid receptors: signaling and biologyAnnu Rev Biochem20047332135415189145
   PubMed Web of Science ®Google Scholar
• OoMLThangadaSWuMTImmunosuppressive and anti-angiogenic sphingosine 1-phosphate receptor-1 agonists induce ubiquitinylation and proteasomal degradation of the receptorJ Biol Chem20072829082908917237497
   PubMed Web of Science ®Google Scholar
• KovarikJMSchmouderRBarillaDWangYKrausGMultiple-dose FTY720: tolerability, pharmacokinetics, and lymphocyte responses in healthy subjectsJ Clin Pharmacol20044453253715102874
   PubMed Web of Science ®Google Scholar
• BuddeKSchmouderRLBrunkhorstRFirst human trial of FTY720, a novel immunomodulator, in stable renal transplant patientsJ Am Soc Nephrol2002131073108311912269
   PubMed Web of Science ®Google Scholar
• KataokaHSugaharaKShimanoKFTY720, sphingosine 1-phosphate receptor modulator, ameliorates experimental autoimmune encephalomyelitis by inhibition of T cell infiltrationCell Mol Immunol2005243944816426494
   PubMed Web of Science ®Google Scholar
• FujinoMFuneshimaNKitazawaYAmelioration of experimental autoimmune encephalomyelitis in Lewis rats by FTY720 treatmentJ Pharmacol Exp Ther2003305707712649354
   PubMed Web of Science ®Google Scholar
• KapposLAntelJComiGOral fingolimod (FTY720) for relapsing multiple sclerosisN Engl J Med2006143551124114016971719
   PubMed Web of Science ®Google Scholar
• O’ConnorPComiGMontalbanXOral fingolimod (FTY720) in multiple sclerosis: two-year results of a phase II extension studyNeurology2009672737919122034
   PubMed Web of Science ®Google Scholar
• ComiGO’ConnorPMontalbanXPhase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year resultsMult Scler20101619720720028707
   PubMed Web of Science ®Google Scholar
• CohenJABarkhofFComiGOral fingolimod or intramuscular interferon for relapsing multiple sclerosisN Engl J Med201036240241520089954
   PubMed Web of Science ®Google Scholar
• KapposLRadueE WO’ConnorPA placebo-controlled trial of oral fingolimod in relapsing multiple sclerosisN Engl J Med201036238740120089952
   PubMed Web of Science ®Google Scholar
• PolmanCHReingoldSCEdanGDiagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria.”Ann Neurol20055884084616283615
   PubMed Web of Science ®Google Scholar
• KovarikJMSladeARiviereGJThe ability of atropine to prevent and reverse the negative chronotropic effect of fingolimod in healthy subjectsBr J Clin Pharmacol20086619920618507656
   PubMed Web of Science ®Google Scholar
• LeypoldtFMünchauAMoellerFBesterMGerloffCHeesenCHemorrhaging focal encephalitis under fingolimod (FTY720) treatment: a case reportNeurology200917721022102419289744
   PubMed Web of Science ®Google Scholar
• Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Conditions_imposed_on_member_states_for_safe_and_effective_use/human/002202/WC500104527.pdf
   Google Scholar
• KasperLHDue BR et ONO-4641 Study GroupA phase I study to evaluate safety, tolerability and pharmacological properties of a selective sphingosine-1-phosphate (S1P) receptor agonist ONO-4641 in patients with multiple sclerosis [poster no P991]26th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis1013–162010Gothenburg, Sweden
   Google Scholar
• ComiGKapposLPalaceJCardiac safety of fingolimod 0.5 mg during the first dose observation in 4-month, open-label, multi-center FIRST study in patients with relapsing MSNeurology201278S41.003
   Web of Science ®Google Scholar
• GeissbühlerYButzkuevenHHernández-DiazSMultinational Gilenya (fingolimod) pregnancy exposure registry in multiple sclerosis: study designNeurology201278P06.189
   Web of Science ®Google Scholar
• European Medicines AgencyEuropean Medicines Agency starts review of Gilenya (fingolimod)2012 Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/public_health_alerts/2012/01/human_pha_detail_000050.jsp&mid=WC0b01ac058001d126Accessed November 19, 2012
   Google Scholar
• European Medicines AgencyQuestions and answers on the review of Gilenya2012 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/04/WC500125689.pdfAccessed November 19, 2012
   Google Scholar