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Review

Spotlight on sirukumab for the treatment of rheumatoid arthritis: the evidence to date

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Pages 3083-3098 | Published online: 26 Sep 2016

References

  • ScottDLWolfeFHuizingaTWRheumatoid arthritisLancet201037697461094110820870100
  • CrossMSmithEHoyDThe global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 studyAnn Rheum Dis20147371316132224550173
  • GabrielSECardiovascular morbidity and mortality in rheumatoid arthritisAm J Med200812110 Suppl 1S9S1418926169
  • LazzeriniPECapecchiPLLaghi-PasiniFSystemic inflammation and arrhythmic risk: lessons from rheumatoid arthritisEur Heart J2016 pii: ehw208. Epub June 1, 2016
  • BrennanFMMcInnesIBEvidence that cytokines play a role in rheumatoid arthritisJ Clin Invest2008118113537354518982160
  • ShettyAHansonRKorstenPTocilizumab in the treatment of rheumatoid arthritis and beyondDrug Des Devel Ther20148349364
  • ReichertJMAntibodies to watch in 2016MAbs20168219720426651519
  • MiharaMHashizumeMYoshidaHSuzukiMShiinaMIL-6/IL-6 receptor system and its role in physiological and pathological conditionsClin Sci (Lond)2012122414315922029668
  • TanakaTKishimotoTThe biology and medical implications of interleukin-6Cancer Immunol Res20142428829424764575
  • LazzeriniPECapperucciCSpreaficoARosuvastatin inhibits spontaneous and IL-1β-induced interleukin-6 production from human cultured osteoblastic cellsJoint Bone Spine201380219520022999910
  • van AkenBEJansenJvan DeventerSJReitsmaPHElevated levels of homocysteine increase IL-6 production in monocytic Mono Mac 6 cellsBlood Coagul Fibrinolysis200011215916410759009
  • LazzeriniPESelviELorenziniSHomocysteine enhances cytokine production in cultured synoviocytes from rheumatoid arthritis patientsClin Exp Rheumatol200624438739316956428
  • InoueKHosoiJDendaMExtracellular ATP has stimulatory effects on the expression and release of IL-6 via purinergic receptors in normal human epidermal keratinocytesJ Invest Dermatol2007127236237116946718
  • CaporaliFCapecchiPLGamberucciAHuman rheumatoid synoviocytes express functional P2X7 receptorsJ Mol Med200886893794918545980
  • AnceyCCorbiPFrogerJSecretion of IL-6, IL-11 and LIF by human cardiomyocytes in primary cultureCytokine200218419920512126642
  • HouTTieuBCRaySRoles of IL-6-gp130 signaling in vascular inflammationCurr Cardiol Rev20084317919219936194
  • TraperoICauliOInterleukin 6 and cognitive dysfunctionMetab Brain Dis201429359360824782046
  • FonsecaJESantosMJCanhãoHChoyEInterleukin-6 as a key player in systemic inflammation and joint destructionAutoimmun Rev20098753854219189867
  • FebbraioMAPedersenBKMuscle-derived interleukin-6: mechanisms for activation and possible biological rolesFASEB J200216111335134712205025
  • SchellerJChalarisASchmidt-ArrasDRose-JohnSThe pro- and anti-inflammatory properties of the cytokine interleukin-6Biochim Biophys Acta20111813587888821296109
  • WolfJRose-JohnSGarbersCInterleukin-6 and its receptors: a highly regulated and dynamic systemCytokine2014701112024986424
  • BoulangerMJChowDCBrevnovaEEGarciaKCHexameric structure and assembly of the interleukin-6/IL-6 alpha-receptor/gp130 complexScience200330056282101210412829785
  • YoshidaYTanakaTInterleukin 6 and rheumatoid arthritisBiomed Res Int20142014 article 698313
  • ContiBTabareanIAndreiCBartfaiTCytokines and feverFront Biosci200491433144914977558
  • OnishiKZandstraPWLIF signaling in stem cells and developmentDevelopment2015142132230223626130754
  • GlundSKrookARole of interleukin-6 signalling in glucose and lipid metabolismActa Physiol200819213748
  • FranchimontNWertzSMalaiseMInterleukin-6: an osteotropic factor influencing bone formation?Bone200537560160616112634
  • SimsNAWalshNCGP130 cytokines and bone remodelling in health and diseaseBMB Rep201043851352320797312
  • Schmidt-ArrasDRose-JohnSIL-6 pathway in the liver: from physiopathology to therapyJ Hepatol20166461403141526867490
  • RothaugMBecker-PaulyCRose-JohnSThe role of interleukin-6 signaling in nervous tissueBiochim Biophys Acta201618636 Pt A1218122727016501
  • SpoorenAKolmusKLaureysGInterleukin-6, a mental cytokineBrain Res Rev2011671–215718321238488
  • EdwardsCJWilliamsEThe role of interleukin-6 in rheumatoid arthritis-associated osteoporosisOsteoporos Int20102181287129320229200
  • HashizumeMMiharaMThe roles of interleukin-6 in the pathogenesis of rheumatoid arthritisArthritis2011201176562422046525
  • HoussiauFADevogelaerJPVan DammeJde DeuxchaisnesCNVan SnickJInterleukin-6 in synovial fluid and serum of patients with rheumatoid arthritis and other inflammatory arthritidesArthritis Rheum19883167847883260102
  • MadhokRCrillyAWatsonJCapellHASerum interleukin 6 levels in rheumatoid arthritis: correlations with clinical and laboratory indices of disease activityAnn Rheum Dis19935232322348484679
  • BailletAGossecLPaternotteSEvaluation of serum interleukin-6 level as a surrogate marker of synovial inflammation and as a factor of structural progression in early rheumatoid arthritis: results from a French national multicenter cohortArthritis Care Res2015677905912
  • GottenbergJEDayerJMLukasCSerum IL-6 and IL-21 are associated with markers of B cell activation and structural progression in early rheumatoid arthritis: results from the ESPOIR cohortAnn Rheum Dis20127171243124822532637
  • AlonziTFattoriELazzaroDInterleukin 6 is required for the development of collagen-induced arthritisJ Exp Med199818744614689463396
  • OhshimaSSaekiYMimaTInterleukin 6 plays a key role in the development of antigen-induced arthritisProc Natl Acad Sci U S A19989514822282269653168
  • PatelAMMorelandLWInterleukin-6 inhibition for treatment of rheumatoid arthritis: a review of tocilizumab therapyDrug Des Devel Ther20104263278
  • HashizumeMTanSLTakanoJTocilizumab, a humanized anti-IL-6R antibody, as an emerging therapeutic option for rheumatoid arthritis: molecular and cellular mechanistic insightsInt Rev Immunol201534326527925099958
  • GugginoGGiardinaARRaimondoSTargeting IL-6 signalling in early rheumatoid arthritis is followed by Th1 and Th17 suppression and Th2 expansionClin Exp Rheumatol2014321778124429356
  • ThiolatASemeranoLPersYMInterleukin-6 receptor blockade enhances CD39+ regulatory T cell development in rheumatoid arthritis and in experimental arthritisArthritis Rheumatol201466227328324504799
  • CarboneGWilsonADiehlSABunnJCooperSMRinconMInterleukin-6 receptor blockade selectively reduces IL-21 production by CD4 T cells and IgG4 autoantibodies in rheumatoid arthritisInt J Biol Sci20139327928823493630
  • IannoneFTampoiaMGianniniMChanges in anti-cyclic citrullinated peptide antibodies and rheumatoid factor isotypes serum levels in patients with rheumatoid arthritis following treatment with different biological drugsClin Exp Rheumatol201634342442926885600
  • MiharaMMoriyaYKishimotoTOhsugiYInterleukin-6 (IL-6) induces the proliferation of synovial fibroblastic cells in the presence of soluble IL-6 receptorBr J Rheumatol19953443213257788145
  • NakaharaHSongJSugimotoMAnti-interleukin-6 receptor antibody therapy reduces vascular endothelial growth factor production in rheumatoid arthritisArthritis Rheum20034861521152912794819
  • AidaYHondaKTanigawaSIL-6 and soluble IL-6 receptor stimulate the production of MMPs and their inhibitors via JAK-STAT and ERK-MAPK signalling in human chondrocytesCell Biol Int201236436737622087578
  • HashizumeMHayakawaNMiharaMIL-6 trans-signalling directly induces RANKL on fibroblast-like synovial cells and is involved in RANKL induction by TNF-alpha and IL-17Rheumatology (oxford)200847111635164018786965
  • MorelandLWCurtisJRSystemic nonarticular manifestations of rheumatoid arthritis: focus on inflammatory mechanismsSemin Arthritis Rheum200939213214319022481
  • GanzTHepcidin and iron regulation, 10 years laterBlood2011117174425443321346250
  • IsaacsJDHarariOKoboldULeeJSBernasconiCEffect of tocilizumab on haematological markers implicates interleukin-6 signalling in the anaemia of rheumatoid arthritisArthritis Res Ther2013156R20424295403
  • BoekholdtSMStroesESThe interleukin-6 pathway and atherosclerosisLancet201237998221176117822421338
  • KlevelandOKunsztGBratlieMEffect of a single dose of the interleukin-6 receptor antagonist tocilizumab on inflammation and troponin T release in patients with non-ST-elevation myocardial infarction: a double-blind, randomized, placebo-controlled phase 2 trialEur Heart J pii:ehw171. Epub582016
  • ChenDYChenYMHsiehTYHsiehCWLinCCLanJLSignificant effects of biologic therapy on lipid profiles and insulin resistance in patients with rheumatoid arthritisArthritis Res Ther2015175225889426
  • ProtogerouADZampeliEFragiadakiKStamatelopoulosKPapamichaelCSfikakisPPA pilot study of endothelial dysfunction and aortic stiffness after interleukin-6 receptor inhibition in rheumatoid arthritisAtherosclerosis2011219273473621968316
  • McInnesIBThompsonLGilesJTEffect of interleukin-6 receptor blockade on surrogates of vascular risk in rheumatoid arthritis: MEASURE, a randomised, placebo-controlled studyAnn Rheum Dis201574469470224368514
  • MakrilakisKFragiadakiKSmithJSfikakisPPKitasGDInterrelated reduction of chemerin and plasminogen activator inhibitor-1 serum levels in rheumatoid arthritis after interleukin-6 receptor blockadeClin Rheumatol201534341942724912961
  • OrmsethMJYanceyPGSolusJFEffect of drug therapy on net cholesterol efflux capacity of HDL-enriched serum in rheumatoid arthritisArthritis Rheumatol10.1002/art.39675 Epub3182016
  • LazzeriniPECapecchiPLAcampaMGaleazziMLaghi-PasiniFArrhythmic risk in rheumatoid arthritis: the driving role of systemic inflammationAutoimmun Rev201413993694424874445
  • LazzeriniPECapecchiPLLaghi-PasiniFLong QT syndrome: an emerging role for inflammation and immunityFront Cardiovasc Med201522610.3389/fcvm.2015.0002626798623
  • HagiwaraYMiyoshiSFukudaKSHP2-mediated signaling cascade through gp130 is essential for LIF-dependent I CaL, [Ca2+]i transient, and APD increase in cardiomyocytesJ Mol Cell Cardiol200743671071617961593
  • MitrokhinVMMladenovMIKamkinAGEffects of interleukin-6 on the bio-electric activity of rat atrial tissue under normal conditions and during gradual stretchingImmunobiology201522091107111226009487
  • AdlanAMPanoulasVFSmithJPFisherJPKitasGDAssociation between corrected QT interval and inflammatory cytokines in rheumatoid arthritisJ Rheumatol201542342142825593223
  • LazzeriniPEAcampaMCapecchiPLAntiarrhythmic potential of anti-cytokine therapy in rheumatoid arthritis: tocilizumab reduces QTc interval by controlling systemic inflammationArthritis Care Res (Hoboken)201567333233925186226
  • MackeyRHKullerLHDeaneKDRheumatoid arthritis, anti-cyclic citrullinated peptide positivity, and cardiovascular disease risk in the women’s health initiativeArthritis Rheumatol20156792311232225988241
  • XuZBouman-ThioEComisarCPharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human studyBr J Clin Pharmacol201172227028121392075
  • ZhuangYXuZde VriesDEPharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjectsInt J Clin Pharmacol Ther201351318719923357841
  • ZhuangYde VriesDEXuZEvaluation of disease-mediated therapeutic protein-drug interactions between an anti-interleukin-6 monoclonal antibody (sirukumab) and cytochrome P450 activities in a phase 1 study in patients with rheumatoid arthritis using a cocktail approachJ Clin Pharmacol201555121386139426054042
  • SmolenJSWeinblattMEShengSZhuangYHsuBSirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapyAnn Rheum Dis20147391616162524699939
  • Janssen Research & DevelopmentA study of CNTO 136 (sirukumab), administered subcutaneously, in patients with active rheumatoid arthritis despite disease-modifying antirheumatic drug (DMARD) therapy (SIRROUND-D) Available from: https://clinicaltrials.gov/ct2/show/NCT01604343?term=NCT01604343&rank=1. NLM identifier: NCT01604343Accessed August 9, 2016
  • AkeuchiTThorneCKarpouzasGEfficacy and safety of sirukimab in patients with active rheumatoid arthritis despite disease-modifying anti-rheumatic drug treatment: results of a randomized, doubled-blind, placebo-controlled studyEULARLondon, UK2016 Abstract SAT0145
  • Janssen Research & DevelopmentA study comparing sirukumab (CNTO 136) monotherapy with adalimumab (HUMIRA®) monotherapy in the treatment of active rheumatoid arthritis (SIRROUND-H) Available from: https://clinicaltrials.gov/ct2/show/NCT02019472?term=NCT02019472&rank=1. NLM identifier: NCT01604343Accessed August 9, 2016
  • Janssen Research & DevelopmentA study of CNTO 136 (sirukumab), a human anti-IL-6 monoclonal antibody, administered subcutaneously, in patients with active rheumatoid arthritis despite anti-TNF-alpha therapy (SIRROUND-T) Available from: https://clinicaltrials.gov/ct2/show/NCT01606761?term=NCT01606761&rank=1. NLM identifier: NCT01606761Accessed August 9, 2016
  • Janssen Research & DevelopmentA study of CNTO 136 (sirukumab) administered subcutaneously in Japanese patients with active rheumatoid arthritis unresponsive to methotrexate or sulfasalazine Available from: https://clinicaltrials.gov/ct2/show/NCT01689532?term=NCT01689532&rank=1. NLM identifier: NCT01689532Accessed August 9, 2016
  • Janssen Research & DevelopmentLong-term safety and efficacy of sirukumab in participants With RA completing studies CNTO136ARA3002 or CNTO136ARA3003 (SIRROUND-LTE) Available from: https://clinicaltrials.gov/ct2/show/NCT01856309?term=NCT01856309&rank=1. NLM identifier: NCT01856309Accessed August 9, 2016
  • TanakaYMartin MolaEIL-6 targeting compared to TNF targeting in rheumatoid arthritis: studies of olokizumab, sarilumab and sirukumabAnn Rheum Dis20147391595159724833786
  • KitaniAHaraMHiroseTAutostimulatory effects of IL-6 on excessive B cell differentiation in patients with systemic lupus erythematosus: analysis of IL-6 production and IL-6R expressionClin Exp Immunol199288175831563109
  • Linker-IsraeliMDeansRJWallaceDJPrehnJOzeri-ChenTKlinenbergJRElevated levels of endogenous IL-6 in systemic lupus erythematosus. A putative role in pathogenesisJ Immunol199114711171232051017
  • LiangBGardnerDBGriswoldDEBugelskiPJSongXYAnti-interleukin-6 monoclonal antibody inhibits autoimmune responses in a murine model of systemic lupus erythematosusImmunology2006119329630517067309
  • IwanoMDohiKHirataEUrinary levels of IL-6 in patients with active lupus nephritisClin Nephrol199340116218358870
  • SzepietowskiJCNilganuwongSWozniackaAPhase I, randomized, double-blind, placebo-controlled, multiple intravenous, dose-ascending study of sirukumab in cutaneous or systemic lupus erythematosusArthritis Rheum201365102661267123896980
  • RovinBvan VollenhovenRAranowCA multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of treatment with sirukumab (CNTO 136) in patients with active lupus nephritisArthritis Rheumatol10.1002/art.39722 Epub4252016
  • GuillevinLRégentATreating giant-cell arteritis: is IL-6 the cytokine to target?Lancet2016387100311882188327203632
  • GlaxoSmithKlineEfficacy and safety study of sirukumab in patients with giant cell arteritis Available from: https://clinicaltrials.gov/ct2/show/NCT02531633?term=NCT02531633&rank=1. NLM identifier: NCT02531633Accessed Aug 9, 2016
  • DowlatiYHerrmannNSwardfagerWA meta-analysis of cytokines in major depressionBiol Psychiatry201067544645720015486
  • HsuBWangDSunYChenGImprovement in measures of depressed mood and anhedonia, and fatigue, in a randomized, placebo-controlled, phase 2 study of sirukumab, a human anti-interleukin-6 antibody, in patients with rheumatoid arthritisAnn Rheum Dis201574Suppl 272072110.1136/annrheumdis-2015-eular.4081
  • Janssen Research & DevelopmentAn efficacy and safety study of sirukumab in participants with major depressive disorder Available from: https://clinicaltrials.gov/ct2/show/NCT02473289?term=NCT02473289&rank=1. NLM identifier: NCT02473289Accessed Aug 9, 2016
  • FeaverRColladoSHoangSThe anti-IL-6 antibody sirukumab inhibits vascular inflammation in a human surrogate model of atherosclerosis2014 ACR/ARHP Annual Meeting Abstract number: 439. Available from: http://acrabstracts.org/abstract/the-anti-il-6-antibody-sirukumab-inhibits-vascular-inflammation-in-a-human-surrogate-model-of-atherosclerosis/Accessed Aug 9, 2016
  • FeaverRColladoSHoangSNeutralization of IL6 by sirukumab (SIR) inhibits inflammation and cellular stress in a human vascular surrogate system of atherosclerosisAnn Rheum Dis20157444444510.1136/annrheumdis-2015-eular.513224297380