Sarilumab: patient-reported outcomes in rheumatoid arthritis

References

• GibofskyAOverview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritisAm J Manag Care20121813 SupplS295S30223327517
   PubMedGoogle Scholar
• McInnesIBSchettGThe pathogenesis of rheumatoid arthritisN Engl J Med2011365232205221922150039
   PubMed Web of Science ®Google Scholar
• SmolenJSAletahaDMcInnesIBRheumatoid arthritisLancet2016388100552023203827156434
   PubMed Web of Science ®Google Scholar
• SinghJASaagKGBridgesSLJr2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritisArthritis Rheumatol2016681126
   PubMed Web of Science ®Google Scholar
• DougadosMSoubrierMAntunezAPrevalence of comorbidities in rheumatoid arthritis and evaluation of their monitoring: results of an international, cross-sectional study (COMORA)Ann Rheum Dis2014731626824095940
   PubMed Web of Science ®Google Scholar
• SturgeonJAFinanPHZautraAJAffective disturbance in rheumatoid arthritis: psychological and disease-related pathwaysNat Rev Rheumatol201612953254227411910
   PubMed Web of Science ®Google Scholar
• MichelsenBKristianslundEKSextonJDo depression and anxiety reduce the likelihood of remission in rheumatoid arthritis and psoriatic arthritis? Data from the prospective multicentre NOR-DMARD studyAnn Rheum Dis201776111906191028733473
   PubMed Web of Science ®Google Scholar
• BoerACHuizingaTWJvan der Helm-van MilAHDepression and anxiety associate with less remission after 1 year in rheumatoid arthritisAnn Rheum Dis Epub201818
   Google Scholar
• MatchamFNortonSScottDLSteerSHotopfMSymptoms of depression and anxiety predict treatment response and long-term physical health outcomes in rheumatoid arthritis: secondary analysis of a randomized controlled trialRheumatology201655226827826350486
   PubMed Web of Science ®Google Scholar
• RathbunAMReedGWHarroldLRThe temporal relationship between depression and rheumatoid arthritis disease activity, treatment persistence and response: a systematic reviewRheumatology201352101785179423236191
   PubMed Web of Science ®Google Scholar
• ChoyEUnderstanding the dynamics: pathways involved in the pathogenesis of rheumatoid arthritisRheumatology201251Suppl 5v3v1122718924
   PubMed Web of Science ®Google Scholar
• DesgeorgesAGabayCSilacciPConcentrations and origins of soluble interleukin 6 receptor-alpha in serum and synovial fluidJ Rheumatol1997248151015169263143
   PubMed Web of Science ®Google Scholar
• DasguptaBCorkillMKirkhamBGibsonTPanayiGSerial estimation of interleukin 6 as a measure of systemic disease in rheumatoid arthritisJ Rheumatol199219122251556695
   PubMed Web of Science ®Google Scholar
• KishimotoTInterleukin-6: from basic science to medicine – 40 years in immunologyAnnu Rev Immunol20052312115771564
   PubMed Web of Science ®Google Scholar
• MadhokRCrillyAWatsonJCapellHASerum interleukin 6 levels in rheumatoid arthritis: correlations with clinical and laboratory indices of disease activityAnn Rheum Dis19935232322348484679
   PubMed Web of Science ®Google Scholar
• HunterCAJonesSACorrigendum: IL-6 as a keystone cytokine in health and diseaseNat Immunol201718111271
   Web of Science ®Google Scholar
• SmolenJSBeaulieuARubbert-RothAEffect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trialLancet2008371961798799718358926
   PubMed Web of Science ®Google Scholar
• BurmesterGRFeistEKellnerHBraunJIking-KonertCRubbert-RothAEffectiveness and safety of the interleukin 6-receptor antagonist tocilizumab after 4 and 24 weeks in patients with active rheumatoid arthritis: the first phase IIIB real-life study (TAMARA)Ann Rheum Dis201170575575921187298
   PubMed Web of Science ®Google Scholar
• RaimondoMGBiggioggeroMCrottiCBeccioliniAFavalliEGProfile of sarilumab and its potential in the treatment of rheumatoid arthritisDrug Des Devel Ther20171115931603
   PubMed Web of Science ®Google Scholar
• HuizingaTWFleischmannRMJassonMSarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trialAnn Rheum Dis20147391626163424297381
   PubMed Web of Science ®Google Scholar
• GenoveseMCFleischmannRKivitzAJSarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III studyArthritis Rheumatol20156761424143725733246
   PubMed Web of Science ®Google Scholar
• FleischmannRvan AdelsbergJLinYSarilumab and nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis and inadequate response or intolerance to tumor necrosis factor inhibitorsArthritis Rheumatol201769227729027860410
   PubMed Web of Science ®Google Scholar
• BurmesterGRLinYPatelREfficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trialAnn Rheum Dis201776584084727856432
   PubMed Web of Science ®Google Scholar
• PincusTYaziciYBergmanMJRAPID3, an index to assess and monitor patients with rheumatoid arthritis, without formal joint counts: similar results to DAS28 and CDAI in clinical trials and clinical careRheum Dis Clin North Am200935477377819962621
   PubMed Web of Science ®Google Scholar
• KirwanJRBoonenAHarrisonMJOMERACT 10 Patient Perspective Virtual Campus – Valuing Health: measuring outcomes in rheumatoid arthritis fatigue, RA sleep, arthroplasty, and systemic sclerosis; and clinical significance of changes in healthJ Rheumatol20113881728173421807793
   PubMed Web of Science ®Google Scholar
• BartonJLImbodenJGrafJGliddenDYelinEHSchillingerDPatient-physician discordance in assessments of global disease severity in rheumatoid arthritisArthritis Care Res (Hoboken)201062685786420535797
   PubMed Web of Science ®Google Scholar
• GossecLDougadosMRinchevalNElaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiativeAnn Rheum Dis200968111680168519054825
   PubMed Web of Science ®Google Scholar
• van TuylLHHewlettSSadlonovaMThe patient perspective on remission in rheumatoid arthritis: ‘You’ve got limits, but you’re back to being you again’Ann Rheum Dis20157461004101024521737
   PubMed Web of Science ®Google Scholar
• BartlettSJHewlettSBinghamCOIdentifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensusAnn Rheum Dis201271111855186022772326
   PubMed Web of Science ®Google Scholar
• BaloghEDiasJOrrCComparison of remission criteria in a tumour necrosis factor inhibitor treated rheumatoid arthritis longitudinal cohort: patient global health is a confounderArthritis Res Ther2013156R22124365061
   PubMed Web of Science ®Google Scholar
• AndersonJCaplanLYazdanyJRheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practiceArthritis Care Res (Hoboken)201264564064722473918
   PubMed Web of Science ®Google Scholar
• StofferMASmolenJSWoolfADevelopment of patient-centred standards of care for osteoarthritis in Europe: the eumusc.net-projectAnn Rheum Dis20157461145114925416720
   PubMed Web of Science ®Google Scholar
• SmolenJSLandewéRBijlsmaJEULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 updateAnn Rheum Dis201776696097728264816
   PubMed Web of Science ®Google Scholar
• KilicLErdenABinghamCOGossecLKalyoncuUThe reporting of patient-reported outcomes in studies of patients with rheumatoid arthritis: a systematic review of 250 articlesJ Rheumatol20164371300130527084908
   PubMed Web of Science ®Google Scholar
• KalyoncuUDougadosMDauresJPGossecLReporting of patient-reported outcomes in recent trials in rheumatoid arthritis: a systematic literature reviewAnn Rheum Dis200968218319018375533
   PubMed Web of Science ®Google Scholar
• GossecLPaternotteSAanerudGJFinalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiativeAnn Rheum Dis201170693594221540201
   PubMed Web of Science ®Google Scholar
• StrandVWrightGCBergmanMJTambiahJTaylorPCPatient expectations and perceptions of goal-setting strategies for disease management in rheumatoid arthritisJ Rheumatol201542112046205426233504
   PubMed Web of Science ®Google Scholar
• BoersMKirwanJRWellsGDeveloping core outcome measurement sets for clinical trials: OMERACT Filter 2.0J Clin Epidemiol201467774575324582946
   PubMed Web of Science ®Google Scholar
• TugwellPWellsGStrandVClinical improvement as reflected in measures of function and health-related quality of life following treatment with leflunomide compared with methotrexate in patients with rheumatoid arthritis: sensitivity and relative efficiency to detect a treatment effect in a twelve-month, placebo-controlled trialArthritis Rheum200043350651410728742
   PubMed Web of Science ®Google Scholar
• WellsGLiTMaxwellLMacleanRTugwellPResponsiveness of patient reported outcomes including fatigue, sleep quality, activity limitation, and quality of life following treatment with abatacept for rheumatoid arthritisAnn Rheum Dis200867226026517846044
   PubMed Web of Science ®Google Scholar
• GossecLDougadosMDixonWPatient-reported outcomes as end points in clinical trials in rheumatoid arthritisRMD Open201511e00001926509052
   PubMed Web of Science ®Google Scholar
• BrundageMBlazebyJRevickiDPatient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standardsQual Life Res20132261161117522987144
   PubMed Web of Science ®Google Scholar
• FelsonDTSmolenJSWellsGAmerican College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trialsAnn Rheum Dis201170340441321292833
   PubMed Web of Science ®Google Scholar
• CouryFRossatATebibARheumatoid arthritis and fibromyalgia: a frequent unrelated association complicating disease managementJ Rheumatol2009361586219132794
   PubMed Web of Science ®Google Scholar
• FonsecaJESantosMJCanhãoHChoyEInterleukin-6 as a key player in systemic inflammation and joint destructionAutoimmun Rev20098753854219189867
   PubMed Web of Science ®Google Scholar
• SongSNTomosugiNKawabataHIshikawaTNishikawaTYoshizakiKDown-regulation of hepcidin resulting from long-term treatment with an anti-IL-6 receptor antibody (tocilizumab) improves anemia of inflammation in multicentric Castleman diseaseBlood2010116183627363420644113
   PubMed Web of Science ®Google Scholar
• GossecLSteinbergGRouanetSCombeBFatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue – the French multicentre prospective PEPS studyClin Exp Rheumatol201533566467026344671
   PubMed Web of Science ®Google Scholar
• FèveBBastardJPThe role of interleukins in insulin resistance and type 2 diabetes mellitusNat Rev Endocrinol20095630531119399017
   PubMed Web of Science ®Google Scholar
• DaneshJKaptogeSMannAGLong-term interleukin-6 levels and subsequent risk of coronary heart disease: two new prospective studies and a systematic reviewPLoS Med200854e7818399716
   PubMed Web of Science ®Google Scholar
• Abdel MeguidMHHamadYHSwilamRSBarakatMSRelation of interleukin-6 in rheumatoid arthritis patients to systemic bone loss and structural bone damageRheumatol Int201333369770322531887
   PubMed Web of Science ®Google Scholar
• Rose-JohnSIL-6 trans-signaling via the soluble IL-6 receptor: importance for the pro-inflammatory activities of IL-6Int J Biol Sci2012891237124723136552
   PubMed Web of Science ®Google Scholar
• Rose-JohnSWinthropKCalabreseLThe role of IL-6 in host defence against infections: immunobiology and clinical implicationsNat Rev Rheumatol201713739940928615731
   PubMed Web of Science ®Google Scholar
• MarzPChengJ-GGadientRASympathetic neurons can produce and respond to interleukin 6Proc Natl Acad Sci U S A1998956325132569501249
   PubMed Web of Science ®Google Scholar
• JostockTMüllbergJOzbekSSoluble gp130 is the natural inhibitor of soluble interleukin-6 receptor transsignaling responsesEur J Biochem2001268116016711121117
   PubMedGoogle Scholar
• JonesSARichardsPJSchellerJRose-JohnSIL-6 transsignaling: the in vivo consequencesJ Interferon Cytokine Res200525524125315871661
   PubMed Web of Science ®Google Scholar
• NowellMARichardsPJHoriuchiSSoluble IL-6 receptor governs IL-6 activity in experimental arthritis: blockade of arthritis severity by soluble glycoprotein 130J Immunol200317163202320912960349
   PubMed Web of Science ®Google Scholar
• MastorakosGChrousosGPWeberJSRecombinant interleukin-6 activates the hypothalamic-pituitary-adrenal axis in humansJ Clin Endocrinol Metab1993776169016948263159
   PubMed Web of Science ®Google Scholar
• MärzPOttenURose-JohnSNeural activities of IL-6-type cytokines often depend on soluble cytokine receptorsEur J Neurosci19991192995300410510164
   PubMed Web of Science ®Google Scholar
• LeeYCEffect and treatment of chronic pain in inflammatory arthritisCurr Rheumatol Rep201315130023292816
   PubMed Web of Science ®Google Scholar
• HeibergTFinsetAUhligTKvienTKSeven year changes in health status and priorities for improvement of health in patients with rheumatoid arthritisAnn Rheum Dis200564219119515647426
   PubMed Web of Science ®Google Scholar
• SchaibleHGNociceptive neurons detect cytokines in arthritisArthritis Res Ther201416547025606597
   PubMed Web of Science ®Google Scholar
• XuHJHaoJXAndell-JonssonSPoliVBartfaiTWiesenfeld-HallinZNociceptive responses in interleukin-6-deficient mice to peripheral inflammation and peripheral nerve sectionCytokine1997912102810339417815
   PubMed Web of Science ®Google Scholar
• Wieseler-FrankJMaierSFWatkinsLRCentral proinflammatory cytokines and pain enhancementNeurosignals200514416617416215299
   PubMedGoogle Scholar
• BaoLZhuYElhassanAMAdjuvant-induced arthritis: IL-1β, IL-6 and TNF-α are up-regulated in the spinal cordNeuroreport200112183905390811742208
   PubMed Web of Science ®Google Scholar
• ObrejaOBiasioWAndratschMFast modulation of heat-activated ionic current by proinflammatory interleukin 6 in rat sensory neuronsBrain200512871634164115817518
   PubMed Web of Science ®Google Scholar
• WatkinsLRWiertelakEPGoehlerLESmithKPMartinDMaierSFCharacterization of cytokine-induced hyperalgesiaBrain Res1994654115267982088
   PubMed Web of Science ®Google Scholar
• BrennDRichterFSchaibleHGSensitization of unmyelinated sensory fibers of the joint nerve to mechanical stimuli by interleukin-6 in the rat: an inflammatory mechanism of joint painArthritis Rheum200756135135917195239
   PubMed Web of Science ®Google Scholar
• VazquezEKahlenbachJBanchetGSKönigCSchaibleHGEbersbergerASpinal interleukin-6 is an amplifier of arthritic pain in the ratArthritis Rheum20126472233224222246633
   PubMed Web of Science ®Google Scholar
• BoettgerMKLeuchtweisJKümmelDGajdaMBräuerRSchaibleHGDifferential effects of locally and systemically administered soluble glycoprotein 130 on pain and inflammation in experimental arthritisArthritis Res Ther2010124R14020626857
   PubMed Web of Science ®Google Scholar
• AndratschMMairNConstantinCEA key role for gp130 expressed on peripheral sensory nerves in pathological painJ Neurosci20092943134731348319864560
   PubMed Web of Science ®Google Scholar
• TownesSVFurstDEThenkondarAThe impact of tocilizumab on physical function and quality of life in patients with rheumatoid arthritis: a systematic literature review and interpretationOpen Access Rheumatol20124879227790016
   PubMedGoogle Scholar
• CrampFHewlettSAlmeidaCNon-pharmacological interventions for fatigue in rheumatoid arthritisCochrane Database Syst Rev20138CD008322
   Google Scholar
• AlikariVSachlasAGiatrakouSFatigue in arthritis: a multidimensional phenomenon with impact on quality of life: fatigue and quality of life in arthritisAdv Exp Med Biol201798724325628971463
   PubMed Web of Science ®Google Scholar
• HewlettSChalderTChoyEFatigue in rheumatoid arthritis: time for a conceptual modelRheumatology20115061004100620819797
   PubMed Web of Science ®Google Scholar
• NikolausSBodeCTaalEvan de LaarMAFatigue and factors related to fatigue in rheumatoid arthritis: a systematic reviewArthritis Care Res (Hoboken)20136571128114623335492
   PubMed Web of Science ®Google Scholar
• SilvermanMNPearceBDBironCAMillerAHImmune modulation of the hypothalamic-pituitary-adrenal (HPA) axis during viral infectionViral Immunol2005181417815802953
   PubMed Web of Science ®Google Scholar
• PapadopoulosASCleareAJHypothalamic–pituitary–adrenal axis dysfunction in chronic fatigue syndromeNat Rev Endocrinol2012812232
   Web of Science ®Google Scholar
• DuXPangTYIs dysregulation of the HPA-axis a core pathophysiology mediating co-morbid depression in neurodegenerative diseases?Front Psychiatry201563225806005
   PubMed Web of Science ®Google Scholar
• TsigosCChrousosGPHypothalamic–pituitary–adrenal axis, neuroendocrine factors and stressJ Psychosom Res200253486587112377295
   PubMed Web of Science ®Google Scholar
• EijsboutsAMvan den HoogenFHLaanRFHermusARSweepCGvan de PutteLBHypothalamic-pituitary-adrenal axis activity in patients with rheumatoid arthritisClin Exp Rheumatol200523565866416173242
   PubMed Web of Science ®Google Scholar
• RohlederNAringerMBoentertMRole of interleukin-6 in stress, sleep, and fatigueAnn N Y Acad Sci201212611889622823398
   PubMed Web of Science ®Google Scholar
• VgontzasANPapanicolaouDABixlerEOCircadian interleukin-6 secretion and quantity and depth of sleepJ Clin Endocrinol Metab19998482603260710443646
   PubMed Web of Science ®Google Scholar
• WeissGGoodnoughLTAnemia of chronic diseaseN Engl J Med2005352101011102315758012
   PubMed Web of Science ®Google Scholar
• MarrieRAWalldRBoltonJMPhysical comorbidities increase the risk of psychiatric comorbidity in immune-mediated inflammatory diseaseGen Hosp Psychiatry201851717829353127
   PubMed Web of Science ®Google Scholar
• PapanicolaouDAPetridesJSTsigosCExercise stimulates interleukin-6 secretion: inhibition by glucocorticoids and correlation with catecholaminesAm J Physiol Endocrinol Metab19962713E601E605
   Web of Science ®Google Scholar
• CarpenterLLGawugaCETyrkaARLeeJKAndersonGMPriceLHAssociation between plasma IL-6 response to acute stress and early-life adversity in healthy adultsNeuropsychopharmacology201035132617262320881945
   PubMed Web of Science ®Google Scholar
• PaceTWMletzkoTCAlagbeOIncreased stress-induced inflammatory responses in male patients with major depression and increased early life stressAm J Psychiatry200616391630163316946190
   PubMed Web of Science ®Google Scholar
• SteptoeAHamerMChidaYThe effects of acute psychological stress on circulating inflammatory factors in humans: a review and meta-analysisBrain Behav Immun200721790191217475444
   PubMed Web of Science ®Google Scholar
• ChourbajiSUraniAIntaIIL-6 knockout mice exhibit resistance to stress-induced development of depression-like behaviorsNeurobiol Dis200623358759416843000
   PubMed Web of Science ®Google Scholar
• Späth-SchwalbeEHansenKSchmidtFAcute effects of recombinant human interleukin-6 on endocrine and central nervous sleep functions in healthy menJ Clin Endocrinol Metab1998835157315799589658
   PubMed Web of Science ®Google Scholar
• KhandakerGMPearsonRMZammitSLewisGJonesPBAssociation of serum interleukin 6 and C-reactive protein in childhood with depression and psychosis in young adult lifeJAMA Psychiatry201471101121112825133871
   PubMed Web of Science ®Google Scholar
• KernSSkoogIBörjesson-HansonAHigher CSF interleukin-6 and CSF interleukin-8 in current depression in older women: results from a population-based sampleBrain Behav Immun201441555824858658
   PubMed Web of Science ®Google Scholar
• SasayamaDHattoriKWakabayashiCIncreased cerebrospinal fluid interleukin-6 levels in patients with schizophrenia and those with major depressive disorderJ Psychiatr Res201347340140623290488
   PubMed Web of Science ®Google Scholar
• LindqvistDJanelidzeSHagellPInterleukin-6 is elevated in the cerebrospinal fluid of suicide attempters and related to symptom severityBiol Psychiatry200966328729219268915
   PubMed Web of Science ®Google Scholar
• BoufidouFLambrinoudakiIArgeitisJCSF and plasma cytokines at delivery and postpartum mood disturbancesJ Affect Disord20091151–228729218708264
   PubMed Web of Science ®Google Scholar
• GirottiMDoneganJJMorilakDAInfluence of hypothalamic IL-6/gp130 receptor signaling on the HPA axis response to chronic stressPsychoneuroendocrinology20133871158116923218517
   PubMed Web of Science ®Google Scholar
• HodesGEMénardCRussoSJIntegrating interleukin-6 into depression diagnosis and treatmentNeurobiol Stress20164152227981186
   PubMed Web of Science ®Google Scholar
• StrandVKosinskiMChenCISarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trialArthritis Res Ther20161819827600829
   PubMed Web of Science ®Google Scholar
• CellaDYountSSorensenMChartashESenguptaNGroberJValidation of the functional assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritisJ Rheumatol200532581181915868614
   PubMed Web of Science ®Google Scholar
• WareJEBjornerJBTurner-BowkerDMaruishMEUser’s Manual for the SF-36v2 Health Survey2nd edLincoln (RI)Quality Metric Incorporated2007
   Google Scholar
• KosinskiMZhaoSZDedhiyaSOsterhausJTWareJEDetermining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritisArthritis Rheum20004371478148710902749
   PubMed Web of Science ®Google Scholar
• GossecLSVProudfootCChenCRheumatoid arthritis (RA) impact following treatment with sarilumab: patient reported outcomes using the RAID scale from two randomized phase III trialsAnn Rheum Dis201776Suppl 2575576
   Google Scholar
• DougadosMBraultYLogeartIvan der HeijdeDGossecLKvienTDefining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID)Arthritis Res Ther2012143R12922647431
   PubMed Web of Science ®Google Scholar