Efficacy, tolerability and safety of biologic therapy in rheumatoid disease: patient considerations

References

• HelmickCGFelsonDTLawrenceRCNational Arthritis Data WorkgroupEstimates of the prevalence of arthritis and other rheumatic conditions in the United StatesArthritis Rheum200858152518163481
   PubMed Web of Science ®Google Scholar
• SödergrenAStegmayrBLundbergVÖhmanMLWållberg-JonssonSIncreased incidence of and impaired prognosis after acute myocardial infarction among patients with seropositive rheumatoid arthritisAnn Rheum Dis20076626326616854951
   PubMed Web of Science ®Google Scholar
• YelinEHenkeCEpsteinWThe work dynamics of the person with rheumatoid arthritisArthritis Rheum1987305075123593434
   PubMed Web of Science ®Google Scholar
• MacholdKPStammTAEnbrelGJMVery recent onset arthritis – clinical, laboratory, and radiological findings during the first year of diseaseJ Rheumatol2002292278228712415582
   PubMed Web of Science ®Google Scholar
• GrigorCCapellHStirlingAEffect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trialLancet200436426326915262104
   PubMed Web of Science ®Google Scholar
• VerstappenSMMJacobsJWGvan der VeenMJIntensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial)Ann Rheum Dis2007661443144917519278
   PubMed Web of Science ®Google Scholar
• ChoyEHSPanayiGSCytokine pathways and joint inflammation in rheumatoid arthritisN Engl J Med2001344909916
   Web of Science ®Google Scholar
• FelsonDTAndersonJJBoersMACR preliminary definition of improvement in rheumatoid arthritisArthritis Rheum1995387277357779114
   PubMed Web of Science ®Google Scholar
• KosinskiMZhaoSZDedhiyaSOsterhausJTWareJEDetermining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritisArthritis Rheum2000431478148710902749
   PubMed Web of Science ®Google Scholar
• GenantHKPeterfyCGWesthovensRAbatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trialAnn Rheum Dis2008671084108918086727
   PubMed Web of Science ®Google Scholar
• MainiRSt ClairEWBreedveldFthe ATTRACT Study GroupInfliximab (chimeric anti-tumour necrosis factor monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trialLancet19993541932193910622295
   PubMed Web of Science ®Google Scholar
• LipskyPEvan der HeijdeDMFMSt ClairEWthe ATTRACT Study GroupInfliximab and methotrexate in the treatment of rheumatoid arthritisN Engl J Med2000301594160211096166
   PubMed Web of Science ®Google Scholar
• St ClairEWvan der HeijdeDMFMSmolenJSCombination of infliximab and methotrexate therapy for early rheumatoid arthritis. A randomized, controlled trialArthritis Rheum2004503432344315529377
   PubMed Web of Science ®Google Scholar
• Goerkoop-RuitermanYPMde Vries-BouwstraJKAllaartCFComparison of treatment strategies in early rheumatoid arthritis. A randomised trialAnn Intern Med200714640641517371885
   PubMed Web of Science ®Google Scholar
• WeinblattMEKeystoneECFurstDEAdalimumab, a fully human anti–tumor necrosis factor monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate. The ARMADA trialArthritis Rheum200348354512528101
   PubMed Web of Science ®Google Scholar
• van der PutteLBAAtkinsCMalaiseMEfficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failedAnn Rheum Dis20046350851615082480
   PubMed Web of Science ®Google Scholar
• BreedveldFCWeismanMHKavanaughAFthe PREMIER InvestigatorsThe PREMIER study. A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatmentArthritis Rheum200654263716385520
   PubMed Web of Science ®Google Scholar
• BejaranoVQuinnMConaghanPGYorkshire Early Arthritis Register ConsortiumEffect of the early use of the anti-tumor necrosis factor adalimumab on the prevention of job loss in patients with early rheumatoid arthritisArthritis Rheum2008591467147418821658
   PubMed Web of Science ®Google Scholar
• WeinblattMEKremerJMBankhurstADA trial of etanercept, a recombinant tumour necrosis factor receptor:Fc fusion protein in patients with rheumatoid arthritis receiving methotrexateN Engl J Med19993402532599920948
   PubMed Web of Science ®Google Scholar
• MorelandLWSchiffMHBaumgartnerSWEtanercept therapy in rheumatoid arthritis. A randomised, controlled trialAnn Intern Med199913047848610075615
   PubMed Web of Science ®Google Scholar
• KlareskogLvan der HeidjeDde JagerJPfor the TEMPO investigatorsTherapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trialLancet200436367568115001324
   PubMed Web of Science ®Google Scholar
• EmeryPBreedveldFCHallSComparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trialLancet200837237538218635256
   PubMed Web of Science ®Google Scholar
• BathonJMMartinRWFleischmannRMA comparison of etanercept and methotrexate in patients with early rheumatoid arthritisNew Engl J Med20003431586159311096165
   PubMed Web of Science ®Google Scholar
• KeystoneEvan der HeijdeDMasonDJrCertolizumab pegol plus methotrexate is significantly more effective in active rheumatoid arthritis: findings of a fifty-two-week, phase III multicenter, randomised, double-blind, placebo-controlled, parallel-group studyArthritis Rheum20095833193329 Epub 2008 Oct 30.18975346
   PubMed Web of Science ®Google Scholar
• SmolenJSLandewéRBMMeasePJEfficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 studyAnn Rheum Dis2009668797804 Epub 2008 Nov 17.
   Google Scholar
• FleischmannRVencovskyJvan VollenhovenEfficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying anti-rheumatic therapy: the FAST4WARD studyAnn Rheum Dis2009668805811 Epub 2008 Nov 17.
   Google Scholar
• KeystoneECGenoveseMCKlareskogLGolimumab, a human antibody to TNFα given by subcutaneous injections, active rheumatoid arthritis despite methotrexate: the GO-FORWARD studyAnn Rheum Dis20096878979619066176
   PubMed Web of Science ®Google Scholar
• EmeryPFleischmannRMMorelandLWGolimumab, a new human anti-TNFα monoclonal antibody, administered subcutaneously every 4 weeks in methotrexate-naive patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, GO-BEFORE studyAnn Rheum Dis200867Suppl 2S179
   Google Scholar
• SmolenJSKayJDoyleMKthe GO-AFTER study investigatorsGolimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trialLancet200937421022119560810
   PubMed Web of Science ®Google Scholar
• MainiRNBreedveldFCKaldenJRTherapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor α monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritisArthritis Rheum199841155215639751087
   PubMed Web of Science ®Google Scholar
• MainiRNBreedveldFCKaldenJRSustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexateArthritis Rheum2004501051106515077287
   PubMed Web of Science ®Google Scholar
• BreedveldFCEmeryPKeystoneEInfliximab in active early rheumatoid arthritisAnn Rheum Dis20046314915514722203
   PubMed Web of Science ®Google Scholar
• QuinnMAConaghanPGO’ConnorPJVery early treatment with inflximab in addition to methotrexate in early, poor-prognosis rheumatoid arthritis reduces magnetic resonance imagng evidenc of synovitis and damage with sustained benefit after infliximab withdrawalArthritis Rheum200552273515641102
   PubMed Web of Science ®Google Scholar
• BejeranoVConaghanPQuinnMSaleemBEmeryPBenefits eight years after a remission induction regime with an infliximab and methotrexate combination in early rheumatoid arthritisRheumatology Submitted 2010
   Google Scholar
• WeinblattMEKeystoneECFurstDEKavanaughAFChartashEKSeguradoOGLong term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended studyAnn Rheum Dis20066575375916308341
   PubMed Web of Science ®Google Scholar
• KeystoneECKavanaughAFSharpJTRadiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti – tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy. A randomized, placebo-controlled, 52-week trialArthritis Rheum2004501400141115146409
   PubMed Web of Science ®Google Scholar
• EmeryPGenoveseMCvan VollenhovenRSharpJTPatraKSassoEHLess radiographic progression with adalimumab plus methotrexate versus methotrexate monotherapy across the spectrum of clinical response in early rheumatoid arthritisJ Rheumatol2009361429144119369462
   PubMed Web of Science ®Google Scholar
• KimelMCifaldiMChenNRevickiDAdalimumab plus methotrexate improved SF-36 scores and reduced the effect of rheumatoid arthritis (RA) on work activity for patients with early RAJ Rheumatol20083520621518085743
   PubMed Web of Science ®Google Scholar
• Van der HeijdeDKlareskogLSinghAPatient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trialAnn Rheum Dis20056532833416079172
   PubMed Web of Science ®Google Scholar
• EmeryPBreedveldFvan der HeijdeDCombination of Methotrexate and Etanercept in Early Rheumatoid Arthritis Trial GroupTwo-year clinical and radiographic results with combination etanerceptmethotrexate therapy versus monotherapy in early rheumatoid arthritisArthritis Rheum20106267468220187135
   PubMed Web of Science ®Google Scholar
• GenoveseMCBathonJMMartinRWEtanercept versus methotrexate in patients with early rheumatoid arthritis. Two-year radiographic and clinical outcomesArthritis Rheum2002461443145012115173
   PubMed Web of Science ®Google Scholar
• GenoveseMCBathonJMFleischmannRMLong-term safety, efficacy and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritisJ Rheumatol2005321232124215996057
   PubMed Web of Science ®Google Scholar
• GenantHKPeterfyCGWesthovensRAbatacept inhibits progression of structural damage in rhuematoid arthritis: results from the long-term extension of the AIM trialAnn Rheum Dis20086710841089 Epub 2007 Dec 17.18086727
   PubMed Web of Science ®Google Scholar
• KremerJMGeneantHKMorelandLWEffects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomised trialAnn Intern Med2006144866876
   Web of Science ®Google Scholar
• KremerJMDougadosMEmeryPTreatement of rheumatoid arthritis with selective costimulation modulator abataceptArthritis Rheum2005522263227116052582
   PubMed Web of Science ®Google Scholar
• GenoveseMCBeckerJCSchiffMAbatacept for rheumatoid arthritis refractory to tumour necrosis factor alpha inhibitionN Engl J Med20053531114112316162882
   PubMed Web of Science ®Google Scholar
• KremerJMGeneantHKMorelandLWResults of a two-year follow up study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexateArthritis Rheum20085895396318383390
   PubMed Web of Science ®Google Scholar
• WesthovensRKremerJMMorelandLWSafetey and efficacy of the selective costimulation modulator abatacept in pateints with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB studyJ Rheumatol20093673674219273451
   PubMed Web of Science ®Google Scholar
• GenoveseMCSchiffMLuggenMEfficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapyAnn Rheum Dis20086754755417921185
   PubMed Web of Science ®Google Scholar
• WesthovensRRoblesMXimenesACClinical efficacy and safety of abatacept in methotrexate-naïve patients with early rheumatoid arthritis and poor prognostic factorsAnn Rheum Dis Epub 2009 Jan 5.
   Google Scholar
• EmeryPDurezPDougadosMThe impact of T-cell co-stimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abataceptAnn Rheum Dis Epub 2009 Nov 23.
   Google Scholar
• ArnettFCEdworthySMBlochDAThe American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritisArthritis Rheum1988313153243358796
   PubMed Web of Science ®Google Scholar
• EmeryPFleischmannRFilipowicz-SsnowskaAthe DANCER study groupThe efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatmentArthritis Rheum2006541390140016649186
   PubMed Web of Science ®Google Scholar
• FurstDEBreedvaldFCKaldenJRUpdated consensus statement on biological agents for the treatment of rheumatic diseases, 2007Ann Rheum Dis200766Suppl 3S2S22
   Google Scholar
• SmolenJSKeystoneECEmeryPConsensus statement on the use of rituximab in patients with rheumatoid arthritisAnn Rheum Dis20076614315017068064
   PubMed Web of Science ®Google Scholar
• DassSRawstronACVitalEMHenshawKMcGonagleDEmeryPHighly sensitive B cell analysis predicts response to rituximab therapy in rheumatoid arthritisArthritis Rheum2008582993299918821683
   PubMed Web of Science ®Google Scholar
• VitalEMDassSRawstronACManagement of non-response to rituximab in rheumatoid arthritis: predictors and outcome of retreatmentArthritis Rheum2010
   Web of Science ®Google Scholar
• EdwardsJCWSzczepańskiLSzechińskiJEfficacy of B-cell targeted therapy with rituximab in patients with rheumatoid arthritisN Engl J Med20043502572258115201414
   PubMed Web of Science ®Google Scholar
• MeasePJRevickDASzechinskiJImproved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab – results of the dose-ranging assessment: international clinical evaluation of rituximab in rheumatoid arthritis (DANCER) trialJ Rheumatol200835203018050385
   PubMed Web of Science ®Google Scholar
• CohenSBEmeryPGreenwaldMWthe REFLEX trial groupRituximab for rheumatoid arthritis refractory to anti-tumour necrosis factor therapyArthritis Rheum2006542793280616947627
   PubMed Web of Science ®Google Scholar
• MuraguchiAHiranoTTangBThe essential role of B cell stimulatory factor 2 (BSF-2/IL-6) for the terminal differentiation of B cellsJ Exp Med19881673323443258006
   PubMed Web of Science ®Google Scholar
• LotzMJirikFKabouridisPB cell stimulating factor 2/interleukin 6 is a costimulant for human thymocytes and T lymphocytesJ Exp Med1989557417435
   Google Scholar
• MainiRNTaylorPCSzechinskiJfor the CHARISMA study groupDouble-blind randomised controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexateArthritis Rheum2006542817282916947782
   PubMed Web of Science ®Google Scholar
• SmolenJSBealieuARubbert-RothAfor the OPTION investigatorsEffect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trialLancet200837198799718358926
   PubMed Web of Science ®Google Scholar
• GenoveseMCMcKayJDNasonevELInterleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugsArthritis Rheum2008582968298018821691
   PubMed Web of Science ®Google Scholar
• EmeryPKeystoneETonyHPIl-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trialAnn Rheum Dis20086715161523 Epub 2008 Jul 14.18625622
   PubMed Web of Science ®Google Scholar
• NishimotoNHashimotoJMiyasakaNStudy of active controlled monotherapy used for rheumatoid arthritis an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumabAnn Rheum Dis20076611621167 Epub 2007 May 7.17485422
   PubMed Web of Science ®Google Scholar
• KremerJFleischmannRMSaurignyDAlecockEBlancoRSafety and tolerability of tocilizumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis and inadequate response to MTX: 1-year results of the LITHE studyAnn Rheum Dis200968Suppl 3444
   Google Scholar
• JonesGSebbaAGuJComparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION studyAnn Rheum Dis Epub 2009 March 17.
   Google Scholar
• SmolenJSAltenRHEGomez-ReinoJEfficacy of tocilizumab in rheumatoid arthritis: interim analysis of long-term extension trials of up to 2.5 yearsAnn Rheum Dis200968Suppl 3401
   Google Scholar
• FurstDESchiffMHFleischmannRMAdalimumab, a fully human anti-tumour necrosis factor-α monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (safety trial of adalimumab in rheumatoid arthritis)J Rheumatol20033012
   Web of Science ®Google Scholar
• BongartzTSuttonAJSweetingMJBuchanIMattesonELMontoriVAnti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignanciesJAMA20062952275228516705109
   PubMed Web of Science ®Google Scholar
• SalliotCGossecLRuyssen-WitrandAInfections during tumour necrosis factor-α blocker therapy for rheumatic diseases in daily practice: a systematic retrospective study of 709 patientsRheumatology20074632733416880188
   PubMed Web of Science ®Google Scholar
• DixonWGSymmonsDPMLuntMWatsonKDHyrichKLSilmanAJBritish Society for Rheumatology Biologics Register Control Centre Consortium. Serious infection following anti-tumor necrosis factor-α therapy in patients with rheumatoid arthritis: Lessons from interpreting data from observational studiesArthritis Rheum2007562896290417763441
   PubMed Web of Science ®Google Scholar
• Van VollenhovenRFEmeryPBinghamCOLong-term safety of rituximab: follow-up of the RA clinical trials and the re-treatment populationAnn Rheum Dis200968Suppl 376
   Google Scholar
• DixonWGHyrichKLWatsonKDDrug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR)Ann Rheum Dis Epub 2009 Oct 22.
   Google Scholar
• FurstDEWallisRBroderMBeenhouwerDOTumor necrosis factor antagonists: different kinetics and/or mechanisms of action may explain differences in the risk for developing granulomatous infectionSem Arth Rheum200636159167
   PubMed Web of Science ®Google Scholar
• CarmonaLGómez-ReinoJJRodríguez-ValverdeVBIOBADASER GroupEffectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonistsArthritis Rheum2005521766177215934089
   PubMed Web of Science ®Google Scholar
• DesaiSBFurstDEProblems encountered during anti-tumour necrosis factor therapyBes Pract Res Clin Rheum200620757790
   PubMed Web of Science ®Google Scholar
• PetersonJRHsuFCSimkinPAWenerMHEffect of tumour necrosis factor alpha antagonists on serum transaminases and viremia in patients with rheumatoid arthritis and chronic hepatitis C infectionAnn Rheum Dis2003621078108214583571
   PubMed Web of Science ®Google Scholar
• ZeinNNEtanercept Study GroupEtanercept as an adjuvant to interferon and ribavirin in treatment-naïve patients with chronic hepatitis C virus infection: a phase 2 randomized, double-blind, placebo-controlled studyJ Hepatol20054231532215791697
   PubMed Web of Science ®Google Scholar
• AmariWZeringueALMcDonaldJRNon-melanoma and melanoma skin cancer risk in a national cohort of veterans with rheumatoid arthritisACR2008 Abstract 1379. Available from: http://acr.confex.com/acr/2009/webprogram/Paper11467.html
   Google Scholar
• AsklingJForedCMBrandtLRisks of solid cancers in patients with rheumatoid arthritis and after treatment with tumour necrosis factor antagonistsAnn Rheum Dis2005641421142615829572
   PubMed Web of Science ®Google Scholar
• DixonWWatsonKDLuntMThe influence of anti-TNF therapy upon cancer incidence in patients with rheumatoid arthritis (RA) who have had prior malignancy: results from the BSRBRArthritis Rheum200858SupplS638S639
   Google Scholar
• MarietteXTubachFRavaudPPatients on anti-TNF have an increased risk of lymphoma compared with the general population: results of the French RATIO observatoryAnn Rheum Dis200867Suppl 232317616556
   PubMed Web of Science ®Google Scholar
• AsklingJForedCMBaecklundEHematopoietic malignancies in rheumatoid arthritis: lymphoma risk and characteristics after exposure to tumour necrosis factor antagonistsAnn Rheum Dis2005641414142015843454
   PubMed Web of Science ®Google Scholar
• WesthovensRYocumDHanJSTART Study GroupThe safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trialArthritis Rheum2006541075108616572442
   PubMed Web of Science ®Google Scholar
• HarrisonMJDixonWGWatsonKDRates of new-onset psoriasis in patients with rheumatoid arthritis receiving anti-TNFα therapy: results from the British Society for Rheumatology Biologics RegisterAnn Rheum Dis20096820921518385277
   PubMed Web of Science ®Google Scholar
• CarsonKREvensAMRicheyEAProgressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports projectBlood200911348344840 Epub 2009 March 5.19264918
   PubMed Web of Science ®Google Scholar
• MannDMcMurrayJPackerMTargeted anticytokine therapy in patients with chronic heart failue: results of the randomised etanercept worldwide evaluation (RENEWAL)Circulation20041091594160215023878
   PubMed Web of Science ®Google Scholar
• HyrichKLSymmonsDPMWatsonKDSilmanAJPregnancy outcome in women who were exposed to anti-tumor necrosis factor agents: results from a national population registerArthritis Rheum2006542701270216871549
   PubMed Web of Science ®Google Scholar
• HyrichKLLuntMWatsonKDSymmonsDPSilmanAJOutcomes after switching from one anti-tumour ncrosis factor alpha agent to a second anti-tumour necrosis factor agent in patients with rheumatoid arthritis: results from a large UK national cohort studyArthritis Rheum200766893899
   Google Scholar
• IkedaKCoxSEmeryPBiological therapy in early arthritis – overtreatment or the way to go?Arthritis Res Ther2007921121717540047
   PubMed Web of Science ®Google Scholar