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Comments on the article “Effectiveness and safety of tofacitinib in rheumatoid arthritis: a cohort study”

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Comments on the article “Effectiveness and safety of tofacitinib in rheumatoid arthritis: a cohort study”
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Thuy Nhu Thai
Ghadeer K. Dawwas
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BMC, Arthritis Research & Therapy
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English

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Thai and Dawwas Arthritis Research & Therapy (2018) 20:198 https://doi.org/10.1186/s13075-018-1651-7; Pages 1-2

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University of Florida
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© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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LETTEROpenAccess Commentsonthearticle“Effectivenessandsafetyoftofacitinibinrheumatoidarthritis:acohortstudy”ThuyNhuThai* andGhadeerK.DawwasWereadwithinterestthestudypublishedbydevilaMachadoetal.regardingthecomparativeeffective-nessandsafetyoftofacitinibandnon-tumornecrosisfac-tor(TNF)inhibitorsamongpatientswithrheumatoidarthritis(RA)[1].Althoughthestudyfindingsareveryin-teresting,thereareseveralconcernsinregardtothestudydesign.First,thestudyusedanexposuredefinitionthatcausedRAdiseaseseveritytobeheterogeneousbetweenandwithinthecomparisongroups.AccordingtoRAtreatmentguidelines,patientsatanearlystageofRAarerecommendedtostartacombinationofDMARDs,ortoinitiateTNFinhibitors,ornon-TNFinhibitorsafterthefailureofDMARDsmonotherapy.Ontheotherhand,pa-tientswithanestablishedRAarerecommendedtouseacombinationofDMARDs,DMARDswithTNFinhibitors,DMARDswithnon-TNFinhibitors,orDMARDswithtofacitinib[2].Therefore,theexposuredefin-itionusedinthisstudymayreflectRApatientsatdifferentstagesofdiseaseseveritywhichhasthepotentialofintro-ducingbiasintheobservedestimates.Forexample,toinitiatetofacitinib,patientshavetofailtheothertreatmentapproachescausingthemtobeatanadvancedRAstagewhencomparedwiththoseintheDMARDsgroupwhoaremorelikelytohaveusedmethotrexateonlybefore.Additionally,itwasnotclearwhytheauthorsgroupedtogetherpatientswhocombinedTNFinhibitorswithDMARDsalongwithpa-tientswhousedTNFinhibitorsalone.Thisexposuregroupmightbecomprisedoftwodifferentpatients'popula-tionssinceitisoftenrecommendedthatpatientscombineTNFinhibitorsandDMARDsaftertreatmentfailurewithTNFinhibitorsalone[2].Second,themedicationpossessionratio(MPR)isknowntobeavalidmeasureofadherenceofasinglemedication.However,MPRtendstooverestimateadher-encewhenpatientsusemorethanonemedication[3].Accordingly,theobservedadherenceofpatientswhousedtwoormoreDMARDsaremorelikelytobeoverestimated.Theproportionofdayscoveredissug-gestedasabetteralternativemeasureofadherenceinthissituation[3].Third,themodelsevaluatingtheef-fectivenessandsafetyomittedtheadjustmentofimport-antvariables.Forexample,theauthorsdidnotadjustforcurrentmethotrexateusewhichmayimpacttheob-servedtreatmenteffectivenessorfactorsthatmayin-creasetheriskofinfectionssuchashumanimmunodeficiencyvirus(HIV)ortheuseofimmunosup-pressantdrugs.Authors’responseMarinaAmaraldevilaMachado,CristianoSoaresdeMoura,SteveFerreiraGuerra,MichalAbrahamowiczandSashaBernatskyWethankThaiandDawwasfortheirinterestinourworkontheeffectivenessandsafetyoftofacitinibinRA[1]andwearepleasedtoclarifysomeaspectsofourstudy.Thefirstcommentconcernedcomparabilityofexposuregroups.WeselectedpatientspreviouslytreatedwithmethotrexateandothernewlydispensedDMARDs,biologics,andtofacitinibbetween2011and2014.Weap-pliedanew-userdesign,suchthatallpatientsinourstudywereinitiatingasecondRAtherapyafterfailureorin-toleranceofmethotrexate.Wedefinedfourcomparisongroups:DMARDs,TNFinhibitorswithorwithoutDMARDs,non-TNFbiologicswithorwithoutDMARDs,andtofacitinibwithorwithoutDMARDs.Non-TNFbio-logicscomprisedthereferencegroup,givenourparticularinterestinassessingsubsequenttherapiesinRA.We *Correspondence:thuythai@ufl.eduDepartmentofPharmaceuticalOutcomesandPolicy,CollegeofPharmacy,UniversityofFlorida,Gainesville,Florida,USA TheAuthor(s).2018OpenAccessThisarticleisdistributedunderthetermsoftheCreativeCommonsAttribution4.0InternationalLicense(http://creativecommons.org/licenses/by/4.0/),whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedyougiveappropriatecredittotheoriginalauthor(s)andthesource,providealinktotheCreativeCommonslicense,andindicateifchangesweremade.TheCreativeCommonsPublicDomainDedicationwaiver(http://creativecommons.org/publicdomain/zero/1.0/)appliestothedatamadeavailableinthisarticle,unlessotherwisestated.ThaiandDawwasArthritisResearch&Therapy (2018) 20:198 https://doi.org/10.1186/s13075-018-1651-7

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allowedthegroupstobeconcomitantlyexposedtoDMARDssince,intherealworld,itisnotuncommonforthesedrugstobegivenincombination,forexamplewithanti-malarialdrugsorotherDMARDs.Previousstudieshaveappliedsimilarapproach[4,5].Uponfurtherreviewofourpaper,wenoticedaninconsistencyinthefourthsentenceofthesecondparagraphoftheMethodssectionthatmayhavecontributedtoamisunderstanding.Westatedthat“Weselectedindividualswithnouseofthesemedicationsanytimebeforecohortentry(minimum12months),althoughprevioususeofDMARDswasallowedforindividualsinthebiologicandtofacitinibgroups.”Infact,patientsinthebiologicandtofacitinibgroupswhohadbeenprescribedDMARDsbeforecohortentrywereconsideredintheDMARDgroup.Regardingthesecondpointabouttheadherenceofpa-tientsoncombinationtherapywithDMARDs,weclarifythatthemedicationpossessionratio(MPR)wasmea-suredseparatelyfortheindexDMARD(identifiedatthepharmacyclaimatcohortentry)andformethotrexate.Then,agivenpatientwasconsideredhighlyadherentforthecombinedtherapyiftheMPRwas80%fortheDMARDorformethotrexate.Finally,theauthorsquestionedtheomissionofsomepotentialconfoundersinthemodels.Wedidnotadjusttheeffectivenessmodelforcurrentmethotrexateusebe-causetheadditionofmethotrexatebetween4and12monthsoffollow-upwaspartoftheoutcomedefinition(criterion3ofthealgorithm).Regardinginfectionrisk,thesafetymodelswereadjustedforpreviousandcurrentuseofglucocorticoids,andprevioushospitalizedinfec-tions[6].WealsoadjustedforCharlsoncomorbidityindex,whichincludesAIDS/HIV.Authors’contributionsTNTandGDdiscussedthestudyconcept,wrotetheletter,andreviewedthefinalversion.Bothauthorsreadandapprovedthefinalmanuscript.EthicsapprovalandconsenttoparticipateNotapplicable.ConsentforpublicationNotapplicable.CompetinginterestsTheauthorsdeclarethattheyhavenocompetinginterests.Publisher’sNoteSpringerNatureremainsneutralwithregardtojurisdictionalclaimsinpublishedmapsandinstitutionalaffiliations. References1.MachadoMA,MouraCS,GuerraSF,CurtisJR,AbrahamowiczM,BernatskyS.Effectivenessandsafetyoftofacitinibinrheumatoidarthritis:acohortstudy.ArthritisResTher.2018;20(1):60.2.SinghJA,SaagKG,BridgesSLJr,etal.2015AmericanCollegeofRheumatologyGuidelinesforthetreatmentofrheumatoidarthritis.ArthritisRheumatol(Hoboken,NJ).2016;68(1):1–26.3.MartinBC,Wiley-ExleyEK,RichardsS,DominoME,CareyTS,SleathBL.Contrastingmeasuresofadherencewithsimpledruguse,medicationswitching,andtherapeuticduplication.AnnPharmacother.2009;43(1):36–44.4.SolomonDH,ShadickNA,WeinblattME,ZakA,FritsM,FranklinJM.Drugsafetyanalysesinarheumatoidarthritisregistry:applicationofdifferentapproachesregardingtimingofexposureandconfoundermeasurement.ArthritisResTher.2017;19(1):130.5.Gomez-ReinoJJ,CarmonaL,BIOBADASERGroup.SwitchingTNFantagonistsinpatientswithchronicarthritis:anobservationalstudyof488patientsoverafour-yearperiod.ArthritisResTher.2006;8(1):R29.6.WiddifieldJ,BernatskyS,PatersonJM,GunrajN,ThorneJC,PopeJ,etal.Seriousinfectionsinapopulation-basedcohortof86,039seniorswithrheumatoidarthritis.ArthritisCareRes(Hoboken).2013;65(3):353–61.ThaiandDawwasArthritisResearch&Therapy (2018) 20:198 Page2of2