类风湿关节炎达标治疗最优方法:3个月时间点策略背景
达标治疗(T2T)为广泛接受的风湿性关节炎管理策略,并且治疗启动后3个月时为关键决定点。在此时间点时,目前仍不清楚哪些患者将从治疗调整或继续现有治疗中获益。
方法我们对RA患者水平临床试验数据的汇总分析。我们通过诊断测试方法以及采用Logistic回归的概率法,评估3个月时何种应答水平能够就6个月时实现目标提供治疗决策。
结果就至少80%敏感性实现6个月时低疾病活动性而言,需要在3个月时观察到简化疾病活动指数/临床疾病活动指数(SDAI或CDAI)发生58%变化。敏感预测缓解(REM)需要更大变化。未达到(较小)SDAI50%应答水平的患者阴性似然比极低(LR)(6个月时实现LDA为0.28,实现REM为0.07)。达到(较大)SDAI85%应答具有显著阳性LR;6个月时实现LDA为9.2,实现REM为6.2。在Logistic回归中,3个月时变化与6个月时实现目标具有显著相关性。
结论3个月时间点为关键决定点。3个月时未达到较小应答意味着6个月时极不可能实现治疗目标,达到较大应答则高度预测实现治疗目标。
Optimisationofatreat-to-targetapproachinrheumatoidarthritis:strategiesforthe3-monthtimepointBackgroundTreat-to-target(T2T)isawidelyacceptedmanagementstrategyforrheumatoidarthritis(RA)withakeydecisionpointat3monthsaftertreatmentinitiation.Atthistimepointremainsunclearwhichpatientswillbenefitfromtreatmentadaptationorfromcontinuationofexistingtreatment.
MethodsWeperformedapooledanalysisofpatient-levelclinicaltrialdataofpatientswithRA.Weusedadiagnostictestingmethodologyandaprobabilisticapproachemployinglogisticregressiontoinvestigatewhichlevelsofresponseat3monthscaninformtreatmentdecisionsinregardtoachievingthetargetat6months.
ResultsTobeatleast80%sensitiveforachievingthelowdiseaseactivity(LDA)targetat6months,achangeat3monthsinSimplifiedDiseaseActivityIndex/ClinicalDiseaseActivityIndex(SDAIorCDAI)of58%needstobeobservedat3months.Higherchangesareneededtosensitivelypredictremission(REM).Notreachingthe(minor)SDAI50%responselevelisafflictedwithverylownegativelikelihoodratios(LRs)(0.28forLDAand0.07forREMat6months).Experiencing(major)SDAI85%responsehassubstantialpositiveLRsof9.2forreachingLDAand6.2forreachingREMat6months.Inlogisticregression,thechangeat3monthsissignificantlyassociatedwithreachingofthetargetat6months.
ConclusionsThe3-monthtimepointisacriticaldecisionpoint.Notachievingminorresponsesat3monthsmakesreachingofthetreatmenttargetat6monthshighlyunlikely,whilereachingmajorresponsesishighlypredictiveofreachingthetreatmenttarget.
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