研究目的

在强直性脊柱炎（AS）患者中确定巴氏强直性脊柱炎疾病活动性指数（BADAI）和巴氏强直性脊柱炎功能指数（BASFI）的最小临床意义改善（MCII）和患者可接受症状状况（PASS）阈值。

研究方法

启用非甾体类抗炎药的AS患者被纳入研究。4周之后，通过外部锚问题确定PASS和MCII（对于PASS，患者将其过去48小时的病情考虑为永久“可接受”；对于MCII，患者报告具有轻度或轻微具临床意义改善）。依据HLA-B27状况、SpA关节外表现存在与否、年龄、性别、疾病持续时间和基线BASDAI/BASFI评分检测MCII和PASS的一致性。利用累积分布75百分位数确定MCII和PASS。

研究结果

共有来自于国际性人群的例患者被纳入研究。BASDAI和BASFI中PASS总体阈值分别为4.1和3.8。BASDAI和BASFI中MCII阈值分别为0.7和0.4。亚组分析显示疾病持续时间和基线BASDAI/BASFI与PASS和MCII显著相关。在限定于活动性疾病患者的亚分析中（基线BASDAI≥4），BASDAI和BASFI中MCII分别为1.1和0.6。

研究结论

BASDAI中PASS的概念可行性由于达到生物治疗启用水平而受到质疑。由于MCII的变异性低于PASS，我们提议在活动性疾病患者中将其专用，并以BASDAI/BASFI的1.1/0.6为阈值。由于上述数值基于研究亚组人群，我们建议在专注于基线BASDAI≥4患者的更大型研究中对其加以验证。

原文摘要

TheMinimumClinicallyImportantImprovementandPatient-acceptableSymptomStateintheBASDAIandBASFIforPatientswithAnkylosingSpondylitis

OBJECTIVES:

Toestablishcutoffsfortheminimumclinicallyimportantimprovement(MCII)andthepatient-acceptablesymptomstate(PASS)fortheBathAnkylosingSpondylitisDiseaseActivityIndex(BASDAI)andtheBathAnkylosingSpondylitisFunctionalIndex(BASFI)inpatientswithankylosingspondylitis(AS).

METHODS:

PatientswithASwhostartednonsteroidalantiinflammatorydrugswereincluded.After4weeks,thePASSandtheMCIIweredefinedusingexternalanchorquestions(forthePASS,patientsconsideringtheirconditionofASovertheprior48has“acceptable”forever;andfortheMCII,thosereportingmoderateorslightlyimportantimprovement).ConsistencyoftheMCIIandPASSweretestedaccordingtoHLA-B27status,presence/absenceofSpAextraarticularmanifestations,age,sex,diseaseduration,andbaselineBASDAI/BASFIscore.The75thpercentileofthecumulativedistributionwasusedtodeterminetheMCIIandPASS.

RESULTS:

Intotal,patientsfromamultinationalcohortwereincluded.OverallcutoffsforthePASSwere4.1intheBASDAIand3.8intheBASFI.CutoffsfortheMCIIwere0.7and0.4fortheBASDAIandBASFI,respectively.SubgroupanalysesrevealedthatdiseasedurationandbaselineBASDAI/BASFIweresignificantlyassociatedwiththePASSandMCII.Inasubanalysislimitedtopatientswithactivedisease(baselineBASDAI≥4),theMCIIwas1.1fortheBASDAIand0.6fortheBASFI.

CONCLUSION:

TheconceptualviabilityofthePASSfortheBASDAIisquestionablebecauselevelsapproachthoserequiredforthestartofbiologicaltherapy.BecausetheMCIIislessvariablethanthePASS,weproposeitsexclusiveuse,withcutoffsof1.1/0.6fortheBASDAI/BASFIinpatientswithactivedisease.Becausethesevaluesarebasedonasubsetofthestudypopulation,were







































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