最新Analyses of Disease Progression by X Ray - U S Food and教学讲义ppt课件.ppt

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1、AnalysesofDiseaseProgressionbyXRay-USFoodandX-rayAnalysesofDiseaseProgressionDMARDs–Leflunomide–Methotrexate–SulfasalazineBiologicAgents–Etanercept–Infliximab–AnakinraPhaseIIITrials:AnalysisofX-rayData34–36jointsinthehands,12infeet44forerosions:0-5;48forjointspacenarrowing:0-4To

2、talscore=sumoferosions+jointspacenarrowingX-raysatbaselineandendpointinallstudiesAllfilmsreadbyDr.JohnSharp;blinded,randomsequenceAllfilmsreadbyDr.ArviLarsen;erosionscorescorrelated12monthITTin301USdespiteentryintoalternatetherapyorexitfromprotocolforactivetreatmentClinicaldatainpatie

3、ntswithandwithoutcompleteradiologicdatawerecomparableSensitivityanalysistoaccountforearlywithdrawalsSharpScoringMethod301MN301/3MN(6mos)(12mos)LEFPLSSZLEFSSZPhaseIIITrials–ChangeinTotalSharpScoresEstimatedYearlyProgressioninback;ChangeatEndpointinfront**LEFvPLp≤0.01SSZvPLp≤0.05ULTR

4、ATrial:US301MeanChangesinErosion+JSNScores:1yearMeanChange0.00.00.00.00.00.0MediansMN301MeanChangesinErosion+JSNScores:6mos.MeanChange0.00.00.00.03.00.5MediansMN302MeanChangesinErosion+JSNScores:1yearMeanChange0.00.00.00.0Medians11/02/98038301US301MN302MNLEFPLMTXLEFPLSSZLEFMTXTotalSha

5、rpScoresforACRRespondersvsNon-RespondersRespondersN712766501850181232Baseline:25.522.627.444.249.340.921.824.7atendpoint:0.21.00.41.34.72.71.70.1Non-respondersN58567239443512399Baseline:20.226.718.548.944.943.329.624.4atEndpoint:1.02.71.4-1.76.0-0.43.03.8PhaseIIITrials%ofPatients

6、withNoNewlyErodedJoints70%MTX68%LEFMN302:73%SSZ66%PL69%LEFMN301:77%MTX72%PL79%LEFULTRA:ERATrial:AnalysisofX-rayDataModifiedSharpScoringMethod36jointsforerosions(grades0-5);42forjointspacenarrowing(grades0-4);summedfortotalscoreX-raysatbaseline,6monthsand1yearModifications:Includedfe

7、et(vanderHeijde)Addedpercentagejointserodedornarrowedtogradingmethod(Rau)Eachcasereadby2of6physicianstrainedinthesamemethod(inter-readervariability:r=0.85)SequenceoffilmsblindedtoreadersMeanage495151Female(%)747474RAduration(meanmonths)11.910.911.9RFpositive(%)898787BaselineHAQDI1.41.

8、51.5M