阿斯利康关于银翘病的临床报告

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1、阿斯利康关于银翘病的临床报告May.9,2014AmgenAndAstraZenecaAnnouncePositiveResultsFromPhase3StudyOfBrodalumab(AMG827)InPatientsWithModerate-to-SeverePlaquePsoriasisStudyEvaluatingNovelInvestigationalIL-17ReceptorAntibodyMeetsAllPrimaryandSecondaryEndpointsTHOUSANDOAKS,Calif,an

2、dLONDON,May9,2014/PRNewswire/-Amgen(NASDAQ:AMGN)andAstraZenecatodayannouncedthatthePhase3AMAGINE-1TMstudyevaluatingbrodalumabinpatientswithmoderate-to-severeplaquepsoriasismetallprimaryandsecondaryendpointsforbothevaluateddoses・Brodalumabistheonlyinvestigationa

3、ltreatmentindevelopmentthatbindstotheinterleukin-17(IL-17)receptorandinhibitsinflammatorysignalingbyblockingthebindingofseveralIL-17ligandstothereceptor.Primaryendpointswerepatientsachievingatleasta75percentimprovementfrombaselineindiseaseseverityatweek12,asmea

4、suredbythePsoriasisAreaSeverityIndex(PASI75),andpatientsachievingclearoralmostclearskinatweek12accordingtothestaticPhysicianGlobalAssessment(sPGA0or1).AsigrdficantlyhigherproportionofpatientstreatedwithbrodalumabachievedaPASI75response(primaryendpoint),aswellas

5、PASI90andPASI100responsesatweek12(secondaryendpoints)comparedtoplacebo.Resultsshowedthat83.3percentofpatientsinthe210mggroupand60.3percentofpatientsinthe140mggroupachievedPASI75responsescomparedtoplacebo(2.7percent).Resultsalsoshowedthat70.3percentofpatientsint

6、he210mggroupand42.5percentofpatientsinthe140mggroupachievedPASI90responsescomparedtoplacebo(0.9percent).Further,41.9percentofpatientsinthe210mggroupand23.3percentofpatientsinthe140mggroupachievedPASI100responsescomparedtoplacebo(0.5percent).Ofthe661patientsenro

7、lledinthisstudy,46percentreportedpriorbiologicuseand28.7percentweighedmorethan100kilograms(kg)atbaseline(meanweightforthestudypopulationwas90.8kg).APASIscoreisameasureofpsoriaticplaqueredness,scalingandthicknessandtheextentofinvolvementineachregionofthebody.Tre

8、atmentefficacyisoftenmeasuredbythereductionofPASIfrombaseline(i.e.,a75percentreductionisknownasPASI75,a90percentreductionisknownasPASI90andPAS1100istotalclearanceofskindisea