目標(biāo)治療課件

狼瘡:“目標(biāo)治療”的曙光?2019趙巖北京協(xié)和醫(yī)院風(fēng)濕免疫科cD20Rituximab):RCT研究EXPLORERLUNARBELIEVERSRINGEHlicacyandsafetyofrituximabinpatientswithactiveproliferativelupusnephritis:theLupusNephritisAssessmentwithRituximabstudy.ArthntisRheum2019;64(4)-1215-26EfficacyandsafetyofrituximabinModerately-to-SeverelyActiveSystemicLupuserythematosusTherandomized,Double-Blind,PhaseIi/lmiSystemicLupuserythematosusEvaluationofrituximabtrialEXPLORER研究:首個(gè)狼瘡治療研究的RcT目標(biāo)治療,并以失敗告終評(píng)價(jià)體系:BLAGAssessmentofflaresinlupuspatientsenrolledinaphasellllstudyofrituximab(EXPLORER).Lupus.2019:20(7):709-16cD20Rituximab):EXPLORER的主要目標(biāo)■主要臨床反應(yīng):24周所有器官BLAG評(píng)分C或更好并維持至52周,且整個(gè)實(shí)驗(yàn)中無(wú)中重度復(fù)發(fā)(中重度復(fù)發(fā):≥1個(gè)新的BLAG評(píng)分AB部分臨床反應(yīng):(1)24周時(shí)所有器官BLAG評(píng)分C或更好并維持16周以上(2)24周時(shí)≤1個(gè)器官BLAG評(píng)分B并維持至52周無(wú)中重度復(fù)發(fā)(3)24周時(shí)≤2個(gè)器官BLAG評(píng)分B并維持至52周無(wú)中重度復(fù)發(fā),但要求患者基線(xiàn)情況是:1A加≥2B,或≥2A,或≥4BAssessmentofflaresinlupuspatientsenrolledinaphasellllstudyofrituximab(EXPLORER).Lupus.2019:20(7):709-16716704口Placebop=0975070IRituximab失敗!8gaocooaoResponder29617215.9125124tients(n)631191421PartiaMCR+PCRResponseResponseAssessmentofflaresinlupuspatientsenrolledinaphasellllstudyofrituximab(EXPLORER).Lupus.2019:20(7):709-16EXPLORER研究的主要啟示:如何設(shè)定狼瘡治療的目標(biāo)Assessmentofflaresinlupuspatientsenrolledinaphasellllstudyofrituximab(EXPLORER).Lupus.2019:20(7):709-16Effcacyandsafetyofbelimumabinpatientswithactivesystemiclupuserythematosus:arandomised,lacebo-controlled,phase3trialSandraNavarra,RenatoMGUzman,AlbertoEGallacher,StephenHall,RogerALevy,RenatoEJimenez,EdmundK-MLiMathewThomeHo-YounKimManuelGLeon,ComanTanasescu,EugenyNasonov,Jong-LiangLan,LiiaPineda,ZjohnZhong,wiliamFreimuthMichelleAPetri.fortheBL/SS-52StudyGroupBLSS52研究:首個(gè)取得成功的狼瘡RCT目標(biāo)治療研究,成功!Lancet2019;377:721-31Belimumab(貝利木單抗}:BL|SS52研究活動(dòng)性狼瘡867例:SLEDAI>6,ANA或anti-dsDNA陽(yáng)性Belimumab10mg/kgo1mgkg(d0,1428以后每28d次至48W)+標(biāo)準(zhǔn)治療(Soc)主要終點(diǎn):SLEresponderindex(SRSLEDAI改善≥4無(wú)新發(fā)BILAGA,或新發(fā)B兒LAGB≤1PGA與基線(xiàn)相比無(wú)惡化(增加≤03/3)Lancet2019;377:721-31狼瘡治療藥物現(xiàn)狀:標(biāo)準(zhǔn)治療(standardofcare,SOC):基于小樣本觀察和開(kāi)放研究EFDA批準(zhǔn)的治