Arthritis Rheumatol :利妥昔单抗+环磷酰胺+贝利木单抗治疗狼疮性肾炎的II期随机试验

2021-09-24 从医路漫漫 MedSci原创

评估利妥昔单抗联合贝利木单抗治疗难治性狼疮肾炎(LN)的安全性、作用机制和初步疗效。

目的:评估利妥昔单抗联合贝利木单抗治疗难治性狼疮肾炎(LN)的安全性、作用机制和初步疗效。

方法。在一项多中心、随机、开放标签的临床试验中,43例复发或难治性LN患者接受利妥昔单抗、环磷酰胺(CYC)和糖皮质激素治疗,随后每周输注贝利木单抗直到第48周(RCB组),或使用利妥昔单抗和CYC但不输注贝利木单抗(RC组)。患者随访至第96周。采用流式细胞术分析患者外周血中总B细胞和自体B细胞亚群的百分比。

结果:贝利木单抗治疗并没有增加难治性LN患者不良事件的发生率。在第48周,接受贝利木单抗治疗的21例患者中有11例(52%)发生了完全或部分肾脏反应,相比之下,RC组未接受贝利木单抗治疗的22例患者中有9例(41%)发生了完全或部分肾脏反应(P = 0.452)。LN缺乏改善或恶化是治疗失败的主要原因。两组均出现B细胞衰竭,但贝利木单抗组B细胞百分比仍较低(第60周B细胞几何平均数量,RCB组53细胞/μl, RC组11细胞/μl;P = 0.0012)。两组中总和自反应性过渡B细胞的百分比从基线到48周均有所增加。然而,与没有贝利木单抗的RC组相比,贝利木单抗组中总和自体反应的初代B细胞百分比从基线到第48周下降(P = 0.0349),这一发现与初代B细胞成熟受损和自体反应B细胞截短增强相一致。

图1 狼疮性肾炎患者外周血单个核细胞(PBMC)中B细胞总数和RC与RCB治疗后B细胞亚群的相对数目。治疗前、治疗后12周(左)和RC或RCB治疗后24-60周重建期间,外周血中A、B细胞计数(左)和RCB治疗后24-60周(右)外周血中A、B细胞计数。每个数据点代表单个患者的外周血液中的临床实验室检测所确定的CD19+B细胞计数。*=P<0.001;**=P<0.01;*=P<0.001。多重比较采用Tukey-Kramer事后调整。B,通过对冻存PBMC的流式细胞术分析,在每个治疗组的每个时间点,每个治疗组中每个B细胞亚群在总B细胞中的平均频率,包括在0周和24周分析的按方案样本和在48周和60周分析的按方案样本。对每个评估时间点的B细胞亚群数据进行分析,找出>50个细胞的亚群。*=治疗组间比较P<0.01。

图2 48周时,在符合方案的人群中,RC与RCB治疗后自身反应性抗核抗体阳性(ANA+)B细胞亚群的重建。A,治疗前和治疗后48周各组ANA+B细胞中B细胞亚群的平均数目。*=P<0.05;**=48周各组间P<0.01。B细胞、ANA+过渡性B细胞和ANA+幼稚B细胞占治疗前和治疗48周时外周血中总B细胞的百分比。每个数据点代表单个患者在每个时间点ANA+移行B细胞(左)或ANA+幼稚B细胞(右)的相对频率,用Fisher‘s精确检验确定P值。

结论:在难治性LN患者中,将贝利木单抗增加到利妥昔单抗和CYC治疗方案中是安全的。这种方案减少了B细胞重建过程中过渡到幼稚B细胞的成熟,并增强了自体反应B细胞的阴性选择。在狼疮性肾炎患者中,利妥昔单抗和环磷酰胺联合贝利木单抗与单独使用B细胞去除治疗策略相比,临床疗效没有改善。

原文出处:

Atisha-Fregoso Y,Malkiel S,Harris KM,et al,Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis.Arthritis Rheumatol 2021 01;73(1)

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    2022-01-26 susan0126

    好文

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1660513, encodeId=3148166051353, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Thu Oct 21 16:06:28 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1972769, encodeId=4e7619e2769c1, content=<a href='/topic/show?id=8a6a2e8839' target=_blank style='color:#2F92EE;'>#Arthritis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2788, encryptionId=8a6a2e8839, topicName=Arthritis)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Wed Jul 06 06:06:28 CST 2022, time=2022-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1188355, encodeId=48c9118835544, content=好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=767b1596691, createdName=susan0126, createdTime=Wed Jan 26 17:39:56 CST 2022, time=2022-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1055365, encodeId=8b9710553653b, content=好文章, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfc84293490, createdName=13f0c37dm61暂无昵称, createdTime=Mon Sep 27 14:46:24 CST 2021, time=2021-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1284379, encodeId=daa112843e994, content=<a href='/topic/show?id=73216852458' target=_blank style='color:#2F92EE;'>#环磷酰胺#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68524, encryptionId=73216852458, topicName=环磷酰胺)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=07f7192, createdName=waiwai3030, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357792, encodeId=3f53135e79253, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387459, encodeId=ddbc138e45992, content=<a href='/topic/show?id=8a3a6814425' target=_blank style='color:#2F92EE;'>#狼疮#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68144, encryptionId=8a3a6814425, topicName=狼疮)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6e2500005, createdName=sunrural_42825357, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1512182, encodeId=2743151218292, content=<a href='/topic/show?id=cfd19846697' target=_blank style='color:#2F92EE;'>#随机试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98466, encryptionId=cfd19846697, topicName=随机试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1c3710444656, createdName=124985dbm09(暂无昵称), createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532302, encodeId=26a215323023d, content=<a href='/topic/show?id=10b5825e4aa' target=_blank style='color:#2F92EE;'>#肾炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82574, encryptionId=10b5825e4aa, topicName=肾炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=84df12331144, createdName=villahu, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=)]
    2021-09-27 13f0c37dm61暂无昵称

    好文章

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1660513, encodeId=3148166051353, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Thu Oct 21 16:06:28 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1972769, encodeId=4e7619e2769c1, content=<a href='/topic/show?id=8a6a2e8839' target=_blank style='color:#2F92EE;'>#Arthritis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2788, encryptionId=8a6a2e8839, topicName=Arthritis)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Wed Jul 06 06:06:28 CST 2022, time=2022-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1188355, encodeId=48c9118835544, content=好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=767b1596691, createdName=susan0126, createdTime=Wed Jan 26 17:39:56 CST 2022, time=2022-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1055365, encodeId=8b9710553653b, content=好文章, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfc84293490, createdName=13f0c37dm61暂无昵称, createdTime=Mon Sep 27 14:46:24 CST 2021, time=2021-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1284379, encodeId=daa112843e994, content=<a href='/topic/show?id=73216852458' target=_blank style='color:#2F92EE;'>#环磷酰胺#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68524, encryptionId=73216852458, topicName=环磷酰胺)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=07f7192, createdName=waiwai3030, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357792, encodeId=3f53135e79253, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387459, encodeId=ddbc138e45992, content=<a href='/topic/show?id=8a3a6814425' target=_blank style='color:#2F92EE;'>#狼疮#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68144, encryptionId=8a3a6814425, topicName=狼疮)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6e2500005, createdName=sunrural_42825357, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1512182, encodeId=2743151218292, content=<a href='/topic/show?id=cfd19846697' target=_blank style='color:#2F92EE;'>#随机试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98466, encryptionId=cfd19846697, topicName=随机试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1c3710444656, createdName=124985dbm09(暂无昵称), createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532302, encodeId=26a215323023d, content=<a href='/topic/show?id=10b5825e4aa' target=_blank style='color:#2F92EE;'>#肾炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82574, encryptionId=10b5825e4aa, topicName=肾炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=84df12331144, createdName=villahu, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1660513, encodeId=3148166051353, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Thu Oct 21 16:06:28 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1972769, encodeId=4e7619e2769c1, content=<a href='/topic/show?id=8a6a2e8839' target=_blank style='color:#2F92EE;'>#Arthritis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2788, encryptionId=8a6a2e8839, topicName=Arthritis)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Wed Jul 06 06:06:28 CST 2022, time=2022-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1188355, encodeId=48c9118835544, content=好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=767b1596691, createdName=susan0126, createdTime=Wed Jan 26 17:39:56 CST 2022, time=2022-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1055365, encodeId=8b9710553653b, content=好文章, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfc84293490, createdName=13f0c37dm61暂无昵称, createdTime=Mon Sep 27 14:46:24 CST 2021, time=2021-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1284379, encodeId=daa112843e994, content=<a href='/topic/show?id=73216852458' target=_blank style='color:#2F92EE;'>#环磷酰胺#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68524, encryptionId=73216852458, topicName=环磷酰胺)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=07f7192, createdName=waiwai3030, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357792, encodeId=3f53135e79253, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387459, encodeId=ddbc138e45992, content=<a href='/topic/show?id=8a3a6814425' target=_blank style='color:#2F92EE;'>#狼疮#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68144, encryptionId=8a3a6814425, topicName=狼疮)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6e2500005, createdName=sunrural_42825357, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1512182, encodeId=2743151218292, content=<a href='/topic/show?id=cfd19846697' target=_blank style='color:#2F92EE;'>#随机试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98466, encryptionId=cfd19846697, topicName=随机试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1c3710444656, createdName=124985dbm09(暂无昵称), createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532302, encodeId=26a215323023d, content=<a href='/topic/show?id=10b5825e4aa' target=_blank style='color:#2F92EE;'>#肾炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82574, encryptionId=10b5825e4aa, topicName=肾炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=84df12331144, createdName=villahu, createdTime=Sun Sep 26 08:06:28 CST 2021, time=2021-09-26, status=1, ipAttribution=)]
    2021-09-26 zhaojie88
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    2021-09-26 villahu

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