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Lancet:依那西普维持治疗可控制类风湿关节炎疾病活动

2013-01-29 Lancet CMT 吴君德 编译

  一项名为PRESERVE的研究显示,对于中度活动的类风湿关节炎(RA)患者,与停用依那西普后单用甲氨蝶呤相比,常规或小剂量依那西普联合甲氨蝶呤对维持低疾病活动水平更有效。论文1月17日在线发表于《柳叶刀》(Lancet)杂志。   该研究纳入了全球80个中心的中度RA患者(18~70岁),给予每周25 mg~50 mg甲氨蝶呤(至少8周);在开放标签时期(36周),则给予

  一项名为PRESERVE的研究显示,对于中度活动的类风湿关节炎(RA)患者,与停用依那西普后单用甲氨蝶呤相比,常规或小剂量依那西普联合甲氨蝶呤对维持低疾病活动水平更有效。论文1月17日在线发表于《柳叶刀》(Lancet)杂志。

  该研究纳入了全球80个中心的中度RA患者(18~70岁),给予每周25 mg~50 mg甲氨蝶呤(至少8周);在开放标签时期(36周),则给予其每周50 mg依那西普+甲氨蝶呤,并维持低疾病活动水平。最终,604例患者进入52周的双盲阶段,随机接受甲氨蝶呤+50 mg、25 mg依那西普,或安慰剂治疗,并用28个关节疾病活动性评分(DAS28)反应进行分层。结果在第88周时,3组低疾病活动水平的患者比例分别为82.6%、79.1%,以及42.6%。


Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial

Background

Clinical remission and low disease activity are essential treatment targets in patients with rheumatoid arthritis. Although moderately active rheumatoid arthritis is common, treatment effects in moderate disease have not been well studied. Additionally, optimum use of biologics needs further investigation, including the use of induction, maintenance, and withdrawal treatment strategies. The aim of the PRESERVE trial was to assess whether low disease activity would be sustained with reduced doses or withdrawal of etanercept in patients with moderately active disease.

Methods

In a randomised controlled trial, patients aged between 18 and 70 years with moderately active rheumatoid arthritis (disease activity score in 28 joints [DAS28] >3·2 and ≤5·1) despite treatment with methotrexate were enrolled at 80 centres in Europe, Latin America, Asia, and Australia between March 6, 2008, and Sept 9, 2009. To be eligible, patients had to have been receiving 15—25 mg of methotrexate every week for at least 8 weeks. In an open-label period of 36 weeks, all patients were given 50 mg etanercept plus methotrexate every week. To be eligible for a subsequent double-blind period of 52 weeks, participants had to have achieved sustained low disease activity. These patients were randomly assigned (1:1:1) by an interactive voice-response system to one of three treatment groups: 50 mg etanercept plus methotrexate, 25 mg etanercept plus methotrexate, or placebo plus methotrexate. Patients were stratified in blocks of three by DAS28 response (low disease activity or remission) at week 36. Patients, investigators, data analysts, and study staff were all masked to treatment allocation. The primary endpoint was the proportion of patients with low disease activity at week 88 in the groups given 50 mg etanercept or placebo in the double-blind period. A conditional primary endpoint was the proportion of patients receiving 25 mg etanercept who achieved low disease activity. Modified intention-to-treat populations were used for analyses. This trial is registered with ClinicalTrials.gov, numberNCT00565409.

Findings

604 (72·4%) of 834 enrolled patients were eligible for the double-blind period, of whom 202 were assigned to 50 mg etanercept plus methotrexate, 202 to 25 mg etanercept plus methotrexate, and 200 to placebo plus methotrexate. At week 88, 166 (82·6%) of 201 patients who had received at least one dose of 50 mg etanercept and one or more DAS28 evaluations had low disease activity, compared with 84 (42·6%) of 197 who had received placebo (mean difference 40·8%, 95% CI 32·5—49·1%; p<0·0001). Additionally, 159 (79·1%) of 201 patients given 25 mg etanercept had low disease activity at week 88 (mean difference from placebo 35·9%, 27·0—44·8%; p<0·0001).

Interpretation

Conventional or reduced doses of etanercept with methotrexate in patients with moderately active rheumatoid arthritis more effectively maintain low disease activity than does methotrexate alone after withdrawal of etanercept.

Funding

Pfizer.

    

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1756022, encodeId=ca671e5602222, content=<a href='/topic/show?id=78e1e06924a' target=_blank style='color:#2F92EE;'>#疾病活动#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70692, encryptionId=78e1e06924a, topicName=疾病活动)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=57fa37069463, createdName=xue8614, createdTime=Fri Apr 26 18:32:00 CST 2013, time=2013-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827512, encodeId=a28a182e51248, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sun Oct 06 23:32:00 CST 2013, time=2013-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1265117, encodeId=39d3126511e92, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1333723, encodeId=d0e91333e23bc, content=<a href='/topic/show?id=5306e6164b6' target=_blank style='color:#2F92EE;'>#类风湿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76164, encryptionId=5306e6164b6, topicName=类风湿)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eq2AGzrugK9ZUjU3eJxzM901ophWib0xJDrSicy49ibWl3zB5pbDto7eoR6tnzwOiaKdbq1a8PcbYFFrw/132, createdBy=6ff22500098, createdName=ms4964546379600229, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1340431, encodeId=2b141340431a0, content=<a href='/topic/show?id=e4ed2693895' target=_blank style='color:#2F92EE;'>#依那西普#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26938, encryptionId=e4ed2693895, topicName=依那西普)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca772500164, createdName=ms1490123962508630, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1597202, encodeId=c008159e202f3, content=<a href='/topic/show?id=fa1710082017' target=_blank style='color:#2F92EE;'>#风湿关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100820, encryptionId=fa1710082017, topicName=风湿关节炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=456818510265, createdName=xuruicheng, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=)]
    2013-10-06 howi
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    2013-01-31 lmm397
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1756022, encodeId=ca671e5602222, content=<a href='/topic/show?id=78e1e06924a' target=_blank style='color:#2F92EE;'>#疾病活动#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70692, encryptionId=78e1e06924a, topicName=疾病活动)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=57fa37069463, createdName=xue8614, createdTime=Fri Apr 26 18:32:00 CST 2013, time=2013-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827512, encodeId=a28a182e51248, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sun Oct 06 23:32:00 CST 2013, time=2013-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1265117, encodeId=39d3126511e92, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1333723, encodeId=d0e91333e23bc, content=<a href='/topic/show?id=5306e6164b6' target=_blank style='color:#2F92EE;'>#类风湿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76164, encryptionId=5306e6164b6, topicName=类风湿)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eq2AGzrugK9ZUjU3eJxzM901ophWib0xJDrSicy49ibWl3zB5pbDto7eoR6tnzwOiaKdbq1a8PcbYFFrw/132, createdBy=6ff22500098, createdName=ms4964546379600229, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1340431, encodeId=2b141340431a0, content=<a href='/topic/show?id=e4ed2693895' target=_blank style='color:#2F92EE;'>#依那西普#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26938, encryptionId=e4ed2693895, topicName=依那西普)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca772500164, createdName=ms1490123962508630, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1597202, encodeId=c008159e202f3, content=<a href='/topic/show?id=fa1710082017' target=_blank style='color:#2F92EE;'>#风湿关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100820, encryptionId=fa1710082017, topicName=风湿关节炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=456818510265, createdName=xuruicheng, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1756022, encodeId=ca671e5602222, content=<a href='/topic/show?id=78e1e06924a' target=_blank style='color:#2F92EE;'>#疾病活动#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70692, encryptionId=78e1e06924a, topicName=疾病活动)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=57fa37069463, createdName=xue8614, createdTime=Fri Apr 26 18:32:00 CST 2013, time=2013-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827512, encodeId=a28a182e51248, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sun Oct 06 23:32:00 CST 2013, time=2013-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1265117, encodeId=39d3126511e92, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1333723, encodeId=d0e91333e23bc, content=<a href='/topic/show?id=5306e6164b6' target=_blank style='color:#2F92EE;'>#类风湿#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76164, encryptionId=5306e6164b6, topicName=类风湿)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eq2AGzrugK9ZUjU3eJxzM901ophWib0xJDrSicy49ibWl3zB5pbDto7eoR6tnzwOiaKdbq1a8PcbYFFrw/132, createdBy=6ff22500098, createdName=ms4964546379600229, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1340431, encodeId=2b141340431a0, content=<a href='/topic/show?id=e4ed2693895' target=_blank style='color:#2F92EE;'>#依那西普#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26938, encryptionId=e4ed2693895, topicName=依那西普)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca772500164, createdName=ms1490123962508630, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1597202, encodeId=c008159e202f3, content=<a href='/topic/show?id=fa1710082017' target=_blank style='color:#2F92EE;'>#风湿关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100820, encryptionId=fa1710082017, topicName=风湿关节炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=456818510265, createdName=xuruicheng, createdTime=Thu Jan 31 07:32:00 CST 2013, time=2013-01-31, status=1, ipAttribution=)]
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