诺华ACZ885在III期临床试验CANTOS受试者亚组中降低心血管风险25%

2017-11-17 诺华制药(中国) 诺华制药(中国)

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在III期临床试验CANTOS的最新分析中,亚组患者在使用卡那奴单抗(ACZ885)治疗之后主要心血管不良事件减少25%。该项新分析在2017年美国心脏协会科学年会上公布1


该分析表明,在开始使用卡那奴单抗3个月后,对于那些体内炎症 -- 按照高敏C反应蛋白(hsCRP)衡量下降到2mg/L以下的患者,心血管死亡率和全因死亡率均下降31%1

高敏C反应蛋白(hsCRP)是对剩余炎症风险进行评估的一种简单、廉价、广泛使用的生物标记物检测2

结果提示,将来医生或可判别哪些患者能从长期的卡那奴单抗治疗中得到最大的心血管获益
分析表明,亚组中需要治疗的患者人数(NNT)估计为16;CANTOS试验所有入组患者中NNT为241

2017年11月13日,在2017年美国心脏协会(AHA)科学年会上,Paul Ridker博士代表诺华公布了III期临床试验CANTOS的最新分析结果。该分析结果也同期发表于《柳叶刀》杂志。预先计划的对一个探索性终点的次级分析表明,在开始使用卡那奴单抗3个月后,对于那些hsCRP下降到2mg/L以下的、既往有心脏病发作病史的患者,与安慰剂组相比,主要心血管不良事件(MACE)减少25%(HRadj=0.75,95% CI 0.66-0.85,p<0.0001)1。此外,这些患者的心血管(CV)死亡率(HRadj=0.69,95% CI 0.56-0.85,p=0.0004)以及全因死亡率(HRadj=0.69, 95% CI 0.58-0.81,p<0.0001)均显著下降了31%1。在使用卡那奴单抗治疗后hsCRP≥2mg/L的患者中,没有观察到这些终点出现显著减少1。该项分析表明,治疗过程中的hsCRP检测也许可以作为一个快速可靠的途径,帮助医生判别哪些患者可以从长期的卡那奴单抗治疗中得到最大获益12,同时也证明,除了降低胆固醇之外,治疗炎症也可以显著降低心血管事件复发风险1

CANTOS研究首席专家、布莱根妇女医院心血管疾病防治中心主任Paul Ridker博士认为:“CANTOS分析结果提示,对卡那奴单抗的早期生物反应可以提供一种简便的方法,帮助医生判别哪些患者最有可能得到长期获益。重要的是,这些数据还支持在治疗有心脏病发作病史的患者时针对炎症施治的重要性,由此强化炎症水平‘越低越好’的医学认识。”

诺华集团全球药品开发负责人兼首席医学官Vas Narasimhan表示:“这个结果是个体化心血管药物领域一个振奋人心的新发展。个体化治疗手段除了能为患者带来有针对性的心血管获益,也可以提高整个医疗保健体系的成本效益。我们希望能在不远的将来为广大患者带去这项创新疗法。”

该分析也评估了需要治疗的患者人数(NNT)。NNT是一个用来描述医疗保健干预有效性的流行病学指标。NNT数值越低说明干预越有效。在该患者亚组中,估计的NNT为16。这意味着,为了避免一次死亡、心脏病发作、中风或冠状动脉血管重建事件,需要16名使用卡那奴单抗治疗hsCRP降至2mg/L以下的患者接受5年治疗1。在CANTOS试验所有入组患者中NNT为241

卡那奴单抗已被证实对炎症有重要作用,炎症与动脉粥样硬化血栓相关,而动脉粥样硬化血栓被认为是急性冠脉综合征和心血管死亡的主要原因13。炎症生物标记物(比如高敏C反应蛋白)升高的患者发生心血管事件的风险相应增加3。hsCRP是一种简单、廉价、广泛使用的生物标记物检测,可用于评估剩余炎症风险2。Paul Ridker博士的这项亚组分析既包括了3个月时hsCRP水平≥2mg/L的患者,也包括了低于2mg/L的患者。2mg/L是hsCRP衡量剩余炎症风险常用的一个临床分割点14。该项分析显示,治疗3个月后hsCRP低于2mg/L的患者可能从卡那奴单抗长期治疗中得到最大获益1。卡那奴单抗在hsCRP降至2mg/L以下的亚组患者中的安全性与参与研究的总体人群一致。在CANTOS研究中,所有剂量的卡那奴单抗组出现不良事件(AE)、严重不良事件以及由于AE导致停药的总体发生率与安慰剂组相当。治疗过程中的hsCRP水平与不良事件无关1

CANTOS是诺华历史上规模最大、持续时间最长的临床试验之一,在超过6年的时间入组患者总数超过1万人。之前公布的CANTOS研究初步数据表明,有心脏病发作病史及炎性动脉粥样硬化的患者使用150mg卡那奴单抗治疗后,MACE(包括心血管死亡、非致死性心肌梗死卒中等)得到了具有统计学意义的15%的下降5

诺华将根据最终监管意见决定是否在2017年第4季度将CANTOS 心血管数据提交监管部门审批。

关于CANTOS(NCT01327846)

卡那奴单抗抗炎血栓结局研究(CANTOS)(NCT01327846)是一项随机、双盲、安慰剂对照、事件驱动的III期临床研究,目的是评价按季度注射卡那奴单抗(ACZ885)联合标准治疗在预防复发性心血管(CV)事件中的有效性、安全性和耐受性,入组人群为10061名有既往心肌梗死(MI)病史并且高敏C反应蛋白(hsCRP)水平≥2mg/L的患者。该研究与安慰剂相比评价了卡那奴单抗的3种不同剂量。研究的主要终点为至首次发生主要心血管不良事件(MACE)的时间,MACE包括心血管死亡、非致死性心肌梗死和非致死性卒中。初步结果表明,相比于安慰剂,卡那奴单抗达到主要终点且使得MACE风险得到具有统计学意义的15%的下降(p值为0.021)5。该获益在整个研究期(随访中值为3.7年)内得到持续,而且总体上在各主要预设基线亚组中的情况一致5。次要终点包括至首次发生复合心血管终点的时间,包括心血管死亡、非致死性心肌梗死、非致死性卒中以及由于不稳定型心绞痛需要进行计划外血运重建导致的住院治疗;在随机时处于糖尿病前期患者中至新发2型糖尿病的时间;至发生非致死性心肌梗死、非致死性卒中或全因死亡的时间;以及至全因死亡的时间。研究持续时间约为6年。所有剂量的卡那奴单抗组出现不良事件(AE)、严重不良事件以及由于不良事件导致停药的总体发生率与安慰剂组相当。在平均3.7年的随访期间,患者报告严重感染的比例分别为11.3%和10.2%,报告恶性肿瘤的比例分别为6.4%和7.1%(分别对应卡那奴单抗150mg和安慰剂)5。致死性感染的情况十分罕见,安慰剂组中致死性感染的发生率约为千分之一5

在一项预设用于探索CANTOS研究中hsCRP降低和事件减少之间关系的次级分析中,研究人员根据治疗过程中的hsCRP水平评估了卡那奴单抗对于MACE、心血管死亡及全因死亡发生率的影响。研究人员使用多变量模型调整了与hsCRP水平相关的基线因素,使用多因素敏感性分析解决残余混杂量级的问题。

关于心脏病发作和炎性动脉粥样硬化

最大的5个欧盟国家每年约有580000例心脏病发作,仅在美国每年就有750000例。6,7虽然已存在优化的标准治疗,但有心脏病发作病史的患者再发主要心血管不良事件(包括心血管死亡、非致死性心肌梗死和非致死性卒中)的风险依然较高。7研究表明,对于约40%的患者,该风险直接与炎性动脉粥样硬化相关的炎症水平升高(生物标志物hsCRP水平≥2mg/L)相关。8炎性动脉粥样硬化患者中复发主要心血管不良事件(MACE)伴随着发病率、死亡率增加以及生活质量下降,因而是当前全世界患者和医疗卫生系统面临的一个主要经济负担。

关于ACZ885(canakinumab,卡那奴单抗)

卡那奴单抗(ACZ885)是一种抑制白介素-1β的选择性、高亲和力、完全人单克隆抗体。白介素-1β是炎症通路中的一种重要细胞因子,被认为会造成炎性动脉粥样硬化的持续发展9-13。卡那奴单抗的作用机制是通过持续阻断白介素-1β的作用,从而抑制由于其过度产生导致的炎症1415。卡那奴单抗是第一款以及唯一一款经证实可通过选择性治疗炎症显著降低心血管风险的研究性疗法。

注:

这是最新发布的CANTOS研究成果,该药物尚未在中国上市。

References

1.      Ridker PM, et al. Relationships of C-Reactive Protein Reduction to Cardiovascular Event Reduction Following Treatment with Canakinumab: Analyses from the Canakinumab Anti-inflammatory Thrombosis Outcomes Study(CANTOS). The Lancet. 2017.

2.      WebMD. Heart Disease and C_Reactive Protein(CRP) Testing. Available at: http://www.webmd.com/heart-disease/guide/heart-disease-c-reactive-protein-crp-testing#1. Last accessed: November 2017.

3.      Ridker PM. Testing the inflammatory hypothesis of atherothrombosis: scientific rationale for the cardiovascular inflammation reduction trial(CIRT). J Throm Haemost. 2009; 7(Suppl.1):332-9.

4.      Goff DC Jr, et al. ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014; 129:S49-S73.

5.      Ridker PM, et al. Anti-inflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med. 2017. 377:119-1131.

6.      EU5 MI trend. Based on Eurostat discharge data. Novartis data on file.

7.      Benjamin E, et al. Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association. Circulation. 2017; 135:e146-e603.

8.      Ridker PM. How Common Is Residual Inflammatory Risk? Circ Res. 2017; 120:617-619.

9.      Fearon WF, Fearon DT. Inflammation and cardiovascular disease: role of the interleukin-1 receptor antagonist. Circulation. 2008; 117:2577-2579.

10.   Duewell P, et al. NLRP3 inflammasomes are required for atherogenesis and activated by cholesterol crystals. Nature. 2010; 464(7293):1357-61.

11.   Rajamaki K, et al. Cholesterol Crystals Activate the NLRP3 Inflammasome in Human Macrophages: A Novel Link between Cholesterol Metabolism and Inflammation. PLoS One. 2010; 5(7):e11765.

12.   Ridker PM, Luscher TF. Anti-inflammatory therapies for cardiovascular disease. Eur Heart J. 2014; 35(27):1782- 91.

13.   Ridker PM. From C-Reactive Protein to Interleukin-6 to Interleukin-1. Circ Res. 2016; 118:145-156.

14.   Ridker PM, et al. Interleukin-1 p inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study(CANTOS). Am Heart J. 2011; 162(4):597-605.

15.   Ridker PM, et al. Effects of Interleukin-ip Inhibition with Canakinumab on Hemoglobin A1c, C-Reactive Protein, Interleukin-6 and Fibrinogen. Circulation. 2012; 126(23):2739-48.

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  3. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1446087, encodeId=d581144608e3a, content=<a href='/topic/show?id=23f4380e5f9' target=_blank style='color:#2F92EE;'>#受试者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38075, encryptionId=23f4380e5f9, topicName=受试者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=24035191312, createdName=xinmeili, createdTime=Sun Nov 19 01:29:00 CST 2017, time=2017-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524629, encodeId=54891524629b7, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sun Nov 19 01:29:00 CST 2017, time=2017-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588002, encodeId=3040158800232, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Sun Nov 19 01:29:00 CST 2017, time=2017-11-19, status=1, ipAttribution=)]
    2018-08-07 juliusluan78
  6. [GetPortalCommentsPageByObjectIdResponse(id=2088692, encodeId=411f208869203, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Wed Apr 25 01:29:00 CST 2018, time=2018-04-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2082433, encodeId=6af72082433f4, content=<a href='/topic/show?id=56658981223' target=_blank style='color:#2F92EE;'>#血管风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89812, encryptionId=56658981223, topicName=血管风险)], attachment=null, authenticateStatus=null, 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  7. 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  8. 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  9. 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