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辉凌将在ACG 2021上展示基于微生物群的在研活体生物治疗药物RBX2660用于治疗艰难梭菌反复感染和IBD患者的获奖真实临床转归分析

2021-10-20 国际文传 网络

值得注意的是,其中一项展示获得了主席壁报奖(The Presidential Poster Award),该奖旨在表彰优质、新颖、独特和有趣的研究。

辉凌医药(Ferring Pharmaceuticals)及辉凌旗下公司Rebiotix今天宣布,它们将在美国胃肠病学院(American College of Gastroenterology)年度科学会议暨研究生课程(ACG 2021)上展示两项回顾性分析的数据。此次会议将于2021年10月22日至27日在拉斯维加斯召开。

艰难梭菌反复感染(CDI)临床试验的入选标准通常是狭义的,不包括较广泛的患者群体。第一项展示将探讨基于微生物群的在研活体生物治疗药物RBX2660用于缓解真实世界环境中CDI患者病况的关键健康转归。第二项分析评估伴有或不伴炎性肠病(IBD)疾病的CDI患者的医疗资源占用和医药费。值得注意的是,其中一项展示获得了主席壁报奖(The Presidential Poster Award),该奖旨在表彰优质、新颖、独特和有趣的研究。

两项展示的摘要已通过审核,概述如下:

壁报P2217描述:真实世界CDI群体酌情给予在研RBX2660用药的回顾性分析。主席壁报奖获得者。

展示作者:康涅狄格州纽黑文耶鲁大学医学院内科助理临床教授、康涅狄格州哈姆登PACT胃肠科Paul Feuerstadt, MD, FACG, AGAF

最早发布时间:美国东部夏令时2021年10月24日下午3:30

壁报P2611描述:回顾性真实世界分析,研究伴有或不伴IBD的CDI医保受益人的费用

展示作者:康涅狄格州纽黑文耶鲁大学医学院内科助理临床教授、康涅狄格州哈姆登PACT胃肠科Paul Feuerstadt, MD, FACG, AGAF

最早发布时间:美国东部夏令时2021年10月24日下午3:30

ACG 2021已在其网站上发布上述摘要。

关于肠道微生物组和艰难梭菌感染

艰难梭菌感染(CDI)是影响全球民众的一种严重且可能致命的疾病。艰难梭菌是一种可引起致残性症状的细菌,例如重度腹泻、发烧、胃压痛或疼痛、食欲丧失、恶心和结肠炎1。美国疾病控制与预防中心(CDC)宣布CDI为公共卫生威胁,CDI每年仅在美国就可导致约50万人患病和数万人死亡,需要立即采取紧急行动1,2,3

艰难梭菌感染通常是复发恶性循环的开始,给患者和医疗系统造成沉重负担4,5。高达35%的CDI病例在初次诊断后会复发6,7,复发者发生进一步感染的风险显著升高8,9,10,11。据估计,首次复发后,高达60%的患者可能会再次复发12

艰难梭菌反复感染(rCDI)与肠道微生物组的破坏或“生态失调”有关。肠道微生物组是高度多样化的微生物群落,对人类健康有着至关重要的作用。越来越多的证据表明,肠道微生物组的组成和/或多样性受到破坏时,可能会带来相关的严重疾病风险,包括CDI。目前rCDI的标准治疗是抗生素,抗生素无法解决潜在的生态失调或恢复肠道微生物组13。研究显示,使用抗生素会破坏肠道微生物组的生态,而且也是rCDI的主要风险因素6,7,13

恢复肠道微生物组越来越被认为是艰难梭菌反复感染的一种有前途的治疗选择14

关于RBX2660

RBX2660是一种在研的、潜在的、同类首创的、基于微生物群的活体生物治疗药物,可将广谱多样的微生物集输送至肠道,以减少艰难梭菌反复感染。RBX2660已获得美国食品药品管理局(FDA)快通道、孤儿药和突破性治疗药物认证。枢纽性3期研究立足于近十年的研究,可靠的临床和微生物组数据采集自6项对照临床试验,参研者逾1,000例。

 

参考文献:

  1. Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.(美国疾病控制与预防中心。何为艰难梭菌?2018年12月17日。请访问https://www.cdc.gov/cdiff/what-is.html
  2. Centers for Disease Control and Prevention. Biggest Threats and Data. 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.(美国疾病控制与预防中心。最大威胁和数据。2019年11月14日。请访问https://www.cdc.gov/drugresistance/biggest-threats.html
  3. Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.(Fitzpatrick F、Barbut F。打破艰难梭菌反复感染的循环。《临床微生物学和感染》2012;18(增刊6):2-4)
  4. Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.(美国疾病控制与预防中心。2020年6月24日。请访问https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
  5. Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.(Feuerstadt P等。《医学经济学杂志》2020;23(6):603-609.)
  6. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.(Lessa FC、Mu Y、Bamberg WM等。美国艰难梭菌感染方面的负担。《新英格兰医学杂志》2015;372(9):825-834.)
  7. Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154–61.(Cornely OA等。艰难梭菌感染首次复发的治疗:非达索霉素vs万古霉素。《临床感染性疾病》2012;55(S2):S154–61.)
  8. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743. (Riddle DJ、Dubberke ER。重症监护病房中的艰难梭菌感染。《北美感染性疾病临床》2009;23(3):727-743.)
  9. Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims. J Manag Care Spec Pharm. Published online March 11, 2021. (Nelson WW等。老年人艰难梭菌反复感染的医疗卫生资源占用和成本:真实世界理赔。《管理式医疗和专科药房杂志》在线发表于2021年3月11日。)
  10. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27. (Kelly, CP. 我们能否识别艰难梭菌反复感染高危患者?《临床微生物学和感染》2012;18(增刊6): 21–27.)
  11. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20. (Smits WK等。艰难梭菌感染。《自然综述疾病引论》2016;2:16020. doi: 10.1038/nrdp.2016.20.)
  12. Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.(Leong C、Zelenitsky S。艰难梭菌反复感染的治疗策略。《加拿大医院药房杂志》2013;66(6):361-368.)
  13. Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med. 2016;8(1):39.(Langdon A、Crook N、Dantas G。抗生素开发全程对微生物组的效应以及治疗性调节的替代方法。《基因组医学》2016;8(1):39.)
  14. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficileN Engl J Med. 2013;368(5):407-415.  (van Nood E、Vrieze A、Nieuwdorp M等。十二指肠输注供体粪便用于治疗艰难梭菌反复。《新英格兰医学杂志》2013;368(5):407-415.)

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  3. [GetPortalCommentsPageByObjectIdResponse(id=1685533, encodeId=f2fe1685533c6, content=<a href='/topic/show?id=33ec184597' target=_blank style='color:#2F92EE;'>#ACG#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1845, encryptionId=33ec184597, topicName=ACG)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a63228213450, createdName=1249842em18(暂无昵称), createdTime=Tue Feb 08 13:07:28 CST 2022, time=2022-02-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1825335, encodeId=b10a182533548, content=<a href='/topic/show?id=702a5065860' target=_blank style='color:#2F92EE;'>#微生物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50658, encryptionId=702a5065860, topicName=微生物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b7c20, createdName=wjcjjian, createdTime=Fri Dec 03 04:07:28 CST 2021, time=2021-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1764014, encodeId=2a291e640149e, content=<a href='/topic/show?id=ecf88800939' target=_blank style='color:#2F92EE;'>#获奖#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88009, encryptionId=ecf88800939, topicName=获奖)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9d5937606588, createdName=若水135, createdTime=Sun Sep 04 20:07:28 CST 2022, time=2022-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1921853, encodeId=7d671921853dc, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Fri Sep 30 23:07:28 CST 2022, time=2022-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1970384, encodeId=2b0d19e038426, content=<a href='/topic/show?id=962a2306488' target=_blank style='color:#2F92EE;'>#临床转归#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23064, encryptionId=962a2306488, topicName=临床转归)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e080359, createdName=surilei, createdTime=Tue Oct 26 04:07:28 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1263675, encodeId=725312636e56c, content=<a href='/topic/show?id=75bc930217' target=_blank style='color:#2F92EE;'>#IBD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9302, encryptionId=75bc930217, topicName=IBD)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fc0372, createdName=bnurmamat, createdTime=Fri Oct 22 02:07:28 CST 2021, time=2021-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1367868, encodeId=d9ff136e868c7, content=<a href='/topic/show?id=2cee50e22c6' target=_blank style='color:#2F92EE;'>#微生物群#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50722, encryptionId=2cee50e22c6, topicName=微生物群)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3609256, createdName=zhu_jun9837, createdTime=Fri Oct 22 02:07:28 CST 2021, time=2021-10-22, status=1, ipAttribution=)]
    2022-09-04 若水135
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    2021-10-22 bnurmamat
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