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诺华推进Cosentyx(R)与Humira(R)和推荐生物类似药阿达木单抗相比的头对头优效性试验

2018-01-09 19:10 消息来源:诺华制药(中国)
  • SURPASS是首个与推荐生物类似药阿达木单抗**相比治疗强直性脊柱炎(AS)的头对头优效性试验1
  • EXCEED是首个与Humira®*相比治疗银屑病关节炎(PsA)的头对头优效性试验2
  • Cosentyx是一种靶向生物制剂,可抑制诱发附着点炎的基础细胞因子IL-17A3

巴塞尔2018年1月9日电 /美通社/ -- 诺华公司今天宣布启动SURPASS,即Cosentyx®(苏金单抗)与推荐生物类似药阿达木单抗**相比治疗强直性脊柱炎(AS)的头对头临床试验。SURPASS是首个研究Cosentyx与推荐生物类似药阿达木单抗相比在减缓脊柱骨损伤中有关AS优效性的头对头临床试验。SURPASS正在招募患者,已在2017年12月完成对“首例患者的首次访视”1

SURPASS和EXCEED是Cosentyx大型风湿病项目的一部分。EXCEED是比较Cosentyx与Humira®(阿达木单抗)治疗银屑病关节炎(PsA)效果的头对头临床试验,现正处于患者招募阶段。EXCEED是首个在PsA中与Humira®*进行比较的大型双盲头对头临床试验,以52周时Cosentyx对ACR20的优效性为主要终点2

荷兰海尔伦阿姆斯特丹风湿病学与临床免疫学中心及Zuyderland医学中心风湿病学教授Robert Landewe博士说:“EXCEED和SURPASS头对头试验正为PsA和AS患者解决悬而未决的重要临床问题。头对头试验提供了最有力的数据,有助于推动临床实践,是临床决策的关键。这次,我们会在证据中纳入此类数据,用于对医生强调不同生物途径的益处。”

诺华全球药品开发负责人兼首席医学官Vas Narasimhan称:“Cosentyx具有强大的临床疗效和安全性数据支持,全球已有超过12.5万例患者从中受益。许多PsA和AS患者因忍受持续疼痛和疲劳而不能享受正常生活,并且有可能长期丧失活动能力。这些患者应该得到最好的治疗,我们希望EXCEED和SURPASS试验能为医生和患者的决策提供有价值的答复。”

Cosentyx是首个抑制IL-17A的特异性靶向生物制剂,而IL-17A是诱发脊柱关节炎附着点炎患者的基础细胞因子,在PsA和AS中起主要作用3-6。这两种疾病均为自身免疫性疾病,活动能力丧失的风险很高。约40%的PsA患者可能出现不可逆的关节损伤和永久性残疾7。对于AS患者,骶髂关节炎症和脊柱新骨形成与IL-17A水平增加相关,严重病例可发展为不可逆性脊柱融合8

Cosentyx是首个、也是唯一一个获批用于治疗AS、PsA和银屑病的全人源IL-17A抑制剂4。该药表现出快速、持久的疗效以及持续有利的安全性,注射部位的疼痛反应率也与安慰剂类似9-15。至今,全球已有超过12.5万例患者使用过Cosentyx9

关于CosentyxIL-17A

Cosentyx(苏金单抗)是首个、也是唯一一个已获批用于治疗强直性脊柱炎(AS)、银屑病关节炎(PsA)和银屑病的全人源性IL-17A抑制剂4。Cosentyx是一种靶向药,能特异性抑制在AS、PsA和银屑病发病机理中发挥重要作用的基础细胞因子IL-17A3-6。Cosentyx已在欧盟、美国和日本等70余个国家和地区获批用于活动性AS和PsA的治疗16

Cosentyx已在80个以上的国家获批用于治疗中重度斑块状银屑病,包括欧盟、日本、瑞士、澳大利亚、美国和加拿大等。在欧洲,Cosentyx获批作为治疗中重度斑块状银屑病成年患者的一线系统性疗法。在美国,Cosentyx也获批用于适合接受系统性治疗或光疗的中重度斑块状银屑病成年患者17

关于SURPASS头对头临床试验1***

诺华已启动SURPASS,这是首个比较Cosentyx和推荐生物类似药阿达木单抗**的头对头优效性临床试验,其主要终点是减缓AS的脊柱骨损伤。对脊柱进行性结构性损伤的影响是临床医生评估AS治疗方案性能时考虑的重要特征之一。通过评估AS治疗的这一重要属性,SURPASS可帮助临床医生和患者做出更好的治疗决策,从而减缓脊柱结构损伤的进展。

SURPASS将成为最大的AS生物治疗随机对照研究。这是一项为期一年的平行研究,包括三个治疗组:在活动性AS患者中皮下注射(sc)Cosentyx 150mg、皮下注射Cosentyx 300mg或皮下注射生物类似药阿达木单抗**40mg。其主要终点是没有脊柱影像学结构进展的患者比例,界定方法为2年时mSASSS相对于基线的变化=<0.5。关键次要终点是2年时mSASSS的平均变化、新的韧带骨赘形成和炎症的MRI测量。

关于EXCEED头对头临床试验2***

诺华已启动EXCEED,这是首个对比评估Humira®*(阿达木单抗)与Cosentyx的大型、双盲头对头临床试验。EXCEED是一项为期一年的Ⅲb期多中心、随机、双盲、主动控制研究,用于评估Cosentyx单药治疗与Humira*单药治疗对接受初始生物疗法的活动性PsA患者的疗效。该研究将纳入一个大型患者群,涉及800个以上的初始生物治疗PsA患者。

其主要终点将评估Cosentyx单药与阿达木单抗单药治疗一年后ACR20缓解率的统计学优效性。在52周时将评估其他次要终点,包括PASI90、ACR50、相对于基线的伤残指数(HAQ-DI评分)和附着点炎的消除率。

关于强直性脊柱炎和银屑病关节炎

强直性脊柱炎(AS)和银屑病关节炎(PsA)都是终身性炎症性疾病。AS的特征在于骶髂关节炎症以及由IL-17A水平增加引起的脊柱中的新骨形成,严重病例发展为不可逆的脊柱融合3,8。AS可能会严重影响脊柱运动和身体机能,从而影响生活质量。二三十岁的人群特别是男性最常受到影响18,19

PsA是一种自身免疫性疾病,具有很高的活动能力丧失风险。PsA的症状包括关节疼痛和僵硬、皮肤和指甲银屑病、脚趾和手指肿胀、肌腱持续肿痛和不可逆转的关节损伤20。高达40%的患者可能会遭遇关节破坏和永久性身体畸形7

IL-17A在AS、PsA和斑块型银屑病的病理发生过程中发挥重要作用。高达30%的银屑病患者在一生中可能发生PsA,高达1/4的银屑病患者可能存在未确诊的PsA20,21

Disclaimer

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关于诺华

诺华致力于为患者及社会提供创新医药健康解决方案,以满足其日益变化的健康需求。总部位于瑞士巴塞尔,诺华集团拥有多元化业务组合以最好地满足这些需求,包含创新药、成本节约型非专利药和生物类似药以及眼科保健产品。诺华在上述各领域均处于全球领先地位。2016年,集团净销售额达485亿美元,集团研发投入约为90亿美元。诺华集团拥有近12.1万名全职员工。诺华的产品在全球155个国家和地区销售。如需更多信息,敬请登录公司网站http://www.novartis.com

关于诺华中国

“诺华”中文取意“承诺中华”,即承诺通过不断创新的产品和服务,致力于提高中国人民的健康水平和生活质量。诺华在中国的业务包括诺华肿瘤、诺华制药、山德士和爱尔康,全国建有三大生产基地,并在上海和江苏设立了两大研发中心。从研发到生产销售,诺华以多元化的业务组合,全面服务中国老百姓的健康。目前,诺华在中国全资或控股的公司共有六家。诺华在华雇员超过8000人。如需更多信息,敬请登录公司中文网站http://www.novartis.com.cn

* 修美乐是艾伯维公司的注册商标。

** SURPASS试验使用的推荐生物类似药阿达木单抗是山德士开发的复合药物,目前正接受欧洲药品管理局审查用于治疗几种免疫性疾病。

*** 此项试验并未在中国大陆开展

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