一项III期、随机、双臂、双盲、平行、活性对照、非劣效性临床试验，旨在比较生物类似药阿达木单抗（CinnoRA®）与参比产品（修美乐®）在活动性类风湿关节炎患者中的疗效和安全性。
A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis.
作者信息
Jamshidi Ahmadreza, Gharibdoost Farhad, Vojdanian Mahdi, Soroosh Soosan G, Soroush Mohsen, Ahmadzadeh Arman, Nazarinia Mohammad Ali, Mousavi Mohammad, Karimzadeh Hadi, Shakibi Mohammad Reza, Rezaieyazdi Zahra, Sahebari Maryam, Hajiabbasi Asghar, Ebrahimi Ali Asghar, Mahjourian Najmeh, Rashti Amin Mohammadinejad
机构信息
Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
AJA university of Medical Sciences Rheumatology research center, Tehran, Iran.
出版信息
Arthritis Res Ther. 2017 Jul 20;19(1):168. doi: 10.1186/s13075-017-1371-4.
BACKGROUND
This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA).
METHODS
In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted in patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the proportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20% (ACR20), 50% (ACR50), and 70% (ACR70) responses along with the disability index of health assessment questionnaire (HAQ), and safety.
RESULTS
Patients who were randomized to CinnoRA® or Humira® arms had comparable demographic information, laboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate EULAR responses in the CinnoRA® group was non-inferior to the Humira® group at 12 and 24 weeks based on both intention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in the proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA® and Humira® groups (all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant.
CONCLUSION
CinnoRA® was shown to be non-inferior to Humira® in terms of efficacy at week 24 with a comparable safety profile to the reference product.
TRIAL REGISTRATION
IRCT.ir, IRCT2015030321315N1 . Registered on 5 April 2015.
背景
本研究旨在比较试验用阿达木单抗（CinnoRA®，CinnaGen公司，伊朗）与原研产品（修美乐®，艾伯维公司，美国）在成年活动性类风湿关节炎（RA）患者中的疗效和安全性。
方法
在这项随机、双盲、活性药物对照、非劣效性试验中，共有136例活动性RA患者被随机分组，每两周接受一次40mg皮下注射CinnoRA®或修美乐®，同时在24周内接受甲氨蝶呤（15mg/周）、叶酸（1mg/天）和泼尼松龙（7.5mg/天）治疗。在基线以及第12周和第24周访视时对患者进行体格检查、生命体征评估和实验室检查。本研究的主要终点是达到基于28个关节红细胞沉降率（DAS28-ESR）的欧洲抗风湿病联盟（EULAR）反应中疾病活动度评分为中度和良好的患者比例。次要终点是达到美国风湿病学会（ACR）20%（ACR20）、50%（ACR50）和70%（ACR70）反应标准的患者比例，以及健康评估问卷（HAQ）残疾指数和安全性。
结果
随机分入CinnoRA®组或修美乐®组的患者在基线时的人口统计学信息、实验室检查结果和疾病特征具有可比性。基于意向性分析（ITT）人群和符合方案（PP）人群，CinnoRA®组在第12周和第24周达到良好和中度EULAR反应的患者比例不劣于修美乐®组（所有p值>0.05）。CinnoRA®组和修美乐®组达到ACR20、ACR50和ACR70反应的患者比例无显著差异（所有p值>0.05）。此外，治疗组之间HAQ评分和安全性指标的差异无统计学意义。
结论
在第24周时，CinnoRA®在疗效方面不劣于修美乐®，且安全性与参比产品相当。
试验注册
IRCT.ir，IRCT2015030321315N1。于2015年4月5日注册。
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