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Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study

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收录情况： ◇ SCIE

作者：
Ye Hua[1] ; Liu Shengyun[2] ; Xu Jian[3] ; Chai Kexia[4] ; He Dongyi[5] ; Fang Yongfei[6] ; Xie Qibing[7] ; Liu Huaxiang[8] ; Liu Ying[9] ; Hua Bingzhu[10] ; Hu Jiankang[11] ; Zhang Zhiyi[12] ; Zhou Mingxuan[13] ; Zhao Dongbao[14] ; Li Yan[15] ; Jiang Zhenyu[16] ; Wang Meimei[17] ; Li Jingyang[18] ; Zhang Zhuoli[19] ; Li Xiaomei[20] ; Li Yang[21] ; Sun Erwei[22] ; Bi Liqi[23] ; Wei Wei[24] ; Tie Ning[25] ; He Lan[26] ; Huang Xiangyang[27] ; Zhang Yan[28] ; Huang Qingchun[29] ; Wang Xiaofei[30] ; Liu Xiangyuan[31] ; Li Jing[32] ; Su Yin[1] ;
机构： [1]Rheumatology Department, Peking University People's Hospital, No. 11, XiZhimen South Street, Beijing, 100044, China. [2]Rheumatology and Immunology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [3]Rheumatology and Immunology Department, First Affiliated Hospital of Kunming Medical University, Kunming, China. [4]Rheumatology and Immunology Department, Qinghai University Affiliated Hospital, Xining, China. [5]Arthrology Department, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China. [6]Rheumatology and Immunology Department of Traditional Chinese Medicine, The Southwest Hospital of Army Medical University, Chongqing, China. [7]Rheumatology and Immunology Department, West China Hospital Sichuan University, Chengdu, China. [8]Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China. [9]Rheumatology and Immunology Department of Traditional Chinese Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. [10]Rheumatology and Immunology Department, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China. [11]Rheumatology and Immunology Department, Pingxiang People's Hospital, Pingxiang, China. [12]Rheumatology and Immunology Department, The First Affiliated Hospital of Harbin Medical University, Harbin, China. [13]Immunology Department, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China. [14]Rheumatology and Immunology Department, Changhai Hospital of Shanghai, Shanghai, China. [15]Rheumatology and Immunology Department, The First Affiliated Hospital of Xiamen University, Xiamen, China. [16]Rheumatology and Immunology Department, The First Hospital of Jilin University, Changchun, China. [17]Rheumatology and Immunology Department, Zhongda Hospital Southeast University, Nanjing, China. [18]Rheumatology and Immunology Department, Zhuzhou Central Hospital, Zhuzhou, China. [19]Rheumatology and Immunology Department, Peking University First Hospital, Beijing, China. [20]Rheumatology and Immunology Department, Anhui Provincial Hospital, Hefei, China. [21]Rheumatology and Immunology Department, The Second Affiliated Hospital of Harbin Medical University, Harbin, China. [22]Rheumatology and Immunology Department, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China. [23]Rheumatology and Immunology Department, China-Japan Union Hospital of Jilin University, Changchun, China. [24]Rheumatology and Immunology Department, Tianjin Medical University General Hospital, Tianjin, China. [25]Rheumatology and Immunology Department, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot City, China. [26]Rheumatology and Immunology Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [27]Rheumatology and Immunology Department, The Second Xiangya Hospital of Central South University, Changsha, China. [28]Rheumatology and Immunology Department, The Second Affiliated Hospital, Tangdu Hospital The Air Force Military Medical University, Xi'an, China. [29]Rheumatology Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. [30]Rheumatology and Immunology Department, Shengjing Hospital of China Medical University, Shenyang, China. [31]Rheumatology and Immunology Department, Peking University Third Hospital, Beijing, China. [32]Mabpharm Limited, Taizhou, China.
出处：
DOI： 10.1007/s40744-023-00544-2
ISSN：

关键词： Infliximab CMAB008 Biosimilar Rheumatoid arthritis Clinical equivalence

摘要：
The aim of this work is to verify the non-inferior efficacy and safety of CMAB008 compared with innovator infliximab in rheumatoid arthritis patients combined with methotrexate.We conducted a randomized, double-blinded, parallel, positive control design, multicenter study, with a stable dose of methotrexate. Patients were enrolled randomly with a ratio of 1:1 to receive intravenously CMAB008 3 mg/kg or innovator infliximab 3 mg/kg at weeks 0, 2, 6, 14, 22 and 30. The primary efficacy endpoint was American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 30. The non-inferiority was established if the lower limit of the one-sided 97.5% confidence interval (CI) for the difference was more than - 15% and the equivalence was established if the two-sided 95% CI was within ± 15% in an exploratory equivalence analysis. The secondary endpoints included other efficacy assessment parameters, as well as immunogenicity, safety, and pharmacokinetics.In the full analysis population (FAS), 110 (57.6%) of 191 patients in the CMAB008 group and 120 (62.2%) of 193 patients in the innovator infliximab group reached the primary outcome of ACR20 at week 30. The differences of the rates were - 4.6% and the lower limit of one-sided 97.5% confidence interval was - 14.29%, not less than the lower limit of the non-inferiority margin (- 15%); so CMAB008 was non-inferior to innovator infliximab. Further, CMAB008 was equivalent to innovator infliximab both in FAS (difference - 4.6%, 95% CI - 14.29% to 5.12%) and PPS (difference - 3.3%, 95% CI - 13.18% to 6.62%). The efficacy, safety, immunogenicity, and pharmacokinetics are highly similar between CMAB008 and innovator infliximab.Non-inferior efficacy of CMAB008 to innovator infliximab is illustrated with similar early and lasting therapeutic effects, and the equivalence is further demonstrated. CMAB008 is well tolerated and has semblable safety compared with the innovator infliximab.NCT03478111.© 2023. The Author(s).

基金：
Chinese National Key Technology R&D Program, Ministry of Science and Technology (Grant number: 2018ZX09301002-001) and Mabpharm Limited. The Open Access fee of this article was funded by Mabpharm Limited.
语种：
外文
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PubmedID：
中科院(CAS)分区：
出版当年[2024]版：
无
最新[2023]版：
大类 | 3 区 医学
小类 | 3 区 风湿病学
JCR分区：
出版当年[2023]版：
Q2 RHEUMATOLOGY
最新[2023]版：
Q2 RHEUMATOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Rheumatology Department, Peking University People's Hospital, No. 11, XiZhimen South Street, Beijing, 100044, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Ye Hua,Liu Shengyun,Xu Jian,et al.Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study[J].Rheumatology and therapy.2023,doi:10.1007/s40744-023-00544-2.
APA：
Ye Hua,Liu Shengyun,Xu Jian,Chai Kexia,He Dongyi...&Su Yin.(2023).Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study.Rheumatology and therapy,,
MLA：
Ye Hua,et al."Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study".Rheumatology and therapy .(2023)

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