Efficacy, Safety and Immunogenicity in Randomized, Double-Blind (DB) and OpenLabel Extension (OLE) Studies Comparing FKB327, an Adalimumab Biosimilar, with the Adalimumab Reference Product (Humira®; RP) in Patients (pts) with Active Rheumatoid Arthritis (RA)

被引：0
|
作者：
Genovese, Mark C. [1 ]
Glover, Josephine [2 ]
Matsunaga, Nobuhito [3 ]
Chisholm, Diane [4 ]
Alten, Rieke [5 ]
机构：
[1] Stanford Univ, Med Ctr, Palo Alto, CA 94304 USA
[2] Coephycient Pharmaceut Consultancy, Guildford, Surrey, England
[3] Fujifilm Kyowa Kirin Biol, Chiyoda Ku, Tokyo, Japan
[4] Fujifilm Kyowa Kirin Biol, Galashiels, Scotland
[5] Univ Med Berlin, Berlin, Germany
来源：
ARTHRITIS & RHEUMATOLOGY | 2017年 / 69卷
关键词：
D O I：
暂无
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
2799
引用
收藏
页数：2
相关论文
共 50 条
  • [21] Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial
    Jinmei Su
    Mengtao Li
    Lan He
    Dongbao Zhao
    Weiguo Wan
    Yi Liu
    Jianhua Xu
    Jian Xu
    Huaxiang Liu
    Lindi Jiang
    Huaxiang Wu
    Xiaoxia Zuo
    Cibo Huang
    Xiumei Liu
    Fen Li
    Zhiyi Zhang
    Xiangyuan Liu
    Lingli Dong
    Tianwang Li
    Haiying Chen
    Jingyang Li
    Dongyi He
    Xin Lu
    Anbin Huang
    Yi Tao
    Yanyan Wang
    Zhuoli Zhang
    Wei Wei
    Xiaofeng Li
    Xiaofeng Zeng
    BioDrugs, 2020, 34 : 381 - 393
  • [22] Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial
    Su, Jinmei
    Li, Mengtao
    He, Lan
    Zhao, Dongbao
    Wan, Weiguo
    Liu, Yi
    Xu, Jianhua
    Xu, Jian
    Liu, Huaxiang
    Jiang, Lindi
    Wu, Huaxiang
    Zuo, Xiaoxia
    Huang, Cibo
    Liu, Xiumei
    Li, Fen
    Zhang, Zhiyi
    Liu, Xiangyuan
    Dong, Lingli
    Li, Tianwang
    Chen, Haiying
    Li, Jingyang
    He, Dongyi
    Lu, Xin
    Huang, Anbin
    Tao, Yi
    Wang, Yanyan
    Zhang, Zhuoli
    Wei, Wei
    Li, Xiaofeng
    Zeng, Xiaofeng
    BIODRUGS, 2020, 34 (03) : 381 - 393
  • [23] Biosimilar BI 695501 and Adalimumab Reference Product (RP) Have Similar Efficacy and Safety in Patients (pts) with Moderately-to-Severely Active Rheumatoid Arthritis (RA): Long-Term Results from a Phase IIIb Extension Study (VOLTAIRE®-RAext)
    Cohen, Stanley
    Czeloth, Niklas
    Lees, Eric
    Klimiuk, Piotr A.
    Peter, Nuala
    Jayadeva, Girish
    ARTHRITIS & RHEUMATOLOGY, 2018, 70
  • [24] A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
    Kay, Jonathan
    Jaworski, Janusz
    Wojciechowski, Rafal
    Wiland, Piotr
    Dudek, Anna
    Krogulec, Marek
    Jeka, Slawomir
    Zielinska, Agnieszka
    Trefler, Jakub
    Bartnicka-Maslowska, Katarzyna
    Krajewska-Wlodarczyk, Magdalena
    Klimiuk, Piotr
    Furst, Daniel
    Lee, SangJoon
    Bae, Yunju
    Yang, Goeun
    Yoo, JaeKyoung
    Lee, HyunJin
    Keystone, Edward C.
    ARTHRITIS & RHEUMATOLOGY, 2020, 72
  • [25] Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab
    Blauvelt, Andrew
    Lacour, Jean-Phillipe
    Fowler, Joseph
    Schuck, Ellen
    Jauch-Lembach, Julia
    Balfour, Alison
    Leonardi, Craig
    ARTHRITIS & RHEUMATOLOGY, 2017, 69
  • [26] A RANDOMISED, DOUBLE-BLIND TRIAL COMPARING THE EFFICACY, SAFETY AND IMMUNOGENICITY OF MSB11022, A PROPOSED BIOSIMILAR OF ADALIMUMAB, VERSUS ADALIMUMAB ORIGINATOR IN PATIENTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS
    Hercogova, J.
    Papp, K. A.
    Edwards, C. J.
    Chyrok, V.
    Halady, T.
    Ullmann, M.
    Vlachos, P.
    ANNALS OF THE RHEUMATIC DISEASES, 2018, 77 : 1602 - 1602
  • [27] SUSTAINED EFFICACY AND COMPARABLE SAFETY AND IMMUNOGENICITY AFTER TRANSITION TO SB5 (AN ADALIMUMAB BIOSIMILAR) VS CONTINUATION OF THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULT OF PHASE III STUDY
    Weinblatt, M.
    Baranauskaite, A.
    Niebrzydowski, J.
    Dokoupilova, E.
    Zielinska, A.
    Sitek-Ziolkowska, K.
    Jaworski, J.
    Racewicz, A.
    Pileckyte, M.
    Jedrychowicz-Rosiak, K.
    Zhdan, V.
    Cheong, S. Y.
    Ghil, J.
    ANNALS OF THE RHEUMATIC DISEASES, 2016, 75 : 487 - 487
  • [28] A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib to Placebo and to Adalimumab, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Methotrexate
    Fleischmann, Roy
    Pangan, Aileen L.
    Mysler, Eduardo
    Bessette, Louis
    Peterfy, Charles
    Durez, Patrick
    Ostor, Andrew
    Li, Yihan
    Zhou, Yijie
    Othman, Ahmed A.
    Song, In-Ho
    Genovese, Mark C.
    ARTHRITIS & RHEUMATOLOGY, 2018, 70
  • [29] Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext)
    Cohen, Stanley B.
    Czeloth, Niklas
    Lee, Eric
    Klimiuk, Piotr A.
    Peter, Nuala
    Jayadeva, Girish
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2019, 19 (10) : 1097 - 1105
  • [30] Sustained Efficacy and Comparable Safety and Immunogenicity after Transition to SB5 (an Adalimumab Biosimilar) Vs. Continuation of SB5 or Reference Adalimumab (Humira®) in Patients with Rheumatoid Arthritis: Results of Phase III Study
    Weinblatt, Michael
    Baranauskaite, Asta
    Niebrzydowski, Jaroslaw
    Dokoupilova, Eva
    Zielinska, Agnieszka
    Sitek-Ziolkowska, Karina
    Jaworski, Janusz
    Racewicz, Artur
    Pileckyte, Margarita
    Jedrychowicz-Rosiak, Krystyna
    Zhdan, Vyacheslav
    Cheong, Soo Yeon
    Ghil, Jeehoon
    ARTHRITIS & RHEUMATOLOGY, 2016, 68
12345