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
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
  • [1] LONG-TERM SAFETY, IMMUNOGENICITY AND EFFICACY IN RANDOMIZED, DOUBLE-BLIND, AND OPEN-LABEL EXTENSION STUDIES COMPARING FKB327, AN ADALIMUMAB BIOSIMILAR, WITH THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS
    Alten, Rieke
    Genovese, Mark C.
    Arai
    Muniz, Rafael
    Kellner, Herbert
    ANNALS OF THE RHEUMATIC DISEASES, 2019, 78 : 1135 - 1135
  • [2] Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis
    Alten, Rieke
    Markland, Colin
    Boyce, Malcolm
    Kawakami, Kazuki
    Muniz, Rafael
    Genovese, Mark C.
    INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, 2020, 23 (11) : 1514 - 1525
  • [3] Immunogenicity of a proposed adalimumab biosimilar, FKB327, and the reference product in patients with rheumatoid arthritis
    Alten, R.
    Markland, C.
    Kawakami, K.
    Boyce, M.
    Casty, F.
    Muniz, R.
    Genovese, M. C.
    JOURNAL OF CROHNS & COLITIS, 2019, 13 : S320 - S320
  • [4] EFFICACY AND SAFETY RESULTS OF A PHASE III STUDY COMPARING FKB327, AN ADALIMUMAB BIOSIMILAR, WITH THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS
    Alten, R.
    Glover, J.
    Matsunaga, N.
    Chisholm, D.
    Genovese, M.
    ANNALS OF THE RHEUMATIC DISEASES, 2017, 76 : 59 - 59
  • [5] Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies
    Genovese, Mark C.
    Kellner, Herbert
    Arai, Yasumasa
    Muniz, Rafael
    Alten, Rieke
    RMD OPEN, 2020, 6 (01):
  • [6] FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension
    Genovese, Mark C.
    Glover, Josephine
    Greenwald, Maria
    Porawska, Wieslawa
    El Khouri, Elias Chalouhi
    Dokoupilova, Eva
    Vargas, Juan Ignacio
    Stanislavchuk, Mykola
    Kellner, Herbert
    Baranova, Elena
    Matsunaga, Nobuhito
    Alten, Rieke
    ARTHRITIS RESEARCH & THERAPY, 2019, 21 (01)
  • [7] FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension
    Mark C. Genovese
    Josephine Glover
    Maria Greenwald
    Wieslawa Porawska
    Elias Chalouhi El Khouri
    Eva Dokoupilova
    Juan Ignacio Vargas
    Mykola Stanislavchuk
    Herbert Kellner
    Elena Baranova
    Nobuhito Matsunaga
    Rieke Alten
    Arthritis Research & Therapy, 21
  • [8] A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis
    Jani, Rajendrakumar H.
    Gupta, Rajiv
    Bhatia, Girish
    Rathi, Gaurav
    Kumar, Patnala Ashok
    Sharma, Reena
    Kumar, Uma
    Gauri, Liyakat A.
    Jadhav, Praveen
    Bartakke, Girishchandra
    Haridas, Vikram
    Jain, Dinesh
    Mendiratta, Sanjeev K.
    INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, 2016, 19 (11) : 1157 - 1168
  • [9] A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Efficacy, Safety and Immunogenicity of a Proposed Adalimumab Biosimilar (GP2017) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
    Wiland, Piotr
    Jeka, Slawomir
    Dokoupilova, Eva
    Miranda Limon, Juan Manuel
    Jauch-Lembach, Julia
    Thakur, Anjali
    Haliduola, Halimuniyazi
    Gaylis, Norman B.
    ARTHRITIS & RHEUMATOLOGY, 2018, 70
  • [10] A Prospective, Randomized, Double-blind, Comparative Clinical Study of Efficacy and Safety of a Biosimilar Adalimumab with Innovator Product in Patients with Active Rheumatoid Arthritis on a Stable Dose of Methotrexate
    Apsangikar, Prasad
    Chaudhry, Sunil
    Naik, Manoj
    Deoghare, Shashank
    Joseph, Jamila
    INDIAN JOURNAL OF RHEUMATOLOGY, 2018, 13 (02) : 84 - 89