Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study

被引：0

作者：

Jonathan Kay

Janusz Jaworski

Rafal Wojciechowski

Piotr Wiland

Anna Dudek

Marek Krogulec

Slawomir Jeka

Agnieszka Zielinska

Jakub Trefler

Katarzyna Bartnicka-Maslowska

Magdalena Krajewska-Wlodarczyk

Piotr A. Klimiuk

Sang Joon Lee

Yun Ju Bae

Go Eun Yang

Jae Kyoung Yoo

Daniel E. Furst

Edward Keystone

机构：

[1] University of Massachusetts Medical School and UMass Memorial Medical,

[2] Reumatika-Centrum Reumatologii,undefined

[3] University Hospital No 2,undefined

[4] Medical University,undefined

[5] Centrum Medyczne AMED,undefined

[6] Rheumatology Clinic NZOZ Lecznica MAK-MED,undefined

[7] Nasz Lekarz Przychodnie Medyczne,undefined

[8] Medycyna Kliniczna Marzena Waszczak-Jeka,undefined

[9] Reuma Centrum,undefined

[10] Centrum Medyczne AMED Oddzial w Lodzi,undefined

[11] University of Warmia and Mazury,undefined

[12] Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk,undefined

[13] Celltrion,undefined

[14] Inc.,undefined

[15] University of California,undefined

[16] University of Washington,undefined

[17] University of Florence,undefined

[18] University of Toronto,undefined

来源：

Arthritis Research & Therapy | / 23卷

关键词：

Adalimumab; Biologics; Biosimilars; Comparative effectiveness; Immunogenicity; Monoclonal antibodies; Rheumatoid arthritis; Safety; Tumor necrosis factor inhibitors;

D O I：

暂无

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学科分类号：

摘要：

引用

共 56 条

[1]

Singh JA(2016)2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis Arthritis Rheumatol. 68 1-26

[2]

Saag KG(2003)Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis) J Rheumatol 30 2563-2571

[3]

Bridges SL(2004)Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial Arthritis Rheum 50 1400-1411

[4]

Akl EA(2004)Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed Ann Rheum Dis 63 508-1588

[5]

Bannuru RR(2017)EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update Ann Rheum Dis 76 960-1209

[6]

Sullivan MC(2010)2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative Ann Rheum Dis 69 1580-48

[7]

Furst DE(1999)Test-based exact confidence intervals for the difference of two binomial proportions Biometrics. 55 1202-1687

[8]

Schiff MH(2018)Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis Arthritis Rheumatol 70 40-921

[9]

Fleischmann RM(2017)Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study Ann Rheum Dis 76 1679-undefined

[10]

Strand V(2018)Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study Ann Rheum Dis 77 914-undefined

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