Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304–16.
Article
Google Scholar
Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76:355–63.
Article
CAS
Google Scholar
Tanaka Y, Yamanaka H, Takeuchi T, Inoue M, Saito K, Saeki Y, et al. Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol. 2017;27:237–45.
Article
CAS
Google Scholar
Glintborg B, Sørensen IJ, Loft AG, Lindegaard H, Linauskas A, Hendricks O, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017;76:1426–31.
Article
CAS
Google Scholar
Brodszky V, Baji P, Balogh O, Péntek M, Brodszky V. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S65-71.
Article
Google Scholar
Valido A, Silva-Dinis J, Saavedra MJ, Iria I, Gonçalves J, Lopes JP, et al. Efficacy, immunogenicity and cost analysis of a systematic switch from originator infliximab to biosimilar CT-P13 of all patients with inflammatory arthritis from a single center. Acta Reumatol Port. 2019;44:303–11.
PubMed
Google Scholar
Lee SJ, Baek K, Lee S, Lee YJ, Park JE, Lee SG. Post-marketing pooled safety analysis for CT-P13 Treatment of patients with immune-mediated inflammatory diseases in observational cohort studies. BioDrugs. 2020;34:513–28.
Article
CAS
Google Scholar
Krintel SB, Grunert VP, Hetland ML, Johansen JS, Rothfuss M, Palermo G, et al. The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure. Rheumatology (Oxford). 2013;52:1245–53.
Article
CAS
Google Scholar
Wolbink GJ, Vis M, Lems W, Voskuyl AE, de Groot E, Nurmohamed MT, Stapel S, et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum. 2006;54:711–5.
Article
Google Scholar
Moots RJ, Xavier RM, Mok CC, Rahman MU, Tsai WC, Al-Maini MH, et al. The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study. PLoS ONE. 2017;12: e0175207.
Article
Google Scholar
Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315–24.
Article
CAS
Google Scholar
Bálint A, Rutka M, Végh Z, Kürti Z, Gecse KB, Banai J, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort. Expert Opin Drug Saf. 2017;16:885–90.
Article
Google Scholar
Patil A, Upadhyaya S, Dawar R, Dadhaniya N, Sood I, Gupta SJ, et al. Anti-drug antibodies and low serum trough infliximab levels correlate with disease activity measures in spondyloarthritis patients on an as-needed infliximab treatment. Int J Rheum Dis. 2019;22:1638–43.
Article
CAS
Google Scholar
Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab biosimilar CT-P13 observational studies for rheumatoid arthritis, inflammatory bowel diseases, and ankylosing spondylitis: pooled analysis of long-term safety and effectiveness. Adv Ther. 2021;38(8):4366–87.
Article
CAS
Google Scholar
Takeuchi T, Miyasaka N, Inui T, Yano T, Yoshinari T, Abe T, Koike T. High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study. Arthritis Res Ther. 2017;19:194.
Article
Google Scholar
Quistrebert J, Hässler S, Bachelet D, Mbogning C, Musters A, Tak PP, et al. Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: a European retrospective multicohort analysis. Semin Arthritis Rheum. 2019;48:967–75.
Article
CAS
Google Scholar
Hambardzumyan K, Hermanrud C, Marits P, Vivar N, Ernestam S, Wallman JK, et al. Association of female sex and positive rheumatoid factor with low serum infliximab and anti-drug antibodies, related to treatment failure in early rheumatoid arthritis: results from the SWEFOT trial population. Scand J Rheumatol. 2019;48:362–6.
Article
CAS
Google Scholar
Westhovens R, Wiland P, Zawadzki M, Ivanova D, Kasay AB, El-Khouri EC, Balázs É, Shevchuk S, Eliseeva L, Stanislavchuk M, Yatsyshyn R, Hrycaj P, Jaworski J, Zhdan V, Trefler J, Shesternya P, Lee SJ, Kim SH, Suh JH, Lee SG, Han NR, Yoo DH. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial. Rheumatology (Oxford). 2021;60(5):2277–87.
Article
CAS
Google Scholar
Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685–99.
Article
CAS
Google Scholar