Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis
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Edwards JCW, Cambridge G. B-cell targeting in rheumatoid arthritis and other autoimmune diseases. Nat Rev Immunol. 2006;6:394–403.
Lopez-Olivo MA, Amezaga Urruela M, McGahan L, et al. Rituximab for rheumatoid arthritis. Cochrane Database Syst Rev. 2015;1:CD007356.
Tak PP, Rigby W, Rubbert-Roth A, et al. Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE. Ann Rheum Dis. 2012;71:351–7.
Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68:1–26.
Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69:964–75.
Kuek A, Hazleman BL, Ostor AJ. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J. 2007;83:251–60.
World Health Organization. Expert Committee on Biological Standardization: Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf . Accessed 14 Feb 2017.
Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency. Guideline on Similar Biological Medicine Products. 23 October 2014. CHMP/437/04 Rev 1. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . Accessed 14 Feb 2017.
US Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Guidance for Industry. 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf . Accessed 14 Feb 2017.
Yoo DH, Suh C, Shim SC, et al. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76(3):566–70.
Yoo DH, Suh C, Shim SC, et al. Efficacy and safety of rituximab biosimilar candidate (CT-P10) and innovator rituximab in patients with rheumatoid arthritis: results from phase I randomized controlled trial over 72 weeks [abstract]. Arthritis Rheumatol. 2015;67(Suppl 10):2449–52.
Generics and Biosimilars Initiative (GaBI). EMA approval for rituximab biosimilar Truxima. 2017. http://www.gabionline.net/Biosimilars/News/EMA-approval-for-rituximab-biosimilar-Truxima . Accessed 14 Feb 2017.
Prevoo MLL, van’t Hof MA, Kuper HH, et al. Modified disease activity scores that include twenty-eight-joint counts development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38:44–8.
van Gestel AM, Prevoo ML, van’t Hof MA, et al. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum. 1996;39:34–40.
Keystone E, Fleischmann R, Emery P, et al. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007;56:3896–908.
Keystone EC, Cohen SB, Emery P, et al. Multiple courses of rituximab produce sustained clinical and radiographic efficacy and safety in patients with rheumatoid arthritis and an inadequate response to 1 or more tumor necrosis factor inhibitors: 5-year data from the REFLEX study. J Rheumatol. 2012;39:2238–46.
Van Vollenhoven RF, Emery P, Bingham CO, et al. Long-term safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010;37:558–67.
Davis-Ajami ML, Wu J, Downton K, et al. Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility. Biologics. 2014;8:155–67.
Flodmark CE, Lilja K, Woehling H, et al. Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden. Biol Ther. 2013;3:35–43.
Wizemann V, Rutkowski B, Baldamus C, et al. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin. 2008;24:625–37.
Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2016;76:346–54.
Yoo DH, Prodanovic N, Jaworski J, 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. 2016;76:355–63.