Rituximab biosimilar CT-P10 for the treatment of rheumatoid arthritis

References

• Bednar KJ, Nycholat CM, Rao TS, et al. Exploiting CD22 to selectively tolerize autoantibody producing B-cells in rheumatoid arthritis. ACS Chem Biol. 2019;14:644–654.
   PubMed Web of Science ®Google Scholar
• De Brito Rocha S, Baldo DC, Andrade LEC. Clinical and pathophysiologic relevance of autoantibodies in rheumatoid arthritis. Adv Rheumatol. 2019;59:2.
   PubMedGoogle Scholar
• Gerlag DM, Safy M, Maijer KI, et al. Effects of B-cell directed therapy on the preclinical stage of rheumatoid arthritis: the PRAIRI study. Ann Rheum Dis. 2019;78:179–185.
   PubMed Web of Science ®Google Scholar
• Marston B, Palanichamy A, Anolik JH. B cells in the pathogenesis and treatment of rheumatoid arthritis. Curr Opin Rheumatol. 2010;22:307–315.
   PubMed Web of Science ®Google Scholar
• Yap H-Y, Tee S, Wong M, et al. Pathogenic role of immune cells in rheumatoid arthritis: implications in clinical treatment and biomarker development. Cells. 2018;7:e161.
   PubMed Web of Science ®Google Scholar
• Rajabally H, Lee MA. Rituximab in the management of rheumatoid arthritis: current practice and future developments. J Clin Pharmacol. 2017;3:1012.
   Google Scholar
• Shaw T, Quan J, Totoritis M. B cell therapy for rheumatoid arthritis: the rituximab (anti-CD20) experience. Ann Rheum Dis. 2003;62(suppl 2):ii55–9.
   PubMed Web of Science ®Google Scholar
• Greenwald M, Tesser J, Sewell KL. Biosimilars have arrived: rituximab. Arthritis. 2018;2018:3762864.
   PubMedGoogle Scholar
• Protheroe A, Edwards J, Simmons A, et al. Remission of inflammatory arthropathy in association with anti-CD20 therapy for non-Hodgkin’s lymphoma. Rheumatology. 1999;38:1150–1152.
   PubMed Web of Science ®Google Scholar
• Edwards JC, Szczepański L, Szechiński J, et al. Efficacy of B-cell–targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350:2572–2581.
   PubMed Web of Science ®Google Scholar
• Emery P, Fleischmann R, Filipowicz‐Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double‐blind, placebo‐controlled, dose‐ranging trial. Arthritis Rheum. 2006;54:1390–1400.
   PubMed Web of Science ®Google Scholar
• Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: results of a multicenter, randomized, double‐blind, placebo‐controlled, phase III trial evaluating primary efficacy and safety at twenty‐four weeks. Arthritis Rheum. 2006;54:2793–2806.
   PubMed Web of Science ®Google Scholar
• Emery P, Deodhar A, Rigby W, et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study evaluating rituximab’s efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis. 2010;69:1629–1635.
   PubMed Web of Science ®Google Scholar
• Rubbert-Roth A, Tak PP, Zerbini C, et al. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology. 2010;49:1683–1693.
   PubMed Web of Science ®Google Scholar
• Mease PJ, Cohen S, Gaylis NB, et al. Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE trial. Rheumatology. 2010;37:917–927.
   Web of Science ®Google Scholar
• Tak P, Rigby W, Rubbert-Roth A, et al. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial. Ann Rheum Dis. 2011;70:39–46.
   PubMed Web of Science ®Google Scholar
• Kalkan A, Hallert E, Bernfort L, et al. Costs of rheumatoid arthritis during the period 1990–2010: a register-based cost-of-illness study in Sweden. Rheumatology. 2013;53:153–160.
   PubMed Web of Science ®Google Scholar
• Park W, Bozic-Majstorovic L, Milakovic D, et al. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. MAbs. 2018;10:934–943.
   PubMed Web of Science ®Google Scholar
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. US food and drug administration. 2015. [cited 2019 April 30]. Avaiable from: https://www.regulations.gov/document?D=FDA-2011-D-0605-0055
   Google Scholar
• Coiffier B. Pharmacokinetics, efficacy and safety of the rituximab biosimilar CT-P10. Expert Rev Clin Pharmacol. 2017;10:923–933.
   PubMed Web of Science ®Google Scholar
• Derbyshire M. USA and Europe differ in interchangeability of biosimilars. GaBI J. 2017;6:183–184.
   Google Scholar
• Dörner T, Strand V, Cornes P, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis. 2016;75:974–982.
   PubMed Web of Science ®Google Scholar
• N E. Commissioning framework for biological medicines (including biosimilar medicines). 2017. [cited 2019 Sep 17]. Avaiable from: https://www.england.nhs.uk/wp-content/uploads/2017/09/biosimilar-medicines-commissioning-framework.pdf.
   Google Scholar
• Kurki P, van Aerts L, Wolff-Holz E, et al. Interchangeability of biosimilars: a European perspective. BioDrugs. 2017;31:83–91.
   PubMed Web of Science ®Google Scholar
• La Noce A, Ernst M. Switching from reference to biosimilar products: an overview of the European approach and real-world experience so far. EMJ. 2018;3:74–81.
   Google Scholar
• Wiland P, Batko B, Brzosko M, et al. Biosimilar switching - current state of knowledge. Rheumatology. 2018;56:234–242.
   PubMedGoogle Scholar
• Yoo DH, Choe JY, Shim SC, et al. Switching to biosimilars in the treatment of rheumatic diseases. Expert Rev Clin Immunol. 2018;14:557–571.
   PubMed Web of Science ®Google Scholar
• Kumar R, Singh J. Biosimilar drugs: current status. Int J App Basic Med Res. 2014;4:63–66.
   PubMedGoogle Scholar
• Bas TG, Oliu Castillo C. Biosimilars in developed and developing east and southeast Asian countries: Japan, South Korea, and Malaysia—overview, evolution, and regulations assessment. BioMed Res Int. 2016;2016:5910403.
   PubMed Web of Science ®Google Scholar
• Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6:469–478.
   PubMedGoogle Scholar
• Kim WS, Buske C, Ogura M, et al. Efficacy, pharmacokinetics and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol. 2017;4:e362–73.
   PubMed Web of Science ®Google Scholar
• Ogura M, Sancho JM, Cho SG, et al. Efficacy, pharmacokinetics and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018;5:e543–53.
   PubMed Web of Science ®Google Scholar
• Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009;62:1006–1012.
   PubMed Web of Science ®Google Scholar
• Deeks ED. CT-P10 (Truxima): A rituximab biosimilar. BioDrugs. 2017;31:275–278.
   PubMed Web of Science ®Google Scholar
• Lee KH, Lee J, Bae JS, et al. Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product. MAbs. 2018;10:380–396.
   PubMed Web of Science ®Google Scholar
• Yoo DH, Suh CH, Shim SC, et al. Efficacy, safety and pharmacokinetics of up to two courses of the rituximab biosimilar CT-P10 versus innovator rituximab in patients with rheumatoid arthritis: results up to week 72 of a phase I randomized controlled trial. BioDrugs. 2017;31:357–367.
   PubMed Web of Science ®Google Scholar
• Liu L. Antibody glycosylation and its impact on the pharmacokinetics and pharmacodynamics of monoclonal antibodies and Fc-fusion proteins. J Pharm Sci. 2015;104:1866–1884.
   PubMed Web of Science ®Google Scholar
• Pereira NA, Chan KF, Lin PC, et al. The “less-is-more” in therapeutic antibodies: afucosylated anti-cancer antibodies with enhanced antibody-dependent cellular cytotoxicity. MAbs. 2018;10:693–711.
   PubMed Web of Science ®Google Scholar
• Congy-Jolivet N, Probst A, Watier H, et al. Recombinant therapeutic monoclonal antibodies: mechanisms of action in relation to structural and functional duality. Crit Rev Oncol Hematol. 2007;64:226–233.
   PubMed Web of Science ®Google Scholar
• Vestrheim AC, Moen A, Egge-Jacobsen W, et al. Different glycosylation pattern of human IgG1 and IgG3 antibodies isolated from transiently as well as permanently transfected cell lines. Scand J Immunol. 2013;77:419–428.
   PubMed Web of Science ®Google Scholar
• Treffers LW, van Houdt M, Bruggeman CW, et al. FcgammaRIIIb restricts antibody-dependent destruction of cancer cells by human neutrophils. Front Immunol. 2018;9:3124.
   PubMed Web of Science ®Google Scholar
• Kamen L, Myneni S, Langsdorf C, et al. A novel method for determining antibody-dependent cellular phagocytosis. J Immunol Methods. 2019;468:55–60.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Truxima summary of product characteristics. 2018 [cited 2019 Mar 8]. Avaiable from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004112/WC500222694.pdf.
   Google Scholar
• CT-P10 A PROPOSED BIOSIMILAR TO RITUXAN®FDA ADVISORY COMMITTEE MEETING BRIEFING DOCUMENT ONCOLOGIC DRUGS ADVISORY COMMITTEE. 2018; [cited 2019 Oct 10]. Availble from: https://www.fda.gov/media/121161/download.
   Google Scholar
• Yoo DH, Suh CH, 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;76:566–570.
   PubMed Web of Science ®Google Scholar
• Park W, Suh CH, Shim SC, et al. 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. BioDrugs. 2017;31:369–377.
   PubMed Web of Science ®Google Scholar
• Suh CH, Yoo DH, Berrocal Kasay A, et al. Long-term efficacy and safety of biosimilar CT-P10 versus innovator rituximab in rheumatoid arthritis: 48-week results from a randomized phase III trial. BioDrugs. 2019;33:79–91.
   PubMed Web of Science ®Google Scholar
• Shim SC, Božić-Majstorović L, Kasay AB, et al. Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial. Rheumatology. 2019 Jun 10;pii: kez152. DOI:10.1093/rheumatology/kez152.
   PubMed Web of Science ®Google Scholar