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Volumn 10, Issue 6, 2018, Pages 934-943

Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial

(27)  Park, Won a   Božić Majstorović, Ljubinka b   Milakovic, Dragana b   Berrocal Kasay, Alfredo c   El Khouri, Elias Chalouhi d   Irazoque Palazuelos, Fedra e   Molina, Francisco Fidencio Cons f   Shesternya, Pavel g   Miranda, Pedro h   Medina Rodriguez, Francisco G i   Wiland, Piotr j   Jeka, Slawomir k   Chavez Corrales, Jose l   Garmish, Olena m   Linde, Thomas n   Rekalov, Dmytro o   Hrycaj, Pawel p   Krause, Andreas q   Fomina, Natalia r   Piura, Olena s   more..


Author keywords

biosimilar; CT P10; equivalence; rheumatoid arthritis; Rituximab

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; CERTOLIZUMAB PEGOL; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; RITUXIMAB; ANTIRHEUMATIC AGENT; BIOSIMILAR AGENT; CT-P10; MONOCLONAL ANTIBODY;

EID: 85050005180     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2018.1487912     Document Type: Article
Times cited : (49)

References (24)
  • 2
    • 77950205489 scopus 로고    scopus 로고
    • B cells in the pathogenesis and treatment of rheumatoid arthritis
    • Marston B, Palanichamy A, Anolik JH., B cells in the pathogenesis and treatment of rheumatoid arthritis. Curr Opin Rheumatol. 2010;22(3):307–315. doi:10.1097/BOR.0b013e3283369cb8
    • (2010) Curr Opin Rheumatol , vol.22 , Issue.3 , pp. 307-315
    • Marston, B.1    Palanichamy, A.2    Anolik, J.H.3
  • 3
    • 24944472774 scopus 로고    scopus 로고
    • B cells: a fundamental role in the pathogenesis of rheumatoid arthritis?
    • Suppl
    • Panayi GS. B cells: a fundamental role in the pathogenesis of rheumatoid arthritis? Rheumatology (Oxford). 2005;44 (Suppl 2):ii3–ii7. doi:10.1093/rheumatology/keh616
    • (2005) Rheumatology (Oxford) , vol.44 , Issue.2 , pp. ii3-ii7
    • Panayi, G.S.1
  • 4
    • 33745263037 scopus 로고    scopus 로고
    • Rituximab, an anti-CD20 monoclonal antibody: history and mechanism of action
    • Pescovitz MD. Rituximab, an anti-CD20 monoclonal antibody: history and mechanism of action. Am Journal Transplant. 2006;6(5 Part 1):859–866. doi:10.1111/j.1600-6143.2006.01288.x
    • (2006) Am Journal Transplant , vol.6 , pp. 859-866
    • Pescovitz, M.D.1
  • 5
    • 33746961890 scopus 로고    scopus 로고
    • 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
    • Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, Keystone EC, Loveless JE, Burmester G-R, Cravets 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(9):2793–2806. doi:10.1002/art.22025
    • (2006) Arthritis Rheum , vol.54 , Issue.9 , pp. 2793-2806
  • 6
    • 2942537697 scopus 로고    scopus 로고
    • Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis
    • Edwards JCW, Szczepanski L, Szechinski J, Filipowicz-Sosnowska A, Emery P, Close DR, Stevens RM, Shaw T. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350(25):2572–2581. doi:10.1056/NEJMoa032534
    • (2004) N Engl J Med , vol.350 , Issue.25 , pp. 2572-2581
  • 7
    • 33646483031 scopus 로고    scopus 로고
    • 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
    • Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, Racewicz AJ, van Vollehoven RF, Li NF, Agarwal S, 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(5):1390–1400. doi:10.1002/art.21778
    • (2006) Arthritis Rheum , vol.54 , Issue.5 , pp. 1390-1400
  • 10
    • 84987818368 scopus 로고    scopus 로고
    • A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis
    • Yoo DH, Suh C-H, Shim SC, Jeka S, Cons Molina FF, Hrycaj P, Wiland P, Lee EY, Medina-Rodriguez FG, Shesternya P, 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):566–570. doi:10.1136/annrheumdis-2016-209540
    • (2017) Ann Rheum Dis , vol.76 , Issue.3 , pp. 566-570
  • 11
    • 85020658439 scopus 로고    scopus 로고
    • 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
    • Park W, Suh C-H, Shim SC, Cons Molina FF, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, 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(4):369–377. doi:10.1007/s40259-017-0233-6
    • (2017) BioDrugs , vol.31 , Issue.4 , pp. 369-377
  • 12
    • 85020702202 scopus 로고    scopus 로고
    • 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
    • Yoo DH, Suh C-H, Shim SC, Jeka S, Cons Molina FF, Hrycaj P, Wiland P, Lee EY, Medina-Rodriguez FG, Shesternya P, 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(4):357–367. doi:10.1007/s40259-017-0232-7
    • (2017) BioDrugs , vol.31 , Issue.4 , pp. 357-367
  • 13
    • 85053428504 scopus 로고    scopus 로고
    • Efficacy and safety of rituximab biosimilar candidate (CTP-10) and innovator rituximab in patients with rheumatoid arthritis: Results from phase I randomized controlled trial over 72 weeks
    • Yoo DH, Park W, Suh C-H, Shim SC, Jeka S, Cons Molina FF, Hrycaj P, Spieler W, Wiland P, Brzezicki J. Efficacy and safety of rituximab biosimilar candidate (CTP-10) and innovator rituximab in patients with rheumatoid arthritis: results from phase I randomized controlled trial over 72 weeks. 2015 ACR/ARHP annual meeting: abstract number 2058. http://acrabstracts.org/abstract/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/
    • (2015) ACR/ARHP Annual Meeting: Abstract Number 2058
    • Yoo, D.H.1    Park, W.2    Suh, C.-H.3    Shim, S.C.4    Jeka, S.5    Cons Molina, F.F.6    Hrycaj, P.7    Spieler, W.8    Wiland, P.9    Brzezicki, J.10
  • 15
    • 85023743077 scopus 로고    scopus 로고
    • 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
    • Kim WS, Buske C, Ogura M, Jurczak W, Sancho JM, Zhavrid E, Kim JS, Hernández-Rivas JÁ, Prokharau A, Vasilica 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(8):e362–e373. doi:10.1016/S2352-3026(17)30120-5
    • (2017) Lancet Haematol , vol.4 , Issue.8 , pp. e362-e373
  • 16
    • 84880038044 scopus 로고    scopus 로고
    • False-positive immunogenicity responses are caused by CD20+ B cell membrane fragments in an anti-ofatumumab antibody bridging assay
    • Chen K, Page JG, Schwartz AM, Lee TN, DeWall SL, Sikkema DJ, Wang C. False-positive immunogenicity responses are caused by CD20+ B cell membrane fragments in an anti-ofatumumab antibody bridging assay. J Immunol Methods. 2013;394(1–2):22–31. doi:10.1016/j.jim.2013.04.011
    • (2013) J Immunol Methods , vol.394 , Issue.1-2 , pp. 22-31
    • Chen, K.1    Page, J.G.2    Schwartz, A.M.3    Lee, T.N.4    DeWall, S.L.5    Sikkema, D.J.6    Wang, C.7
  • 17
    • 84949671505 scopus 로고    scopus 로고
    • 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3–LBA, biomarkers and immunogenicity)
    • Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3–LBA, biomarkers and immunogenicity). Bioanalysis. 2015;7(24):3107–3124 doi:10.4155/bio.15.226
    • (2015) Bioanalysis , vol.7 , Issue.24 , pp. 3107-3124
    • Amaravadi, L.1    Song, A.2    Myler, H.3    Thway, T.4    Kirshner, S.5    Devanarayan, V.6    Ni, Y.G.7    Garofolo, F.8    Birnboeck, H.9    Richards, S.10
  • 18
    • 77955896561 scopus 로고    scopus 로고
    • 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))
    • Emery P, Deodhar A, Rigby WF, Isaacs JD, Combe B, Racewicz AJ, Latinis K, Abud-Mendoza C, Szczepanski LJ, Roschmann RA, 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(9):1629–1635. doi:10.1136/ard.2009.119933
    • (2010) Ann Rheum Dis , vol.69 , Issue.9 , pp. 1629-1635
  • 20
    • 84889688016 scopus 로고    scopus 로고
    • Inequities in access to biologic and synthetic DMARDs across 46 European countries
    • Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, Boonen A. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014;73(1):198–206. doi:10.1136/annrheumdis-2012-202603
    • (2014) Ann Rheum Dis , vol.73 , Issue.1 , pp. 198-206
    • Putrik, P.1    Ramiro, S.2    Kvien, T.K.3    Sokka, T.4    Pavlova, M.5    Uhlig, T.6    Boonen, A.7
  • 21
    • 84995704268 scopus 로고    scopus 로고
    • Safety and efficacy of biosimilars in oncology
    • Schellekens H, Smolen JS, Dicato M, Rifkin RM. Safety and efficacy of biosimilars in oncology. Lancet Oncol. 2016;17(11):e502–e509. doi:10.1016/S1470-2045(16)30374-6
    • (2016) Lancet Oncol , vol.17 , Issue.11 , pp. e502-e509
    • Schellekens, H.1    Smolen, J.S.2    Dicato, M.3    Rifkin, R.M.4
  • 22
    • 85020581561 scopus 로고    scopus 로고
    • The rituximab biosimilar CT-P10 in rheumatology and cancer: a budget impact analysis in 28 European countries
    • Gulacsi L, Brodszky V, Baji P, Rencz F, Pentek M. The rituximab biosimilar CT-P10 in rheumatology and cancer: a budget impact analysis in 28 European countries. Adv Ther. 2017;34(5):1128–1144. doi:10.1007/s12325-017-0522-y
    • (2017) Adv Ther , vol.34 , Issue.5 , pp. 1128-1144
    • Gulacsi, L.1    Brodszky, V.2    Baji, P.3    Rencz, F.4    Pentek, M.5
  • 23
    • 0023945481 scopus 로고
    • The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis
    • Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheumat. 1988;31(3):315–324. doi:10.1002/art.1780310302
    • (1988) Arthritis Rheumat , vol.31 , Issue.3 , pp. 315-324
  • 24
    • 33644790320 scopus 로고    scopus 로고
    • The Disease Activity Score and the EULAR response criteria
    • Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Clin Exp Rheumatol. 2005;23(5 Suppl 39):S93–S99
    • (2005) Clin Exp Rheumatol , vol.23 , pp. S93-S99
    • Fransen, J.1    van Riel, P.L.2


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