메뉴 건너뛰기




Volumn 33, Issue 11, 2013, Pages 795-800

Pharmacokinetics and safety of golimumab in healthy chinese subjects following a single subcutaneous administration in a randomized phase i trial

Author keywords

[No Author keywords available]

Indexed keywords

GOLIMUMAB;

EID: 84886409432     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-013-0124-7     Document Type: Article
Times cited : (21)

References (14)
  • 1
    • 68049099274 scopus 로고    scopus 로고
    • Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: Twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis
    • 19644849 10.1002/art.24638 1:CAS:528:DC%2BD1MXhtV2hsLvJ
    • Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009;60(8):2272-83.
    • (2009) Arthritis Rheum , vol.60 , Issue.8 , pp. 2272-2283
    • Emery, P.1    Fleischmann, R.M.2    Moreland, L.W.3    Hsia, E.C.4    Strusberg, I.5    Durez, P.6
  • 2
    • 67449133560 scopus 로고    scopus 로고
    • Golimumab, a human antibody to tumour necrosis factor α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: The GO-FORWARD Study
    • 19066176 10.1136/ard.2008.099010 1:CAS:528:DC%2BD1MXotVCjtL0%3D
    • Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, et al. Golimumab, a human antibody to tumour necrosis factor α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2009;68(6):789-96.
    • (2009) Ann Rheum Dis , vol.68 , Issue.6 , pp. 789-796
    • Keystone, E.C.1    Genovese, M.C.2    Klareskog, L.3    Hsia, E.C.4    Hall, S.T.5    Miranda, P.C.6
  • 3
    • 67650379733 scopus 로고    scopus 로고
    • Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): A multicentre, randomised, double-blind, placebo-controlled, phase III trial
    • 19560810 10.1016/S0140-6736(09)60506-7 1:CAS:528:DC%2BD1MXos12ru7o%3D
    • Smolen JS, Kay J, Doyle MK, Landewe R, Matteson EL, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374(9685):210-21.
    • (2009) Lancet , vol.374 , Issue.9685 , pp. 210-221
    • Smolen, J.S.1    Kay, J.2    Doyle, M.K.3    Landewe, R.4    Matteson, E.L.5    Wollenhaupt, J.6
  • 4
    • 65249137637 scopus 로고    scopus 로고
    • Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study
    • 19333944 10.1002/art.24403 1:CAS:528:DC%2BD1MXltFenu7g%3D
    • Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976-86.
    • (2009) Arthritis Rheum , vol.60 , Issue.4 , pp. 976-986
    • Kavanaugh, A.1    McInnes, I.2    Mease, P.3    Krueger, G.G.4    Gladman, D.5    Gomez-Reino, J.6
  • 5
    • 55849108826 scopus 로고    scopus 로고
    • Efficacy and safety of golimumab in patients with ankylosing spondylitis: Results of a randomized, double-blind, placebo-controlled, phase III trial
    • 18975305 10.1002/art.23969 1:CAS:528:DC%2BD1cXhsV2hs7nL
    • Inman RD, Davis JC Jr, Heijde D, Diekman L, Sieper J, Kim SI, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008;58(11):3402-12.
    • (2008) Arthritis Rheum , vol.58 , Issue.11 , pp. 3402-3412
    • Inman, R.D.1    Davis, Jr.J.C.2    Heijde, D.3    Diekman, L.4    Sieper, J.5    Kim, S.I.6
  • 6
    • 77953701867 scopus 로고    scopus 로고
    • Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study
    • 20444749 10.1136/ard.2009.116319 1:CAS:528:DC%2BC3cXos1GhsLw%3D
    • Keystone E, Genovese MC, Klareskog L, Hsia EC, Hall S, Miranda PC, et al. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study. Ann Rheum Dis. 2010;69(6):1129-35.
    • (2010) Ann Rheum Dis , vol.69 , Issue.6 , pp. 1129-1135
    • Keystone, E.1    Genovese, M.C.2    Klareskog, L.3    Hsia, E.C.4    Hall, S.5    Miranda, P.C.6
  • 7
    • 33847167546 scopus 로고    scopus 로고
    • Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis
    • 17322150 10.1177/0091270006298188 1:CAS:528:DC%2BD2sXjsVyjt78%3D
    • Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol. 2007;47(3):383-96.
    • (2007) J Clin Pharmacol , vol.47 , Issue.3 , pp. 383-396
    • Zhou, H.1    Jang, H.2    Fleischmann, R.M.3    Bouman-Thio, E.4    Xu, Z.5    Marini, J.C.6
  • 8
    • 77649211091 scopus 로고    scopus 로고
    • Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
    • 19940229 10.1177/0091270009340782 1:CAS:528:DC%2BC3cXjvFyrtrk%3D
    • Xu Z, Wang Q, Zhuang Y, Frederick B, Yan H, Bouman-Thio E, et al. Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects. J Clin Pharmacol. 2010;50(3):276-84.
    • (2010) J Clin Pharmacol , vol.50 , Issue.3 , pp. 276-284
    • Xu, Z.1    Wang, Q.2    Zhuang, Y.3    Frederick, B.4    Yan, H.5    Bouman-Thio, E.6
  • 9
    • 77953758429 scopus 로고    scopus 로고
    • Lack of racial differences in the pharmacokinetics of subcutaneous golimumab in healthy Japanese and Caucasian male subjects
    • 20133508 10.1177/0091270009355162 1:CAS:528:DC%2BC3cXpt1ejtLk%3D
    • Ling J, Lyn S, Xu Z, Achira M, Bouman-Thio E, Shishido A, et al. Lack of racial differences in the pharmacokinetics of subcutaneous golimumab in healthy Japanese and Caucasian male subjects. J Clin Pharmacol. 2010;50(7):792-802.
    • (2010) J Clin Pharmacol , vol.50 , Issue.7 , pp. 792-802
    • Ling, J.1    Lyn, S.2    Xu, Z.3    Achira, M.4    Bouman-Thio, E.5    Shishido, A.6
  • 10
    • 84862964714 scopus 로고    scopus 로고
    • Golimumab pharmacokinetics after repeated subcutaneous and intravenous administrations in patients with rheumatoid arthritis and the effect of concomitant methotrexate: An open-label, randomized study
    • 22169051 10.1016/j.clinthera.2011.11.015 1:CAS:528:DC%2BC38XhsVektbs%3D
    • Zhuang Y, Xu Z, Frederick B, de Vries DE, Ford JA, Keen M, et al. Golimumab pharmacokinetics after repeated subcutaneous and intravenous administrations in patients with rheumatoid arthritis and the effect of concomitant methotrexate: an open-label, randomized study. Clin Ther. 2012;34(1):77-90.
    • (2012) Clin Ther , vol.34 , Issue.1 , pp. 77-90
    • Zhuang, Y.1    Xu, Z.2    Frederick, B.3    De Vries, D.E.4    Ford, J.A.5    Keen, M.6
  • 12
    • 32444438731 scopus 로고    scopus 로고
    • Elimination mechanisms of therapeutic monoclonal antibodies
    • 16478695 10.1016/S1359-6446(05)03638-X 1:CAS:528:DC%2BD28XhsFygt70%3D
    • Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006;11(1-2):81-8.
    • (2006) Drug Discov Today , vol.11 , Issue.1-2 , pp. 81-88
    • Tabrizi, M.A.1    Tseng, C.M.2    Roskos, L.K.3
  • 13
    • 84864397954 scopus 로고    scopus 로고
    • Should clinical pharmacokinetic bridging studies between Caucasian and Asian populations be required for approval of monoclonal antibodies?
    • Zhou H, Tsukamoto Y, Davis HM. Should clinical pharmacokinetic bridging studies between Caucasian and Asian populations be required for approval of monoclonal antibodies? J Clin Pharmacol. 2012;52(8):1273-6.
    • (2012) J Clin Pharmacol , vol.52 , Issue.8 , pp. 1273-1276
    • Zhou, H.1    Tsukamoto, Y.2    Davis, H.M.3
  • 14
    • 84886407318 scopus 로고    scopus 로고
    • Horsham: Janssen Biotech, Inc.
    • Simponi: package insert. Horsham: Janssen Biotech, Inc.; 2013.
    • (2013) Simponi: Package Insert


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.