메뉴 건너뛰기




Volumn 36, Issue 5, 2009, Pages 898-906

Postmarketing surveillance of the safety and effectiveness of etanercept in Japan

(12)  Koike, Takao b   Harigai, Masayoshi c   Inokuma, Shigeko d   Inoue, Kazuhiko e   Ishiguro, Naoki f   Ryu, Junnosuke g   Takeuchi, Tsutomu h   Tanaka, Yoshiya i   Yamanaka, Hisashi j   Fujii, Koichi k   Freundlich, Bruce a   Suzukawa, Michio k  


Author keywords

Efficacy; Etanercept; Japan; Postmarketing surveillance; Rheumatoid arthritis; Safety

Indexed keywords

BUCILLAMINE; CORTICOSTEROID; ETANERCEPT; INFLIXIMAB; METHOTREXATE; SALAZOSULFAPYRIDINE; ANTIRHEUMATIC AGENT; IMMUNOGLOBULIN G; TNFR FC FUSION PROTEIN; TNFR-FC FUSION PROTEIN; TUMOR NECROSIS FACTOR RECEPTOR;

EID: 67449102437     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: 10.3899/jrheum.080791     Document Type: Article
Times cited : (143)

References (26)
  • 1
    • 67649992632 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. MEDWatch Program. [Internet. Accessed February 6, 2009.] Available from: http://www.fda.gov/cder/handbook/medwatch.htm
    • U.S. Food and Drug Administration. MEDWatch Program. [Internet. Accessed February 6, 2009.] Available from: http://www.fda.gov/cder/handbook/medwatch.htm
  • 2
    • 67649983231 scopus 로고    scopus 로고
    • Carleton B, Foerster V, Warren L, Smith MA. Post-marketing pharmaco-surveillance in Canada. Health Canada website. [Internet. Accessed February 6, 2009.] Available from: http://www.hc-sc.gc.ca/hcs-sss/alt-formats/ hpb-dgps/pdf/pharma/ref-can-e.pdf
    • Carleton B, Foerster V, Warren L, Smith MA. Post-marketing pharmaco-surveillance in Canada. Health Canada website. [Internet. Accessed February 6, 2009.] Available from: http://www.hc-sc.gc.ca/hcs-sss/alt-formats/ hpb-dgps/pdf/pharma/ref-can-e.pdf
  • 3
    • 0036838681 scopus 로고    scopus 로고
    • Updated consensus statement on biological agents for the treatment of rheumatoid arthritis and other rheumatic diseases (May 2002)
    • Furst DE, Breedveld FC, Kalden JR, et al. Updated consensus statement on biological agents for the treatment of rheumatoid arthritis and other rheumatic diseases (May 2002). Ann Rheum Dis 2002;61 Suppl 2:ii2-ii7.
    • (2002) Ann Rheum Dis , vol.61 , Issue.SUPPL. 2
    • Furst, D.E.1    Breedveld, F.C.2    Kalden, J.R.3
  • 4
    • 14044260093 scopus 로고    scopus 로고
    • Update on the British Society for Rheumatology guidelines for prescribing TNF-alpha blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001)
    • Ledingham J, Deighton C. Update on the British Society for Rheumatology guidelines for prescribing TNF-alpha blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001). Rheumatology 2005;44:157-63.
    • (2005) Rheumatology , vol.44 , pp. 157-163
    • Ledingham, J.1    Deighton, C.2
  • 5
    • 0036274944 scopus 로고    scopus 로고
    • Etanercept versus methotrexate in patients with early rheumatoid arthritis: Two-year radiographic and clinical outcomes
    • Genovese MC, Bathon JM, Martin RW, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 2002;46:1443-50.
    • (2002) Arthritis Rheum , vol.46 , pp. 1443-1450
    • Genovese, M.C.1    Bathon, J.M.2    Martin, R.W.3
  • 6
    • 67649967868 scopus 로고    scopus 로고
    • Innovations Report. Half of patients with active early rheumatoid arthritis achieved clinical remission. Innovations Report website [Internet. Accessed February 6, 2009.] Available from: http://www.innovationsreport.com/ html/reports/medicine-health/report-95903.html
    • Innovations Report. Half of patients with active early rheumatoid arthritis achieved clinical remission. Innovations Report website [Internet. Accessed February 6, 2009.] Available from: http://www.innovationsreport.com/ html/reports/medicine-health/report-95903.html
  • 7
    • 67649989512 scopus 로고    scopus 로고
    • Japan College of Rheumatology. Introducing Japan College of Rheumatology (JCR). Japan College of Rheumatology website [Internet. Accessed February 6, 2009.] Available from: http://www.ryumachi-jp.com/english/index.html
    • Japan College of Rheumatology. Introducing Japan College of Rheumatology (JCR). Japan College of Rheumatology website [Internet. Accessed February 6, 2009.] Available from: http://www.ryumachi-jp.com/english/index.html
  • 8
    • 72649098710 scopus 로고
    • Therapeutic criteria in rheumatoid arthritis
    • Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. JAMA 1949;140:659-62.
    • (1949) JAMA , vol.140 , pp. 659-662
    • Steinbrocker, O.1    Traeger, C.H.2    Batterman, R.C.3
  • 9
    • 67649995689 scopus 로고    scopus 로고
    • Northrup Grumman Corporation. MedDRA and the MSSO. Northrup Grumman Corporation website [Internet. Accessed February 6, 2009.] Available from: http://www.meddramsso.com/MSSOWeb/index.htm
    • Northrup Grumman Corporation. MedDRA and the MSSO. Northrup Grumman Corporation website [Internet. Accessed February 6, 2009.] Available from: http://www.meddramsso.com/MSSOWeb/index.htm
  • 10
    • 67649921244 scopus 로고    scopus 로고
    • ICH Steering Committee. ICH Harmonised Tripartite Guideline. Clinical safety data management: definitions and standards for expedited reporting. Pharmaceuticals and Medical Devices Agency website [Internet. Accessed February 6, 2009.] Available from: http://www.pmda.go.jp/ich/e/e2a-95-3-20e.pdf
    • ICH Steering Committee. ICH Harmonised Tripartite Guideline. Clinical safety data management: definitions and standards for expedited reporting. Pharmaceuticals and Medical Devices Agency website [Internet. Accessed February 6, 2009.] Available from: http://www.pmda.go.jp/ich/e/e2a-95-3-20e.pdf
  • 11
    • 0030068817 scopus 로고    scopus 로고
    • 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
    • van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. 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.
    • (1996) Arthritis Rheum , vol.39 , pp. 34-40
    • van Gestel, A.M.1    Prevoo, M.L.2    van 't Hof, M.A.3    van Rijswijk, M.H.4    van de Putte, L.B.5    van Riel, P.L.6
  • 12
    • 0028815803 scopus 로고
    • Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis
    • Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. 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.
    • (1995) Arthritis Rheum , vol.38 , pp. 44-48
    • Prevoo, M.L.1    van 't Hof, M.A.2    Kuper, H.H.3    van Leeuwen, M.A.4    van de Putte, L.B.5    van Riel, P.L.6
  • 13
    • 0036169930 scopus 로고    scopus 로고
    • Guidelines for the management of rheumatoid arthritis: 2002 Update
    • American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines
    • American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 Update. Arthritis Rheum 2002;46:328-46.
    • (2002) Arthritis Rheum , vol.46 , pp. 328-346
  • 14
    • 33845475186 scopus 로고    scopus 로고
    • Care pathways in early rheumatoid arthritis
    • Bernatsky S, Feldman D, Shrier I, et al. Care pathways in early rheumatoid arthritis. Can Fam Physician 2006;52:1444-5.
    • (2006) Can Fam Physician , vol.52 , pp. 1444-1445
    • Bernatsky, S.1    Feldman, D.2    Shrier, I.3
  • 15
    • 38749141455 scopus 로고    scopus 로고
    • Systematic review: Comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis
    • Donahue KE, Gartlehner G, Jonas DE, et al. Systematic review: Comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis. Ann Intern Med 2007;124-34.
    • (2007) Ann Intern Med , pp. 124-134
    • Donahue, K.E.1    Gartlehner, G.2    Jonas, D.E.3
  • 16
    • 33750356014 scopus 로고    scopus 로고
    • Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: The ADORE study
    • van Riel PL, Taggart AJ, Sany J, et al. Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: The ADORE study. Ann Rheum Dis 2006;65:1478-83.
    • (2006) Ann Rheum Dis , vol.65 , pp. 1478-1483
    • van Riel, P.L.1    Taggart, A.J.2    Sany, J.3
  • 17
    • 1042290332 scopus 로고    scopus 로고
    • Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: Results of a multicenter, randomized, double-blind, placebo-controlled trial
    • Keystone EC, Schiff MH, Kremer JM, et al. Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:353-63.
    • (2004) Arthritis Rheum , vol.50 , pp. 353-363
    • Keystone, E.C.1    Schiff, M.H.2    Kremer, J.M.3
  • 18
    • 10744223002 scopus 로고    scopus 로고
    • Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: Double-blind randomised controlled trial
    • Klareskog L, van der Heijde D, De Jager JP, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004;363:675-81.
    • (2004) Lancet , vol.363 , pp. 675-681
    • Klareskog, L.1    van der Heijde, D.2    De Jager, J.P.3
  • 19
    • 70350607858 scopus 로고    scopus 로고
    • Inhibition of anti-tuberculosis T-lymphocyte function with tumour necrosis factor antagonists
    • Hamdi H, Mariette X, Godot V, et al. Inhibition of anti-tuberculosis T-lymphocyte function with tumour necrosis factor antagonists. Arthritis Res Ther 2006;8:R114.
    • (2006) Arthritis Res Ther , vol.8
    • Hamdi, H.1    Mariette, X.2    Godot, V.3
  • 20
    • 0042834294 scopus 로고    scopus 로고
    • Reactivation of latent tuberculosis infection in TNF-deficient mice
    • Botha T, Ryffel B. Reactivation of latent tuberculosis infection in TNF-deficient mice. J Immunol 2003;171:3110-8.
    • (2003) J Immunol , vol.171 , pp. 3110-3118
    • Botha, T.1    Ryffel, B.2
  • 21
    • 33748444790 scopus 로고    scopus 로고
    • Problems encountered during anti-tumour necrosis factor therapy
    • Desai SB, Furst DE. Problems encountered during anti-tumour necrosis factor therapy. Best Pract Res Clin Rheumatol 2006;20:757-90.
    • (2006) Best Pract Res Clin Rheumatol , vol.20 , pp. 757-790
    • Desai, S.B.1    Furst, D.E.2
  • 22
    • 0038076340 scopus 로고    scopus 로고
    • Tumour necrosis factor-alpha inhibitors and the reactivation of latent tuberculosis infection
    • Long R, Gardam M. Tumour necrosis factor-alpha inhibitors and the reactivation of latent tuberculosis infection. CMAJ 2003;168:1153-6.
    • (2003) CMAJ , vol.168 , pp. 1153-1156
    • Long, R.1    Gardam, M.2
  • 23
    • 67649908797 scopus 로고    scopus 로고
    • World Health Organization. Global tuberculosis control: surveillance, planning, financing: WHO Report 2007. World Health Organization website. [Internet. Accessed February 6, 2009.] Available from: http://www.who.int/tb/en/
    • World Health Organization. Global tuberculosis control: surveillance, planning, financing: WHO Report 2007. World Health Organization website. [Internet. Accessed February 6, 2009.] Available from: http://www.who.int/tb/en/
  • 24
    • 0034735827 scopus 로고    scopus 로고
    • A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis
    • Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93.
    • (2000) N Engl J Med , vol.343 , pp. 1586-1593
    • Bathon, J.M.1    Martin, R.W.2    Fleischmann, R.M.3
  • 25
    • 0027744086 scopus 로고
    • A comparison of low dose methotrexate bioavailability: Oral solution, oral tablet, subcutaneous and intramuscular dosing
    • Jundt JW, Browne BA, Fiocco GP, Steele AD, Mock D. A comparison of low dose methotrexate bioavailability: oral solution, oral tablet, subcutaneous and intramuscular dosing. J Rheumatol 1993;20:1845-9.
    • (1993) J Rheumatol , vol.20 , pp. 1845-1849
    • Jundt, J.W.1    Browne, B.A.2    Fiocco, G.P.3    Steele, A.D.4    Mock, D.5
  • 26
    • 33751302864 scopus 로고    scopus 로고
    • Once-weekly 50-mg dosing of Etanercept (Enbrel®) is as effective as 25-mg twice-weekly dosing in patients with ankylosing spondylitis
    • van der Heijde D, Da Silva JC, Dougados M, et al. Once-weekly 50-mg dosing of Etanercept (Enbrel®) is as effective as 25-mg twice-weekly dosing in patients with ankylosing spondylitis. Ann Rheum Dis 2006;65:1572-7.
    • (2006) Ann Rheum Dis , vol.65 , pp. 1572-1577
    • van der Heijde, D.1    Da Silva, J.C.2    Dougados, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.