메뉴 건너뛰기




Volumn 25, Issue 2, 2015, Pages 173-186

Pharmacokinetics, efficacy and safety profiles of etanercept monotherapy in Japanese patients with rheumatoid arthritis: Review of seven clinical trials

Author keywords

Clinical trial; Etanercept; Monotherapy; Review; Rheumatoid arthritis

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; C REACTIVE PROTEIN; ETANERCEPT; METHOTREXATE; NEUTRALIZING ANTIBODY; PLACEBO; RHEUMATOID FACTOR; ANTIRHEUMATIC AGENT;

EID: 84924360448     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.3109/14397595.2014.914014     Document Type: Review
Times cited : (14)

References (36)
  • 1
    • 84896906847 scopus 로고    scopus 로고
    • Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort (I)
    • Yamanaka H, Sugiyama N, Inoue E, Taniguchi A, Momohara S. Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort (I). Mod Rheumatol. 2014; 24(1):33–40.
    • (2014) Mod Rheumatol , vol.24 , Issue.1 , pp. 33-40
    • Yamanaka, H.1    Sugiyama, N.2    Inoue, E.3    Taniguchi, A.4    Momohara, S.5
  • 2
    • 0141920503 scopus 로고    scopus 로고
    • Burden of major musculoskeletal conditions
    • Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003; 81(9): 646–56.
    • (2003) Bull World Health Organ , vol.81 , Issue.9 , pp. 646-656
    • Woolf, A.D.1    Pfleger, B.2
  • 3
    • 48149100741 scopus 로고    scopus 로고
    • Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): A randomised, double
    • Emery P, B reedveld F C, H all S, Durez P, C hang D J, R obertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008; 372(9636):375–82.
    • (2008) Lancet , vol.372 , Issue.9636 , pp. 375-382
    • Emery, P.1    B Reedveld, F.C.2    H All, S.3    Durez, P.4    C Hang, D.J.5    R Obertson, D.6
  • 4
    • 33750699312 scopus 로고    scopus 로고
    • What should be our treatment goal in rheumatoid arthritis today?
    • Smolen JS, Aletaha D. What should be our treatment goal in rheumatoid arthritis today? Clin Exp Rheumatol. 2006; 24(6 Suppl 43):S7–S13.
    • (2006) Clin Exp Rheumatol , vol.24 , Issue.6-43 , pp. 7-13
    • Smolen, J.S.1    Aletaha, D.2
  • 5
    • 37449017748 scopus 로고    scopus 로고
    • Japan College of Rheumatology. Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis
    • Koike R, Takeuchi T, Eguchi K, Miyasaka N, Japan College of Rheumatology. Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007; 17(6):451–8.
    • (2007) Mod Rheumatol , vol.17 , Issue.6 , pp. 451-458
    • Koike, R.1    Takeuchi, T.2    Eguchi, K.3    Miyasaka, N.4
  • 6
    • 33645998418 scopus 로고    scopus 로고
    • Guidelines for the proper use of etanercept in Japan
    • Miyasaka N, Takeuchi T, Eguchi K. Guidelines for the proper use of etanercept in Japan. Mod Rheumatol. 2006; 16(2): 63–7.
    • (2006) Mod Rheumatol , vol.16 , Issue.2 , pp. 63-67
    • Miyasaka, N.1    Takeuchi, T.2    Eguchi, K.3
  • 7
    • 67449102437 scopus 로고    scopus 로고
    • Postmarketing surveillance of the safety and effectiveness of etanercept in Japan
    • Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009; 36(5):898–906.
    • (2009) J Rheumatol , vol.36 , Issue.5 , pp. 898-906
    • Koike, T.1    Harigai, M.2    Inokuma, S.3    Inoue, K.4    Ishiguro, N.5    Ryu, J.6
  • 8
    • 83255188765 scopus 로고    scopus 로고
    • Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis
    • Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2011; 21(4):343–51.
    • (2011) Mod Rheumatol , vol.21 , Issue.4 , pp. 343-351
    • Koike, T.1    Harigai, M.2    Inokuma, S.3    Ishiguro, N.4    Ryu, J.5    Takeuchi, T.6
  • 9
    • 84863869931 scopus 로고    scopus 로고
    • Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: A sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis
    • Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis. Rheumatol Int. 2012; 32(6):1511–9.
    • (2012) Rheumatol Int , vol.32 , Issue.6 , pp. 1511-1519
    • Koike, T.1    Harigai, M.2    Inokuma, S.3    Ishiguro, N.4    Ryu, J.5    Takeuchi, T.6
  • 10
    • 84863858372 scopus 로고    scopus 로고
    • Safety and effectiveness of switching from infliximab to etanercept in patients with rheumatoid arthritis: Results from a large Japanese postmarketing surveillance study
    • Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Safety and effectiveness of switching from infliximab to etanercept in patients with rheumatoid arthritis: results from a large Japanese postmarketing surveillance study. Rheumatol Int. 2012; 32(6):1617–24.
    • (2012) Rheumatol Int , vol.32 , Issue.6 , pp. 1617-1624
    • Koike, T.1    Harigai, M.2    Inokuma, S.3    Ishiguro, N.4    Ryu, J.5    Takeuchi, T.6
  • 11
  • 12
    • 84880768046 scopus 로고    scopus 로고
    • A phase 3 randomized, double-blind, multicenter comparative study evaluating the effect of etanercept versus methotrexate on radiographic outcomes, disease activity, and safety in Japanese subjects with active rheumatoid arthritis
    • Takeuchi T, Miyasaka N, Zang C, Alvarez D, Fletcher T, Wajdula J, et al. A phase 3 randomized, double-blind, multicenter comparative study evaluating the effect of etanercept versus methotrexate on radiographic outcomes, disease activity, and safety in Japanese subjects with active rheumatoid arthritis. Mod Rheumatol. 2013; 23(4):623–33.
    • (2013) Mod Rheumatol , vol.23 , Issue.4 , pp. 623-633
    • Takeuchi, T.1    Miyasaka, N.2    Zang, C.3    Alvarez, D.4    Fletcher, T.5    Wajdula, J.6
  • 13
    • 0037229712 scopus 로고    scopus 로고
    • The Stanford Health Assessment Questionnaire: A review of its history, issues, progress, and documentation
    • Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 2003; 30(1): 167–78.
    • (2003) J Rheumatol , vol.30 , Issue.1 , pp. 167-178
    • Bruce, B.1    Fries, J.F.2
  • 14
    • 33644794107 scopus 로고    scopus 로고
    • The Health Assessment Questionnaire (HAQ)
    • Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol. 2005; 23(5 Suppl 39):S14–S8.
    • (2005) Clin Exp Rheumatol , vol.23 , Issue.5-39 , pp. 8-14
    • Bruce, B.1    Fries, J.F.2
  • 15
    • 46549084098 scopus 로고    scopus 로고
    • CHANGE Study Investigators. Clinical investigation in highly disease
    • Miyasaka N, CHANGE Study Investigators. Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Mod Rheumatol. 2008; 18(3):252–62.
    • (2008) Mod Rheumatol , vol.18 , Issue.3 , pp. 252-262
    • Miyasaka, N.1
  • 16
    • 84883163862 scopus 로고    scopus 로고
    • Phase II dose-response study of abatacept in Japanese patients with active rheumatoid arthritis with an inadequate response to methotrexate
    • Takeuchi T, Matsubara T, Nitobe T, Suematsu E, Ohta S, Honjo S, et al. Phase II dose-response study of abatacept in Japanese patients with active rheumatoid arthritis with an inadequate response to methotrexate. Mod Rheumatol. 2013; 23(2): 226–35.
    • (2013) Mod Rheumatol , vol.23 , Issue.2 , pp. 226-235
    • Takeuchi, T.1    Matsubara, T.2    Nitobe, T.3    Suematsu, E.4    Ohta, S.5    Honjo, S.6
  • 17
    • 84860908371 scopus 로고    scopus 로고
    • Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: Results of the GOFORTH study
    • Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, et al. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GOFORTH study. Ann Rheum Dis. 2012; 71(6):817–24.
    • (2012) Ann Rheum Dis , vol.71 , Issue.6 , pp. 817-824
    • Tanaka, Y.1    Harigai, M.2    Takeuchi, T.3    Yamanaka, H.4    Ishiguro, N.5    Yamamoto, K.6
  • 18
    • 84881478571 scopus 로고    scopus 로고
    • Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with diseasemodifying antirheumatic drugs: Results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks
    • Takeuchi T, Harigai M, Tanaka Y, Yamanaka H, Ishiguro N, Yamamoto K, et al. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with diseasemodifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis. 2013; 72(9):1488–95.
    • (2013) Ann Rheum Dis , vol.72 , Issue.9 , pp. 1488-1495
    • Takeuchi, T.1    Harigai, M.2    Tanaka, Y.3    Yamanaka, H.4    Ishiguro, N.5    Yamamoto, K.6
  • 19
    • 34447300492 scopus 로고    scopus 로고
    • Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): Evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab
    • Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007; 66(9):1162–7.
    • (2007) Ann Rheum Dis , vol.66 , Issue.9 , pp. 1162-1167
    • Nishimoto, N.1    Hashimoto, J.2    Miyasaka, N.3    Yamamoto, K.4    Kawai, S.5    Takeuchi, T.6
  • 20
    • 79961102216 scopus 로고    scopus 로고
    • Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from the JESMR study
    • Kameda H, Kanbe K, Sato E, Ueki Y, Saito K, Nagaoka S, et al. Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from the JESMR study. J Rheumatol. 2011; 38(8): 1585–92.
    • (2011) J Rheumatol , vol.38 , Issue.8 , pp. 1585-1592
    • Kameda, H.1    Kanbe, K.2    Sato, E.3    Ueki, Y.4    Saito, K.5    Nagaoka, S.6
  • 21
    • 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, Fleischmann RM, Tesser JR, Schiff MH, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002; 46(6):1443–50.
    • (2002) Arthritis Rheum , vol.46 , Issue.6 , pp. 1443-1450
    • Genovese, M.C.1    Bathon, J.M.2    Martin, R.W.3    Fleischmann, R.M.4    Tesser, J.R.5    Schiff, M.H.6
  • 22
    • 84865376327 scopus 로고    scopus 로고
    • Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: Postmarketing surveillance report of the first 3,000 patients
    • Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients. Mod Rheumatol. 2012; 22(4):498–508.
    • (2012) Mod Rheumatol , vol.22 , Issue.4 , pp. 498-508
    • Koike, T.1    Harigai, M.2    Ishiguro, N.3    Inokuma, S.4    Takei, S.5    Takeuchi, T.6
  • 23
    • 84864422138 scopus 로고    scopus 로고
    • Time-dependent increased risk for serious infection from continuous use of tumor necrosis factor antagonists over three years in patients with rheumatoid arthritis
    • Sakai R, Komano Y, Tanaka M, Nanki T, Koike R, Nagasawa H, et al. Time-dependent increased risk for serious infection from continuous use of tumor necrosis factor antagonists over three years in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012; 64(8): 1125–34.
    • (2012) Arthritis Care Res (Hoboken) , vol.64 , Issue.8 , pp. 1125-1134
    • Sakai, R.1    Komano, Y.2    Tanaka, M.3    Nanki, T.4    Koike, R.5    Nagasawa, H.6
  • 24
    • 79959994678 scopus 로고    scopus 로고
    • Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: A report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety
    • Komano Y, Tanaka M, Nanki T, Koike R, Sakai R, Kameda H, et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol. 2011; 38(7):1258–64.
    • (2011) J Rheumatol , vol.38 , Issue.7 , pp. 1258-1264
    • Komano, Y.1    Tanaka, M.2    Nanki, T.3    Koike, R.4    Sakai, R.5    Kameda, H.6
  • 25
    • 84870312839 scopus 로고    scopus 로고
    • Pneumocystis jirovecii infection: An emerging threat to patients with rheumatoid arthritis
    • Mori S, Sugimoto M. Pneumocystis jirovecii infection: an emerging threat to patients with rheumatoid arthritis. Rheumatology (Oxford). 2012; 51(12): 2120–30.
    • (2012) Rheumatology (Oxford) , vol.51 , Issue.12 , pp. 2120-2130
    • Mori, S.1    Sugimoto, M.2
  • 26
    • 78049508184 scopus 로고    scopus 로고
    • The Japanese experience with biologic therapies for rheumatoid arthritis
    • Takeuchi T, Kameda H. The Japanese experience with biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol. 2010; 6(11): 644–52.
    • (2010) Nat Rev Rheumatol , vol.6 , Issue.11 , pp. 644-652
    • Takeuchi, T.1    Kameda, H.2
  • 27
    • 38749119069 scopus 로고    scopus 로고
    • Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis
    • Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008; 67(2):189–94.
    • (2008) Ann Rheum Dis , vol.67 , Issue.2 , pp. 189-194
    • Takeuchi, T.1    Tatsuki, Y.2    Nogami, Y.3    Ishiguro, N.4    Tanaka, Y.5    Yamanaka, H.6
  • 28
    • 79951640108 scopus 로고    scopus 로고
    • Clinical and radiological features of acute-onset diffuse interstitial lung diseases in patients with rheumatoid arthritis receiving treatment with biological agents: Importance of Pneumocystis pneumonia in Japan revealed by a multicenter study
    • Kameda H, Tokuda H, Sakai F, Johkoh T, Mori S, Yoshida Y, et al. Clinical and radiological features of acute-onset diffuse interstitial lung diseases in patients with rheumatoid arthritis receiving treatment with biological agents: importance of Pneumocystis pneumonia in Japan revealed by a multicenter study. Intern Med. 2011; 50(4): 305–13.
    • (2011) Intern Med , vol.50 , Issue.4 , pp. 305-313
    • Kameda, H.1    Tokuda, H.2    Sakai, F.3    Johkoh, T.4    Mori, S.5    Yoshida, Y.6
  • 29
    • 84883197280 scopus 로고    scopus 로고
    • A retrospective study of serum KL-6 levels during treatment with biological disease-modifying antirheumatic drugs in rheumatoid arthritis patients: A report from the Ad Hoc Committee for Safety of Biological DMARDs of the Japan College of Rheumatology
    • Takamura A, Hirata S, Nagasawa H, Kameda H, Seto Y, Atsumi T, et al. A retrospective study of serum KL-6 levels during treatment with biological disease-modifying antirheumatic drugs in rheumatoid arthritis patients: a report from the Ad Hoc Committee for Safety of Biological DMARDs of the Japan College of Rheumatology. Mod Rheumatol. 2013; 23(2): 297–303.
    • (2013) Mod Rheumatol , vol.23 , Issue.2 , pp. 297-303
    • Takamura, A.1    Hirata, S.2    Nagasawa, H.3    Kameda, H.4    Seto, Y.5    Atsumi, T.6
  • 31
    • 80052991902 scopus 로고    scopus 로고
    • Clinical trial safety and mortality analyses in patients receiving etanercept across approved indications
    • Gottlieb AB, Gordon K, Giannini EH, Mease P, Li J, Chon Y, et al. Clinical trial safety and mortality analyses in patients receiving etanercept across approved indications. J Drugs Dermatol. 2011; 10(3): 289–300.
    • (2011) J Drugs Dermatol , vol.10 , Issue.3 , pp. 289-300
    • Gottlieb, A.B.1    Gordon, K.2    Giannini, E.H.3    Mease, P.4    Li, J.5    Chon, Y.6
  • 32
    • 84867405325 scopus 로고    scopus 로고
    • Drug retention rates and relevant risk factors for drug discontinuation due to adverse events in rheumatoid arthritis patients receiving anticytokine therapy with different target molecules
    • Sakai R, Tanaka M, Nanki T, Watanabe K, Yamazaki H, Koike R, et al. Drug retention rates and relevant risk factors for drug discontinuation due to adverse events in rheumatoid arthritis patients receiving anticytokine therapy with different target molecules. Ann Rheum Dis. 2012; 71(11):1820–6.
    • (2012) Ann Rheum Dis , vol.71 , Issue.11 , pp. 1820-1826
    • Sakai, R.1    Tanaka, M.2    Nanki, T.3    Watanabe, K.4    Yamazaki, H.5    Koike, R.6
  • 33
    • 84865372548 scopus 로고    scopus 로고
    • Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: Retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study)
    • Takeuchi T, Tanaka Y, Kaneko Y, Tanaka E, Hirata S, Kurasawa T, et al. Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study). Mod Rheumatol. 2012; 22(3):327–38.
    • (2012) Mod Rheumatol , vol.22 , Issue.3 , pp. 327-338
    • Takeuchi, T.1    Tanaka, Y.2    Kaneko, Y.3    Tanaka, E.4    Hirata, S.5    Kurasawa, T.6
  • 35
    • 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, Gough A, Kalden J, Malaise M, 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(9410):675–81.
    • (2004) Lancet , vol.363 , Issue.9410 , pp. 675-681
    • Klareskog, L.1    Van Der Heijde, D.2    De Jager, J.P.3    Gough, A.4    Kalden, J.5    Malaise, M.6
  • 36
    • 84885132987 scopus 로고    scopus 로고
    • Safety and effectiveness of 6 months’etanercept monotherapy and combination therapy in Japanese patients with rheumatoid arthritis: Effect of concomitant disease-modifying antirheumatic drugs
    • Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Safety and effectiveness of 6 months’etanercept monotherapy and combination therapy in Japanese patients with rheumatoid arthritis: effect of concomitant disease-modifying antirheumatic drugs. J Rheumatol. 2013; 40(10): 1658–68.
    • (2013) J Rheumatol , vol.40 , Issue.10 , pp. 1658-1668
    • Koike, T.1    Harigai, M.2    Inokuma, S.3    Ishiguro, N.4    Ryu, J.5    Takeuchi, T.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.