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

References

• 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.
   PubMed Web of Science ®Google Scholar
• Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646–56.
   PubMed Web of Science ®Google Scholar
• Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson 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.
   PubMedGoogle Scholar
• Smolen JS, Aletaha D. What should be our treatment goal in rheumatoid arthritis today?Clin Exp Rheumatol. 2006;24(6 Suppl 43): S7–S13.
   Google Scholar
• 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.
   PubMedGoogle Scholar
• Miyasaka N, Takeuchi T, Eguchi K. Guidelines for the proper use of etanercept in Japan. Mod Rheumatol. 2006;16(2):63–7.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar
• Kawai S, Sekino H, Yamashita N, Tsuchiwata S, Liu H, Korth-Bradley JM. The comparability of etanercept pharmacokinetics in healthy Japanese and American subjects. J Clin Pharmacol. 2006;46(4):418–23.
   PubMedGoogle Scholar
• 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.
   PubMedGoogle Scholar
• 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.
   PubMedGoogle Scholar
• Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol. 2005;23(5 Suppl 39):S14–S8.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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 GO-FORTH study. Ann Rheum Dis. 2012;71(6):817–24.
   PubMed Web of Science ®Google Scholar
• 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 disease-modifying 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar
• 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.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Mori S, Sugimoto M. Pneumocystis jirovecii infection: an emerging threat to patients with rheumatoid arthritis. Rheumatology (Oxford). 2012;51(12):2120–30.
   PubMedGoogle Scholar
• Takeuchi T, Kameda H. The Japanese experience with biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol. 2010;6(11):644–52.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar
• 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.
   PubMedGoogle Scholar
• Herrinton LJ, Harrold LR, Liu L, Raebel MA, Taharka A, Winthrop KL, et al. Association between anti-TNF-alpha therapy and interstitial lung disease. Pharmacoepidemiol Drug Saf. 2013; 22(4):394–402.
   PubMedGoogle Scholar
• 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.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000;343(22):1586–93.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar