Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: Postmarketing surveillance report of 7740 patients

References

• Smolen JS, Aletaha D, Koeller M, Weisman MH, Emery P. New therapies for treatment of rheumatoid arthritis. Lancet. 2007;370(9602):1861–74.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Aletaha D, Redlich K. The pathogenesis of rheumatoid arthritis: new insights from old clinical data?Nat Rev Rheumatol. 2012;8(4):235–43.
   PubMed Web of Science ®Google Scholar
• Singh JA, Christensen R, Wells GA, Suarez-Almazor ME, Buchbinder R, Lopez-Olivo MA. Biologics for rheumatoid arthritis: an overview of Cochrane reviews. Cochrane Database Syst Rev. 2009;(4): CD007848.
   Google Scholar
• Curtis JR, Singh JA. Use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther. 2011;33(6):679–707.
   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
• 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 R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K, et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol. 2009;19(4):351–7.
   PubMed Web of Science ®Google Scholar
• Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients. Ann Rheum Dis. 2011;70(12):2148–51.
   PubMed Web of Science ®Google Scholar
• Prevoo ML, van Riel PL, van't Hof MA, van Rijswijk MH, van Leeuwen MA, Kuper HH, et al. Validity and reproducibility of self-administered joint counts. A prospective longitudinal followup study in patients with rheumatoid arthritis. Arthritis Rheum. 1995;38(1):44–8.
   PubMed Web of Science ®Google Scholar
• Subcommittee on Development of Guidelines for the Use of Methotrexate in the Treatment of Rheumatoid Arthritis, Japan College of Rheumatology. Japan College of Rheumatology 2011 Guidelines for the Use of Methotrexate in the Treatment of Rheumatoid Arthritis (in Japanese). Tokyo, Japan: Yodosha; 2011.
   Google Scholar
• Seto Y, Tanaka E, Inoue E, Nakajima A, Taniguchi A, Momohara S, et al. Studies of the efficacy and safety of methotrexate at dosages over 8 mg/week using the IORRA cohort database. Mod Rheumatol. 2011;21(6):579–93.
   PubMed Web of Science ®Google Scholar
• Sakai R, Komano Y, Tanaka M, Nanki T, Koike R, Nakajima A, et al. The REAL database reveals no significant risk of serious infection during treatment with a methotrexate dose of more than 8 mg/week in patients with rheumatoid arthritis. Mod Rheumatol. 2011;21(4):444–8.
   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
• Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26–37.
   PubMed Web of Science ®Google Scholar
• Koike R, Takeuchi T, Eguchi K, Miyasaka N. Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007;17(6):451–8.
   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
• HUMIRA (adalimumab) [prescribing information]. Pharmaceuticals and medical devices agency Web site [In Japanese]. Available at: http://www.info.pmda.go.jp/downfiles/ph/PDF/100159_3999426G1024_1_15.pdf. Accessed 14 March 2013.
   Google Scholar
• Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949;140(8):659–62.
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation (ICH) Steering Committee. ICH Harmonised Tripartite Guideline. Clinical safety data management: definitions and standards for expedited reporting. Pharmaceuticals and medical devices agency Web site. Available at: http://www.pmda.go.jp/ich/e/e2a_95_3_20e.pdf. Accessed 14 March 2013.
   Google Scholar
• van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998;41(10):1845–50.
   PubMed Web of Science ®Google Scholar
• Fransen J, Creemers MC, Van Riel PL. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004;43(10):1252–5.
   PubMed Web of Science ®Google Scholar
• Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum. 2011;63(3):573–86.
   PubMed Web of Science ®Google Scholar
• Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis. 2011;70(3):404–13.
   PubMed Web of Science ®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
• Schiff MH, Burmester GR, Kent JD, Pangan AL, Kupper H, Fitzpatrick SB, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis. 2006;65(7):889–94.
   PubMed Web of Science ®Google Scholar
• Burmester GR, Mease P, Dijkmans BA, Gordon K, Lovell D, Panaccione R, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis. 2009;68(12):1863–9.
   PubMed Web of Science ®Google Scholar
• Björnådal L, Baecklund E, Yin L, Granath F, Klareskog L, Ekbom A. Decreasing mortality in patients with rheumatoid arthritis: results from a large population based cohort in Sweden, 1964-95. J Rheumatol. 2002;29(5):906–12.
   PubMed Web of Science ®Google Scholar
• Gabriel SE, Crowson CS, Kremers HM, Doran MF, Turesson C, O’Fallon WM, et al. Survival in rheumatoid arthritis: a population- based analysis of trends over 40 years. Arthritis Rheum. 2003;48(1): 54–8.
   PubMedGoogle Scholar
• Hakoda M, Oiwa H, Kasagi F, Masunari N, Yamada M, Suzuki G, et al. Mortality of rheumatoid arthritis in Japan: a longitudinal cohort study. Ann Rheum Dis. 2005;64(10):1451–5.
   PubMed Web of Science ®Google Scholar
• Sihvonen S, Korpela M, Laippala P, Mustonen J, Pasternack A. Death rates and causes of death in patients with rheumatoid arthritis: a population-based study. Scand J Rheumatol. 2004;33(4):221–7.
   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
• Tanaka M, Sakai R, Koike R, Komano Y, Nanki T, Sakai F, et al. Pneumocystis jirovecii pneumonia associated with etanercept treatment in patients with rheumatoid arthritis: a retrospective review of 15 cases and analysis of risk factors. Mod Rheumatol. 2012;22(6):849–58.
   Web of Science ®Google Scholar
• Greenberg JD, Reed G, Kremer JM, Tindall E, Kavanaugh A, Zheng C, et al. Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registry. Ann Rheum Dis. 2010;69(2):380–6.
   PubMed Web of Science ®Google Scholar
• van der Veen MJ, van der Heide A, Kruize AA, Bijlsma JW. Infection rate and use of antibiotics in patients with rheumatoid arthritis treated with methotrexate. Ann Rheum Dis. 1994;53(4):224–8.
   PubMed Web of Science ®Google Scholar
• Bernatsky S, Hudson M, Suissa S. Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. Rheumatology. 2007;46(7):1157–60.
   PubMed Web of Science ®Google Scholar
• Doran MF, Crowson CS, Pond GR, O’Fallon WM, Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum. 2002;46(9):2294–300.
   PubMedGoogle Scholar
• Crowson CS, Hoganson DD, Fitz-Gibbon PD, Matteson EL. Development and validation of a risk score for serious infection in patients with rheumatoid arthritis. Arthritis Rheum. 2012;64(9):2847–55.
   PubMedGoogle Scholar
• Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69(4):631–7.
   PubMed Web of Science ®Google Scholar
• Virkki LM, Valleala H, Takakubo Y, Vuotila J, Relas H, Komulainen R, et al. Outcomes of switching anti-TNF drugs in rheumatoid arthritis–a study based on observational data from the Finnish Register of Biological Treatment (ROB-FIN). Clin Rheumatol. 2011;30(11):1447–54.
   PubMed Web of Science ®Google Scholar
• Bombardieri S, Ruiz AA, Fardellone P, Geusens P, McKenna F, Unnebrink K, et al. Effectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-antagonist therapy in clinical practice. Rheumatology (Oxford). 2007;46(7):1191–9.
   PubMed Web of Science ®Google Scholar
• Wick MC, Ernestam S, Lindblad S, Bratt J, Klareskog L, van Vollenhoven RF. Adalimumab (Humira) restores clinical response in patients with secondary loss of efficacy from infliximab (Remicade) or etanercept (Enbrel): results from the STURE registry at Karolinska University Hospital. Scand J Rheumatol. 2005;34(5): 353–8.
   PubMed Web of Science ®Google Scholar