Guidelines for the proper use of etanercept in Japan.

Modern Rheumatology
Nobuyuki MiyasakaKatsumi Eguchi

Abstract

Application of biological agents targeting inflammatory cytokines such as tumor necrosis factor-alpha (TNF-alpha) dramatically caused a paradigm shift in the treatment of rheumatoid arthritis (RA). Infliximab, a chimeric anti-TNF-alpha monoclonal antibody, has initially been introduced to Japan in 2003 and shown to be dramatically effective in alleviating arthritis refractory to conventional treatment. However, serious adverse events such as bacterial pneumonia, tuberculosis, and Pneumocystis jiroveci pneumonia were reported to be in relatively high incidence; i.e., 2%, 0.3%, and 0.4%, respectively, in a strict postmarketing surveillance of an initial 4000 cases in Japan. Etancercept, a recombinant chimeric protein consisting of p75 TNF-alpha receptor and human IgG, was subsequently introduced to Japan in March of 2005. We therefore drew up treatment guidelines for the use of etanercept to avoid potential serous adverse events, since only approximately 150 cases have been included in the clinical study of etanercept in Japan. The guidelines were initially designed by the principal investigators (N.M, T.T., K.E.) of rheumatoid arthritis study groups of the Ministry of Health, Labor and Welfare (MHLW), Japan, and finally approved...Continue Reading

References

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Mar 6, 2004·Lancet·Lars KlareskogUNKNOWN TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators

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Citations

Jan 21, 2010·Modern Rheumatology·Shumpei YokotaUNKNOWN Pediatric Rheumatology Association of Japan
Jun 25, 2010·Modern Rheumatology·Hideto KamedaUNKNOWN Japan Biological Agent Study Integrated Consortium
Jun 30, 2010·Modern Rheumatology·Hiroyuki SakaidaTamiko Takemura
May 28, 2009·Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine·Tsutomu Takeuchi
Feb 12, 2013·Journal of Psychiatric Research·Ute KrügelHubertus Himmerich
Dec 7, 2010·Journal of Clinical Pharmacy and Therapeutics·Y HoraiE Suematsu
Sep 4, 2015·International Journal of Rheumatic Diseases·Chak Sing LauSwan Sim Yeap

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