[Treatment guidelines for the use of biologics in rheumatoid arthritis; present and future].

Application of biological agents targeting tumor necrosis factor alpha (TNFalpha) dramatically caused the paradigm shift in the treatment of rheumatoid arthritis (RA). Infliximab, a chimeric anti-TNFalpha 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. Etanercept, a recombinant chimeric protein consisting of p75 TNFalpha receptor and human IgG, was subsequently introduced to Japan in 2005. The guidelines were initially designed by principle investigators (N.M, T.T, K.E) of RA study groups of the Ministry of Health, Labor and Welfare (MHLW), Japan, and approved by the Japan College of Rheumatology (JCR). We introduce the revised guidelines for the use of biologics in Japanese RA patients in this article.