Vol.19 No.4

Review Article

Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis


Ryuji Koike1,2,3 , Masayoshi Harigai1,3 , Tatsuya Atsumi4 , Koichi Amano5 , Shinichi Kawai6 , Kazuyoshi Saito7 , Tomoyuki Saito8 , Masahiro Yamamura9 , Tsukasa Matsubara10 , Nobuyuki Miyasaka3

  • Department of Pharmacovigilance, Graduate School, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
  • Clinical Research Center, Tokyo Medical and Dental University Hospital, Faculty of Medicine, Tokyo, Japan
  • Department of Medicine and Rheumatology, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan
  • Department of Medicine II, Hokkaido University Graduate School of Medicine, Sapporo, Japan
  • Division of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan
  • Division of Rheumatology, Toho University Omori Medical Center, Tokyo, Japan
  • The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
  • Department of Orthopaedic Surgery, Yokohama City University, Graduate School of Medicine, Yokohama, Japan
  • Department of Rheumatology, Aichi Medical University School of Medicine, Aichi, Japan
  • Matsubara Mayflower Hospital, Kato, Japan

18 March 2009


8 June 2009

Published online:

10 July 2009

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The introduction of biological agents targeting tumor necrosis factor-alpha (TNF-α) has brought about a paradigm shift in the treatment of rheumatoid arthritis (RA). Although these anti-TNF agents have excellent efficacy against RA, a substantial number of patients still show inadequate responses. In Western countries, such patients are already being treated with new classes of antirheumatic drugs such as abatacept and rituximab. Tocilizumab (TCZ) is a humanized monoclonal antibody developed in Japan against the human interleukin-6 (IL-6) receptor. TCZ does not only alleviate the signs and symptoms of RA but also seems to prevent progressive bone and joint destruction. However, there is a concern that TCZ might increase the risk of adverse events such as infections since IL-6 plays a pivotal role in the immune system. Calculating the relative risks of specific adverse outcomes with TCZ use remains difficult, due to insufficient patient numbers enrolled in clinical trials to date. This review presents tentative guidelines for the use of TCZ for RA patients prepared by the Japan College of Rheumatology and based on results of clinical trials in Japan and Western countries. The guidelines are intended as a guide for postmarketing surveillance and clinical practice, and will be revised periodically based on the surveillance.

Key words

Rheumatoid arthritis - Tocilizumab - Anti-TNF - IL-6 - Antirheumatics