TY - JOUR
T1 - Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis
AU - Koike, Ryuji
AU - Takeuchi, Tsutomu
AU - Eguchi, Katsumi
AU - Miyasaka, Nobuyuki
N1 - Funding Information:
Acknowledgments This study was supported by a grant from the Ministry of Health, Labor and Welfare, Japan. The authors express sincere appreciation to the members of the Internal Medicine Rheumatology Study Group of the Ministry of Health, Labor and Welfare, Japan. These include Shigeto Toma, Hisashi Yamanaka, Tetsuji Sawada, Hiroaki Ida,Takao Koike, Hideto Kameda,Yoshiaki Ishigatsubo,Taka-yuki Sumida, Masayoshi Harigai, Kazunori Tomono, Yoshiya Tanaka, Atsuo Nakajima, Norihiro Nishimoto, Kiichiro Tsutani, Hiroyuki Aburaya, Kazuhiko Yamamoto, Atsuo Taniguchi, Shigeto Kobayashi, Satoshi Ito, Toshihiro Nanki, Atsushi Kawakami, Tsuneyo Mimori, Takashi Okamoto, Naoyuki Tsuchiya, Shinichi Shiozawa, Masaaki Nakano, Masataka Uetani, and Kiyoshi Migita. Authors R.K., T.T., K.E., and N.M. are affiliated with Tanabe, Takeda Pharmaceutical, Wyeth, Abbott Japan, Eisai, and Chugai Pharmaceutical.
PY - 2007/12
Y1 - 2007/12
N2 - Application of biological agents targeting tumor necrosis factor-α (TNF-α) caused a paradigm shift in the treatment of rheumatoid arthritis (RA). The introduction of infliximab in 2003 and etanercept in 2005 in Japan had a significant impact on both Japanese rheumatologists and RA patients, although serious adverse effects such as bacterial pneumonia, tuberculosis and Pneumocystis jiroveci pneumonia are significant concerns. Based on the data from post-marketing surveillance in Japan and accumulating evidence worldwide, the Internal Medicine Rheumatology Study Group of the Ministry of Health, Labor and Welfare (MHLW), Japan, has updated the guidelines for the use of anti-TNF-α agents for RA, which were subsequently approved by the Board of Japan College of Rheumatology (JCR). In the present revised guidelines, we combined the guidelines for use of each of infliximab and etanercept together with some modifications and precautions, paying special attention to serious adverse reactions. Although it is still controversial whether the use of TNF-α blocking agents per se increases the risk of infection or not, bacterial pneumonia, regardless of the pathogens, is the most frequent complications in RA. The risk factors associated with pneumonia identified in the post-marketing surveillance of infliximab in Japan are presented in this guideline. The diagnostic algorithm is also designed for early diagnosis and treatment of pulmonary lesions seen during the treatment of biological agents. Preventive measures and precautions against tuberculosis, another frequent and significant complication in Japan, are also described. Furthermore, risk factors for developing Pneumocystis pneumonia, which uniquely occurs at 30- to 50-fold frequency under TNF-α blockade therapy in Japan, are described here and its preventive measures are discussed. It is stressed that secondary-care rheumatologists should be better familiarized with the proper use of TNF-α blocking agents and be alert to any adverse events for a better management of RA patients.
AB - Application of biological agents targeting tumor necrosis factor-α (TNF-α) caused a paradigm shift in the treatment of rheumatoid arthritis (RA). The introduction of infliximab in 2003 and etanercept in 2005 in Japan had a significant impact on both Japanese rheumatologists and RA patients, although serious adverse effects such as bacterial pneumonia, tuberculosis and Pneumocystis jiroveci pneumonia are significant concerns. Based on the data from post-marketing surveillance in Japan and accumulating evidence worldwide, the Internal Medicine Rheumatology Study Group of the Ministry of Health, Labor and Welfare (MHLW), Japan, has updated the guidelines for the use of anti-TNF-α agents for RA, which were subsequently approved by the Board of Japan College of Rheumatology (JCR). In the present revised guidelines, we combined the guidelines for use of each of infliximab and etanercept together with some modifications and precautions, paying special attention to serious adverse reactions. Although it is still controversial whether the use of TNF-α blocking agents per se increases the risk of infection or not, bacterial pneumonia, regardless of the pathogens, is the most frequent complications in RA. The risk factors associated with pneumonia identified in the post-marketing surveillance of infliximab in Japan are presented in this guideline. The diagnostic algorithm is also designed for early diagnosis and treatment of pulmonary lesions seen during the treatment of biological agents. Preventive measures and precautions against tuberculosis, another frequent and significant complication in Japan, are also described. Furthermore, risk factors for developing Pneumocystis pneumonia, which uniquely occurs at 30- to 50-fold frequency under TNF-α blockade therapy in Japan, are described here and its preventive measures are discussed. It is stressed that secondary-care rheumatologists should be better familiarized with the proper use of TNF-α blocking agents and be alert to any adverse events for a better management of RA patients.
KW - Adverse events
KW - Etanercept
KW - Infliximab
KW - Rheumatoid arthritis
KW - Treatment guidelines
KW - Tumor necrosis factor-α antagonists
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U2 - 10.1007/s10165-007-0626-3
DO - 10.1007/s10165-007-0626-3
M3 - Article
C2 - 18084695
AN - SCOPUS:37449017748
VL - 17
SP - 451
EP - 458
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
IS - 6
ER -