Guidelines for the proper use of etanercept in Japan

Nobuyuki Miyasaka, Tsutomu Takeuchi, Katsumi Eguchi

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

Application of biological agents targeting inflammatory cytokines such as tumor necrosis factor-α (TNF-α) dramatically caused a paradigm shift in the treatment of rheumatoid arthritis (RA). Infliximab, a chimeric anti-TNF-α 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-α 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 by the board of directors of the Japan College of Rheumatology. The MHLW assigned a duty to the pharmaceutical companies to perform a complete postmarketing surveillance of an initial 3000 cases to explore any adverse events, and this was performed according to the treatment guidelines shown in this article.

Original languageEnglish
Pages (from-to)63-67
Number of pages5
JournalModern Rheumatology
Volume16
Issue number2
DOIs
Publication statusPublished - 2006 Apr
Externally publishedYes

Fingerprint

Japan
Guidelines
Rheumatoid Arthritis
Tumor Necrosis Factor-alpha
Recombinant Fusion Proteins
Bacterial Pneumonia
Pneumocystis carinii
Pneumocystis Pneumonia
Tumor Necrosis Factor Receptors
Health
Biological Factors
Rheumatology
Arthritis
Etanercept
Tuberculosis
Immunoglobulin G
Monoclonal Antibodies
Research Personnel
Cytokines
Incidence

Keywords

  • Etanercept
  • Japan College of Rheumatology (JCR)
  • Rheumatoid arthritis (RA)
  • Treatment guidelines
  • Tumor necrosis factor-α (TNF-α)

ASJC Scopus subject areas

  • Rheumatology
  • Immunology

Cite this

Guidelines for the proper use of etanercept in Japan. / Miyasaka, Nobuyuki; Takeuchi, Tsutomu; Eguchi, Katsumi.

In: Modern Rheumatology, Vol. 16, No. 2, 04.2006, p. 63-67.

Research output: Contribution to journalArticle

Miyasaka, Nobuyuki ; Takeuchi, Tsutomu ; Eguchi, Katsumi. / Guidelines for the proper use of etanercept in Japan. In: Modern Rheumatology. 2006 ; Vol. 16, No. 2. pp. 63-67.
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