Vol.22 No.4

Original Article

Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients

Authors

Takao Koike1 , Masayoshi Harigai2 , Naoki Ishiguro3 , Shigeko Inokuma4 , Shuji Takei5 , Tsutomu Takeuchi6 , Hisashi Yamanaka7 , Yoshiya Tanaka8

  • Sapporo Medical Center NTT EC, S-1, W-15, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
  • Tokyo Medical Dental University Graduate School, Tokyo, Japan
  • Nagoya University School of Medicine, Nagoya, Japan
  • Japanese Red Cross Medical Center, Tokyo, Japan
  • Faculty of Medicine, Kagoshima University School of Health Science, Kagoshima, Japan
  • Keio University, Tokyo, Japan
  • Tokyo Women’s Medical University, Tokyo, Japan
  • University of Occupational and Environmental Health, Kitakyushu, Japan
Received:

25 July 2011

Accepted:

18 September 2011

Published online:

13 October 2011

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Abstract

This interim analysis of postmarketing surveillance data for adalimumab-treated rheumatoid arthritis (RA) patients summarizes safety and effectiveness during the first 24 weeks of therapy for the first 3,000 patients treated in Japan (June 2008-December 2009). Patient eligibility for antitumor necrosis factor therapy was based on the Japanese College of Rheumatology treatment guidelines and Japanese labeling. All patients were screened for tuberculosis. Approximately 50% of the population was biologic na?¨ve, 66% received concomitant methotrexate (MTX), and 72% received concomitant glucocorticoids. The overall incidence rate of adverse events was 31% (5.5% serious) and that of adverse drug reactions (ADRs) was 27% (4.1% serious). Incidence rates of ADRs and serious ADRs were similar regardless of prior biologic therapy or concomitant MTX use but were significantly higher in patients receiving glucocorticoids compared with those not receiving glucocorticoids. Bacterial/bronchial pneumonia occurred in 1.2% of patients; interstitial pneumonia, 0.6%; Pneumocystis jirovecii pneumonia, 0.3%; tuberculosis, 0.13%; and administration-site reactions, 6.1%. Mean 28-joint Disease Activity Scores decreased significantly after 24 weeks from 5.29 to 3.91. All subgroups showed significant improvement, particularly the biologic-naïve patients receiving concomitant MTX. No new safety concerns were identified. ADR Incidence rates were similar to those of other biologic agents approved for RA.

Key words

Adalimumab - Effectiveness - Postmarketing surveillance - Rheumatoid arthritis - Safety