Vol.21 No.4

Original Article

Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis

Authors

Takao Koike1 , Masayoshi Harigai2 , Shigeko Inokuma3 , Naoki Ishiguro4 , Junnosuke Ryu5 , Tsutomu Takeuchi6 , Yoshiya Tanaka7 , Hisashi Yamanaka8 , Koichi Fujii9 , Takunari Yoshinaga10 , Bruce Freundlich11 , Michio Suzukawa9

  • Hokkaido University Graduate School of Medicine, Sapporo, Japan
  • Tokyo Medical Dental University Graduate School, Tokyo, Japan
  • Japanese Red Cross Medical Center, Tokyo, Japan
  • Nagoya University Graduate School of Medicine, Nagoya, Japan
  • Nihon University School of Medicine, Tokyo, Japan
  • Keio University, Tokyo, Japan
  • University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
  • Tokyo Women’s Medical University, Tokyo, Japan
  • Pfizer Japan Inc., Medical Affairs, Tokyo, Japan
  • Pfizer Japan Inc., Postmarketing Surveillance, Tokyo, Japan
  • University of Pennsylvania, 1252 Lakemont Road, Villanova, Philadelphia, PA 19085, USA
Received:

1 November 2010

Accepted:

2 December 2010

Published online:

25 January 2011

Full Text

PDF　(member's only)

Abstract

Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p < 0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p < 0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics.

Key words

DAS28 - Etanercept - Postmarketing surveillance study - Rheumatoid arthritis