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

Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, Tanaka Y, Yamanaka H, Fujii K, Yoshinaga T, Freundlich B, Suzukawa M.

Hokkaido University Graduate School of Medicine, Sapporo, Japan.

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.

依那西普治疗日本RA患者的安全性与疗效的上市后监察

Koike T,et al.Mod Rheumatol. 2011 Jan 25

本文旨在评估依那西普在实际应用中的安全性和疗效，这是一项为期6个月的上市后监察研究，涵盖了2年内所有使用依那西普的日本RA患者。采集2005年3月至2007年4月13894例患者（1334个医疗机构）的数据。4336例（31.2%）患者和857例（6.2%）患者分别报告了不良事件（AEs）和严重不良事件（SAEs）。最常见的AEs为注射部位反应（n = 610, 4.4%）和皮疹（n = 339, 2.4%），肺炎（n = 116, 0.8%）和肺间质病变（n = 77, 0.6%）是最常见的SAEs。达到EULAR良好反应的患者比例在第4周为17.6%，第24周显著升高至31.6%（p < 0.001）；84.3%患者在第24周达到EULAR良好或中等反应。获得缓解的患者比例在第4周为9.3%，第24周显著上升至18.9%（p < 0.001）。与病情严重的患者相比，早期病情中等的患者较少发生SAEs，更可能获得缓解。这是目前最大规模的生物制剂治疗RA的观察性试验之一，它证实了依那西普的安全性和疗效。