Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Mod Rheumatol. 2011 Aug;21(4):343-51. doi: 10.1007/s10165-010-0406-3. Epub 2011 Jan 25.
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.
我们的目的是在一项为期 6 个月的上市后监测研究中评估其实用安全性和疗效，该研究涵盖了在两年期间接受依那西普治疗的所有日本类风湿关节炎（RA）患者。共收集了 2005 年 3 月至 2007 年 4 月期间登记的 13894 例患者（1334 个部位）的数据。分别有 4336（31.2%）例和 857（6.2%）例患者报告了不良事件（AE）和严重不良事件（SAE）。最常见的 AE 是注射部位反应（n=610，4.4%）和皮疹（n=339，2.4%），而肺炎（n=116，0.8%）和间质性肺病（n=77，0.6%）是最常见的 SAE。从第 4 周（17.6%）到第 24 周（31.6%），观察到具有良好欧洲抗风湿病联盟（EULAR）反应的患者比例显著增加（p<0.001）；第 24 周时，84.3%的患者有良好或中度 EULAR 反应。从第 4 周（9.3%）到第 24 周（18.9%），达到缓解的患者比例显著增加（p<0.001）。与疾病更严重的患者相比，早期中度 RA 患者发生 SAE 的可能性较小，更有可能达到缓解。在迄今为止针对接受生物制剂治疗的 RA 患者进行的最大规模观察性试验之一中，证实了依那西普的安全性和有效性。
