Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis
Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis
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DOI：
10.1136/ard.2007.072967
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发表时间：
2008-02-01
影响因子：
27.4
通讯作者：
Koike, T.
中科院分区：
文献类型：
--
作者：
Takeuchi, T.;Tatsuki, Y.;Koike, T.
目的：一个大规模的上市后监测（PMS）研究进行，以确定在日本患者类风湿关节炎（RA）的安全性概况英夫利西单抗。方法：PMS研究进行了所有患者与RA谁是治疗与英夫利西单抗。在开始英夫利西单抗治疗时，他们在PMS研究中连续登记，并前瞻性监测6个月内记录的所有不良事件。所有的病例报告，其中包括安全性相关的事件，每月收集。结果：药物不良反应（ADR）进行了评估，为6个月，在5000例患者谁是连续入组的PMS研究。总不良反应发生率为28.0%，严重不良反应发生率为6.2%。严重ADR中最常见的是“呼吸道疾病”或“呼吸系统疾病”。2.2%发生细菌性肺炎，0.3%发生结核，0.4%发生疑似耶氏肺孢子虫肺炎（PCP），0.5%发生间质性肺炎。开始治疗后立即开始发生细菌性肺炎（男性、老年人和晚期类风湿性关节炎及合并呼吸道疾病患者的风险最高），而结核病、PCP和间质性肺炎约在1个月后发生。严重的输液反应中观察到0.5%，更有可能发生在患者谁参加了以前的临床试验infliximab.Conclusion：这种上市后的监测研究与英夫利西单抗治疗的患者显示，英夫利西单抗与低剂量MTX相结合，日本患者的活动性RA的耐受性良好。
Objectives: A large-scale postmarketing surveillance (PMS) study was carried out to determine the safety profile of infliximab in Japanese patients with rheumatoid arthritis ( RA).Methods: The PMS study was performed for all patients with RA who were treated with infliximab. They were consecutively registered in the PMS study at the initiation of infliximab treatment and were prospectively monitored with all adverse events noted for a period of 6 months. All case reports, which include safety-related events, were collected monthly.Results: Adverse drug reactions (ADRs) were assessed for 6 months in 5000 patients who were consecutively enrolled in the PMS study. The incidence rates of total and serious ADRs were 28.0% and 6.2%, respectively. "Infections'' or "respiratory disorders'' were most commonly observed among serious ADRs. Bacterial pneumonia developed in 2.2%, tuberculosis in 0.3%, suspected Pneumocystis jiroveci pneumonia (PCP) in 0.4% and interstitial pneumonitis in 0.5%. Bacterial pneumonia ( for which individuals of male gender, of older age and those with advanced rheumatoid arthritis and comorbid respiratory disease were most at risk) began to develop immediately after the start of treatment, while tuberculosis, PCP and interstitial pneumonitis developed about 1 month later. Serious infusion reactions were observed in 0.5% and were more likely to occur in patients who had participated in previous clinical trials of infliximab.Conclusion: This postmarketing surveillance study of patients treated with infliximab showed that infliximab in combination with low-dose MTX was well tolerated in Japanese patients with active RA.