Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis
Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis
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DOI：
10.3109/14397595.2013.854074
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发表时间：
2014-01-01
影响因子：
2.2
通讯作者：
Miyasaka, Nobuyuki
中科院分区：
文献类型：
--
作者：
Takeuchi, Tsutomu;Kawai, Shinichi;Miyasaka, Nobuyuki
目的实施一项上市后监测（PMS）计划，以评估他克莫司（TAC）在日本类风湿关节炎（RA）患者中的安全性和有效性，并确定与药物不良反应（ADRs.Methods）相关的危险因素。采用疾病活动性评分28-CRP（DAS 28-CRP）评价疗效。结果安全性分析中评价了3,172例患者（平均年龄62.2岁）的数据。在安全性人群中，78.5%为女性，25.9%为Steinbrocker功能分级3或4级。52.5%的患者使用TAC作为单药治疗，最常见的伴随疾病缓解抗风湿药（DMARD）是甲氨蝶呤，28.9%的患者使用。AE、严重AE（SAE）、ADR和严重ADR的发生率分别为41.2%、6.4%、36.0%和4.9%。最常见的严重ADR类别为感染和侵染。年龄≥ 65岁、合并肾功能不全和合并糖尿病被确定为ADR的重要危险因素。基于EULAR反应标准，65.4%的患者表现出中度或良好的respond.Conclusions结果表明，TAC是日本患者的活动性RA，包括那些接受伴随甲氨蝶呤，在真实的世界耐受良好。
Objectives A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs).Methods Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP).Results Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 % were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age >= 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response.Conclusions The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.