74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis.
74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis.
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DOI：
10.1186/ar3058
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发表时间：
2010
影响因子：
4.9
通讯作者：
REMITRACT study group
中科院分区：
文献类型：
--
作者：
Delabaye I;De Keyser F;REMITRACT study group
目的是描述在每日临床环境中接受英夫利西单抗和甲氨蝶呤治疗的类风湿关节炎（RA）患者中不良事件（AE）的患病率、类型和预测因素。这是一项前瞻性、多中心、开放标签、74周观察性研究，在接受甲氨蝶呤和至少一种其他疾病缓解抗风湿药物治疗的活动性RA患者中进行。患者在第0、2和6周接受3 mg/kg英夫利西单抗治疗，然后每8周一次。在第0、6、26、50和74周，患者回答健康评估问卷，进行肿胀关节计数，并记录在前一阶段发生的不良事件（AE）。575例患者接受英夫利西单抗治疗，其中346例在研究结束时仍在接受英夫利西单抗治疗，158例停止治疗，71例失访。停药原因包括安全性（n = 74）、择期原因（n = 43）和无效（n = 41）。输注反应（n = 33）和感染（n = 20）是最常见的导致停药的AE，也是总体上最常见的AE。有4例结核病例，均发生在筛选时阴性的患者中。总AE、严重AE和输注反应以及因AE停药在前26周内最常见。较高的年龄是严重不良事件（SAE）、感染和因SAE而停药的预测因子，但比值比接近1。难治性RA患者在英夫利西单抗治疗的前半年最常发生AE和因AE而停药。停止治疗的主要原因是感染和输液反应。结核病和其他感染仍然是这些患者的一个重要问题。
The objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting. This was a prospective, multi-center, open-label, 74-week observational study in patients with active RA despite treatment with methotrexate and at least one other disease-modifying anti-rheumatic drug. Patients were treated with 3 mg/kg infliximab at weeks 0, 2, and 6 and then every 8 weeks. At weeks 0, 6, 26, 50, and 74, patients answered a health assessment questionnaire, a swollen joint count was made, and adverse events (AEs) occurring during the previous period were registered. Five hundred and seventy-five patients were treated with infliximab, of which 346 were still on infliximab at the study end, 158 discontinued treatment, and 71 were lost to follow-up. Reasons for discontinuation included safety (n = 74), elective reasons (n = 43), and inefficacy (n = 41). Infusion reactions (n = 33) and infections (n = 20) were the most common AEs causing discontinuation and the most common AEs overall. There were four cases of tuberculosis, all of which occurred in patients negative at screening. Total AEs, serious AEs, and infusion reactions as well as discontinuations for AEs were most frequent during the first 26 weeks. Higher age was a predictor of serious adverse events (SAEs), infection, and discontinuation due to an SAE, but odds ratios were close to one. AEs and discontinuations due to AEs occur most frequently during the first half year of infliximab treatment in refractory RA patients. The main reasons for discontinuing treatment are infections and infusion reactions. Tuberculosis and other infections remain an important concern in these patients.
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影响因子：
--
作者：
Gómez-Reino, JJ;Carmona, L;Montero, MD
通讯作者：
Montero, MD
影响因子：
4.9
作者：
Kapetanovic, Meliha C.;Larsson, Lotta;Geborek, Pierre
通讯作者：
Geborek, Pierre
影响因子：
3.4
作者：
Bertoli, Ana M.;Strusberg, Ingrid;Strusberg, Alberto M.
通讯作者：
Strusberg, Alberto M.
影响因子：
27.4
作者：
Geborek, P;Crnkic, M;Saxne, T
通讯作者：
Saxne, T
影响因子：
--
作者：
Brown, SL;Greene, MH;Braun, MM
通讯作者：
Braun, MM