Karolinska University Hospital, Stockholm, Sweden.
J Rheumatol. 2010 Mar;37(3):558-67. doi: 10.3899/jrheum.090856. Epub 2010 Jan 28.
To evaluate the longterm safety of rituximab in clinical trials in patients with rheumatoid arthritis (RA).
Pooled analysis of safety data, including adverse events (AE) and infections, from patients treated with rituximab in combination with methotrexate in a global clinical trial program.
A total of 2578 patients with RA received at least 1 course of rituximab. Safety analyses were based on 5013 patient-years of rituximab exposure. The most frequent AE was infusion-related reactions (25% of patients during the first infusion of Course 1). Less than 1% of infusion-related reactions were considered serious. Rates of AE and serious AE (SAE; 17.85 events/100 patient-yrs, 95% CI 16.72, 19.06) were stable following each course. The overall serious infection rate was 4.31/100 patient-years (95% CI 3.77, 4.92). Infections and serious infections over time remained stable across 5 courses at 4-6 events/100 patient-years. Compared with other patients with RA and with the general US population, there was no increased risk of malignancy.
In this longterm safety update in RA clinical trial patients, rituximab remained well tolerated over multiple courses. SAE and infections remained stable over time and by treatment course.
评估利妥昔单抗在类风湿关节炎（RA）临床试验中的长期安全性。
对接受利妥昔单抗联合甲氨蝶呤全球临床试验方案治疗的患者的安全性数据（包括不良事件（AE）和感染）进行汇总分析。
共有 2578 例 RA 患者接受了至少 1 个疗程的利妥昔单抗治疗。安全性分析基于 5013 患者年的利妥昔单抗暴露。最常见的 AE 是输注相关反应（第 1 疗程第 1 次输注时 25%的患者）。不到 1%的输注相关反应被认为是严重的。在每一个疗程后，AE 和严重 AE（SAE；17.85 例/100 患者年，95%CI 16.72，19.06）的发生率保持稳定。严重感染总发生率为 4.31/100 患者年（95%CI 3.77，4.92）。在 5 个疗程中，感染和严重感染的发生率随时间推移保持稳定，每 100 患者年 4-6 例。与其他 RA 患者和一般美国人群相比，恶性肿瘤的风险没有增加。
在 RA 临床试验患者的这项长期安全性更新中，利妥昔单抗在多个疗程中仍具有良好的耐受性。SAE 和感染随时间推移和治疗疗程保持稳定。
