Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan.
Mod Rheumatol. 2012 Feb;22(1):122-7. doi: 10.1007/s10165-011-0488-6. Epub 2011 Jul 8.
We aimed to demonstrate the incidence of serious respiratory infections in patients with rheumatoid arthritis (RA) treated with tocilizumab (TCZ) monotherapy. We analyzed the incidence of serious respiratory infections in 601 RA patients enrolled in TCZ clinical trials and their extension studies (TCZ cohort) and in 601 age- and sex-standardized RA patients treated in daily clinical practice at Tokyo Women's Medical University (IORRA subsample cohort). The rates of serious respiratory infections were 1.77 per 100 patient-years from 1999 to 2008 in the TCZ cohort and 0.53 per 100 patient-years from 2000 to 2009 in the IORRA subsample cohort. With the IORRA subsample cohort regarded as a standard population, the standardized incidence ratio (SIR) of serious respiratory infection in the TCZ cohort was 3.64 [95% confidence interval (CI) 2.56-5.01], standardized for age and sex; 2.35 (95% CI 1.66-3.24), standardized for age sex, and corticosteroid use; 1.85 (95% CI 1.30-2.55), standardized for age sex, and pre-existing pulmonary involvement; and 2.41 (95% CI 1.68-3.34) standardized for age sex, and disease activity. The risk of serious respiratory infection in the TCZ cohort was approximately double that in the IORRA subsample cohort after standardizing for corticosteroid use, pre-existing pulmonary involvement, or disease activity. This is comparable to the risk reported when tumor necrosis factor (TNF) inhibitors are used.
我们旨在展示接受托珠单抗（TCZ）单药治疗的类风湿关节炎（RA）患者严重呼吸道感染的发生率。我们分析了 TCZ 临床试验和扩展研究（TCZ 队列）中 601 例 RA 患者和东京女子医科大学日常临床实践中 601 例年龄和性别标准化的 RA 患者（IORRA 亚样本队列）中严重呼吸道感染的发生率。TCZ 队列中 1999 年至 2008 年严重呼吸道感染的发生率为 1.77/100 患者年，IORRA 亚样本队列中 2000 年至 2009 年为 0.53/100 患者年。以 IORRA 亚样本队列为标准人群，TCZ 队列中严重呼吸道感染的标准化发病率比（SIR）为 3.64（95%可信区间[CI] 2.56-5.01），按年龄和性别标准化；2.35（95%CI 1.66-3.24），按年龄、性别和皮质类固醇使用情况标准化；1.85（95%CI 1.30-2.55），按年龄、性别和既往肺部受累情况标准化；2.41（95%CI 1.68-3.34），按年龄、性别和疾病活动情况标准化。在标准化皮质类固醇使用、既往肺部受累或疾病活动后，TCZ 队列中严重呼吸道感染的风险约为 IORRA 亚样本队列的两倍。这与使用肿瘤坏死因子（TNF）抑制剂时报告的风险相当。
