Department of Internal Medicine 3, University of Erlangen-Nuremberg, Krankenhausstrasse 12, 91054 Erlangen, Germany.
Rheumatology (Oxford). 2012 May;51(5):852-7. doi: 10.1093/rheumatology/ker223. Epub 2011 Aug 24.
To investigate the occurrence and risk factors for infections in RA patients treated with tocilizumab.
A cohort of all RA patients (n = 112) starting tocilizumab therapy between October 2008 and March 2010 in Northern Bavaria was screened for infections. Mild/moderate and severe infections were recorded. Multivariate logistic regression analysis was used to define risk factors for infection.
Overall, 26 patients developed infections [23.2%; 58.0/100 patient-years (py)], 18 of them were mild to moderate (16.1%, 40.1/100 py) and 8 were severe (17.9/100 py). Concomitant use of LEF and prednisone, high disease activity and previous therapy with rituximab were associated with the occurrence of mild/moderate infections. Severe infections were related to longer disease duration, exposure to more than three previous DMARDs and concomitant therapy with proton-pump inhibitors.
The rate of infection in RA patients treated with tocilizumab in clinical practice is higher than in the clinical trial populations. Increased attention should especially be given to patients with longer disease duration, previous exposure to multiple DMARDs, i.e. previous exposure to rituximab and those receiving concomitant LEF, prednisone or proton-pump inhibitor treatment.
研究托珠单抗治疗的类风湿关节炎(RA)患者感染的发生情况及相关危险因素。
本研究对 2008 年 10 月至 2010 年 3 月在巴伐利亚北部接受托珠单抗治疗的所有 RA 患者(n=112)进行了感染筛查。记录轻度/中度和重度感染。采用多变量逻辑回归分析确定感染的危险因素。
共有 26 例患者发生感染[23.2%;58.0/100 患者年(py)],其中 18 例为轻度/中度(16.1%,40.1/100 py),8 例为重度(17.9/100 py)。LEF 和泼尼松的联合使用、疾病活动度高以及利妥昔单抗的既往治疗与轻度/中度感染的发生相关。重度感染与疾病持续时间较长、既往接受过 3 种以上 DMARDs 治疗以及质子泵抑制剂联合治疗有关。
在临床实践中,接受托珠单抗治疗的 RA 患者的感染率高于临床试验人群。对于疾病持续时间较长、既往接受过多种 DMARDs 治疗(即利妥昔单抗治疗)以及同时接受 LEF、泼尼松或质子泵抑制剂治疗的患者,应特别关注。