Department of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan.
Mod Rheumatol. 2012 Nov;22(6):849-58. doi: 10.1007/s10165-012-0615-z. Epub 2012 Feb 22.
The association of anti-tumor necrosis factor therapy with opportunistic infections in rheumatoid arthritis (RA) patients has been reported. The goal of this study was to clarify the clinical characteristics and the risk factors of RA patients who developed Pneumocystis jirovecii pneumonia (PCP) during etanercept therapy.
We conducted a multicenter, case-control study in which 15 RA patients who developed PCP were compared with 74 RA patients who did not develop PCP during etanercept therapy.
PCP developed within 26 weeks following the first injection of etanercept in 86.7% of the patients. All PCP patients presented with a rapid and severe clinical course and the overall mortality was 6.7%. Independent risk factors were identified using multivariate analysis and included age ≥65 years [hazard ratio (HR) 3.35, p = 0.037], coexisting lung disease (HR 4.48, p = 0.009), and concomitant methotrexate treatment (HR 4.68, p = 0.005). In patients having a larger number of risk factors, the cumulative probability of developing PCP was significantly higher (p < 0.001 for patients with two or more risk factors vs. those with no risk factor, and p = 0.001 for patients with one risk factor vs. those with no risk factor).
Physicians must consider the possibility of PCP developing during etanercept therapy in RA patients, particularly if one or more risk factors are present.
已有报道称,肿瘤坏死因子拮抗剂治疗与类风湿关节炎(RA)患者的机会性感染相关。本研究旨在阐明接受依那西普治疗的 RA 患者发生肺孢子菌肺炎(PCP)的临床特征和危险因素。
我们进行了一项多中心病例对照研究,将 15 例接受依那西普治疗期间发生 PCP 的 RA 患者与 74 例未发生 PCP 的 RA 患者进行比较。
86.7%的患者在首次依那西普注射后 26 周内发生 PCP。所有 PCP 患者均表现出快速而严重的临床病程,总死亡率为 6.7%。多因素分析确定了独立的危险因素,包括年龄≥65 岁[风险比(HR)3.35,p=0.037]、并存肺部疾病(HR 4.48,p=0.009)和同时接受甲氨蝶呤治疗(HR 4.68,p=0.005)。在具有较多危险因素的患者中,发生 PCP 的累积概率显著升高(p<0.001,有 2 个或更多危险因素的患者与无危险因素的患者相比;p=0.001,有 1 个危险因素的患者与无危险因素的患者相比)。
医生必须考虑在接受依那西普治疗的 RA 患者中发生 PCP 的可能性,特别是存在 1 个或多个危险因素时。