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作者：Jeffrey R 等 翻译：李常虹 发布者：翟佳羽 审校者：李常虹
背景： 间质性肺病（ILD）是一种常见的类风湿关节炎的关节外表现，但很少有研究系统评估ILD的发生率和接受抗肿瘤坏死因子制剂或其他生物制剂治疗的患者发生ILD的风险因素。
方法： 研究对象为至少使用过一次阿巴西普、利妥昔单抗、托珠单抗或抗TNF制剂治疗的年龄大于18周岁的类风湿关节炎患者，这些患者均来自MarketScan数据库且满足入选标准。采用Cox模型评估ILD发生的风险和ILD相关的住院风险。采用另外一个ILD诊断标准进行敏感性分析。
结果： 研究对象中共有11219例患者使用过13795次生物制剂。平均随访时间为0.7年。接受非抗TNF类生物制剂治疗的患者更倾向于有近期激素加量的病史、先前使用过多种生物制剂、有ILD病史、贫血、慢性阻塞性肺病和其他的肺部疾病史。当使用敏感性定义时，未经调整的ILD发生率为4.0-12.2/1000人年。敏感和/或特异模型分析均显示高龄、男性和有其他的肺部疾病与ILD发生率增加相关，而不同生物制剂种类之间没有明显差异。当采用敏感定义时，住院率分别为55.6（托珠单抗）和262.5（英夫利昔单抗）。在Cox模型中，近期使用MTX与ILD相关的住院率降低有关，而男性和入组前12个月内因哮喘或ILD/肺炎住院的人群与住院风险增加相关。
结论： 接受不同种类生物制剂治疗的RA患者之间ILD及其相关并发症发生的风险无明显差异。为全面评估ILD及其并发症发生的风险，有必要进一步的研究对基线时患者的临床特点差异做出解释。
附原文： Introduction:Interstitial lung disease (ILD) is a common extra-articular condition in rheumatoid arthritis (RA), but few studies have systematically investigated its incidence and risk factors in patients receiving anti-tumor necrosis factor-alpha (anti-TNFα) agents or alternate mechanisms of action (MOAs) (e.g., T-cell, B-cell, and interleukin-6 inhibitors).Methods:RA patients at least 18 years old were selected from the MarketScan databases (2010–2012) if they had at least one prescription/administration of abatacept, rituximab, tocilizumab, or anti-TNF after having discontinued a different biologic agent and meeting enrollment criteria. Cox models estimated the risk of incident ILD and ILD-related hospitalization. Sensitivity analyses used an alternate ILD case definition.Results:We identified 13,795 episodes of biologic exposure in 11,219 patients. Mean (standard deviation) follow-up was 0.7 (0.5) years. Patients receiving alternate MOA agents were more likely to have had recent exposure to steroids, prior exposure to a greater number of biologics, and history of ILD, anemia, chronic obstructive pulmonary disease, and other pulmonary conditions. When the sensitive definition was used, unadjusted ILD incidence rates (95 % confidence interval, or CI) ranged from 4.0 (1.6–8.2, abatacept) to 12.2 (5.6–23.2, infliximab) per 1000 person-years. Being older (hazard ratio (HR) 3.5; 95 % CI 2.1–6.0), being male (HR 3.1; 95 % CI 1.2–8.4), and having another pulmonary condition (HR 4.8; 95 % CI 1.7–13.7) were associated with increased ILD incidence in either sensitive and/or specific models. There were no significant differences by biologic class. Hospitalization rates (95 % CI) when the sensitive definition was used ranged from 55.6 (6.7–200.7, tocilizumab) to 262.5 (71.5–672.2, infliximab). In Cox models, recent methotrexate exposure was associated with reduced ILD hospitalization (HR 0.16; 95 % CI 0.06–0.46), whereas being male (HR 2.5; 95 % CI 1.3–4.8) and having had a hospitalization for asthma (HR 3.4; 95 % CI 1.2–9.8) or ILD/pneumonia (HR 2.3; 95 % CI 1.1–4.7) in the 12 months prior to index were associated with increased hospitalization risk.Conclusions:There were no significant differences in the risk of ILD and its related complications between RA patients receiving anti-TNFα agents and those receiving alternate MOA agents. Further studies are needed that account for differences in baseline characteristics in order to fully evaluate the risk of ILD and its complications.
引自： Jeffrey R. Curtis, Khaled Sarsour, Pavel Napalkov, Laurie A. Costa and Kathy L.Incidence and complications of interstitial lung disease in users of tocilizumab, rituximab, abatacept and anti-tumor necrosis factor α agents, a retrospective cohort study. Schulman,Arthritis Research &Therapy201517:319,DOI: 10.1186/s13075-015-0835-7
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