生物 DMARDs 治疗的早期类风湿关节炎患者的恶性肿瘤风险及其发生率。
The risk of malignancy and its incidence in early rheumatoid arthritis patients treated with biologic DMARDs.
机构信息
Hanyang University Hospital for Rheumatic Diseases, 222-1 wangsimni-ro, Seongdong-gu, Seoul, 04763, South Korea.
Clinical Research Center for Rheumatoid Arthritis (CRCRA), 222 wangsimni-ro, Seongdong-gu, Seoul, 04763, South Korea.
出版信息
Arthritis Res Ther. 2017 Dec 15;19(1):277. doi: 10.1186/s13075-017-1482-y.
BACKGROUND
Treatment with disease-modifying anti-rheumatic drugs (DMARDs) has raised concerns about the risk of malignancies in rheumatoid arthritis (RA) patients. However, the association between biologic DMARDs (bDMARDs) and malignancy in previous reports remains controversial. Therefore we aimed to estimate the incidence of malignancy in early RA patients and to evaluate the relative risk of malignancy with use of bDMARDs.
METHODS
A retrospective cohort of incident RA patients was established using the Korean National Claims Database. Among a total of 14,081 RA patients identified, 1684 patients with a history of malignancy were excluded. We calculated the incidence rate of overall and individual malignancies. The standardized incidence ratio (SIR) of malignancies in bDMARD users was compared to that in nonusers. Multivariable logistic regression analysis was used to evaluate the impact of bDMARDs on the development of malignancies in early RA patients.
RESULTS
A total of 12,397 early RA patients without a history of malignancy were enrolled. During 41,599 person-years (PY) of follow-up, 725 malignancies developed in 561 patients (174.3/10,000 PY) and 21 hematologic malignancies developed (5.0/10,000 PY). Patients treated with bDMARDs had a significantly lower incidence of overall malignancy compared to those not treated with bDMARDs (SIR 0.45 (95% CI 0.28-0.70)). However, this relationship was not significant with regard to hematologic malignancies (SIR 2.65 (95% CI 0.55-7.76)). On multivariable analysis, bDMARD use was a protective factor against the development of overall malignancy (odds ratio 0.42 (95% CI 0.25-0.73)). However, bDMARD use had no significant protective effect against the development of hematologic malignancies (odds ratio 1.69 (95% CI 0.38-7.59)).
CONCLUSIONS
In early RA patients, bDMARD use decreases the overall risk of developing malignancies; however, it does not affect the risk of developing hematologic malignancies.
背景
治疗类风湿关节炎（RA）的疾病修饰抗风湿药物（DMARDs）引起了人们对 RA 患者发生恶性肿瘤风险的关注。然而，之前的报告中生物 DMARDs（bDMARDs）与恶性肿瘤之间的关联仍存在争议。因此，我们旨在评估早期 RA 患者恶性肿瘤的发生率，并评估使用 bDMARDs 治疗与恶性肿瘤发生的相对风险。
方法
使用韩国国家索赔数据库建立了一个回顾性的早期 RA 患者队列。在确定的 14081 例 RA 患者中，排除了 1684 例有恶性肿瘤病史的患者。我们计算了总体和个别恶性肿瘤的发病率。比较了 bDMARD 使用者和非使用者的恶性肿瘤标准化发病率比（SIR）。使用多变量逻辑回归分析评估 bDMARDs 对早期 RA 患者恶性肿瘤发展的影响。
结果
共纳入了 12397 例无恶性肿瘤病史的早期 RA 患者。在 41599 人年（PY）的随访期间，561 例患者中有 725 例发生了恶性肿瘤（174.3/10000 PY），21 例发生了血液恶性肿瘤（5.0/10000 PY）。与未接受 bDMARD 治疗的患者相比，接受 bDMARD 治疗的患者恶性肿瘤总发生率显著降低（SIR 0.45（95%CI 0.28-0.70））。然而，这种关系在血液恶性肿瘤方面并不显著（SIR 2.65（95%CI 0.55-7.76））。多变量分析显示，bDMARD 使用是发生总体恶性肿瘤的保护因素（比值比 0.42（95%CI 0.25-0.73））。然而，bDMARD 使用对血液恶性肿瘤的发生没有显著的保护作用（比值比 1.69（95%CI 0.38-7.59））。
结论
在早期 RA 患者中，bDMARD 使用降低了发生恶性肿瘤的总体风险；然而，它并不影响血液恶性肿瘤的风险。
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