Research Unit, Sociedad Española de Reumatología, Madrid, Spain.
Semin Arthritis Rheum. 2011 Aug;41(1):71-80. doi: 10.1016/j.semarthrit.2010.08.005. Epub 2010 Nov 18.
To describe the risk of cancer in patients exposed to tumor necrosis factor (TNF) antagonists.
The following 2 clinical cohorts were studied: (1) BIOBADASER 2.0: a registry of patients suffering from rheumatic diseases exposed to TNF antagonists (2531 rheumatoid arthritis (RA), 1488 spondyloarthropathies, and 675 other rheumatic conditions); and (2) EMECAR: a cohort of 789 RA patients not exposed to TNF antagonists. Cancer incidence rates (IR) per 1000 patient-years and incidence rate ratios (IRR) were calculated for BIOBADASER 2.0 and EMECAR patients. The IR over time in BIOBADASER 2.0 patients was analyzed by joinpoint regression. The IRR was estimated to compare cancer rates in exposed versus nonexposed RA patients. Standardized incidence and mortality ratios (SIR, SMR) were also estimated. Risk factors for cancer in patients exposed to TNF antagonists were investigated by generalized linear models.
The SMR for cancer in BIODASER 2.0 was 0.67 (95% CI: 0.51-0.86), and the SIR was 0.1 (95% CI 0.03-0.23). The IR in RA patients exposed to TNF antagonists was 5.8 (95% CI: 4.4-7.6), and the adjusted IRR was 0.48 (95% CI: 0.09-2.45). The IR in patients with previous cancer was 26.4 (95% CI: 4.1-171.5). Age, chronic obstructive pulmonary disease, and steroids were associated with a higher risk of developing cancer. The IR decreased after the first 4 months of exposure, without statistical significance.
Overall cancer and mortality rates in patients with rheumatic diseases exposed to TNF antagonists are no higher than in the background Spanish population. However special attention should be paid to elderly patients, those with previous cancers, and patients treated with steroids.
描述接受肿瘤坏死因子（TNF）拮抗剂治疗的患者罹患癌症的风险。
本研究对以下 2 个临床队列进行了研究：（1）BIOBADASER 2.0：一个接受 TNF 拮抗剂治疗的风湿性疾病患者登记处（2531 例类风湿关节炎（RA）、1488 例脊柱关节炎和 675 例其他风湿性疾病）；（2）EMECAR：789 例未接受 TNF 拮抗剂治疗的 RA 患者队列。计算 BIOBADASER 2.0 和 EMECAR 患者的每 1000 患者年的癌症发生率（IR）和发病率比值（IRR）。通过 joinpoint 回归分析 BIOBADASER 2.0 患者随时间的 IR。通过广义线性模型来研究接受 TNF 拮抗剂治疗的患者罹患癌症的风险因素。
BIOBADASER 2.0 中的癌症标准化发病率比（SMR）为 0.67（95%CI：0.51-0.86），标准化死亡率比（SMR）为 0.1（95%CI：0.03-0.23）。接受 TNF 拮抗剂治疗的 RA 患者的 IR 为 5.8（95%CI：4.4-7.6），调整后的 IRR 为 0.48（95%CI：0.09-2.45）。有既往癌症史的患者的 IR 为 26.4（95%CI：4.1-171.5）。年龄、慢性阻塞性肺疾病和类固醇与癌症发生风险增加相关。暴露后前 4 个月的 IR 下降，但无统计学意义。
接受 TNF 拮抗剂治疗的风湿性疾病患者的总体癌症和死亡率与西班牙背景人群相比并不更高。然而，应特别关注老年患者、有既往癌症史的患者和接受类固醇治疗的患者。
