Risk of incident or recurrent malignancies among patients with rheumatoid arthritis exposed to biologic therapy in the German biologics register RABBIT
Risk of incident or recurrent malignancies among patients with rheumatoid arthritis exposed to biologic therapy in the German biologics register RABBIT
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DOI：
10.1186/ar2904
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发表时间：
2010-01-01
影响因子：
4.9
通讯作者：
Zink, Angela
中科院分区：
文献类型：
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作者：
Strangfeld, Anja;Hierse, Franka;Zink, Angela
简介：我们使用德国生物制品登记册 RABBIT（一项全国性前瞻性队列研究）的数据，调查与传统疾病缓解抗风湿药物 (DMARD) 相比，接受生物制品治疗的类风湿性关节炎 (RA) 患者新发或复发恶性肿瘤的风险。方法：该分析基于在生物制品或传统 DMARD 治疗开始时加入 RABBIT 的 RA 患者 2001年5月1日和2006年12月31日。首次或复发性恶性肿瘤的发病率分别进行了分析。采用巢式病例对照设计来调查罹患首次恶性肿瘤的风险。匹配标准为：年龄、性别、随访时间、研究开始时基于 28 个关节计数 (DAS28) 的疾病活动评分、吸烟状况和选定的慢性合并症（阻塞性或其他肺部疾病、肾脏、肝脏或胃肠道疾病、牛皮癣）。 结果：5,120 名患者中有 122 名报告既往患有恶性肿瘤。其中 58 名患者在研究开始时接受了抗 TNF α 药物、9 名阿那白滞素和 55 名传统 DMARD。在 14 名患者（曾接触过抗 TNF α 药物：8 名，阿那白滞素：1 名）中观察到 15 例癌症复发。自首次恶性肿瘤发病以来的平均时间为九年。暴露于抗 TNF α 药物的患者每 1,000 患者年 (pyrs) 的粗复发率为 45.5，阿那白滞素患者为 32.3，仅暴露于 DMARD 的患者为 31.4（抗 TNF α 与 DMARD 的发生率比 = 1.4，P = 0.6）。在既往没有癌症的患者中，74 名患者（70% 为女性，平均年龄：61.3 岁）在观察期间出现了首次恶性肿瘤。这对应于 6.0/1,000pyrs 的发生率 (IR)。其中 44 名患者曾接受过抗 TNF α 治疗（IR = 5.1/1,000pyrs）。在一项比较癌症患者与无癌症对照的巢式病例对照研究中，44 名癌症患者和 44 名无癌症对照曾经暴露于抗 TNF α 药物 (P = 1.0)。结论：暴露或未暴露于抗 TNF α 或阿那白滞素治疗的患者的恶性肿瘤总体发病率没有显着差异。这同样适用于恶性肿瘤复发的风险。然而，特别是最后一个发现需要在更大的数据集中进一步验证。
Introduction: We used the data of the German biologics register RABBIT, a nationwide prospective cohort study, to investigate the risk of new or recurrent malignancy in patients with rheumatoid arthritis (RA) receiving biologics compared to conventional disease modifying anti-rheumatic drugs (DMARDs).Methods: The analysis was based on patients with RA enrolled in RABBIT at the start of a biologic or conventional DMARD therapy between 01 May 2001 and 31 December 2006. Incidences of first or recurrent malignancies were analysed separately. A nested case-control design was used to investigate the risk of developing a first malignancy. Matching criteria were: age, gender, follow-up time, disease activity score based on 28 joint counts (DAS28) at study entry, smoking status, and selected chronic co-morbid conditions (obstructive or other lung disease, kidney, liver or gastrointestinal disease, psoriasis).Results: A prior malignancy was reported in 122 out of 5,120 patients. Fifty-eight of these patients had received anti-TNF alpha agents, 9 anakinra, and 55 conventional DMARDs at study entry. In 14 patients (ever exposed to anti-TNF alpha: eight, to anakinra: one) 15 recurrent cancers were observed. The average time period since the onset of the first malignancy was nine years. Crude recurrence rates per 1,000 patient-years (pyrs) were 45.5 for patients exposed to anti-TNF alpha agents, 32.3 for anakinra patients and 31.4 for patients exposed to DMARDs only (Incidence rate ratio anti-TNF alpha vs. DMARD = 1.4, P = 0.6.). In patients without prior cancer, 74 patients (70% female, mean age: 61.3) developed a first malignancy during the observation. This corresponds to an incidence rate (IR) of 6.0/1,000 pyrs. Forty-four of these patients were ever exposed to anti-TNF alpha treatment (IR = 5.1/1,000 pyrs). In a nested case-control study comparing cancer patients to cancer-free controls, 44 of the cancer patients and 44 of the cancer-free controls were ever exposed to anti-TNF alpha agents (P = 1.0).Conclusions: No significant differences in the overall incidence of malignancies in patients exposed or unexposed to anti-TNF alpha or anakinra treatment were found. The same applied to the risk of recurrent malignancies. However, in particular this last finding needs further validation in larger data sets.