Haynes Kevin, Beukelman Timothy, Curtis Jeffrey R, Newcomb Craig, Herrinton Lisa J, Graham David J, Solomon Daniel H, Griffin Marie R, Chen Lang, Liu Liyan, Saag Kenneth G, Lewis James D
University of Pennsylvania, Department of Epidemiology and Biostatistics, Philadelphia, PA 19104, USA.
Arthritis Rheum. 2013 Jan;65(1):48-58. doi: 10.1002/art.37740.
To compare the incidence of cancer following tumor necrosis factor α (TNFα) inhibitor therapy to that with commonly used alternative therapies across multiple immune-mediated diseases.
The Safety Assessment of Biological Therapeutics study used data from 4 sources: national Medicaid and Medicare databases, Tennessee Medicaid, pharmacy benefits plans for Medicare beneficiaries in New Jersey and Pennsylvania, and Kaiser Permanente Northern California. Propensity score-adjusted hazard ratios (HRs) and 95% confidence intervals (95% CIs) were computed to estimate the relative rates of cancer, comparing those treated with TNFα inhibitors to those treated with alternative disease-modifying therapies. The cancer-finding algorithm had a positive predictive value ranging from 31% for any leukemia to 89% for female breast cancer.
We included 29,555 patients with rheumatoid arthritis (RA) (13,102 person-years), 6,357 patients with inflammatory bowel disease (1,508 person-years), 1,298 patients with psoriasis (371 person-years), and 2,498 patients with psoriatic arthritis (618 person-years). The incidence of any solid cancer was not elevated in RA (HR 0.80 [95% CI 0.59-1.08]), inflammatory bowel disease (HR 1.42 [95% CI 0.47-4.26]), psoriasis (HR 0.58 [95% CI 0.10-3.31]), or psoriatic arthritis (HR 0.74 [95% CI 0.20-2.76]) during TNFα inhibitor therapy compared to disease-specific alternative therapy. Among RA patients, the incidence of any of the 10 most common cancers in the US and of nonmelanoma skin cancer was not increased with TNFα inhibitor therapy compared to treatment with comparator drugs.
Short-term cancer risk was not elevated among patients treated with TNFα inhibitor therapy relative to commonly used therapies for immune- mediated chronic inflammatory diseases in this study.
比较肿瘤坏死因子α（TNFα）抑制剂治疗后与多种免疫介导疾病常用替代疗法后癌症的发病率。
生物治疗安全性评估研究使用了来自4个来源的数据：国家医疗补助和医疗保险数据库、田纳西州医疗补助、新泽西州和宾夕法尼亚州医疗保险受益人的药房福利计划，以及北加利福尼亚永久医疗集团。计算倾向评分调整后的风险比（HRs）和95%置信区间（95% CIs），以估计癌症的相对发生率，比较接受TNFα抑制剂治疗的患者与接受替代疾病缓解疗法治疗的患者。癌症发现算法的阳性预测值范围从任何白血病的31%到女性乳腺癌的89%。
我们纳入了29555例类风湿关节炎（RA）患者（13102人年）、6357例炎症性肠病患者（1508人年）、1298例银屑病患者（371人年）和2498例银屑病关节炎患者（618人年）。与疾病特异性替代疗法相比，TNFα抑制剂治疗期间，RA（HR 0.80 [95% CI 0.59 - 1.08]）、炎症性肠病（HR 1.42 [95% CI 0.47 - 4.26]）、银屑病（HR 0.58 [95% CI 0.10 - 3.31]）或银屑病关节炎（HR 0.74 [95% CI 0.20 - 2.76]）中任何实体癌的发病率均未升高。在RA患者中，与使用对照药物治疗相比，TNFα抑制剂治疗并未增加美国10种最常见癌症中任何一种以及非黑色素瘤皮肤癌的发病率。
在本研究中，与免疫介导的慢性炎症性疾病常用疗法相比，接受TNFα抑制剂治疗的患者短期癌症风险并未升高。
