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生物制剂诱发实体瘤的风险—数据源自英国风湿病患者生物制剂统计中心

 牤牛河畔生 2015-07-05

背景RA患者相较正常人来说易患某些实体肿瘤,特别是肺癌。肿瘤坏死因子拮抗剂TNFI的应用可能会增加罹患肿瘤的风险。


目的:比较RA患者应用生物制剂及传统抗风湿药物治疗罹患实体肿瘤的风险比较。


方法:患者明确诊断为类风湿关节炎,在英国生物制剂应用中心登记注册。一项全英国的前瞻性队列研究,统计从2001年起就收生物制剂治疗,直至发生实体肿瘤、治疗时间长达5年以上或截止到2011年。比较11767例患者既往没有肿瘤病史接受TNFI治疗,以及3246名既往无肿瘤病史使用传统抗风湿药物(sDMARDs药物治疗)。


结果:在TNFI组的52549患病年当中,实体瘤发生427例(8195% CI 98--138per 10000 patient-year),传统抗风湿药物组11672患病年当中136例实体肿瘤(11795% CI 74-89per 10000 patient-year)。经数据校正,表明两组之间发生实体肿瘤的风险无明显差异:HR 0.8395% CI 0.64-1.07)。


结论:在英国,选用TNFI或传统抗风湿药在增加实体肿瘤的风险评价上无明显差异。


文献来源:

Risk of solid cancer in patients exposed to anti-tumour necrosis factor therapy: results from the British Society for Rheumatology for Rheumatoid Arthritis Mercer LK, et al. Ann Rheum Dis 2015;74:10871093. doi:10.1136/annrheumdis-2013-204851


ABSTRACT


Background: Patients with rheumatoid arthritis (RA) have an increased risk of certain solid cancers, in particular lung cancer, compared to the general population. Treatment with tumour necrosis factor (TNF) inhibitors (TNFi) may further enhance this risk.


Objectives :To compare the risk of solid cancer in patients with RA treated with TNFi to that in patients treated with non-biologic (synthetic) disease modifying antirheumatic drugs (sDMARDs).


Methods: Patients with a physician diagnosis of RA enrolled in the British Society for Rheumatology Biologics Register, a national prospective cohort study established in 2001 to monitor the long-term safety of TNFi, were followed via record linkage with the national cancer registries until first solid cancer, death, for 5 years, or until 2011. Rates of solid cancers in 11767 patients without prior cancer who received TNFi were compared to those in 3249 patients without prior cancer treated with sDMARDs.


Results: 427 solid cancers were reported in 52549 patient-years follow-up for the TNFi group (81 (95% CI 74 to 89) per 10 000 patient-years) and 136 cancers were reported in 11672 patient-years in the sDMARD cohort (117 (95% CI 98 to 138) per 10 000 patientyears).After adjusting for differences in baseline characteristics there was no difference in risk of solid cancer for TNFi compared to sDMARD treated patients: HR 0.83 (95% CI 0.64 to 1.07). There was no difference in the relative risk of cancer for any of the individual TNFi drugs.


Conclusions: The addition of TNFi to sDMARD does not alter the risk of cancer in RA patients selected for TNFi in the UK.


翻译:西临床免疫科 王卫涛




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