Is there truly a risk of lymphoma from biologic therapies?

Is there truly a risk of lymphoma from biologic therapies?
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DOI:
10.1111/j.1529-8019.2009.01258.x
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发表时间:
2009-09-01
影响因子:
3.6
通讯作者:
Gelfand, Joel M.
Gelfand, Joel M.
中科院分区:
医学4区
文献类型:
--
作者:
Dommasch, Erica;Gelfand, Joel M.

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随着英夫利昔单抗、依那西普、阿达木单抗、依法珠单抗和阿法西普等生物疗法的出现,银屑病的治疗经历了一场革命。生物制剂通常安全且耐受性良好。然而,由于这些药物的免疫抑制特性,人们一直担心使用这些药物会导致淋巴瘤的风险。本综述总结了目前从病例报告和病例系列、观察性研究、临床试验和荟萃分析中获得的关于生物治疗淋巴瘤风险的证据。T细胞抑制剂的大部分数据来自病例报告和相对较小的短期临床试验。除了已发表的病例报告和病例系列外,TNF-α抑制剂还在大型队列研究和主要来自类风湿性关节炎人群的临床试验荟萃分析中进行了广泛研究。目前的数据既不足以完全排除与生物制剂相关的淋巴瘤风险增加,也不足以确定生物制剂与淋巴瘤之间的因果关系。使用生物制剂进行短期至中期治疗(例如,最多4年)在淋巴瘤风险方面似乎是非常安全的,特别是TNF-α抑制剂,其中它们的潜在风险似乎是明确的。必须继续保持警惕;然而,在适当的患者中,银屑病治疗相对于淋巴瘤风险的风险-获益特征似乎非常有利。
The treatment of psoriasis has undergone a revolution with the advent of biologic therapies, including infliximab, etanercept, adalimumab, efalizumab, and alefacept. Biologics are generally safe and well tolerated. However, there has been concern over the risk of lymphoma with use of these agents because of their immunosuppressive properties. This review summarizes the current evidence in regards to lymphoma risk with biologic therapy obtained from case reports and case series, observational studies, clinical trials, and meta-analyses. The majority of data for T-cell inhibitors comes from case reports and relatively small, short-term clinical trials. In addition to published case reports and case series, TNF-alpha inhibitors have also been studied extensively in large cohort studies and meta-analyses of clinical trials derived primarily from the rheumatoid arthritis population. Current data are neither sufficient to completely rule out an increased risk of lymphoma associated with biologics, nor to firmly establish a causal relationship between biologics and lymphoma. Short- to intermediate-term treatment with biologics (e.g., up to 4 years) appears to be very safe with respect to lymphoma risk, especially with TNF-alpha inhibitors in which their potential risks appear to be well defined. Continued vigilance is warranted; however, in the appropriate patient, the risk-to-benefit profile of psoriasis treatment with respect to lymphoma risk appears highly favorable.