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Safety profile of biological therapies for treating rheumatoid arthritis

机译:用于治疗类风湿性关节炎的生物疗法的安全谱

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Introduction: Biological agents such as tumor necrosis factor inhibitors (TNFi), abatacept, rituximab and tocilizumab have proven efficacy in RA. However, these agents are also associated with adverse events so further data is essential to detect them at the earliest stage possible.Areas covered: Herein, the authors review the safety profile of biological therapy, including TNFi and non-TNF agents including abatacept (ABA), rituximab (RTX) and tocilizumab (TCZ). The authors analyze both published articles and congress communications including clinical trials, meta-analyses, observational studies, data from registries and spontaneous clinical reports. The authors classify studies according to the most common and relevant adverse events associated with biological agents.Expert opinion: Biological therapies have a reasonable safety profile and, globally, the benefits far outweigh the possible risk of adverse events. Currently, the risk of serious infections is low and no increased risk in solid malignancies or cardiovascular events have been found after a long clinical experience with these therapies. However, there are still potential risks as well as concerns of immunogenicity induced by TNFi. More studies are required to understand these risks, design safer drugs, and implement pharmacogenomics into the clinic. This will lead to a more personalized medicine in the future.
机译:简介:肿瘤坏死因子抑制剂(TNFI),Abatacep,Rituximab和Tocilizuab等生物药物已被证明在RA中。然而,这些药剂也与不良事件有关,因此进一步的数据对于尽可能最早的阶段来检测它们是必不可少的。涵盖:本文,本文审查了生物疗法的安全性,包括TNFI和包括ABATACEPT(ABA)的无TNF药剂(ABA) ),Rituximab(RTX)和Tocilizumab(TCZ)。作者分析了公布的文章和国会通信,包括临床试验,荟萃分析,观察研究,来自注册管理机构和自发临床报告的数据。作者根据与生物制剂相关的最常见和相关的不良事件进行分类研究.Pert意见:生物疗法具有合理的安全性,并且在全球范围内具有远离事件的可能风险。目前,在这些疗法的长期临床经验后,已经发现了严重感染的风险低,并且在长期临床经验后,没有增加固体恶性肿瘤或心血管事件的风险。然而,仍存在潜在的风险以及TNFI诱导的免疫原性的担忧。需要更多的研究来了解这些风险,设计更安全的药物,并将药物替补患者进入诊所。这将将来会导致更加个性化的药物。

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