1 Pharmacy Service, University Hospital of Salamanca, Salamanca, Spain.
2 Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Salamanca, Salamanca, Spain.
Ann Clin Biochem. 2019 Jan;56(1):28-41. doi: 10.1177/0004563218782286. Epub 2018 Jun 18.
Tumour necrosis factor inhibitor therapy has drastically changed the management of chronic inflammatory diseases. Some important drawbacks that can cause loss of response during treatment with these drugs are related to their large individual variability, the disease burden and the formation of antidrug antibodies that increase its clearance. Therapeutic drug monitoring of these drugs is not yet recommended by all scientific societies, and if so, only in patients with inflammatory symptoms. Proactive therapeutic drug monitoring represents a new strategy with many potential clinical benefits, including the prevention of immunogenicity, a reduction in the need for rescue therapy and greater durability of tumour necrosis factor inhibitor treatment. The review is based on a systematic search of the literature for controlled trials, systematic reviews, experimental studies, guideline papers and cohort studies addressing the best practice in tumour necrosis factor inhibitor therapeutic drug monitoring. Although there is ample evidence supporting the use of therapeutic drug monitoring in clinical practice to achieve better outcomes, some challenges have been detected. Many studies are focused on finding solutions for the lack of standardization of analytical methods to measure tumour necrosis factor inhibitor and antidrug antibodies concentrations. Other challenges are development of effective cost-saving proactive algorithms to identify optimal drug concentrations and the research on the role of antidrug antibodies, especially in the management and prevention of loss of response. Therapeutic drug monitoring of tumour necrosis factor inhibitor offers a rational approach to the optimization of the treatment of chronic inflammatory disease. Although prospective controlled trials yield little conclusive evidence of its benefits, there is growing acceptance of its value in clinical practice.
肿瘤坏死因子抑制剂治疗极大地改变了慢性炎症性疾病的治疗方法。在使用这些药物治疗过程中,导致失去应答的一些重要缺点与药物个体差异大、疾病负担以及形成增加药物清除率的抗药物抗体有关。这些药物的治疗药物监测尚未被所有科学协会推荐,如果推荐,也仅在有炎症症状的患者中。主动治疗药物监测是一种具有许多潜在临床益处的新策略,包括预防免疫原性、减少挽救性治疗的需要以及提高肿瘤坏死因子抑制剂治疗的持久性。本综述基于对涉及肿瘤坏死因子抑制剂治疗药物监测最佳实践的对照试验、系统评价、实验研究、指南文件和队列研究进行的系统文献检索。尽管有充分的证据支持在临床实践中使用治疗药物监测以获得更好的结果,但也发现了一些挑战。许多研究都集中在寻找解决方法上,以解决分析方法缺乏标准化来测量肿瘤坏死因子抑制剂和抗药物抗体浓度的问题。其他挑战包括开发有效的节省成本的主动算法来确定最佳药物浓度,以及研究抗药物抗体的作用,特别是在管理和预防应答丧失方面。肿瘤坏死因子抑制剂的治疗药物监测为优化慢性炎症性疾病的治疗提供了一种合理的方法。尽管前瞻性对照试验几乎没有提供其益处的确凿证据,但在临床实践中越来越接受其价值。