Van Herwaarden Noortje, Van Den Bemt Bart J F, Wientjes Maike H M, Kramers Cornelis, Den Broeder Alfons A
a Department of Rheumatology , Sint Maartenskliniek Nijmegen , The Netherlands.
b Department of Pharmacy , Sint Maartenskliniek , Nijmegen , The Netherlands.
Expert Opin Drug Metab Toxicol. 2017 Aug;13(8):843-857. doi: 10.1080/17425255.2017.1353602. Epub 2017 Jul 17.
Biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) have improved the treatment outcomes of inflammatory rheumatic diseases including Rheumatoid Arthritis and spondyloarthropathies. Inter-individual variation exists in (maintenance of) response to bDMARDs. Therapeutic Drug Monitoring (TDM) of bDMARDs could potentially help in optimizing treatment for the individual patient. Areas covered: Evidence of clinical utility of TDM in bDMARD treatment is reviewed. Different clinical scenarios will be discussed, including: prediction of response after start of treatment, prediction of response to a next bDMARD in case of treatment failure of the first, prediction of successful dose reduction or discontinuation in case of low disease activity, prediction of response to dose-escalation in case of active disease and prediction of response to bDMARD in case of flare in disease activity. Expert opinion: The limited available evidence does often not report important outcomes for diagnostic studies, such as sensitivity and specificity. In most clinical relevant scenarios, predictive value of serum (anti-) drug levels is absent, therefore the use of TDM of bDMARDs cannot be advocated. Well-designed prospective studies should be done to further investigate the promising scenarios to determine the place of TDM in clinical practice.
生物性抗风湿药物(bDMARDs)改善了包括类风湿关节炎和脊柱关节炎在内的炎性风湿性疾病的治疗效果。个体对bDMARDs(的维持)反应存在差异。bDMARDs的治疗药物监测(TDM)可能有助于为个体患者优化治疗。涵盖领域:回顾了TDM在bDMARD治疗中的临床应用证据。将讨论不同的临床情况,包括:治疗开始后反应的预测、首次治疗失败时对下一种bDMARD反应的预测、疾病活动度低时成功减药或停药的预测、疾病活动时剂量增加反应的预测以及疾病活动复发时对bDMARD反应的预测。专家意见:有限的现有证据往往未报告诊断研究的重要结果,如敏感性和特异性。在大多数临床相关情况下,血清(抗)药物水平缺乏预测价值,因此不提倡使用bDMARDs的TDM。应开展设计良好的前瞻性研究,以进一步研究有前景的情况,确定TDM在临床实践中的地位。
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