Is therapeutic drug monitoring a dancing partner for TNF-α inhibitors in real-world practice? Answers from an updated systematic review and meta-analysis.

IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Review of Clinical Pharmacology Pub Date : 2024-09-21 DOI:10.1080/17512433.2024.2403641
Yang Hu, Zaiwei Song, Yuan Gao, Dan Jiang, Yiwen Ran, Yi Ma, Huibo Li, Rongsheng Zhao
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Abstract

Introduction: This systematic review aimed to determine the effect of therapeutic drug monitoring (TDM) for tumor necrosis factor-α inhibitors (TNF-αI) in immune-mediated inflammatory diseases (IMIDs) based on real-world evidence, as results from published meta-analyses based on randomized controlled trials (RCTs) may not fully capture the nuances of clinical practice due to strict criteria.

Methods: We searched PubMed, Embase, and the Cochrane Library up to 1 August 2023. Cohort studies comparing TDM (proactive and reactive) with empirical management were included. Primary outcome was effectiveness [for IBDs: clinical remission; for rheumatic diseases: clinical remission or low disease activity], with certainty of evidence appraised using the GRADE approach. Secondary outcomes included treatment failure, serious adverse events (SAEs), IMIDs-related surgeries or hospitalizations, and anti-drug antibodies (ADAs) development risk.

Results: Twenty-four cohort studies were included and almost all were on infliximab. For IBDs, compared with empirical management, proactive TDM significantly improved clinical remission (RR = 1.15, 95% CI = 1.04-1.28), reduced IBDs-related surgeries (RR = 0.46, 95% CI = 0.26-0.81), hospitalizations (RR = 0.60, 95% CI = 0.43-0.83), SAEs (RR = 0.23, 95% CI = 0.07-0.76), and ADAs development risk (RR = 0.34, 95% CI = 0.19-0.60). Reactive TDM significantly lowered hospitalization rates and might be cost-effective. Proactive TDM outperformed reactive TDM in secondary outcomes. For rheumatic diseases, benefits of TDM were inconclusive due to limited evidence.

Conclusions: Real-world evidence supports proactive TDM of TNF-αI (particularly infliximab) in IBDs to improve effectiveness, safety, and immunogenicity. However, benefits of TDM for different TNF-αI in other IMIDs remain uncertain.

Protocol registration: www.crd.york.ac.uk/ PROSPERO identifier is CRD42022370846.

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治疗药物监测是 TNF-α 抑制剂在实际应用中的舞伴吗?最新系统综述和荟萃分析给出的答案。
导言:由于基于随机对照试验(RCT)的已发表荟萃分析的结果可能因严格的标准而无法完全反映临床实践的细微差别,因此本系统综述旨在根据现实世界的证据确定肿瘤坏死因子-α抑制剂(TNF-αI)治疗药物监测(TDM)在免疫介导的炎症性疾病(IMIDs)中的效果:我们检索了截至 2023 年 8 月 1 日的 PubMed、Embase 和 Cochrane 图书馆。方法:我们检索了截至 2023 年 8 月 1 日的 PubM、Embase 和 Cochrane 图书馆,纳入了比较 TDM(主动和被动)与经验性管理的队列研究。主要结果为有效性[对于IBD:临床缓解;对于风湿性疾病:临床缓解或低疾病活动性],采用GRADE方法评估证据的确定性。次要结果包括治疗失败、严重不良事件(SAEs)、IMIDs相关手术或住院以及抗药抗体(ADAs)发展风险:结果:共纳入了 24 项队列研究,几乎所有研究都涉及英夫利西单抗。对于 IBDs,与经验性治疗相比,主动性 TDM 可显著改善临床缓解(RR = 1.15,95% CI = 1.04-1.28),减少 IBDs 相关手术(RR = 0.46,95% CI = 0.26-0.81)、住院(RR = 0.60,95% CI = 0.43-0.83)、SAEs(RR = 0.23,95% CI = 0.07-0.76)和 ADAs 发展风险(RR = 0.34,95% CI = 0.19-0.60)。反应性 TDM 能明显降低住院率,可能具有成本效益。在次要结果方面,主动式TDM优于被动式TDM。对于风湿性疾病,由于证据有限,TDM的益处尚无定论:真实世界的证据支持对IBD患者的TNF-αI(尤其是英夫利西单抗)进行主动TDM,以提高有效性、安全性和免疫原性。然而,TDM对其他IMIDs中不同TNF-αI的益处仍不确定。协议注册:www.crd.york.ac.uk/ PROSPERO标识符为CRD42022370846。
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来源期刊
Expert Review of Clinical Pharmacology
Expert Review of Clinical Pharmacology PHARMACOLOGY & PHARMACY-
CiteScore
7.30
自引率
2.30%
发文量
127
期刊介绍: Advances in drug development technologies are yielding innovative new therapies, from potentially lifesaving medicines to lifestyle products. In recent years, however, the cost of developing new drugs has soared, and concerns over drug resistance and pharmacoeconomics have come to the fore. Adverse reactions experienced at the clinical trial level serve as a constant reminder of the importance of rigorous safety and toxicity testing. Furthermore the advent of pharmacogenomics and ‘individualized’ approaches to therapy will demand a fresh approach to drug evaluation and healthcare delivery. Clinical Pharmacology provides an essential role in integrating the expertise of all of the specialists and players who are active in meeting such challenges in modern biomedical practice.
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