Therapeutic drug monitoring of anti‐tumour necrosis factor‐α agents in inflammatory bowel disease: Limits and improvements

• Published in: British journal of clinical pharmacology Vol. 87; no. 5; pp. 2216 - 2227
• Main Authors: Giráldez‐Montero, José María, Gonzalez‐Lopez, Jaime, Campos‐Toimil, Manuel, Lamas‐Díaz, María Jesús
• Format: Journal Article
• Language: English
• Published: England 01.05.2021
• Subjects: inflammatory bowel disease; pharmacokinetic modelling; population pharmacokinetics; therapeutic drug monitoring; tight control strategies; pharmacokinetic modelling; tight control strategies; inflammatory bowel disease; therapeutic drug monitoring; population pharmacokinetics
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/bcp.14654

Aims Since the publication of the American Gastroenterological Association's recommendations in 2017, there have been no significant changes in the biological monitoring recommendations in inflammatory bowel disease. Possible limitations are the lack of evidence to recommend proactive therapeutic drug monitoring (pTDM) over reactive TDM (rTDM), and the limited information about individualized dosing methods. This article aims to review the TDM strategy updates and the use of individualized dosing methods. Methods For the analysis of the TDM strategies and individualized dosing method, a search was carried out in PubMed and Cochrane Central. In the TDM case, since August 2017. Results A total of 263 publications were found, but only 7 related to proactive TDM. Five of these publications directly compared pTDM vs rTDM and 2 were randomized clinical trials. Six studies found benefits of pTDM and 1 found no differences. Regarding the individualized dosing method, 229 distinct results were found. Population pharmacokinetics was the most widely used method to develop individual dosage models and to analyse the influence of factors on drug concentrations (albumin concentration, weight, presence of anti‐drug antibodies etc). Conclusion We have found no major changes in TDM strategies. There is a growing trend towards the use of pTDM because it has shown a longer duration of treatment response, lower rates of discontinuation and relapses. However, the available evidence is limited and of low quality. Despite the common use of population pharmacokinetic methods to analyse pharmacokinetic factors, they are not commonly used for personalized dosing.