Review article: determination of the therapeutic range for therapeutic drug monitoring of adalimumab and infliximab in patients with inflammatory bowel disease.

Tytuł:: Review article: determination of the therapeutic range for therapeutic drug monitoring of adalimumab and infliximab in patients with inflammatory bowel disease.
Autorzy:: Gibson DJ; Departments of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia.
Ward MG; Departments of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia.; Monash University, Melbourne, VIC, Australia.
Rentsch C; The Royal Melbourne Hospital, Melbourne, VIC, Australia.
Friedman AB; Departments of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia.; Monash University, Melbourne, VIC, Australia.
Taylor KM; Departments of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia.; Monash University, Melbourne, VIC, Australia.
Sparrow MP; Departments of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia.; Monash University, Melbourne, VIC, Australia.
Gibson PR; Departments of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia.; Monash University, Melbourne, VIC, Australia.
Źródło:: Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2020 Mar; Vol. 51 (6), pp. 612-628. Date of Electronic Publication: 2020 Jan 21.
Typ publikacji:: Journal Article; Systematic Review
Język:: English
Imprint Name(s):: Publication: Oxford : Wiley-Blackwell
Original Publication: [Oxford, OX] : Blackwell Scientific Publications, [c1987-
MeSH Terms:: Adalimumab/*administration & dosage
Drug Monitoring/*standards
Inflammatory Bowel Diseases/*drug therapy
Infliximab/*administration & dosage
Adalimumab/adverse effects ; Dose-Response Relationship, Drug ; Drug Monitoring/methods ; Humans ; Inflammatory Bowel Diseases/epidemiology ; Infliximab/adverse effects ; Reference Values ; Treatment Outcome ; Tumor Necrosis Factor-alpha/therapeutic use ; Wound Healing/drug effects
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Substance Nomenclature:: 0 (Tumor Necrosis Factor-alpha)
B72HH48FLU (Infliximab)
FYS6T7F842 (Adalimumab)
Entry Date(s):: Date Created: 20200122 Date Completed: 20200828 Latest Revision: 20200828
Update Code:: 20240104
DOI:: 10.1111/apt.15643
PMID:: 31961001
: Czasopismo naukowe

Pełny tekst

Background: Clinical application of therapeutic drug monitoring (TDM) to optimise anti-TNF therapies in patients with IBD depends upon target ranges.
Aims: To review methodology used to determine therapeutic ranges and critically compare and contrast its application to infliximab and adalimumab.
Methods: A systematic review was performed, and relevant literature was summarised and critically examined.
Results: Upper limits of the therapeutic range are determined by toxicity, a plateau response and cost. Lower limits are determined by optimal concentration on the target of action in vitro and/or in vivo, or by correlation of drug levels with clinical efficacy using area-under-receiver-operator-curve (AUROC) analysis. In 43 studies, there were huge variations in time at which infliximab and adalimumab levels were measured, the end-points used (clinical remission to mucosal healing), the clinical setting (active disease vs maintenance phase) and the reason for TDM (proactive vs reactive). In the maintenance phase for infliximab, lower trough limits 2.8-5.7 µg/mL are reported depending upon end-points used, with consistent AUROC 0.68-0.77. Adalimumab TDM targets are even less consistent with a lower limit 5.9-11.8 µg/mL (AUROC 0.66-0.83) in some studies, but no cut-off can be identified that is significantly associated with outcome in others, related to inherent pharmacokinetic and pharmacodynamic differences, and heterogeneity of study design.
Conclusions: Evidence for exposure-response relationship is stronger for infliximab than adalimumab. Due to heterogeneity in settings for drug level measurements, therapeutic ranges vary. These factors need to be taken into account when interpreting the evidence and extending this to therapeutic strategies for IBD patients.
(© 2020 John Wiley & Sons Ltd.)

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