Therapeutic drug monitoring of biologic agents in inflammatory bowel
disease: limits and improvements.
Abstract
Since the publication of the American Gastroenterological Association’s
(AGA) recommendations in 2017, there have been no significant changes in
the biological monitoring recommendations. Lack of evidence on proactive
therapeutic drug monitoring (pTDM) over the reactive therapeutic drug
monitoring (rTDM) and the absence of recommendations on the
individualized dosage methods have been limiting. The aims of this
review were to identify updates on TDM strategies and in individualized
dosing methods. For the analysis of the TDM strategies and
individualized dosing method, a search was carried out in PubMed and
Cochrane Central. In TDM case, since 2017. A total of 263 publications
were found. Only 7 related to pTDM. Two of them were clinical trials and
one systematic review. Of the 8 studies analyzed, 7 found benefit from
pTDM over rTDM and one found no difference. Only one study was
prospective. Regarding the individualized dosing method, 229 results
were found. Population pharmacokinetics was the most widely used
technique to explore and develop individual dosage models. It has been
used to analyze the influence of factors on drug concentrations (serum
albumin, weight… etc. We have not found major changes in TDM
strategies. The available evidence is limited and of low quality.
Retrospective designs and low power of the studies are the main
problems. Population pharmacokinetics methods are the most widely used.
But are more used to identify factors that affect drug concentrations
than for dosage individualization.