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Review
. 2020 Jul;32(4):371-379.
doi: 10.1097/BOR.0000000000000713.

Therapeutic drug monitoring in patients on biologics: lessons from gastroenterology

Konstantinos Papamichael  1 , Adam S Cheifetz
Affiliations
Review

Therapeutic drug monitoring in patients on biologics: lessons from gastroenterology

Konstantinos Papamichael et al. Curr Opin Rheumatol. 2020 Jul.

Abstract

Purpose of review: To give an overview on the role of therapeutic drug monitoring (TDM) of biologics in patients with inflammatory bowel disease (IBD).

Recent findings: Numerous prospective exposure-response relationship studies and post-hoc analyses of randomized controlled trials (RCTs) show a positive correlation between biologic drug concentrations and favorable clinical outcomes in IBD. These studies also demonstrate that higher drug concentrations appear to be needed to achieve more stringent objective therapeutic outcomes. Reactive TDM rationalizes the management of primary nonresponse and secondary loss of response to antitumor necrosis factor (anti-TNF) therapy and is more cost-effective when compared with empiric dose optimization. Furthermore, recent data suggest that proactive TDM, with the goal of targeting a threshold drug concentration, is associated with better therapeutic outcomes when compared with empiric dose escalation and/or reactive TDM of infliximab or adalimumab. Finally, proactive TDM can also efficiently guide infliximab de-escalation or discontinuation in patients with IBD in remission.

Summary: Reactive TDM is currently considered as standard of care, whereas proactive TDM is emerging as a new therapeutic strategy for better optimizing anti-TNF therapy in IBD. However, more data from prospective studies are needed before a wide implementation of TDM-based algorithms in real life clinical practice for newer biologics.

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Conflict of interest statement

Declaration of interest: K.P. received a lecture fee from Mitsubishi Tanabe Pharma. A.S.C.: received a consultancy fee from Janssen, Abbvie, Takeda, Pfizer, Samsung, Arena, Bacainn, EMD Serono, Arsanis, Grifols, Prometheus; and research support from Inform Diagnostics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Figure 1.
Figure 1.
Definition and role of reactive therapeutic drug monitoring of anti-TNF therapy in inflammatory bowel disease. PNR: primary non-response, LOR: loss of response; TDM: therapeutic drug monitoring; TNF: tumor necrosis factor.
Figure 2.
Figure 2.
Definition and role of proactive therapeutic drug monitoring of anti-TNF therapy in inflammatory bowel disease. TDM: therapeutic drug monitoring; TNF: tumor necrosis factor.
Figure 3.
Figure 3.
Reactive therapeutic drug monitoring-based algorithm for optimizing infliximab therapy in inflammatory bowel disease. ATI: antibodies to infliximab; TDM: therapeutic drug monitoring.
See this image and copyright information in PMC

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References

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