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Aliment Pharmacol Ther. 2017 Dec;46(11-12):1037-1053. doi: 10.1111/apt.14368. Epub 2017 Oct 13.

Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases.

Author information

1
Sydney, NSW, Australia.
2
San Diego, CA, USA.
3
Calgary, AB, Canada.
4
Adelaide, SA, Australia.
5
Melbourne, Vic., Australia.
6
Christchurch, New Zealand.
7
Brisbane, Qld, Australia.
8
Newcastle, NSW, Australia.

Abstract

BACKGROUND:

Therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) patients receiving anti-tumour necrosis factor (TNF) agents can help optimise outcomes. Consensus statements based on current evidence will help the development of treatment guidelines.

AIM:

To develop evidence-based consensus statements for TDM-guided anti-TNF therapy in IBD.

METHODS:

A committee of 25 Australian and international experts was assembled. The initial draft statements were produced following a systematic literature search. A modified Delphi technique was used with 3 iterations. Statements were modified according to anonymous voting and feedback at each iteration. Statements with 80% agreement without or with minor reservation were accepted.

RESULTS:

22/24 statements met criteria for consensus. For anti-TNF agents, TDM should be performed upon treatment failure, following successful induction, when contemplating a drug holiday and periodically in clinical remission only when results would change management. To achieve clinical remission in luminal IBD, infliximab and adalimumab trough concentrations in the range of 3-8 and 5-12 μg/mL, respectively, were deemed appropriate. The range may differ for different disease phenotypes or treatment endpoints-such as fistulising disease or to achieve mucosal healing. In treatment failure, TDM may identify mechanisms to guide subsequent decision-making. In stable clinical response, TDM-guided dosing may avoid future relapse. Data indicate drug-tolerant anti-drug antibody assays do not offer an advantage over drug-sensitive assays. Further data are required prior to recommending TDM for non-anti-TNF biological agents.

CONCLUSION:

Consensus statements support the role of TDM in optimising anti-TNF agents to treat IBD, especially in situations of treatment failure.

PMID:
29027257
DOI:
10.1111/apt.14368
[Indexed for MEDLINE]

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