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

Alimentary Pharmacology and Therapeutics - Tập 46 Số 11-12 - Trang 1037-1053 - 2017
Nikola Mitrev1, Niels Vande Casteele2, Cynthia H. Seow3, John M. Andrews4, Susan J. Connor1, Gregory Moore5, Murray L. Barclay6, Jakob Begun7, Robert V. Bryant4, Webber Chan1, Crispin Corte1, Simon Ghaly1, Daniel A. Lemberg1, Viraj C. Kariyawasam1, Peter Lewindon7, Joseph J. Martin8, Réme Mountifield4, Graham Radford‐Smith7, Peter Slobodian4, Miles Sparrow5, Catherine Toong1, Daniel R. van Langenberg5, Mark G. Ward5, Rupert W. Leong1
1Sydney, NSW, Australia
2San Diego, CA, USA
3Calgary, AB, Canada
4Adelaide, SA, Australia
5Melbourne, VIC, Australia
6Christchurch, New Zealand
7Brisbane, QLD, Australia
8Newcastle, NSW, Australia

Tóm tắt

SummaryBackgroundTherapeutic 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.AimTo develop evidence‐based consensus statements for TDM‐guided anti‐TNF therapy in IBD.MethodsA 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.Results22/24 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.ConclusionConsensus statements support the role of TDM in optimising anti‐TNF agents to treat IBD, especially in situations of treatment failure.

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Alimentary Pharmacology and Therapeutics

Tập 46 Số 11-12

1037-1053

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