Review article

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

IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group

Research output: Contribution to journalReview ArticleOtherpeer-review

60 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1037-1053
Number of pages17
JournalAlimentary Pharmacology and Therapeutics
Volume46
Issue number11-12
DOIs
Publication statusPublished - 1 Dec 2017

Cite this

IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group. / Review article : consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. In: Alimentary Pharmacology and Therapeutics. 2017 ; Vol. 46, No. 11-12. pp. 1037-1053.
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title = "Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases",
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.",
author = "N. Mitrev and {Vande Casteele}, N. and Seow, {C. H.} and Andrews, {J. M.} and Connor, {S. J.} and Moore, {G. T.} and M. Barclay and J. Begun and R. Bryant and W. Chan and C. Corte and S. Ghaly and Lemberg, {D. A.} and V. Kariyawasam and P. Lewindon and J. Martin and R. Mountifield and G. Radford-Smith and P. Slobodian and M. Sparrow and C. Toong and {van Langenberg}, D. and Ward, {M. G.} and Leong, {R. W.} and {IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group}",
year = "2017",
month = "12",
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language = "English",
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IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group 2017, 'Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases', Alimentary Pharmacology and Therapeutics, vol. 46, no. 11-12, pp. 1037-1053. https://doi.org/10.1111/apt.14368

Review article : consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. / IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group.

In: Alimentary Pharmacology and Therapeutics, Vol. 46, No. 11-12, 01.12.2017, p. 1037-1053.

Research output: Contribution to journalReview ArticleOtherpeer-review

TY - JOUR

T1 - Review article

T2 - consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases

AU - Mitrev, N.

AU - Vande Casteele, N.

AU - Seow, C. H.

AU - Andrews, J. M.

AU - Connor, S. J.

AU - Moore, G. T.

AU - Barclay, M.

AU - Begun, J.

AU - Bryant, R.

AU - Chan, W.

AU - Corte, C.

AU - Ghaly, S.

AU - Lemberg, D. A.

AU - Kariyawasam, V.

AU - Lewindon, P.

AU - Martin, J.

AU - Mountifield, R.

AU - Radford-Smith, G.

AU - Slobodian, P.

AU - Sparrow, M.

AU - Toong, C.

AU - van Langenberg, D.

AU - Ward, M. G.

AU - Leong, R. W.

AU - IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group

PY - 2017/12/1

Y1 - 2017/12/1

N2 - 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.

AB - 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.

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U2 - 10.1111/apt.14368

DO - 10.1111/apt.14368

M3 - Review Article

VL - 46

SP - 1037

EP - 1053

JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

SN - 0269-2813

IS - 11-12

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