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.
Dr Leong and colleagues from Australia developed evidence-based consensus statements for TDM-guided anti-TNF therapy in IBD.
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.
|Infliximab trough concentrations in the range of 3-8 μg/mL was deemed to achieve clinical remission|
|Alimentary Pharmacology & Therapeutics|
The research team accepted statements with 80% agreement without or with minor reservation.
The researchers found that 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 research team noted that 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, the team observed TDM-guided dosing may avoid future relapse.
The researchers found that 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.
Dr Leong's team concludes, "Consensus statements support the role of TDM in optimizing anti-TNF agents to treat IBD, especially in situations of treatment failure."