|dc.description.abstract||INTRODUCTION: Growing evidence supports the use of therapeutic drug monitoring
(TDM) to guide anti-tumour necrosis factor (TNF) drug treatment among patients with
inflammatory bowel disease (IBD). Currently, TDM for anti-TNF drugs is variably
practiced by gastroenterologists in Australia. Our aim was to develop consensus
statements for TDM of anti-TNF drugs in IBD that will be endorsed by the Australian
IBD Association (AIBDA) of the Gastroenterological Society of Australia (GESA).
METHODS: A consensus committee of 25 Australian and international experts was
assembled. A systematic literature search aided the steering committee in developing
the initial draft statements. A modified Delphi technique was used with three iterations,
with modification of statements based on feedback and anonymous voting.
Statements with 80% agreement without reservation or only minor reservation in the
third voting round were accepted as consensus.
RESULTS: 22/24 statements met criteria for consensus. The committee agreed that
TDM for anti-TNF agents 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
μg/mL and 5-12 μg/mL, respectively, were determined as appropriate. The therapeutic
range may need to be altered for different disease phenotypes or treatment endpoints.
In treatment failure, TDM may identify mechanisms to guide subsequent decisionmaking.
Among patients in remission, TDM-guided anti-TNF drug dose optimisation
may reduce treatment cost and avoid future relapse. Data indicates drug-tolerant antidrug
antibody assays do not offer an advantage over drug-sensitive assays in
predicting outcomes. Further data are required prior to recommending TDM for nonanti-
CONCLUSION: These consensus statements are expected to aid use of TDM by
gastroenterologists in Australia and abroad to guide anti-TNF drug treatment in IBD
|dc.publisher||University of Sydney||en_AU|
|dc.publisher||Sydney Medical School||en_AU|
|dc.rights||The author retains copyright of this thesis. It may only be used for the purposes of research and study. It must not be used for any other purposes and may not be transmitted or shared with others without prior permission.||en_AU|
|dc.subject||inflammatory bowel disease||en_AU|
|dc.subject||therapeutic drug monitoring||en_AU|
|dc.subject||anti-tumor necrosis factor drugs||en_AU|
|dc.title||Therapeutic drug monitoring guided anti-tumour necrosis factor therapy in inflammatory bowel disease (IBD): Gastroenterological Society of Australia (GESA)/ Australian IBD Association (AIBDA) consensus statements||en_AU|
|dc.type.pubtype||Master of Philosophy M.Phil||en_AU|
|Appears in Collections:||Sydney Digital Theses (Open Access)|