1. Therapeutic drug monitoring-guided biological drug therapy in inflammatory bowel disease: Consensus statements of the Australian Inflammatory Bowel Disease Association (AIBDA) and Gastroenterological Society of Australia (GESA).
- Author
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Ward M.G., Toong C., Van Langenberg D., Leong R.W., Moore G., Mitrev N., Vande Casteele N., Seow C., Andrews J.M., Connor S.J., Barclay M., Begun J., Bryant R., Chan W., Corte C., Ghaly S., Lemberg D.A., Kariyawasam V., Lewindon P., Martin J., Mountifield R., Radford-Smith G., Slobodian P., Sparrow M., Ward M.G., Toong C., Van Langenberg D., Leong R.W., Moore G., Mitrev N., Vande Casteele N., Seow C., Andrews J.M., Connor S.J., Barclay M., Begun J., Bryant R., Chan W., Corte C., Ghaly S., Lemberg D.A., Kariyawasam V., Lewindon P., Martin J., Mountifield R., Radford-Smith G., Slobodian P., and Sparrow M.
- Abstract
Introduction: Therapeutic drug monitoring (TDM)-guided biological drug therapy in inflammatory bowel disease (IBD) may improve clinical outcomes and reduce treatment cost, beyond fixed or clinically guided dosing. TDM of biological drugs involves measurement of drug levels and antidrug antibodies, and data are most comprehensive for TDM of anti-tumor necrosis factor (TNF) agents. Reactive TDM is performed during treatment failure to elicit mechanisms of failure and guide appropriate treatment changes (dose escalation versus changing to another agent), while proactive TDM is performed routinely in patients who maintain response in order to optimize drug levels and prevent future disease flares and loss of response. We produced consensus statements based on current evidence to aid implementation of TDM-guided therapy of biological drugs in IBD. Method(s): Consensus statements were produced via a modified Delphi method. A steering committee invited Australian and international experts in IBD and TDM of biological drugs. A literature search aided the steering committee in producing an initial draft of the consensus statements. Two rounds of online voting were undertaken, with modification of statements following each round based on voting results and feedback. On a final face-to-face voting round, each statement was presented, modified, and voted on. Panelists voted on their level of agreement with individual statements as follows: A) agree without reservation; B) agree with minor reservation; C) agree with major reservation; D) disagree with some reservation; E) disagree without reservation; or F) reserved. Statements with >= 80% agreement with no or only minor reservation met criteria for consensus. Level of evidence and grade of recommendation for each statement was agreed upon based on National Health and Medical Research Council (NHMRC) recommendations. Result(s): Of 26 panel nominees, 25 accepted to participate in this project, including the following: 18 Australi
- Published
- 2017