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The final results of a pioneering, randomised controlled study in patients with inflammatory bowel disease (IBD) have helped to better define the role of drug level monitoring during infliximab treatment.1 Researchers in Belgium have confirmed that, while there are substantial advantages to using infliximab drug levels to guide dosing during optimisation of infliximab therapy, continuous drug level monitoring is not needed to maintain this effect. Speaking to journalists at the 21st United European Gastroenterology Week (UEG Week) in Berlin, Germany, Dr Niels Vande Casteele from the Laboratory for Therapeutic and Diagnostic Antibodies in Leuven, Belgium, and one of the study investigators, said he believed the results of this study answered several important clinical questions. "This is the first prospective, randomised controlled study to investigate tailored dosing of infliximab in IBD patients treated with maintenance therapy," he said. "And while we found that dosing to target levels of infliximab resulted in more efficient use of the drug in the initial treatment phase, once treatment had been optimised, dosing decisions based on drug levels or clinical symptoms produced similar clinical outcomes."
The introduction of monoclonal antibodies such as infliximab and adalimumab over a decade ago transformed the management of individuals with IBD, with studies demonstrating unequivocal benefits over conventional treatments. Unfortunately, not all patients respond adequately to these antibodies, with some patients having no response, while others respond initially but later relapse despite increased doses and more frequent administrations. The reasons for this are not entirely clear, but individual differences in drug pharmacokinetics and immunogenicity appear to play a role.2
The TAXIT (Trough level Adapted infliXImab Treatment) study is the first, prospective, randomised controlled study to investigate drug level-tailored dosing of infliximab in IBD patients receiving maintenance infliximab therapy. During the TAXIT study, which involved 178 patients with Crohn's disease (CD) and 85 patients with ulcerative colitis (UC), infliximab dosing was initially optimised based on precisely-measured drug levels. Patients subsequently entering the maintenance phase of the study were then randomised to either clinically-based or drug level-based dosing.
According to Dr Vande Casteele, the dose-optimisation phase of the study revealed that dose intensification of infliximab in CD patients with a low infliximab level resulted in better disease control, whereas dose reductions in patients with CD or UC with high drug levels resulted in a lower drug exposure and drug cost while maintaining disease control. During the maintenance phase, he said, there was no superiority of drug level-based dosing over clinically-based adjustments in terms of maintaining clinical and biological remission. "What this study tells us is that treat-to-target dosing of infliximab results in higher efficacy and better cost-effectiveness of the drug during the dose optimisation phase of treatment. However, once treatment is optimised, clinicians can safely revert to clinical monitoring without compromising treatment outcomes."
 Vande Casteele N, Gils A, Ballet V, et al. Randomised controlled trial of drug level versus clinically based dosing of infliximab maintenance therapy in IBD: final results of the TAXIT study. Presentation at UEG Week 2013. Abstract UEG13-ABS-2468.
 Vermeire S, Gils A. Value of drug level testing and antibody assays in optimising biological therapy. Frontline Gastroenterology 2013;4:41–43.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Week, UEG. "Pioneering study helps define the role of drug level monitoring to guide infliximab dosing in inflammatory bowel disease." Medical News Today. MediLexicon, Intl., 21 Oct. 2013. Web.
4 Dec. 2013. <http://www.medicalnewstoday.com/releases/267629>
Week, U. (2013, October 21). "Pioneering study helps define the role of drug level monitoring to guide infliximab dosing in inflammatory bowel disease." Medical News Today. Retrieved from
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