Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point of Care Testing in Inflammatory Bowel Disease: Results of a Pragmatic Trial.
Autor: | Bossuyt P; Imelda GI Clinical Research Centre, Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium., Pouillon L; Imelda GI Clinical Research Centre, Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium., Claeys S; St-Lucas IBD Clinic, AZ Sint-Lucas, Gent, Belgium., D'Haens S; Imelda GI Clinical Research Centre, Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium., Hoefkens E; Imelda GI Clinical Research Centre, Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium., Strubbe B; St-Lucas IBD Clinic, AZ Sint-Lucas, Gent, Belgium., Marichal D; St-Lucas IBD Clinic, AZ Sint-Lucas, Gent, Belgium., Peeters H; St-Lucas IBD Clinic, AZ Sint-Lucas, Gent, Belgium. |
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Jazyk: | angličtina |
Zdroj: | Journal of Crohn's & colitis [J Crohns Colitis] 2022 Feb 23; Vol. 16 (2), pp. 199-206. |
DOI: | 10.1093/ecco-jcc/jjab127 |
Abstrakt: | Background: With point of care testing [POCT] for infliximab [IFX], ultraproactive therapeutic drug monitoring [TDM] with ad-hoc dose optimisation is possible in patients with inflammatory bowel disease [IBD]. Aim: To compare the clinical outcomes of an ultraproactive TDM algorithm of IFX based on POCT with reactive TDM in patients with IBD, in a pragmatic clinical trial. Methods: All patients with IBD and maintenance IFX treatment were included between June and August 2018 in two centres. Centre A applied an ultra-proactive TDM algorithm incorporating POCT, and centre B applied reactive TDM. Primary endpoint was failure of IFX therapy after 1 year. Secondary endpoints included sustained clinical remission and mucosal remission. Results: In total 187 patients [n = 115/72 cohort A/B] were included. Cohort A had more trough level [TL] measurements compared with cohort B [8.8 vs 1/patient/year; p <0.0001], leading to a significant higher number of dose optimisations. POCT testing was required in 27% after the first round of ultra-proactive TDM and in a mean of 6.3% (standard deviation [SD] 1.9) in the subsequent rounds. Ad-hoc extra dosing was needed in 13% of the POCT. After 1 year, no difference was seen between cohort A and cohort B in IFX failure [19% vs 10%; p = 0.08], nor in sustained clinical remission [75% vs 83%; p = 0.17]. Mucosal remission was evaluated in 71 patients [38%], and was more frequent in the reactive TDM cohort [p = 0.02]. Conclusions: Ultra-proactive TDM in patients with IBD and maintenance IFX treatment leads to equal clinical outcomes as reactive TDM after 1 year of follow-up. (© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.) |
Databáze: | MEDLINE |
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