Colon to Rectum
J Crohns Colitis. 2022;16(2):199–206
Ultra-proactive therapeutic drug monitoring of infliximab based on point of care testing in inflammatory bowel disease: Results of a pragmatic trial
Background: With point of care testing (POCT) for infliximab (IFX), ultra-proactive therapeutic drug monitoring (TDM) with ad-hoc dose optimization is possible in patients with inflammatory bowel disease (IBD).
Aim: To compare the clinical outcomes of an ultra-proactive 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 2 centers. Center A applied an ultra-proactive TDM algorithm incorporating POCT, and center B applied reactive TDM. Primary end point was failure of IFX therapy after 1 year. Secondary end points 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 optimizations. POCT was required in 27% after the first round of ultra-proactive TDM and in a mean of 6.3 ± 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 therapeutic drug monitoring (TDM) in patients with inflammatory bowel disease and maintenance infliximab treatment leads to equal clinical outcomes as reactive TDM after 1 year of follow-up.