Long-Term Effectiveness and Safety of Proactive Therapeutic Drug Monitoring of Infliximab in Paediatric Inflammatory
Susana Clemente Bautista1, Óscar Segarra Cantón2,3, Núria Padullés-Zamora4
1Pharmacy Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, 08035 Barcelona, Spain.
Insights
Proactive therapeutic drug monitoring (TDM) for infliximab in pediatric inflammatory bowel disease (IBD) showed no significant outcome differences versus reactive TDM. Both approaches yielded comparable safety and efficacy, warranting further investigation with larger cohorts.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacology
Background:
- Evaluating long-term effectiveness and safety of proactive therapeutic drug monitoring (TDM) with Bayesian forecasting for infliximab (IFX) in pediatric inflammatory bowel disease (IBD).
- Real-world data analysis comparing early proactive TDM versus reactive TDM for IFX dose adjustment.
Purpose of the Study:
- To assess the long-term effectiveness and safety of a proactive TDM program for infliximab in pediatric IBD patients.
- To compare clinical, biological, and endoscopic outcomes between proactive and reactive TDM strategies.
Main Methods:
- Descriptive, ambispective, single-centre study of 38 pediatric IBD patients (Crohn's disease, ulcerative colitis) from September 2015 to September 2023.
- Patients received reactive TDM (n=17) before Sept 2019 and proactive TDM (n=21) thereafter, with IFX dose adjustments targeting trough concentrations ≥ 5 µg/mL.
- Analysis included remission rates, treatment failure, hospitalizations, emergency visits, and adverse drug reactions.
Main Results:
- Mean IFX trough concentrations were higher in the proactive group (12.38 µg/mL) versus the reactive group (6.83 µg/mL), p=0.08.
- No statistically significant differences were observed in remission rates or treatment failure between the groups.
- The proactive group showed trends towards fewer hospitalizations and shorter hospital stays, with higher rates of adverse reactions, though not statistically significant.
Conclusions:
- Proactive TDM did not demonstrate significant differences in treatment outcomes or safety compared to reactive TDM in this pediatric IBD cohort.
- Outcomes in both groups were comparable to other studies, suggesting current TDM strategies are not inferior.
- Larger sample sizes are required for future studies to optimize treatment strategies for pediatric IBD patients using infliximab.
Background:
This study evaluated the long-term effectiveness and safety of a multidisciplinary early proactive therapeutic drug monitoring (TDM) program combined with Bayesian forecasting for infliximab (IFX) dose adjustment in a real-world dataset of paediatric patients with inflammatory bowel disease (IBD).
Methods:
A descriptive, ambispective, single-centre study of paediatric patients with IBD who underwent IFX serum concentration measurements between September 2015 and September 2023. The patients received reactive TDM before September 2019 (n = 17) and proactive TDM thereafter (n = 21). We analysed for clinical, biological, and endoscopic remission; treatment failure; hospitalisations; emergency visits; and adverse drug reactions. The IFX doses were adjusted to maintain trough concentrations ≥ 5 µg/mL, with specific targets for proactive TDM.
Results:
Of the 38 patients, 21 had Crohn's disease (CD), 16 ulcerative colitis (UC), and 1 undetermined IBD. The mean (standard deviation) IFX trough concentrations were 6.83 (5.66) µg/mL (reactive) and 12.38 (9.24) µg/mL (proactive) (p = 0.08). No statistically significant differences between groups were found in remission rates or treatment failure. The proactive group had fewer hospitalisations (14.29% vs. 23.53%; p = 0.47) and shorter median hospitalisation days (6 vs. 19; p = 0.50), although the difference was not statistically significant. The number of patients with adverse reactions (infusion related reactions and infections) was higher in the proactive group (38.10% vs. 23.53%; p = 0.34) but the difference was not significantly different.
Conclusions:
Proactive TDM showed no significant differences in treatment outcomes compared to reactive TDM. However, the results in both the reactive and proactive TDM groups were not worse than those reported in other studies. Further studies with larger samples are needed to optimize the treatment strategies for pediatric IBD patients.
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