Are Sufficient Induction Dose of Anti-TNF Drug for Avoid Failure Pharmacokinetic in Patients with Inflammatory Bowel Disease? A Study in a Real World Setting
Carles Iniesta Navalón1*, Lidia Díaz Serrano2, Lorena Rentero Redondo1, María Ángeles Nieto Vitoria2, Consolación Pastor Mondéjar1, Rosa Gómez Espín2 and Isabel Nicolás De Prado2
1PhD, Department of Hospital Pharmacy, Reina Sofia Hospital of Murcia, Spain
2MD, Department of Gastroenterology, Reina Sofia Hospital of Murcia, Spain
*Corresponding Author: Carles Iniesta Navalón, PhD, Department of Hospital Pharmacy, Reina Sofia Hospital of Murcia, Spain.
September 14, 2022; Published: September 28, 2022
Objectives: Pharmacokinetic processes associated increased drug clearance could play a key role in primary no-responders to anti-TNF drug in inflammatory bowel disease patients. To our knowledge, little is known about whether drug exposures after induction doses are sufficient to avoid pharmacokinetic failure in real life. The main objective of this study was to determine the proportion of patient adalimumab and infliximab-treated, with pharmacokinetic failure at induction period, and to investigate the factors associated with increase clearance.
Methods: We conducted a retrospective observational study. Patients starting treatment with adalimumab or infliximab during May 2017 to June 2021 were potentially eligible for the study. The primary outcome was to determine the proportion of patients with drug concentration at induction period, and to investigate baseline patient-related characteristics affecting to drug elimination. Individual pharmacokinetic parameters were estimate by Bayesian method for each patient.
Results: A total of 101 patients were included in the study. The proportion of patients with serum concentrations in the therapeutic range was higher in patients treated with adalimumab than infliximab (74.5% vs. 40.0%, respectively; p < 0.001). After multivariate analysis, the factors associated with a short half-life (<163 hours) for infliximab were: diagnosis UC (OR: 5.62 [CI95% 1.01 -32.5]), serum albumin (OR: 0.26 [CI 95%: 0.03 - 0.90]), and anti-TNF-ɑ previous treatment (OR: 8.86 [CI 95%: 1.10-71.48]).No association were found for ADA.
Conclusion: The findings of this study justify the early measurement of drug levels to be able to optimize therapy appropriately and avoid lack of response, especially in patients at risk.
Keywords: Infliximab; Adalimumab; Therapeutic Drug Monitoring; Induction; Inflammatory Bowel Disease; Pharmacokinetic
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