학술논문

Adalimumab Concentration Changes Following Dose Escalation in Inflammatory Bowel Disease
Document Type
Academic Journal
Source
Therapeutic Drug Monitoring. Dec 17, 2020
Subject
Language
English
ISSN
0163-4356
Abstract
BACKGROUND:: Dose escalation of adalimumab (ADA) for loss or response in inflammatory bowel disease (IBD) is a common practice. Recent data suggest improved outcomes with an ADA concentration of 12 μg/mL, but limited data are available on the ability to achieve a target concentration. The aim of this study was to determine the expected change in serum ADA concentration following a dose escalation performed every seven days in patients with IBD. METHODS:: A retrospective cohort of patients with IBD receiving ADA was divided into every fourteen-day dosing, every seven-day dosing, and dose escalation (i.e., q14 to q7 day dosing). The primary outcome was the change in ADA concentration. Multiple logistic regression was performed to identify predictors of achieving a target ADA concentration of ≥ 12 μg/mL. RESULTS:: Overall, 380 patients were identified, of whom 200 underwent dose escalation, 100 remained on q14 day dosing, and 80 were maintained on q7 day dosing. After dose escalation, the mean ADA concentration increased by 5.5 μg/mL (P < 0.0001). Following dose escalation, a significant proportion of patients achieved an ADA concentration ≥ 12 μg/mL (P = 0.0019), as well as clinical remission (P = 0.0053). Based on multiple logistic regression, age of < 46 years [odds ratio (OR): 2.4; 95% CI: 1.3, 4.6; P < 0.01], body mass index (BMI) of < 29 (OR: 0.21; 95% CI: 0.1, 0.5; P < 0.0001), and initial ADA concentration of ≥ 3.0 μg/mL were found to be associated with a target ADA concentration ≥ 12 μg/mL (OR: 4.76; 95% CI: 2.3, 9.7; P < 0.0001). CONCLUSIONS:: The average expected increase in serum ADA concentration following dose escalation from q14 to q7 days was 5.5 μg/mL. The initial ADA concentration, age, and BMI may influence the ability to achieve a target ADA concentration following dose escalation.