No Difference of Adalimumab Pharmacokinetics When Dosed at 40 mg Every Week or 80 mg Every Other Week in IBD Patients in Clinical Remission After Adalimumab Dose Intensification

Introduction The pharmacokinetic equivalence of dose intensification with adalimumab (ADA) 80 mg every other week (EOW) compared to weekly 40 mg has only been supported by modeling systems. Aim of the Study To compare the trough levels of ADA (TLA) and the occurrence of anti-ADA antibodies (AAA) bet...

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Bibliographic Details
Published in:Digestive diseases and sciences 2021-08, Vol.66 (8), p.2744-2749
Main Authors: Paul, Stephane, Williet, Nicolas, Nancey, Stéphane, Veyrard, Pauline, Boschetti, Gilles, Phelip, Jean-Marc, Flourie, Bernard, Roblin, Xavier
Format: Article
Language:English
Subjects:
Adalimumab
Biochemistry
Care and treatment
Comparative analysis
Drug dosages
Gastroenterology
Gastrointestinal diseases
Hepatology
Inflammatory bowel disease
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Monoclonal antibodies
Oncology
Original Article
Patients
Pharmacokinetics
Remission (Medicine)
TNF inhibitors
Transplant Surgery
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Summary:Introduction The pharmacokinetic equivalence of dose intensification with adalimumab (ADA) 80 mg every other week (EOW) compared to weekly 40 mg has only been supported by modeling systems. Aim of the Study To compare the trough levels of ADA (TLA) and the occurrence of anti-ADA antibodies (AAA) between these two treatment regimens. Patients and Methods This was a prospective study including all consecutive patients with inflammatory bowel disease (IBD) who had reached a longstanding and deep remission under treatment with ADA 40 mg once a week. In these patients, the ADA regimen was changed from 40 mg/week to 80 mg EOW. TLA and AAA levels using a drug-tolerant assay were monitored before and ten weeks after from the change in the ADA regimen and the results compared by a Wilcoxon paired test. Results Sixty-two patients (60% CD, mean age 35 years) were included. Before and ten weeks after the changes of ADA regimen, the median TLA were (6.9 µg/mL versus 7.0 µg/mL, respectively; P  = 0.34) and the AAA levels (3.4 µg/ml-eq versus 3.0 µg/ml-eq, respectively; P  = 0.25.) were quite similar. Likewise, quartiles of TLA (Kendall test r  = 0.91; P  
ISSN:0163-2116
1573-2568
DOI:10.1007/s10620-020-06567-x