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

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The pharmacokinetic equivalence of dose intensification with adalimumab (ADA) 80mg every other week (EOW) compared to weekly 40mg has only been supported by modeling systems. To compare the trough levels of ADA (TLA) and the occurrence of anti-ADA antibodies (AAA) between these two treatment regimens. 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 40mg once a week. In these patients, the ADA regimen was changed from 40mg/week to 80mg 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. Sixty-two patients (60% CD, mean age 35years) were included. Before and ten weeks after the changes of ADA regimen, the median TLA were (6.9µg/mL versus 7.0µg/mL, respectively; P = 0.34) and the AAA levels (3.4µg/ml-eq versus 3.0µg/ml-eq, respectively; P = 0.25.) were quite similar. Likewise, quartiles of TLA (Kendall test r = 0.91; P < 0.001) and AAA (r = 0.78; P < 0.001) did not differ before and after ADA regimen. When stratifying all the patients into 4 groups based on drug/antibody levels (immunogenic, subtherapeutic, therapeutic, or supratherapeutic), no patient needed for returning to the previous weekly regimen. In terms of acceptability, more than 60% of patients preferred an injection EOW compared once a week. In IBD patients who achieved a deep clinical remission under ADA 40mg once a week, the pharmacokinetic of ADA was similar when ADA regimen was changed to 80mg EOW. Given the patient's preference for the latter regimen, a modification of injection regimen should be systematically proposed.