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Ther Drug Monit. 2019 Aug 26. doi: 10.1097/FTD.0000000000000686. [Epub ahead of print]

Monitoring of Adalimumab Concentrations at Home in Patients with Inflammatory Bowel Disease using Dried Blood Samples.

Author information

1
Amsterdam UMC, University of Amsterdam, Hospital Pharmacy, Amsterdam, Netherlands.
2
Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, Netherlands.
3
Biologics Lab, Bioanalysis, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
4
Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam, The Netherlands.

Abstract

BACKGROUND:

Adalimumab (ADL) is a subcutaneously administered anti-tumor necrosis factor (TNF) agent used in the treatment of patients with inflammatory bowel disease (IBD). Higher ADL trough concentrations are associated with improved clinical and endoscopic outcomes. Therapeutic drug monitoring (TDM) of ADL might be facilitated by using dried blood samples (DBS) from capillary blood obtained at home. The study aimed to compare serum ADL concentrations obtained via venipuncture to ADL concentrations in DBS.

METHODS:

Patients with Crohn's disease and ulcerative colitis receiving induction or maintenance ADL therapy were enrolled in this prospective cohort study. Blood was obtained via venipuncture and via DBS during a regular outpatient visit (time point 1). Just before the next ADL administration, patients performed DBS at home (time point 2). For this time point, serum ADL concentrations were estimated by Bayesian analysis.

RESULTS:

Thirty-three patients with IBD were enrolled. During the outpatient visit, samples were obtained after a median [interquartile range] of 6 [4-10] days after the last ADL dose. A high correlation was found between DBS and venipuncture results (Pearson's correlation: ≥ 0.96), without any clinically relevant bias. For DBS performed by patients at home, initial comparison showed a moderate correlation between DBS results and predicted ADL serum concentrations (Pearson's correlation: 0.51), although no bias was present. In addition, DBS eluate results compared to predicted ADL serum concentrations showed a mean absolute percentage error (i.e., accuracy) of 45%.

CONCLUSION:

High correlations were found between ADL serum concentrations obtained via conventional venipuncture and DBS, which indicates that this home-based test can facilitate TDM-based ADL dose adjustments in daily practice.

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