Clinical Validation of a Capillary Blood Home-Based Self-Sampling Technique for Monitoring of Infliximab, Vedolizumab, and C-Reactive Protein Concentrations in Patients With Inflammatory Bowel Disease

Antonius T Otten; Hedwig H van der Meulen; Maurice Steenhuis; Floris C Loeff; Daan J Touw; Jos G W Kosterink; Henderik W Frijlink; Theo Rispens; Gerard Dijkstra; Marijn C Visschedijk; Arno R Bourgonje

doi:10.1093/ibd/izad103

Clinical Validation of a Capillary Blood Home-Based Self-Sampling Technique for Monitoring of Infliximab, Vedolizumab, and C-Reactive Protein Concentrations in Patients With Inflammatory Bowel Disease

Inflamm Bowel Dis. 2024 Mar 1;30(3):325-335. doi: 10.1093/ibd/izad103.

Affiliations

¹ Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, the Netherlands.
² Biologics Laboratory, Sanquin Diagnostic Services, Amsterdam, the Netherlands.
³ Department of Pharmaceutical Analysis, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands.
⁴ Department of PharmacoTherapy, Epidemiology and Economy, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands.
⁵ Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands.
⁶ Department of Immunopathology, Sanquin Research, Amsterdam, the Netherlands.

Abstract

Background: Therapeutic drug monitoring provides important guidance for treatment of patients with inflammatory bowel disease (IBD) and could help to early identify treatment failure. This study aimed to validate a finger prick-based capillary blood sampling technique to measure biological trough levels and C-reactive protein (CRP) and evaluate patient performance and -support.

Methods: In this prospective cohort study, patients with IBD receiving infliximab (IFX) or vedolizumab (VEDO) therapy performed finger prick-based capillary blood sampling at home. Additionally, blood was collected through routinely performed in-hospital venepuncture prior to biological infusion. IFX, VEDO, and CRP concentrations were measured by enzyme-linked immunosorbent assay. The concordance between methods was statistically evaluated and a survey was conducted to assess practicality and patient support.

Results: In total, 81 patients (46 IFX, 35 VEDO) were enrolled. Mean differences between both methods were 0.42 (95% confidence interval, -1.74 to 2.58) μg/mL for IFX and 0.72 (95% confidence interval, -5.50 to 6.94) μg/mL for VEDO. Passing-Bablok regressions demonstrated no evidence for systematic or proportional biases. Venous and capillary IFX (ρ = 0.96, P < .001) and VEDO (ρ = 0.97, P < .001) levels strongly correlated and showed high intermethod agreement (Cohen's kappa: IFX = 0.82; VEDO = 0.94). Similarly, venous and capillary CRP levels were strongly correlated (ρ = 0.99, P < .001). Most patients (>95%) were able to successfully perform the self-sampling at home without prior instructions.

Conclusions: This study clinically validated a finger prick-based capillary blood self-sampling technique allowing concomitant home monitoring of biological levels and CRP for patients with IBD, who reported substantial support, tolerability, and practicality.

Keywords: home sampling; inflammatory bowel disease; infliximab; therapeutic drug monitoring; vedolizumab.

MeSH terms

Antibodies, Monoclonal, Humanized*
C-Reactive Protein*
Humans
Inflammatory Bowel Diseases* / drug therapy
Infliximab / pharmacokinetics
Infliximab / therapeutic use
Prospective Studies

Substances

Antibodies, Monoclonal, Humanized
C-Reactive Protein
Infliximab
vedolizumab