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
; 30(3): 325-335, 2024 Mar 01.
Article
in En
| MEDLINE
| ID: mdl-37265165
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 (ρâ =â 0.96, Pâ <â .001) and VEDO (ρâ =â 0.97, Pâ <â .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 (ρâ =â 0.99, Pâ <â .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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
C-Reactive Protein
/
Inflammatory Bowel Diseases
/
Antibodies, Monoclonal, Humanized
Type of study:
Guideline
/
Observational_studies
Limits:
Humans
Language:
En
Journal:
Inflamm Bowel Dis
Journal subject:
GASTROENTEROLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Netherlands