Validation of a finger prick capillary blood sampling test for home monitoring of C-reactive protein and therapeutic drug monitoring of biological therapy in patients with inflammatory bowel disease

Biological therapy has become the mainstay of treatment for patients affected
by Inflammatory Bowel Diseases (IBD). Monitoring of C-reactive protein (CRP)
and Therapeutic Drug Monitoring (TDM) of biological therapy provides important
guidance for the treating physician and the clinical pharmacist. CRP monitoring
and TDM aims to identify over- and undertreatment, indentify
anti-drug-antibodies (ADA) and allows for dose adjustments or switches to
alternative treatment regimens. CRP monitoring and TDM while leveraging a
finger prick blood sampling technique in a home setting would allow caregivers
to closely monitor drug levels and anti-drug antibodies and thereby optimize
biological therapy for patients with IBD. Most importantly, however, it does
not require IBD patients to travel to hospitals, which forms a valuable servic

The primary objective of this study is to validate a capillary blood sampling
technique which can be individually performed by patients themselves in a
home-setting using a finger prick test. This test enables simultaneous
monitoring of systemic inflammation (CRP) and drug levels (TDM) in patients
with IBD who receive biological therapy at home.

A prospective observational single-center study involving Crohn's disease (CD)
and ulcerative colitis (UC) patients. Concentrations of CRP and biological
trough levels as well as anti-drug antibodies (ADA) will be determined in
capillary blood samples obtained through finger prick tests, which will
compared to concentrations in serum obtained by a routinely performed
venipuncture. At the same day that patients will receive in-hospital biological
infusion, patients will be requested to deliver both a blood sample through
routine venipuncture and a finger prick test performed at home. Samples will be
sent to Sanquin Diagnostics Laboratory to perform the laboratory analysis.

Burdens and risks of this study are solely associated with the capillary blood
sampling technique using a finger prick device. Administration of biological
therapy and routinely performed venipunctures are standard of care.
Patients will be asked to perform a single finger prick to obtain capillary
blood samples. More specifically, they will be requested to provide 5 drops of
blood (+/- 200 microliters).
Despite the novelty of this capillary sampling technique using a finger prick
device, the protocol through which these blood samples will be acquired (using
the finger prick device) is already well-established in clinical care. For
instance, patients with diabetes mellitus extensively use finger prick devices
at home to monitor their blood glucose levels. Taking these common practices
into consideration, the widespread use of finger prick devices is thoroughly
documented and the clinical usage of these devices has become common nowadays.
A finger prick method constitutes a minimally invasive procedure with very rare
chances of potential complications. The most common patient complaint is pain
at the place of puncture after the finger prick, which can however be largely
avoided by providing adequate instructions to patients, minimizing chances of
pain sensations.
This study will not provide a direct benefit to participating patients, but the
results of this study will be key to facilitate and optimize biological therapy
at home, thereby effectively reducing disease burden of patients, and,
ultimately, also that of the IBD healthcare system