Patient-centric microsampling for abrocitinib pharmacokinetics: multiple-analytes assay bridging using Tasso device

Area of Science:

• Pharmacokinetics
• Analytical Chemistry
• Clinical Diagnostics

Background:

• Abrocitinib is an important medication requiring therapeutic drug monitoring.
• Traditional venous blood sampling can be invasive and challenging, especially for pediatric populations.
• Microsampling devices offer a less invasive alternative for collecting blood samples.

Purpose of the Study:

• To evaluate the feasibility of using Tasso devices for capillary blood collection to measure abrocitinib and its metabolites.
• To establish assay concordance between capillary and venous blood sampling methods.
• To assess the suitability of Tasso devices for future pediatric studies involving abrocitinib.

Main Methods:

• Capillary blood samples were collected using Tasso-SST® and Tasso+ devices.
• Venous blood samples were collected for comparison.
• Concentrations of abrocitinib and its metabolites (M1, M2, M4) were measured using validated assays for both sample types.
• Assay concordance and pharmacokinetic parameter bioequivalence (AUC_last, C_max) were statistically evaluated.

Main Results:

• High correlation coefficients (>0.98) were observed between capillary serum and venous plasma concentrations for all four analytes across three separate assays.
• Pharmacokinetic parameters, including area under the curve (AUC_last) and maximum concentration (C_max), met bioequivalence criteria when comparing capillary and venous samples.
• The Tasso devices demonstrated reliable performance in sample collection and analyte quantification.

Conclusions:

• Tasso devices are feasible for collecting capillary blood samples for abrocitinib and metabolite analysis.
• The assay concordance and bioequivalence between capillary and venous sampling support the use of Tasso devices.
• Patient-centric microsampling with Tasso devices is a viable option for future abrocitinib pediatric studies.