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Therapeutic Drug Monitoring for Precision Dosing of Janus Kinase Inhibitors: Protocol for a Prospective Observational
Jérémie Tachet1, Laurent A Decosterd2, Monia Guidi1,3,4
1Service of Clinical Pharmacology, Department of Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
JMIR Research Protocols
|September 9, 2025
Summary
This study characterizes Janus kinase inhibitor (JAKI) pharmacokinetics in Switzerland, aiming to establish therapeutic drug monitoring. Findings will optimize JAKI dosing for improved efficacy and safety in inflammatory and hematological disorders.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Metabolism
Background:
- Janus kinase inhibitors (JAKIs) are effective oral treatments for inflammatory and hematological disorders.
- Concerns exist regarding JAKI safety profiles, necessitating further investigation.
- Therapeutic drug monitoring for JAKIs is not yet established but could personalize treatment.
Purpose of the Study:
- Characterize pharmacokinetics of 6 major JAKIs in Switzerland.
- Identify factors influencing drug exposure and explore exposure-response relationships.
- Contribute to establishing therapeutic intervals for JAKIs.
Main Methods:
- Prospective observational study across Switzerland.
- Adult patients prescribed JAKIs enrolled for sparse or detailed pharmacokinetic sampling.
- Nonlinear mixed-effects modeling to analyze pharmacokinetic variability and covariates.
Main Results:
- 276 blood samples collected from 107 patients by August 2024.
- Majority of patients were female (57.9%) with a median age of 51 years.
- Ruxolitinib, upadacitinib, and baricitinib were the most prescribed JAKIs.
Conclusions:
- Study framework enables real-world pharmacokinetic characterization of JAKIs.
- Novel therapeutic drug monitoring approaches will explore exposure-response relationships.
- Essential information for precise JAKI dose optimization is expected.
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