Arizona Tribune - PredictrPK(R) ADA, a Precision-Guided Dosing Test Supporting Adalimumab Treatment Optimization, Demonstrates Strong Clinical Utility in New Study

SAN DIEGO, CA / ACCESS Newswire / June 17, 2025 / Prometheus Laboratories Inc. ("Prometheus"), a leader in precision healthcare, announces the publication of a prospective, cross-sectional multi-center clinical experience study in Pharmaceutics demonstrating the clinical utility of PredictrPK ADA, a precision-guided dosing test, for optimizing adalimumab (ADA) therapy in patients with inflammatory bowel disease (IBD).¹ The study showcases how precision-guided dosing can significantly enhance treatment outcomes by providing healthcare providers (HCPs) with precise dosing recommendations based on individual patient profiles.

A total of 213 cases from a diverse IBD patient population were assessed by 21 HCPs in the United States. By incorporating pharmacokinetic (PK) parameters, including clearance and clinical laboratory data, PredictrPK was found to enable early and more precise optimization of ADA therapy by predicting future trough levels at alternative doses and intervals at any time during the therapy cycle. Over half of patients in this study demonstrated accelerated clearance, which puts them at risk of inadequate drug exposure or antidrug antibody formation, highlighting the need for potential intervention or close monitoring by their HCP.

"Precision-guided dosing allows us to tailor adalimumab therapy to the unique pharmacokinetic and clinical characteristics of each patient, to help achieve better disease control, reduce the likelihood of therapy discontinuation, or expedite a therapy switch, when necessary," shared study lead Dr. Stephen B. Hanauer, MD, FACG, And Professor of Medicine and Medical Director of the Digestive Health Center at Northwestern University's Feinberg School of Medicine. "Of note, this study reinforces the growing evidence that clearance is a crucial pharmacokinetic parameter to evaluate as part of a therapy management plan for IBD patients. An individualized approach to clearance represents another important step toward truly personalized medicine."

Results from the post-program survey underscored the effectiveness of PredictrPK with 81 percent of HCPs indicating it helped them select the optimal ADA dose and/or interval, and 81 percent finding it helpful in discussions with patients regarding dose escalation.

This study validates the clinical utility of PredictrPK^® ADA, a precision-guided dosing test launched by Prometheus in 2023. PredictrPK ADA leverages advanced pharmacokinetic modeling and patient-specific data to measure drug clearance and predict future trough levels with current and alternative dosing options, providing HCPs with objective data to support their ability to better optimize adalimumab therapy for patients. This innovative test addresses the variability in therapeutic response among IBD patients and supports personalized treatment strategies to improve the likelihood of better patient outcomes and reduce healthcare costs.

"This study builds on our foundation of clinical utility research supporting the value of our precision-guided dosing portfolio," stated Patricia Vasquez, President of Prometheus. "By integrating pharmacokinetic insights with clinical data, we continue to empower healthcare providers to make informed, individualized dosing decisions. These findings, along with our previously published studies on PredictrPK IFX,^2,3 reinforce the role of precision-guided dosing in improving patient outcomes and optimizing healthcare resources."

References:

1. Hanauer SB et al. The Clinical Utility of Precision-Guided Dosing for Adalimumab Therapy Optimization in Inflammatory Bowel Disease: A Clinical Experience Program. Pharmaceutics. 2025; 17(4):428.

2. Abraham BP et al. Real-world impact of infliximab precision-guided dosing on management of patients with IBD. Am J Manag Care. 2023 Oct;29(12 Suppl):S227-S235.

3. Alizadeh ER et al. Simulated cost-effectiveness of a novel precision-guided dosing strategy in adult patients with Crohn's disease initiating infliximab maintenance therapy. Pharmacotherapy. 2024 Apr;44(4):331-342.

Dr. Hanauer is a paid consultant and scientific advisor for Prometheus Laboratories.

About PredictrPK

PredictrPK are precision-guided dosing tests available for infliximab, adalimumab and their biosimilars that are intended for IBD patients to support improved outcomes. PredictrPK tests combine serology markers, patient-specific variables, current dosing and proprietary machine-learning algorithms to calculate drug clearance and help providers optimize dosing for individual IBD patients with predicted drug levels for both current and alternate doses and therapy intervals. Precise, individualized dosing guidance can aid patients in achieving and remaining in remission with biologics.

About Prometheus Laboratories

Prometheus Laboratories has been a leading specialty clinical laboratory for 30 years. Our robust portfolio of precision medicine tests improves the healthcare journey for individuals with immune-mediated and gastrointestinal diseases by empowering providers to diagnose, treat and help get their patients into remission faster with precision-guided care. For more information, visit the Prometheus website and follow us on LinkedIn or X (formerly Twitter).

Media Contact

Chrystal Johnson
Sr. Marketing & Events Specialist
Prometheus Laboratories Inc.
[email protected]

SOURCE: Prometheus Laboratories

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