Prometheus Laboratories
9410 Carroll Park Drive | San Diego | CA | 92121
888‐423‐5227 | www.prometheuslabs.com
Prometheus tests are laboratory-developed tests that were developed, and analytically and clinically validated by Prometheus Laboratories Inc. under federal Clinical Laboratory Improvement Amendments (CLIA) guidelines, and are performed exclusively in our high complexity CLIA certified and College of American Pathologists accredited clinical laboratory. As laboratory developed tests, they have not been cleared or approved by the US FDA. The tests may be covered by one or more US pending or issued patents - see prometheuslabs.com/patents. Prometheus, PredictrPK and Anser are registered trademarks of Prometheus Laboratories Inc, San Diego, California. Digestive Disease Week® and DDW® are registered trademarks of DDW LLC. All other trademarks or service marks are the property of their respective owners. ©2024 Prometheus Laboratories Inc. All rights reserved. This material is provided for general information purposes only, as an educational service for healthcare providers. It is not intended as a substitute for medical advice and/or consultation with a physician. PK.5009v1 (04/2024)
Clinical Utility
Poster Su1828 | Precision Dosing Testing For Optimizing Adalimumab (ADA) In IBD: A Real World Evidence Study
This study validates that low ADA concentrations and high clearance are associated with higher risks of therapy discontinuation and active disease. Precision-guided dosing for adalimumab with PredictrPK® ADA allows for precise optimization of ADA dosing and likely mitigation of risks.
Poster Su1825 | Predictive Pharmacokinetic Factors Associate with Improved Therapeutic Outcomes During Maintenance Treatment With Infliximab (IFX) for Adult Crohn's Disease
Longitudinal analysis of the TAILORIX and PredictCrohn studies revealed a higher probability of clinical or biochemical remission when higher IFX troughs and lower IFX clearance were present. For patients with neither, only 23% achieved clinical or biochemical remission during maintenance compared to 88% with at least one factor present (low clearance or high drug levels) highlighting the potential for dose intensification.
Poster Su1826 | Sustained Presence Of Pharmacokinetic Predictive Factors Associated with Improved Therapeutic Outcome During Maintenance of Crohn's Disease Patients on ADA
Longitudinal analysis of 219 patients comparing therapeutic outcomes with pharmacokinetic factors (ADA clearance <0.317 L/day and ADA levels >5 μg/mL). When both pharmacokinetic factors were present, patients were 5-fold more likely to achieve sustained clinical and biochemical remission. However, when both factors were absent, <10% achieved sustained CRP-based clinical remission, sustained fecal calprotectin <100 μg/g, or endoscopic remission.
Poster Su1821 | Association Between 6-Thioguanine Nucleotide (6-TGN) Levels, ADA Drug Concentrations, Anti-ADA Antibodies (ATA) and ADA Drug Clearance
In adult IBD patients treated with combination thiopurine and ADA therapy, detectable ATA, 6-TGN levels >125 pmol/8x108 RBC and every other week dosing were independently associated with drug levels >5 µg/mL and ADA clearance <0.8 L/day. Optimizing thiopurines could have a role in improving ADA pharmacokinetics.
Poster Su1822 | Ustekinumab (UST) Drug Clearance is Better Associated with Crohn's Disease Remission than Serum Trough Concentrations in a Prospective Cohort Study
In a prospective cohort study of Crohn's disease patients treated with 90 mg of UST every 4 to 8 weeks, the UST trough concentration and UST clearance that best associated with remission were >4.5 µg/mL and <0.156 L/day, respectively. At these thresholds, there was a 1.7-fold and 5.6-fold higher likelihood of achieving remission for UST levels and UST clearance, respectively.
Health Economic Outcomes
Poster Su1799 | Comparison of Long-Term Outcomes, Measured as 36-Month Real-World IBD Hospitalizations, Surgeries, & Expenditures, between IFX Dose Optimized Patients using Therapeutic TDM Vs. a No-TDM Control in a US Community GI Practice
TDM with Anser® IFX, as part of routine IBD care, resulted in significantly lower rates of unplanned IBD-related hospitalizations, including ER events and IBD surgeries. IBD surgery expenditures and overall biologic expenditures, during the 36-month study period, were significantly lower compared to a matched cohort within the same community GI specialty group that did not utilize TDM.
Clinical Validity
Poster Su1816 | Capillary Blood Self-Collection Device For IFX Therapeutic Drug Monitoring
Capillary blood specimens, collected with a patient-friendly self-collection device, had similar IFX, antibodies-to-IFX, and IFX clearance results as venous blood specimens. This collection method may facilitate better access to precision-guided testing services in clinical practice.
Poster Su1815 | Poor Prognostic Factors of Pharmacokinetic Origin Predict Outcomes in IBD Patients Treated with Anti-TNF
The impact of pharmacokinetic factors (intrinsic drug clearance >0.326 L/day and HLA DQA1*05 risk variant carriage), prior to start of anti-TNF therapy, on the development of anti-drug antibodies (ADAbs) and disease control in 185 ADA- and 230 IFX-treated patients was assessed. Each pharmacokinetics factor resulted in a higher likelihood of ADAbs and lower likelihood of endoscopic remission. Higher clearance and prior biologic exposure negatively impacted outcomes, but could be mitigated by early biologic optimization.
Poster Su1829 | The Intra-Patient Variability of Adalimumab Clearance During An Intensive Sampling Study Of Crohn's Disease Patients Receiving Maintenance Therapy
Longitudinal analysis assessing intra-patient variability in ADA clearance and ADA concentrations over the 14-day treatment cycle in 12 patients across 70 study visits. For ADA clearance, linear mixed effects models confirmed no significant impact of sample collection time on clearance values, supporting its assessment at any time point within the 14-day treatment cycle.
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