TY - JOUR
T1 - Real-World Impact of Infliximab Precision-Guided Dosing on Management of Patients With IBD
AU - Abraham, Bincy P.
AU - Ziring, David A.
AU - Dervieux, Thierry
AU - Han, Patricia Aragon
AU - Shim, Andrew
AU - Battat, Robert
N1 - Funding Information:
This study and supplement were funded by Prometheus Laboratories Inc.
Funding Information:
EMPOWER IFX CEP was designed by the Chief Scientific Officer of Prometheus Laboratories Inc, Thierry Dervieux, PharmD, PhD. We would like to thank all the health care providers who participated in the program, and Judy Gohndrone for providing exceptional support during the program. Assistance with medical writing and data presentation was provided by Noel N. Kim, PhD, under the direction of the authors. This supplement was supported by Prometheus Laboratories Inc.
Publisher Copyright:
© 2023 Ascend Media. All rights reserved.
PY - 2023/10
Y1 - 2023/10
N2 - OBJECTIVES: Evaluate the clinical utility of a precision-guided dosing test for infliximab (IFX) and its impact on treatment decision-making for inflammatory bowel disease (IBD). STUDY DESIGN: Prospective, multisite, clinical experience program. METHODS: Health care providers were given access to PredictrPK IFX, a precision-guided dosing test, for their patients with IBD on maintenance IFX therapy. Blood samples were drawn 20 to 56 days post infusion. A Bayesian data assimilation tool used clinical and serologic data to generate individual pharmacokinetic profiles and forecast trough IFX. Results were reported to providers to aid in-therapy management decisions and the decision-making process was assessed through questionnaires. Relationships between forecasted IFX concentration, disease activity, and therapy management decisions were analyzed by logistic regression. RESULTS: PredictrPK IFX was used for 275 patients with IBD by 37 providers. In 58% of cases, providers modified treatment plans based on the results, including dose modifications (41%; of these, one-third decreased dose) and discontinuation (8%) of IFX. Of the 42% where treatment was not modified, 97.5% had IFX levels of 5 µg/mL or greater. Patients with IFX concentrations less than 5 µg/mL were 3 and 7.3 times more likely to have active disease or discontinue IFX, respectively. There was unanimous agreement among providers who completed a postprogram survey that PredictrPK IFX was beneficial in guiding treatment decisions and added more value to their practice than routine therapeutic drug monitoring. CONCLUSIONS: PredictrPK IFX enables earlier and more precise dose optimization of IFX in patients with IBD, exerting a substantial impact on treatment decisions that may result in improved health outcomes and overall cost savings.
AB - OBJECTIVES: Evaluate the clinical utility of a precision-guided dosing test for infliximab (IFX) and its impact on treatment decision-making for inflammatory bowel disease (IBD). STUDY DESIGN: Prospective, multisite, clinical experience program. METHODS: Health care providers were given access to PredictrPK IFX, a precision-guided dosing test, for their patients with IBD on maintenance IFX therapy. Blood samples were drawn 20 to 56 days post infusion. A Bayesian data assimilation tool used clinical and serologic data to generate individual pharmacokinetic profiles and forecast trough IFX. Results were reported to providers to aid in-therapy management decisions and the decision-making process was assessed through questionnaires. Relationships between forecasted IFX concentration, disease activity, and therapy management decisions were analyzed by logistic regression. RESULTS: PredictrPK IFX was used for 275 patients with IBD by 37 providers. In 58% of cases, providers modified treatment plans based on the results, including dose modifications (41%; of these, one-third decreased dose) and discontinuation (8%) of IFX. Of the 42% where treatment was not modified, 97.5% had IFX levels of 5 µg/mL or greater. Patients with IFX concentrations less than 5 µg/mL were 3 and 7.3 times more likely to have active disease or discontinue IFX, respectively. There was unanimous agreement among providers who completed a postprogram survey that PredictrPK IFX was beneficial in guiding treatment decisions and added more value to their practice than routine therapeutic drug monitoring. CONCLUSIONS: PredictrPK IFX enables earlier and more precise dose optimization of IFX in patients with IBD, exerting a substantial impact on treatment decisions that may result in improved health outcomes and overall cost savings.
KW - Humans
KW - Infliximab/therapeutic use
KW - Gastrointestinal Agents/therapeutic use
KW - Prospective Studies
KW - Bayes Theorem
KW - Inflammatory Bowel Diseases/drug therapy
KW - Drug Monitoring/methods
UR - http://www.scopus.com/inward/record.url?scp=85174748549&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85174748549&partnerID=8YFLogxK
U2 - 10.37765/AJMC.2023.89447
DO - 10.37765/AJMC.2023.89447
M3 - Article
C2 - 37844322
AN - SCOPUS:85174748549
SN - 1088-0224
VL - 29
SP - S227-S235
JO - American Journal of Managed Care
JF - American Journal of Managed Care
IS - 12 Suppl
ER -