Precision-Guided Dosing

Infliximab dosing is not one size fits all

The unpredictable pharmacokinetic variability of biologic therapies amongst individual
inflammatory bowel disease (IBD) patients makes it extremely difficult to achieve
therapeutic targets quickly and precisely.¹

• Up to 40% of patients who start infliximab (IFX) lose response in year one²
• Over 50% will require dose optimization during their treatment³
• Current tests provide a single point-in-time snapshot on drug levels, but don’t provide insights on dosage or interval to achieve targets.

Conventional dosing poses many challenges for providers and patients alike.^4-6

• Suboptimal therapeutic levels
• Potential loss of response
• Inefficient care
• Negative impact on quality of life

Conventional approaches to drug monitoring can lead to unoptimized therapy
resulting in inefficient care, disease recurrence and potential treatment failure

Control the trajectory of therapeutic drug levels with precision-guided care

PredictrPK^® IFX, available exclusively from Prometheus Laboratories, offers individualized, actionable evidence to expediently fine-tune dosing in support of durable IFX response, dose escalation & de-escalation, and other treatment modifications —during the current dosing cycle. This first-of-its-kind test shifts the paradigm in biologic optimization and aids in controlling the trajectory of therapeutic drug levels and achieving treatment targets.

PredictrPK IFX provides objective, individualized predictions of optimal biologic dosing that empowers:

• An evidence-based approach that accelerates treatments optimization
• Increased likelihood of achieving treatment targets
• Ensures patients get the most from infliximab therapy
• Improved patient confidence and satisfaction

Evidence-based outcomes of dosing optimization:^4-9

• Durability of response
• Improved remission rates
• Reduced healthcare consumption
• Improved quality of life and efficient care

Pharmacokinetically-guided insights at every stage of infliximab therapy
provides evidence to validate treatment plans and empower individualized care

*PredictrPK IFX is validated for use in adult and pediatric IBD patients receiving IFX therapy including patients on combination therapy with an immunomodulator or another therapeutic agent. During induction: Patients are eligible to receive PredictrPK testing ≤3 days prior to induction dose #3. During steady-state maintenance: After 14 weeks of continuous IFX therapy, patients are eligible to receive testing ≤3 days prior to week 14 OR 20+ days after any regular maintenance infusion, up to and including the next trough.

References

• Vermeire S et al. Clin Gastroenterol Hepatol. 2020;18:1291–1299.
• Ben-Horin S et al. Autoimmun Rev. 2014;13(1)24-30.
• O’Donnell S et al. J Crohns Colitis. 2015 Oct 9; (10):830-6.
• Negoescu DM et al. Inflamm Bowel Dis. 2020 Jan 1;26(1):103-111.
• Papamichael K et al. J Crohns Colitis. 2018 Jun 28;12(7):804-810.
• Papamichael K et al. Clin Gastroenterol Hepatol. 2017 Oct;15(10):1580-1588.
• Strik AS et al. Scand J Gastroenterol. 2021 Feb;56(2):145-154.
• Dubinsky MC et al. Inflamm Bowel Dis. 2022 Sep 1;28(9):1375-1385.
• Data on file.