Biologic drugs are prime candidates for therapeutic drug monitoring (TDM) because they are very expensive, relatively few, subject to wide pharmacokinetic variability, and unfortunately, significant primary and secondary failure rates.
March 25, 2020
Biologic drug therapies have proven to be precious in the treatment of inflammatory bowel disease (IBD), rheumatoid arthritis (RA), and other immune-mediated diseases — due to not only their high financial cost but also their finite number and variable longevity. Approved biologic drugs to treat inflammatory bowel disease and/or rheumatoid arthritis include monoclonal antibodies against integrin (vedolizumab and natalizumab), interleukin 12 and 23 (ustekinumab), and TNF (infliximab, adalimumab, golimumab, certolizumab, etanercept and the biosimilars, infliximab-abda and infliximab-dyyb).
Biologic drugs are prime candidates for therapeutic drug monitoring (TDM) because they are very expensive, relatively few, subject to wide pharmacokinetic variability, and unfortunately, significant primary and secondary failure rates. As these biologic drugs comprise a staggering healthcare cost (Humira®, Remicade®, and Stelara® gross $31 billion in 2018), we consider how the use of these precious medications might be optimized by biologic therapeutic drug monitoring.
The clinical value of therapeutic drug monitoring is predicated on the existence of a parallel relationship between measurements of drug (or antibody) in patient sample and outcomes. In the case of biologic drugs, therapeutic drug monitoring also implies the detection and quantitation of anti-drug antibodies. The anti-drug antibody measurement together with the concomitant free drug level provides critical pharmacokinetic and immunogenic assessment that cannot be otherwise be ascertained clinically.
Here, we discuss the application of biologic therapeutic drug monitoring to inform and expedite personalized clinical decision-making, such as:
Patient-specific dose titrating to target or maximally beneficial concentrations
- Diagnosing of immunogenicity
- Determining co-therapies and biologic switching
- Improving longevity of therapy
- Reducing drug waste and overall healthcare costs
- Supporting proactive management
Furthermore, recent data show that some patients with secondary failure due to immunogenicity may recapture clinical response as a result of treating away existing anti- drug antibodies.
The live session takes place on Wednesday, April 8, 2020 at 1pm EDT with guest speakers Dr. Jane Yang, Director of Medical Science at Esoterix Laboratory Services and Dr. Kelly Chun, Vice President and Scientific Director of Esoterix/Endocrine Sciences (Esoterix Laboratory Services and Esoterix/Endocrine Sciences are part of the LabCorp Specialty Testing Group).
For more information or to register for this event, visit Biologic Therapeutic Drug Monitoring: Drug, Anti-drug Antibody Inform Personalized Decisions in Gastroenterology & Rheumatology.
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