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Related Concept Videos

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF01:24

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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
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Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
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Calculating drug dosage and accumulation in multiple-dose regimens is crucial for achieving therapeutic efficacy while avoiding toxicity. This involves determining the plasma drug concentrations over time to optimize dosing schedules. The principle of superposition is fundamental in this process, allowing for the prediction of drug concentration in plasma following multiple doses based on single-dose data.The principle of superposition asserts that the plasma concentration-time curves from...
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Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
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An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry
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Dashboard-Driven Accelerated Infliximab Induction Dosing Increases Infliximab Durability and Reduces Immunogenicity.

Marla C Dubinsky1, Michelle L Mendiolaza1, Becky L Phan1

  • 1Department of Pediatrics, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Inflammatory Bowel Diseases
|January 3, 2022
PubMed
Summary
This summary is machine-generated.

Optimizing infliximab (IFX) induction dosing using a pharmacokinetic (PK) dashboard improved IFX durability and reduced immunogenicity in inflammatory bowel disease (IBD) patients. Adherence to dashboard forecasts was crucial for sustained treatment effectiveness.

Keywords:
PK dashboardaccelerated dosinginfliximab

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Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • Gastroenterology
  • Immunology

Background:

  • Accelerated infliximab (IFX) induction in inflammatory bowel disease (IBD) often relies on clinical factors, potentially overlooking pharmacokinetic (PK) optimization.
  • This study investigates a novel approach using a PK dashboard for guided induction dosing.

Purpose of the Study:

  • To evaluate the impact of a dashboard-guided optimized induction dosing strategy on IFX durability and immunogenicity in IBD patients.
  • To compare outcomes based on adherence to PK dashboard forecasts.

Main Methods:

  • A prospective, single-arm trial enrolled pediatric and adult IBD patients receiving IFX.
  • Adaptive Bayesian modeling generated forecasts to maintain target IFX trough levels (17 μg/mL at INF3, 10 μg/mL at INF4).
  • Data including IFX levels, antibodies, and clinical parameters informed dosing adjustments.

Main Results:

  • Accelerated dosing (AD) was forecast for 41% (INF3) and 69% (INF4) of patients.
  • Nonadherence to the INF4 forecast predicted higher rates of antidrug antibodies and IFX discontinuation.
  • 119 of 123 patients achieved steroid-free remission at week 52.

Conclusions:

  • A PK dashboard effectively optimizes early IFX induction dosing in IBD.
  • Dashboard-guided dosing enhances IFX durability and reduces immunogenicity.
  • Adherence to PK forecasts is critical for successful IFX therapy.