Optimization of infliximab therapy in inflammatory bowel disease using a dashboard approach—an Indian experience

Dave, Mihika B.; Dherai, Alpa J.; Desai, Devendra; Mould, Diane R.; Ashavaid, Tester F.

doi:10.1007/s00228-020-02975-0

Cited by 13 publications

(7 citation statements)

References 34 publications

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“…Dashboards integrate individual clinical and pharmacokinetic data to generate dosing recommendations to achieve prespecified target trough concentrations, via adaptive Bayesian forecasting. [151][152][153] Clinical intuition alone does not accurately predict the need for dose escalation, highlighting the importance of a more robust method of selecting the right dose at the right time for the individual patient. 154 The clinical efficacy of a pharmacokinetic dashboard was shown in the PRECISION trial, in which pharmacokinetic dashboard-driven infliximab dosing was superior to standard dosing in patients with IBD in terms of clinical remission at 1 year.…”

Section: Pharmacokinetic Modelling and Dashboardsmentioning

confidence: 99%

Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives

Papamichael¹,

Afif²,

Drobne³

et al. 2022

The Lancet Gastroenterology & Hepatology

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Section: Pharmacokinetic Modelling and Dashboardsmentioning

confidence: 99%

Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives

Papamichael¹,

Afif²,

Drobne³

et al. 2022

The Lancet Gastroenterology & Hepatology

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“…However, for the application of population pharmacokinetic models, an extensive assessment including internal and external evaluation regarding accuracy, robustness, and predictive performance is crucial [ 64 ]. While different methods have been applied in the respective internal model evaluations, only a fraction of the models has been evaluated with an independent data set [ 34 , 65 , 66 , 67 , 68 ], and a comprehensive external evaluation for predictive model performances has not been conducted yet. External evaluation with an independent data set allows the evaluation of model performance regarding prediction and variability in patients with a clinical background similar to the internal data set and thus evaluates not only the modeling approach itself, but also other study-related factors [ 64 ].…”

Section: Discussionmentioning

confidence: 99%

External Model Performance Evaluation of Twelve Infliximab Population Pharmacokinetic Models in Patients with Inflammatory Bowel Disease

et al. 2021

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Infliximab is approved for treatment of various chronic inflammatory diseases including inflammatory bowel disease (IBD). However, high variability in infliximab trough levels has been associated with diverse response rates. Model-informed precision dosing (MIPD) with population pharmacokinetic models could help to individualize infliximab dosing regimens and improve therapy. The aim of this study was to evaluate the predictive performance of published infliximab population pharmacokinetic models for IBD patients with an external data set. The data set consisted of 105 IBD patients with 336 infliximab concentrations. Literature review identified 12 published models eligible for external evaluation. Model performance was evaluated with goodness-of-fit plots, prediction- and variability-corrected visual predictive checks (pvcVPCs) and quantitative measures. For anti-drug antibody (ADA)-negative patients, model accuracy decreased for predictions > 6 months, while bias did not increase. In general, predictions for patients developing ADA were less accurate for all models investigated. Two models with the highest classification accuracy identified necessary dose escalations (for trough concentrations < 5 µg/mL) in 88% of cases. In summary, population pharmacokinetic modeling can be used to individualize infliximab dosing and thereby help to prevent infliximab trough concentrations dropping below the target trough concentration. However, predictions of infliximab concentrations for patients developing ADA remain challenging.

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“…With the implementation of three trough-level measurements, the model was able to predict drug concentrations and thus be helpful for therapy adjustments [ 54 ]. Precision dosing showed better remission and response rates in adults compared to traditional dosing regimens [ 61 ]. Sufficient models for children in clinical practice have yet to be determined due to the large amount of data needed to test the robustness and identify an appropriate computational model to predict individual drug concentrations.…”

Section: Therapeutic Drug Monitoring To Optimize the Treatment Strate...mentioning

confidence: 99%

Current Role of Monoclonal Antibody Therapy in Pediatric IBD: A Special Focus on Therapeutic Drug Monitoring and Treat-to-Target Strategies

Classen

Hoerning

2023

Children

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In the last two decades, biologicals have become essential in treating children and adolescents with inflammatory bowel disease. TNF-α inhibitors (infliximab, adalimumab and golimumab) are preferentially used. Recent studies suggest that early application of TNF-α inhibitors is beneficial to inducing disease remission and preventing complications such as development of penetrating ulcers and fistulas. However, treatment failure occurs in about one third of pediatric patients. Particularly, children and adolescents differ in drug clearance, emphasizing the importance of pharmacokinetic drug monitoring in the pediatric setting. Here, current data on the choice and effectiveness of biologicals and therapeutic drug monitoring strategies are reviewed.

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Optimization of infliximab therapy in inflammatory bowel disease using a dashboard approach—an Indian experience

Cited by 13 publications

References 34 publications

Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives

Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives

External Model Performance Evaluation of Twelve Infliximab Population Pharmacokinetic Models in Patients with Inflammatory Bowel Disease

Current Role of Monoclonal Antibody Therapy in Pediatric IBD: A Special Focus on Therapeutic Drug Monitoring and Treat-to-Target Strategies

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