Literature DB >> 29381220

Prediction of Individual Serum Infliximab Concentrations in Inflammatory Bowel Disease by a Bayesian Dashboard System.

Alexander Eser1, Christian Primas1, Sieglinde Reinisch1, Harald Vogelsang1, Gottfried Novacek1, Diane R Mould2, Walter Reinisch1.   

Abstract

Despite a robust exposure-response relationship of infliximab in inflammatory bowel disease (IBD), attempts to adjust dosing to individually predicted serum concentrations of infliximab (SICs) are lacking. Compared with labor-intensive conventional software for pharmacokinetic (PK) modeling (eg, NONMEM) dashboards are easy-to-use programs incorporating complex Bayesian statistics to determine individual pharmacokinetics. We evaluated various infliximab detection assays and the number of samples needed to precisely forecast individual SICs using a Bayesian dashboard. We assessed long-term infliximab retention in patients being dosed concordantly versus discordantly with Bayesian dashboard recommendations. Three hundred eighty-two serum samples from 117 adult IBD patients on infliximab maintenance therapy were analyzed by 3 commercially available assays. Data from each assay was modeled using NONMEM and a Bayesian dashboard. PK parameter precision and residual variability were assessed. Forecast concentrations from both systems were compared with observed concentrations. Infliximab retention was assessed by prediction for dose intensification via Bayesian dashboard versus real-life practice. Forecast precision of SICs varied between detection assays. At least 3 SICs from a reliable assay are needed for an accurate forecast. The Bayesian dashboard performed similarly to NONMEM to predict SICs. Patients dosed concordantly with Bayesian dashboard recommendations had a significantly longer median drug survival than those dosed discordantly (51.5 versus 4.6 months, P < .0001). The Bayesian dashboard helps to assess the diagnostic performance of infliximab detection assays. Three, not single, SICs provide sufficient information for individualized dose adjustment when incorporated into the Bayesian dashboard. Treatment adjusted to forecasted SICs is associated with longer drug retention of infliximab.
© 2018, The American College of Clinical Pharmacology.

Entities:  

Keywords:  assay; inflammatory bowel disease; infliximab; population pharmacokinetic model; therapeutic drug monitoring

Mesh:

Substances:

Year:  2018        PMID: 29381220     DOI: 10.1002/jcph.1069

Source DB:  PubMed          Journal:  J Clin Pharmacol        ISSN: 0091-2700            Impact factor:   3.126


  7 in total

Review 1.  Dashboards for Therapeutic Monoclonal Antibodies: Learning and Confirming.

Authors:  Diane R Mould; Richard N Upton; Jessica Wojciechowski; Becky L Phan; Stacy Tse; Marla C Dubinsky
Journal:  AAPS J       Date:  2018-06-14       Impact factor: 4.009

2.  Improved Population Pharmacokinetic Model for Predicting Optimized Infliximab Exposure in Pediatric Inflammatory Bowel Disease.

Authors:  Laura E Bauman; Ye Xiong; Tomoyuki Mizuno; Philip Minar; Tsuyoshi Fukuda; Min Dong; Michael J Rosen; Alexander A Vinks
Journal:  Inflamm Bowel Dis       Date:  2020-02-11       Impact factor: 5.325

3.  Using Real-World Data to Guide Ustekinumab Dosing Strategies for Psoriasis: A Prospective Pharmacokinetic-Pharmacodynamic Study.

Authors:  Shan Pan; Teresa Tsakok; Nick Dand; Dagan O Lonsdale; Floris C Loeff; Karien Bloem; Annick de Vries; David Baudry; Michael Duckworth; Satveer Mahil; Angela Pushpa-Rajah; Alice Russell; Ali Alsharqi; Gabrielle Becher; Ruth Murphy; Shyamal Wahie; Andrew Wright; Christopher E M Griffiths; Nick J Reynolds; Jonathan Barker; Richard B Warren; A David Burden; Theo Rispens; Joseph F Standing; Catherine H Smith
Journal:  Clin Transl Sci       Date:  2020-01-29       Impact factor: 4.689

4.  Outcomes and Strategies to Support a Treat-to-target Approach in Inflammatory Bowel Disease: A Systematic Review.

Authors:  Jean-Frédéric Colombel; Geert D'haens; Wan-Ju Lee; Joel Petersson; Remo Panaccione
Journal:  J Crohns Colitis       Date:  2020-02-10       Impact factor: 9.071

5.  Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial).

Authors:  Marla Dubinsky; Adam Cheifetz; Konstantinos Papamichael; Vipul Jairath; Guangyong Zou; Benjamin Cohen; Timothy Ritter; Bruce Sands; Corey Siegel; John Valentine; Michelle Smith; Niels Vande Casteele
Journal:  BMJ Open       Date:  2022-04-01       Impact factor: 2.692

6.  Dashboards in Health Care Settings: Protocol for a Scoping Review.

Authors:  Danielle Helminski; Jacob E Kurlander; Anjana Deep Renji; Jeremy B Sussman; Paul N Pfeiffer; Marisa L Conte; Oliver J Gadabu; Alex N Kokaly; Rebecca Goldberg; Allison Ranusch; Laura J Damschroder; Zach Landis-Lewis
Journal:  JMIR Res Protoc       Date:  2022-03-02

Review 7.  Individualized Dosing of Therapeutic Monoclonal Antibodies-a Changing Treatment Paradigm?

Authors:  Anne S Strik; Yow-Ming C Wang; Laura E Ruff; William Yashar; Bradley T Messmer; Diane R Mould
Journal:  AAPS J       Date:  2018-09-05       Impact factor: 4.009

  7 in total

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