Evidence map›Paper›PMID 27739008›Full record

ArticleThe AAPS journal2017

Pharmacokinetic Dashboard-Recommended Dosing Is Different than Standard of Care Dosing in Infliximab-Treated Pediatric IBD Patients.

Marla C Dubinsky, Becky L Phan, Namita Singh, Shervin Rabizadeh, Diane R Mould

Abstract read
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.

  1. A Critique of Pharmacokinetic Calculators for Drug Dosing Individualization.European journal of drug metabolism and pharmacokinetics · 2020
    Pooled it
  2. Trial
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  10. Therapeutic drug monitoring in inflammatory bowel disease: A practical approach.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Review
  11. Review
  12. Article
  13. The Role of Therapeutic Drug Monitoring in Children.Gastroenterology clinics of North America · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Marla C DubinskyDepartment of Pediatrics, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Marla.dubinsky@mssm.edu.
Becky L PhanDepartment of Pediatrics, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Namita SinghDepartment of Pediatrics, Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, California, USA.
Shervin RabizadehDepartment of Pediatrics, Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, California, USA.
Diane R MouldProjections Research Inc., Phoenixville, Pennsylvania, USA.
Cedars-Sinai Medical Center · USIcahn School of Medicine at Mount Sinai · USPhoenixville Hospital · US

Funding

THE ROLE OF GWAS IDENTIFIED VARIANTS AS PREDICTORS OF OUTCOME TO ANTI-TNFa THERAPR21DK084554 · NIDDK · CEDARS-SINAI MEDICAL CENTER · PI DUBINSKY, MARLA C · 2009 to 2010
$840k
NIDDK NIH HHS R21 DK084554
6 · The paper itself

Abstract

Standard of care (SOC; combination of 5-10 mg/kg and an interval every 6-8 weeks) dosing of infliximab (IFX) is associated with significant loss of response. Dashboards using covariates that influence IFX pharmacokinetics (PK) may be a more precise way of optimizing anti-TNF dosing. We tested a prototype dashboard to compare forecasted dosing regimens with actual administered regimens and SOC. Fifty IBD patients completing IFX induction were monitored during maintenance (weeks 14-54). Clinical and laboratory data were collected at each infusion; serum was analyzed for IFX concentrations and anti-drug antibodies (ADA) at weeks 14 and 54 (Prometheus Labs, San Diego). Dosing was blinded to PK data. Dashboard-based assessments were conducted on de-identified clinical, laboratory, and PK data. Bayesian algorithms were used to forecast individualized troughs and determine optimal dosing to maintain target trough concentrations (3 μg/mL). Dashboard forecasted dosing post-week 14 was compared to actual administered dose and frequency and SOC. Using week 14 clinical data only, the dashboard recommended either a dose or an interval change (<0.5 mg/kg or <1 week difference) in 43/50 patients; only 44% recommended to have SOC dosing. When IFX14 concentration and ADA status were added to clinical data, dose and/or interval changes based on actual dosing were recommended in 48/50 (96%) patients; SOC dosing was recommended in only 11/50 (22%). Dashboard recommended SOC IFX dosing in a minority of patients. Dashboards will be an important tool to individualize IFX dosing to improve treatment durability.

Indexed as

Standard of CareAntibodiesChildDose-Response Relationship, DrugDrug Administration ScheduleDrug MonitoringFemaleGastrointestinal AgentsHumansInflammatory Bowel DiseasesInfliximabMalePractice Guidelines as TopicTumor Necrosis Factor-alphaAntibodiesGastrointestinal AgentsInfliximabTumor Necrosis Factor-alphaanti-drug antibodiesdashboardsdecision support toolsinflammatory bowel diseaseinfliximabpersonalized medicinetherapeutic monitoringtrough concentrations

Identifiers

PMID27739008
OpenAlexW2530995556

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.