Evidence map›Paper›PMID 37322238›Full record

ArticleEuropean journal of drug metabolism and pharmacokinetics2023

Early At-Home Measurement of Adalimumab Concentrations to Guide Anti-TNF Precision Dosing: A Pilot Study.

Paul A G de Klaver, Ron J Keizer, Rob Ter Heine, Lisa Smits, Paul J Boekema, Inge Kuntzel, Tiny Schaap, Annick de Vries, Karien Bloem, Theo Rispens and 2 more

Open access · greenAbstract read
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In one paragraph

Article in European journal of drug metabolism and pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Retrospective Assessment of an Adalimumab Model-Informed Precision Dosing Support Tool for Use in Pediatric Inflammatory Bowel Disease.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
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

12 authors at 2 institutions in 2 countries.

Paul A G de KlaverDepartment of Clinical Pharmacy and Pharmacology, Máxima Medical Center, 5504 DB, Veldhoven, The Netherlands. p.deklaver@mmc.nl.ORCID http://orcid.org/0000-0002-9711-3946
Ron J KeizerInsightRx Inc, San Francisco, USA.
Rob Ter HeineDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Lisa SmitsDepartment of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands.
Paul J BoekemaDepartment of Gastroenterology, Máxima Medical Center, Veldhoven, The Netherlands.
Inge KuntzelDepartment of Rheumatology, Máxima Medical Center, Eindhoven, The Netherlands.
Tiny SchaapBiologics Laboratory, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
Annick de VriesBiologics Laboratory, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
Karien BloemBiologics Laboratory, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
Theo RispensBiologics Laboratory, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
Frank HoentjenDepartment of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands.
Luc J J DerijksDepartment of Clinical Pharmacy and Pharmacology, Máxima Medical Center, 5504 DB, Veldhoven, The Netherlands.
Radboud University Nijmegen · NLSanquin · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveUnderdosing of adalimumab can result in non-response and poor disease control in patients with rheumatic disease or inflammatory bowel disease. In this pilot study we aimed to predict adalimumab concentrations with population pharmacokinetic model-based Bayesian forecasting early in therapy.

methodsAdalimumab pharmacokinetic models were identified with a literature search. A fit-for-purpose evaluation of the model was performed for rheumatologic and inflammatory bowel disease (IBD) patients with adalimumab peak (first dose) and trough samples (first and seventh dose) obtained by a volumetric absorptive microsampling technique. Steady state adalimumab concentrations were predicted after the first adalimumab administration. Predictive performance was calculated with mean prediction error (MPE) and normalised root mean square error (RMSE).

resultsThirty-six patients (22 rheumatologic and 14 IBD) were analysed in our study. After stratification for absence of anti-adalimumab antibodies, the calculated MPE was -2.6% and normalised RMSE 24.0%. Concordance between predicted and measured adalimumab serum concentrations falling within or outside the therapeutic window was 75%. Three patients (8.3%) developed detectable concentrations of anti-adalimumab antibodies.

conclusionThis prospective study demonstrates that adalimumab concentrations at steady state can be predicted from early samples during the induction phase. CLINICAL

trial registrationThe trial was registered in the Netherlands Trial Register with trial registry number NTR 7692 ( www.trialregister.nl ).

Indexed as

Arthritis, RheumatoidInflammatory Bowel DiseasesAdalimumabBayes TheoremHumansPilot ProjectsProspective StudiesTumor Necrosis Factor InhibitorsAdalimumabTumor Necrosis Factor Inhibitors

Identifiers

PMID37322238
OpenAlexW4380785854

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.