Evidence map›Paper›PMID 38167019›Full record

ArticlePediatric rheumatology online journal2024

Prospective study to characterize adalimumab exposure in pediatric patients with rheumatic diseases.

Tatjana Welzel, Klervi Golhen, Andrew Atkinson, Verena Gotta, David Ternant, Jasmin B Kuemmerle-Deschner, Christine Michler, Gilbert Koch, Johannes N van den Anker, Marc Pfister and 1 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pediatric rheumatology online journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04042792 (Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
3.2field-weighted citation impact, top 9% 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.

NCT04042792 completednot on this map

Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)

TypeobservationalSponsorUniversity Hospital, Basel, SwitzerlandRan2019 to 2021Enrolled28ConditionsRheumatic DiseasesArmspharmacokinetics (PK) measurement
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

11 authors at 3 institutions in 4 countries.

Tatjana Welzel *Pediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland. tatjana.welzel@ukbb.ch.ORCID http://orcid.org/0000-0003-1800-0327
Klervi Golhen *Pediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
Andrew AtkinsonPediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
Verena GottaPediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
David TernantPediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
Jasmin B Kuemmerle-DeschnerDivision of Pediatric Rheumatology, Department of Pediatrics and Autoinflammation Reference Centre Tuebingen (arcT), University Hospital Tuebingen, Tuebingen, Germany.
Christine MichlerDivision of Pediatric Rheumatology, Department of Pediatrics and Autoinflammation Reference Centre Tuebingen (arcT), University Hospital Tuebingen, Tuebingen, Germany.
Gilbert KochPediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
Johannes N van den AnkerPediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
Marc Pfister *Pediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
Andreas Woerner *Pediatric Rheumatology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
University of Basel · CHUniversité de Tours · FRUniversity Children’s Hospital Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn pediatric rheumatic diseases (PRD), adalimumab is dosed using fixed weight-based bands irrespective of methotrexate co-treatment, disease activity (DA) or other factors that might influence adalimumab pharmacokinetics (PK). In rheumatoid arthritis (RA) adalimumab exposure between 2-8 mg/L is associated with clinical response. PRD data on adalimumab is scarce. Therefore, this study aimed to analyze adalimumab PK and its variability in PRD treated with/without methotrexate.

methodsA two-center prospective study in PRD patients aged 2-18 years treated with adalimumab and methotrexate (G

resultsTwenty-eight patients (14 per group), diagnosed with juvenile idiopathic arthritis (71.4%), non-infectious uveitis (25%) or chronic recurrent multifocal osteomyelitis (3.6%) completed the study. G

conclusionThis study revealed a high heterogeneity in adalimumab exposure in PRD. Adalimumab exposure tended to be higher with methotrexate co-treatment compared to adalimumab monotherapy although differences were not statistically significant. Most children showed adalimumab exposure exceeding those reported for RA with clinical response, particularly with methotrexate co-treatment. This highlights the need of further investigations to establish model-based personalized treatment strategies in PRD to avoid under- and overexposure.

trial registrationNCT04042792 , registered 02.08.2019.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAdalimumabAntibodies, Monoclonal, HumanizedChildDrug Therapy, CombinationFemaleHumansMethotrexateProspective StudiesTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatebDMARDsDrug exposureHeterogeneityPharmacodynamicsPharmacokineticsTarget concentrationTherapeutic drug monitoring

Identifiers

PMID38167019
PMCPMC10763375
OpenAlexW4390495191

What OpenQuestion holds

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Registered trials

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.