Evidence map›Paper›PMID 40856306›Full record

ArticlePediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology2025

Model-informed exploration of the boundaries of safe aluminium exposure from allergen immunotherapy in children.

Karin Weisser, Gaby Wangorsch, Niklas Hartung, Wilhelm Huisinga, Brigitte Keller-Stanislawski

Erratum issuedAbstract read
In one paragraph

Article in Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

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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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Model-informed exploration of the boundaries of safe aluminium exposure from allergen immunotherapy in children.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Karin WeisserDivision Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Langen, Germany.ORCID https://orcid.org/0000-0003-1272-0446
Gaby WangorschDivision Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Langen, Germany.
Niklas HartungInstitute of Mathematics, University of Potsdam, Potsdam, Germany.
Wilhelm HuisingaInstitute of Mathematics, University of Potsdam, Potsdam, Germany.
Brigitte Keller-StanislawskiPaul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Langen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe safety of aluminium (Al) exposure from medicinal products for subcutaneous allergen immunotherapy (SCIT) is still under debate due to their administration in many doses over years. Especially for children, model-informed risk assessment is urgently needed in the absence of clinical study data.

methodsWe applied a physiologically-based toxicokinetic Al model for simulation of Al exposure from various SCIT scenarios in children (5 and 10 years) compared to adults (35 years) in addition to continuous Al exposure from dietary intake.

resultsSimulations of a worst-case Al exposure scenario (five-year SCIT; four-weekly injections; 1.25 mg Al per dose) in children reveal substantial, but subtoxic and transient increases in bone Al content. Predicted increases of Al levels in the brain appear negligible. In both of these storage organs, Al levels predicted at 50 years of age were only marginally affected by the previous SCIT treatment. Two exceptional SCIT scenarios, prolongation of treatment duration to 40 years and parallel treatment with two 1.25 mg Al-containing products, were associated with elevated bone Al levels above the normal adult range and close to a level where potential harm to bone metabolism cannot be excluded.

conclusionsSimulations support the tolerability of single SCIT treatments in all age groups ≥5 years, also with respect to the long-term Al body burden. The Pharmacopoeial limit of 1.25 mg Al per dose could be seen as a conservative threshold also for the sum of doses from parallel treatments. The decision to prolong therapy with Al-containing SCIT products should be taken under careful consideration of Al accumulation.

Indexed as

AllergensAluminumDesensitization, ImmunologicAdultBone and BonesChildChild, PreschoolComputer SimulationFemaleHumansInjections, SubcutaneousMaleMiddle AgedRisk AssessmentAllergensAluminumadjuvantsallergen immunotherapyaluminiumcomputer simulationimmunologicpatient safetytoxicokinetics

Identifiers

PMID40856306
PMCPMC12379567

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Registered trials

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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.