Evidence map›Paper›PMID 34878584›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2022

Impact of Antibodies Against Polyethylene Glycol on the Pharmacokinetics of PEGylated Asparaginase in Children with Acute Lymphoblastic Leukaemia: A Population Pharmacokinetic Approach.

Christian Siebel, Claudia Lanvers-Kaminsky, Julia Alten, Petr Smisek, Christa E Nath, Carmelo Rizzari, Joachim Boos, Gudrun Würthwein

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Adverse Impacts of PEGylated Protein Therapeutics: A Targeted Literature Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
  5. 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

8 authors at 5 institutions in 4 countries.

Christian SiebelDepartment of Paediatric Haematology and Oncology, University Children's Hospital Muenster, Albert-Schweitzer-Campus 1, A1, 48149, Muenster, Germany.ORCID http://orcid.org/0000-0003-3518-9483
Claudia Lanvers-KaminskyDepartment of Paediatric Haematology and Oncology, University Children's Hospital Muenster, Albert-Schweitzer-Campus 1, A1, 48149, Muenster, Germany.ORCID http://orcid.org/0000-0002-9764-8035
Julia AltenDepartment of Paediatrics, Christian-Albrechts-University Kiel and University Medical Centre Schleswig-Holstein, Kiel, Germany.
Petr SmisekDepartment of Paediatric Haematology and Oncology, Charles University and University Hospital, Motol, Prague, Czech Republic.ORCID http://orcid.org/0000-0003-3158-7484
Christa E NathBiochemistry Department and Cancer Centre for Children, The Children's Hospital at Westmead, Westmead, NSW, Australia.ORCID http://orcid.org/0000-0002-1013-3646
Carmelo RizzariPaediatric Haematology‑Oncology Unit, Department of Paediatrics, University of Milano-Bicocca, MBBM Foundation, ASST-Monza, Monza, Italy.ORCID http://orcid.org/0000-0002-4828-3893
Joachim BoosDepartment of Paediatric Haematology and Oncology, University Children's Hospital Muenster, Albert-Schweitzer-Campus 1, A1, 48149, Muenster, Germany.ORCID http://orcid.org/0000-0003-2954-2025
Gudrun WürthweinDepartment of Paediatric Haematology and Oncology, University Children's Hospital Muenster, Albert-Schweitzer-Campus 1, A1, 48149, Muenster, Germany. wurthwg@uni-muenster.de.ORCID http://orcid.org/0000-0002-7617-183X
University Hospital Münster · DECharles University · CZChristian-Albrechts-Universität zu Kiel · DEThe University of Sydney · AUUniversity of Milano-Bicocca · IT

Funding

José Carreras Leukämie-Stiftung DJCLSR13/01
6 · The paper itself

Abstract

BACKGROUND AND

objectivesBesides allergic reactions, antibodies against polyethylene glycol (PEG) have been associated with reduced PEG-asparaginase (PEG-ASNase) activity. Population pharmacokinetics (popPK) allow for an in-depth investigation of the influence of anti-PEG antibodies on PEG-ASNase pharmacokinetics.

methodsPEG-ASNase activity (6261 samples) and anti-PEG antibodies (2082/6412 samples prior to/post administration) in 1444 children with acute lymphoblastic leukaemia treated in the AIEOP-BFM ALL 2009 trial were evaluated. Patients received two doses of PEG-ASNase during induction (2500 U/m

resultsHigh pre-existing levels of anti-PEG antibodies increase the initial drug clearance. Analysed separately, both anti-PEG IgG

conclusionPre-existing antibodies against PEG-ASNase significantly increased the initial clearance in a subgroup of patients showing high antibody levels. (Trial registration: EU clinical trials register; EudraCT No: 2007-004270-43; first registered 23 October 2009.).

Indexed as

Antineoplastic AgentsPrecursor Cell Lymphoblastic Leukemia-LymphomaAsparaginaseChildHumansPolyethylene GlycolsAntineoplastic AgentsAsparaginasepegaspargasePolyethylene Glycols

Identifiers

PMID34878584
PMCPMC8917038
OpenAlexW4200014736

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.