Evidence map›Paper›PMID 27804292›Full record

ArticleAnalytical chemistry2016

Analysis of Pre-existing IgG and IgM Antibodies against Polyethylene Glycol (PEG) in the General Population.

Qi Yang, Timothy M Jacobs, Justin D McCallen, Dominic T Moore, Justin T Huckaby, Jasmine N Edelstein, Samuel K Lai

Open access · greenAbstract read
In one paragraph

Article in Analytical chemistry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 188 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
188citing papers in PubMed, 1 pooled it
12.2field-weighted citation impact, top 1% 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

188 citing papers in PubMed, 1 synthesis or guideline pooled it, 354 citations in OpenAlex.

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  8. New approach methodologies (NAMs) for preclinical and translational evaluation of mRNA-lipid nanoparticle (LNP) therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2026
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128 more citing papers are in PubMed but not listed here.

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

7 authors at 2 institutions in 1 country.

Qi YangDivision of Molecular Pharmaceutics, Eshelman School of Pharmacy; ‡Lineberger Cancer Center, Biostatistics Shared Resource; §UNC/NCSU Joint Department of Biomedical Engineering; ∥Department of Microbiology & Immunology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina 27599, United States.
Timothy M JacobsDivision of Molecular Pharmaceutics, Eshelman School of Pharmacy; ‡Lineberger Cancer Center, Biostatistics Shared Resource; §UNC/NCSU Joint Department of Biomedical Engineering; ∥Department of Microbiology & Immunology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina 27599, United States.
Justin D McCallenDivision of Molecular Pharmaceutics, Eshelman School of Pharmacy; ‡Lineberger Cancer Center, Biostatistics Shared Resource; §UNC/NCSU Joint Department of Biomedical Engineering; ∥Department of Microbiology & Immunology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina 27599, United States.
Dominic T MooreDivision of Molecular Pharmaceutics, Eshelman School of Pharmacy; ‡Lineberger Cancer Center, Biostatistics Shared Resource; §UNC/NCSU Joint Department of Biomedical Engineering; ∥Department of Microbiology & Immunology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina 27599, United States.
Justin T HuckabyDivision of Molecular Pharmaceutics, Eshelman School of Pharmacy; ‡Lineberger Cancer Center, Biostatistics Shared Resource; §UNC/NCSU Joint Department of Biomedical Engineering; ∥Department of Microbiology & Immunology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina 27599, United States.
Jasmine N EdelsteinDivision of Molecular Pharmaceutics, Eshelman School of Pharmacy; ‡Lineberger Cancer Center, Biostatistics Shared Resource; §UNC/NCSU Joint Department of Biomedical Engineering; ∥Department of Microbiology & Immunology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina 27599, United States.
Samuel K LaiDivision of Molecular Pharmaceutics, Eshelman School of Pharmacy; ‡Lineberger Cancer Center, Biostatistics Shared Resource; §UNC/NCSU Joint Department of Biomedical Engineering; ∥Department of Microbiology & Immunology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina 27599, United States.
UNC/NCSU Joint Department of Biomedical Engineering · USUniversity of North Carolina at Chapel Hill · US

Funding

Prevalence and characteristics of anti-PEG antibodies in humansR21EB017938 · NIBIB · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAI, SAMUEL · 2014 to 2015
$413k
NIBIB NIH HHS R21 EB017938
6 · The paper itself

Abstract

Circulating antibodies (Ab) that specifically bind polyethylene glycol (PEG), a biocompatible polymer routinely used in protein and nanoparticle therapeutics, have been associated with reduced efficacy of and/or adverse reactions to therapeutics modified with or containing PEG. Unlike most antidrug antibodies that are induced following initial drug dosing, anti-PEG Ab can be found in treatment-naïve individuals (i.e., individuals who have never undergone treatment with PEGylated drugs but most likely have been exposed to PEG through other means). Unfortunately, the true prevalence, quantitative levels, and Ab isotype of pre-existing anti-PEG Ab remain poorly understood. Here, using rigorously validated competitive ELISAs with engineered chimeric anti-PEG monoclonal Ab standards, we quantified the levels of anti-PEG IgM and different subclasses of anti-PEG IgG (IgG1-4) in both contemporary and historical human samples. We unexpectedly found, with 90% confidence, detectable levels of anti-PEG Ab in ∼72% of the contemporary specimens (18% IgG, 25% IgM, 30% both IgG and IgM). The vast majority of these samples contained low levels of anti-PEG Ab, with only ∼7% and ∼1% of all specimens possessing anti-PEG IgG and IgM in excess of 500 ng/mL, respectively. IgG2 was the predominant anti-PEG IgG subclass. Anti-PEG Ab's were also observed in ∼56% of serum samples collected during 1970-1999 (20% IgG, 19% IgM, and 16% both IgG and IgM), suggesting that the presence of PEG-specific antibodies may be a longstanding phenomenon. Anti-PEG IgG levels demonstrated correlation with patient age, but not with gender or race. The widespread prevalence of pre-existing anti-PEG Ab, coupled with high Ab levels in a subset of the population, underscores the potential importance of screening patients for anti-PEG Ab levels prior to administration of therapeutics containing PEG.

Indexed as

AdultAgedAntigen-Antibody ReactionsEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin GImmunoglobulin MMaleMiddle AgedPolyethylene GlycolsYoung AdultImmunoglobulin GImmunoglobulin MPolyethylene Glycols

Identifiers

PMID27804292
PMCPMC6512330
OpenAlexW2548676616

What OpenQuestion holds

Textmetadata
LicenceTDM
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.