Evidence map›Paper›PMID 40871093›Full record

ReviewPharmaceutics2025

Anti-PEG Antibodies and Their Biological Impact on PEGylated Drugs: Challenges and Strategies for Optimization.

Shujun Fu, Xueran Zhu, Fanghua Huang, Xiaoyan Chen

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Pharmaceutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing 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

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

45 citing papers in PubMed.

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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

4 authors.

Shujun FuCenter for Drug Evaluation, Chinese National Medical Product Administration, Beijing 100076, China.
Xueran ZhuState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
Fanghua HuangCenter for Drug Evaluation, Chinese National Medical Product Administration, Beijing 100076, China.
Xiaoyan ChenState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Polyethylene glycol (PEG) has been widely utilized in optimizing therapeutics due to its excellent biocompatibility and chemical stability. However, multiple dosing of PEGylated drugs may result in toxicity due to PEG accumulation in tissues, leading to the formation of anti-PEG antibodies (APAs), which can accelerate drug clearance, reduce efficacy, and alongside enhanced side effects, such as allergic reactions. Notably, pre-existing APAs have also been detected in individuals with no prior exposure to PEGylated drugs, raising additional clinical concerns. This review summarizes the mechanisms of APA generation, the factors influencing PEG immunogenicity, and the biological consequences of APAs on drug pharmacokinetics, efficacy, and safety. We also discuss current challenges in APA detection and highlight strategies to minimize immunogenic responses, including PEG modification, immunomodulation, and alternative polymers. This review aims to provide a comprehensive reference for the rational design, evaluation, and clinical management of PEGylated drugs.

Indexed as

ABC effectanti-PEG antibodiesbiological effectsimmunogenicitypre-existing anti-PEG antibodies

Identifiers

PMID40871093
PMCPMC12388889

What OpenQuestion holds

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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.