Evidence map›Paper›PMID 41808830›Full record

ArticleFrontiers in immunology2026

Investigating tralokinumab-related adverse events in treating atopic dermatitis: insights from the FAERS database.

Yueping Jiang, Xinjuan Sun, Yang Li

Abstract read
In one paragraph

Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

3 authors.

Yueping JiangDepartment of Pharmacy, Gaochun Traditional Chinese Medicine Hospital, Nanjing, Jiangsu, China.
Xinjuan SunDepartment of Endocrinology, Air Force Hospital of Eastern Theater Command, Nanjing, Jiangsu, China.
Yang LiDepartment of Pharmacy, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Dupilumab and tralokinumab are FDA-approved biological agents for the treatment of atopic dermatitis (AD). This study analyzed tralokinumab-related adverse events (AEs) reported by healthcare professionals, utilizing data mined from the FDA Adverse Event Reporting System (FAERS). Furthermore, we compared the frequency of reports for common AEs with dupilumab or tralokinumab as the primary suspect, focusing on injection-site reactions, conjunctivitis, and keratitis. Methods: Disproportionality analysis methods, including the reporting odds ratio (ROR), the Medicines and Healthcare products Regulatory Agency (MHRA) comprehensive method, the Bayesian confidence propagation neural network (BCPNN), and the Multi-item gamma Poisson shrinker (MGPS), were employed to quantify tralokinumab-associated AE signals. Then, the occurrence risk of common AEs between dupilumab and tralokinumab was further compared. Results: Among 1,591,367 AE reports, 1,770 identified tralokinumab as the primary suspect. Tralokinumab-related AEs affected 25 System Organ Classes (SOC), with 49 significant disproportionality primary terms (PTs) consistently detected across all four algorithms. Notable potential AEs included eczema herpeticum, generalized exfoliative dermatitis, alopecia, skin exfoliation, and blepharitis. Most tralokinumab-related AEs occurred within the first month of treatment, with a median onset time of 37 days (interquartile range [IQR]: 13-111 days). The reporting proportion of injection site reactions was significantly higher with dupilumab than with tralokinumab (p < 0.001). In contrast, tralokinumab was associated with a substantially higher reporting proportion of conjunctivitis (p = 0.001) and keratitis (p = 0.039). Conclusion: This study identified potential AE signals that could aid clinical monitoring and risk identification for tralokinumab. Additionally, close monitoring is warranted for dupilumab-associated injection site reactions and tralokinumab-associated conjunctivitis and keratitis throughout treatment.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatitis, AtopicDrug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting SystemsConjunctivitisDatabases, FactualHumansKeratitisUnited StatesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddupilumabconjunctivitisdupilumabFAERSinjection site reactionskeratitispharmacovigilancetralokinumab

Identifiers

PMID41808830
PMCPMC12968180

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.