ArticleFrontiers in pharmacology2024
Assessing the real-world safety of tralokinumab for atopic dermatitis: insights from a comprehensive analysis of FAERS data.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
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Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.Scientific reports · 2025Pooled it
- Real-world analysis of depression-related adverse events associated with the adsorbed anthrax vaccine: integrating pharmacovigilance signals, machine learning risk prediction, and transcriptomic mechanisms.Infectious diseases of poverty · 2026Article
- Dupilumab versus tralokinumab in atopic dermatitis: A propensity score adjusted comparison from BioDay.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Article
- Post-market safety profile and suicide risk signals of vortioxetine: a real-world pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Drug-associated postpartum hemorrhage: a comprehensive disproportionality analysis based on the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Beyond adrenal suppression: a comprehensive post-marketing safety profile of etomidate from real world data.Frontiers in medicine · 2026Article
- Long-term safety evaluation of mirtazapine: A real-world pharmacovigilance study based on the FAERS database.PloS one · 2026Article
- Safety assessment of ustekinumab in inflammatory bowel disease: a real-world analysis based on the FDA adverse event reporting system (FAERS).European journal of medical research · 2025Article
- Real-world safety profile of etelcalcetide in dialysis-related secondary hyperparathyroidism: a pharmacovigilance analysis of FAERS data.Renal failure · 2025Article
- Real-world safety of deucravacitinib: insights from the Food and Drug Administration Adverse Event Reporting System.International journal of clinical pharmacy · 2025Article
- Adverse events associated with Lutetium-177-PSMA-617 (PluvictoBMC cancer · 2025Article
- A pharmacovigilance study of vortioxetine based on data from the FDA adverse event reporting system.Scientific reports · 2025Article
- A real-world pharmacovigilance study of Certolizumab pegol based on FAERS database.Scientific reports · 2025Article
- Real-world safety of ixekizumab: a disproportionality analysis using the FDA adverse event reporting system and the VigiAccess databases.Frontiers in medicine · 2025Article
- Cyclobenzaprine-related adverse events: a comprehensive pharmacovigilance analysis using the FDA Adverse Event Reporting System.Frontiers in medicine · 2025Article
- Eczema: etiology, subtypes, therapeutic approaches and socioeconomic impact.Frontiers in allergy · 2025Review
- Adverse events associated with vismodegib: insights from a real-world pharmacovigilance study using the FAERS database.Frontiers in pharmacology · 2025Article
- Real-world safety profile of sonidegib: a disproportionality analysis based on the FDA adverse event reporting system.Frontiers in oncology · 2025Article
- Adverse drug events associated with insulin glargine: a real-world pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Tralokinumab, a humanized monoclonal antibody targeting interleukin-13, has been primarily used for the treatment of moderate-to-severe atopic dermatitis. Given its extensive use in clinical practice, understanding its safety profile in the real-world setting is crucial. Methods: This study utilized disproportionality analysis to evaluate the safety of tralokinumab in clinical practice by analyzing all adverse event reports since 2021 in the FDA Adverse Event Reporting System database that identified tralokinumab as the primary suspected drug. Reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network were used for disproportionality analyses of adverse events related to tralokinumab. Additionally, the Weibull distribution was employed to model the risk of adverse events over time. Results: Adverse reactions documented on the drug label, such as injection site reactions, conjunctivitis, and upper respiratory infections, displayed positive signals. Additionally, potential adverse reactions not mentioned on the label were also identified, including dizziness, headache, nausea, vomiting, hair loss, and acne. The importance of adverse event monitoring, particularly in the first month after treatment initiation, was emphasized. Conclusion: This study has provided preliminary safety data on the real-world application of tralokinumab, confirming some known adverse reactions and revealing additional potential risks. The findings offer critical safety information for clinicians prescribing tralokinumab to treat atopic dermatitis.
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Registered trials
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