ArticlePloS one2025
Real-world safety assessment of Ixekizumab based on the FDA Adverse Event Reporting System (FAERS).
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Article
- Case Report: First case of West Nile virus meningoencephalitis in Southwest Michigan in a patient on ixekizumab and prednisone.Frontiers in medicine · 2026Article
- Predictors of Super-Responder Status to Anti-IL-23 Therapies in Moderate-to-Severe Plaque Psoriasis: A Real-World Monocenter Study.Journal of clinical medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIxekizumab, a monoclonal antibody targeting IL-17A, is approved for psoriasis (PsO) and psoriatic arthritis (PsA). While clinical trials demonstrate its efficacy, real-world safety insights remain critical due to limitations in detecting rare or delayed adverse events (AEs).
methodsThis study analyzed 28,889 ixekizumab-associated AE reports from the first quarter of 2016 to the third quarter of 2024 in the FDA Adverse Event Reporting System (FAERS) using disproportionality methods (ROR, PRR, MGPS, BCPNN) and Weibull distribution modeling. Subgroup and sensitivity analyses were conducted to evaluate demographic variations and confounding factors.
resultsCommon AEs included injection site reaction, fungal infections, and upper respiratory infections. Novel signals included myocardial infarction, herpes zoster, and inflammatory bowel disease. Subgroup analyses revealed male-predominant cardiac risks and age-dependent patterns (pediatric injection reactions vs elderly herpes zoster). Median time-to-onset was 56 days (IQR:12-205), with early risk escalation (Weibull β = 0.60).
conclusionsThis FAERS analysis confirms ixekizumab's established safety profile while identifying critical demographic-specific and delayed-onset signals. Continuous pharmacovigilance is warranted to optimize risk management, particularly for cardiovascular monitoring in high-risk males and antiviral prophylaxis in elderly patients.
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