ArticleDermatology and therapy2020
Injection Site Reactions in the Federal Adverse Event Reporting System (FAERS) Post-Marketing Database Vary Among Biologics Approved to Treat Moderate-To-Severe Psoriasis.
Article in Dermatology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
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Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- A Systematic Literature Review of Injection Site Pain Perception in Adult Patients Treated with Citrate-Free and Citrate-Containing Biologic Agents.Current rheumatology reviews · 2023Pooled it
- A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections.Journal of cutaneous medicine and surgeryPooled it
- Outcomes of adalimumab biosimilar nonmedical switches in children and young adults with inflammatory bowel disease.JPGN reports · 2026Article
- Adverse events associated with tirzepatide: a focus on subgroup-specific differences.BMC pharmacology & toxicology · 2026Article
- Drug-associated hypertensive crisis: a disproportionality analysis of the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- FDA-Approved Biologics for CRSwNP: A Five-Year Analysis of the FDA Adverse Event Reporting System.Laryngoscope investigative otolaryngology · 2025Article
- Drug-induced kidney stones: a real-world pharmacovigilance study using the FDA adverse event reporting system database.Frontiers in pharmacology · 2025Article
- Risk analysis of enfortumab vedotin: A real-world approach based on the FAERS database.Heliyon · 2024Article
- Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Assessment of safety profile of secukinumab in real-world scenario using United States food and drug administration adverse event reporting system database.Scientific reports · 2024Article
- Biologics in allergology and clinical immunology: Update on therapies for atopic diseases, urticaria, and angioedema and on safety aspects focusing on hypersensitivity reactions.Allergologie select · 2024Review
- Adverse events in patients with advanced urothelial carcinoma treated with erdafitinib: a retrospective pharmacovigilance study.Frontiers in pharmacology · 2023Article
- Injections Site Reactions and Biologics for Psoriasis: A Questionnaire Based Real Life Study.Clinical, cosmetic and investigational dermatology · 2023Article
- A Review of the Safety of Interleukin-17A Inhibitor Secukinumab.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System.Frontiers in pharmacology · 2022Article
- Biologics for atopic diseases: Indication, side effect management, and new developments.Allergologie select · 2021Review
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionBiologics used to treat moderate-to-severe plaque psoriasis may cause injection site reactions (ISRs) characterized by erythema, edema, itch, and sometimes pain. The Federal Adverse Event Reporting System (FAERS) is a repository of spontaneous post-marketing reports of adverse events (AEs) that are reported to the US Food and Drug Administration (FDA). Our objective was to perform a pharmacovigilance analysis of FAERS reports of ISRs associated with the use of subcutaneously administered biologic products approved to treat moderate-to-severe plaque psoriasis.
methodsThe products included in our assessment were adalimumab, etanercept, ixekizumab, secukinumab, and ustekinumab. Reports from the date of US approval for each biologic as treatment for plaque psoriasis through 2 years were included using the search term "injection site."
resultsThe results show that the FAERS database contained reports of ISRs for all of the included biologics during the 2 years following FDA approval. The most common reports on ISRs were on pain, irritation, and erythema for adalimumab; reaction, pain, and erythema for etanercept; erythema, pain, and reaction for ixekizumab; bruising, pain, hemorrhage for secukinumab; and pain, induration, and swelling for ustekinumab. FAERS does not include data on total patient exposure; therefore, ISR rates could not be calculated.
conclusionsSpecific ISRs varied among the biologic therapies assessed. The findings presented could be helpful when patients consider switching therapies due to ISRs.
fundingEli Lilly and Company.
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