ArticleDermatology and therapy2025
Brodalumab: Seven-Year US Pharmacovigilance Report.
Article in Dermatology and therapy, 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
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.
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.
- Prescribing Biologic Immune-Modifying Therapies for Patients with a History of Cancer: A Cross-Specialty Review.Current oncology (Toronto, Ont.) · 2026Review
- The Impact of Biologic Therapy on Quality of Life and Mental Health in Patients with Psoriasis.Journal of clinical medicine · 2026Review
- Interleukin-17 in disease pathogenesis and therapy: recent advances in targeted drug design and medicinal chemistry.Frontiers in pharmacology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionBrodalumab, a human interleukin-17 receptor A antagonist, is approved for treating adults with moderate-to-severe plaque psoriasis who qualify for systemic therapy or phototherapy and have experienced treatment failure or loss of response to other systemic treatments. Although brodalumab is distributed in the USA under a Risk Evaluation and Mitigation Strategy that includes a boxed warning regarding suicidal ideation and behavior, a direct causal relationship has not been established. This report examines pharmacovigilance data collected over 7 years of clinical usage to provide an assessment of the long-term safety characteristics of brodalumab.
methodsThis report evaluated adverse events (AEs) submitted to Ortho Dermatologics from US healthcare providers and patients during the period spanning August 15, 2017 to August 14, 2024. We calculated crude AE reporting rates per 100 patients using Medical Dictionary for Regulatory Activities (MedDRA) v27.0 Preferred Terms and standardized MedDRA queries. Treatment duration was determined by measuring the time between initial and latest prescription-dispensing authorization dates.
resultsThe study encompassed 5449 US patients, representing approximately 7845 patient-years of exposure across the 7-year reporting period. There were no new adjudicated cases of major adverse cardiovascular events in year 7 (0.24/100 patients for the 7-year reporting period), and serious infection cases occurred at a rate of 2.17/100 patients. Among 64 reported malignancies in 55 patients, 4 were assessed as potentially treatment related. Throughout the 7-year period, no completed suicides were reported, and one suicide attempt occurred in year 3.
conclusionThe 7-year pharmacovigilance dataset reinforces the safety profile of brodalumab previously established through clinical trials and earlier pharmacovigilance reports, with no completed suicides and a low fungal infection rate.
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Registered trials
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.