Brodalumab: Seven-Year US Pharmacovigilance Report
Mark G Lebwohl1, John Y Koo2, April W Armstrong3
1Icahn School of Medicine at Mount Sinai, 5 East 98th Street, 5th Floor, New York, NY, 10029, USA. lebwohl@aol.com.
Dermatology and Therapy
|July 29, 2025
Summary
Brodalumab (Kyntheum) safety in plaque psoriasis patients over 7 years shows no completed suicides and low serious infection rates. This long-term pharmacovigilance data supports brodalumab
Area of Science:
- Immunodermatology
- Pharmacovigilance
- Drug Safety
Background:
- Brodalumab, an IL-17RA antagonist, treats moderate-to-severe plaque psoriasis unresponsive to other systemic therapies.
- US distribution includes a Risk Evaluation and Mitigation Strategy with a boxed warning for suicidal ideation/behavior, though causality is not established.
Purpose of the Study:
- To assess the long-term safety profile of brodalumab.
- Evaluate adverse events over 7 years of clinical use.
Main Methods:
- Pharmacovigilance data from US healthcare providers and patients (Aug 2017-Aug 2024).
- Calculated adverse event reporting rates per 100 patients using MedDRA v27.0.
- Determined treatment duration via prescription dispensing data.
Main Results:
- 5449 US patients, ~7845 patient-years of exposure.
- No new major adverse cardiovascular events in year 7; serious infections at 2.17/100 patients.
- 64 malignancies reported (4 potentially treatment-related); 1 suicide attempt, no completed suicides.
Conclusions:
- 7-year pharmacovigilance data reinforce brodalumab's established safety profile.
- No completed suicides and a low rate of fungal infections observed.
- Safety findings align with prior clinical trial and pharmacovigilance reports.
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