Brodalumab: 5-Year US Pharmacovigilance Report
Mark G Lebwohl1, John Y Koo2, April W Armstrong3
1Icahn School of Medicine at Mount Sinai, 5 East 98 Street, 5 Floor, New York, NY, 10029, USA. lebwohl@aol.com.
Dermatology and Therapy
|May 9, 2024
Summary
Five years of brodalumab pharmacovigilance data show a consistent safety profile for plaque psoriasis treatment. No new safety concerns emerged, including cardiovascular events, serious infections, or suicidal behavior.
Area of Science:
- Dermatology
- Pharmacovigilance
- Immunology
Background:
- Brodalumab is an interleukin-17 receptor A antagonist for moderate-to-severe plaque psoriasis.
- US prescribing information includes a boxed warning for suicidal ideation and behavior, though causality is not established.
- This study analyzes 5 years of US pharmacovigilance data for brodalumab.
Purpose of the Study:
- To summarize 5 years of brodalumab pharmacovigilance data in the US.
- To assess the safety profile of brodalumab, focusing on adverse events and special interests.
- To identify any new safety signals associated with brodalumab treatment.
Main Methods:
- Data collected from US patients and healthcare providers from August 2017 to August 2022.
- Analysis of common adverse events (≥1% incidence) and adverse events of special interest.
- Brodalumab exposure estimated from prescription data (4744 patients, 5815 patient-years).
Main Results:
- 11 major adverse cardiovascular events reported (0.23/100 patients), lower than a comparative registry.
- 106 serious infections, no serious fungal infections; 42 COVID-19 cases with no new deaths.
- 49 malignancies reported (42 patients), 3 possibly related to brodalumab; no completed suicides or new attempts.
Conclusions:
- Five-year pharmacovigilance data align with established safety profiles from clinical trials.
- No new safety signals were identified in the analyzed patient population.
- Brodalumab demonstrates a consistent safety profile in real-world use for plaque psoriasis.
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