Brodalumab: 4-Year US Pharmacovigilance Report
Journal of Drugs in Dermatology : JDD
|April 7, 2023
Summary
Four-year pharmacovigilance data for brodalumab, an interleukin-17 receptor A antagonist, show a safety profile consistent with clinical trials. Common adverse events included arthralgia, with no completed suicides reported.
Area of Science:
- Dermatology
- Pharmacovigilance
- Immunology
Background:
- Brodalumab is an interleukin-17 receptor A antagonist for moderate-to-severe psoriasis.
- It carries a boxed warning for suicidal ideation and behavior in the US.
- This study analyzes 4-year US pharmacovigilance data (2017-2021) for brodalumab.
Discussion:
- Evaluated 4019 patients with 4563 patient-years of brodalumab exposure.
- Most common adverse event (AE) was arthralgia (2.52 events per 100 patient-years).
- No completed suicides or new suicidal attempts were reported.
Key Insights:
- 102 cases of serious infections were reported; no serious fungal infections occurred.
- 26 COVID-19 cases were reported, with 3 fatalities among patients with comorbidities.
- No new cases of Crohn's disease or malignancies related to brodalumab were observed.
Outlook:
- Four-year safety data align with established profiles from clinical trials and prior pharmacovigilance.
- Continued monitoring is essential for long-term safety assessment of brodalumab.
- Further research may explore specific AE management strategies in psoriasis patients.
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