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    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.

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    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.