Brodalumab: Six-Year US Pharmacovigilance Report

Area of Science:

• Immunodermatology
• Pharmacovigilance
• Drug Safety

Background:

• Brodalumab is an interleukin-17 receptor A antagonist for moderate-to-severe plaque psoriasis unresponsive to other systemic therapies.
• The drug carries a boxed warning for suicidal ideation and behavior in the US, necessitating long-term safety assessment.
• This study evaluates six years of real-world clinical practice data to assess brodalumab's long-term safety.

Purpose of the Study:

• To summarize pharmacovigilance data and assess the long-term safety of brodalumab in plaque psoriasis patients.
• To analyze adverse event reporting rates, including major adverse cardiovascular events, serious infections, malignancies, and suicidal behavior.

Main Methods:

• Calculated crude adverse event (AE) reporting rates per 100 patients for common and special interest AEs.
• Estimated brodalumab exposure from prescription dispensing data over a six-year period (August 2017 - August 2023).
• Defined AEs using Medical Dictionary for Regulatory Activities (MedDRA) v26.0 Preferred Terms and standardized queries.

Main Results:

• Data from 5138 US patients (6900 patient-years) revealed 13 major adverse cardiovascular events (0.25/100 patients) and 2.20 serious infections per 100 patients.
• One new case of Candida infection and one serious fungal infection were reported since the 5-year assessment.
• No new suicide attempts were reported in the sixth year, and no completed suicides occurred over the six-year period; 4 of 57 malignancies were possibly related to brodalumab.

Conclusions:

• Six-year pharmacovigilance data align with brodalumab's established clinical trial safety profile.
• The safety profile remains consistent, with no completed suicides and a low rate of fungal infections observed.
• Real-world data support the long-term safety of brodalumab for plaque psoriasis management.