Brodalumab: Seven-Year US Pharmacovigilance Report.

Abstract

Introduction: Brodalumab, a human interleukin-17 receptor A antagonist, is approved for treating adults with moderate-to-severe plaque psoriasis who qualify for systemic therapy or phototherapy and have experienced treatment failure or loss of response to other systemic treatments. Although brodalumab is distributed in the USA under a Risk Evaluation and Mitigation Strategy that includes a boxed warning regarding suicidal ideation and behavior, a direct causal relationship has not been established. This report examines pharmacovigilance data collected over 7 years of clinical usage to provide an assessment of the long-term safety characteristics of brodalumab.

Methods: This report evaluated adverse events (AEs) submitted to Ortho Dermatologics from US healthcare providers and patients during the period spanning August 15, 2017 to August 14, 2024. We calculated crude AE reporting rates per 100 patients using Medical Dictionary for Regulatory Activities (MedDRA) v27.0 Preferred Terms and standardized MedDRA queries. Treatment duration was determined by measuring the time between initial and latest prescription-dispensing authorization dates.

Results: The study encompassed 5449 US patients, representing approximately 7845 patient-years of exposure across the 7-year reporting period. There were no new adjudicated cases of major adverse cardiovascular events in year 7 (0.24/100 patients for the 7-year reporting period), and serious infection cases occurred at a rate of 2.17/100 patients. Among 64 reported malignancies in 55 patients, 4 were assessed as potentially treatment related. Throughout the 7-year period, no completed suicides were reported, and one suicide attempt occurred in year 3.

Conclusion: The 7-year pharmacovigilance dataset reinforces the safety profile of brodalumab previously established through clinical trials and earlier pharmacovigilance reports, with no completed suicides and a low fungal infection rate.