Brodalumab: 4-Year US Pharmacovigilance Report
April 2023 | Volume 22 | Issue 4 | 419 | Copyright © April 2023
Published online March 14, 2023
Mark Lebwohl MDa, John Koo MDb, Craig Leonardi MDc, April Armstrong MD MPHd, Nicole Rawnsley PharmD BSce, Earl Goehring Jrf, Abby Jacobson MS PA-Ce
aIcahn School of Medicine at Mount Sinai, New York, NY
bPsoriasis and Skin Treatment Center, University of California, San Francisco, San Francisco, CA
cCentral Dermatology, St. Louis, MO
dUniversity of Southern California, Los Angeles, CA
eOrtho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ
fBausch Health, Bridgewater, NJ
Abstract
Brodalumab is an interleukin-17 receptor A antagonist approved for the treatment of moderate-to-severe psoriasis in adults without response or with loss of response to other systemic therapies. Brodalumab carries a boxed warning in the United States regarding suicidal ideation and behavior, though no causal relationship has been established. Here, we summarize 4 years of pharmacovigilance data, from August 15, 2017, through August 14, 2021, reported to Ortho Dermatologics by US patients and healthcare providers. The most common AEs listed in the brodalumab package insert (incidence ≥1%) and AEs of special interest are described. Brodalumab exposure estimates were calculated using the time between the first prescription-dispensing authorization date and last prescription-dispensing authorization date. Data were collected from 4019 patients with an estimated brodalumab exposure of 4563 patient-years. The most common AE was arthralgia (115 events; 2.52 events per 100 patient-years). No completed suicides and no new suicidal attempts were reported. There were 102 cases with serious infections; however, no serious fungal infections (including no new cases of oral candidiasis) were reported. There were 26 COVID-19 cases, and 3 of the cases with comorbid conditions were fatal. There were no new cases of Crohn’s disease. Of 37 reported malignancies among 32 cases, none were deemed related to brodalumab. Four-year pharmacovigilance data are consistent with the established safety profile reported in long-term clinical trials and 3-year pharmacovigilance data.
J Drugs Dermatol. 2023;22(4) doi:10.36849/JDD.7344
Citation: Lebwohl M, Koo J, Leonardi C, et al. Brodalumab: 4-Year US pharmacovigilance report.
J Drugs Dermatol. 2023;22(4):419-422. doi:10.36849/JDD.7344
INTRODUCTION
Brodalumab is an interleukin-17 receptor A antagonist indicated for the systemic treatment of moderate-to-severe plaque psoriasis in adult patients who have lost response or failed to respond to other systemic therapies.1 Although the safety profile of brodalumab has been characterized in one phase 2 study, multiple phase 3 studies, and US pharmacovigilance reports for years 1 through 3, a boxed warning is included in the US package insert regarding suicidal ideation and behavior.1-8 In brodalumab clinical trials, screening/exclusion of candidates was not based on a history of suicidal behavior or depression, and no causal relationship between brodalumab and suicidal behavior has been demonstrated.1,9
Because of the chronic nature of psoriasis, it is necessary to assess long-term data regarding adverse events (AEs) in a real-world setting. This report provides an update based on 4-year pharmacovigilance data, building upon the 3-year pharmacovigilance report.4
MATERIALS AND METHODS
This analysis summarizes pharmacovigilance data reported to Ortho Dermatologics by US patients and healthcare providers (HCPs) from August 15, 2017, through August 14, 2021. The most common AEs (with an incidence ≥1%) listed on the brodalumab package insert1 and other AEs of clinical interest are summarized with descriptive statistics and assessed as exposure-adjusted rates per 100 patient-years (PYs).
Brodalumab exposure was calculated as the time from the first prescription-dispensing authorization date to last prescription-dispensing authorization date. Patients with the same initial and last prescription-dispensing authorization date were excluded from the analysis. Detailed patient medical histories, including prior psoriatic medications and time between prior therapy and brodalumab initiation, were not included in pharmacovigilance reports.5
