Two-Year US Pharmacovigilance Report on Brodalumab
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ORIGINAL RESEARCH
Two-Year US Pharmacovigilance Report on Brodalumab Mark Lebwohl . Craig Leonardi . Jashin J. Wu . April Armstrong . Nicole Rawnsley . Mohammed Merchant . Binu Alexander . Abby Jacobson
Received: October 27, 2020 / Accepted: November 26, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the United States, brodalumab carries a boxed warning about suicidal ideation and behavior; however, no causal association was established between brodalumab and suicides reported during pivotal trials. We have previously
M. Lebwohl (&) Icahn School of Medicine at Mount Sinai, New York, NY, USA e-mail: [email protected] C. Leonardi Saint Louis University School of Medicine, St. Louis, MO, USA J. J. Wu Dermatology Research and Education Foundation, Irvine, CA, USA A. Armstrong University of Southern California, Los Angeles, CA, USA N. Rawnsley A. Jacobson Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ, USA M. Merchant B. Alexander Bausch Health, Bridgewater, NJ, USA
reported results from an analysis of 1-year pharmacovigilance data in patients in the United States who took brodalumab, in which the most commonly reported adverse event was psoriasis flare. There were no completed suicides, suicide attempts, or serious fungal infections. Here, we provide a 2-year US pharmacovigilance report. Methods: This analysis summarizes pharmacovigilance data reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017, through August 14, 2019. The most common adverse events listed in the brodalumab package insert (incidence C 1%; arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection-site reactions, influenza, neutropenia, and tinea infections) and adverse events of special interest are reported. Results: Data were collected from 2677 patients in the United States who took brodalumab, with an estimated exposure of 1656 patient-years. Arthralgia was the most commonly reported adverse event (73 events; 0.04 events per patient-year). No suicide attempts or completed suicides were reported; there were 25 reports of depression. There were 46 serious infections and no serious fungal infections. One event of Crohn’s disease was reported, which led to discontinuation. There were 13 malignancies, with none deemed related to brodalumab. Conclusions: This pharmacovigilance report supports the safety profile of brodalumab previously reported from long-term analyses of clinical trials and 1-year pharmacovigilance data.
Dermatol Ther (Heidelb)
Keywords: Adverse events; Brodalumab; Pharmacovigilance; Psoriasis; Real-world data; Safety; Suicidal ideation and behavior Key Summary Points Why carry out this study? Adult patients with moderate-to-severe plaque psoriasis who
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