{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,15]],"date-time":"2026-02-15T21:01:00Z","timestamp":1771189260699,"version":"3.50.1"},"reference-count":13,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,9,5]],"date-time":"2021-09-05T00:00:00Z","timestamp":1630800000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Dermatologic Therapy"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Brodalumab, an interleukin\u201017 receptor A antagonist, is approved for treatment of moderate\u2010to\u2010severe plaque psoriasis in adults without response or with loss of response to other systemic therapies. In the United States, there is a boxed warning for brodalumab regarding suicidal ideation and behavior; however, no causal relationship between brodalumab and suicidality was established during pivotal trials. In the 2\u2010year pharmacovigilance data, no completed suicides or suicide attempts were reported. The most frequent adverse event (AE) was arthralgia. The safety profile of brodalumab is now being updated after 3\u2009years of pharmacovigilance data. Here, we outline pharmacovigilance data reported to Ortho Dermatologics by patients and healthcare professionals in the United States from August 15, 2017, to August 14, 2020. Brodalumab exposure estimates were obtained by calculating the time between first and last prescription\u2010dispensing authorization dates. Data from 1854 patients were collected, and brodalumab exposure was estimated to be 2736 patient\u2010years. The most frequent AE was arthralgia (111 events; 0.04 events per patient\u2010year). One episode of suicide attempt was reported in a patient with a history of depression. No completed suicides were reported. There were 81 serious infections reported, none of which were fungal. Over the 3\u2010year period, 30 malignancies occurred in 25 patients, none of which were determined to be related to brodalumab. Three\u2010year pharmacovigilance data are consistent with the safety profile of brodalumab previously reported in long\u2010term analyses of clinical trials and the 2\u2010year pharmacovigilance data.<\/jats:p>","DOI":"10.1111\/dth.15105","type":"journal-article","created":{"date-parts":[[2021,8,21]],"date-time":"2021-08-21T20:39:50Z","timestamp":1629578390000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Three\u2010year U.S. pharmacovigilance report of <scp>brodalumab<\/scp>"],"prefix":"10.1155","volume":"34","author":[{"given":"Mark","family":"Lebwohl","sequence":"first","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Craig","family":"Leonardi","sequence":"additional","affiliation":[{"name":"Saint Louis University School of Medicine  St Louis Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"April","family":"Armstrong","sequence":"additional","affiliation":[{"name":"University of Southern California  Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicole","family":"Rawnsley","sequence":"additional","affiliation":[{"name":"Ortho Dermatologics (A Division of Bausch Health US, LLC)  Bridgewater New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Binu","family":"Alexander","sequence":"additional","affiliation":[{"name":"Bausch Health  Bridgewater New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Jr","given":"Earl","family":"Goehring","sequence":"additional","affiliation":[{"name":"Bausch Health  Bridgewater New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco","family":"Kerdel","sequence":"additional","affiliation":[{"name":"Florida Academic Dermatology Center  Coral Gables Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abby","family":"Jacobson","sequence":"additional","affiliation":[{"name":"Ortho Dermatologics (A Division of Bausch Health US, LLC)  Bridgewater New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,9,5]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"Siliq [package insert]. 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