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Three‐year U.S. pharmacovigilance report of brodalumab
Brodalumab, an interleukin‐17 receptor A antagonist, is approved for treatment of moderate‐to‐severe 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 behavio...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286594/ https://www.ncbi.nlm.nih.gov/pubmed/34418244 http://dx.doi.org/10.1111/dth.15105 |
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author | Lebwohl, Mark Leonardi, Craig Armstrong, April Rawnsley, Nicole Alexander, Binu Goehring, Earl Kerdel, Francisco Jacobson, Abby |
author_facet | Lebwohl, Mark Leonardi, Craig Armstrong, April Rawnsley, Nicole Alexander, Binu Goehring, Earl Kerdel, Francisco Jacobson, Abby |
author_sort | Lebwohl, Mark |
collection | PubMed |
description | Brodalumab, an interleukin‐17 receptor A antagonist, is approved for treatment of moderate‐to‐severe 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‐year 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 years 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‐dispensing authorization dates. Data from 1854 patients were collected, and brodalumab exposure was estimated to be 2736 patient‐years. The most frequent AE was arthralgia (111 events; 0.04 events per patient‐year). 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‐year period, 30 malignancies occurred in 25 patients, none of which were determined to be related to brodalumab. Three‐year pharmacovigilance data are consistent with the safety profile of brodalumab previously reported in long‐term analyses of clinical trials and the 2‐year pharmacovigilance data. |
format | Online Article Text |
id | pubmed-9286594 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92865942022-07-19 Three‐year U.S. pharmacovigilance report of brodalumab Lebwohl, Mark Leonardi, Craig Armstrong, April Rawnsley, Nicole Alexander, Binu Goehring, Earl Kerdel, Francisco Jacobson, Abby Dermatol Ther Original Articles Brodalumab, an interleukin‐17 receptor A antagonist, is approved for treatment of moderate‐to‐severe 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‐year 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 years 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‐dispensing authorization dates. Data from 1854 patients were collected, and brodalumab exposure was estimated to be 2736 patient‐years. The most frequent AE was arthralgia (111 events; 0.04 events per patient‐year). 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‐year period, 30 malignancies occurred in 25 patients, none of which were determined to be related to brodalumab. Three‐year pharmacovigilance data are consistent with the safety profile of brodalumab previously reported in long‐term analyses of clinical trials and the 2‐year pharmacovigilance data. John Wiley & Sons, Inc. 2021-09-05 2021 /pmc/articles/PMC9286594/ /pubmed/34418244 http://dx.doi.org/10.1111/dth.15105 Text en © 2021 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Lebwohl, Mark Leonardi, Craig Armstrong, April Rawnsley, Nicole Alexander, Binu Goehring, Earl Kerdel, Francisco Jacobson, Abby Three‐year U.S. pharmacovigilance report of brodalumab |
title | Three‐year U.S. pharmacovigilance report of brodalumab
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title_full | Three‐year U.S. pharmacovigilance report of brodalumab
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title_fullStr | Three‐year U.S. pharmacovigilance report of brodalumab
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title_full_unstemmed | Three‐year U.S. pharmacovigilance report of brodalumab
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title_short | Three‐year U.S. pharmacovigilance report of brodalumab
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title_sort | three‐year u.s. pharmacovigilance report of brodalumab |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286594/ https://www.ncbi.nlm.nih.gov/pubmed/34418244 http://dx.doi.org/10.1111/dth.15105 |
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