Three-year U.S. pharmacovigilance report of brodalumab.
Three-year U.S. pharmacovigilance report of brodalumab.
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DOI：
10.1111/dth.15105
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发表时间：
2021-11
影响因子：
3.6
通讯作者：
Jacobson, Abby
中科院分区：
文献类型：
--
作者：
Lebwohl, Mark;Leonardi, Craig;Armstrong, April;Rawnsley, Nicole;Alexander, Binu;Goehring, Earl, Jr.;Kerdel, Francisco;Jacobson, Abby
Brodalumab是一种白细胞介素-17受体A拮抗剂，被批准用于治疗对其他全身治疗无反应或无反应的成人中重度斑块状银屑病。在美国，brodalumab有关于自杀意念和行为的黑框警告;然而，在关键试验期间，brodalumab和自杀之间没有因果关系。在2年药物警戒数据中，未报告自杀未遂或自杀未遂。最常见的不良事件（AE）为关节痛。3年药物警戒数据后，目前正在更新brodalumab的安全性特征。在此，我们概述了2017年8月15日至2020年8月14日期间美国患者和医疗保健专业人员向Ortho Dermatologics报告的药物警戒数据。通过计算首次和末次处方分发许可日期之间的时间，获得Brodalumab暴露估计值。收集了1854例患者的数据，估计brodalumab暴露量为2736患者年。最常见的AE为关节痛（111起事件; 0.04起事件/患者年）。1例有抑郁症病史的患者报告了1次自杀未遂事件。没有自杀未遂的报告。报告了81例严重感染，其中无真菌感染。在3年期间，25例患者发生了30例恶性肿瘤，均未确定与brodalumab相关。3年药物警戒数据与先前在临床试验长期分析和2年药物警戒数据中报告的brodalumab安全性特征一致。
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.
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DOI：
10.1111/bjd.19132
发表时间：
2020-12
期刊：
The British journal of dermatology
影响因子：
--
作者：
Papp K;Menter A;Leonardi C;Soung J;Weiss S;Pillai R;Jacobson A
通讯作者：
Jacobson A
影响因子：
158.5
作者：
Lebwohl, M.;Strober, B.;Nirula, A.
通讯作者：
Nirula, A.
影响因子：
--
作者：
Fieldhouse, Keira A;Ukaibe, Samantha;Gooderham, Melinda J
通讯作者：
Gooderham, Melinda J
影响因子：
3.5
作者：
Xu, Guomei;Xia, Meng;Duan, Xingwu
通讯作者：
Duan, Xingwu
影响因子：
13.8
作者：
Lebwohl, Mark G.;Papp, Kim A.;Israel, Robert J.
通讯作者：
Israel, Robert J.