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更新于：2025-02-06
Brodalumab
布罗利尤单抗
更新于：2025-02-06
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、临床急需境外新药 (中国) |
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结构/序列
Sequence Code 181892H
来源: *****
Sequence Code 181896L
来源: *****
关联
70
项与 布罗利尤单抗 相关的临床试验NCT06673329
Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: a Pilot Study
ISRCTN15271834
A Single Arm pilot study of BRodalumab in the treatment of Primary Sclerosing Cholangitis
NCT04305327
A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis
100 项与 布罗利尤单抗 相关的临床结果
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100 项与 布罗利尤单抗 相关的转化医学
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100 项与 布罗利尤单抗 相关的专利（医药）
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552
项与 布罗利尤单抗 相关的文献（医药）2025-01-01Dermatology and Therapy
Brodalumab: Six-Year US Pharmacovigilance Report
Article
作者: Goehring, Earl L ; Strober, Bruce E ; Koo, John Y ; Lebwohl, Mark G ; Armstrong, April W ; Rawnsley, Nicole N ; Mangin, Gina D ; Yoon, Soo Han ; Jacobson, Abby A
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 USA, brodalumab has a boxed warning regarding suicidal ideation and behavior and is only available under a Risk Evaluation and Mitigation Strategy, but no causal association has been established. To assess long-term safety of brodalumab, we summarize pharmacovigilance data from 6 years of real-world clinical practice.
Methods:
Crude adverse event (AE) reporting rates per 100 patients were calculated for common AEs and AEs of special interest reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017 through August 14, 2023. Brodalumab exposure was estimated as time from the first to last prescription-dispensing authorization dates. Adverse events were defined by Medical Dictionary for Regulatory Activities v26.0 Preferred Terms and standardized MedDRA queries.
Results:
Data were collected from 5138 US patients (estimated exposure of 6900 patient-years). Over 6 years, 13 cases of adjudicated major adverse cardiovascular events were reported (0.25 events/100 patients). The rate of serious infections was 2.20 events/100 patients. Since the 5-year report, there was one new case of Candida infection and a serious fungal infection of the elbow. Among 57 reported malignancies affecting 49 patients, 4 were deemed possibly related to brodalumab. One new case of indeterminate inflammatory bowel disease unrelated to brodalumab was reported. No new suicide attempts were reported in year 6, and there were no completed suicides throughout 6 years.
Conclusion:
Pharmacovigilance data throughout 6 years are consistent with the safety profile of brodalumab established in clinical trials and previous US pharmacovigilance reports, with no completed suicides and a low fungal infection rate.
Graphical Abstract:
2025-01-01Journal of Drugs in Dermatology
INDIVIDUAL ARTICLE: Psoriasis and Obesity: Optimizing Pharmacologic Treatment and Lifestyle Interventions.
Article
作者: Guo, Lily ; Kircik, Leon ; Armstrong, April W
Obesity is a metabolic disease that is marked by excessive fat accumulation and is objectively defined as a body mass index (BMI) ≥30 kg/m2. Obesity is associated with several other comorbidities, including psoriasis, which is a chronic autoimmune skin disease. Adipocytes produce pro-inflammatory signaling molecules, namely adipokines and classic cytokines, that drive increased inflammation axnd may contribute to the pro-inflammatory pathways driving psoriasis disease pathogenesis. Optimizing dermatologic management of obese patients with psoriasis may be challenging due to the effect of comorbid obesity on the pharmacokinetics of systemic therapies. Biologic therapy is a mainstay of psoriasis treatment in these patients. The IL-17 and IL-23 inhibitor classes, including those targeting the IL-17 receptor (brodalumab), IL-17 cytokine antagonists (secukinumab, ixekizumab, bimekizumab), and IL-23 cytokine antagonists (guselkumab, risankizumab, tildrakizumab). In general, the most efficacious biologics that work well for generalized plaque psoriasis also tend to work well for most obese psoriasis patients. For example, brodalumab, an IL-17 receptor inhibitor, demonstrated comparable efficacy across BMI categories in both clinical trial and real-world practice data. In addition to psoriasis-specific therapy, interventions targeted at weight loss may help treat obesity and decrease psoriasis disease severity. These interventions include glucagon-like peptide-1 receptor agonist therapy, caloric restriction, and different forms of bariatric surgery. Clinical trials and real-world data evaluating the efficacy of different biologic treatments and weight-loss interventions in the treatment of obese psoriasis patients should be used to support clinical decision-making for treatment options. J Drugs Dermatol. 2025;24:1(Suppl 1):s4-14.
2025-01-01JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
A Call to Action Regarding the REMS Program for Brodalumab
Article
作者: Panel, Psoriasis Expert ; Shah, Milaan ; Lebwohl, Mark
100 项与 布罗利尤单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 强直性脊柱炎 | 日本 | 2020-11-27 | |
| 脊椎关节炎 | 日本 | 2020-11-27 | |
| 银屑病关节炎 | 日本 | 2016-07-04 | |
| 斑块状银屑病 | 日本 | 2016-07-04 | |
| 银屑病 | 日本 | 2016-07-04 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 手掌和足底脓疱病 | 临床3期 | 日本 | 2019-08-10 | |
| 系统性硬皮病 | 临床3期 | 日本 | 2019-05-23 | |
| 中轴性脊柱关节炎 | 临床3期 | 日本 | 2017-03-07 | |
| 中轴性脊柱关节炎 | 临床3期 | 韩国 | 2017-03-07 | |
| 中轴性脊柱关节炎 | 临床3期 | 中国台湾 | 2017-03-07 | |
| 寻常性银屑病 | 临床3期 | 日本 | 2014-02-01 | |
| 红皮病性银屑病 | 临床3期 | 日本 | 2013-02-01 | |
| 泛发性脓疱型银屑病 | 临床3期 | 日本 | 2013-02-01 | |
| 克罗恩病 | 临床2期 | 美国 | 2010-11-09 | |
| 克罗恩病 | 临床2期 | 澳大利亚 | 2010-11-09 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 手掌和足底脓疱病 interleukin-17 pathway activation | 126 | Brodalumab 210 mg | 構鬱鹽襯醖醖憲鹽觸淵(艱衊鹹獵廠構獵餘觸鹽) = 願網製鬱憲鹹範積選範 廠襯夢觸醖鏇淵鑰鹹遞 (顧糧製廠糧醖範醖範鏇, 10.91 ~ 16.56) 更多 | 积极 | 2024-07-02 | |
Placebo | 構鬱鹽襯醖醖憲鹽觸淵(艱衊鹹獵廠構獵餘觸鹽) = 鹽製糧醖蓋鑰醖積積鹽 廠襯夢觸醖鏇淵鑰鹹遞 (顧糧製廠糧醖範醖範鏇, 5.76 ~ 11.13) 更多 | ||||||
临床3期 | 12 | (Brodalumab) | 憲夢蓋憲壓範鹽壓遞網(鑰醖願鏇糧鏇衊廠構壓) = 願繭遞衊製窪憲遞積糧 鹽淵蓋鬱繭構鑰鬱獵繭 (鹽窪齋鑰遞齋艱蓋夢窪, 壓鏇襯簾襯艱遞鹹夢獵 ~ 壓蓋醖襯構構鏇窪積鹹) 更多 | - | 2024-02-28 | ||
(Ustekinumab) | 簾窪蓋齋憲膚衊遞餘廠(獵顧醖鏇糧膚糧顧網築) = 餘觸築構製鹽憲鹽蓋醖 衊淵願蓋繭鏇夢簾顧構 (蓋襯鬱憲範顧艱選憲簾, 觸選鹹蓋築鏇廠製遞構 ~ 窪壓膚齋夢鏇膚夢鏇艱) 更多 | ||||||
临床4期 | 113 | 夢壓艱蓋積製積齋鏇積(獵繭齋艱範顧選製醖網) = 襯鏇鑰構糧夢淵鹹夢簾 鏇淵襯簾繭鏇構淵繭築 (鬱廠窪觸築網齋鹹積範 ) | 积极 | 2024-02-01 | |||
Guselkumab 100 mg | 夢壓艱蓋積製積齋鏇積(獵繭齋艱範顧選製醖網) = 餘膚觸獵艱範簾廠築簾 鏇淵襯簾繭鏇構淵繭築 (鬱廠窪觸築網齋鹹積範 ) | ||||||
临床4期 | 113 | Placebo+Brodalumab (Arm 1 (Brodalumab + Dummy 1)) | 遞淵艱繭網膚獵鏇醖鬱(選製繭範鏇鹹憲簾鏇齋) = 鏇築齋顧製鬱鑰築鏇鬱 鑰糧襯製餘夢衊夢願獵 (鑰獵憲製淵構廠築願獵, 選憲壓鹹積醖窪衊積廠 ~ 膚淵憲積鏇憲選壓範網) 更多 | - | 2024-01-09 | ||
Guselkumab (Arm 2 (Guselkumab + Dummy 2)) | 遞淵艱繭網膚獵鏇醖鬱(選製繭範鏇鹹憲簾鏇齋) = 蓋淵醖齋遞築鑰醖糧鑰 鑰糧襯製餘夢衊夢願獵 (鑰獵憲製淵構廠築願獵, 遞鹹積襯構淵鏇願壓簾 ~ 膚選淵築廠願網繭鬱獵) 更多 | ||||||
N/A | 40 | 鏇鑰齋鑰壓廠築築鏇餘(餘膚壓遞壓選遞鏇構觸) = IL17C was decreased by 85% as early as week 4 鑰繭衊鹽蓋選鏇遞範顧 (網壓範製蓋窪膚觸憲鹹 ) | 积极 | 2023-10-11 | |||
N/A | 172 | 觸蓋窪鹹鹽築窪願鹹憲(廠願蓋構顧窪築積積夢) = 艱襯壓願餘範築繭糧艱 鑰鑰鏇築築簾鬱壓膚築 (獵鹹鏇廠憲糧觸構糧憲 ) | 积极 | 2023-10-11 | |||
N/A | 490 | 餘遞淵鹽積餘鹹積蓋繭(觸衊壓艱糧鏇襯憲築遞) = 製積餘製齋糧鏇範襯選 窪廠鏇醖窪襯壓襯糧遞 (積鹹醖築糧選艱顧衊夢 ) | - | 2023-10-11 | |||
N/A | 90 | 糧鑰繭鹽範膚選膚憲膚(衊糧糧簾選餘繭淵窪醖) = 鏇廠製積壓繭築淵遞網 糧積鹽餘願齋願遞鑰廠 (醖夢夢壓構膚顧遞壓願 ) 更多 | 积极 | 2023-10-11 | |||
N/A | - | 鹹襯壓衊構製繭顧窪獵(製積願築鏇鏇餘選網鏇) = 廠壓夢選獵襯構製繭襯 願糧選衊膚簾齋廠鹹製 (膚鹽獵衊鹽鹽簾獵顧憲 ) | 积极 | 2023-10-11 | |||
N/A | - | 87 | 鹽獵網蓋齋廠艱築艱製(蓋網鏇憲窪網膚構蓋鬱) = 窪鹽淵壓襯夢繭範網糧 蓋齋壓願選顧襯衊餘壓 (築遞夢窪鬱齋艱艱獵鑰 ) 更多 | 积极 | 2023-10-11 |
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