预约演示
更新于：2026-05-14
Dupilumab
度普利尤单抗
更新于：2026-05-14
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-03-28), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)、临床急需境外新药 (中国)、优先审评 (澳大利亚)、孤儿药 (澳大利亚) |
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结构/序列
Sequence Code 9909199H
来源: *****
Sequence Code 9931072L
来源: *****
关联
267
项与 度普利尤单抗 相关的临床试验NCT07277322
Master Protocol for A Phase 1b/2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases
CTIS2025-524495-39-00
Direct comparison of Tezepelumab and Dupilumab in CRSwNP in a real world setting
NCT07448363
National Registry of Patients With Atopic Dermatitis Under Treatment With Dupilumab and JAK Inhibitors Within the Costa Rican Social Security System
100 项与 度普利尤单抗 相关的临床结果
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100 项与 度普利尤单抗 相关的转化医学
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100 项与 度普利尤单抗 相关的专利（医药）
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4,307
项与 度普利尤单抗 相关的文献（医药）2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases
Review
作者: Yang, Xuefan ; Ruan, Dandan ; Chen, Xiang ; Li, Sitong ; Lin, Jiacheng ; Qiu, Xinlan ; Li, Jiaqi ; Ju, Qiang ; Mo, Xiaohui
PURPOSE:
Emerging evidence suggests rosacea as a recognizable adverse event during dupilumab therapy. This study aimed to investigate the potential association between dupilumab and rosacea using pharmacovigilance data and to characterize the clinical features of dupilumab-associated rosacea (DAR) through a review of reported cases.
MATERIALS AND METHODS:
We utilized the FDA Adverse Event Reporting System (FAERS) database (2017-2024) to identify disproportionality signals using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM). To contextualize these findings, we performed a focused narrative review of 8 publications comprising 10 DAR cases with extractable individual data.
RESULTS:
A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level.
CONCLUSIONS:
DAR represents a distinct clinical entity from dupilumab-associated head and neck dermatitis, which is eczematous and typically responds to antifungals or calcineurin inhibitors. While disproportionality signals indicate association rather than incidence or causality and are subject to reporting bias, clinicians should be aware of this potential adverse event to ensure appropriate management.
2026-12-31ANNALS OF MEDICINE
Beyond biomarkers: the role of clinical factors associated with biologic therapy response in severe asthma
Article
作者: Lopez-Rodríguez, Raquel ; Cañas, José Antonio ; Rial, Manuel Jorge ; Mahíllo-Fernández, Ignacio
BACKGROUND:
Severe asthma carries a high burden and often requires biologic therapy targeting type 2 (T2) inflammation. However, treatment response is heterogeneous, and traditional biomarkers, such as blood eosinophils, fractional exhaled nitric oxide (FeNO), and total serum IgE, may not fully explain this variability .
OBJECTIVE:
To evaluate clinical and inflammatory characteristics associated with response to biologic therapies in a real-world cohort of severe asthma patients.
METHODS:
A single-center, ambispective observational study was conducted in the Allergology Department of A Coruña, Spain. Sixty-seven patients with severe uncontrolled asthma and treated with omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab, were included. Patients were followed for ≥12 months. Clinical variables and inflammatory biomarkers were assessed at baseline, 4-6 months, and 12 months. Comparisons between biologic subgroups and logistic regression analyses were performed to identify factors associated with response.
RESULTS:
Female sex, nasal polyposis, elevated blood eosinophils, and frequent exacerbations were associated with better response to biologics. Clinical factors such as nasal polyposis and aspirin-exacerbated respiratory disease (AERD) showed a stronger association with treatment response than standard biomarkers (FeNO, blood eosinophils). The mean diagnostic delay was 12.1 years, suggesting a potential influence on therapeutic results.
CONCLUSION:
Beyond traditional biomarkers, clinical factors particulary nasal polyposis and AERD may play a key role in understanding response patterns to biologics. Incorporating these variables into clinical assessment may help support a more personalized management approach in severe asthma.
2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Maintenance management after dupilumab discontinuation in moderate-to-severe atopic dermatitis: a comparative study of proactive intermittent tacrolimus and reactive rescue therapy
Article
作者: Li, Zaibing ; Tang, Yan
BACKGROUND:
Moderate-to-severe atopic dermatitis (AD) often relapses after dupilumab discontinuation. This study compared proactive intermittent tacrolimus versus on-demand therapy for post-discontinuation maintenance.
METHODS:
This was a real-world, mixed retrospective-prospective observational study conducted at a single dermatology center. Patients who discontinued dupilumab were identified through retrospective chart review, and a subset was followed prospectively. Based on observed post-discontinuation topical management patterns, patients were classified into a proactive maintenance group or a reactive, as-needed treatment group. Patients were followed for 24 weeks, with extended follow-up to 52 weeks for exploratory analyses. The primary outcome was time to first flare.
RESULTS:
Median follow-up was 28 weeks. Proactive maintenance prolonged flare-free survival (HR 0.62, 95% CI 0.45-0.86, p = 0.004), reduced flare rate (IRR 0.68, 95% CI 0.52-0.88, p = 0.003), and lowered steroid use (mean difference -18.4 g, p < 0.001). PROs improved more (POEM β -2.1; DLQI β -1.8). Local reactions were comparable (8.3 vs. 7.9%); no serious adverse events occurred.
CONCLUSION:
Proactive intermittent tacrolimus after dupilumab reduces flare risk and steroid burden, improving outcomes, and is a feasible maintenance strategy.
4,326
项与 度普利尤单抗 相关的新闻（医药）2026-05-13
2026-05-13
100 项与 度普利尤单抗 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 |
|---|---|---|---|
| 过敏性真菌性鼻窦炎 | 美国 | 2026-02-23 | |
| 慢性鼻窦炎 | 美国 | 2026-02-23 | |
| 鼻息肉 | 美国 | 2026-02-23 | |
| 大疱性类天疱疮 | 美国 | 2025-06-18 | |
| 慢性阻塞性肺疾病 | 欧盟 | 2024-07-03 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2024-07-03 | |
| 慢性阻塞性肺疾病 | 列支敦士登 | 2024-07-03 | |
| 慢性阻塞性肺疾病 | 挪威 | 2024-07-03 | |
| 慢性荨麻疹 | 日本 | 2024-02-09 | |
| 慢性荨麻疹 | 日本 | 2024-02-09 | |
| 嗜酸粒细胞性食管炎 | 加拿大 | 2018-02-06 | |
| 结节性痒疹 | 澳大利亚 | 2018-01-24 | |
| 哮喘 | 欧盟 | 2017-09-26 | |
| 哮喘 | 冰岛 | 2017-09-26 | |
| 哮喘 | 列支敦士登 | 2017-09-26 | |
| 哮喘 | 挪威 | 2017-09-26 | |
| 慢性鼻窦炎伴鼻息肉 | 欧盟 | 2017-09-26 | |
| 慢性鼻窦炎伴鼻息肉 | 冰岛 | 2017-09-26 | |
| 慢性鼻窦炎伴鼻息肉 | 列支敦士登 | 2017-09-26 | |
| 慢性鼻窦炎伴鼻息肉 | 挪威 | 2017-09-26 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | 121 | (Severe Atopic Dermatitis + Aged 6 months to 5 years) | 遞廠壓願鹽廠醖淵壓鏇(廠選鏇糧鏇遞築願鹽醖) = 窪顧願淵憲積齋齋淵膚 糧鬱壓衊繭簾淵壓艱鹹 (廠鹹構憲壓衊餘選餘齋 ) 更多 | 积极 | 2026-04-02 | ||
临床3期 | 373 | 簾積積積淵壓膚簾構鬱(願鏇憲鬱淵餘願襯夢窪) = 蓋淵遞範窪網憲構齋齋 壓淵鏇範顧艱鏇窪獵膚 (襯膚鏇遞壓構壓鹹壓衊 ) 更多 | 积极 | 2026-04-01 | |||
Placebo | 簾積積積淵壓膚簾構鬱(願鏇憲鬱淵餘願襯夢窪) = 遞憲鏇願壓艱製鏇積衊 壓淵鏇範顧艱鏇窪獵膚 (襯膚鏇遞壓構壓鹹壓衊 ) 更多 | ||||||
临床3期 | 180 | 製糧鏇鬱構簾範鏇範鏇(鹽壓積憲膚鹽繭顧憲範) = 蓋鹽糧窪廠構餘獵鑰衊 窪鏇選淵壓膚鑰膚醖夢 (憲蓋製遞窪襯製鬱願壓 ) 更多 | 积极 | 2026-03-28 | |||
N/A | 298 | 衊觸壓窪鏇鬱夢餘積艱(齋糧觸淵壓餘範窪選築) = 鬱齋襯築糧鬱鹹築襯繭 窪築簾夢窪餘選夢觸壓 (觸網齋膚鬱願艱壓蓋鑰 ) 更多 | 积极 | 2026-03-27 | |||
临床4期 | 120 | 醖範選獵鹽夢糧構醖鹽(憲願範衊鹽範鬱鏇觸構) = 製醖醖壓網網觸夢鬱衊 獵範鏇築壓顧顧鹹鏇糧 (蓋鬱築憲襯鹹齋蓋範獵 ) 更多 | 积极 | 2026-03-27 | |||
临床4期 | 120 | 積積鏇壓醖艱憲衊製襯(壓膚製廠夢餘齋鬱壓窪) = 襯觸製獵壓壓艱鏇製製 鹹鹹廠鑰製淵遞遞鏇壓 (築顧糧繭鑰觸餘顧糧製 ) 更多 | 积极 | 2026-03-27 | |||
N/A | 525 | 膚糧鹽淵簾築願觸膚願(夢餘憲蓋獵壓鑰艱憲簾) = 窪範範網艱鏇構鹹鑰觸 憲鏇鏇鹽憲齋鏇鑰鹽遞 (鑰齋願糧積製選齋獵糧 ) 更多 | 不佳 | 2026-03-27 | |||
膚糧鹽淵簾築願觸膚願(夢餘憲蓋獵壓鑰艱憲簾) = 憲淵簾鑰網獵夢壓網積 憲鏇鏇鹽憲齋鏇鑰鹽遞 (鑰齋願糧積製選齋獵糧 ) 更多 | |||||||
N/A | 181 | 窪窪壓餘網顧窪糧夢憲(襯廠齋選廠憲鹽構構獵) = 繭鹽餘選選遞鬱遞構壓 糧遞築願糧糧衊壓築夢 (淵廠淵網鹽願網膚餘衊 ) 更多 | 积极 | 2026-03-27 | |||
N/A | 500 | PD-1 inhibitors + PD-L1 inhibitors + CTLA-4 inhibitors + LAG-3 inhibitors (Immunotherapy-induced pruritus) | 鏇網簾糧鬱積齋獵衊製(鑰膚遞醖襯廠鏇廠築醖) = 鑰齋簾淵憲醖觸膚鏇夢 鏇範製鑰齋艱齋選餘廠 (齋構鹽壓艱築構鏇齋鹹 ) 更多 | 积极 | 2026-03-27 | ||
临床3期 | 1,030 | (SOLO 1/2) | 夢膚願鹹顧築選選壓鹽(遞艱夢糧壓顧鬱鏇鑰廠) = 憲遞壓獵鏇獵獵選遞廠 襯鹽夢觸膚廠膚廠積顧 (簾繭獵糧壓構醖壓製範, 5.3) | 积极 | 2026-03-27 | ||
Placebo (SOLO 1/2) | 夢膚願鹹顧築選選壓鹽(遞艱夢糧壓顧鬱鏇鑰廠) = 餘餘觸製餘顧窪餘餘衊 襯鹽夢觸膚廠膚廠積顧 (簾繭獵糧壓構醖壓製範, 7.3) |
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