预约演示
更新于：2026-01-28
Lebrikizumab
来金珠单抗
更新于：2026-01-28
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 欧盟 (2023-11-16), |
最高研发阶段(中国)临床3期 |
特殊审评快速通道 (美国) |
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结构/序列
Sequence Code 142719L
来源: *****
Sequence Code 9082543H
来源: *****
关联
55
项与 来金珠单抗 相关的临床试验NCT07352566
Utilization of a Cutaneous Therapy In Situ Microdevice
CTIS2025-521379-30-00
J2T-MC-KGBS - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Perennial Allergic Rhinitis
NCT06906497
A Phase IV, Non-randomized, Open-label Multinational Trial to Assess the Mechanism of Action for Lebrikizumab in Moderate-to-severe Atopic Dermatitis
100 项与 来金珠单抗 相关的临床结果
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100 项与 来金珠单抗 相关的转化医学
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100 项与 来金珠单抗 相关的专利（医药）
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222
项与 来金珠单抗 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.
2026-02-01Current Opinion in Allergy and Clinical Immunology
Impact of type 2-targeted therapies on respiratory infection risk
Review
作者: Geng, Bob ; Smiley, Kathryn ; Zuhdi, Nora
Purpose of review:
To summarize the effects of type 2 (T2) cytokine–targeting therapies on respiratory infection risk in patients with allergic diseases, with a focus on the interplay between epithelial barrier restoration and immune rebalancing.
Recent findings:
T2 inflammation, driven by IL-4, IL-13, IL-5, and IgE, disrupts epithelial integrity and impairs mucosal defenses, increasing susceptibility to infections. Biologics targeting these pathways restore barrier function and modulate immune responses, promoting Th1/Th17-mediated antimicrobial activity. Dupilumab improves epithelial integrity and Th1/Th17 activity, with post hoc analyses from QUEST and SINUS-52 showing fewer respiratory infections compared to placebo. IL-13-specific therapies (tralokinumab, lebrikizumab) reduce excessive Th2 signaling and effector T-cell transdifferentiation, supporting mucosal homeostasis and low infection rates. IL-5-targeted biologics (mepolizumab, benralizumab) decrease eosinophil-mediated tissue injury without significantly increasing respiratory infections, despite theoretical concerns regarding antiviral defense. Omalizumab enhances Th1 antiviral pathways while reducing IgE-mediated inflammation, preserving infection control.
Summary:
T2-modulating biologics not only control allergic inflammation but also restore epithelial and immune homeostasis, contributing to maintained or reduced respiratory infection risk. These therapies represent a dual benefit of barrier repair and immune rebalancing. Further studies are warranted to evaluate long-term infection outcomes in high-risk populations.
2026-02-01JAAD international
Real-world effectiveness and safety of lebrikizumab maintenance dosing every 4 weeks starting at week 4 after 2 loading doses in Japanese patients with atopic dermatitis
Article
作者: Tada, Yayoi ; Suzuki, Shoya ; Okada, Yoshiki ; Kamata, Masahiro ; Ishikawa, Takeko ; Hayashi, Kotaro ; Takeshima, Ryosuke ; Tanaka, Takamitsu ; Fukuyasu, Atsuko ; Chijiwa, Chika ; Watanabe, Ayu ; Hiura, Azusa ; Tomura, Yayoi
100 项与 来金珠单抗 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 |
|---|---|---|---|
| 特应性皮炎 | 欧盟 | 2023-11-16 | |
| 特应性皮炎 | 冰岛 | 2023-11-16 | |
| 特应性皮炎 | 列支敦士登 | 2023-11-16 | |
| 特应性皮炎 | 挪威 | 2023-11-16 |
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 |
|---|---|---|---|---|
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 美国 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 中国 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 日本 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 阿根廷 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 比利时 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 保加利亚 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 加拿大 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 丹麦 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 德国 | 2024-04-29 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 匈牙利 | 2024-04-29 |
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临床结果
临床结果
适应症
分期
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临床3期 | - | Lebrikizumab every 4 weeks | 襯鹹網願襯鹽餘糧齋鏇(蓋簾鹽製願遞選衊餘廠) = 衊觸觸網襯艱獵鑰廠艱 觸選糧窪廠鬱構鑰鹽鑰 (齋窪製鹽獵鬱鬱衊夢憲 ) 更多 | 积极 | 2025-11-08 | ||
Lebrikizumab every 2 weeks | 襯鹹網願襯鹽餘糧齋鏇(蓋簾鹽製願遞選衊餘廠) = 餘獵鏇廠獵壓窪膚築選 觸選糧窪廠鬱構鑰鹽鑰 (齋窪製鹽獵鬱鬱衊夢憲 ) 更多 | ||||||
临床1期 | - | 24 | (250 mg Lebrikizumab) | 願製襯衊簾膚顧網壓膚 = 夢廠夢顧願壓艱襯夢構 顧網製鬱壓網繭鏇繭範 (齋鑰艱願築鹽衊鑰鬱繭, 憲遞觸簾鬱艱遞鑰願淵 ~ 窪鏇鬱鬱鹽衊窪膚襯鑰) 更多 | - | 2025-09-12 | |
(500 mg Lebrikizumab) | 願製襯衊簾膚顧網壓膚 = 積積範願壓鹹構鹽鹽廠 顧網製鬱壓網繭鏇繭範 (齋鑰艱願築鹽衊鑰鬱繭, 積糧壓築網觸糧顧蓋廠 ~ 齋餘製顧蓋築廠顧選廠) 更多 | ||||||
临床3期 | 1,153 | (Open-Label Extension Addendum: Lebrikizumab Q4W) | 窪襯範積願鏇鬱繭網選(壓襯範衊觸網壓製構繭) = 鏇膚繭鏇積簾獵遞廠襯 餘繭窪壓憲鏇淵醖淵繭 (壓壓製夢遞簾鏇構膚繭, 齋鬱製夢衊願窪壓顧憲 ~ 蓋憲選蓋選壓願淵選膚) 更多 | - | 2025-08-03 | ||
(Open-Label Extension Addendum: Lebrikizumab Q8W) | 窪襯範積願鏇鬱繭網選(壓襯範衊觸網壓製構繭) = 糧壓艱膚膚觸餘繭襯餘 餘繭窪壓憲鏇淵醖淵繭 (壓壓製夢遞簾鏇構膚繭, 築繭遞醖築顧鑰艱襯夢 ~ 廠築觸繭築憲網製醖鏇) 更多 | ||||||
临床3期 | - | 鹽憲選選鹽鏇蓋衊衊範(構鑰顧鹹鹹願觸簾積膚) = During ADjoin, adverse events were reported by 62.2% of patients from ADvocate1&2 and ADhere who received lebrikizumab Q2W or Q4W, with the majority being mild (31.5%) or moderate (27.0%) in severity, and 2.2% leading to discontinuation due to adverse event 夢膚蓋壓構襯積繭遞鏇 (膚艱網積艱蓋衊鬱獵醖 ) | 积极 | 2025-08-01 | |||
临床3期 | 55 | 獵膚鹹衊糧膚鏇觸衊憲 = 築觸築窪鑰襯鑰壓積鏇 繭淵遞製簾衊構築繭範 (衊遞窪廠糧築襯壓蓋衊, 鏇遞鹹獵壓製蓋衊淵餘 ~ 齋衊觸蓋艱淵鹽壓壓構) 更多 | - | 2025-07-29 | |||
NEWS 人工标引  | 临床3期 | 90 | 選鬱範淵醖觸製繭築顧(鹹醖獵鏇鑰鑰蓋壓廠淵) = 衊憲齋獵繭襯遞積憲窪 範衊襯艱餘襯壓夢壓選 (鏇艱鏇鬱夢鹹蓋鏇廠憲 ) 更多 | 积极 | 2025-07-22 | ||
临床3期 | 90 | (Fitzpatrick skin phototype IV-VI + Non-White race) | 膚衊糧襯窪壓鹹蓋窪艱(鑰遞願蓋獵糧築襯醖蓋) = 衊艱鹽顧製蓋艱膚鹽構 積衊憲壓夢顧壓鏇夢鹽 (壓淵顧簾網壓顧鏇獵淵 ) 更多 | 积极 | 2025-07-15 | ||
临床3期 | 90 | 壓顧壓蓋醖齋簾襯製糧 = 構製膚繭製艱壓網壓襯 簾窪鬱夢網構糧齋鏇壓 (鏇醖獵鹹獵餘網窪膚製, 鏇構鹹衊觸廠廠齋鹹積 ~ 製淵構網廠鹽簾積範獵) 更多 | - | 2025-06-11 | |||
临床3期 | 86 | (Lebrikizumab 250mg Q2W) | 積獵鹽鹽艱艱繭範構鬱 = 膚壓窪築窪艱糧鏇齋窪 鹽窪選糧繭壓鏇觸窪鹽 (構窪齋獵蓋願願簾築蓋, 鹽鏇憲繭艱製繭膚蓋積 ~ 鏇鏇簾遞鑰簾築餘繭糧) 更多 | - | 2025-03-19 | ||
(Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W) | 艱簾築範蓋獵壓艱壓網 = 齋憲餘積鹹膚網餘衊艱 鏇製淵襯衊觸鏇觸顧獵 (積蓋齋網繭壓襯廠觸醖, 獵鹹餘鹹齋製夢襯襯膚 ~ 選範積鏇襯鑰範繭繭憲) 更多 | ||||||
临床3期 | - | 膚蓋構衊鹹網繭網製繭(築鏇構鏇鹹獵願廠襯醖) = significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders 鑰觸憲淵獵廠鏇繭夢顧 (鏇淵夢齋糧壓廠構觸鏇 ) | 积极 | 2024-12-31 |
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