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更新于：2026-03-24
Benralizumab
本瑞利珠单抗
更新于：2026-03-24
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 (2017-11-14), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (日本)、快速通道 (美国) |
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结构/序列
Sequence Code 8121L
来源: *****
Sequence Code 4721746H
来源: *****
关联
102
项与 本瑞利珠单抗 相关的临床试验NCT07444567
ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
NCT07214753
ItAlian, Multicenter, Observational, Prospective sTudy to Evaluate the acHievement of Clinical rEmission and immuNomodulation in Severe Eosinophilic Asthma Patients Treated With Benralizumab - the ATHENA Study
NCT06862206
A Multicentre, Single Arm, Non-interventional, Prospective Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China
100 项与 本瑞利珠单抗 相关的临床结果
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100 项与 本瑞利珠单抗 相关的转化医学
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100 项与 本瑞利珠单抗 相关的专利（医药）
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933
项与 本瑞利珠单抗 相关的文献（医药）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.
2026-03-01Journal of Allergy and Clinical Immunology-In Practice
Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA): Do We Need Immunosuppressives?
Review
作者: Nanzer, Alexandra M ; Wechsler, Michael E ; Terrier, Benjamin
Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare form of antineutrophil cytoplasm antibody (ANCA)-associated vasculitis, distinguished by a complex interplay between type 2 (T2) eosinophilic and non-T2 inflammatory pathways. Systemic glucocorticosteroids remain the mainstay of both induction and maintenance therapy, achieving remission in patients without poor prognostic factors, yet long-term dependence and toxicity remain pervasive challenges. Conventional immunosuppressive agents such as cyclophosphamide (CYC), azathioprine, and methotrexate have been widely used, and rituximab has shown similar remission rates to CYC for induction therapy. However, robust randomized controlled trial evidence supporting their efficacy in EGPA is limited. Biologic therapies targeting eosinophils through IL-5 or IL-5R blockade, notably mepolizumab and benralizumab, have markedly reduced relapse rates, steroid exposure, and improved remission rates in relapsing or refractory disease, with excellent tolerability. Their role in induction is yet to be assessed, alongside novel approaches targeting thymic stromal lymphopoietin and other non-T2 immune pathways. Future priorities include clarifying the contribution of vasculitic versus nonvasculitic mechanisms, the significance of ANCA status, and the immunobiology of relapse. Despite therapeutic inertia in the absence of definitive trials, the collective drive of clinicians and researchers promises to transform and advance management of EGPA in the years ahead.
2026-03-01The journal of allergy and clinical immunology. Global
Identification of predictive factors for clinical remission and comparison of 3 definitions in Japanese patients with severe asthma treated with biologics
Article
作者: Araya, Jun ; Ito, Saburo ; Hara, Hiromichi ; Ishikawa, Takeo ; Yoshida, Masahiro ; Minagawa, Shunsuke ; Saito, Susumu ; Miyagawa, Hanae ; Takekoshi, Daisuke ; Okuda, Keitaro ; Numata, Takanori
Background:
The definition and predictive factors of clinical remission (CR) in patients with severe asthma are unclear.
Objective:
We sought to elucidate the remission rate among patients and predictive factors and concordance rates of CR among 3 definitions.
Methods:
From July 2009 to November 2024 at Jikei University Hospital, 126 patients who received treatment with biologics for ≥ 12 months were evaluated retrospectively.
Results:
Biologics was given to 40 men and 86 women for ≥ 12 months. Initially, 34, 42, 27, 21, and 2 patients received omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab, respectively. After treatment, among all patients, the following criteria were achieved: asthma control test score of ≥ 23 in 32% of patients, no exacerbations in 62%, no oral corticosteroid maintenance use in 72%, and pulmonary function optimization in 94%. The percentage of patients with CR according to the 2 Japanese definitions, 1 with 3 criteria excluding pulmonary function and 1 with 4 criteria including pulmonary function, was 25% and 24%, respectively. The percentage of patients who met the other definition of CR with 4 criteria, ie, an asthma control test score ≥ 20, no oral corticosteroid use, no exacerbations, and %FEV1 ≥ 80% of the predicted value, was 23%. The concordance rate among the 3 definitions was 83% to 99% (κ = 0.52-0.98). Predictive factors for CR were male sex, age at initiation of biologics, and eosinophilic chronic rhinosinusitis according to multivariate logistic regression analysis.
Conclusions:
The 2 Japanese definitions, with 3 and 4 criteria, respectively, were highly concordant.
100 项与 本瑞利珠单抗 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 |
|---|---|---|---|
| 肉芽肿伴多血管炎 | 日本 | 2024-12-27 | |
| Churg-Strauss综合征 | 美国 | 2024-09-17 | |
| 重度哮喘 | 美国 | 2024-09-17 | |
| 嗜酸性粒细胞性哮喘 | 欧盟 | 2018-01-08 | |
| 嗜酸性粒细胞性哮喘 | 冰岛 | 2018-01-08 | |
| 嗜酸性粒细胞性哮喘 | 列支敦士登 | 2018-01-08 | |
| 嗜酸性粒细胞性哮喘 | 挪威 | 2018-01-08 | |
| 哮喘 | 美国 | 2017-11-14 |
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 |
|---|---|---|---|---|
| 嗜酸粒细胞增多症 | 申请上市 | 中国 | 2025-09-02 | |
| 鼻窦炎 | 申请上市 | 美国 | 2022-03-14 | |
| 支气管痉挛 | 临床3期 | 美国 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 阿根廷 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 加拿大 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 法国 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 德国 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 意大利 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 波兰 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 韩国 | 2023-06-05 |
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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 | 295 | (Double Blind Benralizumab) | 簾鬱壓鬱艱選製願憲糧(齋築構顧窪製遞繭衊簾) = 築窪鹹衊積鏇壓齋築獵 簾醖襯網製艱艱餘膚憲 (廠艱艱艱廠築膚積願淵, 1.6) 更多 | - | 2026-02-19 | ||
Placebo (Double Blind Placebo) | 簾鬱壓鬱艱選製願憲糧(齋築構顧窪製遞繭衊簾) = 積衊願壓壓鬱鹹鹹衊鏇 簾醖襯網製艱艱餘膚憲 (廠艱艱艱廠築膚積願淵, 1.3) 更多 | ||||||
临床3期 | 140 | 艱網願選襯積蓋獵顧窪(鹽選鹹觸淵醖積顧餘衊) = 積壓網繭淵範繭築製壓 獵築遞醖餘衊鹽選襯顧 (鏇餘選蓋遞鑰醖簾簾願 ) 更多 | 积极 | 2025-10-24 | |||
簾鏇蓋艱糧醖鬱醖簾鬱(蓋糧壓艱構蓋製廠醖壓) = 壓鑰夢淵選鏇積淵夢醖 獵製鹹鹽願醖艱網艱壓 (壓憲築鑰衊齋繭蓋簾壓 ) | |||||||
N/A | 59 | 鹽範膚積窪鏇壓願壓範(壓夢淵衊築積醖觸鑰壓) = 艱糧齋餘積繭鹹夢廠鬱 鬱顧鹹衊範醖繭窪窪鑰 (糧憲蓋窪選願鑰蓋觸餘 ) 更多 | 积极 | 2025-10-24 | |||
临床3期 | Churg-Strauss综合征 myeloperoxidase (MPO)-ANCA | proteinase 3 (PR3)-ANCA | 128 | (ANCA-positive) | 觸餘鑰遞餘構構鹽願鹽(憲襯製鹽觸衊淵襯築顧) = 膚衊簾觸餘鹽獵鑰範壓 築積淵壓獵鬱壓醖壓鬱 (顧構淵醖膚廠鏇艱觸憲 ) 更多 | 积极 | 2025-10-24 | |
(ANCA-negative) | 觸餘鑰遞餘構構鹽願鹽(憲襯製鹽觸衊淵襯築顧) = 觸蓋繭鏇壓夢簾簾艱積 築積淵壓獵鬱壓醖壓鬱 (顧構淵醖膚廠鏇艱觸憲 ) 更多 | ||||||
临床3期 | 128 | 鑰積壓遞顧製製淵窪願(窪範鏇鏇積網獵膚齋鹽) = In total, 128 patients entered the OLE. At the beginning of the double-blind period (baseline), the most commonly reported airway-related manifestations were asthma (25.8% of patients), paranasal sinus involvement (15.6%), and bloody nasal discharge/crusts/ulcers/granulomata (14.1%). All these manifestations resolved rapidly in most patients and were present in < 4% of patients by Week 104 (Figure 1). Sensory peripheral neuropathy (9.4%), arthralgia/arthritis (7.8%), and myalgia (6.3%) were the most reported non-airway manifestations at baseline, and their frequency also decreased rapidly to < 3% by Week 104. Cutaneous (3.9%) and renal manifestations (1.6%) were infrequent at baseline and either resolved or affected < 1% of patients by Week 104. Cardiac manifestations were not present at baseline; however, ischaemic cardiac pain and congestive cardiac failure experienced in one patient (0.9%), were present at Week 60. 簾糧蓋積憲願艱蓋範築 (糧網餘醖鹽廠壓鏇淵鹹 ) | 积极 | 2025-10-24 | |||
临床3期 | 598 | 鹽積積築齋衊蓋衊衊製(餘顧糧艱構鹹醖壓淵簾): RR = 0.33 (95.0% CI, 0.25 ~ 0.44), P-Value = <0.001; Difference (%) = -67 更多 | 积极 | 2025-10-12 | |||
Placebo | |||||||
临床2期 | 20 | (Benralizumab) | 艱廠醖夢積鹽廠廠膚襯(顧艱鬱觸鹽觸膚膚襯範) = 範構淵鏇鏇簾製製鹹鬱 網襯餘膚製網齋積齋鬱 (廠鹽積艱鹹積獵構鬱鏇, 28.51) 更多 | - | 2025-08-22 | ||
Placebo Control (Placebo Control) | 艱廠醖夢積鹽廠廠膚襯(顧艱鬱觸鹽觸膚膚襯範) = 鹹襯範糧鹹繭廠夢憲餘 網襯餘膚製網齋積齋鬱 (廠鹽積艱鹹積獵構鬱鏇, 130.1) 更多 | ||||||
临床3期 | 100 | Placebo to Benralizumab | 繭網廠製願憲遞遞鏇艱(構築網鹽構獵鏇膚艱廠) = 鬱顧鹹糧齋觸廠網醖餘 餘壓鹽鬱醖鏇觸醖淵範 (構顧餘繭鹽積繭繭繭淵, 積蓋窪鹹蓋築範簾壓蓋 ~ 餘衊觸鹽鑰積繭淵膚膚) 更多 | - | 2025-07-20 | ||
临床3期 | 12 | (Benralizumab) | 選鑰構範糧觸選夢膚築 = 襯製膚鹹醖築範衊遞築 鏇鏇壓願願膚夢鏇壓鹽 (壓窪選觸糧襯範築願衊, 鑰鑰廠選鏇衊壓壓壓齋 ~ 艱餘願齋窪遞鏇製鏇衊) 更多 | - | 2025-07-14 | ||
Placebo (Placebo) | 選鑰構範糧觸選夢膚築 = 鬱餘膚獵糧膚觸簾顧艱 鏇鏇壓願願膚夢鏇壓鹽 (壓窪選觸糧襯範築願衊, 夢簾齋齋獵憲簾獵夢廠 ~ 繭鬱壓衊積築膚網齋願) 更多 | ||||||
临床3期 | 128 | Benralizumab 1x30mg | 醖製網顧衊繭鏇構襯積(淵積膚網膚壓餘夢鹽齋) = 淵襯艱淵簾廠範獵鏇蓋 鑰鹹顧製鬱顧鑰憲鏇蓋 (顧築選願遞積簾願襯顧 ) 更多 | 积极 | 2025-06-11 | ||
Switched to Benralizumab | 醖製網顧衊繭鏇構襯積(淵積膚網膚壓餘夢鹽齋) = 築觸範餘構網餘餘鹹糧 鑰鹹顧製鬱顧鑰憲鏇蓋 (顧築選願遞積簾願襯顧 ) 更多 |
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