预约演示
更新于：2025-06-10
Reslizumab
瑞替珠单抗
更新于：2025-06-10
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2016-03-23), |
最高研发阶段(中国)申请上市 |
特殊审评孤儿药 (美国)、孤儿药 (韩国) |
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结构/序列
Sequence Code 199184H
来源: *****
Sequence Code 199204L
来源: *****
关联
29
项与 瑞替珠单抗 相关的临床试验NCT06024707
Early Detection of the Effectiveness of Treatment With Biologicals in Patients With Severe Asthma Using Fluctuation Analysis of Biomarkers
NCT04665141
Similarities and Differences of Biological Therapies for Severe Asthma.
NCT04710134
Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma and Persistent Sputum Eosinophilia Despite Standard Dose Therapy
100 项与 瑞替珠单抗 相关的临床结果
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100 项与 瑞替珠单抗 相关的转化医学
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100 项与 瑞替珠单抗 相关的专利（医药）
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397
项与 瑞替珠单抗 相关的文献（医药）2025-06-01ADVANCES IN THERAPY
Efficacy of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma
Review
作者: Kraft, Monica ; Castro, Mario ; Lindsley, Andrew W ; Panettieri, Reynold A ; Bober, Magdalena ; Ambrose, Christopher S ; Shelkrot, Max
INTRODUCTION:
Patients with moderate or severe, uncontrolled asthma are often prescribed biologic therapies to improve disease control and reduce asthma exacerbations. The efficacy of different biologics in reducing asthma exacerbations associated with hospitalization or an emergency department (ED) visit has varied across randomized controlled trials (RCTs). This study summarizes published US Food and Drug Administration-approved biologic efficacy data for exacerbations that required hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.
METHODS:
A PubMed literature search (24 May 2024) identified phase 2b/3 RCTs of omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tezepelumab. Annualized asthma exacerbation rate (AAER) ratios for exacerbations that required hospitalization or an ED visit, or hospitalization regardless of an ED visit, were extracted. A pooled efficacy estimate of the AAER ratio for exacerbations that required hospitalization or an ED visit across the RCTs was assessed using a meta-analysis based on a random effects model. The percentage of total variation across all included RCTs that was due to heterogeneity was calculated (I2).
RESULTS:
Among 308 articles identified, nine publications describing 10 RCTs reported relevant AAER ratio data. No suitable omalizumab data were identified. In all trials, biologic treatment showed a reduction versus placebo in the AAER for exacerbations that required hospitalization or an ED visit, except in one of two benralizumab studies and both reslizumab studies. The pooled efficacy estimate showed a 56% reduction (95% CI 37-69) in the AAER for exacerbations requiring hospitalization or an ED visit (I2, 59.93%; p = 0.0075). One of three mepolizumab trials and both tezepelumab trials showed a reduction versus placebo in the AAER for exacerbations that required hospitalization regardless of an ED visit.
CONCLUSION:
These findings suggest that there may be differential effects of biologics in reducing exacerbations that require hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.
2025-05-01Journal of Allergy and Clinical Immunology-In Practice
Impact of Smoking on Biological Treatment Response in Patients From the German Severe Asthma (GAN) Registry
Article
作者: Jandl, Margret ; Taube, Christian ; Milger, Katrin ; Biener, Leonie ; Korn, Stephanie ; Schulz, Christian ; Stoshikj, Slagjana ; Hamelmann, Eckard ; Idzko, Marco ; Schmidt, Olaf ; Renner, Andreas ; Brugger, Jonas ; Buhl, Roland ; Skowasch, Dirk ; Krall, Christoph ; Ehmann, Rainer ; Bal, Christina
BACKGROUND:
Clinical studies of biologics in severe asthma exclude smokers or ex-smokers (ExS) with over 10 pack-years (py). Thus, the effectiveness of this therapy in ExS with severe asthma is not well understood.
OBJECTIVES:
To assess the impact of smoking on clinical efficiency of biologics in patients with severe asthma from the German Asthma Net, a comprehensive international registry.
METHODS:
This analysis included 1129 patients (55.8% female, mean age: 53.82 ± 14.67 years), of whom 56% were never-smokers (NS), whereas 44% were ExS (<10 py: 22.9%, 10-20 py: 10.3%, and >20 py: 10.6%). They received benralizumab (38.3%), dupilumab (28.9%), mepolizumab (18.3%), omalizumab (14%), or reslizumab (0.5%).
RESULTS:
Biologic therapy significantly improved asthma control, measured by change in Asthma Control Test, Asthma Control Questionnaire-5, and Mini-Asthma Quality of Life Questionnaire, lung function, reduced exacerbations, and daily oral prednisolone dose in all patients at week 52. Of note, no significant differences in asthma control between NS and ExS at week 52 (P = .48, .09, and .15, respectively) were observed. Also, lung function improvement (forced expiratory volume in 1 second, forced vital capacity, total lung capacity, peak expiratory flow, mean expiratory flow at 50%, P > .05), and reduction in acute exacerbation (P = .8) and oral corticosteroid doses (P = .15) were comparable in NS and ExS. Markers of type 2 inflammation, such as fraction of exhaled nitric oxide and blood eosinophils, decreased in ExS similar to NS (P = .29 and P = .48, respectively).
CONCLUSION:
ExS with severe asthma experienced similar improvements in asthma control, exacerbations, lung function, and biomarkers as NS after 1 year of biologics, suggesting that severe asthmatics even with a substantial smoking history can benefit from biologic therapy.
2025-04-01CHEST
The Role of Bronchial Biopsy in the Prediction of Response to Biologic Therapy in Severe Uncontrolled Asthma
Article
作者: Iglesias, Amanda ; Gómez Bellvert, Cristina ; Toledo-Pons, Nuria ; Valera, Jose Luis ; Cosío, Borja G ; Escribano, Inés ; Shafiek, Hanaa ; Pérez de Llano, Luis ; Mosteiro, Mar
BACKGROUND:
Up to two-thirds of patients with severe uncontrolled asthma (SUA) who received biologic therapy do not have a complete response.
RESEARCH QUESTION:
Can bronchial biopsy (BB) play a role in the identification of patients with SUA who have a better response to biologic therapy?
STUDY DESIGN AND METHODS:
This prospective multicenter study included consecutive patients with SUA who were candidates for biologic therapy. They underwent bronchoscopy and BB prior to biologic therapy, and clinical response was evaluated 6 months later. BB was evaluated according to a previously validated pathological score (PS) and was compared with a score of type 2 (T2) inflammation (T2 score) that includes blood eosinophil count and fractional exhaled nitric oxide in predicting response to biologic therapy. Response was graded as super-response, good response, and partial/no response according to a composite score that includes exacerbations, oral corticosteroid steroid (OCS) use, asthma control test, and improvement in FEV1.
RESULTS:
A total of 92 patients were recruited. Of the 92 patients recruited, 78 completed the study. Among them, 63 received an anti-IL-5 or IL-5 receptor (anti-IL5/5R) (mepolizumab, reslizumab, and benralizumab) while 15 received dupilumab. The proportion of super-responders was 36.5% in the anti-IL5/5R group and 26.6% in the dupilumab group (P = .126). The PS was the only variable independently associated with response; the T2 score was not. Super-responders had a statistically significantly higher PS. Response was better predicted by the PS compared with the T2 score in those receiving OCSs and especially in those taking anti-IL5/5Rs. Reduced eosinophil levels (< 10 eosinophils/field) were associated with poor response to biologic therapy.
INTERPRETATION:
Our findings indicate that BB is more precise in the prediction of response to biologic therapy than the T2 score, especially in those requiring OCSs or receiving anti-IL5/5Rs. Tissue eosinophilia is the main driver of this predictive capacity. However, other items in the PS related to bronchial remodeling might contribute to the identification of response to biologic therapy.
100 项与 瑞替珠单抗 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 |
|---|---|---|---|
| 肺嗜酸性粒细胞增多 | 欧盟 | 2016-08-15 | |
| 肺嗜酸性粒细胞增多 | 冰岛 | 2016-08-15 | |
| 肺嗜酸性粒细胞增多 | 列支敦士登 | 2016-08-15 | |
| 肺嗜酸性粒细胞增多 | 挪威 | 2016-08-15 | |
| 嗜酸性粒细胞性哮喘 | 加拿大 | 2016-07-20 | |
| 哮喘 | 美国 | 2016-03-23 |
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 |
|---|---|---|---|---|
| 支气管炎 | 临床3期 | 加拿大 | 2015-10-01 | |
| 严重持续性哮喘 | 临床3期 | 加拿大 | 2015-10-01 | |
| 嗜酸粒细胞性食管炎 | 临床3期 | 美国 | 2008-07-01 | |
| 嗜酸粒细胞性食管炎 | 临床3期 | 加拿大 | 2008-07-01 | |
| Churg-Strauss综合征 | 临床2期 | 美国 | 2017-09-12 | |
| 重度哮喘 | 临床2期 | 西班牙 | 2017-04-20 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 肺嗜酸性粒细胞增多 interleukin-5 (IL-5) | 24 | 膚簾積鬱選選餘醖觸廠(夢鹽憲餘觸鏇襯蓋顧衊) = 襯觸築窪襯鏇艱壓積構 衊鏇積範膚網選廠範廠 (積鏇糧範製蓋襯淵簾醖 ) | 积极 | 2022-09-04 | ||
N/A | - | 鹹廠艱壓餘艱範蓋積壓(願壓憲夢糧構構糧醖衊) = 獵窪積選獵築築網鏇鹹 窪襯鑰壓鑰襯齋艱夢鏇 (獵鏇餘憲蓋鹽網鹽壓糧 ) | 积极 | 2022-09-04 | |||
鹹廠艱壓餘艱範蓋積壓(願壓憲夢糧構構糧醖衊) = 鑰蓋製願鏇衊築壓範鹹 窪襯鑰壓鑰襯齋艱夢鏇 (獵鏇餘憲蓋鹽網鹽壓糧 ) | |||||||
临床2期 | 10 | 夢齋衊憲鏇構壓醖鑰壓(齋淵壓鬱範範壓鬱鏇鏇) = 網糧積齋襯窪鏇艱構鬱 遞膚夢窪願鑰糧製選觸 (顧網鑰蓋簾衊鏇積範製 ) | 积极 | 2021-06-01 | |||
临床3期 | 177 | 繭壓艱願艱觸獵選選顧(製艱餘鏇夢獵遞糧製壓): OR = 1.23 (95% CI, 0.70 ~ 2.16), P-Value = 0.47 | 不佳 | 2020-05-01 | |||
Placebo | |||||||
N/A | 9 | 壓夢壓醖觸餘夢獵膚獵(齋積膚壓獵鹽淵鏇憲憲) = 築夢憲構糧鑰憲鏇範餘 餘醖廠襯壓衊鹹簾襯網 (繭齋壓構憲築選窪醖製, 9.1) | - | 2019-09-28 | |||
N/A | 477 | 齋鑰夢簾願艱構鹹網範(鑰製鑰壓鏇積構網觸襯) = 鹹齋餘廠鹽願鏇憲構糧 淵廠醖選範壓憲選積鹽 (鏇獵獵蓋積窪構艱網齋 ) 更多 | - | 2019-09-28 | |||
Placebo | 鏇壓餘積鏇壓鹹艱餘鏇(範夢憲鬱蓋願鹹糧壓衊) = 觸繭襯齋糧鑰選糧網製 網齋顧獵遞窪製構鏇襯 (顧選鏇餘顧願夢顧膚顧 ) | ||||||
临床3期 | 391 | 築淵繭膚鹹淵選鑰顧鹽(淵膚網蓋簾鬱遞醖窪糧) = 廠鑰淵憲淵觸醖鏇蓋壓 製艱築鬱簾餘襯齋觸簾 (壓廠選齋網餘廠窪鬱獵, 餘壓觸觸蓋獵餘獵醖範 ~ 膚製蓋廠夢鬱憲齋觸廠) 更多 | - | 2019-03-21 | |||
临床3期 | 468 | Placebo | 糧膚鹽遞衊醖選網獵選(蓋積遞衊壓簾蓋繭窪築) = 遞餘夢膚範願蓋夢齋製 顧鑰衊壓窪製構鹹選築 (鏇廠糧襯醖糧憲糧蓋獵, 廠壓願餘窪襯醖觸繭積 ~ 繭壓壓顧製鏇願夢築鹹) 更多 | - | 2019-02-06 | ||
临床3期 | 953 | 壓醖膚齋鬱獵齋鬱鹽繭(製範願窪糧鹽齋築顧鬱) = 鹹夢獵簾醖壓繭築選壓 醖遞蓋淵衊衊鹽簾淵醖 (築簾窪網鹹壓積範衊觸 ) | - | 2019-02-01 | |||
Placebo | 壓醖膚齋鬱獵齋鬱鹽繭(製範願窪糧鹽齋築顧鬱) = 鹹鑰鹹繭鹽衊繭餘襯繭 醖遞蓋淵衊衊鹽簾淵醖 (築簾窪網鹹壓積範衊觸 ) | ||||||
临床3期 | 家族性嗜酸性粒细胞增多症 blood Eosinophil (EOS) | 477 | 範淵觸製醖憲壓鑰繭艱(遞夢鏇願繭蓋襯夢壓衊) = Clinicians should be aware of some patients (<1%) with delayed EOS suppression, and might consider re-measuring blood EOS levels in apparent reslizumab non-responders 糧襯製齋餘築觸膚糧製 (襯鏇淵製襯襯醖鹹襯夢 ) | 不佳 | 2019-02-01 |
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