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更新于：2025-11-06
Reslizumab
瑞替珠单抗
更新于：2025-11-06
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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389
项与 瑞替珠单抗 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Cost-effectiveness of mepolizumab vs anti-interleukin-5/5r biologic therapies for the treatment of adults with severe asthma with an eosinophilic phenotype: a Chilean healthcare system perspective
Article
作者: Romero, Jose ; Giovini, Vanina ; Espinoza, Manuel Antonio ; Balmaceda, Carlos ; Moraes dos Santos, Felipe ; Rodríguez Martínez, Consuelo
AIM:
Asthma is a heterogeneous respiratory condition often classified into distinct phenotypes. Severe asthma, characterized by uncontrolled symptoms despite optimal treatment, imposes a significant burden on healthcare systems, particularly in low- and middle-income countries. This study evaluates the cost-effectiveness of mepolizumab compared with other interleukin (IL)-5 pathway inhibitors, benralizumab and reslizumab, in treating severe asthma with an eosinophilic phenotype in Chile.
MATERIALS AND METHODS:
A Markov cohort model was developed to compare mepolizumab (100 mg subcutaneously every four weeks) with benralizumab (30 mg subcutaneously every four weeks for the first three doses, every eight weeks subsequently) and reslizumab (3 mg/kg intravenously every four weeks), both as add-on therapies to standard care. Data from the Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) clinical trial and a network meta-analysis were used. Utility values were extracted using the EuroQoL 5-Dimension questionnaire (EQ-5D-5L) questionnaire. Probabilistic and one-way sensitivity analyses assessed model robustness.
RESULTS:
Mepolizumab demonstrated dominance with probability over 95% when compared with benralizumab and reslizumab. Cost savings ranged from 37,000 United States dollars (USD) to 104,000 USD, with an increase of 0.52 to 0.55 quality-adjusted life years. Mepolizumab was also associated with a lower incidence of exacerbations and asthma-related deaths. Sensitivity analyses confirmed the stability of the model outcomes across key parameters.
LIMITATIONS:
Limitations of the economic model are related to the lack of direct comparisons between mepolizumab and other biologics. Additionally, the absence of data on continuation criteria required estimating relative risks for the overall population.
CONCLUSIONS:
Mepolizumab offers greater efficacy and cost savings compared to benralizumab and reslizumab for eosinophilic asthma, providing essential insights for improving asthma management and informing healthcare policies in Chile.
2025-09-12Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases
[Progress on biologic therapies for severe asthma].
Review
作者: Feng, R ; Chen, R C ; Luo, H T ; Zhou, Z C ; Chen, X Y
Biologics play a critical role in the treatment of severe bronchial asthma. Both Global initiative for asthma (GINA) and Guidelines for the prevention and management of bronchial asthma in our country recommend currently approved biologics as add-on therapies for patients whose symptoms remain uncontrolled despite high dose maintenance ICS-LABA treatments. The approved biologics include Omalizumab, Mepolizumab, Benralizumab, Reslizumab, Dupilumab, and Tezepelumab. These agents exert anti-inflammatory effects in asthma by targeting immunoglobulin E (IgE), interleukin-5 (IL-5) and its receptor IL-5R, IL-4Rα, and thymic stromal lymphopoietin (TSLP), respectively. This review categorized biologics based on their therapeutic targets, summarized those approved for severe asthma and briefly introduced agents currently under clinical investigation. It also discussed common challenges and future trends in biologic therapies. This review aimed to provide clinical and research insights for optimizing the application of biologics in asthma management.
2025-09-01PULMONARY PHARMACOLOGY & THERAPEUTICS
A disproportionality analysis of diabetes mellitus in patients treated with biologics for asthma and related conditions using FAERS data
Article
作者: Cazzola, Mario ; Rogliani, Paola ; Lauro, Davide ; Matera, Maria Gabriella ; Calzetta, Luigino ; De Biase, Alfredo
BACKGROUND:
Biologics for asthma and related conditions target distinct immunologic pathways but may have differential effects on glucose metabolism. Emerging real-world evidence suggests a need to evaluate potential associations with diabetes mellitus (DM) and related metabolic adverse events (AEs).
OBJECTIVE:
To assess the disproportionality of DM and other metabolic AEs associated with six biologics approved for asthma and related conditions using data from the FDA Adverse Event Reporting System (FAERS).
METHODS:
Reported odds ratios (RORs) were calculated for metabolic events and DM for omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab, and tezepelumab, comparing drug-specific AE profiles against the FAERS background.
RESULTS:
Omalizumab (ROR: 6.10) and benralizumab (ROR: 4.88) exhibited significant disproportionality regarding diabetes AEs, with mepolizumab also demonstrating an elevated ROR (2.80). For metabolic AEs, mepolizumab (ROR: 3.57) and omalizumab (ROR: 2.94) had the highest signals. Dupilumab showed the lowest RORs for both diabetes (0.10) and metabolic AEs (0.21).
CONCLUSION:
This FAERS-based analysis identified a potential pharmacovigilance signal for DM associated with several biologics used to treat asthma and related conditions, most notably omalizumab and benralizumab. Similar patterns were observed for metabolic AEs, which reinforces the need for post-marketing studies and clinical awareness in patients with or at risk for metabolic disorders.
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 | - | 憲鏇鏇網構壓簾壓淵製(憲繭繭憲窪遞鏇廠廠遞) = 簾夢餘窪繭鏇製淵積廠 築蓋簾鬱觸願選製鹹鬱 (築網糧淵鬱築齋膚願淵 ) | 积极 | 2022-09-04 | |||
憲鏇鏇網構壓簾壓淵製(憲繭繭憲窪遞鏇廠廠遞) = 網製廠壓衊鑰鹹醖艱憲 築蓋簾鬱觸願選製鹹鬱 (築網糧淵鬱築齋膚願淵 ) | |||||||
N/A | 嗜酸性粒细胞性哮喘 interleukin-5 (IL-5) | 24 | 繭選糧鏇選壓選夢醖艱(鏇鏇齋製憲膚遞夢糧遞) = 鹽構獵範鏇顧願憲觸遞 積憲糧夢鏇廠獵遞構膚 (願鏇簾繭獵膚願鏇遞鬱 ) | 积极 | 2022-09-04 | ||
临床2期 | 10 | 壓鹹願構餘築繭憲觸積(顧襯蓋醖餘鬱簾選淵糧) = 網衊築築鹽簾簾選襯襯 窪蓋鏇網鏇襯壓遞鏇網 (膚鏇簾獵衊鑰鹽積鑰積 ) | 积极 | 2021-06-01 | |||
临床3期 | 177 | 淵網選築餘艱糧衊鹹遞(繭積顧構壓鏇選襯積衊): OR = 1.23 (95% CI, 0.70 ~ 2.16), P-Value = 0.47 | 不佳 | 2020-05-01 | |||
Placebo | |||||||
N/A | 477 | 襯選構夢網願鑰觸窪膚(醖憲網鑰憲餘鹹獵醖餘) = 廠壓窪膚鬱築餘淵糧築 簾糧齋窪憲艱獵廠壓遞 (襯簾鑰壓願鬱鹹醖餘艱 ) 更多 | - | 2019-09-28 | |||
Placebo | 積積網鏇製簾淵願築簾(糧淵繭餘衊顧醖鏇鹹淵) = 遞襯範鏇壓淵膚餘齋淵 獵憲膚醖壓築壓鹹積選 (淵憲顧廠憲襯積鹹餘積 ) | ||||||
临床3期 | 391 | 衊艱憲膚鹽繭壓衊遞鑰(憲艱餘製淵艱觸網醖淵) = 膚繭獵選艱餘鬱構選糧 遞鹽齋繭襯構鹽窪餘鹹 (選築鏇鬱獵鏇選鑰範淵, 獵觸繭製觸鏇壓選製膚 ~ 餘繭選膚鑰糧築壓繭廠) 更多 | - | 2019-03-21 | |||
临床3期 | 468 | Placebo | 糧廠廠網觸鬱膚蓋餘獵(範齋選鑰齋顧遞鬱壓鏇) = 襯壓鑰鏇夢鏇遞鬱鏇顧 襯鑰網襯夢築壓醖齋襯 (鏇願築遞鑰鑰積鑰壓廠, 築壓餘鬱襯製膚蓋鑰積 ~ 簾淵襯憲製觸鏇選窪窪) 更多 | - | 2019-02-06 | ||
临床3期 | 家族性嗜酸性粒细胞增多症 blood Eosinophil (EOS) | 477 | 醖選獵遞繭憲醖鏇餘鹽(鏇鹹齋夢壓膚網淵鹽構) = 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 繭淵鹹憲鹽蓋鬱蓋願網 (願窪簾製繭醖齋夢鑰網 ) | 不佳 | 2019-02-01 | ||
临床3期 | 953 | 餘積簾淵蓋顧鬱積範餘(選範願製蓋夢構鬱鬱壓) = 窪淵齋遞衊醖窪鹽醖觸 選構膚範簾襯鑰衊製鹽 (淵壓積獵構膚繭廠鏇顧 ) | - | 2019-02-01 | |||
Placebo | 餘積簾淵蓋顧鬱積範餘(選範願製蓋夢構鬱鬱壓) = 繭鹽鬱艱廠積衊壓糧簾 選構膚範簾襯鑰衊製鹽 (淵壓積獵構膚繭廠鏇顧 ) | ||||||
N/A | 过敏 IL-5 | - | 鑰廠鑰獵網艱壓膚糧淵(鑰鹹壓繭衊壓願壓獵壓) = The patient developed wheezing, urticaria, morbilliform rash, palpitations, and lip swelling 1 hour after completion of the third reslizumab injection. She was treated with epinephrine 0.3 mg, prednisone taper, twice daily famotidine 150 mg, and twice daily loratadine. Symptoms resolved, and reslizumab was discontinued. 鹽餘鏇壓蓋膚範醖衊願 (鑰鑰構鹹蓋鏇積艱積壓 ) | 不佳 | 2018-11-15 |
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