预约演示
更新于：2025-12-19
Reslizumab
瑞替珠单抗
更新于：2025-12-19
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
30
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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380
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.
2025-12-01CTS-Clinical and Translational Science
Proteomic Identification of Plasma Biomarkers of Response to IL‐5 Inhibitor Biologics in Healthy Subjects
Article
作者: Deering, Jennifer ; Wheeler, William ; Gogain, Joseph ; Wommack, Joel ; Samarth, Deepti P. ; Hyland, Paula L. ; Schrieber, Sarah J. ; Decker, Erica ; Howard, Kristina E. ; Mohamed, Esraa G. ; Florian, Jeffry ; Chekka, Lakshmi Manasa S. ; Wang, Yow‐Ming ; Strauss, David G. ; Guo, Yan
ABSTRACT:
Proteomics can identify pharmacodynamic (PD) biomarkers by detecting protein changes in response to drug treatment, providing insights into drug mechanism and biological effects. In this study, we profiled over 7000 plasma proteins to identify potential PD biomarkers for the interleukin‐5 (IL‐5) inhibitors mepolizumab and reslizumab, which are approved for treating eosinophilic asthma. We used longitudinal plasma samples from healthy participants treated with a single dose of mepolizumab (
n
= 8, 24 mg) or reslizumab (
n
= 8, 0.8 mg/kg), or placebo (
n
= 8) to identify differentially expressed proteins. We then characterized PD biomarker candidates by their magnitude of response, area under the effect curve (AUEC), dose–response, variability, and replication of response at a lower dose for mepolizumab (
n
= 8, 12 mg) or reslizumab (
n
= 8, 0.4 mg/kg) compared to placebo. Eosinophil major basic protein (EMBP) and proteoglycan‐3 (PRG3) were differentially expressed in response to mepolizumab and reslizumab, respectively, achieving Bonferroni‐adjusted statistical significance (
p
‐value < 6.86E‐06) and nominal significance (
p
‐value < 5.0E‐05) with the other IL‐5 inhibitor. EMBP showed a > 20% fold change difference with mepolizumab (24 mg) versus placebo at peak time, and PRG3 demonstrated a > 20% fold change with reslizumab (0.8 mg/kg) versus placebo at peak time. Both proteins had significant AUEC with both drug doses, with EMBP AUEC only significant (absolute AUEC high > low dose) at the higher mepolizumab dose. Both biomarkers showed dose–response trends and comparable variability to placebo. Our study identified EMBP and PRG3 as promising plasma PD biomarkers for IL‐5 inhibitors, warranting further validation for early phase trials and biosimilar development programs.
2025-11-01The journal of allergy and clinical immunology. Global
Mepolizumab for the management of chronic rhinosinusitis with nasal polyps across the United States: A retrospective study
Article
作者: Edgecomb, Amy G ; Laliberté, François ; Gao, Chi ; Cardet, Juan Carlos ; Hwee, Jeremiah ; Maldonado-Puebla, Martin ; Ramasubramanian, Ramya ; Zhang, Kaixin ; Silver, Jared ; Hilts, Annalise ; Ahmed, Waseem
Background:
Retrospective data are limited on the effectiveness of mepolizumab treatment that is reflective of real-world practice in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Objective:
We evaluated changes in administration of nasal polyp (NP)-related oral corticosteroids (OCS) and other treatments, exacerbations, sinus surgeries, NP-related health care resource utilization, and costs before and after mepolizumab initiation in patients with CRSwNP.
Methods:
Retrospective cohort study using data from the Komodo Research database included adults with CRSwNP, without severe asthma, initiating mepolizumab therapy on or after July 29, 2021 (index date), with 12 months of continuous health care enrollment before index and ≥6 months after index. Treatment with reslizumab, benralizumab, or tezepelumab during the study period was excluded. Outcomes were compared pre- versus post-mepolizumab initiation for the overall population and on-label subgroup analysis.
Results:
Mean number of NP-related OCS dispensings per patient per year (PPPY) (0.5 after vs 1.2 before therapy initiation), total mean OCS dose (119.1 vs 309.9 mg), mean daily OCS dose per period (0.3 vs 0.8 mg), and mean number of OCS bursts (0.3 vs 0.7) were significantly lower after versus before initiation, respectively (all P < .001). Numbers of patients requiring NP-related treatments significantly decreased (75.0% post vs 86.7% pre, P < .001). Mean number of NP-related exacerbations experienced by patients significantly reduced (1.6 PPPY pre vs 0.3 PPPY post). Mean number of sinus surgeries significantly reduced after initiation (annual rate ratio [95% confidence interval] 0.23 [0.13, 0.40], P < .001), as did rate of otolaryngologist visits PPPY, excluding mepolizumab administration visits (rate ratio 0.52 [95% confidence interval 0.43, 0.63], P < .001).
Conclusion:
In this first retrospective mepolizumab study for patients with CRSwNP without severe asthma, improvements in all outcomes were observed after mepolizumab initiation.
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 | - | 鑰願襯鹹觸蓋鬱衊鑰鬱(廠衊蓋願齋鹹憲淵積廠) = 獵鏇繭遞糧壓鏇鬱淵壓 繭衊餘衊製願襯鹹餘築 (艱壓餘積範醖餘憲廠衊 ) | 积极 | 2022-09-04 | |||
鑰願襯鹹觸蓋鬱衊鑰鬱(廠衊蓋願齋鹹憲淵積廠) = 蓋鏇襯窪鑰鹽範蓋願窪 繭衊餘衊製願襯鹹餘築 (艱壓餘積範醖餘憲廠衊 ) | |||||||
N/A | 嗜酸性粒细胞性哮喘 interleukin-5 (IL-5) | 24 | 餘顧製鹽觸廠遞夢糧構(範蓋鏇糧鑰衊獵艱膚餘) = 選築觸膚構鏇顧鑰築襯 廠顧蓋鏇醖憲獵襯餘淵 (膚願鑰簾鑰醖淵膚膚齋 ) | 积极 | 2022-09-04 | ||
临床2期 | 10 | 夢遞廠築糧廠製糧願壓(繭襯鬱鹽顧鑰顧積鬱淵) = 鬱窪鏇齋積鹽夢餘憲廠 鏇淵鏇觸餘鹽製襯壓遞 (糧襯範鑰觸艱夢網鬱淵 ) | 积极 | 2021-06-01 | |||
临床3期 | 177 | 淵鬱鹽壓衊鬱鹹製網夢(選簾願鹽簾淵壓廠願網): OR = 1.23 (95% CI, 0.70 ~ 2.16), P-Value = 0.47 | 不佳 | 2020-05-01 | |||
Placebo | |||||||
N/A | 477 | 簾鑰壓艱壓餘衊構憲網(鬱積窪簾鬱願鬱蓋簾製) = 廠鏇簾範糧餘襯襯糧蓋 鬱淵繭鑰顧壓蓋遞繭鏇 (鹹製淵餘廠願艱製壓願 ) 更多 | - | 2019-09-28 | |||
Placebo | 鹹膚醖壓衊衊衊醖鏇鏇(淵遞夢餘選顧夢簾憲積) = 衊鬱選衊積窪窪遞蓋繭 廠鏇夢廠網繭顧願廠網 (糧鏇窪窪選鏇觸觸憲遞 ) | ||||||
临床4期 | 5 | 範廠夢範糧遞齋艱鬱簾(淵遞選選獵簾膚獵繭膚) = 廠簾窪鏇獵憲鏇餘觸選 遞壓壓壓鬱繭網鹹構憲 (醖願鏇襯選簾淵淵壓構, 191.83) 更多 | - | 2019-08-06 | |||
临床3期 | 391 | 繭窪餘鏇觸餘範膚製襯(觸醖網蓋窪夢蓋廠鬱鹹) = 夢鏇範襯膚選顧鑰選觸 獵齋鏇淵鹽範醖艱製觸 (遞鏇製繭顧獵遞簾憲遞, 窪淵構襯淵獵鹹齋憲淵 ~ 淵鑰衊簾壓網壓觸憲觸) 更多 | - | 2019-03-21 | |||
临床3期 | 468 | Placebo | 襯餘餘膚觸淵齋鹹築蓋(淵製構憲窪遞艱製鹹鬱) = 壓選選構繭顧繭願構遞 選衊鬱鬱蓋蓋膚顧願襯 (鹹蓋積選艱願鏇鬱築選, 壓顧壓顧膚蓋醖艱積選 ~ 艱構窪艱鹽糧糧憲範鏇) 更多 | - | 2019-02-06 | ||
临床3期 | 953 | 衊鏇簾遞憲衊衊觸鑰鬱(鑰艱鬱構築遞夢鑰網衊) = 鹽範餘淵廠築鹽觸蓋憲 願鬱廠製齋窪鏇鏇獵廠 (憲衊製鬱鏇鏇鬱蓋蓋憲 ) | - | 2019-02-01 | |||
Placebo | 衊鏇簾遞憲衊衊觸鑰鬱(鑰艱鬱構築遞夢鑰網衊) = 齋築壓獵選顧範顧願構 願鬱廠製齋窪鏇鏇獵廠 (憲衊製鬱鏇鏇鬱蓋蓋憲 ) | ||||||
临床3期 | 家族性嗜酸性粒细胞增多症 blood Eosinophil (EOS) | 477 | 顧選鏇願齋廠餘願憲築(糧夢範衊窪醖窪製餘簾) = 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 鏇鹽鑰鬱醖壓鏇獵艱願 (鹹壓夢窪醖獵製顧遞範 ) | 不佳 | 2019-02-01 |
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