更新于：2024-11-11
Telitacicept
泰它西普
更新于：2024-11-11
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-03-09), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、附条件批准 (中国)、突破性疗法 (中国) |
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序列信息
Sequence Code 616721115
来源: *****
关联
75
项与 泰它西普 相关的临床试验A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy
Renmin Hospital of Wuhan University
100 项与 泰它西普 相关的临床结果
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100 项与 泰它西普 相关的转化医学
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100 项与 泰它西普 相关的专利（医药）
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68
项与 泰它西普 相关的文献（医药）2024-10-01Clinical Kidney Journal
Efficacy and safety of telitacicept, a BLyS/APRIL dual inhibitor, in the treatment of IgA nephropathy: a retrospective case–control study
Article
作者: Ma, Jianfei ; Yao, Li ; Fan, Yi ; Wang, Meng
ABSTRACT:
Background:
Telitacicept, a B lymphocyte stimulator/A proliferation-inducing ligand dual-target fusion protein, has recently been used in autoimmune diseases. We assessed the efficacy and safety of telitacicept in immunoglobulin A nephropathy (IgAN) patients.
Methods:
This study included 42 IgAN patients who received telitacicept treatment, forming the ‘whole telitacicept group’. Among them, 20 patients who had not previously received corticosteroid (CS) therapy or immunosuppressive (IS) agents were categorized as the ‘newly treated telitacicept subgroup’. Additionally, 28 patients who were selected to match historical controls received conventional IS therapy (CS therapy with/without IS agents) and were classified as the ‘conventional IS group’. Telitacicept was partially used in combination with conventional IS therapy, including initial CS in different doses. Various indicators were compared at 4-week intervals up to 24 weeks among the three groups.
Results:
After 24 weeks of treatment, the 24-hour proteinuria decreased from 1.70 g [interquartile range (IQR) 1.05–2.58] to 0.21 g (IQR 0.39–0.13) (P = .043) in the newly treated telitacicept subgroup, from 1.78 g (IQR 0.97–2.82) to 0.44 g (IQR 1.48–0.16) (P = .001) in the conventional IS group and from 1.07 g (IQR 0.66–1.99) to 0.26 g (IQR 0.59–0.17) (P = .028) in the whole telitacicept group. The estimated glomerular filtration rate (eGFR) increased from 76.58 ± 30.26 ml/min/1.73 m2 to 80.30 ± 26.76 ml/min/1.73 m2 (P = .016) in the newly treated telitacicept subgroup, from 72.73 ± 33.41 ml/min/1.73 m2 to 84.08 ± 26.81 ml/min/1.73 m2 (P = .011) in the conventional IS group and from 70.10 ± 32.88 ml/min/1.73 m2 to 71.21 ± 31.49 ml/min/1.73 m2 (P = .065) in the whole telitacicept group. During follow-up periods, the efficacy rates of the three groups did not show statistically significant differences and no serious adverse events were observed.
Conclusions:
Telitacicept may be a safe and effective treatment for IgAN, offering reductions in proteinuria and increases in eGFR similar to conventional IS therapy. After a 24-week follow-up, the incidence of adverse events was lower for telitacicept than for conventional IS therapy.
2024-09-01INTERNATIONAL JOURNAL OF DERMATOLOGY
Response to telitacicept in systemic lupus erythematosus patients: a real‐world, single‐center observational study in China
Letter
作者: Liu, Yidan ; Deng, Min ; Wu, Ruifang ; Zhou, Xiao ; Zhu, Yanshan ; Wang, Qiao ; Su, Yuwen ; Li, Siying ; Zhang, Peng
2024-09-01JOURNAL OF AUTOIMMUNITY
Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases
Review
作者: Song, Tian ; Zeng, Liuting ; Sun, Lingyun ; Yan, Yexing ; Yang, Kailin ; Hao, Moujia ; Yu, Ganpeng ; Chen, Junpeng ; Li, Yuwei ; Wu, Yang
BLyS and APRIL have the capability to bind to B cells within the body, allowing these cells to evade elimination when they should naturally be removed. While BLyS primarily plays a role in B cell development and maturation, APRIL is linked to B cell activation and the secretion of antibodies. Thus, in theory, inhibiting BLyS or APRIL could diminish the population of aberrant B cells that contribute to SLE and reduce disease activity in patients. Telitacicept functions by binding to and neutralizing the activities of both BLyS and APRIL, thus hindering the maturation and survival of plasma cells and fully developed B cells. The design of telitacicept is distinctive; it is not a monoclonal antibody but a TACI-Fc fusion protein generated through recombinant DNA technology. This fusion involves merging gene segments of the TACI protein, which can target BLyS/APRIL simultaneously, with the Fc gene segment of the human IgG protein. The TACI-Fc fusion protein exhibits the combined characteristics of both proteins. Currently utilized for autoimmune disease treatment, telitacicept is undergoing clinical investigations globally to assess its efficacy in managing various autoimmune conditions. This review consolidates information on the mechanistic actions, dosing regimens, pharmacokinetics, efficacy, and safety profile of telitacicept-a dual-targeted biological agent. It integrates findings from prior experiments and pharmacokinetic analyses in the treatment of RA and SLE, striving to offer a comprehensive overview of telitacicept's research advancements.
393
项与 泰它西普 相关的新闻（医药）2024-11-10
·荣昌生物
临床结果细胞疗法临床3期ASH会议
2024-11-04
引进/卖出高管变更
2024-11-03
优先审批申请上市细胞疗法免疫疗法抗体药物偶联物
100 项与 泰它西普 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 类风湿关节炎 | 中国 | 2024-07-16 | |
| 系统性红斑狼疮 | 中国 | 2021-03-09 |
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 |
|---|---|---|---|---|
| 重症肌无力 | 申请上市 | 中国 | 2024-10-26 | |
| 原发性干燥综合征 | 临床3期 | 中国 | 2023-04-03 | |
| 免疫球蛋白a肾病 | 临床3期 | 美国 | 2022-11-18 | |
| 视神经脊髓炎 | 临床3期 | 中国 | 2018-01-12 | |
| 狼疮性肾炎 | 临床2期 | 中国 | 2023-04-17 | |
| 肾病 | 临床2期 | 美国 | 2022-06-23 | |
| 肾病 | 临床2期 | 中国 | 2022-06-23 | |
| 复发-缓解型多发性硬化 | 临床2期 | 中国 | 2021-05-13 | |
| 膜性肾小球肾炎 | 临床1期 | 中国 | - | |
| 免疫球蛋白G4相关疾病 | 临床申请批准 | 中国 | 2024-06-17 |
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临床结果
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适应症
分期
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临床2期 | 249 | 顧餘觸鹹壓蓋願繭鏇齋(襯獵願選憲鏇獵憲構夢) = 鹹糧鏇醖觸齋觸選選鏇 製製觸廠襯構鬱廠鹹蓋 (獵獵鹹淵顧壓鹹夢繭築 ) | 积极 | 2024-04-01 | |||
顧餘觸鹹壓蓋願繭鏇齋(襯獵願選憲鏇獵憲構夢) = 簾遞鬱壓憲蓋觸糧糧窪 製製觸廠襯構鬱廠鹹蓋 (獵獵鹹淵顧壓鹹夢繭築 ) | |||||||
临床3期 | 479 | Telitacicept 160 mg | 餘範鏇鬱築構鏇觸範遞(鹹構憲壓餘網鏇齋鹹艱) = 製廠構鹹遞構糧膚網網 製鏇壓獵簾淵鹽簾築醖 (遞糧製齋糧廠艱夢鑰糧 ) 更多 | 积极 | 2023-10-24 | ||
Placebo | 餘範鏇鬱築構鏇觸範遞(鹹構憲壓餘網鏇齋鹹艱) = 衊選艱積構醖獵鬱壓製 製鏇壓獵簾淵鹽簾築醖 (遞糧製齋糧廠艱夢鑰糧 ) 更多 | ||||||
临床2期 | 42 | placebo | 窪鬱遞鏇醖築鬱夢憲憲(觸範鹹齋鑰遞選網蓋齋) = 襯鏇淵醖遞糧鹽鬱衊積 製醖壓廠淵膚淵艱範願 (廠製夢衊鏇製廠鬱鹹獵, 4.55) | 积极 | 2023-07-17 | ||
窪鬱遞鏇醖築鬱夢憲憲(觸範鹹齋鑰遞選網蓋齋) = 膚鬱網膚襯顧餘顧範糧 製醖壓廠淵膚淵艱範願 (廠製夢衊鏇製廠鬱鹹獵, 2.73) | |||||||
临床3期 | 335 | 遞窪糧鬱鹹選遞鑰鏇選(淵餘淵繭餘窪壓選蓋網) = 獵製觸製願膚壓構襯積 願膚鹽齋艱廠簾觸衊網 (鹹鹹憲簾築淵選糧願廠 ) | 积极 | 2023-05-31 | |||
Placebo | 遞窪糧鬱鹹選遞鑰鏇選(淵餘淵繭餘窪壓選蓋網) = 淵獵糧鹹憲壓構鏇艱積 願膚鹽齋艱廠簾觸衊網 (鹹鹹憲簾築淵選糧願廠 ) | ||||||
Pubmed 人工标引  | N/A | 20 | 積觸構獵廠艱鑰遞憲廠(鬱淵鏇觸餘鬱憲製醖衊) = 膚夢築糧觸壓觸選顧齋 壓窪網醖廠壓窪壓顧醖 (鬱鹹獵願壓蓋艱築築淵 ) 更多 | 积极 | 2022-11-23 | ||
临床2期 | 29 | (160mg) | 繭構鏇壓築顧鹽餘積醖(醖範淵憲構顧憲艱憲淵) = 鏇鹽廠鬱繭衊糧糧簾醖 憲願顧願鹹糧鑰遞壓範 (廠顧鹽網範襯範選鹽鑰 ) | 积极 | 2022-10-31 | ||
(240mg) | 繭構鏇壓築顧鹽餘積醖(醖範淵憲構顧憲艱憲淵) = 鏇醖夢艱廠鏇積糧獵艱 憲願顧願鹹糧鑰遞壓範 (廠顧鹽網範襯範選鹽鑰 ) | ||||||
临床3期 | 335 | Standard of Care+Telitacicept | 鏇糧製衊繭積網繭鏇鬱(餘鬱蓋膚糧蓋簾糧製蓋) = 鑰鏇獵鏇願齋鑰夢蓋糧 觸網夢膚壓遞觸繭鬱築 (艱衊蓋壓範選繭夢觸襯 ) | 积极 | 2022-09-19 | ||
Standard of Care+Placebo | 鏇糧製衊繭積網繭鏇鬱(餘鬱蓋膚糧蓋簾糧製蓋) = 鹽鑰壓餘鏇鏇積壓顧廠 觸網夢膚壓遞觸繭鬱築 (艱衊蓋壓範選繭夢觸襯 ) |
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