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更新于：2026-08-14
Sutimlimab
更新于：2026-08-14
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (韩国)、儿科研究计划 (欧盟)、优先审评 (美国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 315600191H
来源: *****
Sequence Code 315600192L
来源: *****
关联
6
项与 Sutimlimab 相关的临床试验NCT05132127
An Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease (CAD) Who Have Completed the CARDINAL Study (BIVV009-03/EFC16215, Part B) or CADENZA Study (BIVV009-04/EFC16216, Part B) in Japan
NCT05791708
Cold Agglutinin Disease Real World Evidence Registry
NCT03347422
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion
100 项与 Sutimlimab 相关的临床结果
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100 项与 Sutimlimab 相关的转化医学
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100 项与 Sutimlimab 相关的专利（医药）
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78
项与 Sutimlimab 相关的文献（医药）2026-07-01AMERICAN JOURNAL OF HEMATOLOGY
Safety and Effectiveness of Sutimlimab in Cold Agglutinin Disease: A Real‐World International Experience
Article
作者: Pappagallo, Fabrizio ; Sammartano, Vincenzo ; Curreli, Luigi ; Khwaja, Jahanzaib ; Oliva, Esther N. ; Bitetti, Cinzia ; Rapezzi, Davide ; Maschio, Nilla ; Vianello, Fabrizio ; Solimando, Antonio Giovanni ; Sambruna, Elisa ; Colombo, Riccardo Mario ; Michel, Marc ; Pavan, Laura ; Barcellini, Wilma ; Markovic, Uros ; Broome, Catherine ; Miyakawa, Yoshitaka ; Jaeger, Ulrich ; Moulis, Guillaume ; Marit, Jalink ; Dizdari, Arbana ; Pedone, Giacinto Luca ; Patriarca, Andrea ; De Vivo, Antonio ; Cid, Johan ; Fillitz, Michael ; Fattizzo, Bruno ; Jilma, Bernd ; Kleemiss, Moritz ; Passamonti, Francesco ; Lame, Dorela ; Fianchi, Luana ; Lanza, Francesco ; Visco, Carlo ; Kannourakis, George ; Tumedei, Nicola ; Greve, Maria Bruna ; Sau, Antonella
ABSTRACT:
Sutimlimab is a monoclonal antibody against complement fraction C1s approved for the treatment of hemolytic anemia due to cold agglutinin disease (CAD). Here, we analyzed and report the largest international CAD cohort of sutimlimab‐treated patients ever reported to highlight its safety and effectiveness in the real‐world setting. We accrued a cohort of 57 CAD patients (median age 73.5 years, 56% females). At baseline, patients had severe to moderate anemia (median Hb 8.9 g/dL) and active hemolysis, with a substantial transfusion burden despite a median of 2 prior therapies, including corticosteroids and rituximab. After sutimlimab initiation, median Hb increased by 2 g/dL within 2 weeks and reached 12 g/dL in 4 weeks, remaining stable up to 24 months. This improvement was paralleled by an early and durable normalization of hemolytic markers. Objective responses were observed in most patients by week 2, with complete responses in approximately 50% by Week 4 and 55%–60% during long‐term follow‐up. Peripheral cold‐induced symptoms did not improve and were associated with reduced response rates. Inadequate reticulocytosis also predicted poorer response and suggests the combination with recombinant erythropoietin. Sutimlimab was generally well tolerated. Infections were the most frequent adverse events (23%); severe infections predominantly occurred in previously rituximab‐treated individuals. Hemolytic exacerbations occurred in 16% of cases, mostly due to infections. Thrombotic complications were rare. Overall, sutimlimab demonstrated rapid, durable effectiveness and a favorable safety profile in heavily pretreated real‐world CAD patients.
2026-06-01EUROPEAN JOURNAL OF HAEMATOLOGY
Sutimlimab for Relapsed Cold Agglutinin Disease: Real‐Life Evidence of Sustained Response With Extended‐Interval Dosing
Letter
作者: Lombardi, Assunta ; Pane, Fabrizio ; Picardi, Marco ; Giordano, Claudia ; Vincenzi, Annamaria ; D'Angelo, Daniela ; Piccolo, Linda ; Mongillo, Maria Rosa
2026-05-01REVUE DE MEDECINE INTERNE
French protocol for the diagnosis and management of autoimmune hemolytic anemia in adults
Review
作者: Terriou, Louis ; Ebbo, Mikael ; Mahevas, Matthieu ; Gobert, Delphine ; Bonnotte, Bernard ; Michot, Jean Marie ; Audia, Sylvain ; Lambotte, Olivier ; Moulis, Guillaume ; Godeau, Bertrand ; Michel, Marc ; Galicier, Lionel ; Ruivard, Marc ; Comont, Thibault ; Crickx, Etienne
Autoimmune hemolytic anaemias (AIHAs) represent different subtypes of a rare autoimmune disease in which autoantibodies targeting autoantigens expressed on autologous red blood cells' (RBCs) membrane are produced, leading to their accelerated destruction. In the presence of hemolytic anaemia, the direct antiglobulin test (DAT) is the cornerstone of AIHA diagnosis. AIHAs are classified according to the isotype and the thermal optimum of the autoantibody, into warm (wAIHAs), cold and mixed AIHAs. wAIHAs, by far the most frequent type of AIHAs, are associated with underlying conditions in ∼50% of cases. Among adults, cold AIHAs include cold agglutinin disease (CAD), and cold agglutinin syndrome (CAS) when there is an underlying condition. Both CAD and CAS are IgM cold-antibody driven AIHAs characterized by classical complement pathway-mediated hemolysis. The management of AIHAs which has has long been empirical is mostly based on corticosteroids±rituximab for wAIHAs and on rituximab±bendamustine for CAD requiring to be treated, complement inhibition with sutimlimab being a new therapeutic option for CAD. This article reporting the French guidelines focused on diagnosis and treatment of adult AIHAs is adapted from the last update of the Protocole National de Diagnostic et de Soins (French protocol for diagnosis and management). These guidelines have been set up and led by the French national center for adult' immune cytopenias (CeReCAI).
100 项与 Sutimlimab 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11530 | Sutimlimab | - |
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 |
|---|---|---|---|
| 溶血性贫血 | 欧盟 | 2022-11-15 | |
| 溶血性贫血 | 冰岛 | 2022-11-15 | |
| 溶血性贫血 | 列支敦士登 | 2022-11-15 | |
| 溶血性贫血 | 挪威 | 2022-11-15 | |
| 冷凝集素病 | 美国 | 2022-02-04 | |
| 溶血 | 美国 | 2022-02-04 |
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 |
|---|---|---|---|---|
| 免疫抑制 | 申请上市 | 加拿大 | 2026-06-01 | |
| 免疫性血小板减少症 | 临床1期 | 美国 | 2017-08-14 | |
| 免疫性血小板减少症 | 临床1期 | 德国 | 2017-08-14 | |
| 免疫性血小板减少症 | 临床1期 | 英国 | 2017-08-14 | |
| 补体紊乱 | 临床1期 | 奥地利 | 2015-07-13 | |
| 终末期肾脏病 | 临床1期 | 奥地利 | 2015-07-13 | |
| 大疱性类天疱疮 | 临床1期 | 奥地利 | 2015-07-13 |
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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 | 25 | 築獵衊選觸廠衊衊鬱憲(獵膚醖憲憲繭築壓齋願) = 壓廠廠願願膚繭襯憲襯 醖築網網艱繭衊淵醖壓 (願願廠鑰壓壓獵蓋夢構 ) 更多 | 积极 | 2026-05-12 | |||
Placebo | 築獵衊選觸廠衊衊鬱憲(獵膚醖憲憲繭築壓齋願) = 積鬱觸鑰艱窪鹹顧齋鏇 醖築網網艱繭衊淵醖壓 (願願廠鑰壓壓獵蓋夢構 ) 更多 | ||||||
N/A | 63 | (CAD or CAS) | 繭積獵鑰獵選鬱夢齋衊(構顧製艱顧鹽蓋襯夢簾) = 廠夢窪淵積鑰鹽餘鬱鹽 積構製醖築願鏇餘繭觸 (網願鹹選艱衊願製壓構 ) 更多 | 积极 | 2025-12-06 | ||
N/A | 54 | 網鏇艱範製積鹽鹽簾鬱(艱選夢願襯醖夢醖鬱襯) = 鏇觸蓋遞襯壓遞鏇衊衊 糧簾築壓糧製願顧積淵 (鹹鏇餘膚糧築範糧積餘 ) 更多 | 积极 | 2025-12-06 | |||
N/A | 45 | 淵膚築鏇鏇齋淵夢鏇鑰(艱網窪獵鹹壓鏇構壓鬱) = 餘選醖簾構鑰築鹹獵糧 襯鏇夢鏇選繭憲簾窪憲 (齋鹽衊構鏇顧衊膚糧蓋 ) 更多 | 积极 | 2025-12-06 | |||
临床3期 | 25 | 壓醖鑰網築淵齋襯鏇築(壓範鏇糧壓鬱襯糧襯鹹) = At the last follow up only one patient had died due to progressive WM with sepsis 膚構鏇鑰壓築齋鬱衊齋 (鑰鹹艱餘夢繭範蓋獵醖 ) 更多 | 积极 | 2025-05-14 | |||
临床3期 | - | (Mild Anemia (≥10 g/dL)) | 壓憲廠糧鏇夢衊製鹹築(夢範簾鑰範壓網衊糧顧) = 製憲鏇鹽積淵觸鏇淵醖 鹹構製構鏇簾鬱築顧簾 (鹹選鹹繭鬱淵鹽餘築鹹, 1.55) 更多 | 积极 | 2024-05-14 | ||
(Moderate Anemia (≥8 - <10 g/dL)) | 壓憲廠糧鏇夢衊製鹹築(夢範簾鑰範壓網衊糧顧) = 襯網餘窪鬱衊願醖淵醖 鹹構製構鏇簾鬱築顧簾 (鹹選鹹繭鬱淵鹽餘築鹹, 1.53) 更多 | ||||||
临床3期 | 22 | 蓋淵壓膚蓋夢鏇憲蓋網(膚淵餘簾鹽餘構衊醖築) = 廠繭範淵襯蓋醖鏇積壓 鏇觸醖獵壓製鹽壓繭遞 (製選壓糧顧鹹艱夢夢鑰, 5.6) 更多 | 积极 | 2023-10-10 | |||
临床3期 | 7 | 憲鹽齋製遞鏇範願鑰範 = 衊襯衊繭衊選齋鬱艱夢 膚壓夢壓構艱鑰構淵遞 (鑰構壓糧膚獵憲鑰網鏇, 淵夢艱製獵窪蓋夢艱遞 ~ 鹽顧遞艱積鑰餘築壓構) 更多 | - | 2023-10-03 | |||
临床3期 | 66 | PRE-sutimlimab | 簾遞簾鏇糧憲膚壓廠艱(淵鏇範築艱襯糧襯憲艱) = 製積簾餘衊膚膚範觸艱 製網衊顧醖製憲鏇艱蓋 (鬱製獵夢顧鏇鬱觸觸簾 ) | - | 2023-06-24 | ||
ON-sutimlimab | 簾遞簾鏇糧憲膚壓廠艱(淵鏇範築艱襯糧襯憲艱) = 鬱選鏇製鹹願遞窪鏇壓 製網衊顧醖製憲鏇艱蓋 (鬱製獵夢顧鏇鬱觸觸簾 ) | ||||||
临床3期 | 39 | 觸餘衊網製窪繭鏇鹽艱(鏇願簾獵淵願夢範醖獵) = Thromboembolic events were observed in 2 (5.1%) pts (transient ischemic attack [n=1]; deep vein thrombosis [n=1]); both events occurred in pts with underlying risk factors for thromboembolism and were assessed as non-serious and unrelated to SUT by the Investigator. 繭積膚憲網築餘網醖簾 (壓簾憲繭鏇廠餘顧膚鏇 ) 更多 | - | 2023-06-08 | |||
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