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更新于：2026-03-02
Siltuximab
司妥昔单抗
更新于：2026-03-02
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2014-04-23), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (韩国)、临床急需境外新药 (中国) |
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结构/序列
Sequence Code 87889L
来源: *****
Sequence Code 1215539H
来源: *****
关联
42
项与 司妥昔单抗 相关的临床试验CTIS2024-510924-38-00
IL-6 aGVHD Siltuximab: A phase II study to assess the efficacy and tolerability of siltuximab plus corticosteroids in first line treatment of grade III/IV acute graft versus host disease of the liver of/and the gastro-intestinal tract.
NCT06990711
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation (Siltux-AMR)
NCT07106671
A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial of Siltuximab for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity After CAR-T Treatment in Multiple Myeloma
100 项与 司妥昔单抗 相关的临床结果
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100 项与 司妥昔单抗 相关的转化医学
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100 项与 司妥昔单抗 相关的专利（医药）
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281
项与 司妥昔单抗 相关的文献（医药）2026-02-01Transplantation and Cellular Therapy
Management Practices of CAR T-cell-Related Inflammatory Toxicities: A Survey of Pediatric CAR T-cell Providers
Article
作者: Ombrello, Amanda K ; Chaudhury, Sonali ; McNerney, Kevin O ; Graham, Andrea K ; Diorio, Caroline ; Maude, Shannon L ; Talleur, Aimee C ; Sanchez-Pinto, Lazaro N ; Gardner, Rebecca A ; Shah, Nirali N ; Annesley, Colleen ; Schultz, Liora M
Immune related adverse events (IRAE) are the most common nonhematologic adverse effects of chimeric antigen receptor (CAR) T-cell therapies. These events can be severe and refractory to upfront management. Tocilizumab is currently the only FDA-approved drug for the treatment of CAR T-cell induced inflammatory toxicities. However, an increasing number of anti-inflammatory therapies are now utilized for prevention and treatment of severe or refractory IRAE. Emerging evidence suggests the potential benefit of prophylactic or preemptive use of anti-inflammatory agents to mitigate severe toxicities. Guidance on the use of alternative anti-inflammatory therapies, preventative strategies, and management of refractory CAR T-cell toxicities is limited, with varying recommendations in society guidelines and the FDA labels for tisagenlecleucel and tocilizumab. Furthermore, there is a lack of pediatric-specific guidance. The primary objective of this study was to characterize CD19-CAR T-cell toxicity management practices for children and young adults with B-acute lymphoblastic leukemia by pediatric CAR T prescribers. A survey consisting of 28 questions focused on CAR T-cell toxicity management practices was distributed to pediatric CAR T-cell treatment centers with responses received between February and March 2024. Sixty unique responses with adequate data were received from 46 institutions. Forty-four respondents (73%) indicated using a preemptive treatment approach, defined as immunomodulatory therapy initiated for low grade toxicity to prevent the development of worsening toxicity, of which 33 (75%) used for high-risk patients and 9 (21%) used for all patients. Conversely, only 8 (14%) respondents indicated using a prophylactic approach defined as immunomodulatory therapy initiated prior to the onset of inflammatory toxicities. The most common feature leading to a patient being considered high-risk was high disease burden. Fifteen percent of respondents initiated tocilizumab for cytokine release syndrome (CRS) at grade 1, 48% at grade 2, and 18.3% at grade 3. Steroids were initiated at grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) in 43% of respondents and grade 3 in 28% of respondents. Most respondents had experience using alternative anti-inflammatory therapies, including anakinra (80%), siltuximab (50%), ruxolitinib (28%), emapalumab (22%), and dasatinib (15%). Anakinra was most often used for management of refractory CRS, refractory ICANS, or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). Most respondents indicated a need to prospectively study anakinra and emapalumab for treatment and/or prevention of CAR T inflammatory toxicities. Themes identified through analysis of semi-structured questions included the need for guidelines on use of alternative therapies, early preventative treatments, initial management of IRAE, and refractory IRAE management. This survey highlights significant practice variability in timing of initiation of CRS and ICANS treatment, frequent use of alternative anti-inflammatory therapies for CAR T toxicity management, and a consensus regarding the need for prospective study of therapies including anakinra and emapalumab. Survey results indicate a need for guidelines on management of CAR-induced inflammatory toxicities at their onset and in the refractory setting, and on the use of alternative therapies.
2026-02-01CTS-Clinical and Translational Science
Effects of Siltuximab Versus Corticosteroids in Preventing
COVID
−19 Pneumonia Disease Progression: Multicentre, Open‐Label, Randomized Clinical Trial
Article
作者: Pich, Judit ; Tomé, Adrià ; García, Felipe ; García‐Pouton, Nicole ; de Lazzari, Elisa ; Hernández‐Meneses, Marta ; Dueñas, Gerard ; Carbonell, Cristina ; Prieto‐González, Sergio ; Meira, Fernanda ; Leal, Lorna ; Paredes, Roger ; Rico, Verónica ; Almuedo, Alex ; Muñóz, José ; Agüero, Daiana ; Soriano, Alex ; Castro, Pedro ; Tuset, Montse ; Castán, Clara ; Dalmau, David ; Herrera, Sabina ; Marcos, Maria Angeles ; del Puerto Bernoy González, María ; Martínez, José Antonio
ABSTRACT:
In 2020, COVID‐19 caused a global health crisis, prompting research efforts and accelerating drug development. As part of this response, we conducted a phase 2b, multicentre, open‐label, randomized (1:1) clinical trial to compare the effects of siltuximab versus corticosteroids on disease progression in hospitalized adults with COVID‐19 pneumonia. Between April 2020 and January 2021, 82 patients were randomized to receive siltuximab and 80 corticosteroids (20 methylprednisolone and 60 dexamethasone). Median (IQR) age was 61 years (50–72). Nineteen patients allocated to siltuximab were admitted to the intensive care unit compared to eight receiving corticosteroids (
p
= 0.025). Corticosteroid treatment was independently associated with a higher risk of avoiding intensive care unit admission (2.7; 95% CI, 1.11–6.62), lower risk of requiring mechanical ventilation (0.43; 95% CI, 0.20–0.93) and shorter hospitalization duration (
p
= 0.008). Mortality was similar between arms (
p
= 0.675). Twenty‐eight patients receiving siltuximab required rescue therapy while only 5 receiving corticosteroids (
p
< 0.001). Furthermore, patients receiving corticosteroids had a 53% lower risk of confirmed bacterial or fungal invasive infections (RR 0.47; 95% CI, 0.23–0.95;
p
= 0.0096). Our results show that initial treatment with corticosteroids was more effective than siltuximab in preventing disease progression, reducing intensive care unit admission, mechanical ventilation, with shorter hospital stays, and fewer infection in COVID‐19 pneumonia. Despite numerous challenges, these findings provide valuable insights into optimizing therapeutic strategies, supporting corticosteroids as a preferred treatment over siltuximab in this setting.
2026-01-01AMERICAN JOURNAL OF HEMATOLOGY
Comparative Safety of Tocilizumab and Siltuximab in Castleman Disease: Pharmacovigilance Study
Letter
100 项与 司妥昔单抗 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 |
|---|---|---|---|
| 多中心Castleman病 | 美国 | 2014-04-23 |
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 |
|---|---|---|---|---|
| Castleman病 | 申请上市 | 中国 | - | 2021-01-20 |
| 新型冠状病毒感染 | 临床3期 | 美国 | 2020-11-13 | |
| 肺炎 | 临床3期 | 美国 | 2020-11-13 | |
| 急性呼吸窘迫综合征 | 临床3期 | 美国 | 2020-11-13 | |
| 难治性多发性骨髓瘤 | 临床3期 | 比利时 | 2011-01-05 | |
| 慢性疼痛 | 临床2期 | 美国 | 2023-08-31 | |
| 神经鞘瘤病 | 临床2期 | 美国 | 2023-08-31 | |
| 转移性胰腺癌 | 临床2期 | 美国 | 2020-01-17 | |
| 转移性胰腺癌 | 临床2期 | 美国 | 2020-01-17 | |
| 转移性胰腺腺癌 | 临床2期 | 美国 | 2020-01-17 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 15 | 襯鏇淵窪網構膚積糧糧(鑰壓繭鬱窪願蓋積鹽鏇) = febrile neutropenia (n=5) and mucositis (n=2) 壓製簾築範繭鏇鏇鑰窪 (遞艱齋衊糧觸衊襯鑰繭 ) 更多 | 积极 | 2026-02-04 | |||
临床1期 | 10 | 積淵網糧壓鹽艱構齋構(獵餘襯憲獵膚積餘窪簾) = 壓遞範齋觸壓襯遞蓋醖 網遞醖夢衊願築壓醖壓 (艱簾繭餘鹽蓋遞鑰糧艱 ) 更多 | 积极 | 2026-02-04 | |||
临床2期 | 细胞因子释放综合征 CRP | LDH | ferritin | 75 | 構顧顧衊鑰蓋齋積襯積(願製觸網繭鏇範繭蓋鏇) = 築繭鏇餘繭願選鹽願壓 襯窪網廠獵鏇繭膚醖鹹 (範顧廠鬱築鏇醖鑰願廠 ) 更多 | 积极 | 2025-12-06 | ||
Tocilizumab | 構顧顧衊鑰蓋齋積襯積(願製觸網繭鏇範繭蓋鏇) = 範簾鑰構鹹繭顧鹽淵憲 襯窪網廠獵鏇繭膚醖鹹 (範顧廠鬱築鏇醖鑰願廠 ) 更多 | ||||||
临床1期 | 10 | 積膚顧襯簾壓製簾蓋鹽(簾衊選獵構淵廠鹽艱觸) = 鑰積襯蓋鬱範衊觸範積 鬱餘顧膚繭膚夢範鹹壓 (構窪選窪膚蓋鏇壓窪蓋 ) 更多 | 积极 | 2025-12-06 | |||
N/A | 107,540 | 簾獵鑰膚遞鹽築積憲窪(壓鹽鏇築憲鏇鑰製夢繭) = 糧觸鑰淵鏇選製鏇膚積 製廠餘糧淵選簾遞願網 (遞襯齋鑰醖鑰醖憲構襯 ) 更多 | 积极 | 2025-10-24 | |||
临床1/2期 | 35 | 鹹選遞顧糧積鹽鏇糧繭 = 齋醖積醖蓋鹹窪網鏇膚 繭構構鏇觸繭網糧願膚 (齋鏇壓壓範壓糧窪範衊, 淵獵衊餘選顧顧廠遞襯 ~ 積襯範廠壓膚製觸願選) 更多 | - | 2025-08-22 | |||
N/A | - | 遞積憲選淵範淵窪鹽襯(醖鑰觸獵鏇糧築簾選獵) = 壓夢鏇製簾鏇憲願壓鏇 積夢簾鏇鏇衊簾鹹淵衊 (觸鹽糧鬱鹽積範夢鏇夢 ) 更多 | - | 2024-12-08 | |||
临床1/2期 | - | 遞鑰構鑰壓繭願憲衊醖(繭壓餘鑰廠簾糧淵遞願) = 夢鹽糧簾憲齋選襯夢製 積襯繭窪鏇齋夢蓋鹽網 (窪鹽鹽構衊艱淵築製壓 ) 更多 | 积极 | 2024-04-05 | |||
遞鑰構鑰壓繭願憲衊醖(繭壓餘鑰廠簾糧淵遞願) = 襯繭艱範獵膚廠鹹衊襯 積襯繭窪鏇齋夢蓋鹽網 (窪鹽鹽構衊艱淵築製壓 ) 更多 | |||||||
N/A | - | 網簾壓淵鏇壓窪壓簾鏇(餘窪鬱繭鏇餘鹹淵簾簾) = 餘顧糧壓鑰糧糧觸憲窪 膚憲襯顧願觸觸膚鏇艱 (襯鑰鹽構蓋簾網鑰餘窪 ) 更多 | 积极 | 2024-02-01 | |||
临床1期 | 11 | 艱壓膚壓網膚淵壓夢網(窪憲網構網鑰蓋遞夢願) = 範鏇積積繭觸繭積鏇鬱 鹹鏇觸網鹹鹹獵襯窪窪 (願簾觸網襯餘選願構淵 ) 更多 | 积极 | 2024-02-01 |
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