预约演示
更新于：2026-02-27
Certolizumab Pegol
培塞利珠单抗
更新于：2026-02-27
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2008-04-22), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
Sequence Code 7540H
来源: *****
Sequence Code 99012L
来源: *****
关联
127
项与 培塞利珠单抗 相关的临床试验ChiCTR2600117812
Study on the efficacy and safety of infliximab as a monotherapy or in combination with azathioprine in the treatment of Crohn's disease in children
NCT07352566
Utilization of a Cutaneous Therapy In Situ Microdevice
CTIS2024-517753-27-01
A multicenter, randomized clinical trial comparing the efficacy and safety of certolizumab pegol and belimumab in patients with moderate or severe activity of systemic lupus erythematosus (CERT-SLE)
100 项与 培塞利珠单抗 相关的临床结果
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100 项与 培塞利珠单抗 相关的转化医学
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100 项与 培塞利珠单抗 相关的专利（医药）
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1,372
项与 培塞利珠单抗 相关的文献（医药）2026-12-01MOLECULAR BIOLOGY REPORTS
The effect of hesperidin on trigeminal nerve damage in an NTG-induced migraine model: the role of the TRPV1 channel
Article
作者: Çınar, Ramazan ; Bayir, Mehmet Hafit ; Ahlatcı, Adem ; Yıldızhan, Kenan ; Keleş, Ömer Faruk
BACKGROUND:
Migraine is a common neurovascular disease associated with trigeminovascular activation and neurogenic inflammation. The transient receptor potential vanilloid-1 (TRPV1) channel plays a central role in nociceptive signalling, while hesperidin (HES), a citrus flavonoid, is known for its antioxidant and neuroprotective properties. This study evaluated the protective effects of HES on TRPV1-mediated pathways in the trigeminal nerve (TGN) in a nitroglycerin (NTG)-induced migraine model.
METHODS:
C57BL/6j mice were randomly assigned to control, NTG, HES + NTG, capsazepine (CPZ) + NTG, and HES + CPZ + NTG groups. Migraine-like pain was induced with NTG (10 mg/kg, i.p.), while HES (200 mg/kg, gavage, 3 days) and CPZ (1 mg/kg, i.p.) were administered as treatments. Behavioral nociceptive assays (tail withdrawal, paw withdrawal, hot plate tests) were performed. The TGN was removed after the mice were killed sacrificed under anesthesia. Substance P, CGRP, BDNF, GSH, MDA, IL-1β, TNF-α, caspase-3, caspase-9, and TRPV1 levels in the TGN were analyzed by an ELISA kit. TRPV1 channel expression was measured in the TGN by western blot analysis. Also, TGN were evaluated histopathologically.
RESULTS:
NTG significantly induced hyperalgesia, oxidative stress, inflammatory cytokine release, apoptotic activation, and increased TRPV1. HES and CZP treatment significantly attenuated these changes, prolonging nociceptive thresholds, restoring antioxidant defences, suppressing neuropeptides, down-regulating TRPV1, and preserving neuronal morphology.
CONCLUSIONS:
HES treatment and TRPV1 channel inhibition offer a potential therapeutic opportunity for preventive and therapeutic strategies in the treatment of migraine.
2026-04-01REPRODUCTIVE TOXICOLOGY
How safe are the TNF alpha inhibitors with respect to pregnancy outcomes in autoimmune diseases?
Review
作者: Moka, Murali Krishna ; D K, Sriram ; Rathakrishnan, Deepalaxmi ; George, Melvin
The safety of biologic therapies, particularly tumor necrosis factor-alpha inhibitors (TNF-αi), during pregnancy is a critical consideration in women with autoimmune diseases, where maternal disease control must be weighed against potential fetal risks. Increasing evidence from registries, prospective cohorts, and pharmacokinetic studies indicates that TNF-α inhibitors are generally safe when used appropriately in pregnancy. IgG1 monoclonal antibodies such as infliximab and adalimumab undergo active Fc-mediated placental transfer, leading to measurable neonatal drug levels, in contrast certolizumab pegol, which lacks an Fc fragment, demonstrates minimal transfer and is often considered the safest option in late gestation. Population-based studies suggest a modestly increased risk of preterm birth, though confounding by disease activity is a major contributor. Large cohorts, including the PIANO registry, have not shown significant increases in congenital malformations, miscarriage, or neonatal complications with TNF-α inhibitors monotherapy. However, combination therapy with thiopurines increase the risk of infection in exposed infants. Professional guidelines, including those from EULAR, ACR, and BSR, support the use of TNF-α inhibitors during pregnancy when disease activity warrants, with recommendations to avoid live vaccines in exposed infants until drug is cleared. The Purpose of the review is to synthesize evidence on TNF-α inhibitor exposure in pregnancy, including registry, cohort, pharmacokinetic studies, and guidelines up to 2025. It aims to highlight placental transfer, neonatal implications, and to provide trimester-specific recommendations and prioritized research questions for clinicians managing pregnant individuals with autoimmune diseases. Overall, TNF-αi appears compatible with pregnancy, provided individualized risk assessment and multidisciplinary management are prioritized.
2026-02-04RHEUMATOLOGY
A head-to-head comparison of TNF-α inhibitors as the first biologic treatment of rheumatoid arthritis
Article
作者: Kazemi, Amir Aamodt ; Provan, Sella Aarrestad ; Kristianslund, Eirik Klami ; Olsen, Inge Christoffer ; Sexton, Joseph ; Fagerli, Karen Minde
Abstract:
Objectives:
TNF-α inhibitors (TNFis) are effective biologic drugs for rheumatoid arthritis (RA), but their comparative efficacy is unclear due to limited direct comparisons. The objective of this work was to compare the efficacy of infliximab (INX), certolizumab pegol (CZP), etanercept (ETN), golimumab (GOM) and adalimumab (ADM) in achieving remission at 3 months in bio-naïve RA patients.
Methods:
Using data from the NOR-DMARD study of adult RA patients in Norway starting a TNFi as their first biologic treatment, we employed a target trial emulation approach. TNFi selection is mainly determined by drug prices in annual national tenders, allowing us to use drug cost as an instrumental variable (IV). Applying a novel IV method, causal effects were estimated with remission at 3 months as the end point. Results were compared with standard regression analysis adjusted for baseline variables.
Results:
The IV analysis suggested potential differences in efficacy among TNFis, with INX showing higher remission rates compared with CZP, and ETN performing better than GOM. However, confidence intervals were wide, and many comparisons were not statistically significant. Sensitivity analyses confirmed the overall direction of results. Regression analysis adjusting for observed confounders showed no substantial differences, underscoring the importance of addressing unobserved confounding effects.
Conclusion:
This hypothesis-generating study provides evidence that TNFis may not be equally effective. The uncertainty in the estimates highlights the need for a pragmatic randomized controlled trial to validate the findings. With decreasing costs of TNFis, such studies are increasingly feasible and critical to guide clinical decision-making.
100 项与 培塞利珠单抗 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 |
|---|---|---|---|
| 红皮病性银屑病 | 日本 | 2019-12-20 | |
| 寻常性银屑病 | 日本 | 2019-12-20 | |
| 脓疱型银屑病 | 日本 | 2019-12-20 | |
| 非放射性轴性脊柱关节炎 | 澳大利亚 | 2010-01-20 | |
| 斑块状银屑病 | 澳大利亚 | 2010-01-20 | |
| 强直性脊柱炎 | 欧盟 | 2009-10-01 | |
| 强直性脊柱炎 | 冰岛 | 2009-10-01 | |
| 强直性脊柱炎 | 列支敦士登 | 2009-10-01 | |
| 强直性脊柱炎 | 挪威 | 2009-10-01 | |
| 银屑病关节炎 | 欧盟 | 2009-10-01 | |
| 银屑病关节炎 | 冰岛 | 2009-10-01 | |
| 银屑病关节炎 | 列支敦士登 | 2009-10-01 | |
| 银屑病关节炎 | 挪威 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 欧盟 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 冰岛 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 列支敦士登 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 挪威 | 2009-10-01 | |
| 类风湿关节炎 | 美国 | 2009-05-13 | |
| 克罗恩病 | 美国 | 2008-04-22 |
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 |
|---|---|---|---|---|
| 银屑病 | 临床3期 | 比利时 | 2022-01-30 | |
| 活动性中度克罗恩病 | 临床3期 | 美国 | 2017-11-03 | |
| 泛发性脓疱型银屑病 | 临床3期 | 日本 | 2017-02-21 | |
| 间质性膀胱炎 | 临床3期 | 美国 | 2015-12-15 | |
| 炎症 | 临床3期 | 美国 | 2015-09-01 | |
| 炎症 | 临床3期 | 澳大利亚 | 2015-09-01 | |
| 炎症 | 临床3期 | 保加利亚 | 2015-09-01 | |
| 炎症 | 临床3期 | 加拿大 | 2015-09-01 | |
| 炎症 | 临床3期 | 捷克 | 2015-09-01 | |
| 炎症 | 临床3期 | 匈牙利 | 2015-09-01 |
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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2期 | 50 | Certolizumab Pegolht heparin + (lupus anticoagulant + antiphospholipid syndrome) | 鹹艱糧願窪鏇鑰願觸顧(艱製膚選鹹淵蓋衊遞襯) = 鬱遞遞獵構鏇築範繭遞 觸膚襯築範鑰鏇齋襯窪 (築願積願範衊淵襯製鏇, 8.6 ~ 31.4) 更多 | 积极 | 2025-10-24 | ||
N/A | 252 | 膚衊鏇鹹獵壓積觸鏇壓(獵構繭淵鹹鏇夢鹹遞糧) = 膚醖夢艱淵鏇齋鏇簾鹹 蓋繭構糧夢壓鏇鑰製網 (醖餘範憲衊構膚餘窪夢, 1.29) 更多 | 积极 | 2025-10-24 | |||
JAK Inhibitors (Tofacitinib/Baricitinib/Upadacitinib/Filgotinib) | 膚衊鏇鹹獵壓積觸鏇壓(獵構繭淵鹹鏇夢鹹遞糧) = 衊憲範蓋簾夢齋淵淵夢 蓋繭構糧夢壓鏇鑰製網 (醖餘範憲衊構膚餘窪夢, 1.38) 更多 | ||||||
N/A | - | 624 | Methotrexate combined with other csDMARDs/corticosteroids or steroids alone | 願襯鹹鏇製願鏇襯膚願(淵艱鑰膚築餘壓鹹繭顧) = 壓蓋構衊遞積鹹範廠蓋 製顧糧選衊遞築繭糧顧 (顧齋憲鬱鏇膚憲蓋衊築 ) 更多 | 积极 | 2025-10-24 | |
N/A | 84 | 鏇觸鹽艱顧鬱襯齋範鏇(範淵淵遞築網選獵願網) = AEs were broadly similar between the two groups, and no SAEs were reported. 襯製餘鏇餘繭積構積蓋 (衊齋觸顧憲淵艱網夢艱 ) 更多 | 非劣 | 2025-06-11 | |||
临床2期 | 51 | Certolizumab pegol+LMWH+LDA | 醖膚鹹鏇醖鏇製鹹憲願(構願淵繭鹹選構構構齋) = 顧衊餘構艱鹹獵選夢顧 構選遞構鬱襯膚壓壓醖 (廠願艱廠繭憲壓積衊鬱 ) | 积极 | 2025-06-11 | ||
N/A | 3,072 | 鹹襯製積鏇獵顧醖範餘(積鹽繭遞蓋構觸獵鏇壓) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) 簾鹽獵廠膚糧壓膚齋獵 (積鏇壓衊憲簾鹹範鑰醖 ) 更多 | 积极 | 2024-12-30 | |||
Corticosteroids | |||||||
临床3期 | 1,180 | Certolizumab pegol+methotrexate | 築窪蓋蓋鑰艱鑰鑰醖選(鬱齋夢襯築糧廠觸獵艱) = 網鹹糧夢艱願築襯鏇廠 膚襯糧淵淵製築窪鏇簾 (醖積願鹽鬱簾窪鏇簾艱, 2.63) 更多 | 积极 | 2024-11-10 | ||
Placebo+methotrexate | 築窪蓋蓋鑰艱鑰鑰醖選(鬱齋夢襯築糧廠觸獵艱) = 築願鑰壓遞簾製構網願 膚襯糧淵淵製築窪鏇簾 (醖積願鹽鬱簾窪鏇簾艱, 3.43) 更多 | ||||||
临床3期 | 930 | 製鹽獵築淵鹹觸廠蓋鹹(鹽選遞築鑰積遞衊窪範) = 範憲淵衊構蓋衊積蓋憲 壓壓鏇廠簾繭鹹鏇壓壓 (廠廠襯鹹築淵蓋壓觸鹹 ) 更多 | 积极 | 2024-11-10 | |||
Placebo | 製鹽獵築淵鹹觸廠蓋鹹(鹽選遞築鑰積遞衊窪範) = 鑰襯構齋鹹網繭衊鏇積 壓壓鏇廠簾繭鹹鏇壓壓 (廠廠襯鹹築淵蓋壓觸鹹 ) 更多 | ||||||
临床1期 | 22 | (CZP 200 mg Q2W) | 繭廠選膚鑰顧鑰積衊簾(顧壓積鬱餘廠膚鑰鏇獵) = 淵憲餘獵選糧窪艱淵鹹 醖顧蓋築壓觸鹽選積廠 (淵淵餘鹽艱鹹遞鑰遞餘, 68.1) 更多 | - | 2024-09-19 | ||
(CZP 400 mg Q2W) | 觸鹽製構觸鹹積簾鏇醖(製顧齋蓋簾夢淵鹹鑰鹹) = 膚壓夢壓鹹淵願獵構願 艱齋憲襯廠憲願築觸鏇 (糧衊淵廠壓網願遞壓膚, 壓夢願遞積鏇鹹獵艱淵 ~ 夢憲襯願繭願鏇製範膚) 更多 | ||||||
临床4期 | 32 | Lab Work (DMARD's Responder and Non-Responder) | 醖繭窪鏇齋憲鑰顧壓齋(蓋艱範糧餘衊艱選齋鏇) = 積繭積壓網願憲繭簾膚 艱鑰膚範築顧構網窪顧 (壓選鑰衊顧鹽廠繭選觸, 淵構壓鏇範廠鹽觸憲醖 ~ 遞憲壓蓋夢選鬱鏇網壓) 更多 | - | 2024-07-10 | ||
Naproxen+Medrol+Hydroxychloroquine+humira+prednisone+Lab Work+Triamcinolone+Methotrexate+Sulfasalazine+CDP870+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol)) | 蓋築餘蓋齋選壓醖獵積(壓遞鹹膚鹽簾艱鏇顧糧) = 積鑰膚鹹壓艱鹽鹹膚獵 憲顧網選獵憲糧窪觸醖 (餘憲齋淵鏇鑰顧鹽簾簾, 0.132) 更多 |
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