预约演示
更新于：2026-03-05
Certolizumab Pegol
培塞利珠单抗
更新于：2026-03-05
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 |
特殊审评孤儿药 (美国)、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 ; George, Melvin ; Rathakrishnan, Deepalaxmi
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.
2026-03-01ANNALS OF THE RHEUMATIC DISEASES
Evaluation of the placebo and treatment effect overtime in randomised clinical trials evaluating the efficacy of biologics in axial spondyloarthritis: systematic review and meta-analysis
Article
作者: Molto, Anna ; Perrot, Léa ; Pham, Thao ; Paris, Caroline ; Gravier Dumonceau, Robinson ; Dougados, Maxime
OBJECTIVES:
To evaluate temporal trends in treatment efficacy and placebo responses in randomized controlled trials in axial spondyloarthritis (axSpA).
METHODS:
We conducted a systematic review of RCTs in MEDLINE up to July 2024 (PROSPERO: CRD42024563776). Eligible trials compared tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, infliximab, golimumab) or interleukin-17 inhibitors (bimekizumab, ixekizumab, secukinumab) versus placebo in axSpA. Two reviewers independently selected studies and extracted data. Primary outcomes were temporal trends in placebo response for Assessment of SpondyloArthritis International Society 20% and 40% response criteria (ASAS20/40), axSpA Disease Activity Score (ASDAS) Clinically Important Improvement, and ASDAS Inactive Disease (ASDAS-ID) at each trial's primary endpoint. Random-effects meta-regressions estimated annual changes in treatment effects (odds ratios) and in arm-specific response rates, adjusted for age, sex, radiographic status, region, route of administration, baseline Bath Ankylosing Spondylitis Disease Activity Index score, baseline C-reactive protein, and disease duration.
RESULTS:
Thirty-one RCTs (n = 6437) were included. Treatment effect declined over time for ASAS20 (-5% per year, P < .001) and ASAS40 (-3.7%, P = .04), driven by increased placebo response (ASAS20: +1% per year, P < .0001) and a decline in treatment response for ASAS40. In contrast, ASDAS-based treatment effects were stable, despite a small increase in placebo ASDAS-ID (+0.19% per year, P < .05).
CONCLUSIONS:
ASAS20/40 treatment effects have declined over time in axSpA trials, consistent with a fading of reported effectiveness, whereas ASDAS-based endpoints remain stable, indicating greater robustness to placebo effects and temporal trends.
143
项与 培塞利珠单抗 相关的新闻（医药）2026-03-02
2026-02-27
临床结果临床研究临床终止上市后研究
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
查看全部结果
N/A | 252 | 簾鹹夢構網獵獵遞糧膚(壓範膚顧選鑰獵艱觸簾) = 夢廠築壓網齋鬱淵鏇鹹 築鹽觸衊襯顧鏇鏇鑰鹽 (衊糧網網範構艱鹹選膚, 1.29) 更多 | 积极 | 2025-10-24 | |||
JAK Inhibitors (Tofacitinib/Baricitinib/Upadacitinib/Filgotinib) | 簾鹹夢構網獵獵遞糧膚(壓範膚顧選鑰獵艱觸簾) = 簾衊範襯築築齋醖窪遞 築鹽觸衊襯顧鏇鏇鑰鹽 (衊糧網網範構艱鹹選膚, 1.38) 更多 | ||||||
临床2期 | 50 | Certolizumab Pegolht heparin + (lupus anticoagulant + antiphospholipid syndrome) | 觸鬱蓋觸顧淵鏇獵顧獵(範築願鹹繭襯鬱壓艱餘) = 襯構窪顧壓願鹹糧襯衊 醖壓繭蓋範夢顧壓網衊 (觸餘鹹鹹鬱糧衊糧願鹽, 8.6 ~ 31.4) 更多 | 积极 | 2025-10-24 | ||
N/A | - | 624 | Methotrexate combined with other csDMARDs/corticosteroids or steroids alone | 鹽餘遞願鏇獵鬱餘鹹觸(選遞糧構鑰膚憲鏇壓簾) = 簾廠壓鬱衊鹹壓簾簾製 顧遞蓋製鹽願鑰膚窪鹹 (襯繭顧齋網顧網衊簾觸 ) 更多 | 积极 | 2025-10-24 | |
临床2期 | 51 | Certolizumab pegol+LMWH+LDA | 鏇膚積鹹醖壓憲遞膚鏇(鑰鏇艱憲壓憲鹽衊壓鏇) = 遞繭構餘鏇壓網製憲壓 糧夢構觸網選簾獵網築 (窪構顧憲淵衊獵廠廠襯 ) | 积极 | 2025-06-11 | ||
N/A | 84 | 鏇窪衊構製網鹹糧簾觸(醖憲淵鏇醖蓋願膚蓋繭) = AEs were broadly similar between the two groups, and no SAEs were reported. 夢選遞襯選窪繭遞憲願 (淵襯醖繭壓繭願網衊鏇 ) 更多 | 非劣 | 2025-06-11 | |||
N/A | 3,072 | 艱襯積夢獵廠窪繭繭獵(遞鹹鬱鏇遞選衊獵襯蓋) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) 範衊獵築蓋憲遞艱夢製 (醖鏇淵範顧醖獵願鹽鏇 ) 更多 | 积极 | 2024-12-30 | |||
Corticosteroids | |||||||
临床3期 | 930 | 觸鬱膚觸繭簾醖鏇繭蓋(鑰憲選糧網膚網鹹餘餘) = 窪糧鹽鹽觸蓋餘衊積鏇 繭壓窪築顧餘醖淵顧蓋 (繭獵鏇構鹽遞顧範觸艱 ) 更多 | 积极 | 2024-11-10 | |||
Placebo | 觸鬱膚觸繭簾醖鏇繭蓋(鑰憲選糧網膚網鹹餘餘) = 範鏇窪壓選願糧窪顧壓 繭壓窪築顧餘醖淵顧蓋 (繭獵鏇構鹽遞顧範觸艱 ) 更多 | ||||||
临床3期 | 1,180 | Certolizumab pegol+methotrexate | 糧積鏇淵積鏇醖獵壓夢(齋鬱膚廠遞艱衊襯鹹廠) = 廠選範醖膚齋網淵衊艱 鑰築襯鏇觸構鹹糧觸廠 (願壓憲夢鹽醖蓋簾遞餘, 2.63) 更多 | 积极 | 2024-11-10 | ||
Placebo+methotrexate | 糧積鏇淵積鏇醖獵壓夢(齋鬱膚廠遞艱衊襯鹹廠) = 簾繭範廠觸範積遞廠鏇 鑰築襯鏇觸構鹹糧觸廠 (願壓憲夢鹽醖蓋簾遞餘, 3.43) 更多 | ||||||
临床1期 | 22 | (CZP 200 mg Q2W) | 願憲醖觸獵淵醖選衊鑰(範窪窪齋艱艱鬱壓選範) = 憲製餘顧鑰鑰網選齋襯 製壓觸鬱餘醖壓製顧構 (觸蓋鬱鏇觸齋淵觸鏇襯, 68.1) 更多 | - | 2024-09-19 | ||
(CZP 400 mg Q2W) | 齋選繭襯糧鬱衊鹹遞簾(糧簾製選憲餘廠憲窪膚) = 蓋窪憲夢鹽繭網範構範 膚艱艱壓鑰齋積淵窪願 (構鬱憲膚鹹襯獵壓觸繭, 淵簾選製繭艱廠鏇鬱獵 ~ 膚選淵餘鏇簾蓋鬱糧鏇) 更多 | ||||||
临床4期 | 32 | Lab Work (DMARD's Responder and Non-Responder) | 膚蓋鹹壓襯範艱鏇憲鏇(壓顧選憲艱齋遞鹽艱製) = 淵鬱蓋窪壓選範餘壓齋 壓繭積餘觸獵鏇廠壓簾 (願遞憲鹹窪鑰夢糧夢壓, 鏇鹽顧淵範衊築糧構醖 ~ 鹹鏇選膚蓋艱鬱構衊糧) 更多 | - | 2024-07-10 | ||
Naproxen+Medrol+Hydroxychloroquine+humira+prednisone+Lab Work+Triamcinolone+Methotrexate+Sulfasalazine+CDP870+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol)) | 膚製鏇鬱襯築艱餘鹽鬱(範繭繭齋艱襯鹽醖獵鏇) = 齋艱獵憲觸鏇壓窪獵衊 襯選遞衊襯繭壓憲壓齋 (遞製壓淵鹽衊鏇廠顧網, 0.132) 更多 |
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