更新于：2024-09-21
Golimumab
戈利木单抗
更新于：2024-09-21
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基本信息
最高研发阶段批准上市 |
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特殊审评孤儿药 (美国) |
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序列信息
Sequence Code 10217CDR2-L
来源: *****
Sequence Code 34550CDR3-L
来源: *****
Sequence Code 208354L
来源: *****
Sequence Code 1694337H
来源: *****
Sequence Code 13027041CDR2-H
来源: *****
Sequence Code 535237464CDR3-H
来源: *****
Sequence Code 559603504CDR1-L
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Sequence Code 1167865419CDR1-H
来源: *****
关联
141
项与 戈利木单抗 相关的临床试验T1D-PLUS: An adaptive platform trial by INNODIA - a randomised, adaptive, open label, parallel group, multi-centre platform trial in adults with newly diagnosed type 1 diabetes
TRAMP: Tumor Necrosis Factor- α Blockade and AR Inhibition in Men With CRPC
一项在中重度活动性溃疡性结肠炎受试者中评价古塞奇尤单抗和戈利木单抗联合诱导和维持治疗的疗效和安全性的IIb期、随机、双盲、活性和安慰剂对照、平行组、多中心研究
100 项与 戈利木单抗 相关的临床结果
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100 项与 戈利木单抗 相关的转化医学
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100 项与 戈利木单抗 相关的专利（医药）
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1,680
项与 戈利木单抗 相关的文献（医药）2024-04-01British journal of pharmacology
Formation and clearance of TNF–TNF inhibitor complexes during TNF inhibitor treatment
Article
作者: Hart, Margaretha Hendrika Louise ; Vermeire, Severine ; I'Ami, Merel Jeanne ; Thomas, Debby ; Wolbink, Gerrit Jan ; Hooijberg, Femke ; Nurmohamed, Michael Twahier ; Vidarsson, Gestur ; Vogelzang, Erik Hans ; Kruithof, Simone ; Ten Brinke, Anja ; Bentlage, Arthur Ebel Herman ; Berkhout, Lea Catharina ; Rispens, Theo
Abstract:
Background and Purpose:
Millions of patients with inflammatory diseases are treated with tumour necrosis factor (TNF) inhibitors (TNFi). Individual treatment response varies, in part related to variable drug clearance. The role of TNF–TNFi complexes in clearance of the different TNFi is controversial. Moreover, mechanistic insight into the structural aspects and biological significance of TNF–TNFi complexes is lacking. We hypothesized a role for Fc‐mediated clearance of TNF–TNFi immune complexes. Therefore, we investigated circulating TNF–TNFi complexes upon treatment with certolizumab—lacking Fc tails—in comparison with adalimumab, golimumab, infliximab and etanercept.
Experimental Approach:
Drug‐tolerant ELISAs were developed and used to quantify TNF during adalimumab, golimumab, etanercept, certolizumab and infliximab treatment in patients with inflammatory arthritis or ulcerative colitis for a maximum follow‐up of 1 year. Effects on in vitro TNF production and Fc‐mediated uptake of TNF–TNFi complexes were investigated for all five TNFi.
Key Results:
Circulating TNF concentrations were >20‐fold higher during certolizumab treatment compared with adalimumab, reaching up to 23.1 ng·ml−1. Internalization of TNF–TNFi complexes by macrophages depended on Fc valency, with efficient uptake for the full antibody TNFi (three Fc tails), but little or no uptake for etanercept and certolizumab (one and zero Fc tail, respectively). TNF production was not affected by TNFi. Total TNF load did not affect clearance rate of total TNFi.
Conclusions and Implications:
Differences in TNFi structure profoundly affect clearance of TNF, while it is unlikely that TNF itself significantly contributes to target‐mediated drug disposition of TNFi.
2024-03-03Expert review of clinical immunology
How should we approach management of childhood onset chronic anterior uveitis refractory to adalimumab?
Review
作者: Foeldvari, Ivan ; Petrushkin, Harry
INTRODUCTION:
The management of refractory juvenile idiopathic associated uveitis (JIAU) or childhood-onset chronic anterior uveitis (CAU) is a challenge. There is no clear consensus or evidence base for to suggest the most appropriate therapy after primary or secondary failure of biweekly adalimumab. In this scenario, most clinicians advocate switching to another anti-tumor necrosis factor alpha inhibitor; however, there are a variety of other disease modifying agents to choose from albeit with a differing levels of evidence.
AREAS COVERED:
We discuss how to define nonresponse and potential treatment options for patients with JIAU and CAU refractory to biweekly adalimumab.
EXPERT OPINION:
Uncontrolled CAU and JIAU remain one of the most challenging diseases to manage and can lead to irreversible loss of vision in a third of those affected. Amongst the possible choices, weekly adalimumab, infliximab, tocilizumab and abatacept have more evidence to support their use. JAK inhibitors seem to be a promising option. Golimumab and Rituximab has also been thought to be partially effective in some refractory cases, whereas IL-17, IL-23, and IL-12 inhibition along with apremilast seem not to be a therapeutic option currently. The route of administration should also be considered as there can be significant pros and cons for different children.
2024-02-26Modern rheumatology
Risk of hospitalized infections in older elderly patients with rheumatoid arthritis treated with tocilizumab or other biological/targeted synthetic disease-modifying antirheumatic drugs: Evaluation of data from a Japanese claims database
Article
作者: Iwasaki, Katsuhiko ; Shoji, Ayako ; Yamashita, Katsuhisa ; Igarashi, Ataru ; Harigai, Masayoshi ; Kawahito, Yutaka ; Fujii, Takao ; Okada, Norihiro ; Yoshida, Amika ; Makishima, Misako ; Yamaguchi, Hiroko ; Sakai, Ryoko
ABSTRACT:
Objective:
We compared the incidence rates of hospitalized infections (HIs) between tocilizumab (TCZ) and other biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in adults aged ≥75 years with rheumatoid arthritis (RA).
Methods:
We used a Japanese claims database from Medical Data Vision Co., Ltd (Tokyo, Japan) to perform a retrospective longitudinal population-based study in patients with RA who were prescribed b/tsDMARDs between 2014 and 2019. We calculated adjusted risk ratios (aRRs) for HIs in three age groups (<65, ≥65 and <75, and ≥75 years).
Results:
Of 5506 patients, 2265 (41.1%) were <65 years, 1709 (31.0%) were 65–74 years, and 1532 (27.8%) were ≥75 years. Crude incidence rates (/100 person-years) of HIs were 3.99, 7.27, and 10.77, respectively. In the oldest group, aRRs (95% confidence interval) for HIs (b/tsDMARDs versus TCZ) were as follows: etanercept, 2.40 (1.24–4.61); adalimumab, 1.90 (0.75–4.83); golimumab, 1.21 (0.66–2.23); and abatacept, 0.89 (0.49–1.62). In the other age groups, the noticeable difference was a lower aRR of etanercept versus TCZ in the youngest group (0.30, 0.11–0.85).
Conclusion:
In patients with RA aged ≥75 years, b/tsDMARDs have a similar risk of HIs to tocilizumab except for etanercept.
100 项与 戈利木单抗 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 |
|---|---|---|---|
| AxSpA | 欧盟 | 2009-10-01 | |
| AxSpA | 冰岛 | 2009-10-01 | |
| AxSpA | 列支敦士登 | 2009-10-01 | |
| AxSpA | 挪威 | 2009-10-01 | |
| 溃疡性结肠炎 | 欧盟 | 2009-10-01 | |
| 溃疡性结肠炎 | 冰岛 | 2009-10-01 | |
| 溃疡性结肠炎 | 列支敦士登 | 2009-10-01 | |
| 溃疡性结肠炎 | 挪威 | 2009-10-01 | |
| 幼年特发性关节炎 | 欧盟 | 2009-10-01 | |
| 幼年特发性关节炎 | 冰岛 | 2009-10-01 | |
| 幼年特发性关节炎 | 列支敦士登 | 2009-10-01 | |
| 幼年特发性关节炎 | 挪威 | 2009-10-01 | |
| 非放射性轴性脊柱关节炎 | 欧盟 | 2009-10-01 | |
| 非放射性轴性脊柱关节炎 | 冰岛 | 2009-10-01 | |
| 非放射性轴性脊柱关节炎 | 列支敦士登 | 2009-10-01 | |
| 非放射性轴性脊柱关节炎 | 挪威 | 2009-10-01 | |
| 多关节型幼年特发性关节炎 | 欧盟 | 2009-10-01 | |
| 多关节型幼年特发性关节炎 | 冰岛 | 2009-10-01 | |
| 多关节型幼年特发性关节炎 | 列支敦士登 | 2009-10-01 | |
| 多关节型幼年特发性关节炎 | 挪威 | 2009-10-01 |
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 |
|---|---|---|---|---|
| 炎症 | 临床3期 | 比利时 | 2017-11-08 | |
| 涎腺多形性腺瘤 | 临床3期 | 英国 | 2015-10-27 | |
| 附着点炎 | 临床3期 | 葡萄牙 | 2014-08-01 | |
| 多发性关节炎 | 临床3期 | 美国 | 2010-12-01 | |
| 多发性关节炎 | 临床3期 | 美国 | 2010-12-01 | |
| 多发性关节炎 | 临床3期 | 奥地利 | 2010-12-01 | |
| 多发性关节炎 | 临床3期 | 奥地利 | 2010-12-01 | |
| 多发性关节炎 | 临床3期 | 比利时 | 2010-12-01 | |
| 多发性关节炎 | 临床3期 | 比利时 | 2010-12-01 | |
| 多发性关节炎 | 临床3期 | 巴西 | 2010-12-01 |
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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3期 | 127 | 遞淵糧糧觸築鏇簾餘鹽(襯築積餘簾遞鹽夢願鏇) = AEs and SAEs were reported in 92.1% and 19.7% of pts, respectively. One death (septic shock) occurred. 夢積願簾遞簾遞遞製廠 (壓繭範遞鹽鹽觸築膚夢 ) | 积极 | 2023-11-12 | |||
Placebo | |||||||
N/A | - | 窪繭膚鬱夢積淵積積獵(構築憲鹽廠積鹽願夢齋) = 28 SJS/TEN cases related secondary to GA has been reported the period 2010 to 2021 world-wide with a female preponderance and majority of case developing within 6 to 12 months after inception of the medication 憲窪鏇積顧糧廠窪網簾 (蓋齋窪鹹襯鬱夢選夢鑰 ) | - | 2023-07-03 | |||
临床3期 | 1,228 | 製鏇夢憲蓋餘膚遞範顧(夢醖獵觸廠築製蓋廠醖) = 蓋選鹽艱繭鬱願憲鹽範 餘齋衊壓憲膚願憲積鑰 (夢壓遞鬱壓襯網鏇醖齋 ) | 积极 | 2023-07-01 | |||
製鏇夢憲蓋餘膚遞範顧(夢醖獵觸廠築製蓋廠醖) = 醖鏇網鹹鏇衊艱選遞鹹 餘齋衊壓憲膚願憲積鑰 (夢壓遞鬱壓襯網鏇醖齋 ) | |||||||
N/A | 227 | 醖鬱願襯簾積齋鬱蓋鑰(襯觸壓觸積觸網觸網夢): hazard ratio = 1.58 (95% CI, 0.96 ~ 2.6), P-Value = 0.069 | 不佳 | 2023-05-31 | |||
临床4期 | 1,270 | 廠鏇築糧觸衊願簾襯製(淵襯鬱鬱鹹糧夢範膚鏇) = 衊遞艱觸鹽窪願夢齋鹹 鑰積襯積獵衊觸蓋廠鹽 (鹹構選夢窪製築獵繭襯 ) 更多 | - | 2023-02-23 | |||
廠鏇築糧觸衊願簾襯製(淵襯鬱鬱鹹糧夢範膚鏇) = 遞顧鏇蓋膚獵廠夢襯蓋 鑰積襯積獵衊觸蓋廠鹽 (鹹構選夢窪製築獵繭襯 ) 更多 | |||||||
N/A | - | 餘壓築壓製鬱蓋鹹糧鹹(遞淵襯鬱鹹願夢壓鹽醖) = p=0.03 by χ2-test 憲簾範餘鹽積繭艱糧範 (觸淵築齋鹽鹽糧製選醖 ) 更多 | 积极 | 2022-11-13 | |||
N/A | - | 鬱醖網築觸淵獵齋選願(鏇鏇網蓋選鏇構窪鹽網) = 廠選齋鬱窪醖網繭齋壓 鹽窪衊蓋顧憲夢獵鹹鏇 (襯艱築築願糧積築遞網 ) 更多 | - | 2022-11-13 | |||
N/A | 712 | 積願壓築顧窪獵選襯膚(衊鬱鬱範積鹽鹹顧製鹹) = 醖遞積遞糧齋製鏇觸簾 鹹網夢鏇鹽製鹹簾選範 (襯鏇繭築範淵蓋繭蓋糧 ) 更多 | 积极 | 2022-11-12 | |||
临床2期 | 84 | placebo (Placebo) | 鹽憲簾憲壓獵繭蓋選廠(範觸鹹淵衊襯鹹窪鬱窪) = 窪選鑰遞夢膚鑰網範鏇 壓願餘餘糧餘簾築糧鹹 (製觸觸艱築淵網壓衊襯, 餘積膚顧艱觸鹹製壓鑰 ~ 鹹夢選廠網願鏇獵簾醖) 更多 | - | 2022-07-14 | ||
(Golimumab) | 鹽憲簾憲壓獵繭蓋選廠(範觸鹹淵衊襯鹹窪鬱窪) = 艱膚艱淵餘鏇鹽餘選鬱 壓願餘餘糧餘簾築糧鹹 (製觸觸艱築淵網壓衊襯, 壓壓選壓餘顧窪製憲鬱 ~ 鏇鬱遞醖顧蓋顧蓋製範) 更多 | ||||||
N/A | 530 | 網製膚窪構夢糧遞廠積(遞糧蓋廠鏇觸鏇鏇遞艱) = 鹽艱糧鏇顧夢繭窪鬱鹹 膚淵窪鹽夢積淵壓選鏇 (糧製製築願製鑰顧積夢 ) 更多 | - | 2022-06-01 |
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