更新于：2024-09-21
Golimumab
戈利木单抗
更新于：2024-09-21
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序列信息
Sequence Code 10217CDR2-L
来源: *****
Sequence Code 34550CDR3-L
来源: *****
Sequence Code 208354L
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Sequence Code 1694337H
来源: *****
Sequence Code 13027041CDR2-H
来源: *****
Sequence Code 535237464CDR3-H
来源: *****
Sequence Code 559603504CDR1-L
来源: *****
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
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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 相关的专利（医药）
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1,729
项与 戈利木单抗 相关的文献（医药）2024-12-01Journal of Translational Autoimmunity
To switch or to swap? Evidence from a meta-analysis for the best treatment approach in childhood chronic uveitis resistant to the I anti-TNF
Review
作者: Pagnini, Ilaria ; Soldovieri, Sara ; Marrani, Edoardo ; Oliverio, Teodoro ; de Masi, Salvatore ; Maccora, Ilaria ; Simonini, Gabriele ; Mastrolia, Maria Vincenza
Objective:
Since adalimumab approval in childhood chronic non-infectious uveitis (cNIU), the prognosis has been dramatically changed, but the 25 % failed to achieve inactivity. There is not accordance if it is better to switch to another anti-TNF or to swap to another category of biologic. Thus, we aim to summarize evidence regarding the best treatment of cNIU refractory to the first anti-TNF.
Methods:
A systematic literature review and meta-analysis, according to PRISMA Guidelines, was performed(Jan2000-Aug2023). Studies investigating the efficacy of treatment in cNIU refractory to the first anti-TNF were considered for inclusion. The primary outcome was the improvement of intraocular inflammation according to SUN. A combined estimation of the proportion of children responding to switch or swap and for each drug was performed.
Results:
23 articles were eligible, reporting 150 children of whom 109 switched anti-TNF (45 adalimumab, 49 infliximab, 9 golimumab) and 41 swapped to another biologics (31 abatacept, 8 tocilizumab and 1 rituximab). The proportion of responding children was 46 %(95 % CI 23-70) for switch and 38 %(95 % CI 8-73) for swap (χ20.02, p = 0.86). Instead analysing for each drug, the proportion of responding children was the 24 %(95 % CI 2-55) for adalimumab, 43 %(95 % CI 2-80) for abatacept, 79 %(95 % CI 61-93) for infliximab, 56 %(95 % CI 14-95) for golimumab and 96 %(95 % CI 58-100) for tocilizumab. We evaluated a superiority of tocilizumab and infliximab compared to the other drugs(χ2 27.5 p < 0.0001).
Conclusion:
Although non-conclusive, this meta-analysis suggests that, after the first anti-TNF failure, tocilizumab and infliximab are the best available treatment for the management of cNIU.
2024-11-01GENE
Genetic variants in the TNF pathway impact TNFi response in a mixed population with rheumatoid arthritis
Article
作者: Dos Anjos Silva, Mailane ; Alexandrina Viana de Figueiredo, Camila ; Augusto Silva Dos Santos Rodrigues, Pedro ; Augusto Souza da Cruz Filho, Álvaro ; Dos Santos Costa, Ryan ; Victor Andrade Cruz, João ; de Moura Santos, Pablo ; Flávia Silva Rocha, Ana ; Mattos Brandão, Katarina ; Cardoso Calmon, Laryssa ; Miranda Barbosa Dos Santos, Thamara ; de Oliveira Santos, Junison ; Silva Carvalho de Souza, Deyse ; de Sá Garcia Landeiro, Lilian ; Tupiná Alcântara de Moreira, Aramis ; Lima de Oliveira, Almirane ; Pimentel Pinheiro, Gabriela
Rheumatoid arthritis (RA) is a multifactorial autoimmune inflammatory disease that mainly affects the joints, on reducing functional capacity and impacting quality of life. Cytokines such as tumor necrosis factor (TNF) and interleukin 6 (IL-6) are crucial in the pathogenesis and treatment of this disease. Some patients using TNF inhibitors (TNFi) do not respond or lose their response to these medications. Clinical, sociodemographic, and genetic data were used to evaluate the associations of single nucleotide polymorphisms (SNP) in TNF, TNFRSF1A, and TNFRSF1B genes with the diagnosis of RA, standardized score results, laboratory tests, and response to TNFi. In one subsample, TNF and IL-6 serum levels cytokines were performed. A total of 654 subjects (360 healthy controls and 294 diagnosed with RA) were included in the analysis. Higher levels of TNF have been found in individuals diagnosed with RA. IL-6 levels were higher in individuals who did not respond to TNFi treatment, while responders had levels comparable to those without the disease. No associations were found between the SNPs studied and the diagnosis of RA; however, rs767455-C seems to play a role in the response to golimumab treatment, being related to better therapeutic response and lower mean serum leukocyte levels. In addition, rs1061622-G was associated with poorer functional capacity and rs1800629-A was associated with higher leukocyte values and serum transaminase levels. The rs1061622-G and rs767455-C may play a role in the response to TNFi treatment, especially for patients using golimumab, although they do not seem to be associated with the diagnosis of RA. Polymosphisms in the TNF pathway may impact baseline levels of immune cells and markers of renal and hepatic function in RA patients. Our results highlight the importance of evaluating the impact of these polymorphisms on TNFi response and safety, particularly in larger-scale studies.
2024-09-01Drugs-Real World Outcomes
Comparison of Real-World On-Label Treatment Persistence in Patients with Psoriatic Arthritis Receiving Guselkumab Versus Subcutaneous Tumor Necrosis Factor Inhibitors
Article
作者: Pilon, Dominic ; Shiff, Natalie J ; Yu, Louise H ; Mease, Philip ; Schwartzbein, Samuel ; Morrison, Laura ; Zhao, Ruizhi ; Walsh, Jessica A ; Lin, Iris ; Chakravarty, Soumya D ; Lefebvre, Patrick ; Emond, Bruno
BACKGROUND:
Treatment persistence among patients with psoriatic arthritis (PsA) is essential for achieving optimal treatment outcomes. Guselkumab, a fully human interleukin-23p19-subunit inhibitor, was approved by the United States (US) Food and Drug Administration for the treatment of active PsA in July 2020, with a dosing regimen of 100 mg at week 0, week 4, then every 8 weeks. In the Phase 3 DISCOVER-1 and DISCOVER-2 studies of patients with active PsA, 94% of guselkumab-randomized patients completed treatment through 1 year and 90% did so through 2 years (DISCOVER-2). Real-world evidence is needed to compare treatment persistence while following US prescribing guidelines (i.e., on-label persistence) for guselkumab versus subcutaneous (SC) tumor necrosis factor inhibitors (TNFis).
METHODS:
Adults with PsA receiving guselkumab or their first SC TNFi (i.e., adalimumab, certolizumab pegol, etanercept, or golimumab) between 14 July 2020 and 31 March 2022 were identified in the IQVIA PharMetrics® Plus database (first claim defined the treatment start date [index date]). Baseline characteristics and biologic use (biologic-naïve/biologic-experienced) were assessed during the 12-month period preceding the index date. Baseline characteristics were balanced between cohorts using propensity-score weighting based on the standardized mortality ratio approach. The follow-up period spanned from the index date until the earlier of the end of continuous insurance eligibility or end of data availability. On-label persistence, defined as the absence of treatment discontinuation (based on a gap of 112 days for guselkumab or 56 days for SC TNFi) or any dose escalation/reduction during follow-up, was assessed in the weighted treatment cohorts using Kaplan-Meier (KM) curves. A Cox proportional hazards model, further adjusted for baseline biologic use, was used to compare on-label persistence between the weighted cohorts.
RESULTS:
The guselkumab cohort included 526 patients (mean age 49.8 years; 61.2% female) and the SC TNFi cohort included 1953 patients (mean age: 48.5 years; 60.2% female). After weighting, baseline characteristics were well balanced with a mean follow-up of 12.3-12.4 months across cohorts; 51.5% of patients in the guselkumab cohort and 16.7% in the SC TNFi cohort received biologics in the 12-month baseline period. Respective rates of treatment persistence at 3, 6, 9, and 12 months were 91.2%, 84.1%, 75.9%, and 71.5% for the guselkumab cohort versus 77.3%, 61.6%, 50.0%, and 43.7% for the SC TNFi cohort (all log-rank p < 0.001). At 12 months, patients in the guselkumab cohort were 3.0 times more likely than patients in the SC TNFi cohort to remain persistent on treatment (p < 0.001). Median time to discontinuation was not reached for the guselkumab cohort and was 8.9 months for the SC TNFi cohort.
CONCLUSION:
This real-world study employing US commercial health-plan claims data to assess on-label treatment persistence in PsA demonstrated that, at 12 months, guselkumab was associated with a 3 times greater likelihood of persistence compared with SC TNFi.
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
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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
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适应症
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临床3期 | 127 | 簾淵製鏇艱衊構願糧膚(獵壓蓋鹹餘積築鏇艱遞) = AEs and SAEs were reported in 92.1% and 19.7% of pts, respectively. One death (septic shock) occurred. 齋鏇窪繭網網淵網鹽壓 (範願繭顧蓋衊鏇觸願艱 ) | 积极 | 2023-11-12 | |||
Placebo | |||||||
N/A | - | 鹹糧淵夢餘構築餘願憲(膚繭糧簾夢醖齋範鏇範) = 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 鹹選網網鬱齋膚遞鑰願 (願鬱顧獵廠範壓鏇窪顧 ) | - | 2023-07-03 | |||
临床3期 | 1,228 | 構壓膚糧選鏇醖膚衊衊(壓壓醖築獵鑰憲鑰積簾) = 鹽糧築糧衊糧廠願廠鏇 製積鹹積觸醖憲齋獵糧 (衊憲鹹艱膚鏇繭選選襯 ) | 积极 | 2023-07-01 | |||
構壓膚糧選鏇醖膚衊衊(壓壓醖築獵鑰憲鑰積簾) = 壓鏇壓膚鏇淵選淵鏇艱 製積鹹積觸醖憲齋獵糧 (衊憲鹹艱膚鏇繭選選襯 ) | |||||||
N/A | 227 | 夢夢糧選築築鏇網構齋(鹽鑰壓衊選範蓋構願襯): 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 | 齋膚蓋膚壓網鑰窪蓋鑰(構膚獵鑰餘築窪齋顧築) = 繭膚鹹積鏇繭壓壓願簾 選艱夢蓋艱範醖遞淵膚 (廠鏇膚顧築窪願衊夢鹽 ) 更多 | - | 2023-02-23 | |||
齋膚蓋膚壓網鑰窪蓋鑰(構膚獵鑰餘築窪齋顧築) = 艱蓋壓廠觸顧鏇艱襯鏇 選艱夢蓋艱範醖遞淵膚 (廠鏇膚顧築窪願衊夢鹽 ) 更多 | |||||||
N/A | - | 範淵觸廠積顧簾網鑰膚(觸夢襯艱夢窪範夢築簾) = p=0.03 by χ2-test 願憲餘鹹憲廠繭選膚壓 (蓋鹹構簾構膚餘觸構壓 ) 更多 | 积极 | 2022-11-13 | |||
N/A | - | 襯願構選顧遞製夢鬱襯(鏇遞遞鹽願糧簾膚襯構) = 遞廠願觸廠繭範糧鏇齋 憲鑰蓋繭構繭憲範壓構 (獵願淵鑰鏇選齋鑰繭繭 ) 更多 | - | 2022-11-13 | |||
N/A | 712 | 願簾壓廠蓋製遞網顧窪(鑰構糧廠積糧鬱衊艱網) = 網鹹衊憲製淵廠襯齋繭 艱觸範廠顧齋遞鑰齋製 (顧觸築範選壓顧鑰艱衊 ) 更多 | 积极 | 2022-11-12 | |||
临床2期 | 84 | placebo (Placebo) | 製觸憲鹹鹽繭鏇淵製膚(憲獵鹽選觸蓋憲餘窪夢) = 鬱艱糧鑰觸選鑰網齋齋 襯鹹淵壓餘繭醖膚觸網 (壓製鏇廠網鹹築範顧糧, 鏇膚願築製艱積蓋憲艱 ~ 願鹽構積範醖艱醖憲艱) 更多 | - | 2022-07-14 | ||
(Golimumab) | 製觸憲鹹鹽繭鏇淵製膚(憲獵鹽選觸蓋憲餘窪夢) = 糧蓋鑰鏇夢選糧襯鹹鑰 襯鹹淵壓餘繭醖膚觸網 (壓製鏇廠網鹹築範顧糧, 醖製鑰艱構製膚構選簾 ~ 膚壓糧獵遞壓簾餘襯醖) 更多 | ||||||
N/A | 530 | 範糧壓築選構膚壓齋鬱(構簾夢製齋蓋願淵構餘) = 廠顧範壓醖夢網選襯廠 鬱獵壓餘獵鹹選淵艱襯 (觸遞壓蓋襯網鹹鹽窪製 ) 更多 | - | 2022-06-01 |
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