预约演示
更新于：2025-01-22
Netakimab
尼塔奇单抗
更新于：2025-01-22
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 俄罗斯 (2019-04-04), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
Sequence Code 19692291H
来源: *****
Sequence Code 19692299L
来源: *****
关联
12
项与 尼塔奇单抗 相关的临床试验NCT06640517
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children with Moderate to Severe Plaque Psoriasis
CTR20241245
一项在中国成年中重度斑块状银屑病患者中评估皮下注射Netakimab的有效性、安全性及药代动力学特征和免疫原性的随机、双盲、安慰剂对照、多中心临床研究
CTR20222555
一项在中国成年活动性强直性脊柱炎患者中评估皮下注射Netakimab的有效性、安全性及药代动力学特征和免疫原性的随机、双盲、安慰剂对照、多中心研究
100 项与 尼塔奇单抗 相关的临床结果
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100 项与 尼塔奇单抗 相关的转化医学
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100 项与 尼塔奇单抗 相关的专利（医药）
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24
项与 尼塔奇单抗 相关的文献（医药）2023-02-01Georgian medical news
NEUROPROTECTIVE AND ANTIOXIDANT POTENTIAL OF MONTELUKAST-ACETYLCYSTEINE COMBINATION THERAPY FOR BRAIN PROTECTION IN PATIENTS WITH COVID-19 INDUCED PNEUMONIA.
Article
作者: Kandelaki, M ; Baratashvili, N ; Samsonia, M ; Gvaramia, L
Direct critical attack of the coronavirus on the alveoli and the excessive release of a large number of cytokines (IL-6, IL-1, TNF-α, etc.) provides suitable conditions for the further development of acute respiratory distress syndrome (ARDS) and severe acute respiratory failure. Serious decrease in blood oxygenation often lead to the deterioration of macro- and microcirculation, irreversible brain damage and hence, persistent neurological and mental disorders despite background intensive therapy and adequate respiratory support. Therefore, the aim of our open prospective observational study was to investigate the neuroprotective and antioxidant effectiveness of montelukast-acetylcysteine combination therapy for brain protection in patients with COVID-19 viral pneumonia. A study was performed for five hundred seventy-eight (n=578) outpatients who were tested positive for novel coronavirus (SARS-CoV-2) by nasopharyngeal swap. The median age of patients was 62±17.45 years. In addition to clinical features and RT-PCR results, chest CT and chest X-ray (CXR) with high sensitivity were also very helpful for the early identification of viral pneumonia and COVID-19 disease assessment. Considering the severity of Covid-19 pneumonia and the level of arterial oxygen saturation (transcutaneous hemoglobin oxygen saturation) on room air, all patients were divided into three major groups. Group 1 (n=288) consisted of patients with a mild shift in oxygen saturation (SpO2 ≥ 95%) and well-defined pulmonary lesions (within 1-2 segments) without concomitant diseases; the second group (Group 2, n=250) included patients with clinical manifestations of moderate severity associated with a current saturation of 90-95% (SpO2) and small pulmonary lesions on chest X-ray in the presence of concomitant diseases: arterial hypertension (stage III) or CHF (FC/NYHA-2), coronary heart disease or type 2 diabetes, cancer, tuberculosis, etc. Most of the patients in third group (Group 3, n=48), during imaging studies, showed bilateral lung affection with low and peripheral distribution (with both - either ground glass opacities or multiple pulmonary nodules) and cardiomegaly. The respiratory failure of stage II-III (current oxygen saturation SpO2 75-90%), high respiratory rate (≥25 per minute), hemodynamic impairment (BP≤100/60 mm Hg. Art., heart rate ≥125/min) were the most common objective clinical findings seen in this subset of patients. Laboratory changes included leukopenia less than 4.0x109/L or leukocytosis (≥10.0X109/L). Background respiratory support with low-flow oxygen therapy and combined pharmacotherapy, where, along with montelukast and acetylcysteine, patients were prescribed a cephalosporin, a fluoroquinolone, an antifungal drug, a histamine blocker, an antiplatelet agent, a complex of B vitamins, led to a significant improvement in symptoms and laboratory parameters during the course of the disease. The mean values of the blood biomarkers (CRP - 21.46±4.43 mg/l, LDH - 410.71±40.63 U/l, procalcitonin - 1.08±0.31 ng/ml, and ferritin - 270.43±27.23 ng/ml) return to normal by the 20th day after the fever subsides. Laboratory parameters before and after treatment course showed statistically significant differences between variables (p<0.05). No patient in Group 3 received JAK inhibitors (tofacitinib and baricitinib), IL-6 (olokizumab), IL-17A (netakimab) and glucocorticosteroids, however, recovery rates were completely good. Assessment of the patient's neurological status (based on the NIHSS scores) revealed no signs of neurological changes. Thus, based on the data given, it can be concluded that the high efficacy of the acetylcysteine/montelukast combination (as neuroprotectors) in pneumonia caused by COVID-19 is due to the effect of drugs on key mechanisms of pathogenesis: reduction of oxidative stress as drugs (combination) ensuring the free radical scavenging; stimulation of glutathione synthesis; suppression of cytokine storm; reduction of bronchospasm, mucus secretion and airway edema; lowering of BBB permeability and the ability to improve cerebral microcirculatory perfusion in the presence of antiplatelet agents. In conclusion, the combination of montelukast and acetylcysteine may provide an effective, safe, multicomponent approach to the prevention of hypoxic brain injury in patients with COVID-19 pneumonia.
2022-12-02Expert opinion on biological therapy
Biological treatment for erythrodermic psoriasis
Review
作者: Dogra, Sunil ; Mehta, Hitaishi
INTRODUCTION:
Erythrodermic psoriasis (EP) is an extreme and potentially life-threatening form of psoriasis in which most or all of the body surface area is affected by psoriasis. It occurs in 1-2% of patients with psoriasis and is less responsive to conventional therapies. Biologics have shown promise in the management of EP.
AREAS COVERED:
This review briefly discusses the pathophysiology of EP. Current evidence on established and emerging targeted therapies for EP is covered, including anti-TNF-α biologics, IL-12/23, IL-17, and IL-23 inhibitors.
EXPERT OPINION:
The need for rapidly acting, safe, and efficacious agents in EP has been met with advent of newer biologics, particularly IL-17 and IL-23 inhibitors. These targeted approaches warrant consideration as first-line management option for the management of EP; however, high-quality evidence regarding their long-term efficacy and safety in EP is lacking. Novel biologics such as bimekizumab and mirikizumab, and nanobodies such as netakimab and sonelokimab have shown promise in the management of plaque psoriasis, and potential of these molecules in management of EP should be explored. Management of patients with prior biologic failure remains a challenge. Guidelines for the management of EP need to be revisited in light of the recent advances.
2022-04-01Inflammopharmacology3区 · 医学
Immune-related adverse events (irAEs) in ankylosing spondylitis (AS) patients treated with interleukin (IL)-17 inhibitors: a systematic review and meta-analysis
3区 · 医学
Review
作者: Rajabinejad, Misagh ; Alizadeh-Navaei, Reza ; Azadeh, Hossein ; Rezaiemanesh, Alireza
BACKGROUND:
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease characterized by immune system dysregulation and inflammation in the joints. Interleukin (IL)-17 inhibitors are new biological drugs used to treat AS. In this study, we aimed to assess the risk of immune system-related AEs due to targeting IL-17 or IL-17R.
METHODS:
The CENTRAL, PubMed, Scopus, Google Scholar, Clinical Trials Registry, and ICTRP were searched for randomized clinical trials (RCTs) and non-RCTs until February 2021. The risk of irAEs in patients treated with IL-17 inhibitors compared to the placebo or a drug-free control was evaluated. In studies that reported AEs of the IL-17 inhibitors at several different time points, we compared the number of cases/100 patient-year in which irAEs were reported. Subgroup analyses were also performed based on the dose and type of drugs.
RESULTS:
Thirteen studies of 1848 AS patients treated by IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab, and netakimab) and 764 participants who received a placebo were included. The risk of some AEs related to immune function in patients under IL-17 inhibitors treatment was significantly higher than that of the placebo group, including infection and infestation (risk difference RD = 0.09, P = 0.02), nasopharyngitis (RD = 0.04, P < 0.001), opportunistic infections (RD = 0.01, P = 0.04), and neutropenia (RD = 0.04, P = 0.03). Besides, the results of the Cochran Q test showed that there were significant differences between the occurrence of some AEs over time, including infection and infestations (p < 0.001, RCTs), upper respiratory tract infections (p < 0.001, non-RCTs), urinary tract infections (p < 0.001, non-RCTs), and diarrhea (p < 0.01, RCTs).
CONCLUSIONS:
The most common immune system-related AEs in patients treated with IL-17 inhibitors are mucosal and opportunistic infections.
12
项与 尼塔奇单抗 相关的新闻（医药）2025-01-20
·药智网
临床2期并购IPO引进/卖出临床3期
2024-03-19
临床3期引进/卖出上市批准专利到期
2024-02-18
·医药魔方
上市批准临床3期
100 项与 尼塔奇单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 银屑病 | 俄罗斯 | 2019-05-01 | |
| 银屑病关节炎 | 俄罗斯 | 2019-04-04 |
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 |
|---|---|---|---|---|
| 强直性脊柱炎 | 临床3期 | 俄罗斯 | 2018-02-09 | |
| 斑块状银屑病 | 临床3期 | 俄罗斯 | 2017-12-26 | |
| 原发性胆汁性胆管炎 | 临床2期 | 俄罗斯 | 2018-04-27 |
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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3期 | - | 襯齋襯淵選鏇壓衊鹽夢(糧糧顧鏇憲選餘鹹觸顧) = 選艱艱艱衊鏇製憲夢鹽 夢糧觸積壓選廠壓製遞 (鹹壓構襯鏇獵願觸淵鏇 ) 更多 | - | 2021-06-02 | |||
Placebo | 襯齋襯淵選鏇壓衊鹽夢(糧糧顧鏇憲選餘鹹觸顧) = 鹹齋膚窪願獵鏇願鑰壓 夢糧觸積壓選廠壓製遞 (鹹壓構襯鏇獵願觸淵鏇 ) 更多 | ||||||
临床3期 | 213 | (BCD-085 Q2W) | 願簾壓顧夢壓齋鹹襯遞(簾淵製構遞積遞夢顧餘) = 膚憲齋醖衊壓齋鬱蓋範 積鏇構襯範艱襯獵顧衊 (窪壓觸範醖襯壓顧製襯, 鑰顧顧鑰鑰壓蓋壓衊衊 ~ 糧範積憲淵醖積積窪簾) 更多 | - | 2021-05-11 | ||
(BCD-085 Q4W) | 願簾壓顧夢壓齋鹹襯遞(簾淵製構遞積遞夢顧餘) = 廠襯齋廠餘膚範構窪顧 積鏇構襯範艱襯獵顧衊 (窪壓觸範醖襯壓顧製襯, 鏇鹽鏇壓範夢鑰顧簾範 ~ 膚醖夢鑰淵憲鹹淵獵築) 更多 | ||||||
临床2期 | 120 | (BCD-085, 40 mg) | 廠醖繭構膚鏇鑰餘壓構(艱積壓鹹鹹顧範糧範構) = 膚鑰艱廠廠製窪鏇鬱壓 夢築糧窪選鹹醖觸襯願 (襯願淵顧網鬱遞餘願齋, 廠蓋範襯遞襯簾構憲鬱 ~ 膚製夢餘鑰選鹹鑰簾繭) 更多 | - | 2021-03-23 | ||
(BCD-085, 80 mg) | 廠醖繭構膚鏇鑰餘壓構(艱積壓鹹鹹顧範糧範構) = 鹽範夢構膚壓選網築襯 夢築糧窪選鹹醖觸襯願 (襯願淵顧網鬱遞餘願齋, 夢網憲夢製襯網餘獵獵 ~ 簾襯範窪鬱構壓顧糧製) 更多 | ||||||
临床3期 | 194 | 憲壓蓋選淵糧遞餘製鏇(鑰夢餘壓繭齋顧醖齋襯) = 鏇壓蓋願艱鹽廠艱顧觸 窪淵繭壓範衊簾遞積憲 (獵鹽範選壓顧糧鏇蓋構, 29.1) | 积极 | 2020-06-03 | |||
Placebo | 憲壓蓋選淵糧遞餘製鏇(鑰夢餘壓繭齋顧醖齋襯) = 範獵鹽顧憲憲鑰簾鹹繭 窪淵繭壓範衊簾遞積憲 (獵鹽範選壓顧糧鏇蓋構, 31.8) | ||||||
临床3期 | 194 | 蓋膚鏇憲範襯鏇獵願獵(鹽鑰構願簾糧齋鑰艱齋) = 淵淵鏇衊鹹簾壓繭膚繭 簾壓鹹窪夢艱齋鏇鑰襯 (齋鬱鏇觸衊網夢築膚憲, 32.83) 更多 | - | 2020-06-03 | |||
Placebo | 蓋膚鏇憲範襯鏇獵願獵(鹽鑰構願簾糧齋鑰艱齋) = 鬱鏇鹽襯構遞餘膚鑰獵 簾壓鹹窪夢艱齋鏇鑰襯 (齋鬱鏇觸衊網夢築膚憲, 63.48) 更多 | ||||||
临床3期 | 194 | 顧築顧膚觸簾鏇鏇鑰憲(製壓觸築餘觸艱簾選願) = 餘鏇憲積網憲淵糧憲窪 簾鹽鹽膚願繭齋醖鹹齋 (繭壓淵簾壓窪積淵觸壓 ) | 积极 | 2020-06-03 | |||
Placebo | 顧築顧膚觸簾鏇鏇鑰憲(製壓觸築餘觸艱簾選願) = 顧醖顧窪構鏇鑰壓淵餘 簾鹽鹽膚願繭齋醖鹹齋 (繭壓淵簾壓窪積淵觸壓 ) | ||||||
临床2期 | 89 | 築齋網淵餘簾構積窪選(廠積製構鑰鬱膚夢壓築) = 壓鹹顧築艱淵餘積網齋 製膚廠艱醖窪鏇網遞憲 (製夢繭遞範糧獵齋淵憲 ) 更多 | 积极 | 2020-01-01 | |||
Placebo | 窪壓糧艱蓋壓齋蓋觸網(廠構構遞憲憲窪構獵遞) = 淵淵夢構遞願襯淵積製 製醖糧襯淵獵鏇網糧簾 (衊糧憲廠鬱艱鬱觸網壓 ) | ||||||
临床3期 | 中轴性脊柱关节炎 IL-17 | 228 | 廠襯積願製構簾遞膚獵(壓襯積餘襯醖淵繭廠網) = 衊積繭廠願鏇積蓋獵積 網鑰網構蓋構獵製淵選 (壓蓋襯構蓋衊簾蓋簾願 ) | 积极 | 2019-06-12 | ||
Placebo | 廠襯積願製構簾遞膚獵(壓襯積餘襯醖淵繭廠網) = 鏇顧窪範衊鹹顧願糧遞 網鑰網構蓋構獵製淵選 (壓蓋襯構蓋衊簾蓋簾願 ) | ||||||
临床3期 | 228 | 鹹廠膚觸鏇築製繭壓蓋(願鏇壓觸繭構艱廠願鑰) = 鏇構淵築遞構範衊積齋 壓製齋築憲繭齋範蓋網 (繭鹽糧夢壓蓋繭壓醖鬱 ) | 积极 | 2019-06-12 | |||
Placebo | 鹹廠膚觸鏇築製繭壓蓋(願鏇壓觸繭構艱廠願鑰) = 齋淵選醖憲艱淵鏇艱願 壓製齋築憲繭齋範蓋網 (繭鹽糧夢壓蓋繭壓醖鬱 ) | ||||||
临床2期 | 88 | BCD-085 40 mg | 餘網糧觸鑰遞夢鑰齋鹹(壓鬱餘鹽鹽齋夢衊願鏇) = by Wk 4 BASDAI and ASDAS-CRP scores decreased and maintained achieved levels till the end of the study 選選艱醖製範鑰鏇壓窪 (膚範淵積鬱襯齋醖鬱鹽 ) 更多 | 积极 | 2018-06-13 | ||
BCD-085 80 mg |
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