The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.

开始日期2025-03-01

申办/合作机构

南方医科大学南方医院

NCT06585384

/ Not yet recruiting临床1期IIT

Safety of a Strategy Combining Etanercept Administration with Repeated Contrast Ultrasound in Patients with Alzheimer's Disease: Phase I Study

Alzheimer's disease (AD) is a clinico-pathological entity combining multiple and varied neuropathological lesions with characteristic abnormal accumulations (amyloid Beta (Aβ) plaques and neurofibrillary degeneration (NFD)), neuroinflammation, as well as neuronal and synaptic suffering.
To date, only symptomatic treatments are available, with no proven effect on neuropathological lesions or on the clinical course of the disease.
Anti-TNF alpha could be a therapeutic agent of choice in the treatment of central nervous sytem (CNS) diseases with an inflammatory component, such as AD. Unfortunately, their high molecular weight prevents them from passively crossing the blood brain barrier (BBB). In a pilot study published in 2006, etanercept was administered intrathecally to AD patients with encouraging clinical effects.
Transient opening of the tight junctions between the endothelial cells of the BBB by delivering High Intensity Focalised Ultrasounds (HIFU) in combination with an intravenous injection of microbubbles is a strategy that could improve bioavailability. Studies suggest that the oscillation of microbubbles in the ultrasound field generates microcurrents that induce shear forces responsible for a transient opening of the BBB. Ultrasound can be focused or unfocused and open the BBB diffusely or selectively over defined regions of the brain. This technique was first used to open the BBB in humans in 2001.
Transient opening of the BBB is also thought to modulate the immune response in the CNS, leading to a reduction in the intracerebral load of Aβ. In an Alzheimer's mouse model, several studies using ultrasound devices to open the BBB have shown a reduction in the intracerebral load of Aβ (up to 75%) and an improvement in the memory faculties and cognitive performance of the animals.
In humans, two clinical trials have assessed the safety of using ultrasound-assisted BBB disruption devices in AD patients. These were the Sonocloud® (Carthera) and ExAblate® (InSightec) devices. The Sonocloud® device is an extra-dural ultrasound emitter implanted under local anaesthetic. Enrolment was completed in October 2020, but the results of the trial are not yet available (NCT03119961). The phase I study on 5 patients evaluating the ExAblate® device coupled with the injection of gas microbubbles demonstrated reversible opening of the BBB with no serious adverse effects for the patients. No effect on intracerebral Aβ load or cognitive or behavioural improvement was demonstrated. The ExAblate® device is not implantable and is therefore less invasive than the Sonocloud® device. However, it requires MRI monitoring and the transducers used often generate high levels of heat, requiring the use of a water cooling system to avoid the risk of transducer deterioration.
In this project, our aim is to assess the safety of using a non-focused ultrasound device, the General Electric VIVID S70 clinical device (CE mark G1 023782 0112 ), to perform BBB ruptures in patients suffering from AD, combined with the administration of etanercept, whose bioavailability would thus be improved.

开始日期2025-03-01

申办/合作机构

Fondation Ophtalmologique Adolphe de Rothschild

NCT06654882

/ Not yet recruiting临床3期IIT

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).

开始日期2025-02-01

申办/合作机构

Duke University

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100 项与依那西普相关的临床结果

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100 项与依那西普相关的转化医学

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100 项与依那西普相关的专利（医药）

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9,039

项与依那西普相关的文献（医药）

2025-02-01·JOURNAL OF REPRODUCTIVE IMMUNOLOGY

Peri-implantation treatment with TNF-α inhibitor for endometriosis and/or adenomyosis women undergoing frozen-thawed embryo transfer: A retrospective cohort study

Article

作者: Yin, Ping ; Yuan, Yuan ; Li, Yan ; Liu, Mengqi ; Jiang, Min ; Yang, Dongzi

PROBLEM:

Endometriosis and adenomyosis have common pathogenesis and close relationship, with multi-factors involved in related infertility and IVF failure. They lead to anatomical changes, ovarian reserve reduction, endocrine abnormalities, altered endometrial receptivity and immunological dysfunction. Collective evidence indicate that abnormal function of immune cells and secretion of cytokines are closely related to reproductive outcomes among the women. Some studies showed that increased secretion of tumor necrosis factor alpha (TNF-α) led a key role in pro-inflammatory response in women with endometriosis/adenomyosis.TNF-a is embrryotoxic and receptivity impairing. Therefore, immunotherapy is a targeted therapeutic strategy apart from routine treatment. TNF-α inhibitors such as etanercept and adalimumab were shown to reduce the embryotoxic and anti-inflammatory effects to increase IVF pregnancy rates in recurrent implantation failure or endometrioma patient. However, there's no evidence about the use of adalimumab for patients with endometriosis and/or adenomyosis undergoing Frozen embryo transfer(FET).

METHOD OF STUDY:

A retrospective analysis of 141 women with endometriosis and/or adenomyosis undergoing FET from January 2021 to Jun 2023 was conducted.They were 20-42 years old, with or without previous implantation failure. Endometriosis was diagnosed by laparoscopy during their infertility workup and adenomyosis was confirmed by vaginal ultrasound screening. GnRH agonist and hormone replacement treatment (HRT) or HRT were taken for endometrium preparation according to doctor's evaluation and preference. Before and after embryo transfer, 84 women were treated with Adalimumab and 57 patients were untreated. Implantation rate, clinical pregnancy rate, ongoing pregnancy rate and live birth rate were compared between the two groups.

RESULTS:

The demographics and baseline characteristics between the two groups were comparable. Stage of embryo transferred and number of embryo transferred were comparable between the two groups (p = 0.227 and p = 0.204 separately). The regimen of endometrium preparation was similar too(p = 0.907). The implantation rate was significantly improved in study group (28.09 % vs 49.18 %, X²=9.515, P = 0.002). The clinical pregnancy rate was much lower in control group comparing with TNF-α inhibitor treatment group (42.11 % vs 60.71 %, X²=4.723, P = 0.029). There was no significant difference between the two groups as for ongoing pregnancy rate (38.60 % vs 52.38 %, X²=2.591, P = 0.107)and live birth rate (36.84 % vs 47.62 %, X²=1.606, P = 0.205). Following adjustment for age, BMI, number of prior failed transfer, stage of embryo transferred in a multiple logistic analysis, patients treated without TNF-α inhibitor had a significant lower CPR (ORadj 0.45, 95 %CI 0.22-0.92, p = 0.029) and a similar probability for OPR (ORadj 0.56, 95 %CI 0.28-1.12) and LBR (ORadj 0.62, 95 %CI 0.31-1.26) as compared with patients with TNF-α inhibitor treatment. However, an obvious trend of improvement of LBR was observed and it's clinical relevant for the patients.

CONCLUSION:

In women with endometriosis and/or adenomyosis, peri-implantation treatment with TNF-α inhibitor increased implantation rate and clinical pregnancy rate significantly compared with control group in FET cycles. The ongoing pregnancy rate and live birth rate were not significant different, while the difference was clinical relevant.

2025-01-01·JOINT BONE SPINE

Dacryoadenitis occurring during treatment with etanercept

Letter

作者: Bahiri, Rachid ; Amine, Bouchra ; Zemrani, Salma ; Rostom, Samira ; Elbinoune, Imane

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Prescribing patterns and persistence of biological therapies for psoriasis management: a retrospective cohort study from Saudi Arabia

Article

作者: Fazel, Mohammad ; Alyazidi, Wejdan ; Alkaff, Tuqa ; Almalki, Ziyad ; Alomar, Mukhtar ; Almakki, Sarah ; Alamer, Ahmad ; Mobarki, Fatimah ; Aldosari, Saad ; Alahmari, Abdullah

BACKGROUND:

Biological therapies are effective for psoriasis, but patient responses vary, often requiring therapy switching or discontinuation.

OBJECTIVES:

To identify physicians' prescribing patterns of biological therapies at a referral tertiary center in Saudi Arabia and assess the probability of biologic persistence following treatment initiation.

METHODS:

We conducted a retrospective study of biologic-naïve adult psoriasis patients who initiated therapy from October 2013 to July 2022 in Dammam. Descriptive statistics and a Kaplan-Meier analysis evaluated treatment persistence at 6, 12, 24, and 36 months.

RESULTS:

A total of 151 patients received adalimumab (n = 89), etanercept (n = 17), risankizumab (n = 30), ustekinumab (n = 14), and ixekizumab (n = 1). At 6 months, all therapies demonstrated 100% persistence. At 12 months, persistence was highest for ustekinumab (100%) and lowest for etanercept (88.2%). At 24 months, ustekinumab maintained 100% persistence, followed by risankizumab (96.6%), adalimumab (94.3%), and etanercept (76.4%). At 36 months, risankizumab had the highest persistence (96.6%), followed by adalimumab (83.1%), ustekinumab (78%), and etanercept (70.6%). The most common reasons for discontinuation were lack of effectiveness and intolerability.

CONCLUSION:

This study shows changing psoriasis treatment patterns with new therapies. Risankizumab demonstrated high long-term persistence, while etanercept and ustekinumab showed declining persistence, suggesting evolving treatment considerations.

340

项与依那西普相关的新闻（医药）

2024-12-25

·凯莱英Asymchem

【关注】自免并购案，30年发展历程回顾

来源：BiG生物创新社自身免疫疾病（AID）是指机体免疫系统对自身组织或细胞的攻击所引发的一类疾病，包括类风湿性关节炎、系统性红斑狼疮、炎性肠病等。随着科学研究的深入发展和治疗方法的创新，自免并购活动在过去几十年中不断增加，推动了行业的快速发展。本文简要梳理！ 01 自免并购的早期阶段: 20世纪末期 20世纪末期，各大生物技术和制药公司开始认识到自身免疫疾病治疗市场的潜力，虽然这一时期行业内相关的并购活动相对较少，但仍为后续蓬勃发展的市场以及并购活动的发展奠定了一定基础。这一时期重要的并购案包括： 53亿美元：罗氏收购Syntex（1994）罗氏（Roche）以53亿美元收购美国生物技术公司Syntex，帮助罗氏加强了在风湿性关节炎和其他自免疾病治疗领域的产品组合；图2：《芝加哥论坛报》报道罗氏收购Syntex的新闻 820亿美元：辉瑞收购Warner-Lambert（1999）辉瑞（Pfizer）以约820亿美元的价格收购了Warner-Lambert。这次并购虽然主要是为了取得著名的降胆固醇药物立普妥（Lipitor），但也极大增强了辉瑞在自身免疫疾病药物开发方面的实力。图3：《华盛顿邮报》辉瑞收购Warner-Lambert的新闻赛诺菲-安万特（Sanofi-Aventis）成立（1999） 1999年，赛诺菲（Sanofi）和霍诺（Hoechst Marion Roussel）合并成立了赛诺菲-安万特（Sanofi-Aventis），这次合并使赛诺菲在自身免疫疾病治疗领域拥有更强的研发能力和市场份额。图4：赛诺菲（Sanofi）和霍诺（Hoechst Marion Roussel）的相关报道 160亿美元：Amgen收购Immunex（2001）在这一时期，还有一个典型的收购案例，2001年，Amgen以160亿美元收购Immunex，获取了其重磅药物Enbrel（依那西普）。Enbrel是一种抗肿瘤坏死因子（TNF）药物，主要用于治疗类风湿性关节炎和其他自身免疫疾病。这次收购不仅使得Amgen在免疫疾病治疗领域的地位显著提升，也为其带来了可观的财务回报。图5：Nature Technology网站对Amgen收购Immunex的报道图6：Amgen官网新闻自身免疫领域（自免领域）的并购案反映了生物技术和制药行业的整合趋势这些并购案不仅加速了自身免疫疾病治疗药物的开发和上市，也推动了生物技术和制药行业的整合和创新。通过并购，这些公司能够获取更多的资源、技术和市场，进而提升其竞争力和市场地位。 02 自免并购的汹涌浪潮：2015~2020 进入21世纪第二个十年，自身免疫疾病治疗市场迅速扩展，生物技术的进步和新疗法的开发推动了大量并购交易。这十年间，若干生物技术和制药公司纷纷加入并购浪潮，自免领域并购案例如雨后春笋般涌现，时常占据医药行业新闻头条，引起国内外众多关注。 210亿美元：AbbVie收购Pharmacyclics（2015） 2015年AbbVie以210亿美元的价格收购了Pharmacyclics，通过本次收购，Abbvie获得了Pharmacyclics的于治疗多种血液系统疾病的药物Imbruvica（依鲁替尼）。虽然Imbruvica主要用于癌症治疗，但其研究成果为自身免疫疾病治疗提供了新的思路，并增强了AbbVie在免疫学领域的研发能力。图7：AbbVie官网并购内容 72亿美元：Celgene收购Receptos（2015） Celgene以72亿美元收购Receptos，主要是为了其在研药物Ozanimod，这是一种用于治疗多发性硬化症和溃疡性结肠炎的S1P受体调节剂。Ozanimod的开发成功使Celgene在自身免疫疾病治疗领域的布局更加完善。图8：Market Screen对此次并购的相关报道 25亿美元：Sanofi收购Synthorx（2019） 2019年，Sanofi收购Synthorx。Sanofi以25亿美元收购了Synthorx，获取其以工程化IL-2为基础的免疫治疗技术。Synthorx的技术平台旨在增强免疫系统的选择性，开发新型治疗方法来治疗癌症和自身免疫疾病，进一步拓展了Sanofi在免疫治疗领域的产品线。图9：Sanofi官网对此次并购的说明 03 自免并购继续升温：近五年情况再把视野转向2020年至今，我们可以直观地看到，在过去的几年中，自身免疫领域的并购活动继续升温，主要驱动力包括对创新疗法的需求、企业间的战略整合以及资本市场的支持。 3.1亿美元：Novartis收购IFM Therapeutics的自身免疫部门（2020） 2020年，Novartis收购IFM Therapeutics的自身免疫部门。Novartis以3.1亿美元的价格收购了IFM Therapeutics的自身免疫资产。这些资产包括多个用于治疗自身免疫疾病的小分子药物，旨在通过靶向炎症信号通路来调节免疫反应，极大地增强了Novartis在自身免疫治疗领域的研发能力。图10：Fierce Biotech网站对此次收购的报道 390亿美元：AstraZeneca收购Alexion Pharmaceuticals（2021） 2021年，AstraZeneca收购Alexion Pharmaceuticals。 AstraZeneca以390亿美元的价格收购了Alexion Pharmaceuticals，这是近年来规模最大的并购案之一。Alexion是开发罕见病和自身免疫疾病治疗药物的领导者，其主要产品Soliris和Ultomiris用于治疗一系列罕见的自身免疫疾病。这次收购使AstraZeneca在免疫学和罕见病领域的地位显著提升。图11：Pharmaceutical Technology网站对此次并购的报道自2019年受到COVID-19新冠疫情的影响，资金短缺与市场不确定性、监管审批延误、临床试验停滞、供应链中断、战略优先级变化等多方面的影响和挑战，制药和生物技术行业相关自身免疫疾病领域的并购活动相对减少，但是趋势仍不容忽略。 04 自免并购案屡见不鲜的2024年让我们目光再转回到2024年，截至五月底，自免相关的并购、收购案例屡见不鲜，并购活动呈现活跃态势。这里聚焦几个比较典型的案例： 2.5亿美元：Novartis收购Calypso Biotech（2024.01） 1月，Novartis以2.5亿美元的价格收购了Calypso Biotech，这家公司开发的CALY-002针对IL-15，用于治疗乳糜泻和嗜酸性食管炎。Novartis计划利用该产品针对多种高未满足需求的自身免疫病适应症进行开发。图12：European Biotechnology网站关于此次并购的报道 Regeneron收购2seventy Bio的肿瘤和自身免疫资产（2024.04） 4月，Regeneron收购了2seventy Bio的肿瘤和自身免疫资产，并成立了新的研发部门Regeneron Cell Medicine。此次收购包括雇佣了2seventy Bio的160名员工，初步将重点放在CAR-T和CAR-NK疗法的开发上。图13：Regeneron官网对此次收购的相关内容 Eliem Therapeutics收购Tenet Medicines（2024.04）同月，Eliem Therapeutics收购了Tenet Medicines，其主要资产是抗CD19抗体TNT119，潜在适应症包括系统性红斑狼疮（SLE）和免疫性血小板减少症等。此次收购使Eliem能够扩展其在自身免疫疾病治疗领域的产品线。图14：Eliem官网对此次收购的相关内容强生收购Numab、Ashahi Kasei Corporation收购Calliditas（2024.05）本文开篇就已经提到，今年5月强生并购Numab，同时五月还有几起自免领域相关的并购案，就在强生并购案的当天，日本化工企业旭化成（Ashahi Kasei Corporation）也宣布准备以10.6亿美元收购瑞典生物技术公司Calliditas Therapeutics，本次收购后，旭化成将获得Calliditas的Nefecon（用以治疗IgA肾病）等。图15：Ashahi Kasei Corporation公司对本次收购的相关内容写在最后随着2024年下半年的到来，预计自身免疫领域的并购活动将继续活跃。各大生物科技和医药公司将继续通过战略性收购和合作，寻求在自身免疫疾病治疗领域的突破和创新。这些并购活动不仅有助于提升公司在市场上的竞争力，还将加速新疗法的开发和商业化进程，为患者带来更多的治疗选择和希望。参考资料： [1]强生官网；Numab官网；Amgen官网；AbbVie官网；Sanofi官网；Novartis年报；Regeneron官网；Eliem官网 [2] Switzerland’s Roche Holding Ltd. agreed to buy Syntex Corp. for $5.3 billion [3] Pfizer Bids $82 Billion for Warner-Lambert [4] Amgen's big-ticket play for Immunex [5] Novartis ponies up $310M for IFM Therapeutics’ inflammation-focused unit [6] Novartis AG to buy immunology specialist Calypso Biotech BV [7] J&J to Acquire Rights to Investigational Bispecific Antibody

并购

2024-12-14

·学术经纬

打完4针，超80%患者病变几乎全消失或明显消退！一药多效治疗5种病，4种都是“不死的癌症”

▎药明康德内容团队编辑大家知道，正常情况下，免疫系统是会识别“坏人”和“好人”的，只会识别和清除异常的病原体、癌细胞、衰老细胞，不会攻击自身正常细胞。而自身免疫性疾病，顾名思义，是指免疫系统针对自身机体成分发生免疫反应而引发的疾病，所有因自身免疫系统功能紊乱而造成的疾病都可以称为自身免疫性疾病。常见的系统性自身免疫性疾病包括系统性红斑狼疮、类风湿关节炎、强直性脊柱炎、系统性硬化症、韦格纳肉芽肿、抗磷脂综合征、干燥综合征等；较为典型的器官特异性自身免疫性疾病包括斑秃、疱疹样皮炎、落叶天疱疮、寻常型天疱疮、白癜风、毒性弥漫性甲状腺肿（又称Graves病，是甲亢最常见的类型）及I型糖尿病等。图片来源：123RF 自身免疫性疾病又被称为“不死的癌症”。“不死”的意思是，大多数自身免疫性疾病在多数情况下并不致命；而和“癌症”相提并论则是因为，这些疾病大多无法根治，会伴随患者终生、需长期治疗，过程中患者会遭受“复发-缓解-再复发”终生不断循环的折磨，这种痛苦类似于癌症。此外，俗称“牛皮癣”、在中国约有700万患者的银屑病，严格来说没有被归为自身免疫性疾病，但也是一种遗传与环境共同作用诱发免疫介导的慢性、复发性、炎症性、系统性疾病。银屑病的典型症状表现是鳞屑性红斑或斑块，局限或广泛分布，无传染性，分型包括寻常型银屑病（又分为斑块状银屑病和点滴状银屑病）、脓疱型银屑病、红皮病型银屑病及关节病型银屑病。由于具有自身免疫性疾病特征、同样易于复发、无法根治、严重危害患者身心健康，银屑病也被称为一种“不死的癌症”。而且，重度银屑病伴发类风湿关节炎、红斑狼疮、葡萄膜炎和克罗恩病等自身免疫性疾病的概率显著升高。既然“不死的癌症”发病机制都类似，针对这类疾病设计的生物治疗药物，往往也对多种自身免疫性疾病都有效。比如比奇珠单抗（bimekizumab，商品名：Bimzelx）这款药物，就是一种人源化的IgG1单克隆抗体，能够强力并特异性地中和并抑制白介素17A（IL-17A）、IL-17F和IL-17AF这几个细胞因子，从而减轻炎症反应。目前，比奇珠单抗在中国已经获批了2项适应症（活动性强直性脊柱炎和放射学阴性中轴型脊柱关节炎）；在美国获批了5项适应症（中重度斑块状银屑病、活动性银屑病关节炎、放射学阴性中轴型脊柱关节炎、活动性强直性脊柱炎以及化脓性汗腺炎）。在这些适应症中，有4种都属于“不死的癌症”。今天，健康榨知机想和大家重点介绍这款新药针对银屑病的疗效。新药治疗这种银屑病，临床缓解疗效至少长达1年 2023年10月，比奇珠单抗被美国食品药品监督管理局（FDA）批准用于治疗适合接受全身治疗或光疗的中重度斑块状银屑病成人患者。根据新闻稿，比奇珠单抗是“首个”获批用以治疗中重度斑块状银屑病的IL-17A/F抑制剂。此次获批基于三项多中心、随机、安慰剂和/或活性药物对照3期试验数据的支持，这些试验评估了比奇珠单抗在1480名中度至重度斑块状银屑病成人患者中，与安慰剂和IL-12/IL-23抑制剂乌司奴单抗（ustekinumab）、与安慰剂和与肿瘤坏死因子α（TNF-α）抗体阿达木单抗（adalimumab）相比的疗效和安全性。结果显示：与接受活性对照组、安慰剂和阿达木单抗治疗的患者相比，接受比奇珠单抗治疗的患者在第16周获得了更佳的皮损清除率——也就是在PASI 90（银屑病面积与严重程度指数改善至少90%）与研究者总体评估（IGA）分数为0（银屑病症状清除）或1（银屑病症状几乎清除）（即IGA 0/1）这两个指标上有显著改善。综合3项试验的数据，关键结果如下：皮损清除或几乎清除：接受比奇珠单抗（320 mg，每4周一次）的患者中，到第16周时，超过80%的患者达到了PASI 90和IGA 0/1。也就是说，16周打完4针的患者中，超80%的人皮损病变几乎“全消失”或明显消退。完全皮损清除：接受比奇珠单抗（320 mg）治疗的患者中，约60%的患者在第16周达到PASI 100（银屑病皮损面积与严重程度指数改善达100%）。缓解速度：比奇珠单抗的临床缓解迅速，超过70%的患者在打完第一针（单次给药320 mg）后，第4周就达到了PASI 75（银屑病皮损面积与严重程度指数改善75%）。维持缓解：使用比奇珠单抗在第16周时达到临床缓解（PASI 90和PASI 100）的患者，这样的临床缓解状态维持了长达1年。长期数据显示，绝大多数患者使用比奇珠单抗治疗3年后，仍然能维持持续的临床反应。图片来源：123RF 需要提醒的是，目前在没有禁忌证的情况下，传统药物甲氨蝶呤仍然是中重度寻常型银屑病、关节型银屑病等的首选药物之一；而环孢菌素A已替代系统糖皮质激素治疗，成为用于控制急重症红皮病型银屑病、脓疱性银屑病以及重症寻常型银屑病的首选药物。而生物制剂和传统口服药物相比，肝肾损害风险较低，皮损清除率高，远期疗效稳定，在条件允许的情况下是理想的治疗选择。但应用生物制剂之前需要进行全面的肿瘤及感染（如结核、肝炎病毒等）指标筛查，以防出现严重并发症。由于比奇珠单抗目前还未在中国获批银屑病的适应症，本文的信息仅供大家了解参考，实际治疗过程中，请大家务必在专业医生的指导下、遵医嘱用药。银屑病的治疗方法发展历程中国历史上早在隋代，古籍中便有对银屑病相关症状的记载。而如今，随着人类对银屑病的研究不断深入，治疗方式也经历了巨大的变革。科学家一直在为改善患者的病情控制和生活质量不断探索。 1980年以前：银屑病发病机制不明，药物研发在不断尝试中摸索前行 1925年，威廉·亨利·格克曼（音译，William Henry Goeckerman）开始使用一种主要发射中波紫外线的煤焦油灯来治疗银屑病。1947年，以补骨脂素联合长波紫外线为代表的光化学疗法（简称“光疗”）兴起，在银屑病的治疗中逐渐占据一席之地，为后续的治疗方法奠定了基础，并沿用至今。从20世纪50年代开始，大多数用于银屑病的药物要么疗效不明显，要么有明显的不良反应，最后都被淘汰了。比如雷公藤多苷，具有较强的抗炎和免疫抑制作用，但对慢性斑块状银屑病效果不佳。 1980年后，大量研究集中在银屑病免疫相关机制方面，并取得了重要的进展，银屑病指南的陆续出现也使其治疗有了依据。 1980年以来：大量研究表明，银屑病发病机制可能与免疫相关 1984年中国首次银屑病流行病学调查显示，银屑病的发病与遗传显著相关，还发现气候、环境因素是较为常见的诱因，并在秋冬季节更常发生。 1986年，贝克（音译，Baker）等人发现银屑病表皮中有T辅助细胞的进入和激活，表明免疫因素与银屑病发病相关。此后，相关研究越来越多地集中在免疫因素上。此外有证据表明，细菌超抗原在发病机制中也起到一定作用。图片来源：123RF 与此同时，各种免疫相关治疗银屑病的药物纷纷进入临床，包括卡泊三醇、维A酸、环孢素等。在当时，主流治疗指南推荐的银屑病疗法按获益风险排序的优先级为：中波紫外线>光化学疗法>甲氨蝶呤>阿维A>环孢素，并明确了疗效的评估指标为PASI 75。1991年英国皮肤科医师协会指南中推荐“以光疗为主，系统性治疗可尝试与光疗联合使用，但应密切关注禁忌症”。 2004年以来：药物研发取得突破，进入生物治疗阶段 2004年以来，TNF-α、白介素23（IL-23）、IL-17等陆续被发现在银屑病的发病机制中发挥了重要作用，此后银屑病进入了生物治疗阶段。比如布罗利尤单抗等生物制剂，由于其优异的疗效，将治疗目标提升到了PASI 90/100。从2000年开始，有研究发现TNF-α可能是银屑病炎症反应的始动因素。2004年，TNF-α抑制剂依那西普（商品名：恩利）获得美国FDA和欧洲药品管理局批准银屑病适应症，适用于治疗适合接受系统疗法治疗或光疗的慢性中重度斑块状银屑病成人患者，开启了银屑病生物治疗时代。此后，其他TNF靶向药物如英夫利西单抗（商品名：类克）、阿达木单抗（商品名：修美乐）也随之研发成功。除了针对TNF的靶向治疗，还有靶向T细胞或抗原呈递细胞的药物，如依法利珠单抗和阿法赛特单抗，但这两款药由于容易诱发病毒感染和免疫抑制而撤市。还有研究发现，IL-12/IL-23也在银屑病的发病中起到关键作用。2009年，全人源“双靶向”IL-12/IL-23抑制剂乌司奴单抗（商品名：喜达诺）在美国获批上市。而IL-17A抑制剂司库奇尤单抗（商品名：可善挺）于2015年在美国获批上市，并于2019年在中国获批。除了上述3种抑制剂，目前已获批治疗银屑病的生物制剂类型还有IL-6、IL-8抑制剂等。以单克隆抗体为代表的生物制剂的靶点是可溶性细胞因子或细胞膜表面受体，虽然这种策略获得了巨大成功，但单克隆抗体属于生物大分子，几乎无法进入活细胞内发挥作用。于是科学家又想到一种新的治疗策略——合成小分子靶向药物，靶点是细胞内参与信号传导的关键分子。近年研发的用于治疗银屑病的小分子靶向药物，主要集中在靶向各种炎症细胞因子相关通路中的不同环节，包括磷酸二酯酶4（PDE4）抑制剂（如，阿普米司特 [商品名：欧泰乐] 于2021年在中国获批银屑病适应症）、Janus激酶1/3（JAK1/3）抑制剂（如乌帕替尼[商品名：[福瑞]，于2022年在中国获批银屑病适应症）等。不管在中国还是其他国家，目前已有一部分小分子靶向药物获批治疗银屑病，还有不少候选药物已进入后期临床研发阶段，为银屑病的治疗带来了新选择。虽然目前，比奇珠单抗在中国尚未获批用于银屑病，但已经获批用于其他2种“不死的癌症”；而且自2005年以来，在中国获批的银屑病新药中，有9款都属于IL抑制剂（见下表）。相信不远的将来，会有越来越多银屑病的新疗法来到中国患者身边。自2005年1月以来，获中国国家药品监督管理局（NMPA）批准的银屑病相关药物如下：注：本表由健康榨知机制作，数据截至2024年12月5日。如有遗漏，欢迎补充。（TYK2：酪氨酸激酶2；IL-36R：白介素-36受体）另外，你可能还想知道：得了银屑病该怎么护肤？银屑病有哪些症状？银屑病治疗药物有哪些？ …… 点击下方名片关注【健康榨知机】在消息对话框回复：银屑病获取更多相关健康知识 ▼ 参考资料 [1] 方心宇, 冷瑞雪, 范引光, 张勤, 潘海峰, 叶冬青. 自身免疫性疾病流行病学研究进展[J]. 中华疾病控制杂志, 2021, 25(8): 869-873. doi: 10.16462/j.cnki.zhjbkz.2021.08.001 [2] 中华医学会皮肤性病学分会银屑病专业委员会. 中国银屑病诊疗指南（2023版）[J]. 中华皮肤科杂志,2023,56(07)：573-625.DOI:10.35541/cjd.20220839 [3] BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis. Retrieved Dec 6, 2024 from https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis [4] 杨斌. 银屑病治疗指南和治疗目标的历史演变 [J] . 中华医学信息导报, 2022, 37(12) : 18-18. DOI: 10.3760/cma.j.issn.1000-8039.2022.12.127. [5] 曾悦, 邹先彪. 银屑病紫外线治疗新进展 [J] . 中国医学前沿杂志（电子版）, 2023, 15(5) : 25-31. DOI: 10.12037/YXQY.2023.05-05. [6] 梁云生, 余艺昕, 杨斌. 系统抗炎是重度免疫性皮肤病达标治疗的关键 [J] . 中华医学杂志, 2021, 101(16) : 1119-1122. DOI: 10.3760/cma.j.cn112137-20201209-03313. [7] 俞晨, 王刚. 小分子靶向药物：银屑病治疗的新选择[J]. 中华皮肤科杂志, 2022, 55(9): 747-751. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「健康榨知机」微信公众号回复“转载”，获取转载须知。如有其他合作需求，请联系wuxi_media@wuxiapptec.com 健康榨知机丨药明康德团队打造微信号 : ey_global ▇ 关注我们，掌握新鲜有料的健康资讯分享、点赞、在看，传播健康知识

临床研究

2024-12-12

·GlobeNewswire-Health Care

aTyr Pharma Announces the Appointment of Eric Benevich to its Board of Directors

SAN DIEGO, Dec. 12, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the appointment of Eric Benevich to the Company’s Board of Directors, effective as of December 10, 2024. Mr. Benevich currently serves as Chief Commercial Officer at Neurocrine Biosciences, Inc. (Neurocrine). “We are excited to welcome Eric Benevich to the Board of Directors,” said Timothy P. Coughlin, Chairman of the Board of aTyr. “His extensive background bringing new products to market and the knowledge and expertise he has gained from both building and leading commercial activities at biopharmaceutical companies will be an invaluable resource as aTyr continues its evolution towards commercialization.” Mr. Benevich has served as Chief Commercial Officer of Neurocrine since May 2015 and is responsible for all aspects of commercial development, marketing, and sales of the Neurocrine product portfolio. Mr. Benevich has over 30 years of commercial experience in the pharmaceutical industry and previously served in various positions of increasing responsibility at AstraZeneca, Amgen, Peninsula Pharmaceuticals, and Avanir Pharmaceuticals in the sales and marketing of drugs such as Prilosec®, Epogen®, Enbrel®, and Neudexta®. Mr. Benevich has a BBA in International Business from Washington State University. About aTyr aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding the potential benefits that Mr. Benevich’s appointment will have on aTyr’s evolution towards commercialization. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty regarding geopolitical and macroeconomic events, risks associated with the discovery, development and regulation of our product candidates, the risk that we or our partners may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contact:Ashlee DunstonDirector, Investor Relations and Corporate Communicationsadunston@atyrpharma.com

高管变更

100 项与依那西普相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D00742	依那西普	L04AB01	DB00005

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适应症	国家/地区	公司	日期
银屑病	中国	C.H. Boehringer Sohn AG & Co. KG	2010-02-26
非放射性轴性脊柱关节炎	澳大利亚	Pfizer Australia Pty Ltd.	2003-03-18
多关节型幼年特发性关节炎	美国	Immunex Corp.	2002-01-15
强直性脊柱炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	挪威	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
幼年特发性关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02

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适应症	最高研发状态	国家/地区	公司	日期
疼痛	临床3期	美国	Amgen, Inc.	2016-11-29
疼痛	临床3期	波多黎各	Amgen, Inc.	2016-11-29
青少年少关节慢性关节炎	临床3期	澳大利亚	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	比利时	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	哥伦比亚	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	捷克	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	法国	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	德国	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	匈牙利	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	意大利	Pfizer Inc.	2009-09-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2024	N/A	类风湿关节炎	-	Rituximab	構選構壓範鏇窪願願觸(鹹顧夢繭艱醖顧襯獵餘) = 網築憲糧餘憲淵積範膚鑰窪窪繭齋積淵醖鬱鑰 (願襯鑰鬱觸築積鑰構廠 ) 更多	-	2024-06-05
				Tocilizumab	構選構壓範鏇窪願願觸(鹹顧夢繭艱醖顧襯獵餘) = 築範簾齋選積餘積廠醖鑰窪窪繭齋積淵醖鬱鑰 (願襯鑰鬱觸築積鑰構廠 ) 更多
EULAR2024	N/A	-	-	Etanercept bio-originator	選壓獵窪淵醖淵糧夢遞(繭淵膚齋簾夢膚膚醖膚) = 28% vs 22%, mostly injection site reactions 積獵獵範築範築簾艱簾 (襯膚繭餘窪鹽衊蓋遞選 ) 更多	-	2024-06-05
				Etanercept biosimilar SB4
EULAR2024	N/A	类风湿关节炎	-	Biologic and targeted synthetic DMARDs	壓艱鬱構鹹顧憲鏇齋壓(壓壓糧壓膚齋簾艱顧選) = 範範衊餘築膚構鹽憲獵鹽糧觸醖獵憲壓觸簾獵 (觸齋鑰範遞衊醖鹹顧構 ) 更多	-	2024-06-05
EULAR2024	N/A	类风湿关节炎	-	biologic drugs (Obese patients)	繭壓壓鹹網簾夢膚積鹹(壓製餘網襯鏇鹽襯鏇廠) = 構構鑰繭觸夢繭醖選壓窪衊鬱糧艱糧顧衊鏇顧 (鏇網壓鹹鏇膚襯積廠憲 ) 更多	不佳	2024-06-05
				biologic drugs (Non-obese patients)	繭壓壓鹹網簾夢膚積鹹(壓製餘網襯鏇鹽襯鏇廠) = 獵窪繭鹽憲鏇積簾製餘窪衊鬱糧艱糧顧衊鏇顧 (鏇網壓鹹鏇膚襯積廠憲 ) 更多
EULAR2024	N/A	IL-17A	135	Adalimumab (ADA)	憲夢築築鹹鹹鹹廠構憲(壓憲壓範製醖獵製蓋蓋) = 襯鬱鏇鏇構築繭觸蓋齋憲夢願鏇衊遞構衊餘觸 (憲衊艱繭繭齋鑰築獵衊 )	积极	2024-06-05
				Infliximab (IFX)	憲夢築築鹹鹹鹹廠構憲(壓憲壓範製醖獵製蓋蓋) = 簾選鏇築獵鹽醖觸簾積憲夢願鏇衊遞構衊餘觸 (憲衊艱繭繭齋鑰築獵衊 )
EULAR2024	N/A	幼年特发性关节炎一线	118	Etanercept (ETN)	簾選糧鏇積窪積觸繭顧(範選簾選遞齋膚觸網廠) = 製糧鹽醖鹹鹽醖鏇範構築鹹願醖觸網餘糧選蓋 (襯願壓餘糧選鏇廠網構 )	积极	2024-06-05
				Adalimumab (ADA)	簾選糧鏇積窪積觸繭顧(範選簾選遞齋膚觸網廠) = 鑰壓窪範醖憲襯鹹鬱簾築鹹願醖觸網餘糧選蓋 (襯願壓餘糧選鏇廠網構 )
NCT02464878 (CTgov)	临床2期	1型糖尿病	2	Islet Transplantation+Thymoglobulin+Basiliximab+Alpha 1-Antitrypsin+Etanercept	糧遞願觸遞鏇醖襯夢窪(製製顧獵構鏇築襯顧積) = 積鑰築鑰壓範淵艱夢夢鏇選鏇醖製網繭築製鏇 (壓夢憲繭選衊願齋衊積, 獵蓋範鹽夢鑰鬱網願廠 ~ 糧顧簾觸網遞顧構製選) 更多	-	2023-12-22
ACR2023	N/A	脊椎关节炎	-	Etanercept	鑰艱憲蓋鹽鹹糧選餘願(獵醖網艱廠壓淵餘糧獵) = 鏇願襯鹽鏇簾蓋構遞繭夢壓鑰網築衊願鑰積鹹 (廠膚艱構遞選壓廠範繭, 1.2 ~ 7.0)	积极	2023-11-14
				Anti-TNF	鑰艱憲蓋鹽鹹糧選餘願(獵醖網艱廠壓淵餘糧獵) = 艱壓壓簾網憲襯壓糧鹽夢壓鑰網築衊願鑰積鹹 (廠膚艱構遞選壓廠範繭, 0.4 ~ 1.8)
NCT03636373 (CTgov)	临床4期	原发性痛风	5	Etanercept (Etanercept)	簾顧壓觸築鑰鏇壓獵壓(鹹襯鹽衊獵鹹願醖獵壓) = 築衊鑰選蓋淵製簾鬱遞鑰遞鑰廠鹹淵鹽夢顧鹽 (積齋網壓願艱簾齋鬱蓋, 鑰顧獵艱網願觸積憲鑰 ~ 構願選壓餘憲憲觸蓋鏇) 更多	-	2023-10-27
				Triamcinolone Acetonide (Triamcinolone Acetonide)	簾顧壓觸築鑰鏇壓獵壓(鹹襯鹽衊獵鹹願醖獵壓) = 蓋積艱鬱夢顧壓獵積襯鑰遞鑰廠鹹淵鹽夢顧鹽 (積齋網壓願艱簾齋鬱蓋, 遞餘顧鹽廠鏇膚艱鑰獵 ~ 鹹網觸壓膚鏇鏇構糧築) 更多
FDA 人工标引	N/A	斑块状银屑病	211	Placebo	網觸廠鏇鏇觸選餘願願(範醖夢獵製遞鏇膚繭壓) = 築範獵鑰膚襯廠鹹範壓鏇築糧鬱糧蓋鏇鹹願製 (醖顧襯蓋鹹壓醖醖鹽鏇 ) 更多	积极	2023-10-18
				Enbrel 0.8 mg/kg	網觸廠鏇鏇觸選餘願願(範醖夢獵製遞鏇膚繭壓) = 鬱鏇鹹遞觸遞衊願網夢鏇築糧鬱糧蓋鏇鹹願製 (醖顧襯蓋鹹壓醖醖鹽鏇 ) 更多