更新于：2024-05-01

Lung Diseases, Interstitial

间质性肺疾病

更新于：2024-05-01

基本信息

别名

Diffuse Parenchymal Lung Disease、Diffuse Parenchymal Lung Diseases、Diffuse parenchymal lung disease

+ [58]

简介

A diverse group of lung diseases that affect the lung parenchyma. They are characterized by an initial inflammation of PULMONARY ALVEOLI that extends to the interstitium and beyond leading to diffuse PULMONARY FIBROSIS. Interstitial lung diseases are classified by their etiology (known or unknown causes), and radiological-pathological features.

关联

535

项与间质性肺疾病相关的药物

Lebrikizumab

来金珠单抗

靶点

IL-13

作用机制

IL-13抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

欧盟 [+3]

首次获批日期2023-11-16

Vilobelimab

韦洛利单抗

靶点

C5a

作用机制

C5a抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-04-04

XENON XE 129 hyperpolarized

氙[129Xe]

靶点-

作用机制

磁共振成像增强剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2022-12-23

2,636

项与间质性肺疾病相关的临床试验

NCT06079931 / Recruiting临床2期IIT

The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonitis in Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Clinical Trial

Radiation pneumonitis (RP) is a common complication of radiotherapy for thoracic tumors, and the incidence rate of grade 2 or above RP is 20% -40%; The use of antibiotics after secondary bacterial infection due to radiation pneumonia or the use of systemic glucocorticoids for radiation pneumonia itself have significant adverse effects on the survival of NSCLC patients. At present, FDA has not approved drugs to prevent the occurrence of radiation pneumonia. traditional Chinese patent Babaodan (BBD) capsule has the effect of controlling macrophages to produce proinflammatory cytokines, such as significantly inhibiting the release of IL-6. Through prospective research, this study evaluates the incidence of symptomatic pneumonia (G ≥ 2) in the treatment of locally advanced non-small cell lung cancer with BBD combined with concurrent radiotherapy and chemotherapy.

开始日期2024-12-05

申办/合作机构-

NCT06350110 / Not yet recruiting临床1/2期IIT

T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.

开始日期2024-11-10

申办/合作机构

埃森生物技术公司

JPRN-UMIN000021218 / RecruitingN/AIIT

Evaluation of iron chelator administration, and cochlear implantation for s uperficial siderosis (ECHACISS) - ECHACISS

开始日期2024-09-30

申办/合作机构-

100 项与间质性肺疾病相关的临床结果

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100 项与间质性肺疾病相关的转化医学

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0 项与间质性肺疾病相关的专利（医药）

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96,413

项与间质性肺疾病相关的文献（医药）

2024-12-01·Annals of medicine

Body mass index and weight loss as risk factors for poor outcomes in patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis.

Review

作者: Xing He ; Jiaqi Ji ; Chi Liu ; Zeli Luo ; Jialong Tang ; Haiying Yan ; Lu Guo

OBJECTIVE:

The association between nutritional status and prognosis of idiopathic pulmonary fibrosis (IPF) remains unclear. This systematic review and meta-analysis aimed to explore the effect of body mass index (BMI) and weight loss on the prognosis of IPF patients.

METHODS:

We accumulated studies on IPF, BMI, and weight loss from databases including PubMed, Embase, Web of science, Scopus, Ovid and Cochrane Library up to 4 August 2023. Using Cox proportional hazard regression model for subgroup analysis, hazard ratio (HR) and 95% confidence intervals (CI) for BMI in relation to mortality, acute exacerbation (AE), and hospitalization in IPF patients were calculated, and HR, odds ratio (OR), and 95% CI for weight loss corresponding to IPF patient mortality were assessed. Sensitivity analysis was peformed by eliminating every study one by one, and publication bias was judged by Egger's test and trim-and-fill method.

RESULTS:

A total of 34 eligible studies involving 18,343 IPF patients were included in the meta-analysis. The pooled results by univariate Cox regression analysis showed that baseline BMI was a predictive factor for IPF mortality (HR = 0.93, 95%CI = [0.91, 0.94]). Furthermore, the results by the multivariable regression model indicated that baseline BMI was an independent risk factor for predicting IPF mortality (HR = 0.94, 95%CI = [0.91, 0.98]). Weight loss was identified as a risk factor for IPF mortality (HR = 2.74, 95% CI = [2.12, 3.54]; OR = 4.51, 95% CI = [1.72, 11.82]) and there was no predictive value of BMI for acute exacerbation (HR = 1.00, 95% CI= [0.93, 1.07]) or hospitalization (HR = 0.95, 95% CI = [0.89, 1.02]).

CONCLUSION:

Low baseline BMI and weight loss in the course of IPF may indicate a high risk of mortality in patients with IPF, so it is meaningful to monitor and manage the nutritional status of IPF patients, and early intervention should be conducted for low BMI and weight loss.

2024-06-01·Journal of translational autoimmunity

Effect of traditional therapeutics on prevalence and clinical outcomes of coronavirus disease 2019 in Chinese patients with autoimmune diseases

Article

作者: Huang, Saisai ; Ma, Xiaolei ; Cao, Juan ; Du, Mengru ; Zhao, Zhiling ; Wang, Dandan ; Xu, Xue ; Liang, Jun ; Sun, Lingyun

The impact of the Coronavirus disease 2019 (COVID-19) pandemic on autoimmune diseases (AID) patients has been an important focus. This study was undertaken to characterize the incidence, clinical manifestations and hospitalization among AID affected by COVID-19 and to analyze the association between immunomodulatory medication and these outcomes. Clinical, demographic, maintenance treatment, symptoms and disease course data and outcomes of AID patients with COVID-19 infection were assessed via an online survey tool and printed copy from 1 January till February 28, 2023. A total of 432 patients with AID were enrolled in the study. The results showed the most common conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was hydroxychloroquine (HCQ). The usage of csDMARDs didn't increase the risk of COVID-19 infection. Patients who warranted hospitalization were significantly older. ILD was associated with higher hospitalization rate. No csDMARDs other than calcineurin inhibitor (CNI) was associated with increased risk of hospitalization. HCQ intake was associated with cough. Compared with no glucocorticoids (GCs) group, high doses of GCs were accompanied with higher proportion of gastrointestinal symptoms and tachycardia, lower proportion of sore throat and ageusia. GCs didn't provoke the COVID-19 infection in patients with AID, but chronic use of oral GCs was significantly more common in those requiring hospitalization, and higher dose of GCs were correlated with higher risk of hospitalization. 97 patients discontinued csDMARDs after infection, which resulted in an elevated risk of hospitalization. Meanwhile, withdrawal of csDMARDs was associated with higher odds of disease flare and lower proportion of remission than maintenance groups. Collectively, our analysis provides the evidence that maintenance treatment of csDMARDs may be more prudent for AID patients during COVID-19 pandemic.

2024-05-01·Genes & diseases

LKB1 depletion-mediated epithelial-mesenchymal transition induces fibroblast activation in lung fibrosis

Article

作者: Xu, Zijian ; Davies, Elizabeth R. ; Yao, Liudi ; Zhou, Yilu ; Li, Juanjuan ; Alzetani, Aiman ; Marshall, Ben G. ; Hancock, David ; Wallis, Tim ; Downward, Julian ; Ewing, Rob M. ; Davies, Donna E. ; Jones, Mark G. ; Wang, Yihua

The factors that determine fibrosis progression or normal tissue repair are largely unknown. We previously demonstrated that autophagy inhibition-mediated epithelial-mesenchymal transition (EMT) in human alveolar epithelial type II (ATII) cells augments local myofibroblast differentiation in pulmonary fibrosis by paracrine signalling. Here, we report that liver kinase B1 (LKB1) inactivation in ATII cells inhibits autophagy and induces EMT as a consequence. In IPF lungs, this is caused by downregulation of CAB39L, a key subunit within the LKB1 complex. 3D co-cultures of ATII cells and MRC5 lung fibroblasts coupled with RNA sequencing (RNA-seq) confirmed that paracrine signalling between LKB1-depleted ATII cells and fibroblasts augmented myofibroblast differentiation. Together these data suggest that reduced autophagy caused by LKB1 inhibition can induce EMT in ATII cells and contribute to fibrosis via aberrant epithelial-fibroblast crosstalk.

3,154

项与间质性肺疾病相关的新闻（医药）

2024-04-08

·PRNewswire

Patient Enrolment Completed in CYP-006TK Diabetic Foot Ulcer Clinical Trial

MELBOURNE, Australia, April 7, 2024 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: " CYP", "Cynata", or the "Company"), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce the completion of patient enrolment in its Phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU). CYP-006TK is Cynata's Cymerus™ iPSC[1]-derived MSC[2] topical wound dressing product candidate, which comprises MSCs seeded onto a novel silicon dressing. Due to reduced blood flow, patients with diabetes are at risk of developing non-healing wounds on the feet/lower limbs, which are also known as DFU. In addition to causing severe pain and discomfort, DFU pose a significant risk of infection, and if therapy is unsuccessful, amputation may be necessary. In this trial, CYP-006TK is being investigated as a potential treatment to promote wound healing in patients with DFU. The pre-specified sample size has now been reached, with a total of 30 patients with DFU randomised on a 1:1 basis to receive either: (i) CYP‑006TK treatment for four weeks, followed by standard of care treatment for the rest of the study; or (ii) standard of care treatment throughout the study. In accordance with the study protocol, patients will be followed for 24 weeks following treatment initiation, which means that the last patient visit in this trial is expected to occur around September 2024. Dr Jolanta Airey MD, Cynata's Chief Medical Officer, said: "We are delighted to have completed enrolment, and we extend our thanks to all of the investigators, study staff and patients for helping us to achieve this milestone. We recently announced very encouraging initial data from the first 16 patients enrolled in this trial after 10 weeks' follow-up, with a median percentage reduction in wound surface area of 87.6% in the active CYP-006TK group, compared to 51.1% in the control group. We now look forward to completing the follow-up period and releasing the full results from this study shortly thereafter." -ENDS- Authorised for release by Dr Kilian Kelly, CEO & Managing Director About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata's lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. A Phase 2 clinical trial in GvHD under a cleared US FDA IND, as well as trials of Cymerus products in osteoarthritis (Phase 3) and diabetic foot ulcers (DFU) are currently ongoing, while a trial in renal transplant is expected to commence in the near future. In addition, Cynata has also demonstrated utility of its Cymerus technology in preclinical models of numerous diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, Automic Group. [1] iPSC = induced pluripotent stem cell [2] MSC = mesenchymal stem (or stromal) cell SOURCE Cynata Therapeutics

临床1期细胞疗法临床结果临床2期临床3期

2024-04-07

·药渡Daily

罗氏利妥昔单抗皮下注射剂型获NMPA批准上市!

2024年4月7日，国家药品监督管理局（NMPA）官网送达信息显示，罗氏（Roche）提交的利妥昔单抗注射液（皮下注射）上市申请已正式获批。罗氏此次获批的利妥昔单抗注射液（皮下注射）是一种含有透明质酸酶的皮下制剂，可暂时且可逆地降解透明质酸。透明质酸是一种在皮下细胞之间形成屏障的凝胶状物质。该皮下制剂能够在更大面积上快速分散和吸收。利妥昔单抗由罗氏旗下基因泰克（Genentech）公司研发，最早在1997年11月26日于美国获批，是一个针对表面具CD20标记的靶细胞的治疗性单克隆抗体。在美国、欧洲和其他国家，利妥昔单抗被批准用于治疗患有以下血癌的成人：既往未经治疗的复发/难治性滤泡性淋巴瘤、既往未经治疗的弥漫性大B细胞淋巴瘤以及既往未经治疗的复发/难治性慢性淋巴细胞白血病；还被批准用于治疗成人自身免疫性疾病：严重活动性类风湿关节炎、寻常型天疱疮以及严重活动性肉芽肿性多血管炎和显微镜下多血管炎。利妥昔单抗注射液（商品名：美罗华）于2000年在中国上市，已获批了非霍奇金淋巴瘤、慢性淋巴细胞白血病、滤泡性淋巴瘤等适应症。目前国内上市的利妥昔单抗生物类似药有4款，具体信息如下：来源：药渡数据除此之外，国内利妥昔单抗类似物申报上市的企业有盛禾（中国）生物制药、山东新时代药业以及上海中信国健药业；处于III期临床阶段的企业有华兰基因工程、南京优科生物以及浙江海正药业等。来源：药渡数据参考资料1.MabThera / Rituxan (rituximab)：https://www.roche.com/solutions/pharma/productid-b0eb216f-addf-4ed1-b01e-0b12fe0b1ef62.MabThera SC / Rituxan Hycela (rituximab hyaluronidase):https://www.roche.com/solutions/pharma/productid-8abc3f49-f39f-4c6e-93ae-235c95c7efc6

上市批准临床3期生物类似药

2024-04-05

·药明康德

首款！不限癌种，重磅ADC获FDA加速批准

▎药明康德内容团队编辑今日，美国FDA宣布加速批准由第一三共（Daiichi Sankyo）和阿斯利康（AstraZeneca）联合开发的重磅抗体偶联药物（ADC）Enhertu（trastuzumab deruxtecan）用于治疗不可切除或转移性HER2阳性（免疫组化[IHC] 3+）实体瘤成年患者，这些患者已接受过先前治疗且缺乏满意的替代治疗选项。之前新闻稿指出，Enhertu是首款具有不限癌种适应症的HER2靶向ADC疗法。值得注意的是，这项批准对于罹患HER2阳性罕见癌症的患者尤为重要，因为专门针对这些患者进行临床试验的机会较为有限。这次批准主要基于在192名经治、不可切除或转移性HER2阳性（IHC 3+）实体瘤成人患者中的疗效评估结果，这些患者参加以下三项多中心试验之一：DESTINY-PanTumor02、DESTINY-Lung01和DESTINY-CRC02。所有三项试验皆排除有间质性肺病（ILD）或需要类固醇治疗肺炎病史的患者，或着在筛选时患有ILD、肺炎或临床上显著心脏疾病的患者。试验还排除了具有活动性脑转移或ECOG体能状态>1的患者。入组患者持续接受治疗，直至病情进展、死亡、撤回同意或出现不可接受的毒性。三项试验的主要疗效结果指标是确认客观缓解率（ORR），另一个疗效指标是缓解持续时间（DOR）。所有结果均由独立中央审评（ICR）基于RECIST v1.1标准进行评估。在DESTINY-PanTumor02中，患者的ORR为51.4%（95% CI：41.7，61.0），中位DOR为19.4个月（范围1.3，27.9+）。在DESTINY-Lung01中，ORR为52.9%（95% CI：27.8，77.0），中位DOR为6.9个月（范围4.0，11.7+）。在DESTINY-CRC02中，ORR为46.9%（95% CI：34.3，59.8），DOR为5.5个月（范围1.3+，9.7+）。试验中最常见的不良反应（≥20%）包括：实验室指标异常，白细胞计数减少、恶心、血红蛋白减少、中性粒细胞计数减少、疲劳、淋巴细胞计数减少、血小板计数减少、天冬氨酸氨基转移酶升高、丙氨酸氨基转移酶升高、血液碱性磷酸酶升高、呕吐、食欲下降、脱发、腹泻、血钾降低、便秘、钠降低、口腔炎和上呼吸道感染。Enhertu是阿斯利康和第一三共联合开发的ADC疗法。它采用第一三共专有的DXd ADC技术平台设计，由靶向HER2的人源化单克隆抗体通过四肽可裂解连接子，与拓扑异构酶1抑制剂有效载荷连接组成。此前，它已经获得美国FDA授予的突破性疗法认定，用于治疗转移性HER2阳性实体瘤。Enhertu在2019年首次获美国FDA批准，用以治疗无法切除或转移性HER2阳性乳腺癌患者。除了共同开发Enhertu，阿斯利康和第一三共也共同开发Trop2靶向ADC datopotamab deruxtecan（Dato-DXd）。美国FDA在这个月接受两家公司所递交该疗法的生物制品许可申请，用于治疗无法切除或转移性HR阳性、HER2阴性乳腺癌成人患者，这些患者已接受过前期全身治疗。除了与阿斯利康进行合作以外，第一三共也在去年10月与默沙东（MSD）就该公司的三个ADC候选药物：patritumab deruxtecan（HER3-DXd）、ifinatamab deruxtecan（I-DXd）和raludotatug deruxtecan（R-DXd）达成了全球开发和商业化协议，将在全球范围内共同开发和潜在商业化这些候选ADC疗法。▲Enhertu（DS-8201）结构示意图（图片来源：参考资料[2]）ADC是新药开发的热点领域之一，近年多家大药企通过并购或授权协议在这一领域加码布局。去年3月，辉瑞（Pfizer）以430亿美元收购了ADC先驱公司Seagen以扩展其肿瘤学管线。去年12月，艾伯维（AbbVie）以总额达约101亿美元收购ImmunoGen，获得其“first-in-class”抗体偶联药物Elahere（mirvetuximab soravtansine）。今年1月，强生（Johnson & Johnson）斥资高达约20亿美元收购Ambrx Biopharma，囊获其分别靶向前列腺特异性膜抗原（PSMA）与HER2的抗体偶联药物ARX517与ARX788。宜联生物（MediLink Therapeutics）也在同月宣布与罗氏（Roche）达成全球合作和许可协议，将合作开发靶向间质表皮转化因子（c-MET）的下一代ADC候选产品YL211（c-MET ADC），用于治疗实体瘤。此外，在研ADC的开发也呈爆发式增长趋势。根据摩根士丹利（Morgan Stanley）公司去年发布的一项报告，目前至少有1400项ADC的临床试验正在进行中。大家都在看▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. Retrieved April 5, 2024 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2[2] Global Pharma Innovator with Competitive Advantage in Oncology. Retrieved April 5, 2024, from https://www.daiichisankyo.com/files/investors/library/materials/2020/pdf/20210113%E2%80%97JPM%20Conference.pdf[3] FDA grants Enhertu tumor-agnostic accelerated approval. Retrieved April 5, 2024 from https://endpts.com/fda-grants-enhertu-tumor-agnostic-accelerated-approval/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「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

抗体药物偶联物临床结果突破性疗法