Primary objective To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 24.
Secondary objective:
To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 12.
To evaluate the clinical response of enthesitis to upadacitinib by LEI, at week 12 and week 24.
To evaluate the clinical response of disease activity by DAPSA, at week 12 and week 24.
Study Design: single-arm, observational longitudinal, prospective study
Population: The study population will consist of adult patients (aged ≥ 18 years old and ≤ 65 years old) with PsA according to CASPAR classification criteria, who have been prescribed upadacitinib over the course of routine practice, in accordance with the applicable approved label and local regulatory and reimbursement policies ("In patients with psoriatic arthritis, upadacitinib would be a therapeutic alternative after failure, inadequate response or intolerance to csDMARDs and anti-TNF") and have at least one ultrasound-determined peripheral enthesitis.

开始日期2023-12-01

申办/合作机构

Hospital Universitario de Canarias

NCT06686082

/ Enrolling by invitationN/AIIT

Effectiveness of Biologics on Synovitis and Enthesitis Using Musculoskeletal Ultrasound Assessment in Subclinical Psoriatic Arthritis: a 12-week Observational Real-world Study

Psoriatic arthritis (PsA) is one of the most common comorbidities in patients with psoriasis (PsO). Current research suggests that the progression from PsO to PsA can be divided into five stages of the disease: PsO, preclinical PsA, subclinical PsA, prodromal PsA, and clinical PsA. Subclinical PsA refers to psoriasis participants who do not exhibit any clinical symptoms of arthritis but show evidence of synovio-enthesitis on ultrasound (US). However, there is currently no definitive biomarker that can accurately predict the progression from PsO to PsA. Synovitis and enthesitis are considered important features of PsA. Musculoskeletal ultrasound, using B-mode ultrasound and power Doppler (PD), can visualize synovitis and enthesitis, allowing for the early detection of subclinical PsA, as confirmed by multiple studies. Biologics are currently widely used in the treatment of PsA, with current treatment interventions primarily focusing on patients already diagnosed with PsA. In this study, we conducted a rigorous screening process to identify potential subclinical PsA patients among those with moderate to severe psoriasis. We treated these subclinical PsA patients with biologics and used musculoskeletal ultrasound as a method of efficacy assessment to observe the improvement of synovitis and enthesitis in subclinical PsA patients after 12 weeks of treatment.

开始日期2023-11-01

申办/合作机构

福建医科大学附属第一医院

DRKS00025563

/ Suspended临床4期

The DIagnostic VAlue of Musculoskeletal UltraSound (MSUS) in the detection of Early signs ofpsoriatic arthritis - An open label, proof-of-concept study using Apremilast in a cohort of very earlypsoriatic arthritis in patients with ultrasound-enthesitis and arthralgia (The DIVAMUSE-study) - DIVAMUSE

开始日期2022-05-01

申办/合作机构

Universitätsklinikum Freiburg

100 项与附着点炎相关的临床结果

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0 项与附着点炎相关的专利（医药）

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项与附着点炎相关的文献（医药）

2025-12-01·Current Rheumatology Reports

A Review on Imaging in Axial Spondyloarthritis: SPARTAN 2024 Annual Meeting Proceedings

Review

作者: Bittar, Mohamad ; Maksymowych, Walter P

PURPOSE OF REVIEWThe purpose of this publication is to review the role of imaging in axial spondyloarthritis. These findings were presented at the SPARTAN annual meeting in May 2024.RECENT FINDINGSImaging plays a major role in the diagnosis and monitoring of axial spondyloarthritis. Magnetic resonance imaging (MRI) findings of active inflammatory lesions (bone marrow edema, capsulitis, inflammation in an erosion cavity, enthesitis, fluid in the joint) and structural lesions (erosions, fat lesions, fat metaplasia in an erosion cavity, bone bud, ankylosis) aid in the early diagnosis of axial spondyloarthritis. Recent data strongly suggests that positive imaging of the sacroiliac joint, especially MRI signs of inflammation, can predict axial spondyloarthritis progression and prognosis. Emerging data supports that MRI findings at baseline might play a role in predicting treatment response. This review covered different imaging concepts, including the role of imaging in early diagnosis as well as prediction of progression, prognosis, and treatment response.

2025-07-01·Cellular Signalling

Mechanical stretch promotes the neutrophil recruitment potential of fibroblasts through the Piezo/NFAT1/LIF axis

Article

作者: Zhang, Weihao ; Lin, Jiajie ; Wu, Yanfeng ; Shen, Guozhen ; Yu, Wenhui ; Li, Jinteng ; Li, Zhikun ; Xiao, Zipeng ; Su, Zepeng ; Xie, Zhongyu ; Zeng, Yipeng ; Zhou, Yi ; Wang, Peng ; Shen, Huiyong

The entheses are the sites where tendons or ligaments insert into osseous structures and play a crucial role in transmitting mechanical stress from muscles to bones. Under excessive mechanical loads, the entheses may sustain inflammation, leading to isolated enthesitis. However, the specific mechanisms through which enthesitis occurs have not yet been fully elucidated. In our study, we discovered that mechanical stress is a critical factor that drives fibroblasts to recruit neutrophils through the secretion of leukemia inhibitory factor (LIF). Further research revealed that fibroblasts convert mechanical stress, a physical signal, into a chemical signal through the Piezo mechanosensitive ion channel, subsequently activating the transcription factor NFAT1 and upregulating LIF expression. This study not only helps elucidate the mechanisms underlying the development of enthesitis but also offers potential insights into the clinical management and treatment of patients with enthesitis.

2025-04-01·Seminars in Arthritis and Rheumatism

Disease characteristics, co-morbidities and treatment response in a contemporary axial spondyloarthritis cohort: Analysis of 717 patients from the Greek AxSpA registry

Article

作者: Tektonidou, Maria G ; Fragoulis, George E ; Kaltsonoudis, Evripidis ; Koutsianas, Christos ; Kougkas, Nikolaos ; Skepastianos, Vasileios ; Zoupidou, Konstantina ; Karamanakos, Anastasios ; Mole, Evangelia ; Fytanidis, Nikolaos ; Karokis, Dimitrios ; Patrikos, Dimos ; Pappa, Maria ; Daoussis, Dimitrios ; Grika, Eleftheria P ; Voulgari, Paraskevi V ; Kalavri, Eleni ; Koletsos, Nikolaos ; Gazi, Sousana ; Katsimpri, Pelagia ; Sampatakaki, Eleni ; Papagoras, Charalampos ; Dimitroulas, Theodoros ; Krikelis, Michael ; Vassilopoulos, Dimitrios ; Konsta, Maria ; Kataxaki, Evangelia ; Sfikakis, Petros P ; Bournazos, Ilias ; Klavdianou, Kalliopi ; Iliopoulos, Georgios ; Iliopoulos, Alexios ; Sfontouris, Charalampos ; Katsifis, Gkikas ; Mavrea, Evgenia ; Kottas, Konstantinos

BACKGROUNDSignificant advances have recently reshaped the management of axial spondyloarthritis (AxSpA). Real-world data from contemporary cohorts are important to capture the current landscape in AxSpA.METHODSA prospective multicenter observational study of patients with AxSpA was undertaken supported by the Greek Rheumatology Society. Here we analyze disease characteristics, comorbidities and treatment patterns at baseline.RESULTS717 patients (64.9% males) with a mean age of 50 years and a median disease duration of 13 years were included. Two thirds of patients had r-AxSpA. The prevalence of peripheral arthritis ever (45%) equaled that of enthesitis, with hip involvement affecting 28% of patients. The leading comorbidities were increased BMI (60%), dyslipidemia (30%) hypertension (30%), depression (14%) and osteoporosis (10%). Most patients (78%) received a bDMARD, while 12% received no treatment at all. Inactive disease or low disease activity was attained by 65% of patients. ASDAS, BASDAI and BASFI were comparable between r-AxSpA and nr-AxSpA, but nr-AxSpA patients reported higher Global and Pain VAS scores. In multivariable analyses, predictors of high ASDAS were dactylitis ever, current smoking and the number of previous bDMARDs, while HLA B27 positivity and low alcohol intake were associated with a lower ASDAS. Male sex, HLA B27 positivity, high CRP at diagnosis, older age and longer diagnosis delay independently predicted the presence of syndesmophytes.CONCLUSIONIn this sizable contemporary AxSpA cohort, one third of patients still miss treatment targets. Additional to cardiovascular risk factors, depression and osteoporosis are considerably prevalent. Smoking predicts a higher ASDAS, while HLA B27 positivity predicts syndesmophyte formation, but also better ASDAS responses.

项与附着点炎相关的新闻（医药）

2025-05-03

·恒瑞医药

世界强直性脊柱炎日｜重视早诊早治，关注脊柱健康

—————————每年5月的第一个星期六是世界强直性脊柱炎国际联盟（ASIF）倡议设立的世界强直性脊柱炎日，旨在普及强直性脊柱炎的基本知识、提高大众和患者认知，降低疾病给患者身心带来的危害。强直性脊柱炎（Ankylosing Spondylitis，AS）是一种慢性炎症性疾病，主要破坏脊柱、骶髂关节，还可累及外周关节、关节外器官。目前我国AS患者有近400万（患病率0.3%左右）[1]。AS起病隐袭，其特征性标志和早期表现之一为骶髂关节炎，附着点炎为本病的特征性病理改变，患者常出现腰背部或骶髂部疼痛和/或晨僵，多数病情会由腰椎向胸、颈椎发展，严重影响患者生活质量，降低生存率[1]。AS作为一种慢性疾病，其治疗目标是缓解症状和体征、恢复功能、防止关节损伤、提高患者生活质量、防止脊柱疾病的并发症。AS的治疗包括非药物治疗、药物治疗和外科治疗。早期以药物治疗为主，晚期脊柱或髋、膝等大关节发生强直或严重畸形时以外科手术治疗为主。非甾体抗炎药（Non-steroidal anti-inflammatory drugs，NSAIDs）是治疗AS的一线药物，对NSAIDs治疗后病情仍活动或者不耐受的AS患者，推荐使用生物制剂类药物[2]。虽然目前AS无法根治，但通过科学治疗和康复锻炼，大多数患者可以维持正常的生活和工作能力，其关键在于早发现、早治疗，配合科学的康复管理，定期复查和调整治疗方案控制病情进展。多年来，恒瑞医药始终关注强直性脊柱炎等免疫系统疾病领域临床需求，致力于通过创新研发为患者带来更多治疗选择。其中，中国首个自主研发的JAK1抑制剂用于对一种或多种TNF抑制剂疗效不佳或不耐受的活动性强直性脊柱炎成人患者适应症已获批上市，研究表明[3]，其在临床试验中表现出了良好的有效性和安全性，标志着中国自主研发JAK1抑制剂在口服制剂技术水平上取得了新的飞跃，为AS治疗提供新的"中国方案"。公司自主研发的重组抗IL-17A人源化单克隆抗体用于常规治疗疗效欠佳的活动性强直性脊柱炎成人患者适应症也已获批上市，研究结果显示[4]：与安慰剂相比，IL-17A单克隆抗体对活动性强直性脊柱炎具有统计学显著性和临床意义的改善，为AS成人患者带来新的治疗选择和希望。此外，JAK1抑制剂还开展了用于活动性放射学阴性中轴型脊柱关节炎的临床研究，目前已推进至Ⅲ期。未来，恒瑞医药将继续坚持“以患者为中心”的理念，持续关注强直性脊柱炎治疗现状，致力于相关药物的研究和应用，以期为患者带来更多治疗选择，为守护患者健康贡献恒瑞力量。参考文献：1.黄烽,朱剑,王玉华,等. 强直性脊柱炎诊疗规范[J]. 中华内科杂志,2022,61(8):893-900.2.Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023;82(1):19-34.3.2024 EULAR poster: https://doi-org.libproxy1.nus.edu.sg/10.1136/annrheumdis-2024-eular.1981.4.POS0803：VUNAKIZUMAB IN ACTIVE ANKYLOSING SPONDYLITIS: A RANDOMIZED, DOUBLE-BLIND, ADAPTIVE, SEAMLESS, PHASE 2/3 STUDY.DOI: 10.1136/annrheumdis-2024-eular.868排版：程梦真责编：王玲往期精选| 研发创新 |恒瑞创新药、中国首个自主研发JAK1抑制剂硫酸艾玛昔替尼片获批上市全球首个超长效PCSK9单抗！恒瑞降脂创新药瑞卡西单抗获批上市| 国际化 |恒瑞医药与默沙东就Lp(a)抑制剂HRS-5346签订独家许可协议| 重磅奖项 |喜报！恒瑞医药荣获2023年度国家科技进步奖恒瑞医药连续六年入选全球制药企业50强榜单！| 社会公益 |“健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

临床3期临床结果放射疗法

2025-04-14

·BioBAY

研发动态丨盛迪亚夫那奇珠单抗新适应症获批，为强直性脊柱炎成人患者提供治疗新选择

近日，恒瑞医药子公司、BioBAY园内企业盛迪亚收到国家药品监督管理局核准签发夫那奇珠单抗（安达静®）的《药品注册证书》，批准增加适应症：本品适用于常规治疗疗效欠佳的活动性强直性脊柱炎（AS）成人患者。此次获批新适应症标志着中国自主研发重组抗IL-17A人源化单克隆抗体在AS治疗领域取得了重要突破，将为AS成人患者带来新的治疗选择和希望。AS是一种慢性炎症性疾病。目前我国AS患者有近400万（患病率0.3%左右）。AS起病隐袭，其特征性标志和早期表现之一为骶髂关节炎，附着点炎为本病的特征性病理改变，患者常出现腰背部或骶髂部疼痛和/或晨僵，多数病情会由腰椎向胸、颈椎发展，严重影响患者生活质量，降低生存率。传统药物可改善炎症临床症状，但对附着点炎和结构进展疗效欠佳；而生物制剂直接作用于AS炎症级联核心（涉及IL-17A、TNF-α等炎性细胞因子），TNF抑制剂可改善患者症状和附着点炎，对Th17细胞介导的IL-17A等通路调控有限，广泛抑制还可能导致安全性风险增加。因此，临床亟需强效且安全的治疗新手段。近年来，随着对AS发病机制的研究不断深入，发现IL-17A是驱动AS慢性炎症主要效应因子，能作用于多种类型的下游细胞，进而促使细胞因子和趋化因子的释放，引发炎症等一系列病理反应。此外，IL-17A也是调控AS附着点炎病理进程的关键细胞因子，并参与了AS骨代谢的调控，在骨侵蚀和新骨形成中均发挥重要作用。最后，IL-17A还介导了AS的炎症性和神经病理性疼痛，造成患者的疼痛反应。因此，IL-17A抑制剂等创新药物已逐渐成为AS的重要治疗手段之一。夫那奇珠单抗是人源化的IgG1抗IL-17A单克隆抗体，保持与IL-17A的高亲和力，可选择性地与IL-17A结合，阻断其与受体的作用，从而抑制下游信号通路，为AS的精准靶向治疗提供了新的思路。此次新适应症获批是基于一项在全国开展的随机、双盲、多中心、安慰剂对照的适应性无缝II/III期临床研究。研究结果显示：与安慰剂相比，夫那奇珠单抗对活动性强直性脊柱炎具有统计学显著性和临床意义的改善——第16周，夫那奇珠单抗组较安慰剂显著提升ASAS 20、ASAS 40应答率分别至65.6%与46.3%，ASAS 5/6应答率提升至55.4%。安全性方面，夫那奇珠单抗组核心期不良事件发生率与安慰剂组相似，无受试者因为不良反应而停止治疗或终止研究。此外，夫那奇珠单抗密集期仅需注射3次，全年注射14次，注射便捷性大大提高。▌文章来源：盛迪亚责编：赵家帅审核：任旭推荐阅读全球首个！盛迪亚抗PD-L1/TGF-βRII双功能融合蛋白申报上市研发动态丨中国首款saRNA药物获批临床！中美瑞康RAG-1C开启PVR治疗新篇章研发动态丨丹诺医药启动TNP-2092关节腔注射给药治疗人工关节感染2期临床试验

临床结果申请上市临床研究

2025-04-10

·健识局

夫那奇珠单抗新适应症获批

近日，恒瑞医药子公司苏州盛迪亚生物医药有限公司宣布，其自主研发的1类创新药——夫那奇珠单抗（安达静）已正式获得国家药品监督管理局（NMPA）的批准，适用于常规治疗疗效欠佳的活动性强直性脊柱炎（AS）成人患者。此次获批标志着继银屑病（PsO）适应症之后，中国自主研发的人源化抗IL-17A单克隆抗体在AS治疗领域取得了重大突破，为AS患者带来了新的治疗选择和希望。AS是一种慢性炎症性疾病，目前我国AS患者有近400万。AS起病隐袭，其特征性标志和早期表现之一为骶髂关节炎，附着点炎为本病的特征性病理改变，患者常出现腰背部或骶髂部疼痛和/或晨僵，多数病情会由腰椎向胸、颈椎发展，严重影响患者生活质量，降低生存率。此次新适应症获批是基于一项在全国开展的随机、双盲、多中心、安慰剂对照的适应性无缝II/III期临床研究。研究结果显示：与安慰剂相比，夫那奇珠单抗对活动性强直性脊柱炎具有统计学显著性和临床意义的改善——第16周，夫那奇珠单抗组较安慰剂显著提升ASAS 20、ASAS 40应答率分别至65.6%与46.3%，ASAS 5/6应答率提升至55.4% 。在安全性方面，夫那奇珠单抗组核心期不良事件发生率与安慰剂组相似，无受试者因为不良反应而停止治疗或终止研究。此外，夫那奇珠单抗密集期仅需注射3次，全年注射14次，注射便捷性高。运营｜李木子声明：健识局原创内容，未经许可请勿转载“最大”连锁药店，去年关店1270家三次IPO失败，曾被举报财务造假，中药饮片巨头转战港交所新事 | 艾迪药业：新冠特效药，停止开发！

IPO临床2期