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Patient profiles and early response in patients with systemic lupus erythematosus initiating anifrolumab: interim analysis from the ongoing multicentre observational REVEAL study 启动anfrolumab的系统性红斑狼疮患者的患者概况和早期反应:来自正在进行的多中心观察性REVEAL研究的中期分析
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-05 DOI: 10.1016/S2665-9913(25)00316-9
Chiara Tani MD , Chiara Cardelli MD , Luca Moroni MD , Prof Margherita Zen MD , Francesca Bottazzi MD , Micaela Fredi MD , Prof Alessandra Bortoluzzi MD , Prof Matteo Piga MD , Flavia Riccio MD , Prof Fulvia Ceccarelli MD , Ginevra De Marchi MD , Lucia Manfredi MD , Rita Mulè MD , Edoardo Biancalana MD , Prof Mariele Gatto MD , Laura Coladonato MD , Paola Conigliaro MD , Prof Maria Gerosa MD , Prof Andrea Picchianti Diamanti MD , Giuseppe Alvise Ramirez MD , Prof Marta Mosca MD
<div><h3>Background</h3><div>Anifrolumab is a type I interferon receptor antagonist approved for the treatment of systemic lupus erythematosus (SLE). However, real-world evidence on its use, especially from large, unselected cohorts, is scarce. The ongoing REVEAL study is designed to collect real-world data on anifrolumab use. The data reported here are the pre-specified 6-month interim analysis, which aims to provide a phenotypic characterisation of a large real-world cohort of patients with SLE initiating anifrolumab, and to evaluate early treatment response in routine clinical practice.</div></div><div><h3>Methods</h3><div>REVEAL is a 5-year, multicentre, prospective observational study conducted in 25 tertiary rheumatology centres across Italy. A pre-specified interim analysis was planned when the first 50 patients completed the first 6 months of follow-up; this analysis includes all patients who initiated anifrolumab by the data cutoff of Feb 10, 2025. Patients with SLE were consecutively enrolled on the day of their first infusion of anifrolumab, prescribed according to clinical judgement and Italian indications for use. Eligible patients were aged 18 years or older, had a clinical diagnosis of SLE fulfilling at least one set of established classification criteria valid at the time of diagnosis (1997 American College of Rheumatology [ACR], 2012 Systemic Lupus International Collaborating Clinics, or 2019 European Alliance of Associations for Rheumatology–ACR), had active disease warranting anifrolumab treatment (including compassionate use programmes), and were naive to anifrolumab. Data were collected at baseline and at 1 month, 3 months, and 6 months. The primary outcome was the number of patients reaching remission (defined according to the Definition of Remission in SLE criteria as a clinical SLEDAI-2K score of 0, physician global assessment score of <0·5 [on a 0–3 scale], with a prednisone-equivalent dose ≤5 mg per day, and stable antimalarials or immunosuppressants), Lupus Low Disease Activity State (LLDAS; defined as a SLEDAI-2K ≤4 [with no activity in major organ systems and no new disease activity], physician global assessment ≤1·0, and a prednisone-equivalent dose ≤7·5 mg per day), and LLDAS5 (a modified version of the LLDAS with a prednisone-equivalent dose ≤5 mg per day) at 6 months. Adverse and serious adverse events were also recorded. No people with lived experience of SLE were involved in designing or conducting the study. This study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT07215754</span><svg><path></path></svg></span>) and with the Italian Medicines Agency (Agenzia Italiana del Farmaco; ID number 247) and recruitment is ongoing.</div></div><div><h3>Findings</h3><div>Between May 25, 2023, and Feb 10, 2025, 236 patients were recruited and included in this interim analysis. Of these, 219 (93%) were female, 17 (7%) were male, 218 (92%) were White, and the median
背景:Anifrolumab是一种I型干扰素受体拮抗剂,被批准用于治疗系统性红斑狼疮(SLE)。然而,关于其使用的真实证据,特别是来自大量未选择的队列的证据很少。正在进行的REVEAL研究旨在收集anifrolumab使用的真实数据。本文报告的数据是预先指定的为期6个月的中期分析,旨在提供一个大型真实世界SLE患者队列的表型特征,并评估常规临床实践中的早期治疗反应。方法:REVEAL是一项在意大利25个三级风湿病中心进行的为期5年的多中心前瞻性观察研究。当前50名患者完成前6个月的随访时,计划进行预先指定的中期分析;该分析包括截至2025年2月10日开始使用anifrolumab的所有患者。SLE患者在首次输注anifrolumab当日连续入组,根据临床判断和意大利适应症用药。符合条件的患者年龄在18岁或以上,SLE临床诊断满足诊断时至少一套有效的已建立的分类标准(1997年美国风湿病学会[ACR], 2012年系统性狼疮国际合作诊所,或2019年欧洲风湿病协会联盟-ACR),有活动性疾病需要anifrolumab治疗(包括同情使用计划),并且对anifrolumab没有经验。在基线、1个月、3个月和6个月时收集数据。主要结局是达到缓解的患者数量(根据SLE标准中缓解的定义,临床SLEDAI-2K评分为0,医生总体评估评分为结果):在2023年5月25日至2025年2月10日期间,招募了236例患者并将其纳入该中期分析。其中女性219例(93%),男性17例(7%),白人218例(92%),中位年龄46.9岁(IQR 36.0 ~ 53.6)。基线时,SLEDAI-2K的中位数为7 (IQR为6-9),anfrolumab的主要适应症是粘膜(157[67%])和关节(116[49%])受累。6个月时,140例患者中37例(26%)达到缓解,80例(57%)达到LLDAS5, 93例(66%)达到LLDAS。1例患者因缺少医师总体评估数据而被排除在结果分析之外。在6个月的随访期间,记录了108例不良事件;其中83例(77%)为感染。发生了5起严重不良事件,导致6人住院。解释:该研究首次提供了大规模的真实证据,证明了anfrolumab在SLE患者中的应用,支持其临床益处和在常规护理中的快速起效。资金:没有。
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引用次数: 0
Correction to Lancet Rheumatol 2026; published online Jan 21. https://doi.org/10.1016/S2665-9913(25)00284-X Lancet Rheumatol 2026修正;1月21日在网上发表。https://doi.org/10.1016/s2665 - 9913 (25) 00284 - x。
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-23 DOI: 10.1016/S2665-9913(26)00047-0
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引用次数: 0
Current status of cardiovascular risk factor control in antiphospholipid syndrome: where are we now? 抗磷脂综合征心血管危险因素控制现状:进展如何?
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2025-11-19 DOI: 10.1016/S2665-9913(25)00285-1
Can Huang , Mengtao Li
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引用次数: 0
Can we prevent the onset of rheumatoid arthritis in patients with high-risk features? 我们能否预防具有高危特征的类风湿关节炎患者的发病?
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-20 DOI: 10.1016/S2665-9913(26)00006-8
Janet E Pope
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引用次数: 0
Cardiovascular risk factor control in antiphospholipid syndrome, and differences between primary and systemic lupus erythematosus-related antiphospholipid syndrome (SURF-SLE and APS project): a cross-sectional study of 1003 individuals from 11 countries 抗磷脂综合征的心血管危险因素控制,原发性和系统性红斑狼疮相关抗磷脂综合征的差异(SURF-SLE和APS项目):来自11个国家1003人的横断面研究。
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2025-11-19 DOI: 10.1016/S2665-9913(25)00257-7
Eleana Bolla MD , Anne Grete Semb MD , Prof Michelle Petri MD , Prof Petros P Sfikakis MD , Bahar Artim-Esen MD , Gabriela Hernandez-Molina MD , Prof Eric Hachulla MD , Prof Haner Direskeneli MD , Prof George A Karpouzas MD , Dina Zucchi MD , Mohit Goyal MD , Prof Nathalie Costedoat-Chalumeau MD , Prof Angela Tincani MD , Ayten Yazici MD , Karoline Lerang MD , Anne Troldborg MD , Sofia Ajeganova MD , Tatiana V Popkova MD , Elisabet Svenungsson MD , Nikos Pantazis PhD , Esin Yilmaz
<div><h3>Background</h3><div>The European Alliance of Associations for Rheumatology recommendations for cardiovascular risk management highlighted the importance of traditional cardiovascular risk factor control in antiphospholipid syndrome (APS). However, cardiovascular risk factor target attainment in APS and differences between primary APS and systemic lupus erythematosus (SLE)-related APS remain uncertain.</div></div><div><h3>Methods</h3><div>Cardiovascular risk factor data were collected from medical records of patients in 17 centres from 11 countries between Jan 1, 2015, and Jan 1, 2020 (extended to 2022 for some centres unable to complete the survey by the end of 2020 due to the COVID-19 pandemic), and analysed cross-sectionally. Included patients were 18 years or older and met the revised Sapporo APS classification criteria. Patients who also met the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE were classified as having SLE-related APS. Patients with APS in association with systemic autoimmune diseases other than SLE were excluded. Cardiovascular risk was estimated using the Systematic Coronary Risk Evaluation algorithm, and cardiovascular risk factor target attainment was assessed using European Society of Cardiology guidelines. Unadjusted and adjusted mixed effects logistic regression models were fitted. People with lived experience were not involved in the study design.</div></div><div><h3>Findings</h3><div>In total, 1003 patients with APS were included (779 [78%] women and 224 [22%] men; 662 [66%] of 1000 were White), with a median age of 47·0 years (IQR 38·0–57·0) and a median disease duration of 11·0 years (5·0–18·0). 539 (54%) patients had primary APS and 464 (46%) had SLE-related APS. We found a high prevalence of cardiovascular risk factors (hypertension, 411 [41%] of 1003; hyperlipidaemia, 344 [34%] of 1003; obesity, 295 [32%] of 919; current smoking, 186 [19%] of 963) and inadequate individual (blood pressure less than 130/80 mm Hg, BMI, and lipids) and composite cardiovascular risk factor control in all patients. A higher prevalence of hypertension (234 [50%] of 464 <em>vs</em> 177 [33%] of 539; p<0·0001) and hyperlipidaemia (184 [40%] of 464 <em>vs</em> 160 [30%] of 539; p=0·0009) was observed in SLE-related APS versus primary APS, but a lower prevalence of current smoking (72 [16%] of 452 <em>vs</em> 114 [22%] of 511; p=0·012). Patients with primary APS had worse target attainment for smoking cessation (397 [78%] of 511 <em>vs</em> 380 [84%] of 452; p=0·012), blood pressure less than 130/80 mm Hg (246 [48%] of 514 <em>vs</em> 258 [57%] of 456; p=0·0067), and two or more cardiovascular risk factor targets (of smoking, BMI, blood pressure, LDL) than patients with SLE-related APS in the entire group, as well as worse target attainment for smoking cessation, blood pressure less than 130/80 mmHg, BMI, LDL, triglycerides, two or more and three or more targets in the high and ve
背景:欧洲风湿病协会联盟关于心血管风险管理的建议强调了抗磷脂综合征(APS)传统心血管风险因素控制的重要性。然而,APS患者的心血管危险因素目标实现情况以及原发性APS与系统性红斑狼疮(SLE)相关APS之间的差异仍不确定。方法:收集2015年1月1日至2020年1月1日(部分中心因2019冠状病毒病大流行无法在2020年底前完成调查,将调查时间延长至2022年)11个国家17个中心的患者病历中的心血管危险因素数据,并进行横断面分析。纳入的患者年龄在18岁或以上,符合修订的Sapporo APS分类标准。同时符合2012系统性狼疮国际合作诊所(SLICC) SLE分类标准的患者被归类为SLE相关APS。排除与系统性自身免疫性疾病(SLE除外)相关的APS患者。使用系统冠状动脉风险评估算法估计心血管风险,使用欧洲心脏病学会指南评估心血管危险因素目标实现情况。拟合未调整和调整混合效应logistic回归模型。有生活经验的人没有参与研究设计。结果:共纳入1003例APS患者(女性779例[78%],男性224例[22%];1000例中白人662例[66%]),中位年龄47.0岁(IQR 38.0 ~ 57.0),中位病程11.0年(5.0 ~ 18.0)。539例(54%)患者为原发性APS, 464例(46%)患者为slee相关APS。我们发现心血管危险因素(高血压,1003例中411例[41%];高脂血症,1003例中344例[34%];肥胖,919例中295例[32%];目前吸烟,963例中186例[19%])和个体(血压低于130/80毫米汞柱、BMI和血脂)和心血管危险因素综合控制在所有患者中都很普遍。解释:在这项大型现实世界研究中,APS患者的高血压患病率较高(234 [50%]vs 177[33%]),心血管危险因素控制不佳,强调需要提高心血管风险意识,特别是原发性APS患者,他们的心血管风险经常被忽视。资金:没有。
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引用次数: 0
Rapid remission and effect on organ manifestations with anifrolumab 抗瘤单抗快速缓解及对器官表现的影响。
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-05 DOI: 10.1016/S2665-9913(25)00369-8
Martin Aringer
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引用次数: 0
Early screening for rheumatoid arthritis-associated interstitial lung disease: statistical nuances challenge the role of disease activity 类风湿关节炎相关间质性肺疾病的早期筛查:统计上的细微差别对疾病活动的作用提出了挑战。
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-29 DOI: 10.1016/S2665-9913(26)00003-2
Suhai Qian , Yibo Jin , Xinghong Ding
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引用次数: 0
Frailty care in England deemed deficient 英国的体弱多病护理被认为不足。
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-05 DOI: 10.1016/S2665-9913(26)00044-5
Heather Van Epps
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引用次数: 0
Research in Brief 研究简介
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-23 DOI: 10.1016/S2665-9913(26)00050-0
Jennifer Thorley
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引用次数: 0
The path to interception in psoriatic disease: from conceptual clarity to clinical translation 银屑病的阻断途径:从概念清晰到临床转化。
IF 16.4 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-23 DOI: 10.1016/S2665-9913(25)00348-0
Dylan McGagh BMBCh , Ashley Elliott PhD , Teresa Grohmann PhD , Wendy Wagenaar PhD , Prof Stephen R Pennington PhD , Prof Oliver FitzGerald MD , Laura C Coates PhD
Psoriatic arthritis develops in up to one-third of individuals with psoriasis, typically following a prolonged subclinical phase. Diagnostic delays are common, often exceeding 2 years, and can result in irreversible joint damage. The growing recognition of this latent period has fuelled interest in earlier identification and interception. However, efforts are hampered by inconsistent definitions of early or subclinical psoriatic arthritis, insufficient prognostic tools, and an absence of consensus on the outcome for interception studies. This Review synthesises a rapidly evolving field, offering a framework organised around four crucial questions: first, what defines progression from psoriasis to psoriatic arthritis? Second, who is most at risk of transition? Third, how can progression be reliably measured using imaging, molecular biomarkers, or digital health technologies? Fourth, when should preventive intervention be considered? We critically examine new conceptual models, the limitations of existing classification criteria, advances in imaging and biomarker research, and the promise of digital phenotyping. Addressing the current challenges in definitions, risk stratification, measurement, and trial design is essential for the development of biologically grounded, ethically robust interception strategies.
银屑病关节炎在多达三分之一的银屑病患者中发展,通常是在长时间的亚临床阶段之后。诊断延迟是常见的,通常超过2年,并可导致不可逆的关节损伤。越来越多的人认识到这一潜伏期,引起了人们对早期识别和拦截的兴趣。然而,由于早期或亚临床银屑病关节炎的定义不一致,预后工具不足,以及对拦截研究结果缺乏共识,这些努力受到阻碍。这篇综述综合了一个快速发展的领域,围绕四个关键问题提供了一个框架:首先,什么定义了从银屑病到银屑病关节炎的进展?其次,谁面临的转型风险最大?第三,如何使用成像、分子生物标志物或数字卫生技术可靠地测量进展?第四,什么时候应该考虑预防性干预?我们批判性地研究了新的概念模型,现有分类标准的局限性,成像和生物标志物研究的进展,以及数字表型的前景。解决当前在定义、风险分层、测量和试验设计方面的挑战,对于制定生物学基础、道德健全的拦截策略至关重要。
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引用次数: 0
期刊
Lancet Rheumatology
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