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Factors affecting the duration of initial medical care seeking among older rural patients diagnosed with rheumatoid arthritis: a retrospective cohort study. 影响农村老年类风湿关节炎患者初次就医时间的因素:一项回顾性队列研究。
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-06-06 DOI: 10.1186/s41927-024-00392-9
Ryuichi Ohta, Chiaki Sano

Background: Early diagnosis and treatment of rheumatoid arthritis (RA) are essential to prevent progressive joint destruction and improve the quality of life (QOL) of patients. This study aimed to identify the factors associated with the duration from symptom onset to seeking initial medical care among older rural patients diagnosed with RA.

Methods: This retrospective cohort study was conducted in Unnan City, Japan, using electronic patient records. Data from patients aged > 65 years, who were admitted to the Unnan City Hospital between April 2016 and March 2021, were analyzed. The primary outcome was the duration from symptom onset to the initial visit to the medical institution. Demographic factors, laboratory data, and data on symptoms were collected and analyzed using statistical tests and regression models.

Results: In total, 221 participants were included in this study. The longer duration from symptom onset to medical care usage was significantly associated with age (adjusted odds ratio [OR]: 1.09, 95% confidence interval [CI]: 1.03-1.15), isolated conditions (adjusted OR: 4.45, 95% CI: 1.85-10.70), and wrist symptoms (adjusted OR: 3.22, 95% CI: 1.44-7.17). Higher education level and alcohol consumption were also associated with the duration from symptom onset to medical care usage.

Conclusions: Older age, isolated conditions, and specific joint symptoms were significant factors influencing delays in seeking medical care among older rural patients with RA. Interventions to improve health literacy, increase social support, and raise awareness of RA symptoms are essential for expediting diagnosis and improving patient QOL. Further research is needed to explore additional psychosocial factors and beliefs that affect health-seeking behaviors in patients with RA.

背景:类风湿性关节炎(RA)的早期诊断和治疗对于防止关节的逐渐破坏和改善患者的生活质量(QOL)至关重要。本研究旨在确定农村老年类风湿关节炎患者从症状出现到寻求初步医疗护理的持续时间的相关因素:这项回顾性队列研究在日本宇南市进行,使用的是电子病历。研究分析了 2016 年 4 月至 2021 年 3 月期间在宇南市医院住院的 65 岁以上患者的数据。主要结果是从症状出现到首次到医疗机构就诊的持续时间。研究人员收集了人口统计学因素、实验室数据和症状数据,并使用统计检验和回归模型进行了分析:本研究共纳入 221 名参与者。从症状出现到就医的持续时间较长与年龄(调整后比值比 [OR]:1.09,95% 置信区间 [CI]:1.03-1.15)、孤立条件(调整后比值比 [OR]:4.45,95% 置信区间 [CI]:1.85-10.70)和腕部症状(调整后比值比 [OR]:3.22,95% 置信区间 [CI]:1.44-7.17)显著相关。较高的教育水平和饮酒量也与从症状出现到就医的持续时间有关:结论:高龄、孤立条件和特定关节症状是影响农村老年RA患者延迟就医的重要因素。提高健康素养、增加社会支持和提高对RA症状的认识等干预措施对于加快诊断和改善患者的生活质量至关重要。还需要进一步研究,探索影响RA患者就医行为的其他社会心理因素和信念。
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引用次数: 0
Patient-reported outcomes and healthcare resource utilization in systemic lupus erythematosus: impact of disease activity 系统性红斑狼疮的患者报告结果和医疗资源利用率:疾病活动的影响
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-06-05 DOI: 10.1186/s41927-023-00355-6
Zahi Touma, Karen H. Costenbader, Ben Hoskin, Christian Atkinson, David Bell, James Pike, Pamela Berry, Chetan S. Karyekar
Limited real-world data exists on clinical outcomes in systemic lupus erythematosus (SLE) patients by SLE Disease Activity Index 2000 (SLEDAI-2 K), hereafter, SLEDAI. We aimed to examine the association between SLEDAI score and clinical, patient-reported and economic outcomes in patients with SLE. Rheumatologists from the United States of America and Europe provided real-world demographic, clinical, and healthcare resource utilization (HCRU) data for SLE patients. Patients provided self-reported outcome data, capturing their general health status using the EuroQol 5-dimension 3-level questionnaire (EQ-5D-3 L), health-related quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) and work productivity using the Work Productivity and Activity Impairment questionnaire (WPAI). Low disease activity was defined as SLEDAI score ≤ 4 and ≤ 7.5 mg/day glucocorticoids; patients not meeting these criteria were considered to have “higher” active disease. Data were compared between patients with low and higher disease activity. Logistic regression estimated a propensity score for SLE based on demographic and clinical characteristics. Propensity score matched analyses compared HCRU, patient-reported outcomes, income loss and treatment satisfaction in patients with low disease activity versus higher active disease. Data from 296 physicians reporting on 730 patients (46 low disease activity, 684 higher active disease), and from 377 patients’ self-reported questionnaires (24 low disease activity, 353 higher active disease) were analyzed. Flaring in the previous 12 months was 2.6-fold more common among patients with higher versus low active disease. Equation 5D-3 L utility index was 0.79 and 0.88 and FACIT-Fatigue scores were 34.78 and 39.79 in low versus higher active disease patients, respectively, indicating better health and less fatigue, among patients with low versus higher active disease. Absenteeism, presenteeism, overall work impairment, and total activity impairment were 47.0-, 2.0-, 2.6- and 1.5-fold greater in patients with higher versus low disease activity. In the previous 12 months there were 28% more healthcare consultations and 3.4-fold more patients hospitalized in patients with higher versus low disease activity. Compared to SLE patients with higher active disease, patients with low disease activity experienced better health status, lower HCRU, less fatigue, and lower work productivity impairment, with work absenteeism being substantially lower in these patients.
根据系统性红斑狼疮疾病活动指数 2000(SLEDAI-2 K)(以下简称 SLEDAI)得出的系统性红斑狼疮(SLE)患者临床疗效的真实世界数据有限。我们的目的是研究 SLEDAI 评分与系统性红斑狼疮患者的临床、患者报告和经济效益之间的关联。来自美国和欧洲的风湿病专家为系统性红斑狼疮患者提供了真实世界的人口、临床和医疗资源利用(HCRU)数据。患者提供了自我报告的结果数据,其中包括使用 EuroQol 5 维 3 级问卷(EQ-5D-3 L)记录的一般健康状况、使用慢性疾病治疗功能评估(FACIT)记录的与健康相关的生活质量,以及使用工作效率和活动障碍问卷(WPAI)记录的工作效率。低疾病活动度的定义是 SLEDAI 评分≤ 4 分且糖皮质激素≤ 7.5 毫克/天;不符合这些标准的患者被视为 "较高 "活动度。对低度和高度疾病活动患者的数据进行了比较。逻辑回归根据人口统计学和临床特征估算出系统性红斑狼疮的倾向得分。倾向得分匹配分析比较了疾病活动度低和疾病活动度高患者的 HCRU、患者报告的结果、收入损失和治疗满意度。分析了 296 名医生对 730 名患者(46 名疾病活动度低,684 名疾病活动度高)的报告数据,以及 377 名患者(24 名疾病活动度低,353 名疾病活动度高)的自我报告问卷数据。疾病活动度较高的患者与疾病活动度较低的患者相比,前 12 个月出现哮鸣音的比例高出 2.6 倍。等式 5D-3 L 实用指数在低活动性和高活动性患者中分别为 0.79 和 0.88,FACIT-疲劳评分分别为 34.78 和 39.79,这表明低活动性和高活动性患者的健康状况更好,疲劳程度更低。疾病活动度高的患者与疾病活动度低的患者相比,缺勤率、缺勤率、总体工作受损程度和总体活动受损程度分别高出 47.0 倍、2.0 倍、2.6 倍和 1.5 倍。在过去的12个月中,疾病活动度高的患者接受的医疗咨询比疾病活动度低的患者多28%,住院治疗的患者比疾病活动度低的患者多3.4倍。与疾病活动度较高的系统性红斑狼疮患者相比,疾病活动度低的患者的健康状况更好、HCRU 更低、疲劳更少、工作效率受损更低,缺勤率也大大降低。
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引用次数: 0
Epidemiology and diagnosis of gout in sub-saharan Africa: a scoping review. 撒哈拉以南非洲地区痛风的流行病学和诊断:范围界定综述。
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-05-23 DOI: 10.1186/s41927-024-00391-w
Ayouba Tinni Ismael, Kabore Fulgence, Bayala Yannick Laurent Tchenadoyo, Yameogo Wendyam Nadège, Zabsonre/Tiendrebeogo Wendlassida Stéphanie Joelle, Ouedraogo Aboubakar, Zongo Yamyelle Enselme, Traore Awa, Bonkoungou Marcellin, Ouedraogo Dieu-Donné

Background: The episodic nature of gout and diagnostic uncertainty in the absence of microcrystal evidence make it particularly difficult to estimate the frequency of gout. Our aim was to review the literature on the epidemiological and diagnostic aspects of gout in sub-Saharan Africa.

Methods: This literature review was conducted using the MEDLINE database (via PUBMED), Google Scholar, and conference abstracts. The selection process was based on reading the titles first, then the abstracts, and then the full texts once the articles had been selected. Studies were included in this review if they presented original findings on the epidemiological and/or diagnostic aspects of gout in sub-Saharan Africa. Two groups of two investigators independently reviewed the studies. The results were analysed descriptively.

Results: The literature search identified 131 articles and 22 conference abstracts. Nineteen articles were included in our review. Twelve studies were retrospective, five were cross-sectional, one was prospective, and one was both retrospective and cross-sectional. The duration of the studies ranged from 1 to 15 years, and the sample size ranged from 15 to 511 patients, for a total of 2557 patients. Gout was quite common, with a maximum frequency of 11.87%. Fourteen articles diagnosed gout via criteria, including 9 studies totaling 1174 patients via the 1977 ACR criteria. Gout tophi were reported in 15 articles involving 464 patients. Of these studies, seven looked for monosodium urate crystals in 317 (43.85%) of 723 patients. Among the 317 patients, monosodium urate crystals were detected in 263 (82.97%) patients. Eleven studies reported mean uricemia values ranging from 452.09 µmol/L to 642.44 µmol/L, with a mean of 510.63 µmol/L.

Conclusions: This review revealed that all the studies conducted in sub-Saharan Africa were intrahospital studies, and the majority were retrospective. Consequently, there is a clear need for population-based studies.

背景:痛风的偶发性和缺乏微晶证据的诊断不确定性使得痛风发病率的估算变得尤为困难。我们的目的是回顾撒哈拉以南非洲地区痛风的流行病学和诊断方面的文献:本次文献综述使用了 MEDLINE 数据库(通过 PUBMED)、谷歌学术和会议摘要。在筛选过程中,首先阅读标题,然后阅读摘要,选定文章后再阅读全文。只要是对撒哈拉以南非洲地区痛风的流行病学和/或诊断方面有原创性发现的研究,均可纳入本综述。由两名调查人员组成的两组独立审查了这些研究。结果进行了描述性分析:文献检索发现了 131 篇文章和 22 份会议摘要。19篇文章被纳入我们的审查范围。其中 12 篇为回顾性研究,5 篇为横断面研究,1 篇为前瞻性研究,1 篇既有回顾性研究又有横断面研究。研究持续时间从1年到15年不等,样本量从15到511名患者不等,共计2557名患者。痛风相当常见,最高发病率为 11.87%。14篇文章通过标准对痛风进行了诊断,其中9项研究通过1977年ACR标准对1174名患者进行了诊断。有 15 篇文章报告了痛风病灶,涉及 464 名患者。在这些研究中,有 7 项研究对 723 名患者中的 317 名(43.85%)患者进行了尿酸单钠结晶检测。在这 317 名患者中,有 263 名(82.97%)患者检测出单钠尿酸盐结晶。11 项研究报告的平均尿酸血症值从 452.09 微摩尔/升到 642.44 微摩尔/升不等,平均值为 510.63 微摩尔/升:综述显示,在撒哈拉以南非洲地区进行的所有研究均为院内研究,且大多数为回顾性研究。因此,显然有必要开展基于人群的研究。
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引用次数: 0
Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study. 古舍库单抗对既往使用过一种肿瘤坏死因子抑制剂但疗效不佳和/或不耐受的活动性银屑病关节炎患者的疗效和安全性:SOLSTICE 研究方案,一项 3B 期、多中心、随机、双盲、安慰剂对照研究。
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-05-21 DOI: 10.1186/s41927-024-00386-7
Alexis Ogdie, Joseph F Merola, Philip J Mease, Christopher T Ritchlin, Jose U Scher, Kimberly Parnell Lafferty, Daphne Chan, Soumya D Chakravarty, Wayne Langholff, Yanli Wang, Olivia Choi, Yevgeniy Krol, Alice B Gottlieb

Background: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.

Methods: The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel-Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively.

Discussion: Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.

Trial registration: This trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.

背景:肿瘤坏死因子抑制剂(TNFi)经常被选为银屑病关节炎(PsA)患者的首选生物制剂。鉴于许多 PsA 患者对 TNFi 反应不足(TNF-IR;疗效不佳或不耐受),因此需要利用其他作用机制进行治疗。在三期研究中,全人白细胞介素(IL)-23p19亚基抑制剂古舍库单抗对包括TNFi-IR在内的活动性PsA患者有疗效。TNFi-naïve和TNFi-experi经验组之间的疗效基本一致;然而,在后者中,就某些终点而言,Q4W给药方案比Q8W给药方案的反应率更高,这表明有必要评估更频繁的给药是否能为TNFi-IR患者带来更多临床益处:3b期SOLSTICE研究将评估Guselkumab对TNFi-IR PsA患者的疗效和安全性。资格标准包括:PsA确诊时间≥6个月;疾病处于活动期(肿胀关节≥3个,压痛关节≥3个,C反应蛋白≥0.3 mg/dL);对既往一种TNFi治疗效果不佳和/或不耐受。参与者将按1:1:1的比例随机分配到古舍库单抗Q4W或Q8W或安慰剂→古舍库单抗Q4W(第24周)。主要终点是第24周时美国风湿病学会标准(ACR20)改善≥20%的患者比例。主要次要终点包括:ACR50、ACR70;银屑病研究者全球评估(IGA)评分为0/1,且评分降低≥2级,银屑病面积和严重程度指数改善≥90%(均为银屑病影响体表面积≥3%且基线IGA≥2的患者);疾病活动度极低/极低;以及健康评估问卷-残疾指数、36项短式健康调查身体成分摘要和慢性疾病治疗功能评估-疲劳评分与基线相比的变化。假设双侧α=0.05,目标样本量(N=450)估计能提供大于90%的功率,以检测每个guselkumab组与安慰剂组在主要终点上的差异。Cochran-Mantel-Haenszel检验和协方差分析将分别用于比较二元终点和连续终点的疗效:SOLSTICE 3b 期研究的设计参考了之前进行的 3 期研究的结果,预计该研究结果将为 TNFii-IR PsA 患者接受古谢库单抗治疗提供重要的疗效和安全性信息:该试验于2021年6月23日在ClinicalTrials.gov上注册,注册号为NCT04936308。
{"title":"Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study.","authors":"Alexis Ogdie, Joseph F Merola, Philip J Mease, Christopher T Ritchlin, Jose U Scher, Kimberly Parnell Lafferty, Daphne Chan, Soumya D Chakravarty, Wayne Langholff, Yanli Wang, Olivia Choi, Yevgeniy Krol, Alice B Gottlieb","doi":"10.1186/s41927-024-00386-7","DOIUrl":"10.1186/s41927-024-00386-7","url":null,"abstract":"<p><strong>Background: </strong>Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.</p><p><strong>Methods: </strong>The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel-Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively.</p><p><strong>Discussion: </strong>Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.</p><p><strong>Trial registration: </strong>This trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"20"},"PeriodicalIF":2.2,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11106968/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141074499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Design of ANCHOR-RA: a multi-national cross-sectional study on screening for interstitial lung disease in patients with rheumatoid arthritis. ANCHOR-RA 的设计:一项关于类风湿关节炎患者间质性肺病筛查的多国横断面研究。
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-05-21 DOI: 10.1186/s41927-024-00389-4
Jeffrey A Sparks, Philippe Dieudé, Anna-Maria Hoffmann-Vold, Gerd R Burmester, Simon Lf Walsh, Michael Kreuter, Christian Stock, Steven Sambevski, Margarida Alves, Paul Emery

Background: Patients with rheumatoid arthritis (RA) are at risk of developing interstitial lung disease (ILD), which is associated with high mortality. Screening tools based on risk factors are needed to decide which patients with RA should be screened for ILD using high-resolution computed tomography (HRCT). The ANCHOR-RA study is a multi-national cross-sectional study that will develop a multivariable model for prediction of RA-ILD, which can be used to inform screening for RA-ILD in clinical practice.

Methods: Investigators will enrol consecutive patients with RA who have ≥ 2 of the following risk factors for RA-ILD: male; current or previous smoker; age ≥ 60 years at RA diagnosis; high-positive rheumatoid factor and/or anti-cyclic citrullinated peptide (titre > 3 x upper limit of normal); presence or history of certain extra-articular manifestations of RA (vasculitis, Felty's syndrome, secondary Sjögren's syndrome, cutaneous rheumatoid nodules, serositis, and/or scleritis/uveitis); high RA disease activity in the prior 12 months. Patients previously identified as having ILD, or who have had a CT scan in the prior 2 years, will not be eligible. Participants will undergo an HRCT scan at their local site, which will be assessed centrally by two expert radiologists. Data will be collected prospectively on demographic and RA-related characteristics, patient-reported outcomes, comorbidities and pulmonary function. The primary outcomes will be the development of a probability score for RA-ILD, based on a multivariable model incorporating potential risk factors commonly assessed in clinical practice, and an estimate of the prevalence of RA-ILD in the study population. It is planned that 1200 participants will be enrolled at approximately 30 sites in the USA, UK, Germany, France, Italy, Spain.

Discussion: Data from the ANCHOR-RA study will add to the body of evidence to support recommendations for screening for RA-ILD to improve detection of this important complication of RA and enable early intervention.

Trial registration: clinicaltrials.gov NCT05855109 (submission date: 3 May 2023).

背景:类风湿性关节炎(RA)患者有患间质性肺病(ILD)的风险,这种疾病与高死亡率相关。需要基于风险因素的筛查工具来决定哪些类风湿性关节炎患者应使用高分辨率计算机断层扫描(HRCT)进行间质性肺病筛查。ANCHOR-RA研究是一项多国横断面研究,它将建立一个预测RA-ILD的多变量模型,该模型可用于临床实践中的RA-ILD筛查:研究人员将连续招募具有以下 RA-ILD 风险因素中≥ 2 个因素的 RA 患者:男性;目前或曾经吸烟;确诊 RA 时年龄≥ 60 岁;类风湿因子和/或抗环瓜氨酸肽阳性率高(滴度 > 3 x 正常值上限);存在或曾有某些 RA 的关节外表现(血管炎、费尔蒂综合征、继发性斯约格伦综合征、皮肤类风湿结节、血清炎和/或巩膜炎/葡萄膜炎);前 12 个月 RA 疾病活动度高。之前被确认为患有 ILD 的患者或在过去两年中接受过 CT 扫描的患者将不符合条件。参与者将在当地接受 HRCT 扫描,并由两名放射科专家进行集中评估。将前瞻性地收集有关人口统计学和 RA 相关特征、患者报告结果、合并症和肺功能的数据。主要结果将是根据一个多变量模型,结合临床实践中通常评估的潜在风险因素,得出RA-ILD的概率分值,并估计RA-ILD在研究人群中的患病率。计划将在美国、英国、德国、法国、意大利和西班牙的约 30 个地点招募 1200 名参与者:ANCHOR-RA研究的数据将为支持RA-ILD筛查的建议提供更多证据,以提高对RA这一重要并发症的检出率,并实现早期干预。试验注册:clinicaltrials.gov NCT05855109(提交日期:2023年5月3日)。
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引用次数: 0
Clinical and economic burden of organ damage among patients with systemic lupus erythematosus in a real-world setting in Germany. 德国现实环境中系统性红斑狼疮患者器官损伤的临床和经济负担。
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-05-17 DOI: 10.1186/s41927-024-00387-6
Michael Schultze, Elena Garal-Pantaler, Marc Pignot, Roger A Levy, Heike Carnarius, Matthias Schneider, Kerry Gairy

Background: Systemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease, carries high risk of organ damage and burden to healthcare systems. SLE disease modification aims to reduce disease activity with minimal treatment toxicity and preventing or minimizing organ damage development. This real-world study utilizing healthcare administrative claims data assessed organ damage development, associated costs and healthcare resource utilization (HCRU) in patients with SLE in Germany.

Methods: Claims data from January 1, 2007, to December 31, 2017, were obtained from the Betriebskrankenkassen German Sickness Fund Database. Adults (> 18 years) with a confirmed SLE diagnosis between January 1, 2009, and December 31, 2014, (inclusion period) were included. The index date was calculated based on the first recorded SLE diagnosis during this period. Patients were propensity score-matched (1:3) to a comparator cohort without SLE by age, sex, and comorbidities (Charlson comorbidity index). Organ damage was identified using an algorithm developed based on conditions described in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), using ICD-10-GM diagnostic codes, healthcare procedures, and/or treatments.

Results: 2121 patients with SLE and 6308 comparator patients were included (mean follow-up time: 6.4 years). Organ damage prevalence increased from 60.5% at baseline to 83.0% during 6 years of follow-up in all patients with SLE, while 17.0% of patients with SLE did not develop organ damage. Patients with newly confirmed SLE diagnosis without organ damage at baseline were nearly twice as likely to develop organ damage within 5 years versus the comparator cohort (52.0% vs. 27.0%). Total annual costs per patient-year for patients with SLE with organ damage were more than double those of patients with SLE without organ damage; both the number of inpatient admissions and length of stay were higher.

Conclusions: The application of a recently developed algorithm allowed us to use claims data to elucidate SLE organ damage, and its associated high clinical and economic burden, in a large, representative sample in Germany. To our knowledge, this is the first European analysis of its kind involving a broad cohort of patients with SLE treated in the routine care setting.

背景:系统性红斑狼疮(SLE系统性红斑狼疮(SLE)是一种慢性多系统自身免疫性疾病,极易造成器官损伤,给医疗系统带来沉重负担。系统性红斑狼疮的疾病调整旨在减少疾病活动,同时将治疗毒性降至最低,防止或尽量减少器官损伤的发生。这项真实世界的研究利用医疗行政报销数据,评估了德国系统性红斑狼疮患者器官损伤的发展、相关费用和医疗资源利用率(HCRU):从 Betriebskrankenkassen 德国疾病基金数据库中获取了 2007 年 1 月 1 日至 2017 年 12 月 31 日的理赔数据。2009年1月1日至2014年12月31日(纳入期)期间确诊为系统性红斑狼疮的成年人(大于18岁)被纳入其中。指数日期根据在此期间首次记录的系统性红斑狼疮诊断结果计算。根据年龄、性别和合并症(Charlson 合并症指数),将患者与无系统性红斑狼疮的参照队列进行倾向评分匹配(1:3)。根据系统性红斑狼疮国际合作诊所/美国风湿病学会损害指数(SDI)中描述的情况,使用ICD-10-GM诊断代码、医疗程序和/或治疗方法,采用一种算法确定器官损害。在所有系统性红斑狼疮患者中,器官损伤发生率从基线时的60.5%上升到随访6年期间的83.0%,而17.0%的系统性红斑狼疮患者没有发生器官损伤。新确诊的系统性红斑狼疮患者在基线时没有器官损伤,但在 5 年内出现器官损伤的几率几乎是对照组的两倍(52.0% 对 27.0%)。有器官损害的系统性红斑狼疮患者每名患者每年的总费用是无器官损害的系统性红斑狼疮患者的两倍多;住院人数和住院时间都更长:应用最近开发的算法,我们可以利用索赔数据,在德国一个具有代表性的大样本中阐明系统性红斑狼疮的器官损伤及其相关的高临床和经济负担。据我们所知,这是欧洲首次对在常规护理环境中接受治疗的大量系统性红斑狼疮患者进行此类分析。
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引用次数: 0
Association between systemic lupus erythematosus and osteoporosis: a mendelian randomization analysis. 系统性红斑狼疮与骨质疏松症之间的关系:孟德尔随机分析。
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-05-06 DOI: 10.1186/s41927-024-00388-5
Danfeng Xu, Bing Wu

Background: Systemic Lupus Erythematosus (SLE) and Osteoporosis are two prevalent medical conditions. Previous studies have suggested a possible correlation between SLE and osteoporosis, though the underpinning causal relationship remains largely unknown. The current study aimed to elucidate the causal association between SLE and osteoporosis by employing a Mendelian randomization (MR) approach.

Methods: We performed two-sample MR analysis using the inverse variance-weighted (IVW), weighted median, and MR-Egger methods on publicly available summary statistics datasets using a SLE genome-wide association study (GWAS) as an exposure and osteoporosis GWASs in people with East Asia ancestry as outcomes. The pleiotropy and heterogeneity were examined using a variety of techniques, including the MR-Egger intercept, the MR-PRESSO approach, and the Cochran's Q test.

Results: We selected 26 single-nucleotide polymorphisms from a SLE GWAS as instrumental variables for osteoporosis. The IVW (p < 0.05) method results support a potential association between SLE and osteoporosis. MR-Egger intercept (p = 0.82) and MR-PRESSO global test (p = 0.80) did not suggest evidence of horizontal or directional pleiotropy. Cochran's Q test (p = 0.78) showed that there was no heterogeneity between IVs.

Conclusion: The results of MR analysis indicated that SLE is likely associated with an increased risk of osteoporosis incidence. Our findings highlight the need for increased awareness the potential risk of osteoporosis among SLE patients.

背景:系统性红斑狼疮(SLE)和骨质疏松症是两种常见的疾病。以往的研究表明,系统性红斑狼疮与骨质疏松症之间可能存在相关性,但其背后的因果关系在很大程度上仍不为人所知。本研究旨在通过孟德尔随机法(MR)阐明系统性红斑狼疮与骨质疏松症之间的因果关系:我们以系统性红斑狼疮全基因组关联研究(GWAS)为暴露,以东亚血统人群的骨质疏松症 GWAS 为结果,使用反方差加权法(IVW)、加权中位数法和 MR-Egger 法对公开的汇总统计数据集进行了双样本 MR 分析。我们采用了多种技术,包括MR-Egger截距法、MR-PRESSO法和Cochran's Q检验法,对多义性和异质性进行了检验:我们从系统性红斑狼疮基因组学研究中选取了 26 个单核苷酸多态性作为骨质疏松症的工具变量。IVW(pMR分析结果表明,系统性红斑狼疮可能与骨质疏松症发病风险增加有关。我们的研究结果突出表明,有必要提高系统性红斑狼疮患者对骨质疏松症潜在风险的认识。
{"title":"Association between systemic lupus erythematosus and osteoporosis: a mendelian randomization analysis.","authors":"Danfeng Xu, Bing Wu","doi":"10.1186/s41927-024-00388-5","DOIUrl":"10.1186/s41927-024-00388-5","url":null,"abstract":"<p><strong>Background: </strong>Systemic Lupus Erythematosus (SLE) and Osteoporosis are two prevalent medical conditions. Previous studies have suggested a possible correlation between SLE and osteoporosis, though the underpinning causal relationship remains largely unknown. The current study aimed to elucidate the causal association between SLE and osteoporosis by employing a Mendelian randomization (MR) approach.</p><p><strong>Methods: </strong>We performed two-sample MR analysis using the inverse variance-weighted (IVW), weighted median, and MR-Egger methods on publicly available summary statistics datasets using a SLE genome-wide association study (GWAS) as an exposure and osteoporosis GWASs in people with East Asia ancestry as outcomes. The pleiotropy and heterogeneity were examined using a variety of techniques, including the MR-Egger intercept, the MR-PRESSO approach, and the Cochran's Q test.</p><p><strong>Results: </strong>We selected 26 single-nucleotide polymorphisms from a SLE GWAS as instrumental variables for osteoporosis. The IVW (p < 0.05) method results support a potential association between SLE and osteoporosis. MR-Egger intercept (p = 0.82) and MR-PRESSO global test (p = 0.80) did not suggest evidence of horizontal or directional pleiotropy. Cochran's Q test (p = 0.78) showed that there was no heterogeneity between IVs.</p><p><strong>Conclusion: </strong>The results of MR analysis indicated that SLE is likely associated with an increased risk of osteoporosis incidence. Our findings highlight the need for increased awareness the potential risk of osteoporosis among SLE patients.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"17"},"PeriodicalIF":2.2,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11071324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140853454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evolution of therapeutic management of patients with ANCA associated vasculitis in France after licensing Rituximab use 利妥昔单抗使用许可发放后法国 ANCA 相关性血管炎患者治疗管理的演变
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-04-28 DOI: 10.1186/s41927-024-00385-8
Cécile-Audrey Durel, Eric Simon Thervet, Dominique Chauveau, Aurélie Schmidt, Benjamin Terrier, Pierre M Bataille
In 2013, rituximab was approved in France for the treatment of ANCA-associated vasculitis (AAV). The aim of the study was to compare the treatment and health events of adult incident patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), included before rituximab approval (over 2010–2012, Group 1) and those included after rituximab approval (over 2014–2017, Group 2). Data were extracted from the French National Health Insurance database (SNDS) including outpatient health care consumption and hospital discharge forms. Comparisons between inclusion periods were performed using Wilcoxon and χ² tests. Kaplan-Meier method was used to model the duration of treatment induction, maintenance, and off-drug periods. Fine and Gray tests were used to compare treatment phase durations. A total of 694 GPA and 283 MPA patients were included in Group 1, while 668 GPA and 463 MPA patients were included in Group 2. Between the two inclusion periods, the proportions of patients treated with rituximab increased in the induction and maintenance phases whereas treatment with azathioprine declined. These proportions remained stable in the case of methotrexate, cyclophosphamide, and glucocorticoid-treated patients. Frequency of first-time hospitalized infections, diabetes and renal failure during the first year after inclusion increased for both groups. This is a retrospective study based on claims data including only 76% of people covered by health insurance in France. The period studied includes the learning phase of using rituximab. This study lacks biological data and precise quantitative analysis for the use of steroids, therefore the criteria for establishing diagnosis and therapeutic choice were unknown. Introduction of rituximab reduced the use of azathioprine without affecting the use of glucocorticoids or cyclophosphamide.
2013年,法国批准利妥昔单抗用于治疗ANCA相关性血管炎(AAV)。该研究旨在比较利妥昔单抗批准前(2010-2012年间,第1组)和利妥昔单抗批准后(2014-2017年间,第2组)肉芽肿伴多血管炎(GPA)和显微镜下多血管炎(MPA)成人患者的治疗和健康事件。数据来自法国国家医疗保险数据库(SNDS),包括门诊医疗消费和出院表。采用Wilcoxon和χ²检验对纳入期进行比较。采用 Kaplan-Meier 法对诱导治疗期、维持治疗期和停药期的持续时间进行建模。Fine 和 Gray 检验用于比较治疗阶段的持续时间。第一组共纳入了 694 名 GPA 和 283 名 MPA 患者,第二组共纳入了 668 名 GPA 和 463 名 MPA 患者。在两个纳入期之间,使用利妥昔单抗治疗的患者比例在诱导期和维持期有所增加,而使用硫唑嘌呤治疗的患者比例则有所下降。甲氨蝶呤、环磷酰胺和糖皮质激素治疗患者的比例保持稳定。两组患者入院后第一年内首次住院感染、糖尿病和肾功能衰竭的发生率均有所增加。这是一项基于索赔数据的回顾性研究,仅包括法国 76% 的医保患者。研究期间包括使用利妥昔单抗的学习阶段。这项研究缺乏使用类固醇的生物数据和精确的定量分析,因此诊断和治疗选择的标准不明。利妥昔单抗的引入减少了硫唑嘌呤的使用,但没有影响糖皮质激素或环磷酰胺的使用。
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引用次数: 0
Seronegative primary Sjögren’s syndrome, a distinct subtype of primary Sjögren’s syndrome in Chinese patients 血清阴性原发性斯约格伦综合征--中国患者原发性斯约格伦综合征的一个独特亚型
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-04-16 DOI: 10.1186/s41927-024-00384-9
Jingying Lan, Chaoqiong Deng, Heqing Huang, Peishi Rao, Yangchun Chen, Yingying Shi, Jie Chen, Guixiu Shi, Yuan Liu, Shiju Chen
To investigate the clinical and immune characteristics of patients with primary Sjögren’s syndrome (pSS) who were negative for anti–Sjögren’s-syndrome-related antigen A antibodies (anti-SSA) and anti–Sjögren’s-syndrome-related antigen B antibodies (anti-SSB) in Chinese population. A retrospective study were performed and 232 patients with pSS were analyzed. Patients positive for anti-SSA or/and anti-SSB were termed as seropositive pSS, and these negative for both anti-SSA and anti-SSB (non-antinuclear antibodies) as seronegative pSS. Clinical manifestations and laboratory findings were compared between the two groups. Among the 232 patients with pSS, 192 (82.8%) were seropositive pSS and 40 (17.2%) were seronegative pSS. Compared to seropositive pSS, seronegative pSS were older and with higher percentage of low disease activity (ESSDAI < 5), xerostomia and xerophthalmia, with higher platelet count and level of creatine kinase. This subgroup was with lower levels of gamma globulin, immunoglobulin G, immunoglobulin A and autoantibodies including rheumatoid factor and antinuclear antibody in serum, and less immunoglobulin G deposition in labial gland. Seronegative pSS was a distinct subtype of pSS different from seropositive pSS. Clinical manifestations in seronegative pSS subgroup were restricted to exocrine gland and less B lymphocyte activation, while seropositive pSS were prone to present with systemic involvement and high disease activity. Specific underlying pathogenesis mechanisms and therapeutic strategies in this subgroup needed to be further studied.
研究中国原发性斯约格伦综合征(pSS)患者抗斯约格伦综合征相关抗原A抗体(抗SSA)和抗斯约格伦综合征相关抗原B抗体(抗SSB)阴性的临床和免疫特征。研究人员进行了一项回顾性研究,分析了 232 名 pSS 患者。抗SSA或/和抗SSB阳性的患者被称为血清阳性pSS,抗SSA和抗SSB(非抗核抗体)均阴性的患者被称为血清阴性pSS。对两组患者的临床表现和实验室检查结果进行了比较。在 232 名 pSS 患者中,192 人(82.8%)为血清反应阳性 pSS,40 人(17.2%)为血清反应阴性 pSS。与血清反应阳性的 pSS 相比,血清反应阴性的 pSS 患者年龄更大,疾病活动度低(ESSDAI < 5)、口干和眼干的比例更高,血小板计数和肌酸激酶水平更高。该亚组的血清中γ球蛋白、免疫球蛋白G、免疫球蛋白A和自身抗体(包括类风湿因子和抗核抗体)水平较低,唇腺中免疫球蛋白G沉积较少。血清阴性 pSS 是 pSS 的一个独特亚型,有别于血清阳性 pSS。血清阴性 pSS 亚组的临床表现仅限于外分泌腺,B 淋巴细胞活化较少,而血清阳性 pSS 则易出现全身受累和高疾病活动性。该亚组的具体发病机制和治疗策略有待进一步研究。
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引用次数: 0
Determination of IL-23 receptor expression and gene polymorphism (rs1884444) in Iranian patients with ankylosing spondylitis 伊朗强直性脊柱炎患者 IL-23 受体表达和基因多态性(rs1884444)的测定
IF 2.2 Q3 RHEUMATOLOGY Pub Date : 2024-04-11 DOI: 10.1186/s41927-024-00383-w
Atiyeh Mellati, Samaneh Soltani, Tohid Kazemi, Nooshin Ahmadzadeh, Maryam Akhtari, Elham Madreseh, Ahmadreza Jamshidi, Elham Farhadi, Mahdi Mahmoudi
Through investigating genetic variations, it has been demonstrated that single nucleotide polymorphisms (SNPs) in the IL-23 receptor (IL23R) gene have a critical role in the pathophysiology of ankylosing spondylitis (AS). Here, we investigated whether the IL23R variant (rs1884444) is associated with AS in the Iranian population. In this research, we analyzed rs1884444 in a group of 425 patients with AS and 400 matched controls. For DNA extraction, the phenol/chloroform technique was utilized. Peripheral blood mononuclear cells (PBMCs) were obtained from the whole blood of 39 patients and 43 healthy controls and total RNA was extracted. Genotyping was performed by amplification-refractory mutation system (ARMS)–PCR method. Afterward, the expression level of IL23R was analyzed by the real-time quantitative (Q)-PCR method. We observed no significant association between the distribution of alleles and genotypes of rs1884444 and susceptibility to AS. In addition, the expression level of IL23R did not differ between PBMCs from AS patients compared to the control group (P = 0.167). Furthermore, the relative expression level of IL23R was positively correlated with the BASDAI (P < 0.01) and BASFI (P < 0.05) scores of the patients. It appears that IL23R polymorphism (rs1884444) and the level of gene expression might not contribute to the susceptibility to AS in the Iranian population. The correlation of IL23R expression with the level of BASDAI and BASFI scores in patients may be due to the role of the IL-23/IL-23R signaling cascade in inflammation and exert a critical role in the development of AS.
通过研究基因变异,已经证明 IL-23 受体(IL23R)基因中的单核苷酸多态性(SNPs)在强直性脊柱炎(AS)的病理生理学中起着至关重要的作用。在此,我们调查了伊朗人群中的 IL23R 变异(rs1884444)是否与强直性脊柱炎有关。在这项研究中,我们分析了425名强直性脊柱炎患者和400名匹配对照组中的rs1884444。DNA 提取采用苯酚/氯仿技术。从 39 名患者和 43 名健康对照者的全血中获得了外周血单核细胞(PBMC),并提取了总 RNA。基因分型采用扩增-难治性突变系统(ARMS)-PCR 方法进行。随后,采用实时定量(Q)-PCR 方法分析了 IL23R 的表达水平。我们观察到 rs1884444 的等位基因和基因型分布与强直性脊柱炎易感性之间无明显关联。此外,与对照组相比,AS 患者的 PBMCs IL23R 表达水平没有差异(P = 0.167)。此外,IL23R的相对表达水平与患者的BASDAI(P<0.01)和BASFI(P<0.05)评分呈正相关。由此看来,IL23R 多态性(rs1884444)和基因表达水平可能不会导致伊朗人群对强直性脊柱炎的易感性。IL23R表达与患者BASDAI和BASFI评分水平的相关性可能是由于IL-23/IL-23R信号级联在炎症中的作用,并在强直性脊柱炎的发展中发挥了关键作用。
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引用次数: 0
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BMC Rheumatology
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