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Serum syndecan1 has the potential to reflect activity at diagnosis and predict death during follow-up in patients with ANCA-associated vasculitis 血清syndecan1可反映ANCA相关性血管炎患者诊断时的活动情况并预测随访期间的死亡情况
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-20 DOI: 10.1186/s13075-024-03393-8
Taejun Yoon, Jang Woo Ha, Jung Yoon Pyo, Eunhee Ko, Sung Soo Ahn, Jason Jungsik Song, Yong-Beom Park, Sang-Won Lee
This study investigated whether serum syndecan1 at diagnosis reflects activity at diagnosis and predicts poor outcomes during follow-up in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). The study included 79 patients with AAV from the cohort of Korean patients diagnosed with AAV. AAV-specific indices, including the Birmingham vasculitis activity score (BVAS), five-factor score (FFS), 36-item short-form survey (SF-36) physical and mental component summary (PCS and MCS), and vasculitis damage index (VDI), were assessed. Laboratory data including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were also collected. The highest tertile and upper half of the BVAS were tentatively defined as having high AAV activity. Serum syndecan1 levels were measured in sera stored at diagnosis. Serum syndecan1 at diagnosis was significantly correlated with AAV activity and functional status, as assessed by BVAS, FFS, SF-36 PCS, MCS, and acute-phase reactants, including ESR and CRP. Patients with serum syndecan1 ≥ 76.1 ng/mL at diagnosis, and those with serum syndecan1 ≥ 60.0 ng/mL at diagnosis showed significantly higher risks for the highest tertile and the upper half of BVAS at diagnosis than those without, respectively. Patients with serum syndecan1 ≥ 120.1 ng/mL at diagnosis had a significantly higher risk for all-cause mortality during follow-up than those without, and further, exhibited a significantly lower cumulative patients’ survival rate than those without. Serum syndecan1 at diagnosis may not only reflect AAV activity at diagnosis but may also be associated with all-cause mortality during follow-up.
本研究调查了抗中性粒细胞胞浆抗体(ANCA)相关性血管炎(AAV)患者在诊断时的血清syndecan1是否反映了诊断时的活动性,并预测了随访期间的不良预后。该研究从韩国确诊的 AAV 患者队列中纳入了 79 名 AAV 患者。研究人员评估了 AAV 的特异性指标,包括伯明翰脉管炎活动评分(BVAS)、五因素评分(FFS)、36 项短式调查(SF-36)身体和精神部分摘要(PCS 和 MCS)以及脉管炎损伤指数(VDI)。此外,还收集了包括红细胞沉降率(ESR)和C反应蛋白(CRP)水平在内的实验室数据。BVAS的最高三分位数和上半部分被初步定义为具有高AAV活性。对诊断时储存的血清中的血清辛迪加1水平进行测定。诊断时的血清辛迪加1与AAV活性和功能状态(通过BVAS、FFS、SF-36 PCS、MCS和急性期反应物(包括血沉和CRP)评估)显著相关。诊断时血清syndecan1≥76.1 ng/mL的患者和诊断时血清syndecan1≥60.0 ng/mL的患者诊断时BVAS最高三分位数和上半部分的风险分别显著高于无血清syndecan1的患者。诊断时血清syndecan1≥120.1 ng/mL的患者在随访期间的全因死亡风险明显高于未检测到syndecan1的患者,而且患者的累积生存率也明显低于未检测到syndecan1的患者。诊断时的血清syndecan1不仅可以反映诊断时的AAV活性,还可能与随访期间的全因死亡率有关。
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引用次数: 0
A versatile role for lung ultrasound in systemic autoimmune rheumatic diseases related pulmonary involvement: a narrative review 肺部超声在系统性自身免疫性风湿病相关肺部受累中的多功能作用:叙述性综述
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-18 DOI: 10.1186/s13075-024-03399-2
Yukai Wang, Shaoqi Chen, Shaoyu Zheng, Zexuan Zhou, Weijin Zhang, Guangzhou Du, Angelina Mikish, Barbara Ruaro, Cosimo Bruni, Anna-Maria Hoffmann-Vold, Luna Gargani, Marco Matucci-Cerinic, Daniel E Furst
Systemic autoimmune rheumatic diseases (SARDs) related pulmonary disease is highly prevalent, with variable clinical presentation and behavior, and thus is associated with poor outcomes and negatively impacts quality of life. Chest high resolution computed tomography (HRCT) is still considered a fundamental imaging tool in the screening, diagnosis, and follow-up of pulmonary disease in patients with SARDs. However, radiation exposure, economic burden, as well as lack of point-of-care CT equipment limits its application in some clinical situation. Ultrasound has found a place in numerous aspects of the rheumatic diseases, including the vasculature, skin, muscle, joints, kidneys and in screening for malignancies. Likewise it has found increasing use in the lungs. In the past two decades, lung ultrasound has started to be used for pulmonary parenchymal diseases such as pneumonia, pulmonary edema, lung fibrosis, pneumothorax, and pleural lesions, although the lung parenchymal was once considered off-limits to ultrasound. Lung ultrasound B-lines and irregularities of the pleural line are now regarded two important sonographic artefacts related to diffuse parenchymal lung disease and they could reflect the lesion extent and severity. However, its role in the management of SARDs related pulmonary involvement has not been fully investigated. This review article will focus on the potential applications of lung ultrasound in different pulmonary scenarios related with SARDs, such as interstitial lung disease, diffuse alveolar hemorrhage, diaphragmatic involvement, and pulmonary infection, in order to explore its value in clinical daily practice.
与系统性自身免疫性风湿病(SARDs)相关的肺部疾病发病率很高,临床表现和行为多变,因此与不良预后相关,并对生活质量产生负面影响。胸部高分辨率计算机断层扫描(HRCT)仍被认为是筛查、诊断和随访 SARDs 患者肺部疾病的基本成像工具。然而,辐射暴露、经济负担以及缺乏床旁 CT 设备限制了它在某些临床情况下的应用。超声波在风湿病的许多方面都占有一席之地,包括血管、皮肤、肌肉、关节、肾脏以及恶性肿瘤的筛查。同样,它在肺部的应用也越来越广泛。在过去的二十年中,肺部超声开始用于肺实质疾病,如肺炎、肺水肿、肺纤维化、气胸和胸膜病变,尽管肺实质曾一度被认为是超声检查的禁区。现在,肺部超声 B 线和胸膜线不规则被认为是与弥漫性肺实质疾病有关的两个重要超声伪影,它们可以反映病变的范围和严重程度。然而,其在与 SARDs 相关的肺部受累治疗中的作用尚未得到充分研究。这篇综述文章将重点讨论肺部超声在与 SARDs 相关的不同肺部病变(如间质性肺病、弥漫性肺泡出血、膈肌受累和肺部感染)中的潜在应用,以探讨其在日常临床实践中的价值。
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引用次数: 0
Pain catastrophizing negatively impacts drug retention rate in patients with Psoriatic Arthritis and axial Spondyloarthritis: results from a 2-years perspective multicenter GIRRCS (Gruppo Italiano di Ricerca in Reumatologia Clinica) study 疼痛灾难化对银屑病关节炎和轴性脊柱关节炎患者的药物保留率有负面影响:GIRRCS(Gruppo Italiano di Ricerca in Reumatologia Clinica)多中心 2 年透视研究的结果
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-18 DOI: 10.1186/s13075-024-03396-5
Damiano Currado, Francesca Saracino, Piero Ruscitti, Annalisa Marino, Ilenia Pantano, Marta Vomero, Onorina Berardicurti, Viktoriya Pavlych, Claudio Di Vico, Francesco Caso, Luisa Costa, Marco Tasso, Federica Camarda, Francesca Misceo, Francesco De Vincenzo, Addolorata Corrado, Luisa Arcarese, Amelia Rigon, Marta Vadacca, Erika Corberi, Lyubomyra Kun, Francesca Trunfio, Andrea Pilato, Ludovica Lamberti, Francesco Paolo Cantatore, Federico Perosa, Giuliana Guggino, Raffaele Scarpa, Paola Cipriani, Francesco Ciccia, Roberto Giacomelli, Luca Navarini
Chronic pain and inflammation are common features of rheumatic conditions such as Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (axSpA), often needing prolonged medication treatment for effective management. Maintaining drug retention is essential for both achieving disease control and improving patients' quality of life. This study investigates the influence of pain catastrophizing, a psychological response to pain, on the drug retention rates of PsA and axSpA patients. A two-year prospective multicenter observational study involved 135 PsA and 71 axSpA patients. Pain Catastrophizing Scale (PCS) was employed to assess pain catastrophizing. Univariable and multivariable regression analyses were utilized to identify factors associated with drug retention. In the PsA group, patients early discontinuing therapy showed higher baseline disease activity as well as higher incidence of comorbid fibromyalgia. Notably, pain catastrophizing, specifically the domains of Helplessness, Magnification, and Rumination, were significantly elevated in PsA patients who interrupted the treatment. Multivariable analysis confirmed pain catastrophizing as an independent predictor of drug suspension within two years. In axSpA, drug discontinuation was associated with female gender, shorter disease duration, higher baseline disease activity as well as elevated levels of pain catastrophizing. Univariable analysis supported the role of pain catastrophizing, including its domains, as predictors of treatment interruption. However, limited events in axSpA patients precluded a multivariate analysis. This prospective study emphasizes the impact of pain catastrophizing on drug retention in patients with PsA and axSpA.
慢性疼痛和炎症是银屑病关节炎(PsA)和轴性脊柱关节炎(axSpA)等风湿性疾病的常见特征,通常需要长期药物治疗才能有效控制。要实现疾病控制和改善患者的生活质量,就必须维持药物治疗。本研究调查了疼痛灾难化(一种对疼痛的心理反应)对 PsA 和 axSpA 患者药物保留率的影响。这项为期两年的前瞻性多中心观察研究涉及 135 名 PsA 和 71 名 axSpA 患者。采用疼痛灾难化量表(PCS)评估疼痛灾难化。采用单变量和多变量回归分析来确定与药物保留相关的因素。在 PsA 组中,早期停止治疗的患者基线疾病活动度较高,合并纤维肌痛的发生率也较高。值得注意的是,中断治疗的PsA患者的疼痛灾难化程度,特别是无助感、放大和反刍领域,明显升高。多变量分析证实,疼痛灾难化是两年内停药的独立预测因素。在 axSpA 中,停药与女性性别、较短的病程、较高的基线疾病活动度以及疼痛灾难化水平升高有关。单变量分析支持疼痛灾难化(包括其领域)是预测治疗中断的因素。然而,由于 axSpA 患者的活动有限,因此无法进行多变量分析。这项前瞻性研究强调了疼痛灾难化对 PsA 和 axSpA 患者留药的影响。
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引用次数: 0
Use of belimumab in treating patients with systemic lupus erythematosus: a single-center, real-world retrospective study 使用贝利木单抗治疗系统性红斑狼疮患者:一项单中心真实世界回顾性研究
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-18 DOI: 10.1186/s13075-024-03389-4
Zhaohui Su, Chunyi Zhang, Congcong Gao, Chaoying Li, Ruxv Li, Zhaohui Zheng
To investigate the efficacy and safety of belimumab in the treatment of systemic lupus erythematosus (SLE) in a real-world setting and provide a valuable reference for clinical treatment. In this retrospective study, 101 patients with SLE who came to our hospital from March 2020 to September 2022, 56 of whom with lupus nephritis (LN), were selected. All patients received belimumab in combination with standard of care(SoC)therapy regimen for more than 52 weeks and their clinical/laboratory data, assessment of disease activity, glucocorticoids dosage and occurrence of adverse events were recorded. Lupus Low Disease Activity State (LLDAS) and DORIS remission as a primary goal in the treatment of SLE. The groups were classified according to the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2 K): SLEDAI-2 K < 6 was categorized as the mild group (mild activity) and SLEDAI-2 K ≥ 6 was categorized as the active group (moderate-severe activity). The disease of the two groups mentioned above were assessed using the SELENA-SLEDAI Flare Index (SFI) and the SLE Responder Index-4 (SRI-4), respectively. Furthermore, we used complete remission (CR) and partial remission (PR) in the kidney as the standard for efficacy evaluation for LN patients. After 52 weeks of treatment with belimumab, patients’ complement levels increased significantly (p < 0.05); Other indicators such as 24-hour urine protein quantification and daily glucocorticoids dose decreased compared to pretreatment (p < 0.05). At 52 weeks, (i) after evaluation, the whole group of patients showed significant improvement in their condition; (ii) 55.4% of patients achieved LLDAS and 23.8% achieved DORIS remission; (iii) 73.2% of patients with LN achieved CR, 16.1% achieved PR. Adverse reactions were observed in 15 patients (14.9%), all of which normalized after symptomatic treatment. In general, during treatment with belimumab, immunological and biochemical indices improved in SLE patients, urinary protein levels were reduced in LN patients, and the rate of renal function remission was effectively increased; At the same time, the use of belimumab is associated with a low frequency of side effects, good overall tolerability and a favorable safety profile.
研究贝利木单抗治疗系统性红斑狼疮(SLE)的有效性和安全性,为临床治疗提供有价值的参考。在这项回顾性研究中,我们选取了2020年3月至2022年9月来我院就诊的101名系统性红斑狼疮患者,其中56人患有狼疮性肾炎(LN)。所有患者均接受了贝利木单抗联合标准护理(SoC)治疗方案52周以上,并记录了他们的临床/实验室数据、疾病活动性评估、糖皮质激素用量和不良反应发生情况。狼疮低疾病活动状态(LLDAS)和DORIS缓解是系统性红斑狼疮治疗的首要目标。根据系统性红斑狼疮疾病活动指数 2000(SLEDAI-2 K)对各组进行分类:SLEDAI-2 K < 6 为轻度组(轻度活动),SLEDAI-2 K ≥ 6 为活动组(中度-重度活动)。上述两组患者的病情分别用 SELENA-SLEDAI 爆发指数(SFI)和系统性红斑狼疮反应者指数-4(SRI-4)进行评估。此外,我们还将肾脏完全缓解(CR)和部分缓解(PR)作为LN患者疗效评估的标准。使用贝利木单抗治疗52周后,患者的补体水平显著升高(P<0.05);与治疗前相比,24小时尿蛋白定量和每日糖皮质激素剂量等其他指标均有所下降(P<0.05)。52 周时,(i) 经评估,全组患者病情均有明显改善;(ii) 55.4%的患者达到 LLDAS 缓解,23.8%达到 DORIS 缓解;(iii) 73.2%的 LN 患者达到 CR,16.1%达到 PR。15名患者(14.9%)出现了不良反应,在对症治疗后,所有不良反应均恢复正常。总体而言,在使用贝利木单抗治疗期间,系统性红斑狼疮患者的免疫和生化指标得到改善,LN患者的尿蛋白水平降低,肾功能缓解率有效提高;同时,使用贝利木单抗的副作用发生率低,总体耐受性好,安全性高。
{"title":"Use of belimumab in treating patients with systemic lupus erythematosus: a single-center, real-world retrospective study","authors":"Zhaohui Su, Chunyi Zhang, Congcong Gao, Chaoying Li, Ruxv Li, Zhaohui Zheng","doi":"10.1186/s13075-024-03389-4","DOIUrl":"https://doi.org/10.1186/s13075-024-03389-4","url":null,"abstract":"To investigate the efficacy and safety of belimumab in the treatment of systemic lupus erythematosus (SLE) in a real-world setting and provide a valuable reference for clinical treatment. In this retrospective study, 101 patients with SLE who came to our hospital from March 2020 to September 2022, 56 of whom with lupus nephritis (LN), were selected. All patients received belimumab in combination with standard of care(SoC)therapy regimen for more than 52 weeks and their clinical/laboratory data, assessment of disease activity, glucocorticoids dosage and occurrence of adverse events were recorded. Lupus Low Disease Activity State (LLDAS) and DORIS remission as a primary goal in the treatment of SLE. The groups were classified according to the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2 K): SLEDAI-2 K < 6 was categorized as the mild group (mild activity) and SLEDAI-2 K ≥ 6 was categorized as the active group (moderate-severe activity). The disease of the two groups mentioned above were assessed using the SELENA-SLEDAI Flare Index (SFI) and the SLE Responder Index-4 (SRI-4), respectively. Furthermore, we used complete remission (CR) and partial remission (PR) in the kidney as the standard for efficacy evaluation for LN patients. After 52 weeks of treatment with belimumab, patients’ complement levels increased significantly (p < 0.05); Other indicators such as 24-hour urine protein quantification and daily glucocorticoids dose decreased compared to pretreatment (p < 0.05). At 52 weeks, (i) after evaluation, the whole group of patients showed significant improvement in their condition; (ii) 55.4% of patients achieved LLDAS and 23.8% achieved DORIS remission; (iii) 73.2% of patients with LN achieved CR, 16.1% achieved PR. Adverse reactions were observed in 15 patients (14.9%), all of which normalized after symptomatic treatment. In general, during treatment with belimumab, immunological and biochemical indices improved in SLE patients, urinary protein levels were reduced in LN patients, and the rate of renal function remission was effectively increased; At the same time, the use of belimumab is associated with a low frequency of side effects, good overall tolerability and a favorable safety profile.","PeriodicalId":8419,"journal":{"name":"Arthritis Research & Therapy","volume":"10 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142236429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Truth unveiled by time and the marbled definition of D2T-RA: retrospective analysis on the persistence of the difficult-to-treat status among refractory RA patients 时间和D2T-RA大理石花纹定义揭示的真相:难治性RA患者难治状态持续存在的回顾性分析
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-17 DOI: 10.1186/s13075-024-03390-x
Gilberto Cincinelli, Gabriella Maioli, Cristina Posio, Ennio Giulio Favalli, Francesca Ingegnoli, Roberto Caporali
The current EULAR definition of difficult-to-treat rheumatoid arthritis (D2T-RA) identifies patients with active disease refractory to multiple treatments at a single time point, without considering the persistence of this condition over time. The study aimed to assess difficult-to-treat rheumatoid arthritis (D2T-RA) over 12 months, considering persistence over time rather than a single time point, in a real-life cohort. In a single-center real-life cohort, demographic and clinic data were cross-sectionally collected for each patient at baseline and retrospectively over the previous 12 months bimonthly. For each timepoint, the prevalence of D2T-RA patients was calculated, and patients meeting the EULAR definition for at least 6 months were defined as persistent D2T-RA (pD2T-RA). Finally, the clinical characteristics associated with the time-based definition of pD2T-RA were analyzed. Among 610 adult RA patients, 104 were refractory to ≥ 2 treatments. Initially, 41.3% met D2T-RA criteria, but only 27.9% fulfilled persistent D2T-RA (pD2T-RA) criteria over 6 months. The pD2T-RA group was associated with male gender, higher HAQ and Charlson Comorbidity Index scores, more failed treatments, and use of non-NSAID analgesics. Logistic regression linked pD2T-RA to higher SDAI and CRP values, and the use of glucocorticoids or analgesics. Chronic use of glucocorticoids was strongly associated with pD2T-RA. The application of a temporal criterion allowed for the selection of a subgroup of pD2T-RA patients who differ from those who meet the definition of D2T-RA only episodically. Chronic use of glucocorticoids was the factor most strongly associated with pD2T-RA status. What is already known about this subject? Since the institution of the D2T-RA definition, many efforts have been made to characterize this subpopulation's prevalence as well as clinical and demographical features. However, no studies have so far faced the temporal maintenance of the D2T-RA status. What does this study add? A definition of persistent or episodic D2T-RA is proposed according to the temporal trajectory of D2T-RA status, resulting in approximately 27% of D2T-RA patients persistently fulfilling the pD2T-RA definition. At each single time point, one-third of D2T-RA patients are represented by episodic D2T-RA patients. How might this impact on clinical practice? Persistent D2T-RA definition may serve to further homogenize the D2T-RA population.
目前EULAR对难以治疗的类风湿关节炎(D2T-RA)的定义是指在单一时间点对多种治疗方法难治的活动性疾病患者,而不考虑这种疾病在一段时间内的持续性。该研究旨在评估12个月内的难治性类风湿性关节炎(D2T-RA),考虑的是现实生活中队列的长期持续性,而不是单一的时间点。在单个中心的真实队列中,每个患者的人口统计学和临床数据都是在基线时横向收集的,并在过去的 12 个月中每两个月回顾一次。在每个时间点计算D2T-RA患者的患病率,符合EULAR定义至少6个月的患者被定义为持续性D2T-RA(pD2T-RA)。最后,分析了与基于时间定义的 pD2T-RA 相关的临床特征。在610名成年RA患者中,有104人对≥2种治疗方法均无效。最初,41.3%的患者符合D2T-RA标准,但只有27.9%的患者在6个月内符合持续D2T-RA(pD2T-RA)标准。pD2T-RA组与男性性别、较高的HAQ和Charlson综合指数评分、较多的治疗失败以及使用非NSAID镇痛药有关。逻辑回归将 pD2T-RA 与较高的 SDAI 和 CRP 值以及使用糖皮质激素或镇痛药联系起来。长期使用糖皮质激素与 pD2T-RA 密切相关。应用时间性标准可筛选出 pD2T-RA 患者亚群,他们不同于仅在偶发情况下符合 D2T-RA 定义的患者。长期使用糖皮质激素是与 pD2T-RA 状态最密切相关的因素。对这一主题已有哪些了解?自从确定了 D2T-RA 的定义以来,人们已经做了很多努力来描述这个亚群的发病率以及临床和人口学特征。然而,迄今为止,还没有任何研究关注过 D2T-RA 状态在时间上的维持情况。本研究有何新意?根据 D2T-RA 状态的时间轨迹,提出了持续性或发作性 D2T-RA 的定义,结果约有 27% 的 D2T-RA 患者持续符合 pD2T-RA 的定义。在每个单一时间点,D2T-RA 患者中有三分之一为发作性 D2T-RA 患者。这会对临床实践产生什么影响?持续性 D2T-RA 定义可能会使 D2T-RA 患者进一步同质化。
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引用次数: 0
Prevalence of cardiovascular events in a population-based registry of patients with systemic lupus erythematosus 系统性红斑狼疮患者人群登记中的心血管事件发生率
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-14 DOI: 10.1186/s13075-024-03395-6
Daniel P. Joyce, Jeffrey S. Berger, Allison Guttmann, Ghadeer Hasan, Jill P. Buyon, H. Michael Belmont, Jane Salmon, Anca Askanase, Joan Bathon, Laura Geraldino-Pardilla, Yousaf Ali, Ellen M. Ginzler, Chaim Putterman, Caroline Gordon, Charles G. Helmick, Kamil E. Barbour, Heather T. Gold, Hilary Parton, Peter M. Izmirly
The Manhattan Lupus Surveillance Program (MLSP), a population-based retrospective registry of patients with systemic lupus erythematosus (SLE), was used to investigate the prevalence of cardiovascular disease events (CVE) and compare rates among sex, age and race/ethnicity to population-based controls. Patients with prevalent SLE in 2007 aged ≥ 20 years in the MLSP were included. CVE required documentation of a myocardial infarction or cerebrovascular accident. We calculated crude risk ratios and adjusted risk ratios (ARR) controlling for sex, age group, race and ethnicity, and years since diagnosis. Data from the 2009–2010 National Health and Nutrition Examination Survey (NHANES) and the 2013–2014 NYC Health and Nutrition Examination Survey (NYC HANES) were used to calculate expected CVE prevalence by multiplying NHANES and NYC HANES estimates by strata-specific counts of patients with SLE. Crude prevalence ratios (PRs) using national and NYC estimates and age standardized prevalence ratios (ASPRs) using national estimates were calculated. CVE occurred in 13.9% of 1,285 MLSP patients with SLE, and risk was increased among men (ARR:1.7, 95%CI:1.2–2.5) and older adults (age > 60 ARR:2.5, 95%CI:1.7–3.8). Compared with non-Hispanic Asian patients, CVE risk was elevated among Hispanic/Latino (ARR:3.1, 95%CI:1.4-7.0) and non-Hispanic Black (ARR:3.5, 95%CI1.6-7.9) patients as well as those identified as non-Hispanic and in another or multiple racial groups (ARR:4.2, 95%CI:1.1–15.8). Overall, CVE prevalence was higher among patients with SLE than nationally (ASPR:3.1, 95%CI:3.0-3.1) but did not differ by sex. Compared with national race and ethnicity-stratified estimates, CVE among patients with SLE was highest among Hispanics/Latinos (ASPR:4.3, 95%CI:4.2–4.4). CVE was also elevated among SLE registry patients compared with all NYC residents. Comparisons with age-stratified national estimates revealed PRs of 6.4 (95%CI:6.2–6.5) among patients aged 20–49 years and 2.2 (95%CI:2.1–2.2) among those ≥ 50 years. Male (11.3, 95%CI:10.5–12.1), Hispanic/Latino (10.9, 95%CI:10.5–11.4) and non-Hispanic Black (6.2, 95%CI:6.0-6.4) SLE patients aged 20–49 had the highest CVE prevalence ratios. These population-based estimates of CVE in a diverse registry of patients with SLE revealed increased rates among younger male, Hispanic/Latino and non-Hispanic Black patients. These findings reinforce the need to appropriately screen for CVD among all SLE patients but particularly among these high-risk patients.
曼哈顿红斑狼疮监测计划(MLSP)是一项基于人群的系统性红斑狼疮(SLE)患者回顾性登记计划,该计划用于调查心血管疾病事件(CVE)的发病率,并将不同性别、年龄和种族/民族的发病率与基于人群的对照组进行比较。2007 年,MLSP 纳入了年龄≥ 20 岁的系统性红斑狼疮患者。CVE要求有心肌梗塞或脑血管意外的记录。我们计算了粗风险比和调整风险比(ARR),并对性别、年龄组、种族和民族以及确诊后的年数进行了控制。2009-2010 年美国国家健康与营养调查(NHANES)和 2013-2014 年纽约市健康与营养调查(NYC HANES)的数据被用来计算预期的 CVE 患病率,方法是将 NHANES 和 NYC HANES 的估计值乘以特定阶层的系统性红斑狼疮患者人数。利用全国和纽约市的估计值计算出粗患病率比(PRs),并利用全国的估计值计算出年龄标准化患病率比(ASPRs)。在1285名MLSP系统性红斑狼疮患者中,13.9%的患者发生了CVE,男性(ARR:1.7,95%CI:1.2-2.5)和老年人(年龄大于60岁,ARR:2.5,95%CI:1.7-3.8)发生CVE的风险更高。与非西班牙裔亚裔患者相比,西班牙裔/拉美裔(ARR:3.1,95%CI:1.4-7.0)和非西班牙裔黑人(ARR:3.5,95%CI:1.6-7.9)患者以及被确认为非西班牙裔和其他或多种种族群体的患者的 CVE 风险较高(ARR:4.2,95%CI:1.1-15.8)。总体而言,系统性红斑狼疮患者的 CVE 患病率高于全国的患病率(ASPR:3.1, 95%CI:3.0-3.1),但没有性别差异。与全国种族和民族分层估计值相比,西班牙裔/拉丁裔系统性红斑狼疮患者的 CVE 最高(ASPR:4.3, 95%CI:4.2-4.4)。与所有纽约市居民相比,系统性红斑狼疮登记患者的 CVE 也较高。与全国年龄分层估计值相比,20-49 岁患者的 PR 值为 6.4(95%CI:6.2-6.5),≥50 岁患者的 PR 值为 2.2(95%CI:2.1-2.2)。20-49岁的男性(11.3,95%CI:10.5-12.1)、西班牙裔/拉美裔(10.9,95%CI:10.5-11.4)和非西班牙裔黑人(6.2,95%CI:6.0-6.4)系统性红斑狼疮患者的CVE患病率最高。这些以人群为基础的系统性红斑狼疮患者登记数据显示,年轻男性、西班牙裔/拉美裔和非西班牙裔黑人患者的CVE发病率有所上升。这些发现加强了在所有系统性红斑狼疮患者中适当筛查心血管疾病的必要性,尤其是在这些高危患者中。
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引用次数: 0
Association of anti-HMGCR antibodies of the IgM isotype with refractory immune-mediated necrotizing myopathy IgM 同工酶型抗 HMGCR 抗体与难治性免疫介导的坏死性肌病的关系
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-11 DOI: 10.1186/s13075-024-03387-6
Hongxia Yang, Chao Sun, Lifang Ye, Yuetong Xu, Sang Lin, Qinglin Peng, Guochun Wang, Xin Lu
Anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) autoantibodies are one of the myositis-specific antibodies which is associated with immune-mediated necrotizing myopathy (IMNM). However, the relationship between anti-HMGCR isotypes and prognosis has not yet been fully investigated. This study was conducted to gain insight into the association between anti-HMGCR isotypes and clinical, and prognosis in IMNM patients who were positive for anti-HMGCR antibodies. Levels of anti-HMGCR isotypes (IgG, IgA and IgM) were assessed by enzyme-linked immunosorbent assay (ELISA) in 123 consecutive serum samples obtained from 71 patients who were positive for anti-HMGCR IgG at baseline. Disease activity was assessed by manual muscle testing (MMT) 8, Physician’s Global Assessment (PGA) visual analog scale (VAS), and muscle VAS. Baseline anti-HMGCR IgG levels were correlated with PGA VAS (r = 0.24; p = 0.04), muscle VAS (r = 0.32; p < 0.01), and MMT8(r=-0.24; p = 0.04), and baseline anti-HMGCR IgM levels were positively correlated with PGA VAS (r = 0.27, p = 0.02), muscle VAS (r = 0.24, p = 0.04). Anti-HMGCR IgM positive patients had a lower age of onset [29(25,46) vs. 51(33,65), p = 0.006], and a higher proportion of neck weakness (63.5% vs. 34.6%, p = 0.031) compared with anti-HMGCR IgM negative patients. Longitudinal analysis showed that the changes in anti-HMGCR IgG levels were correlated with the changes in the PGA VAS (β = 3.830; p < 0.0001), muscle VAS (β = 2.893; p < 0.0001), MMT8 (β=-19.368; p < 0.0001), and creatine kinase (CK) levels (β = 3900.05, p < 0.0001). Anti-HMGCR IgM levels were weakly correlated with anti-HMGCR IgA levels at baseline (r = 0.33, p < 0.01), and the variations in anti-HMGCR IgA levels were correlated with the changes in anti-HMGCR IgM levels during follow-up (β = 0.885; p < 0.0001). There were more patients with anti-HMGCR IgM who showed a refractory course than those who were with anti-HMGCR IgM negative (polycyclic course: 40% vs. 25%; chronic continuous course: 46.7% vs. 20.5%, p = 0.018). In anti-HMGCR IgG-positive IMNM patients, the levels of anti-HMGCR IgG are associated with disease activity, and anti-HMGCR IgM is associated with refractory outcome and poor prognosis. • Anti-HMGCR IgM-positive patients had a younger age of onset and more neck weakness than anti-HMGCR IgM-negative patients. • The levels of anti-HMGCR IgG and IgM are associated with disease activity in anti-HMGCR-positive patients. • Anti-HMGCR IgM is associated with refractory outcome and poor prognosis.
抗-3-羟基-3-甲基戊二酰辅酶 A 还原酶(HMGCR)自身抗体是肌炎特异性抗体之一,与免疫介导的坏死性肌病(IMNM)有关。然而,抗HMGCR同型抗体与预后之间的关系尚未得到充分研究。本研究旨在深入了解抗-HMGCR抗体阳性的IMNM患者的抗-HMGCR异型与临床和预后之间的关系。研究人员通过酶联免疫吸附试验(ELISA)评估了 71 名基线抗 HMGCR IgG 阳性患者的 123 份连续血清样本中抗 HMGCR 同型抗体(IgG、IgA 和 IgM)的水平。疾病活动性通过人工肌肉测试 (MMT) 8、医生总体评估 (PGA) 视觉模拟量表 (VAS) 和肌肉 VAS 进行评估。基线抗 HMGCR IgG 水平与 PGA VAS(r = 0.24;p = 0.04)、肌肉 VAS(r = 0.32;p < 0.01)和 MMT8(r =-0.24;p = 0.04)相关,而基线抗 HMGCR IgM 水平与 PGA VAS(r = 0.27,p = 0.02)、肌肉 VAS(r = 0.24,p = 0.04)呈正相关。与抗-HMGCR IgM 阴性患者相比,抗-HMGCR IgM 阳性患者的发病年龄较低 [29(25,46) vs. 51(33,65), p = 0.006],颈部无力的比例较高 (63.5% vs. 34.6%, p = 0.031)。纵向分析显示,抗-HMGCR IgG 水平的变化与 PGA VAS(β=3.830;p <0.0001)、肌肉 VAS(β=2.893;p <0.0001)、MMT8(β=-19.368;p <0.0001)和肌酸激酶(CK)水平(β=3900.05;p <0.0001)的变化相关。抗 HMGCR IgM 水平与基线抗 HMGCR IgA 水平呈弱相关(r = 0.33,p < 0.01),随访期间抗 HMGCR IgA 水平的变化与抗 HMGCR IgM 水平的变化呈相关(β = 0.885;p < 0.0001)。与抗-HMGCR IgM 阴性患者相比,抗-HMGCR IgM 患者中出现难治性病程的人数更多(多环病程:40% 对 25%;慢性持续病程:46.7% 对 20.5%,p = 0.018)。在抗-HMGCR IgG 阳性的 IMNM 患者中,抗-HMGCR IgG 水平与疾病活动性相关,而抗-HMGCR IgM 与难治性结果和不良预后相关。- 与抗-HMGCR IgM 阴性患者相比,抗-HMGCR IgM 阳性患者的发病年龄更小,颈部更无力。- 抗-HMGCR IgG 和 IgM 的水平与抗-HMGCR 阳性患者的疾病活动性有关。- 抗-HMGCR IgM与难治性结果和不良预后有关。
{"title":"Association of anti-HMGCR antibodies of the IgM isotype with refractory immune-mediated necrotizing myopathy","authors":"Hongxia Yang, Chao Sun, Lifang Ye, Yuetong Xu, Sang Lin, Qinglin Peng, Guochun Wang, Xin Lu","doi":"10.1186/s13075-024-03387-6","DOIUrl":"https://doi.org/10.1186/s13075-024-03387-6","url":null,"abstract":"Anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) autoantibodies are one of the myositis-specific antibodies which is associated with immune-mediated necrotizing myopathy (IMNM). However, the relationship between anti-HMGCR isotypes and prognosis has not yet been fully investigated. This study was conducted to gain insight into the association between anti-HMGCR isotypes and clinical, and prognosis in IMNM patients who were positive for anti-HMGCR antibodies. Levels of anti-HMGCR isotypes (IgG, IgA and IgM) were assessed by enzyme-linked immunosorbent assay (ELISA) in 123 consecutive serum samples obtained from 71 patients who were positive for anti-HMGCR IgG at baseline. Disease activity was assessed by manual muscle testing (MMT) 8, Physician’s Global Assessment (PGA) visual analog scale (VAS), and muscle VAS. Baseline anti-HMGCR IgG levels were correlated with PGA VAS (r = 0.24; p = 0.04), muscle VAS (r = 0.32; p < 0.01), and MMT8(r=-0.24; p = 0.04), and baseline anti-HMGCR IgM levels were positively correlated with PGA VAS (r = 0.27, p = 0.02), muscle VAS (r = 0.24, p = 0.04). Anti-HMGCR IgM positive patients had a lower age of onset [29(25,46) vs. 51(33,65), p = 0.006], and a higher proportion of neck weakness (63.5% vs. 34.6%, p = 0.031) compared with anti-HMGCR IgM negative patients. Longitudinal analysis showed that the changes in anti-HMGCR IgG levels were correlated with the changes in the PGA VAS (β = 3.830; p < 0.0001), muscle VAS (β = 2.893; p < 0.0001), MMT8 (β=-19.368; p < 0.0001), and creatine kinase (CK) levels (β = 3900.05, p < 0.0001). Anti-HMGCR IgM levels were weakly correlated with anti-HMGCR IgA levels at baseline (r = 0.33, p < 0.01), and the variations in anti-HMGCR IgA levels were correlated with the changes in anti-HMGCR IgM levels during follow-up (β = 0.885; p < 0.0001). There were more patients with anti-HMGCR IgM who showed a refractory course than those who were with anti-HMGCR IgM negative (polycyclic course: 40% vs. 25%; chronic continuous course: 46.7% vs. 20.5%, p = 0.018). In anti-HMGCR IgG-positive IMNM patients, the levels of anti-HMGCR IgG are associated with disease activity, and anti-HMGCR IgM is associated with refractory outcome and poor prognosis. • Anti-HMGCR IgM-positive patients had a younger age of onset and more neck weakness than anti-HMGCR IgM-negative patients. • The levels of anti-HMGCR IgG and IgM are associated with disease activity in anti-HMGCR-positive patients. • Anti-HMGCR IgM is associated with refractory outcome and poor prognosis.","PeriodicalId":8419,"journal":{"name":"Arthritis Research & Therapy","volume":"383 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142166285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Activation of circulating TFH17 cells associated with activated naive and double negative 2 B cell expansion, and disease activity in systemic lupus erythematosus patients 循环 TFH17 细胞的活化与系统性红斑狼疮患者活化的天真和双阴性 2 型 B 细胞扩增及疾病活动有关
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-11 DOI: 10.1186/s13075-024-03394-7
Tipanan Khunsri, Pongsakorn Thawornpan, Pachara Tianpothong, Thanitta Suangtamai, Pintip Ngamjanyaporn, Chaniya Leepiyasakulchai, Kittikorn Wangriatisak, Prapaporn Pisitkun, Patchanee Chootong
Systemic lupus erythematosus (SLE) is the quintessential autoimmune disease, as it is characterized by hyperactivity of CD4+ T cells and subsequently drives lupus pathology. Follicular helper T (TFH) cells play an important role in B cell maturation and antibody production. However, which specific subset of cTFH cells drives B cell function and contributes to the development of anti-dsDNA antibodies and SLE pathogenesis remains unclear. Peripheral blood mononuclear cells from SLE patients with inactive (n = 11) and active (n = 21) were used to determine and detect frequencies and phenotypes of circulating TFH cells (cTFH), memory cTFH, and B cell subsets. The correlations among cTFH cell subsets and phenotypes, B cell subsets, anti-dsDNA autoantibodies, and clinical parameters were analyzed. In subjects with active SLE, cTFH1 and cTFH17 cells were significantly expanded and activated. These expanded cTFH cells expressed memory phenotypes; cTFH1 cells were predominantly central memory (CM) type, while cTFH17 cells were largely effector memory (EM) type. Phenotyping B cell subsets in these patients showed increased frequencies of aNAV and DN2 B cells. Clinically, ICOS+ cTFH1, ICOS+ cTFH17 cells, and SLEDAI-2k scores were found to be correlated. Analysis of cTFH-B cell relationship revealed positive correlations among ICOS+ cTFH1 cells, aNAV B cells, and anti-dsDNA antibodies. Activation of ICOS+ cTFH17 cells was significantly related to the expansion of aNAV and DN2 B cells. The presence of CM cells in cTFH1 and cTFH17 subsets was correlated with aNAV and DN2 B cell frequencies. SLE cTFH cells were found to be polarized toward cTFH1 and cTFH17 cells; activation of these cTFH subsets was significantly associated with disease activity score, aNAV, DN2 B cell expansion, and anti-dsDNA antibody level. Thus, the interactions among cTFH1, cTFH17, and B cells likely contribute to the development of autoantibodies and the pathogenesis in SLE.
系统性红斑狼疮(SLE)是典型的自身免疫性疾病,其特点是 CD4+ T 细胞活性亢进,继而引发狼疮病理变化。滤泡辅助 T(TFH)细胞在 B 细胞成熟和抗体产生过程中发挥着重要作用。然而,究竟是哪个特定的cTFH细胞亚群驱动了B细胞功能,并促成了抗dsDNA抗体的产生和系统性红斑狼疮的发病机制,目前仍不清楚。研究人员使用非活动性(11 人)和活动性(21 人)系统性红斑狼疮患者的外周血单核细胞来确定和检测循环 TFH 细胞(cTFH)、记忆 cTFH 和 B 细胞亚群的频率和表型。分析了 cTFH 细胞亚群和表型、B 细胞亚群、抗dsDNA 自身抗体和临床参数之间的相关性。在活动性系统性红斑狼疮患者中,cTFH1和cTFH17细胞明显扩增和活化。这些扩增的cTFH细胞表现出记忆表型;cTFH1细胞主要是中心记忆(CM)型,而cTFH17细胞主要是效应记忆(EM)型。这些患者的 B 细胞亚群表型显示,aNAV 和 DN2 B 细胞的频率增加。临床发现,ICOS+ cTFH1、ICOS+ cTFH17 细胞与 SLEDAI-2k 评分相关。对cTFH-B细胞关系的分析表明,ICOS+ cTFH1细胞、aNAV B细胞和抗dsDNA抗体之间存在正相关。ICOS+ cTFH17细胞的激活与aNAV和DN2 B细胞的扩增明显相关。cTFH1和cTFH17亚群中CM细胞的存在与aNAV和DN2 B细胞频率相关。研究发现,系统性红斑狼疮 cTFH 细胞向 cTFH1 和 cTFH17 细胞极化;这些 cTFH 亚群的激活与疾病活动评分、aNAV、DN2 B 细胞扩增和抗dsDNA 抗体水平显著相关。因此,cTFH1、cTFH17 和 B 细胞之间的相互作用可能有助于自身抗体的形成和系统性红斑狼疮的发病机制。
{"title":"Activation of circulating TFH17 cells associated with activated naive and double negative 2 B cell expansion, and disease activity in systemic lupus erythematosus patients","authors":"Tipanan Khunsri, Pongsakorn Thawornpan, Pachara Tianpothong, Thanitta Suangtamai, Pintip Ngamjanyaporn, Chaniya Leepiyasakulchai, Kittikorn Wangriatisak, Prapaporn Pisitkun, Patchanee Chootong","doi":"10.1186/s13075-024-03394-7","DOIUrl":"https://doi.org/10.1186/s13075-024-03394-7","url":null,"abstract":"Systemic lupus erythematosus (SLE) is the quintessential autoimmune disease, as it is characterized by hyperactivity of CD4+ T cells and subsequently drives lupus pathology. Follicular helper T (TFH) cells play an important role in B cell maturation and antibody production. However, which specific subset of cTFH cells drives B cell function and contributes to the development of anti-dsDNA antibodies and SLE pathogenesis remains unclear. Peripheral blood mononuclear cells from SLE patients with inactive (n = 11) and active (n = 21) were used to determine and detect frequencies and phenotypes of circulating TFH cells (cTFH), memory cTFH, and B cell subsets. The correlations among cTFH cell subsets and phenotypes, B cell subsets, anti-dsDNA autoantibodies, and clinical parameters were analyzed. In subjects with active SLE, cTFH1 and cTFH17 cells were significantly expanded and activated. These expanded cTFH cells expressed memory phenotypes; cTFH1 cells were predominantly central memory (CM) type, while cTFH17 cells were largely effector memory (EM) type. Phenotyping B cell subsets in these patients showed increased frequencies of aNAV and DN2 B cells. Clinically, ICOS+ cTFH1, ICOS+ cTFH17 cells, and SLEDAI-2k scores were found to be correlated. Analysis of cTFH-B cell relationship revealed positive correlations among ICOS+ cTFH1 cells, aNAV B cells, and anti-dsDNA antibodies. Activation of ICOS+ cTFH17 cells was significantly related to the expansion of aNAV and DN2 B cells. The presence of CM cells in cTFH1 and cTFH17 subsets was correlated with aNAV and DN2 B cell frequencies. SLE cTFH cells were found to be polarized toward cTFH1 and cTFH17 cells; activation of these cTFH subsets was significantly associated with disease activity score, aNAV, DN2 B cell expansion, and anti-dsDNA antibody level. Thus, the interactions among cTFH1, cTFH17, and B cells likely contribute to the development of autoantibodies and the pathogenesis in SLE.","PeriodicalId":8419,"journal":{"name":"Arthritis Research & Therapy","volume":"16 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142166283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48) 比较托珠单抗生物类似物 BAT1806/BIIB800 与托珠单抗参比产品,治疗对甲氨蝶呤反应不佳的中重度类风湿性关节炎患者的 3 期随机、双盲、主动对照临床试验:治疗期 2(第 24 周至第 48 周)分析
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-07 DOI: 10.1186/s13075-024-03375-w
Xiaomei Leng, Piotr Leszczyński, Slawomir Jeka, Shengyun Liu, Huaxiang Liu, Malgorzata Miakisz, Jieruo Gu, Lali Kilasonia, Mykola Stanislavchuk, Xiaolei Yang, Yinbo Zhou, Qingfeng Dong, Marian Mitroiu, Janet Addison, Mourad F. Rezk, Xiaofeng Zeng
Equivalent efficacy and comparable pharmacokinetic, immunogenicity, and safety profiles of the biosimilar BAT1806/BIIB800 and reference tocilizumab (TCZ) in participants with moderate-to-severe rheumatoid arthritis (RA) have been reported up to week 24 (treatment period [TP] 1) of the phase 3 study. Here we present results for TP2 (study weeks 24–48). In this phase 3, multicenter, multiregional, double-blind, active-controlled, equivalence study, participants with active RA despite methotrexate were randomized (1:1:2) to intravenous administration of 8 mg/kg TCZ every 4 weeks to week 48 (TCZ group), or TCZ to week 24 followed by BAT1806/BIIB800 to week 48 (TCZ to BAT1806/BIIB800 group), or BAT1806/BIIB800 to week 48 (BAT1806/BIIB800 group). Efficacy in TP2 was evaluated using American College of Rheumatology (ACR) response criteria (ACR20/50/70) and change from baseline in Disease Activity Score on 28 joints (DAS28). Pharmacokinetics (trough levels), safety, and immunogenicity were also evaluated. Of 621 randomized participants, 577 (92.9%) completed TP1 and entered TP2 (TCZ: N = 145 [93.5%]; TCZ to BAT1806/BIIB800: N = 142 [92.2%]; BAT1806/BIIB800: N = 290 [92.9%]). Proportions of ACR20 responders were similar between treatment groups throughout TP2 (87.8%, 90.3%, and 90.4%, respectively, at week 48), as were proportions of ACR50 and ACR70 responders, and reduction in DAS28. Drug trough levels and antidrug antibody incidences were comparable between the treatment groups. Adverse events were balanced across the treatment groups and no fatal events were reported. In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups. NCT03830203 and EudraCT 2018-002202-31.
据报道,生物类似药BAT1806/BIIB800和参考药托西珠单抗(TCZ)对中重度类风湿性关节炎(RA)患者的疗效相同,药代动力学、免疫原性和安全性也相当,且均已进行到3期研究的第24周(治疗期[TP]1)。在此,我们将介绍TP2(研究第24-48周)的结果。在这项 3 期、多中心、多区域、双盲、主动对照、等效性研究中,使用甲氨蝶呤治疗活动性 RA 的参与者被随机(1:1:2),静脉注射8 mg/kg TCZ,每4周一次,直至第48周(TCZ组),或TCZ至第24周,然后BAT1806/BIIB800至第48周(TCZ至BAT1806/BIIB800组),或BAT1806/BIIB800至第48周(BAT1806/BIIB800组)。TP2的疗效采用美国风湿病学会(ACR)反应标准(ACR20/50/70)和28个关节疾病活动度评分(DAS28)与基线相比的变化进行评估。此外,还对药代动力学(谷值水平)、安全性和免疫原性进行了评估。在 621 名随机参与者中,577 人(92.9%)完成了 TP1 并进入 TP2(TCZ:145 人 [93.5%];TCZ 至 BAT1806/BIIB800:142 人 [92.2%]):N=142[92.2%];BAT1806/BIIB800:N = 290 [92.9%]).在整个TP2期间,各治疗组的ACR20应答者比例相似(第48周时分别为87.8%、90.3%和90.4%),ACR50和ACR70应答者比例也相似,DAS28也有所下降。各治疗组的药物谷值和抗药抗体发生率相当。各治疗组的不良事件发生率均衡,无死亡事件报告。在TP2中,TCZ组、TCZ至BAT1806/BIIB800组和BAT1806/BIIB800组的疗效、安全性、免疫原性和药代动力学特征相当。NCT03830203和EudraCT 2018-002202-31。
{"title":"A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)","authors":"Xiaomei Leng, Piotr Leszczyński, Slawomir Jeka, Shengyun Liu, Huaxiang Liu, Malgorzata Miakisz, Jieruo Gu, Lali Kilasonia, Mykola Stanislavchuk, Xiaolei Yang, Yinbo Zhou, Qingfeng Dong, Marian Mitroiu, Janet Addison, Mourad F. Rezk, Xiaofeng Zeng","doi":"10.1186/s13075-024-03375-w","DOIUrl":"https://doi.org/10.1186/s13075-024-03375-w","url":null,"abstract":"Equivalent efficacy and comparable pharmacokinetic, immunogenicity, and safety profiles of the biosimilar BAT1806/BIIB800 and reference tocilizumab (TCZ) in participants with moderate-to-severe rheumatoid arthritis (RA) have been reported up to week 24 (treatment period [TP] 1) of the phase 3 study. Here we present results for TP2 (study weeks 24–48). In this phase 3, multicenter, multiregional, double-blind, active-controlled, equivalence study, participants with active RA despite methotrexate were randomized (1:1:2) to intravenous administration of 8 mg/kg TCZ every 4 weeks to week 48 (TCZ group), or TCZ to week 24 followed by BAT1806/BIIB800 to week 48 (TCZ to BAT1806/BIIB800 group), or BAT1806/BIIB800 to week 48 (BAT1806/BIIB800 group). Efficacy in TP2 was evaluated using American College of Rheumatology (ACR) response criteria (ACR20/50/70) and change from baseline in Disease Activity Score on 28 joints (DAS28). Pharmacokinetics (trough levels), safety, and immunogenicity were also evaluated. Of 621 randomized participants, 577 (92.9%) completed TP1 and entered TP2 (TCZ: N = 145 [93.5%]; TCZ to BAT1806/BIIB800: N = 142 [92.2%]; BAT1806/BIIB800: N = 290 [92.9%]). Proportions of ACR20 responders were similar between treatment groups throughout TP2 (87.8%, 90.3%, and 90.4%, respectively, at week 48), as were proportions of ACR50 and ACR70 responders, and reduction in DAS28. Drug trough levels and antidrug antibody incidences were comparable between the treatment groups. Adverse events were balanced across the treatment groups and no fatal events were reported. In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups. NCT03830203 and EudraCT 2018-002202-31.","PeriodicalId":8419,"journal":{"name":"Arthritis Research & Therapy","volume":"40 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Factors related to elevated serum immunoglobulin G4 (IgG4) levels in a Japanese general population 日本普通人群血清免疫球蛋白 G4 (IgG4) 水平升高的相关因素
IF 4.9 2区 医学 Q1 Medicine Pub Date : 2024-09-06 DOI: 10.1186/s13075-024-03391-w
Shunsuke Tsuge, Hiroshi Fujii, Mami Tamai, Hiromasa Tsujiguchi, Misaki Yoshida, Nobuhiro Suzuki, Yoshinori Takahashi, Akari Takeji, Shigeto Horita, Yuhei Fujisawa, Takahiro Matsunaga, Takeshi Zoshima, Ryo Nishioka, Hiromi Nuka, Satoshi Hara, Yukiko Tani, Yasunori Suzuki, Kiyoaki Ito, Kazunori Yamada, Satoshi Nakazaki, Akinori Hara, Atsushi Kawakami, Hiroyuki Nakamura, Ichiro Mizushima, Yasunori Iwata, Mitsuhiro Kawano
Elevated serum immunoglobulin G4 (IgG4) concentrations are one of the characteristic findings in IgG4-related disease (IgG4-RD). This study investigated the frequency of elevated serum IgG4 levels and associated factors in a general Japanese population. Serum IgG4 concentrations were measured in 1,201 residents of Ishikawa prefecture who underwent general medical examinations. Factors associated with elevated serum IgG4 concentrations were assessed by logistic regression analysis. Participants with elevated serum IgG4 were subjected to secondary examinations. The mean serum IgG4 concentration was 44 mg/dL, with 42 (3.5%) participants having elevated serum IgG4 levels. Age- and sex-adjusted logistic regression analyses showed that male sex, older age, and lower intake of lipids and polyunsaturated fatty acids and higher intake of carbohydrates in daily diet were associated with elevated serum IgG4 concentration. Subgroup analyses in men showed that older age, lower estimated glomerular filtration rates based on serum cystatin C (eGFR-cysC) levels, and higher hemoglobin A1c (HbA1c) levels were associated with elevated serum IgG4 concentration. Analyses in women showed that lower intake of lipids and fatty acids and higher intake of carbohydrates were significantly associated with elevated serum IgG4 concentration. One of the 15 participants who underwent secondary examinations was diagnosed with possible IgG4-related retroperitoneal fibrosis. Elevated serum IgG4 levels in a Japanese general population were significantly associated with older age, male gender, and dietary intake of nutrients, with some of these factors identical to the epidemiological features of IgG4-RD.
血清免疫球蛋白 G4(IgG4)浓度升高是 IgG4 相关疾病(IgG4-RD)的特征性结果之一。本研究调查了日本普通人群中血清 IgG4 水平升高的频率及相关因素。对石川县 1201 名接受一般体检的居民进行了血清 IgG4 浓度测定。通过逻辑回归分析评估了与血清 IgG4 浓度升高相关的因素。对血清 IgG4 浓度升高的参与者进行了二次检查。平均血清 IgG4 浓度为 44 mg/dL,其中 42 人(3.5%)的血清 IgG4 水平升高。年龄和性别调整后的逻辑回归分析表明,男性、年龄较大、日常饮食中脂类和多不饱和脂肪酸摄入量较低以及碳水化合物摄入量较高与血清 IgG4 浓度升高有关。对男性进行的亚组分析表明,年龄较大、根据血清胱抑素 C(eGFR-cysC)水平估算的肾小球滤过率较低以及血红蛋白 A1c(HbA1c)水平较高与血清 IgG4 浓度升高有关。对女性进行的分析表明,脂类和脂肪酸摄入量较低和碳水化合物摄入量较高与血清 IgG4 浓度升高有显著关系。在接受二次检查的 15 名参与者中,有一人被诊断出可能患有与 IgG4 相关的腹膜后纤维化。在日本普通人群中,血清IgG4水平升高与年龄、男性和膳食营养摄入量明显相关,其中一些因素与IgG4-RD的流行病学特征相同。
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Arthritis Research & Therapy
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