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Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment. 奥洛单抗加甲氨蝶呤:106 周治疗的安全性和有效性。
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2023-225473
Eugen Feist, Roy M Fleischmann, Saeed Fatenejad, Daria Bukhanova, Sergey Grishin, Sofia Kuzkina, Michael Luggen, Evgeniy Nasonov, Mikhail Samsonov, Josef S Smolen

Objective: To report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study.

Methods: Cumulative data from three phase 3 core trials and their OLE were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 (C-reactive protein) <3.2, CDAI remission and low disease activity (LDA), SDAI remission and LDA, HAQ-DI decrease of 0.22 unit and Boolean 2.0 remission.

Results: A total of 2304 patients received OKZ in combination with MTX either once every 2 weeks or once every 4 weeks. Event rates per 100 patient-years in OKZ every 2 weeks and OKZ every 4 weeks, respectively, were 9.57 and 9.13 for SAEs; 2.95 and 2.34 for serious infections; 0.09 and 0.05 for gastrointestinal perforations; 0.58 and 0.83 for major adverse cardiovascular events; and 0.45 and 0.50 for malignancies. No increase in the rate of any AE was observed over 106 weeks of treatment. The evaluation of laboratory variables demonstrated the expected changes, like neutropenia, elevation of liver enzymes and blood lipids. Clinical response rates remained stable during the OLE.

Conclusion: The long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106. These findings support OKZ as a treatment option for patients with active RA.

目的利用三项随机临床试验(RCT)和开放标签扩展研究(OLE)的汇总数据,报告奥洛珠单抗(OKZ)联合甲氨蝶呤(MTX)治疗活动性类风湿性关节炎(RA)患者的长期安全性和耐受性:分析了三项三期核心试验及其开放标签扩展研究的累积数据。评估的安全性变量包括治疗突发不良事件(AE)、严重不良事件(SAE)、特别关注的不良事件和实验室结果。疗效评估包括 ACR20/50/70 反应、疾病活动评分 28(C 反应蛋白)结果:共有2304名患者接受了OKZ与MTX联合治疗,治疗方案为每2周1次或每4周1次。OKZ每2周1次和OKZ每4周1次的每100例患者年SAE发生率分别为9.57和9.13;严重感染发生率分别为2.95和2.34;胃肠道穿孔发生率分别为0.09和0.05;主要心血管不良事件发生率分别为0.58和0.83;恶性肿瘤发生率分别为0.45和0.50。在106周的治疗过程中,未观察到任何不良反应发生率的增加。实验室变量评估显示了预期的变化,如中性粒细胞减少、肝酶和血脂升高。在OLE期间,临床反应率保持稳定:OKZ联合MTX的长期安全性和耐受性保持稳定。结论:OKZ 与 MTX 联用的长期安全性和耐受性保持稳定,OKZ 的疗效维持到第 106 周。这些研究结果支持将 OKZ 作为活动性 RA 患者的一种治疗选择。
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引用次数: 0
Racial variability in immune responses only partially explains differential systemic sclerosis disease severity. 免疫反应的种族差异只能部分解释系统性硬化症疾病严重程度的不同。
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2023-225458
Kamini E Kuchinad, Ji Soo Kim, Adrianne Woods, Gwen Leatherman, Laura Gutierrez-Alamillo, Maureen D Mayes, Robyn Domsic, Paula S Ramos, Richard M Silver, John Varga, Lesley Ann Saketkoo, Suzanne Kafaja, Victoria K Shanmugan, Jessica Gordon, Lorinda Chung, Elana J Bernstein, Pravitt Gourh, Francesco Boin, Daniel L Kastner, Scott L Zeger, Livia Casciola-Rosen, Fredrick M Wigley, Ami A Shah

Objective: To understand if autoantibodies account for racial variation in disease severity, we compared autoantibody distribution and associated phenotype between self-identified black and white systemic sclerosis (SSc) patients.

Methods: 803 black and 2178 white SSc patients had systematic testing for autoantibodies using Euroimmun (centromere (ACA), RNA-polymerase III (POLR3), Scl70, PM/Scl, NOR90, Th/To, Ku, U3RNP and Ro52) and commercial ELISA (U1RNP). In this observational study, logistic regression was performed to assess the association between self-identified race and outcomes, adjusting for autoantibodies. To estimate whether the effect of race was mediated by autoantibody status, race coefficients from multivariate models including and excluding autoantibodies were compared.

Results: Anti-Scl70, anti-U1RNP, anti-U3RNP, anti-Th/To, anti-Ku and anti-NOR90 were more common in the black cohort than in the white cohort, which was enriched for ACA, anti-POLR3 and anti-PM/Scl. Black individuals had a higher prevalence of severe Raynaud's, skin, lung, gastrointestinal and renal disease whereas white individuals had a higher prevalence of severe heart and muscle disease. Adjusting for autoantibodies decreased the effect of race on outcome for telangiectasias, forced vital capacity <70%, pulmonary hypertension and severe lung, heart, muscle and gastrointestinal disease by 11%-44% and increased the association between race and renal crisis and severe kidney disease by 37%-52%.

Conclusions: This study is the largest systematic analysis of autoantibody responses in a geographically diverse population of black SSc patients. Black and white individuals with SSc have distinct autoantibody profiles. Autoantibodies explain only a fraction of the effect of race on clinical outcomes, suggesting other factors contribute to disparate outcomes between these groups.

目的方法:803 名黑人和 2178 名白人 SSc 患者使用 Euroimmun(中心粒 (ACA)、RNA 聚合酶 III (POLR3)、Scl70、PM/Scl、NOR90、Th/To、Ku、U3RNP 和 Ro52)和商用 ELISA(U1RNP)系统检测了自身抗体。在这项观察性研究中,对自身抗体进行调整后,采用逻辑回归法评估自我认定的种族与结果之间的关系。为了估计种族的影响是否由自身抗体状态介导,比较了包括和不包括自身抗体的多变量模型中的种族系数:黑人队列中抗Scl70、抗U1RNP、抗U3RNP、抗Th/To、抗Ku和抗NOR90比白人队列中更常见,而白人队列中则富含ACA、抗POLR3和抗PM/Scl。对自身抗体进行调整后,种族对毛细血管扩张症、强迫生命体征能力结果的影响有所降低:这项研究是对不同地域的黑人 SSc 患者自身抗体反应进行的最大规模的系统分析。黑人和白人 SSc 患者的自身抗体情况截然不同。自身抗体只能解释种族对临床结果影响的一小部分,这表明其他因素导致了这些群体之间的结果差异。
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引用次数: 0
From fibrositis to fibromyalgia to nociplastic pain: how rheumatology helped get us here and where do we go from here? 从纤维肌炎到纤维肌痛再到神经性疼痛:风湿病学如何帮助我们走到这一步,我们又该何去何从?
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2023-225327
Daniel J Clauw

Rheumatologists and rheumatology have had a prominent role in the conceptualisation of nociplastic pain since the prototypical nociplastic pain condition is fibromyalgia. Fibromyalgia had been previously known as fibrositis, until it became clear that this condition could be differentiatied from autoimmune disorders because of a lack of systemic inflammation and tissue damage. Nociplastic pain is now thought to be a third descriptor/mechanism of pain, in addition to nociceptive pain (pain due to peripheral damage or inflammation) and neuropathic pain. Nociplastic pain can occur in isolation, or as a co-morbidity with other mechanisms of pain, as commonly occurs in individuals with autoimmune disorders. We now know that the cardinal symptoms of nociplastic pain are widespread pain (or pain in areas not without evidence of inflammation/damage), accompanied by fatigue, sleep and memory issues. There is objective evidence of amplification/augmentation of pain, as well as of non-painful stimuli such as the brightness of lights and unpleasantness of sound or odors. Nociplastic pain states can be triggered by a variety of stressors such as trauma, infections and chronic stressors. Together these features suggest that the central nervous system (CNS) is playing a major role in causing and maintaining nociplastic pain, but these CNS factors may in some be driven by ongoing peripheral nociceptive input. The most effective drug therapies for nociplastic pain are non-opioid centrally acting analgesics such as tricyclics, serotonin-norepinephrine reuptake inhibitors and gabapentinoids. However the mainstay of therapy of nociplastic pain is the use of a variety of non-pharmacological integrative therapies, especially those which improve activity/exercise, sleep and address psychological co-morbidities.

风湿病学家和风湿病学在非结节性疼痛的概念化方面发挥了重要作用,因为非结节性疼痛的典型病症是纤维肌痛。纤维肌痛以前被称为纤维肌炎,直到人们逐渐认识到,由于缺乏全身性炎症和组织损伤,这种病症可以与自身免疫性疾病区分开来。除了痛觉痛(外周损伤或炎症引起的疼痛)和神经病理性疼痛之外,现在人们认为非运动性疼痛是疼痛的第三种描述方法/机制。神经痉挛性疼痛可以单独发生,也可以与其他疼痛机制同时发生,常见于自身免疫性疾病患者。我们现在知道,非运动性疼痛的主要症状是广泛性疼痛(或疼痛部位没有炎症/损伤的证据),同时伴有疲劳、睡眠和记忆问题。有客观证据表明,疼痛以及非疼痛刺激(如灯光的亮度、声音或气味的难闻程度)会被放大/增强。外伤、感染和慢性压力等各种压力都可能引发非可塑性疼痛状态。这些特征共同表明,中枢神经系统(CNS)在引起和维持非痉挛性疼痛方面发挥着主要作用,但这些中枢神经系统因素在某些情况下可能是由持续的外周痛觉输入驱动的。治疗非痉挛性疼痛最有效的药物疗法是非阿片类中枢作用镇痛剂,如三环类、5-羟色胺-去甲肾上腺素再摄取抑制剂和加巴喷丁类。然而,治疗非痉挛性疼痛的主要方法是使用各种非药物综合疗法,尤其是那些能改善活动/运动、睡眠和解决心理并发症的疗法。
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引用次数: 0
Correspondence on 'Current myositis clinical trials and tribulations' by Saygin et al. 关于 Saygin 等人撰写的 "当前肌炎的临床试验和磨难 "的通讯。
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2024-225751
Sofia Ferreira Azevedo, Antonia Valenzuela, Cristian Alejandro Benitez, David A Isenberg, Elie Naddaf, Hector Chinoy, Jiří Vencovský, Latika Gupta, Liza McCann, Masataka Kuwana, Mazen M Dimachkie, Susan Shenoi, Lesley Ann Saketkoo, Pedro M Machado
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引用次数: 0
Paraspinal tophi. 脊柱旁硬结
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2024-226687
Juan Wu, Yun Zhang
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引用次数: 0
Allogenic bone marrow-derived mesenchymal stromal cell-based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study). 基于异基因骨髓间充质基质细胞的慢性腰背痛患者疗法:一项前瞻性、多中心、随机安慰剂对照试验(RESPINE 研究)。
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2024-225771
Yves-Marie Pers, Robert Soler-Rich, Gianluca Vadalà, Rosanna Ferreira, Claire Duflos, Marie-Christine Picot, Fanchon Herman, Sylvie Broussous, Ana Sánchez, David Noriega, Francisco Ardura, Mercedes Alberca Zaballos, Verónica García, Virginia Gordillo Cano, Margarita González-Vallinas, Vicenzo Denaro, Fabrizio Russo, Jérôme Guicheux, Joan Vilanova, Lluís Orozco, Hans-Jörg Meisel, Matias Alfonso, Francois Rannou, Yves Maugars, Francis Berenbaum, Frank P Barry, Karin Tarte, Pascale Louis-Plence, Guilherme Ferreira-Dos-Santos, Javier García-Sancho, Christian Jorgensen

Objectives: To assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP).

Methods: Participants were randomised in a prospective, double-blind, controlled study to receive either sham injection or intradiscal injection of 20 million allogeneic BM-MSC, between April 2018 and December 2022. The first co-primary endpoint was the rate of responders defined by improvement of the Visual Analogue Scale (VAS) for pain of at least 20% and 20 mm, or improvement of the Oswestry Disability Index (ODI) of 20% between baseline and month 12. The secondary structural co-primary endpoint was assessed by the disc fluid content measured by quantitative MRI T2, between baseline and month 12. Secondary endpoints included pain VAS, ODI, the Short Form (SF)-36 and the minimal clinically important difference in all timepoints (1, 3, 6, 12 and 24 months). We determined the immune response associated with allogeneic cell injection between baseline and 6 months. Serious adverse events (SAEs) were recorded.

Results: 114 patients were randomised (n=58, BM-MSC group; n=56, sham placebo group). At 12 months, the primary outcome was not reached (74% in the BM-MSC group vs 69% in the placebo group; p=0.77). The groups did not differ in all secondary outcomes. No SAE related to the intervention occurred.

Conclusions: While our study did not conclusively demonstrate the efficacy of allogeneic BM-MSCs for LBP, the procedure was safe. Long-term outcomes of MSC therapy for LBP are still being studied.

Trial registration number: EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461.

研究目的评估慢性腰背痛(LBP)患者一次椎间盘内注射异体骨髓间充质干细胞(BM-MSCs)与假安慰剂的疗效:在2018年4月至2022年12月期间,参与者在一项前瞻性双盲对照研究中随机接受假注射或2000万异体骨髓间充质干细胞椎间盘内注射。第一个共同主要终点是基线至第12个月期间,疼痛视觉模拟量表(VAS)改善至少20%和20毫米,或奥斯韦特里残疾指数(ODI)改善20%的应答者比率。次要结构性共同主要终点通过定量核磁共振成像 T2 测量基线至第 12 个月期间的椎间盘液含量来评估。次要终点包括疼痛 VAS、ODI、简表 (SF)-36 和所有时间点(1、3、6、12 和 24 个月)的最小临床重要差异。我们确定了基线至 6 个月期间与异体细胞注射相关的免疫反应。我们还记录了严重不良事件(SAE):114名患者被随机分组(58人,BM-间充质干细胞组;56人,假安慰剂组)。12个月后,主要结果未达到(BM-间充质干细胞组为74%,安慰剂组为69%;P=0.77)。两组在所有次要结果上没有差异。没有发生与干预相关的 SAE:结论:虽然我们的研究并未最终证明异体间充质干细胞治疗枸杞多糖症的疗效,但该疗法是安全的。间充质干细胞治疗枸杞多糖症的长期疗效仍在研究中:EudraCT 2017-002092-25/ClinicalTrials.gov:NCT03737461。
{"title":"Allogenic bone marrow-derived mesenchymal stromal cell-based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study).","authors":"Yves-Marie Pers, Robert Soler-Rich, Gianluca Vadalà, Rosanna Ferreira, Claire Duflos, Marie-Christine Picot, Fanchon Herman, Sylvie Broussous, Ana Sánchez, David Noriega, Francisco Ardura, Mercedes Alberca Zaballos, Verónica García, Virginia Gordillo Cano, Margarita González-Vallinas, Vicenzo Denaro, Fabrizio Russo, Jérôme Guicheux, Joan Vilanova, Lluís Orozco, Hans-Jörg Meisel, Matias Alfonso, Francois Rannou, Yves Maugars, Francis Berenbaum, Frank P Barry, Karin Tarte, Pascale Louis-Plence, Guilherme Ferreira-Dos-Santos, Javier García-Sancho, Christian Jorgensen","doi":"10.1136/ard-2024-225771","DOIUrl":"10.1136/ard-2024-225771","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP).</p><p><strong>Methods: </strong>Participants were randomised in a prospective, double-blind, controlled study to receive either sham injection or intradiscal injection of 20 million allogeneic BM-MSC, between April 2018 and December 2022. The first co-primary endpoint was the rate of responders defined by improvement of the Visual Analogue Scale (VAS) for pain of at least 20% and 20 mm, or improvement of the Oswestry Disability Index (ODI) of 20% between baseline and month 12. The secondary structural co-primary endpoint was assessed by the disc fluid content measured by quantitative MRI T2, between baseline and month 12. Secondary endpoints included pain VAS, ODI, the Short Form (SF)-36 and the minimal clinically important difference in all timepoints (1, 3, 6, 12 and 24 months). We determined the immune response associated with allogeneic cell injection between baseline and 6 months. Serious adverse events (SAEs) were recorded.</p><p><strong>Results: </strong>114 patients were randomised (n=58, BM-MSC group; n=56, sham placebo group). At 12 months, the primary outcome was not reached (74% in the BM-MSC group vs 69% in the placebo group; p=0.77). The groups did not differ in all secondary outcomes. No SAE related to the intervention occurred.</p><p><strong>Conclusions: </strong>While our study did not conclusively demonstrate the efficacy of allogeneic BM-MSCs for LBP, the procedure was safe. Long-term outcomes of MSC therapy for LBP are still being studied.</p><p><strong>Trial registration number: </strong>EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461.</p>","PeriodicalId":8087,"journal":{"name":"Annals of the Rheumatic Diseases","volume":null,"pages":null},"PeriodicalIF":20.3,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142405958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recommendations for early referral of individuals with suspected polymyalgia rheumatica: an initiative from the international giant cell arteritis and polymyalgia rheumatica study group. 对疑似风湿性多肌痛患者早期转诊的建议:来自国际巨细胞动脉炎和风湿性多肌痛研究组的倡议。
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2023-225134
Kresten Krarup Keller, Chetan B Mukhtyar, Andreas Wiggers Nielsen, Andrea Katharina Hemmig, Sarah Louise Mackie, Sebastian Eduardo Sattui, Ellen-Margrethe Hauge, Anisha Dua, Toby Helliwell, Lorna Neill, Daniel Blockmans, Valérie Devauchelle-Pensec, Eric Hayes, Annett Jansen Venneboer, Sara Monti, Cristina Ponte, Eugenio De Miguel, Mark Matza, Kenneth J Warrington, Kevin Byram, Kinanah Yaseen, Christine Peoples, Michael Putman, Lindsay Lally, Michael Finikiotis, Simone Appenzeller, Ugo Caramori, Carlos Enrique Toro-Gutiérrez, Elisabeth Backhouse, María Camila Guerrero Oviedo, Victor Román Pimentel-Quiroz, Helen Isobel Keen, Claire Elizabeth Owen, Thomas Daikeler, Annette de Thurah, Wolfgang A Schmidt, Elisabeth Brouwer, Christian Dejaco

Objective: To develop international consensus-based recommendations for early referral of individuals with suspected polymyalgia rheumatica (PMR).

Methods: A task force including 29 rheumatologists/internists, 4 general practitioners, 4 patients and a healthcare professional emerged from the international giant cell arteritis and PMR study group. The task force supplied clinical questions, subsequently transformed into Population, Intervention, Comparator, Outcome format. A systematic literature review was conducted followed by online meetings to formulate and vote on final recommendations. Levels of evidence (LOE) (1-5 scale) and agreement (LOA) (0-10 scale) were evaluated.

Results: Two overarching principles and five recommendations were developed. LOE was 4-5 and LOA ranged between 8.5 and 9.7. The recommendations suggest that (1) each individual with suspected or recently diagnosed PMR should be considered for specialist evaluation, (2) before referring an individual with suspected PMR to specialist care, a thorough history and clinical examination should be performed and preferably complemented with urgent basic laboratory investigations, (3) individuals with suspected PMR with severe symptoms should be referred for specialist evaluation using rapid access strategies, (4) in individuals with suspected PMR who are referred via rapid access, the commencement of glucocorticoid therapy should be deferred until after specialist evaluation and (5) individuals diagnosed with PMR in specialist care with a good initial response to glucocorticoids and a low risk of glucocorticoid related adverse events can be managed in primary care.

Conclusions: These are the first international recommendations for referral of individuals with suspected PMR, which complement the European Alliance of Associations for Rheumatology/American College of Rheumatology management guidelines for established PMR.

目的:为疑似风湿性多肌痛(PMR)患者的早期转诊制定国际共识建议。方法:来自国际巨细胞动脉炎和PMR研究组的工作组包括29名风湿病学家/内科医生、4名全科医生、4名患者和1名医疗保健专业人员。工作组提供临床问题,随后转化为人口、干预、比较、结果格式。在进行了系统的文献综述之后,进行了在线会议,以制定最终建议并对其进行投票。评估证据水平(LOE)(1-5分)和一致性水平(LOA)(0-10分)。结果:制定了两项总体原则和五项建议。LOE为4-5,LOA为8.5 - 9.7。建议建议:(1)每个疑似PMR患者或最近确诊的PMR患者都应考虑接受专家评估;(2)在将疑似PMR患者转诊给专科治疗之前,应进行全面的病史和临床检查,并最好辅以紧急的基础实验室检查;(3)症状严重的疑似PMR患者应转诊接受专家评估,采用快速获取策略。(4)对于通过快速通道转诊的疑似PMR患者,应将糖皮质激素治疗的开始推迟到专家评估之后;(5)在专科护理中诊断为PMR的患者,如果对糖皮质激素有良好的初始反应,并且糖皮质激素相关不良事件的风险较低,可以在初级保健中进行管理。结论:这是第一个关于疑似PMR患者转诊的国际建议,补充了欧洲风湿病协会联盟/美国风湿病学会针对已确诊PMR的管理指南。
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引用次数: 0
Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations. 系统性红斑狼疮的管理:为 2023 年 EULAR 建议更新提供信息的系统性文献综述。
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2023-225319
Myrto Kostopoulou, Chetan B Mukhtyar, George Bertsias, Dimitrios T Boumpas, Antonis Fanouriakis

Objectives: To analyse the new evidence (2018-2022) for the management of systemic lupus erythematosus (SLE) to inform the 2023 update of the European League Against Rheumatism (EULAR) recommendations.

Methods: Systematic literature reviews were performed in the Medline and the Cochrane Library databases capturing publications from 1 January 2018 through 31 December 2022, according to the EULAR standardised operating procedures. The research questions focused on five different domains, namely the benefit/harm of SLE treatments, the benefits from the attainment of remission/low disease activity, the risk/benefit from treatment tapering/withdrawal, the management of SLE with antiphospholipid syndrome and the safety of immunisations against varicella zoster virus and SARS-CoV2 infection. A Population, Intervention, Comparison and Outcome framework was used to develop search strings for each research topic.

Results: We identified 439 relevant articles, the majority being observational studies of low or moderate quality. High-quality randomised controlled trials (RCTs) documented the efficacy of the type 1 interferon receptor inhibitor, anifrolumab, in non-renal SLE, and belimumab and voclosporin, a novel calcineurin inhibitor, in lupus nephritis (LN), when compared with standard of care. For the treatment of specific organ manifestations outside LN, a lack of high-quality data was documented. Multiple observational studies confirmed the beneficial effects of attaining clinical remission or low disease activity, reducing the risk for multiple adverse outcomes. Two randomised trials with some concerns regarding risk of bias found higher rates of relapse in patients who discontinued glucocorticoids (GC) or immunosuppressants in SLE and LN, respectively, yet observational cohort studies suggest that treatment withdrawal might be feasible in a subset of patients.

Conclusion: Anifrolumab and belimumab achieve better disease control than standard of care in extrarenal SLE, while combination therapies with belimumab and voclosporin attained higher response rates in high-quality RCTs in LN. Remission and low disease activity are associated with favourable long-term outcomes. In patients achieving these targets, GC and immunosuppressive therapy may gradually be tapered. Cite Now.

目的:分析系统性红斑狼疮(SLE)管理的新证据(2018-2022 年),为欧洲抗风湿联盟(EULAR)2023 年的建议更新提供信息:根据 EULAR 标准化操作程序,在 Medline 和 Cochrane 图书馆数据库中对 2018 年 1 月 1 日至 2022 年 12 月 31 日期间的出版物进行了系统文献综述。研究问题集中在五个不同的领域,即系统性红斑狼疮治疗的益处/害处、达到缓解/低疾病活动度的益处、治疗减量/停药的风险/益处、系统性红斑狼疮合并抗磷脂综合征的管理以及水痘带状疱疹病毒和SARS-CoV2感染免疫接种的安全性。我们采用了 "人群、干预、比较和结果 "框架来为每个研究课题制定检索字符串:我们发现了 439 篇相关文章,其中大部分是中低质量的观察性研究。高质量的随机对照试验(RCT)证明了1型干扰素受体抑制剂anifrolumab对非肾性系统性红斑狼疮的疗效,以及贝利木单抗和新型钙神经蛋白抑制剂voclosporin对狼疮肾炎(LN)的疗效。在治疗狼疮肾炎以外的特定器官表现方面,缺乏高质量的数据。多项观察性研究证实,达到临床缓解或低疾病活动度可降低多种不良后果的风险。两项随机试验发现,在系统性红斑狼疮和LN患者中,停用糖皮质激素(GC)或免疫抑制剂的患者复发率较高,但观察性队列研究表明,部分患者可能可以停用治疗:结论:在肾外系统性红斑狼疮的治疗中,阿尼单抗和贝利木单抗能比标准疗法更好地控制疾病,而在LN的高质量研究中,贝利木单抗和voclosporin联合疗法能获得更高的应答率。缓解和低疾病活动度与良好的长期疗效相关。对于达到这些目标的患者,可逐渐减少GC和免疫抑制疗法。立即引用。
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引用次数: 0
Clinical efficacy and autoantibody seroconversion with CD19-CAR T cell therapy in a patient with rheumatoid arthritis and coexisting myasthenia gravis. 类风湿性关节炎和重症肌无力并存患者接受 CD19-CAR T 细胞疗法的临床疗效和自身抗体血清转换。
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2024-226017
Aiden Haghikia, Tobias Hegelmaier, Denise Wolleschak, Martin Böttcher, Vaia Pappa, Jeremias Motte, Dominic Borie, Ralf Gold, Eugen Feist, Georg Schett, Dimitrios Mougiakakos
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引用次数: 0
Referral of patients with suspected polymyalgia rheumatica: how complete is our view of 'planet PMR?' 转诊疑似多发性风湿病患者:我们对'多发性风湿病星球'的认识有多全面?
IF 20.3 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-21 DOI: 10.1136/ard-2023-225217
Dario Camellino, Eric L Matteson
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引用次数: 0
期刊
Annals of the Rheumatic Diseases
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