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Immunosuppression, nirmatrelvir-ritonavir, and post-COVID condition. 免疫抑制、nirmatrelvir-ritonavir 和后 COVID 状态。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-11-08 DOI: 10.1016/S2665-9913(24)00304-7
Jeffrey A Sparks, Zachary S Wallace
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引用次数: 0
Detection of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease using home monitoring in the Netherlands (DecreaSSc): a prospective, observational study. 荷兰利用家庭监测检测系统性硬化症相关间质性肺病患者肺功能下降的情况(DecreaSSc):一项前瞻性观察研究。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-11-08 DOI: 10.1016/S2665-9913(24)00236-4
Arthiha Velauthapillai, Catharina C Moor, Jeska K de Vries-Bouwstra, Marlies S Wijsenbeek-Lourens, Cornelia H M van den Ende, Madelon C Vonk
<p><strong>Background: </strong>In patients with systemic sclerosis, interstitial lung disease (ILD) is the leading cause of mortality. Early detection of progressive ILD associated with systemic sclerosis is warranted for timely adjustment of management strategies and improved prognosis. We aimed to investigate the validity of home spirometry to detect a decline in pulmonary function in patients with systemic sclerosis-associated ILD.</p><p><strong>Methods: </strong>DecreaSSc was a prospective, observational study done in two tertiary referral centres in the Netherlands. Eligible patients were aged 18 years or older, fulfilled the American College of Rheumatology-European Alliance of Associations for Rheumatology criteria for systemic sclerosis, had a disease duration from first non-Raynaud phenomenon symptom of 5 years or less, had high-resolution CT-confirmed diagnosis of ILD, and had a maximum immunosuppressive treatment duration of 8 weeks at baseline. Patients took weekly home spirometry measurements using a handheld spirometer for 1 year. At baseline and at semi-annual study visits, patients pulmonary function testing was done in the hospital and patients completed questionnaires on patient-reported outcome measurements. The primary outcome was the κ agreement between home and hospital measurements after 1 year to detect a decline in force vital capacity (FVC) of 5% or more, estimated using separate linear regression analyses for home-based and hospital-based FVC% predicted in individual patients. The sensitivity and specificity of home spirometry to detect an absolute decline in FVC% predicted of 5% or more was assessed using the hospital pulmonary function test as the gold standard. The longitudinal correlation between hospital and home measurements was assessed with regression analysis, whereas the cross-sectional correlation was assessed with the intraclass coefficient. People with lived experience were involved at several stages of the study.</p><p><strong>Findings: </strong>Between Jan 26, 2021, and Feb 27, 2023, 43 patients were enrolled, 35 of whom completed 6 months of follow-up and 31 of whom completed 12 months of follow-up. The last follow-up visit took place on March 28, 2024. 20 (57%) of patients were women and 15 (43%) were men; 32 (91%) were White. Mean age was 57·7 years (SD 10·7). The agreement between hospital and home measurements had a κ value of 0·40 (95% CI 0·01-0·79). The sensitivity of home spirometry to detect a decline in FVC% predicted of 5% or more was 60% (95% CI 44-76) and specificity was 87% (75-98). Regression analysis showed that the course of pulmonary function was not different between hospital and home assessment as the interaction term was not significant (-0·0003 [95% CI -0·0006 to 0·000008]; p=0·057) with a longitudinal correlation of 0·55 (95% CI 0·26-0·74; p=0·0070). The intraclass coefficient between both measurements was 0·85 (95% CI 0·73-0·92; p<0·0001) at baseline, 0·84 (0·71-0·92; p<0·0001) at
背景:在系统性硬化症患者中,间质性肺病(ILD)是导致死亡的主要原因。为了及时调整治疗策略和改善预后,有必要及早发现与系统性硬化症相关的进行性间质性肺病。我们旨在研究家庭肺活量测定法检测系统性硬化症相关 ILD 患者肺功能下降的有效性:DecreaSSc是一项前瞻性观察研究,在荷兰的两个三级转诊中心进行。符合条件的患者年龄在 18 岁或以上,符合美国风湿病学会-欧洲风湿病学协会联盟的系统性硬化症标准,自首次出现非雷诺现象症状起病程在 5 年或以下,经高分辨率 CT 确诊为 ILD,基线免疫抑制治疗时间最长为 8 周。患者每周使用手持式肺活量计进行家庭肺活量测量,为期一年。在基线和半年一次的研究回访中,患者在医院进行肺功能检测,并填写患者报告结果测量问卷。研究的主要结果是一年后家庭和医院测量结果的κ吻合度,以检测患者体力活动能力(FVC)是否下降了5%或更多,该结果是通过对单个患者的家庭和医院预测FVC%进行单独的线性回归分析来估算的。以医院肺功能测试作为金标准,评估了家庭肺活量测定检测 FVC% 预测值绝对值下降 5% 或以上的灵敏度和特异性。医院和家庭测量结果之间的纵向相关性通过回归分析进行评估,而横向相关性则通过类内系数进行评估。有生活经验的人参与了研究的多个阶段:2021年1月26日至2023年2月27日,43名患者入组,其中35人完成了6个月的随访,31人完成了12个月的随访。最后一次随访于 2024 年 3 月 28 日进行。20名患者(57%)为女性,15名患者(43%)为男性;32名患者(91%)为白人。平均年龄为 57-7 岁(SD 10-7)。医院和家庭测量结果的κ值为0-40(95% CI 0-01-0-79)。家庭肺活量测量对预测 FVC% 下降 5% 或以上的检测灵敏度为 60% (95% CI 44-76),特异性为 87% (75-98)。回归分析表明,医院和家庭评估的肺功能变化过程并无不同,交互项不显著(-0-0003 [95% CI -0-0006 to 0-000008];p=0-057),纵向相关性为 0-55 (95% CI 0-26-0-74; p=0-0070)。两种测量值之间的类内系数为 0-85 (95% CI 0-73-0-92; p解释:家庭肺活量测量有可能在常规医疗管理的基础上更早地发现系统性硬化症相关 ILD 患者肺功能的下降。未来的研究将揭示家庭肺活量测定是否有助于改善系统性硬化症相关性 ILD 患者的预后:资助:Galapagos 和 Boehringer Ingelheim。
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引用次数: 0
Association of nirmatrelvir-ritonavir with post-acute sequelae and mortality among patients who are immunocompromised with COVID-19 in Hong Kong: a retrospective cohort study. 香港感染 COVID-19 病毒的免疫力低下患者中,尼马瑞韦-利托那韦与急性后遗症和死亡率的关系:一项回顾性队列研究。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-11-08 DOI: 10.1016/S2665-9913(24)00224-8
Guozhang Lin, Yuchen Wei, Huwen Wang, Christopher Boyer, Katherine Min Jia, Chi Tim Hung, Xiaoting Jiang, Conglu Li, Carrie Ho Kwan Yam, Tsz Yu Chow, Yawen Wang, Shi Zhao, Zihao Guo, Kehang Li, Aimin Yang, Chris Ka Pun Mok, David S C Hui, Ka Chun Chong, Eng Kiong Yeoh

Background: The effect of nirmatrelvir-ritonavir on post-COVID-19 outcomes for individuals who are immunocompromised is understudied. We aimed to examine the association of nirmatrelvir-ritonavir with post-acute sequelae and mortality among patients who are immunocompromised and admitted to hospital with COVID-19.

Methods: We did a retrospective cohort study using territory-wide electronic health records from the Hong Kong Hospital Authority and Hong Kong Department of Health. Eligible patients were adults aged 18 years or older who tested positive for SARS-CoV-2 during the study period (March 11, 2022, to Nov 9, 2023) and were admitted to hospital with COVID-19. Four exposure groups were formed based on immune status (immunocompromised or immunocompetent) and nirmatrelvir-ritonavir status (yes or no). The primary outcome was post-acute inpatient death, starting from 21 days after the positive RT-PCR date. Standardised mortality ratio weighting with doubly robust adjustment was applied to control for confounders. Cox models were used to estimate hazard ratios (HRs) for the outcomes.

Findings: Between March 11, 2022, and Nov 9, 2023, there were 89 772 individuals with positive RT-PCR tests, of whom 39 923 met eligibility criteria and were included in the study cohort. 19 914 (49·9%) of 39 923 patients were female, 20 009 (50·1%) were male and the median age was 75·0 years (IQR 63·0-85·0). 846 (38·2%) of 2217 patients who were immunocompromised and 14 586 (38·7%) of 37 706 patients who were immunocompetent were prescribed nirmatrelvir-ritonavir. Among the patients who were immunocompromised, those patients who received nirmatrelvir-ritonavir had significantly lower risk of post-acute inpatient death (HR 0·58, 95% CI 0·45-0·74; p<0·0001) and hospitalisation for acute respiratory distress syndrome (0·43, 0·20-0·90; p=0·024) than those who did not. A significant negative interaction was found between immune status and nirmatrelvir-ritonavir on post-acute all-cause hospitalisation (relative excess risk due to interaction -0·84, 95% CI -1·30 to -0·37; p=0·0004).

Interpretation: Nirmatrelvir-ritonavir was associated with reduced risk of post-acute inpatient death among patients who were immunocompromised and admitted to hospital with COVID-19. However, the effectiveness of nirmatrelvir-ritonavir on post-acute hospitalisation outcomes was less pronounced in patients who were immunocompromised than in patients who were immunocompetent.

Funding: Health and Medical Research Fund, Research Grants Council theme-based research schemes, and Research Grants Council Collaborative Research Fund.

背景:目前还没有充分研究尼马瑞韦-利托那韦对免疫功能低下患者 COVID-19 后遗症的影响。我们的目的是研究在因 COVID-19 而入院的免疫力低下患者中,尼马瑞韦-利托那韦与急性后遗症和死亡率之间的关系:我们利用香港医院管理局和香港卫生署的全港电子健康记录进行了一项回顾性队列研究。符合条件的患者是在研究期间(2022 年 3 月 11 日至 2023 年 11 月 9 日)对 SARS-CoV-2 检测呈阳性并因 COVID-19 入院的 18 岁或以上成年人。根据免疫状态(免疫功能低下或免疫功能健全)和尼马替雷韦-利托那韦状态(是或否)分为四组。主要结果是急性期后住院病人死亡,从 RT-PCR 阳性日期后 21 天开始计算。采用标准化死亡率加权和双重稳健调整来控制混杂因素。采用Cox模型估算结果的危险比(HRs):2022年3月11日至2023年11月9日期间,共有89 772人的RT-PCR检测结果呈阳性,其中39 923人符合资格标准并被纳入研究队列。39 923 名患者中有 19 914 人(49-9%)为女性,20 009 人(50-1%)为男性,年龄中位数为 75-0 岁(IQR 63-0-85-0)。在 2217 名免疫力低下的患者中,有 846 人(38-2%)获得了尼马瑞韦-利托那韦处方;在 37 706 名免疫力正常的患者中,有 14 586 人(38-7%)获得了尼马瑞韦-利托那韦处方。在免疫力低下的患者中,接受尼马瑞韦-利托那韦治疗的患者急性住院后死亡的风险显著降低(HR 0-58,95% CI 0-45-0-74;P解释:尼马瑞韦-利托那韦治疗的患者急性住院后死亡的风险显著降低(HR 0-58,95% CI 0-45-0-74):在因感染COVID-19而入院的免疫力低下患者中,接受尼马替尼-利托那韦治疗可降低急性期后住院患者的死亡风险。然而,与免疫功能正常的患者相比,免疫功能低下的患者使用尼尔马特雷韦-利托那韦对急性期后住院治疗结果的效果并不明显:经费来源:健康与医学研究基金、研究资助委员会主题研究计划和研究资助委员会合作研究基金。
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引用次数: 0
Barriers to CAR T-cell therapy in rheumatology. 风湿病学 CAR T 细胞疗法的障碍。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-11-05 DOI: 10.1016/S2665-9913(24)00240-6
Karolina Lungova, Michael Putman

Chimeric antigen receptor (CAR) T cells have recently shown remarkable promise in treating rheumatic diseases, including systemic lupus erythematosus (SLE), idiopathic inflammatory myopathies, and systemic sclerosis. Currently, there are 37 clinical trials registered for CAR T-cell therapy in rheumatic diseases and many more are being planned. Much of this enthusiasm is justifiable, but widespread adoption of CAR T-cell therapy in rheumatology faces several barriers. The trajectory of autoimmune diseases differs from malignancies and a surprisingly narrow population could be eligible for CAR T-cell therapy. Current CAR T-cell approaches rely on B-cell depletion, which has a mixed record of success for many diseases. The high cost of CAR T-cell therapy and potential safety concerns, such as cytokine release syndrome and long-term infection risks, also pose substantial challenges. Moving forward, more targeted CAR T-cell approaches, such as antigen-specific chimeric autoantibody receptors or chimeric autoantigen T-cell receptors, could offer greater efficacy and safety in treating rheumatic diseases.

嵌合抗原受体(CAR)T 细胞最近在治疗风湿性疾病(包括系统性红斑狼疮(SLE)、特发性炎症性肌病和系统性硬化症)方面显示出了显著的前景。目前,已有 37 项 CAR T 细胞疗法在风湿病领域的临床试验注册,还有更多的临床试验正在计划中。这种热情在很大程度上是合理的,但在风湿病学中广泛采用 CAR T 细胞疗法面临着一些障碍。自身免疫性疾病的发展轨迹不同于恶性肿瘤,有资格接受 CAR T 细胞疗法的人群少得惊人。目前的 CAR T 细胞疗法依赖于 B 细胞耗竭,而这种疗法在许多疾病上的成功率参差不齐。CAR T 细胞疗法的高成本和潜在的安全问题,如细胞因子释放综合征和长期感染风险,也构成了巨大的挑战。展望未来,更具针对性的 CAR T 细胞疗法,如抗原特异性嵌合自身抗体受体或嵌合自身抗原 T 细胞受体,可为治疗风湿性疾病提供更高的疗效和安全性。
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引用次数: 0
Patient-initiated follow-up supported by asynchronous telemedicine versus usual care in spondyloarthritis (TeleSpA-study): a randomised controlled trial of clinical and cost-effectiveness. 脊柱关节炎患者主动随访与异步远程医疗支持下的常规护理(TeleSpA-study):临床和成本效益随机对照试验。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-30 DOI: 10.1016/S2665-9913(24)00229-7
Kasper Hermans, Casper Webers, Annelies Boonen, Harald E Vonkeman, Astrid van Tubergen

Background: With rising health-care expenditures and workforce shortages, sustainable alternatives to traditional outpatient follow-up strategies are required to optimise care efficiency. We aimed to investigate the cost-effectiveness and clinical effectiveness of patient-initiated follow-up (PIFU) supported by asynchronous telemedicine for patients with spondyloarthritis compared with usual care in daily practice.

Methods: TeleSpA was a multicentre, pragmatic, open-label, randomised controlled trial. Patients with spondyloarthritis and stable disease were randomly assigned (1:1) to either the PIFU and asynchronous telemedicine group or usual care group. All patients received a scheduled outpatient visit at baseline and after 1 year. Patients were monitored remotely at 6 months (PIFU and asynchronous telemedicine) or at the discretion of the treating rheumatologist (usual care). The primary outcome was the number of rheumatology visits within a 1-year period. A trial-based 1-year health-economic evaluation from a Dutch health-care perspective (only including health-care costs) and societal perspective (also including travel costs and work productivity losses), per the Dutch guidelines was used to estimate cost-effectiveness. The safety analysis was done in the intention-to-treat population and was based on spontaneous reports of adverse events and serious adverse events or as observed by the research team. The primary analysis was in the intention-to-treat population. Individuals with relevant lived experience were involved in the study design. This trial was registered with the Dutch National Trial Register (NL71041.068.19) and ClinicalTrials.gov (NCT04673825) and is completed.

Findings: Between Dec 2, 2020, and June 20, 2022, 200 patients were randomly assigned to PIFU and asynchronous telemedicine (n=100) or usual care (n=100). 79 (40%) of 200 participants were women, 121 (60%) were men, and the mean age was 55·0 years (SD 11·9). After 1 year, the mean number of rheumatology visits was 1·9 (SD 1·5) for the PIFU and asynchronous telemedicine group and 2·6 (1·3) in the usual care group (mean difference -0·7 [95% CI -1·0 to -0·3]; 25·4% reduction; p<0·0001). PIFU and asynchronous telemedicine was cost-effective from a health-care perspective, saving health-care costs (-€180 [95% CI -921 to 560]) without a loss in quality-adjusted life-years (0·004 [95 % CI -0·022 to 0·030]). Seven non-trial-related adverse events occurred in the PIFU and asynchronous telemedicine group and eight in usual care group (including one death).

Interpretation: PIFU and asynchronous telemedicine resulted in significant and clinically meaningful reductions in rheumatology visits. This was not at the expense of health outcomes and saved health-care costs.

Funding: Dutch Arthritis Society.

背景:随着医疗保健支出的不断增加和劳动力的短缺,需要有可持续的方法来替代传统的门诊随访策略,以优化医疗保健效率。我们旨在研究脊柱关节炎患者在异步远程医疗支持下接受患者主动随访(PIFU)与日常常规护理相比的成本效益和临床效果:TeleSpA是一项多中心、务实、开放标签、随机对照试验。患有脊柱关节炎且病情稳定的患者被随机分配(1:1)到PIFU和异步远程医疗组或常规护理组。所有患者均在基线和一年后接受定期门诊。患者在 6 个月时接受远程监测(PIFU 和异步远程医疗),或由主治风湿病专家决定是否接受监测(常规护理)。主要结果是 1 年内风湿病就诊次数。根据荷兰指南,从荷兰医疗保健角度(仅包括医疗保健成本)和社会角度(还包括旅行成本和工作效率损失)进行了为期 1 年的试验性健康经济评估,以估算成本效益。安全性分析是在意向治疗人群中进行的,基于自发报告的不良事件和严重不良事件或研究团队观察到的不良事件。主要分析在意向治疗人群中进行。具有相关生活经验的人员参与了研究设计。该试验已在荷兰国家试验注册中心(NL71041.068.19)和ClinicalTrials.gov(NCT04673825)注册,并已完成:2020年12月2日至2022年6月20日期间,200名患者被随机分配至PIFU和异步远程医疗(100人)或常规护理(100人)。200名参与者中有79名(40%)为女性,121名(60%)为男性,平均年龄为55-0岁(SD 11-9)。1 年后,PIFU 和异步远程医疗组的平均风湿病就诊次数为 1-9 次(SD 1-5 次),常规护理组为 2-6 次(1-3 次)(平均差异为 -0-7 [95% CI -1-0 至 -0-3];减少 25-4%;P 解释:PIFU 和异步远程医疗组的平均风湿病就诊次数为 1-9 次(SD 1-5 次),常规护理组为 2-6 次(1-3 次):PIFU和异步远程医疗显著减少了风湿病就诊次数,具有临床意义。这并非以牺牲健康结果和节省医疗成本为代价:荷兰关节炎协会。
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引用次数: 0
Digital remote monitoring in rheumatology: using health economics to support wider adoption. 风湿病学中的数字远程监护:利用卫生经济学支持更广泛的应用。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-30 DOI: 10.1016/S2665-9913(24)00306-0
Sean P Gavan
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引用次数: 0
Effect of apremilast on hand and whole-body MRI assessments of inflammation in patients with psoriatic arthritis (MOSAIC): a phase 4, multicentre, single-arm, open-label study. 阿普司特对银屑病关节炎患者手部和全身核磁共振炎症评估的影响(MOSAIC):一项第 4 期、多中心、单臂、开放标签研究。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-30 DOI: 10.1016/S2665-9913(24)00232-7
Mikkel Østergaard, Mikael Boesen, Walter P Maksymowych, Robert G Lambert, Michael R Bubb, Olga Kubassova, Guillermo Valenzuela, Jyotsna Reddy, Stephen Colgan, Yuri Klyachkin, Cynthia Deignan, Zhenwei Zhou, Hamid Amouzadeh, Philip J Mease
<p><strong>Background: </strong>The Psoriatic Arthritis Magnetic Resonance Imaging Scoring System (PsAMRIS) and MRI Whole-Body Scoring System for Inflammation in Peripheral Joints and Entheses in Inflammatory Arthritis (MRI-WIPE) have not been used together to assess treatment of psoriatic arthritis in a clinical trial. We aimed to assess the effect of apremilast treatment on inflammation, with outcomes measured by PsAMRIS and MRI-WIPE.</p><p><strong>Methods: </strong>MOSAIC was a phase 4, multicentre, single-arm, open-label study conducted at 29 sites across ten countries (Belgium, Canada, Denmark, Germany, Italy, Russia, Spain, Switzerland, the UK, and the USA). Adults aged 18 years or older with a documented diagnosis of psoriatic arthritis for a duration of 3 months to 5 years self-enrolled and were included if they met the classification criteria for active psoriatic arthritis at screening. Patients were required to have at least three swollen and three tender joints with hand involvement and at least one active enthesitis site according to the Spondyloarthritis Research Consortium of Canada enthesitis index or the Leeds enthesitis index. Patients were excluded if they had previous treatment with a biological disease-modifying antirheumatic drug or previous treatment with more than two conventional synthetic disease-modifying antirheumatic drugs. After a 5-day titration period, patients received apremilast 30 mg orally twice per day. Concomitant stable methotrexate up to 25 mg per week was permitted. The primary endpoint was change from baseline to week 24 in a composite inflammation score of bone marrow oedema, synovitis, and tenosynovitis in the hand as assessed by PsAMRIS. The full analysis set and safety population included all enrolled patients who received at least one dose of apremilast. This completed study is registered with ClinicalTrials.gov (NCT03783026).</p><p><strong>Findings: </strong>Between Feb 6, 2019, and May 11, 2022, 123 patients were enrolled in the MOSAIC study. Of these 123 patients, 122 (99%) were treated with apremilast and included in the full analysis set and safety population. 67 (55%) of 122 patients were female, 55 (45%) were male, and 116 (95%) were White. 80 (66%) of 122 patients completed 48 weeks of treatment. The least squares mean change from baseline to week 24 in the composite inflammation score of bone marrow oedema, synovitis, and tenosynovitis as assessed by PsAMRIS was -2·32 (95% CI -4·73 to 0·09). 95 (78%) of 122 patients had at least one treatment-emergent adverse event. Six (5%) patients had a severe treatment-emergent adverse event and six (5%) patients had a serious treatment-emergent adverse event. No serious treatment-emergent adverse events were considered to be related to apremilast.</p><p><strong>Interpretation: </strong>Apremilast improved inflammation in joints and entheses on assessment of MRI measures in the hand and the whole body. Our findings encourage the use of MRI, including whol
背景:银屑病关节炎磁共振成像评分系统(PsAMRIS银屑病关节炎磁共振成像评分系统(PsAMRIS)和炎症性关节炎外周关节和内膜炎症核磁共振成像全身评分系统(MRI-WIPE)尚未在临床试验中同时用于评估银屑病关节炎的治疗。我们旨在通过PsAMRIS和MRI-WIPE测量结果,评估阿普司特治疗对炎症的影响:MOSAIC是一项4期、多中心、单臂、开放标签研究,在10个国家(比利时、加拿大、丹麦、德国、意大利、俄罗斯、西班牙、瑞士、英国和美国)的29个地点进行。年龄在18岁或18岁以上、被确诊患有银屑病关节炎3个月至5年的成人自行报名参加,如果他们在筛查时符合活动性银屑病关节炎的分类标准,则被纳入研究范围。根据加拿大脊柱关节炎研究联合会(Spondyloarthritis Research Consortium of Canada)的关节炎指数或利兹关节炎指数,患者必须至少有三个关节肿胀和三个关节触痛,且手部受累,并至少有一个活动性关节炎部位。如果患者曾接受过生物改善病情抗风湿药物治疗,或曾接受过两种以上传统合成改善病情抗风湿药物治疗,则排除在外。经过 5 天的滴定期后,患者开始口服阿普司特 30 毫克,每天两次。允许同时服用稳定的甲氨蝶呤,每周不超过25毫克。主要终点是PsAMRIS评估的手部骨髓水肿、滑膜炎和腱鞘炎综合炎症评分从基线到第24周的变化。完整的分析集和安全性人群包括所有接受了至少一次阿普司特治疗的入组患者。这项已完成的研究已在ClinicalTrials.gov(NCT03783026)上注册:2019年2月6日至2022年5月11日期间,MOSAIC研究共招募了123名患者。在这123名患者中,有122人(99%)接受了阿普司特治疗,并纳入了完整的分析集和安全人群。122名患者中有67名(55%)为女性,55名(45%)为男性,116名(95%)为白人。122名患者中有80名(66%)完成了48周的治疗。PsAMRIS评估的骨髓水肿、滑膜炎和腱鞘炎综合炎症评分从基线到第24周的最小二乘法平均变化为-2-32(95% CI -4-73至0-09)。122 名患者中有 95 人(78%)至少出现过一次治疗突发不良事件。6名患者(5%)发生了严重的治疗突发不良事件,6名患者(5%)发生了严重的治疗突发不良事件。没有严重治疗突发不良事件被认为与阿普司特有关:阿普瑞米司特改善了手部和全身核磁共振成像评估中关节和内膜的炎症。我们的研究结果鼓励将核磁共振成像(包括全身核磁共振成像)作为银屑病关节炎患者试验的客观结果测量指标:安进公司。
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引用次数: 0
Facial ulcerations in anti-MDA5 dermatomyositis. 抗MDA5皮肌炎患者的面部溃疡。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-29 DOI: 10.1016/S2665-9913(24)00273-X
Rajat Ranka, Sukdev Manna, Venkatesh Srinivasa Pai
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引用次数: 0
Identification of red flags for IgG4-related disease: an international European Reference Network for Rare Connective Tissue Diseases framework. 识别 IgG4 相关疾病的红色信号:欧洲罕见结缔组织病国际参考网络框架。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-29 DOI: 10.1016/S2665-9913(24)00192-9
Emanuel Della-Torre, Rosaria Talarico, Jose Ballarin, Emanuele Bozzalla-Cassione, Chiara Cardamone, Cosimo Cigolini, Francesco Ferro, Tomas Fonseca, George E Fragoulis, Ilaria Galetti, Maria Gerosa, José Hernández-Rodríguez, Marco Lanzillotta, Diana Marinello, Thierry Martin, Fernando Martinez-Valle, Maria Maślińska, Michele Moretti, Marta Mosca, Ulf Müller-Ladner, Cecilia Nalli, Giovanni Orsolini, Cristina Pamfil, Guillermo Perez-Garcia, Roberta Priori, Giacomo Quattrocchio, Andreas Ramming, Francesca Regola, Vasco C Romão, Augusto Silva, Jan A M van Laar, Maria Jose Vicente-Edo, Shlomo Vinker, Tobias Alexander

IgG4-related disease is a rare fibroinflammatory condition. Prompt recognition is fundamental to initiate treatment and to prevent organ damage. Diagnostic and classification criteria are primarily intended for use by clinicians with established expertise in IgG4-related disease. Absence of disease awareness among primary care physicians and specialists without expertise in IgG4-related disease remains the main cause of diagnostic delay. We aimed to identify red flags that might increase the suspicion of IgG4-related disease in primary and secondary care settings. A task force of experts in IgG4-related disease from the European Reference Network for Rare Connective Tissue Diseases (ERN-ReCONNET), patient representatives, and primary care physicians derived potential red flags for IgG4-related disease through a systematic literature search and a level of agreement exercise. Five red flags reached 100% agreement among experts: swelling in one or more organ system; pancreatic and biliary tree involvement; increased serum IgG4; IgG4+ plasma cell tissue infiltration; and obliterative phlebitis. Red flags for IgG4-related disease are intended for use in primary and secondary care to improve referral to centres of expertise and prompt early diagnosis.

IgG4 相关疾病是一种罕见的纤维炎症。及时识别是开始治疗和防止器官损伤的基础。诊断和分类标准主要供具有 IgG4 相关疾病专业知识的临床医生使用。初级保健医生和不具备 IgG4 相关疾病专业知识的专科医生缺乏对疾病的认识仍然是导致诊断延误的主要原因。我们的目标是找出可能增加初级和二级医疗机构对 IgG4 相关疾病怀疑的信号。一个由欧洲罕见结缔组织病参考网络(ERN-ReCONNET)IgG4 相关疾病专家、患者代表和初级保健医生组成的工作组,通过系统的文献检索和共识度练习,得出了 IgG4 相关疾病的潜在信号。专家们对以下五个红旗征兆达成了 100% 的一致意见:一个或多个器官系统肿胀;胰腺和胆管受累;血清 IgG4 增高;IgG4+ 浆细胞组织浸润;以及闭塞性静脉炎。IgG4 相关疾病的红旗旨在用于初级和中级医疗,以改善向专业中心的转诊,并及时进行早期诊断。
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引用次数: 0
Proximod as a potential therapy for rheumatoid arthritis. Proximod 作为类风湿性关节炎的一种潜在疗法。
IF 15 1区 医学 Q1 RHEUMATOLOGY Pub Date : 2024-10-22 DOI: 10.1016/S2665-9913(24)00237-6
Chao Liang
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引用次数: 0
期刊
Lancet Rheumatology
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