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Biosimilars in childhood chronic rheumatic diseases: friend or foe? 儿童慢性风湿病的生物仿制药:是敌是友?
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-06-03 DOI: 10.1016/S2665-9913(24)00127-9
Ilaria Maccora , Gabriele Simonini
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引用次数: 0
Sex as a predictor of clinical phenotype and determinant of immune response in IgG4-related disease: a retrospective study of patients fulfilling the American College of Rheumatology–European League Against Rheumatism classification criteria 性别是 IgG4 相关疾病临床表型的预测因素和免疫反应的决定因素:对符合美国风湿病学会-欧洲抗风湿病联盟分类标准的患者进行的回顾性研究。
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-30 DOI: 10.1016/S2665-9913(24)00089-4
Isha Jha BS , Grace A McMahon BS , Cory A Perugino DO , Guy Katz MD , Zachary S Wallace MD , Ana Fernandes MA , Bohang Jiang MPH , Prof Yuqing Zhang DSc , Aubree E McMahon MPH , Thomas V Guy MD , Hang Liu MD , Yasmin G Hernandez-Barco MD , Prof Shiv Pillai MBBS , Prof John H Stone MD

Background

IgG4-related disease is a multiorgan fibroinflammatory disease considered to have an autoimmune origin. Case series describing individual organ involvement have suggested differences in phenotypic expression between males and females. We aimed to characterise differences in IgG4-related disease manifestations between male and female patients in a large single-centre cohort.

Methods

In this retrospective, single-centre cohort study, patients were recruited from the Massachusetts General Hospital Rheumatology Clinic (Boston, MA, USA) and classified according to the American College of Rheumatology–European Alliance of Associations for Rheumatology (ACR–EULAR) classification criteria. Only patients satisfying the ACR–EULAR classification criteria were included in the study. Data on age at diagnosis, organ involvement at baseline, treatment status, and pre-treatment laboratory values were collected. Circulating plasmablasts and B-cell subsets were quantitated by flow cytometry. Active disease was defined by an IgG4-related disease Responder Index score of more than 0. Laboratory values were analysed for patients who were untreated at baseline and had active IgG4-related disease. The main outcomes were assessed in all participants with available data.

Findings

Of the 564 participants enrolled in the Massachusetts General Hospital Rheumatology Clinic IgG4-related disease Registry, 328 fulfilled ACR–EULAR classification criteria and were included between January, 2008, and May, 2023. There was a strong male predominance (male:female ratio 2·2:1) with 226 (69%) males and 102 (31%) females, which contrasted markedly with our general rheumatology clinic population (0·4:1; p<0·001). The male predominance increased with each decade of life starting at age 40 years. On average, male patients were 5·5 years older at diagnosis than female patients (63·7 years vs 58·2 years; p=0·0031). We observed male patients to have higher ACR–EULAR classification criteria scores at baseline with a median score of 35·0 (IQR 28·0–46·0), compared with 29·5 (25·0–39·0) for females (p=0·0010). The proportion of male patients with pancreatic and renal involvement was almost double the proportion observed in female patients (50% of the male patients had pancreatic involvement, compared with about 26% of the female patients; p<0·0001). Male patients were more likely to have serological abnormalities at baseline. The distribution of IgG4 values differed significantly between male an female sexes, favouring higher values in males. We found that male patients with IgG4-related disease were more likely to have active B-cell responses in the blood as defined by plasmablast expansions.

Interpretation

IgG4-related disease is unusual among autoimmune diseases in that it is more likely to affect males than females and to present with a striking sex-dependent organ dis

背景IgG4 相关疾病是一种多器官纤维炎症性疾病,被认为是一种自身免疫性疾病。描述个别器官受累的系列病例表明,男性和女性在表型表达上存在差异。我们的目的是在一个大型单中心队列中描述男女患者 IgG4 相关疾病表现的差异:在这项回顾性单中心队列研究中,患者从麻省总医院风湿病诊所(美国马萨诸塞州波士顿)招募,并根据美国风湿病学会-欧洲风湿病学协会联盟(ACR-EULAR)的分类标准进行分类。只有符合 ACR-EULAR 分类标准的患者才被纳入研究。研究人员收集了患者的诊断年龄、基线器官受累情况、治疗状态和治疗前实验室值等数据。通过流式细胞术对循环浆细胞和B细胞亚群进行定量。基线时未接受治疗且患有活动性 IgG4 相关疾病的患者的实验室值将进行分析。对所有提供数据的参与者进行了主要结果评估:在麻省总医院风湿病诊所 IgG4 相关疾病登记处登记的 564 名参与者中,有 328 人符合 ACR-EULAR 分类标准,并在 2008 年 1 月至 2023 年 5 月期间被纳入。其中男性占绝大多数(男女比例为 2-2:1),男性 226 人(占 69%),女性 102 人(占 31%),这与我们一般的风湿病门诊人群(0-4:1;P解释:IgG4 相关疾病在自身免疫性疾病中并不常见:IgG4相关疾病在自身免疫性疾病中并不常见,因为它更容易影响男性而非女性,而且其器官分布和B细胞反应程度与性别密切相关。这些发现凸显了IgG4相关疾病与其他通常被认为具有自身免疫基础的疾病之间的重要差异。与 IgG4 相关疾病形成鲜明对比的是,大多数自身免疫性疾病都表现出女性比男性更易患病的明显倾向。围绕这种疾病的病因和病理生理学的假设需要考虑到IgG4相关疾病患者中这种不寻常的性别分布:美国国立卫生研究院、美国国立过敏与传染病研究所、风湿病学研究基金会、美国国立关节炎、肌肉骨骼和皮肤病研究所。
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引用次数: 0
Welcome new evidence on self-management of back pain 欢迎关于背部疼痛自我管理的新证据。
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-30 DOI: 10.1016/S2665-9913(24)00116-4
Chris Maher , Chung-Wei Christine Lin
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引用次数: 0
Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness 在基层医疗机构通过互联网干预支持腰背痛的自我管理,同时提供或不提供电话支持(SupportBack 2):临床和成本效益随机对照试验。
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-30 DOI: 10.1016/S2665-9913(24)00086-9
Adam W A Geraghty PhD , Taeko Becque PhD , Prof Lisa C Roberts PhD , Prof Jonathan C Hill PhD , Prof Nadine E Foster DPhil , Prof Lucy Yardley PhD , Prof Beth Stuart PhD , David A Turner MSc , Prof Elaine Hay MD , Prof Gareth Griffiths MD , Frances Webley , Lorraine Durcan BSc , Alannah Morgan BSc , Stephanie Hughes MSc , Sarah Bathers , Stephanie Butler-Walley BSc , Simon Wathall HND , Gemma Mansell PhD , Malcolm White BA , Firoza Davies , Prof Paul Little MD

Background

Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack).

Methods

Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486.

Findings

Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference –0·5 [97·5% CI –1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (–0·6 [–1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care.

Interpretation

The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice.

Funding

National Institute for Health and Care Research Health Technology Assessment (16/111/78).

背景:腰背痛是一种常见病,也是导致残疾的主要原因之一。我们的目的是确定一种支持行为自我管理的可扩展互联网干预措施(SupportBack)的临床和成本效益:方法:英国初级医疗机构中患有腰背痛且无严重脊柱病变的参与者通过计算机算法按残疾程度和电话支持中心进行分层,以 1:1:1 的比例随机分配到常规护理、常规护理和 SupportBack,或常规护理和带有理疗师电话支持的 SupportBack(三次简短通话)。主要结果为 6 周、3 个月、6 个月和 12 个月的腰背痛相关残疾(罗兰-莫里斯残疾问卷 [RMDQ] 评分),采用重复测量模型,使用 97-5% CIs 进行意向治疗分析。同时还从医疗服务的角度进行了经济评估,以估算成本效益。有腰背痛生活经验的人从一开始就参与了这项试验。这项已完成的试验已在 ISRCTN 注册,编号为 ISRCTN14736486:2018年11月29日至2021年1月12日期间,825名参与者被随机分配(274人接受常规护理,275人仅接受SupportBack,276人接受SupportBack与电话支持)。参与者的平均年龄为 54 岁(SD 15),821 人中有 479 人(58%)为女性,342 人(42%)为男性,641 人中有 591 人(92%)为白人。随访率分别为:6 周时 687 人(83%),3 个月时 598 人(73%),6 个月时 589 人(72%),12 个月时 652 人(79%)。在主要分析中,对 736 名参与者进行了分析(249 人接受了常规护理,245 人接受了 "背靠背支持",242 人接受了 "背靠背支持 "和电话支持)。在 0-025 的显著性水平下,12 个月内,SupportBack 与常规护理相比,RMDQ 没有差异(调整后的平均差异为-0-5 [97-5% CI -1-2 to 0-2];p=0-085),有电话支持的 SupportBack 与常规护理相比,RMDQ 也没有差异(-0-6 [-1-2 to 0-1];p=0-048)。没有发生与治疗相关的严重不良事件。经济评价结果显示,SupportBack 组比常规护理组更有效,成本更低。在每质量调整生命年 20 000 英镑的临界值下,与常规护理相比,两种干预措施都可能具有成本效益:与常规治疗相比,SupportBack 网络干预在 12 个月内并未显著减少腰背痛相关的残疾。这些干预措施可能具有成本效益且安全。在决定是否将这些干预措施应用于临床实践时,应综合考虑临床有效性、成本效益和安全性:国家健康与护理研究所健康技术评估(16/111/78)。
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引用次数: 0
Sex bias in IgG4-related disease: from clinical phenotype to mechanisms IgG4 相关疾病中的性别偏见:从临床表型到机制。
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-30 DOI: 10.1016/S2665-9913(24)00133-4
Jiaxin Zhou , Wen Zhang
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引用次数: 0
Stop ticking boxes: it just doesn't work 不要再打勾了:这样做是行不通的。
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-21 DOI: 10.1016/S2665-9913(24)00150-4
Jules Morgan
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引用次数: 0
Research in Brief 研究简介
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-21 DOI: 10.1016/S2665-9913(24)00125-5
Jennifer Thorley
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引用次数: 0
Time to listen to women about their pain 是时候倾听女性的痛苦了
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-21 DOI: 10.1016/S2665-9913(24)00126-7
The Lancet Rheumatology
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引用次数: 0
Identifying key health system components associated with improved outcomes to inform the re-configuration of services for adults with rare autoimmune rheumatic diseases: a mixed-methods study 确定与改善疗效相关的关键医疗系统要素,为重新配置针对罕见自身免疫性风湿病成人患者的服务提供信息:一项混合方法研究
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-21 DOI: 10.1016/S2665-9913(24)00082-1
Rosemary J Hollick PhD , Warren R G James PhD , Avril Nicoll PhD , Prof Louise Locock PhD , Prof Corri Black MBChB , Prof Neeraj Dhaun MD , Allyson C Egan MRCP , Prof Nicholas Fluck DPhil , Lynn Laidlaw BA , Prof Peter C Lanyon DM , Prof Mark A Little PhD , Prof Raashid Ahmed Luqmani DM , Laura Moir BSc , Maureen McBain RGN , Prof Neil Basu PhD

Background

Adults with rare autoimmune rheumatic diseases face unique challenges and struggles to navigate health-care systems designed to manage common conditions. Evidence to inform an optimal service framework for their care is scarce. Using systemic vasculitis as an exemplar, we aimed to identify and explain the key service components underpinning effective care for rare diseases.

Methods

In this mixed-methods study, data were collected as part of a survey of vasculitis service providers across the UK and Ireland, interviews with patients, and from organisational case studies to identify key service components that enable good care. The association between these components and patient outcomes (eg, serious infections, mortality) and provider outcomes (eg, emergency hospital admissions) were examined in a population-based data linkage study using routine health-care data obtained from patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis from national health datasets in Scotland. We did univariable and multivariable analyses using Bayesian poisson and negative binomial regression to estimate incident rate ratios (IRRs), and Cox proportional hazards models to estimate hazard ratios (HRs). People with lived experiences were involved in the research and writing process.

Findings

Good care was characterised by service components that supported timely access to services, integrated care, and expertise. In 1420 patients with ANCA-associated vasculitis identified from national health datasets, service-reported average waiting times for new patients of less than 1 week were associated with fewer serious infections (IRR 0·70 [95% credibility interval 0·55–0·88]) and fewer emergency hospital admissions (0·78 [0·68–0·92]). Nurse-led advice lines were associated with fewer serious infections (0·76 [0·58–0·93]) and fewer emergency hospital admissions (0·85 [0·74–0·96]). Average waiting times for new patients of less than 1 week were also associated with reduced mortality (HR 0·59 [95% credibility interval 0·37–0·93]). Cohorted clinics, nurse-led clinics, and specialist vasculitis multi-disciplinary team meetings were associated with fewer serious infections (IRR 0·75 [0·59–0·96] for cohorted clinics; 0·65 [0·39–0·84] for nurse-led clinics; 0·72 [0·57–0·90] for specialist vasculitis multi-disciplinary team meetings) and emergency hospital admissions (0·81 [0·71–0·91]; 0·75 [0·65–0·94]; 0·86 [0·75–0·96]). Key components were characterised by their ability to overcome professional tensions between specialties.

Interpretation

Key service components associated with important health outcomes and underpinning factors were identified to inform initiatives to improve the design, delivery, and effectiveness of health-care models for rare autoimmune rheumatic diseases.

Funding

Versus Arthritis.

背景患有罕见自身免疫性风湿病的成年人面临着独特的挑战,他们在为管理常见疾病而设计的医疗保健系统中举步维艰。为他们的治疗提供最佳服务框架的证据还很少。在这项混合方法研究中,我们通过对英国和爱尔兰脉管炎服务提供者的调查、对患者的访谈以及组织案例研究收集数据,以确定实现良好护理的关键服务要素。在一项基于人口的数据关联研究中,我们利用从苏格兰国家健康数据集中获得的抗中性粒细胞胞浆抗体(ANCA)相关性脉管炎患者的常规医疗保健数据,对这些要素与患者预后(如严重感染、死亡率)和医疗服务提供者预后(如急诊入院率)之间的关联进行了研究。我们使用贝叶斯泊松回归和负二项回归进行了单变量和多变量分析,以估算发病率比 (IRR),并使用 Cox 比例危险模型估算危险比 (HR)。有亲身经历者参与了研究和撰写过程。研究结果良好护理的特点是服务内容支持及时获得服务、综合护理和专业知识。在从国家健康数据集中确认的1420名ANCA相关性血管炎患者中,服务机构报告的新患者平均等待时间少于1周与较少的严重感染(IRR为0-70 [95%可信区间为0-55-0-88])和较少的急诊入院(0-78 [0-68-0-92])有关。护士主导的咨询热线与较少的严重感染(0-76 [0-58-0-93])和较少的急诊入院(0-85 [0-74-0-96])相关。新患者平均候诊时间少于 1 周也与死亡率降低有关(HR 0-59 [95% 可信区间 0-37-0-93])。联合门诊、护士主导的门诊以及脉管炎多学科专家团队会议与较少的严重感染有关(联合门诊的 IRR 为 0-75 [0-59-0-96] ,联合门诊的 IRR 为 0-65 [0-39-0-96] ,联合门诊的 IRR 为 0-65 [0-39-0-96] );0-65[0-39-0-84];脉管炎多学科专家小组会议为 0-72 [0-57-0-90])和急诊入院率(0-81[0-71-0-91];0-75[0-65-0-94];0-86[0-75-0-96])。关键要素的特点是能够克服专科之间的专业紧张关系。释义确定了与重要健康结果和基础因素相关的关键服务要素,为改善罕见自身免疫性风湿病医疗保健模式的设计、提供和有效性提供了信息。
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引用次数: 0
Additional SARS-CoV-2 vaccine doses: a little is better than none 额外的 SARS-CoV-2 疫苗剂量:有总比没有好。
IF 25.4 1区 医学 Q1 Medicine Pub Date : 2024-05-08 DOI: 10.1016/S2665-9913(24)00119-X
Alfred H J Kim
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引用次数: 0
期刊
Lancet Rheumatology
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