Pub Date : 2025-11-01Epub Date: 2025-10-20DOI: 10.1016/S2665-9913(25)00254-1
Dennis A Ton , Nikolet K den Hollander , Hanna W van Steenbergen , Annette H M van der Helm-van Mil
{"title":"MRI in rheumatoid arthritis and at-risk populations: the importance of context – Authors' reply","authors":"Dennis A Ton , Nikolet K den Hollander , Hanna W van Steenbergen , Annette H M van der Helm-van Mil","doi":"10.1016/S2665-9913(25)00254-1","DOIUrl":"10.1016/S2665-9913(25)00254-1","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 11","pages":"Pages e759-e760"},"PeriodicalIF":16.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145327040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-09-03DOI: 10.1016/S2665-9913(25)00255-3
Dafna D Gladman
{"title":"Challenges in the therapeutic management of psoriatic arthritis","authors":"Dafna D Gladman","doi":"10.1016/S2665-9913(25)00255-3","DOIUrl":"10.1016/S2665-9913(25)00255-3","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 11","pages":"Pages e749-e750"},"PeriodicalIF":16.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-09-04DOI: 10.1016/S2665-9913(25)00153-5
Venkatesh Krishnan PhD , Stuart Y Keller BSc , Christine Chew PhD , Jonathan T Sims PhD , Ching-Yun Chang PhD , Ernst R Dow PhD , Robert J Benschop PhD , Rona Wang MD , Prof Athimalaipet V Ramanan FMedSci
<div><h3>Background</h3><div>Baricitinib has previously been shown to improve clinical response in patients with juvenile idiopathic arthritis (JIA) in the JUVE-BASIS trial. In this post-hoc analysis we aimed to identify whether pharmacodynamic changes in serum biomarkers in response to baricitinib treatment could help reaffirm the clinical utility of baricitinib in patients with JIA.</div></div><div><h3>Methods</h3><div>JUVE-BASIS was a randomised, double-blind, placebo-controlled, withdrawal, efficacy, safety, phase 3 trial, done in 75 centres in 20 countries. Eligible patients were children and adolescents (aged 2 to <18 years), with polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related arthritis, or juvenile psoriatic arthritis, as per the International League of Associations for Rheumatology criteria and an inadequate response (≥12 weeks) or intolerance to one or more conventional synthetic or biological disease-modifying antirheumatic drugs (DMARDs). Here we report post-hoc analyses of serum samples from patients who received open-label baricitinib in the 12-week lead-in period of the JUVE-BASIS trial. Samples were assessed using an Olink Explore 3072 panel at baseline and week 12. Baricitinib-mediated pharmacodynamic changes in serum protein markers were measured as changes from baseline to week 12 derived from a mixed model with repeated measurement. Pearson correlations of the change in serum biomarkers and clinical disease activity (JADAS-27 scores) comparing baseline with week 12 were examined. Proportional changes in biomarkers were classified into three response subsets based on JIA-ACR response rates: JIA-ACR <30% (non-responders), JIA-ACR 30–70% (responders), and JIA-ACR 70–100% (super-responders). People with lived experience of JIA were not involved in the design or conduct of this study. The JUVE-BASIS trial was registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT03773978</span><svg><path></path></svg></span>, and is completed.</div></div><div><h3>Findings</h3><div>Between Dec 17, 2018 and March 3, 2021, 220 patients were enrolled in JUVE-BASIS and received at least one dose of baricitinib in the open-label lead-in period. In this post-hoc analysis, 168 serum samples from 84 patients were analysed: 67 (80%) of 84 patients were female, 17 (20%) were male, 67 (80%) were White and the mean age was 14 years (SD 2). 10 (12%) of 84 were non-responders, 27 (32%) were responders, and 47 (56%) were super-responders based on clinical response. Several serum biomarkers showed significant changes following 12 weeks of baricitinib treatment for all patients with higher magnitude changes seen in responders and super-responders. Changes in biomarkers associated with macrophage activation (CCL7, CCL18, and IL-6) and regulation of matrix composition (matrix metalloproteinase-3) were positively correlated with clinical response.</div><
背景:Baricitinib先前在JUVE-BASIS试验中被证明可以改善幼年特发性关节炎(JIA)患者的临床反应。在这项事后分析中,我们旨在确定baricitinib治疗后血清生物标志物的药效学变化是否有助于重申baricitinib在JIA患者中的临床应用。方法:JUVE-BASIS是一项随机、双盲、安慰剂对照、停药、疗效、安全性的3期试验,在20个国家的75个中心进行。研究结果:在2018年12月17日至2021年3月3日期间,220名患者入组juv - basis,并在开放标签导入期间接受了至少一剂巴西替尼。在这项事后分析中,分析了84例患者的168份血清样本:84例患者中67例(80%)为女性,17例(20%)为男性,67例(80%)为白人,平均年龄为14岁(SD 2)。84例患者中10例(12%)为无反应者,27例(32%)为反应者,47例(56%)为基于临床反应的超反应者。baricitinib治疗12周后,所有患者的几种血清生物标志物均出现显著变化,反应者和超反应者的变化幅度较大。与巨噬细胞活化相关的生物标志物(CCL7、CCL18和IL-6)和基质组成调节(基质金属蛋白酶-3)的变化与临床反应呈正相关。解释:据我们所知,这是首次在baricitinib对JIA患者进行干预试验的背景下测量血清蛋白标志物的研究。与临床反应相关的生物标志物变化可能允许医生潜在地识别最有可能对巴西替尼治疗有反应的患者。融资:礼来公司(Eli Lilly and Company)获得Incyte许可。
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Pub Date : 2025-11-01Epub Date: 2025-08-06DOI: 10.1016/S2665-9913(25)00135-3
Prof Mark Hancock PhD , Prof Anne Smith PhD , Prof Peter O'Sullivan PhD , Robert Schütze PhD , J P Caneiro PhD , Robert Laird PhD , Prof Kieran O'Sullivan , Prof Jan Hartvigsen PhD , Prof Amity Campbell PhD , Deborah Wareham DPT , Ruth Chang MSc , Peter Kent PhD
<div><h3>Background</h3><div>Interventions for low back pain typically produce small and short-term effects. Cognitive functional therapy (CFT) has shown large effects up to 12 months, but long-term effects are unclear. We aimed to compare the long-term (3-year) effectiveness of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic disabling low back pain.</div></div><div><h3>Methods</h3><div>The RESTORE trial was a randomised, controlled, three-arm parallel group, phase 3, clinical trial that investigated CFT delivered with or without biofeedback compared with usual care for the treatment of chronic low back pain. Treatment was delivered in 20 primary care physiotherapy clinics in Australia. This study is the 3-year follow-up of the RESTORE trial. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation and average back pain of at least 4 on a 0–10 scale. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. At the 1-year follow-up, all participants were invited to provide consent to be followed up 2 years later—ie, 3 years after randomisation. The primary outcome was pain-related physical activity limitation, self-reported via the Roland Morris Disability Questionnaire (0–24 scale) at 3 years. The secondary outcome was pain intensity at 3 years, assessed using the numeric pain rating scale. Adverse event data were not collected at the 3-year follow-up. All outcomes were assessed in the intention-to-treat population. Participants in both CFT groups received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. People with lived experience of chronic low back pain were involved in the study design and conduct. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).</div></div><div><h3>Findings</h3><div>Between Oct 23, 2018, and Aug 3, 2020, 1011 people were assessed for eligibility for the RESTORE trial. 492 (49%) were eligible and randomly assigned to one of three treatments; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. At the 1-year follow-up, 359 (73%) of 492 participants provided consent to be contacted to complete the 3-year questionnaire. 312 (87%) of those 359 participants were successfully followed up at 3 years, with similar proportions across each treatment group; 104 (63%) of 164 in the CFT only group, 106 (65%) of 163 in the CFT plus biofeedback group, and 102 (62%) of 165 in the usual care group. 188 (60%) of 312 participants were female, 124 (40%) were male, and the mean age was 48·1 years (SD 14·6). CFT only (mean difference –3·5 [95% CI –4·9 to –2·0]) and CFT plus biofeedback (–4·1 [–5·6 to –2·6]) were both more effective than usual care in reducing activity
背景:对腰痛的干预通常产生小而短期的效果。认知功能疗法(CFT)显示出长达12个月的巨大效果,但长期效果尚不清楚。我们的目的是比较有或没有运动传感器生物反馈的CFT与常规护理对慢性致残性腰痛患者的长期(3年)疗效。方法:RESTORE试验是一项随机、对照、三臂平行组、3期临床试验,研究了CFT在有或没有生物反馈的情况下与常规治疗相比治疗慢性腰痛的效果。治疗在澳大利亚的20个初级保健理疗诊所进行。这项研究是RESTORE试验的3年随访。我们招募了腰痛持续3个月以上的成年人(年龄≥18岁),至少有中度疼痛相关的身体活动限制,平均背痛在0-10分中至少为4分。参与者通过集中适应性计划随机分配(1:1:1)到常规护理,仅CFT或CFT加生物反馈。在1年的随访中,所有参与者都被邀请同意在随机化后的2年后(即3年后)进行随访。主要结果是疼痛相关的身体活动限制,3年后通过罗兰莫里斯残疾问卷(0-24量表)自我报告。次要结果是3年时的疼痛强度,使用数字疼痛评定量表进行评估。3年随访期间未收集不良事件数据。在意向治疗人群中评估所有结果。两个CFT组的参与者在12周内最多接受7次治疗,并在26周时接受一次强化治疗。物理治疗师和病人没有被蒙面。有慢性腰痛生活经验的人参与了研究的设计和实施。该试验已在澳大利亚新西兰临床试验登记处注册(ACTRN12618001396213)。结果:在2018年10月23日至2020年8月3日期间,1011人被评估为RESTORE试验的资格。492例(49%)符合条件,随机分配到三种治疗中的一种;仅CFT组164例(33%),CFT加生物反馈组163例(33%),常规护理组165例(34%)。在1年的随访中,492名参与者中有359名(73%)同意联系完成为期3年的问卷调查。359名参与者中有312人(87%)在3年后成功随访,每个治疗组的比例相似;仅CFT组164例中有104例(63%),CFT加生物反馈组163例中有106例(65%),常规护理组165例中有102例(62%)。312例受试者中,女性188例(60%),男性124例(40%),平均年龄48.1岁(SD 14.6)。仅CFT(平均差值为-3·5 [95% CI为-4·9至-2·0])和CFT加生物反馈(-4·1[-5·6至-2·6])在减少3年活动限制方面都比常规护理更有效。单纯CFT与CFT加生物反馈处理之间的差异很小且不显著(平均差异为- 0.6 [95% CI -2 ~ 0.9])。对于3年疼痛强度,CFT单独治疗(-1·0[-1·6至-0·5])和CFT加生物反馈治疗(-1·5[-2·1至-0·9])也比常规治疗更有效,CFT单独治疗和CFT加生物反馈治疗之间的差异很小,不显著(-0·5[-1·1至0·1])。解释:CFT治疗对慢性下腰痛患者产生持续3年的效果。这些长期效果是新颖的,如果干预措施可以广泛实施,将为显著减少慢性背痛的影响提供机会。实施需要扩大临床医生培训,以增加各种卫生保健系统的可及性和重复性研究。资助:澳大利亚国家卫生和医学研究委员会和科廷大学。
{"title":"Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): 3-year follow-up of a randomised, controlled trial","authors":"Prof Mark Hancock PhD , Prof Anne Smith PhD , Prof Peter O'Sullivan PhD , Robert Schütze PhD , J P Caneiro PhD , Robert Laird PhD , Prof Kieran O'Sullivan , Prof Jan Hartvigsen PhD , Prof Amity Campbell PhD , Deborah Wareham DPT , Ruth Chang MSc , Peter Kent PhD","doi":"10.1016/S2665-9913(25)00135-3","DOIUrl":"10.1016/S2665-9913(25)00135-3","url":null,"abstract":"<div><h3>Background</h3><div>Interventions for low back pain typically produce small and short-term effects. Cognitive functional therapy (CFT) has shown large effects up to 12 months, but long-term effects are unclear. We aimed to compare the long-term (3-year) effectiveness of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic disabling low back pain.</div></div><div><h3>Methods</h3><div>The RESTORE trial was a randomised, controlled, three-arm parallel group, phase 3, clinical trial that investigated CFT delivered with or without biofeedback compared with usual care for the treatment of chronic low back pain. Treatment was delivered in 20 primary care physiotherapy clinics in Australia. This study is the 3-year follow-up of the RESTORE trial. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation and average back pain of at least 4 on a 0–10 scale. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. At the 1-year follow-up, all participants were invited to provide consent to be followed up 2 years later—ie, 3 years after randomisation. The primary outcome was pain-related physical activity limitation, self-reported via the Roland Morris Disability Questionnaire (0–24 scale) at 3 years. The secondary outcome was pain intensity at 3 years, assessed using the numeric pain rating scale. Adverse event data were not collected at the 3-year follow-up. All outcomes were assessed in the intention-to-treat population. Participants in both CFT groups received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. People with lived experience of chronic low back pain were involved in the study design and conduct. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).</div></div><div><h3>Findings</h3><div>Between Oct 23, 2018, and Aug 3, 2020, 1011 people were assessed for eligibility for the RESTORE trial. 492 (49%) were eligible and randomly assigned to one of three treatments; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. At the 1-year follow-up, 359 (73%) of 492 participants provided consent to be contacted to complete the 3-year questionnaire. 312 (87%) of those 359 participants were successfully followed up at 3 years, with similar proportions across each treatment group; 104 (63%) of 164 in the CFT only group, 106 (65%) of 163 in the CFT plus biofeedback group, and 102 (62%) of 165 in the usual care group. 188 (60%) of 312 participants were female, 124 (40%) were male, and the mean age was 48·1 years (SD 14·6). CFT only (mean difference –3·5 [95% CI –4·9 to –2·0]) and CFT plus biofeedback (–4·1 [–5·6 to –2·6]) were both more effective than usual care in reducing activity","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 11","pages":"Pages e789-e798"},"PeriodicalIF":16.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-09-04DOI: 10.1016/S2665-9913(25)00189-4
Stephanie KA Wong , Marinka Twilt
{"title":"Biomarkers for juvenile idiopathic arthritis treatment response—have we identified them?","authors":"Stephanie KA Wong , Marinka Twilt","doi":"10.1016/S2665-9913(25)00189-4","DOIUrl":"10.1016/S2665-9913(25)00189-4","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 11","pages":"Pages e752-e754"},"PeriodicalIF":16.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145015246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-07-31DOI: 10.1016/S2665-9913(25)00154-7
Troels Kjeldsen , Inger Mechlenburg
{"title":"Group-based cycling and education for hip osteoarthritis","authors":"Troels Kjeldsen , Inger Mechlenburg","doi":"10.1016/S2665-9913(25)00154-7","DOIUrl":"10.1016/S2665-9913(25)00154-7","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 11","pages":"Pages e748-e749"},"PeriodicalIF":16.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144776666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}