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Local immune effector cell-associated toxicity syndrome in CAR T-cell treated patients with refractory systemic lupus erythematosus – Authors' reply CAR - t细胞治疗难治性系统性红斑狼疮患者的局部免疫效应细胞相关毒性综合征——作者的答复。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-08-12 DOI: 10.1016/S2665-9913(25)00222-X
Melanie Hagen , Fabian Müller , Andreas Wirsching , Soraya Kharboutli , Silvia Spoerl , Christina Düsing , Tobias Krickau , Markus Metzler , Simon Völkl , Michael Aigner , Sascha Kretschmann , Ingrid Vasova , Marc Saake , Stefan Schliep , Torsten Kubacki , Nicolas Hunzelmann , Laura Bucci , Jule Taubmann , Christina Bergmann , Andrea-Hermina Györfi , Georg Schett
{"title":"Local immune effector cell-associated toxicity syndrome in CAR T-cell treated patients with refractory systemic lupus erythematosus – Authors' reply","authors":"Melanie Hagen , Fabian Müller , Andreas Wirsching , Soraya Kharboutli , Silvia Spoerl , Christina Düsing , Tobias Krickau , Markus Metzler , Simon Völkl , Michael Aigner , Sascha Kretschmann , Ingrid Vasova , Marc Saake , Stefan Schliep , Torsten Kubacki , Nicolas Hunzelmann , Laura Bucci , Jule Taubmann , Christina Bergmann , Andrea-Hermina Györfi , Georg Schett","doi":"10.1016/S2665-9913(25)00222-X","DOIUrl":"10.1016/S2665-9913(25)00222-X","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 10","pages":"Pages e667-e669"},"PeriodicalIF":16.4,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859807","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}
引用次数: 0
Local immune effector cell-associated toxicity syndrome in CAR T-cell treated patients with refractory systemic lupus erythematosus CAR - t细胞治疗难治性系统性红斑狼疮患者的局部免疫效应细胞相关毒性综合征。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-08-12 DOI: 10.1016/S2665-9913(25)00221-8
Chunmei Wu , Ran Wang , Yan Ye , Shuang Ye , Qiong Fu
{"title":"Local immune effector cell-associated toxicity syndrome in CAR T-cell treated patients with refractory systemic lupus erythematosus","authors":"Chunmei Wu , Ran Wang , Yan Ye , Shuang Ye , Qiong Fu","doi":"10.1016/S2665-9913(25)00221-8","DOIUrl":"10.1016/S2665-9913(25)00221-8","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 10","pages":"Page e667"},"PeriodicalIF":16.4,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859808","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}
引用次数: 0
Personalised gait retraining for medial compartment knee osteoarthritis: a randomised controlled trial 个性化步态再训练治疗内侧室膝骨关节炎:一项随机对照试验。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-08-12 DOI: 10.1016/S2665-9913(25)00151-1
Scott D Uhlrich PhD , Valentina Mazzoli PhD , Amy Silder PhD , Andrea K Finlay PhD , Feliks Kogan PhD , Prof Garry E Gold MD , Prof Scott L Delp PhD , Gary S Beaupre PhD , Julie A Kolesar PhD
{"title":"Personalised gait retraining for medial compartment knee osteoarthritis: a randomised controlled trial","authors":"Scott D Uhlrich PhD , Valentina Mazzoli PhD , Amy Silder PhD , Andrea K Finlay PhD , Feliks Kogan PhD , Prof Garry E Gold MD , Prof Scott L Delp PhD , Gary S Beaupre PhD , Julie A Kolesar PhD","doi":"10.1016/S2665-9913(25)00151-1","DOIUrl":"10.1016/S2665-9913(25)00151-1","url":null,"abstract":"<div><h3>Background</h3><div>Retraining individuals with medial compartment knee osteoarthritis to walk with a patient-specific change in their foot angle (ie, toe-in or toe-out angle) can reduce excessive joint loading related to disease progression. This study investigated the clinical, biomechanical, and structural efficacy of personalised foot progression angle modifications compared with sham treatment in patients with mild-to-moderate medial compartment knee osteoarthritis.</div></div><div><h3>Methods</h3><div>In this single-center, parallel-group, randomised controlled trial, we recruited individuals with symptomatic medial compartment knee osteoarthritis at the Human Performance Laboratory and Lucas Center for Imaging at Stanford University, CA, USA, using online and print media. Eligible participants (aged ≥18 years) were randomly assigned (1:1) by a computer to an intervention or sham group. During six walking retraining visits to a university gait laboratory, all participants received real-time biofeedback instructing them to walk consistently with a personalised target foot progression angle. The intervention group's target was the 5° or 10° change in foot progression angle that maximally reduced their knee loading, and the sham group's target was their natural foot progression angle. Participants and staff involved in data analysis were masked to group allocation; staff performing the gait analysis visits were not. Primary outcomes were 1-year changes in medial knee pain (numeric rating scale) and medial knee loading (knee adduction moment peak). Secondary outcomes were 1-year changes in cartilage microstructure estimated from MRI (T<sub>1ρ</sub> and T<sub>2</sub> relaxation times). We evaluated safety by monitoring the number and type of adverse events. Intention-to-treat linear regression analyses, comprising all randomly assigned participants, were conducted. People with lived experience of knee osteoarthritis were involved in the design and conduct of this study. This study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT02767570</span><svg><path></path></svg></span>, and is closed to enrollment.</div></div><div><h3>Findings</h3><div>Between Aug 1, 2016, and June 25, 2019, 1582 individuals were screened for eligibility. 107 participants completed an initial gait analysis and 68 were randomly assigned to either the intervention (n=34) or the sham (n=34) group. 41 (60%) of 68 participants were female, 27 (40%) were male, and 54 (79%) were White; mean age was 64·4 years (SD 7·6). After 1 year, participants in the intervention group had greater reductions in medial knee pain (between-group difference –1·2, 95% CI –1·9 to –0·5; p=0·0013) and knee adduction moment peak (between-group difference –0·26 % bodyweight × height, 95% CI –0·39 to –0·13; p=0·0001) than participants in the sham group. The MRI-estimated change in cartilage microstructure (T<sub>1ρ</sub>) in the medial compar","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 10","pages":"Pages e708-e718"},"PeriodicalIF":16.4,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859809","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}
引用次数: 0
Further progression in patients with systemic sclerosis-associated interstitial lung disease – Authors' reply 系统性硬化症相关间质性肺病患者的进一步进展——作者的答复
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-08-12 DOI: 10.1016/S2665-9913(25)00217-6
Anna-Maria Hoffmann-Vold , Oliver Distler , on behalf of the authors
{"title":"Further progression in patients with systemic sclerosis-associated interstitial lung disease – Authors' reply","authors":"Anna-Maria Hoffmann-Vold , Oliver Distler , on behalf of the authors","doi":"10.1016/S2665-9913(25)00217-6","DOIUrl":"10.1016/S2665-9913(25)00217-6","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 10","pages":"Pages e670-e671"},"PeriodicalIF":16.4,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859805","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}
引用次数: 0
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 认知功能疗法加或不加运动传感器生物反馈对比常规治疗慢性致残性腰痛(RESTORE):一项为期3年的随机对照试验随访。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-08-06 DOI: 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
{"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":"2025-08-06","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}
引用次数: 0
Towards sustainable relief in chronic low back pain 对慢性腰痛的持续缓解。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-08-06 DOI: 10.1016/S2665-9913(25)00164-X
Dimitrios Lytras
{"title":"Towards sustainable relief in chronic low back pain","authors":"Dimitrios Lytras","doi":"10.1016/S2665-9913(25)00164-X","DOIUrl":"10.1016/S2665-9913(25)00164-X","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 11","pages":"Pages e751-e752"},"PeriodicalIF":16.4,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805106","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}
引用次数: 0
Preload deficiency as a treatable cause of fatigue and exercise intolerance in SLE 预负荷不足是SLE患者疲劳和运动不耐受的可治疗原因。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-08-04 DOI: 10.1016/S2665-9913(25)00188-2
Yoo Jin Kim , Phebe Ismail , Michelle Petri , Andrea Fava , Luigi Adamo
{"title":"Preload deficiency as a treatable cause of fatigue and exercise intolerance in SLE","authors":"Yoo Jin Kim , Phebe Ismail , Michelle Petri , Andrea Fava , Luigi Adamo","doi":"10.1016/S2665-9913(25)00188-2","DOIUrl":"10.1016/S2665-9913(25)00188-2","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 9","pages":"Pages e601-e602"},"PeriodicalIF":16.4,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144800668","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}
引用次数: 0
Clinical and cost-effectiveness of a cycling and education intervention versus usual physiotherapy care for the treatment of hip osteoarthritis in the UK (CLEAT): a pragmatic, randomised, controlled trial 英国(CLEAT):一项实用、随机、对照试验:骑车和教育干预与常规物理治疗治疗髋关节骨关节炎的临床和成本效益。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-07-31 DOI: 10.1016/S2665-9913(25)00102-X
Prof Thomas W Wainwright PhD , Tikki Immins MSc , Sharon Docherty PhD , Geoff Saunders MSc , Annie Hawton PhD , Elizabeth Goodwin PhD , Tim Rees PhD , Matthew Low MSc , Jo Samways MA , Fran Webley , Nikki Howard , Paul H Lee PhD , Prof Robert G Middleton FRCS [Orth]
{"title":"Clinical and cost-effectiveness of a cycling and education intervention versus usual physiotherapy care for the treatment of hip osteoarthritis in the UK (CLEAT): a pragmatic, randomised, controlled trial","authors":"Prof Thomas W Wainwright PhD , Tikki Immins MSc , Sharon Docherty PhD , Geoff Saunders MSc , Annie Hawton PhD , Elizabeth Goodwin PhD , Tim Rees PhD , Matthew Low MSc , Jo Samways MA , Fran Webley , Nikki Howard , Paul H Lee PhD , Prof Robert G Middleton FRCS [Orth]","doi":"10.1016/S2665-9913(25)00102-X","DOIUrl":"10.1016/S2665-9913(25)00102-X","url":null,"abstract":"<div><h3>Background</h3><div>Osteoarthritis of the hip is a leading cause of chronic disability. The cycling and education intervention (CLEAT) trial aimed to compare the clinical and cost-effectiveness of the cycling against hip pain (CHAIN) intervention, a group-based cycling and education programme, with usual physiotherapy care for patients with hip osteoarthritis referred for physiotherapy at a UK hospital.</div></div><div><h3>Methods</h3><div>CLEAT was a pragmatic, single-centre, randomised controlled trial done in Bournemouth, UK. Patients older than 18 years with activity-related joint pain, either no morning stiffness or morning stiffness lasting no longer than 30 min, and who met the primary-care criteria for exercise referral were eligible to participate. Patients aged 18–45 years were only eligible to participate if an x-ray confirmed the presence of hip osteoarthritis. Participants were randomly assigned (1:1) to either the CHAIN intervention or usual physiotherapy care using random permuted blocks of sizes 2, 4, and 6. Participants in the CHAIN intervention group attended an 8-week group programme at a local leisure centre comprised of education and static cycling. Participants in the physiotherapy group had usual one-to-one care with a physiotherapist at the local hospital or by telephone, depending on usual care at the time of treatment. The primary outcome was the difference in Hip Disability and Osteoarthritis Outcome Score (HOOS) activities of daily living subscale at 10 weeks post-treatment (visit 4) between groups. The trial included a parallel economic evaluation from the primary perspective of the UK NHS and personal social services. All participants who provided data at visit 4 were included in the efficacy analysis, and data on safety and adverse events were collected between baseline and visit 4. People with lived experience of hip osteoarthritis were involved in the design and management of the study. This trial is registered with ISRCTN (ISRCTN19778222).</div></div><div><h3>Findings</h3><div>Between Feb 24, 2020, and April 28, 2023, 221 participants were recruited to the study and randomly assigned to the CHAIN intervention (110 [50%]) or usual physiotherapy care (111 [50%]). 126 (57%) participants were female, 95 (43%) were male, 217 (98%) were White, and the mean age was 64·4 years (SD 9·5). Participants in the CHAIN group had greater improvements in mean HOOS activities of daily living subscale scores (from 60·8 [SD 19·2] at baseline to 73·5 [20·0] at 10 weeks) compared with participants in the usual physiotherapy care group (from 59·3 [19·6] to 65·4 [19·9]; adjusted mean difference 6·9 [95% CI 2·5–11·2]; p=0·0023). Although the primary outcome showed a statistically significant improvement for CHAIN over usual physiotherapy, the between-group difference of 6·9 HOOS points did not meet the pre-defined minimum clinically important difference of 7·4. CHAIN cost £4092 per quality-adjusted life year gained compared with","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 11","pages":"Pages e764-e775"},"PeriodicalIF":16.4,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144776665","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}
引用次数: 0
Group-based cycling and education for hip osteoarthritis 以团体为基础的骑行和髋关节骨关节炎的教育。
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-07-31 DOI: 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":"2025-07-31","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}
引用次数: 0
Effect of a 1-month methotrexate delay on pneumococcal vaccine immunogenicity and disease control in patients with early rheumatoid arthritis (VACIMRA): an open-label randomised trial 甲氨蝶呤延迟1个月对早期类风湿关节炎(VACIMRA)患者肺炎球菌疫苗免疫原性和疾病控制的影响:一项开放标签随机试验
IF 16.4 1区 医学
Lancet Rheumatology Pub Date : 2025-07-29 DOI: 10.1016/S2665-9913(25)00071-2
Prof Jacques Morel MD , Prof Emmanuelle Dernis MD , Prof Christian Roux MD , Prof Christophe Richez MD , Olivier Brocq MD , Prof Bruno Fautrel MD , Carine Salliot MD , Prof Olivier Vittecoq MD , Prof Xavier Mariette MD , Prof Frederic Lioté MD , Slim Lassoued MD , Prof Cécile Gaujoux-Viala MD , Prof Arnaud Constantin MD , Prof Martin Soubrier MD , Prof Valérie Devauchelle-Pensec MD , Prof Vincent Goeb MD , Prof Jacques-Eric Gottenberg MD , Prof Hubert Marotte MD , Anouck Rémy Moulard MD , Prof Claire Daien MD , Jacques MOREL
{"title":"Effect of a 1-month methotrexate delay on pneumococcal vaccine immunogenicity and disease control in patients with early rheumatoid arthritis (VACIMRA): an open-label randomised trial","authors":"Prof Jacques Morel MD , Prof Emmanuelle Dernis MD , Prof Christian Roux MD , Prof Christophe Richez MD , Olivier Brocq MD , Prof Bruno Fautrel MD , Carine Salliot MD , Prof Olivier Vittecoq MD , Prof Xavier Mariette MD , Prof Frederic Lioté MD , Slim Lassoued MD , Prof Cécile Gaujoux-Viala MD , Prof Arnaud Constantin MD , Prof Martin Soubrier MD , Prof Valérie Devauchelle-Pensec MD , Prof Vincent Goeb MD , Prof Jacques-Eric Gottenberg MD , Prof Hubert Marotte MD , Anouck Rémy Moulard MD , Prof Claire Daien MD , Jacques MOREL","doi":"10.1016/S2665-9913(25)00071-2","DOIUrl":"10.1016/S2665-9913(25)00071-2","url":null,"abstract":"<div><h3>Background</h3><div>Pneumococcal vaccination is recommended for patients with rheumatoid arthritis. Because immunosuppressant therapies for rheumatoid arthritis hinder vaccine efficacy, vaccination should be administered before initiating immunosuppressive drugs. We aimed to compare humoral responses in patients with rheumatoid arthritis receiving the pneumococcal 13-valent conjugate vaccine (PCV13) before methotrexate initiation or simultaneously.</div></div><div><h3>Methods</h3><div>In this randomised, multicentre, open-label trial, patients were recruited from 26 rheumatology departments in 22 university hospitals and four general hospitals in France. Adult patients (aged 18–80 years) with active rheumatoid arthritis (Disease Activity Score in 28 joints >3·2), who were naive to targeted disease-modifying anti rheumatic drugs (DMARDs), had not had methotrexate or leflunomide in the past 3 months, and had no previous pneumococcal vaccinations were included. Patients were excluded in case of treatment with methotrexate or with leflunomide within the previous 3 months and absolute or relative contraindications to methotrexate. Patients were vaccinated with PCV13 at randomisation, before being randomly assigned (1:1) to either the immediate group (methotrexate treatment [maximum dose 15 mg per week] initiated at the same time as PCV13 vaccine) or the delay group (methotrexate initiated 1 month after PCV13 vaccine). Randomisation was stratified by sex (self-reported) and DMARD naive status. 2 months later, patients in both groups were vaccinated with the 23-valent pneumococcal polysaccharide vaccine. Humoral responses, disease activity, infections, and adverse events were assessed at baseline and at 1, 3, 6, and 12 months after PCV13. The primary outcome was the responder rate at 1 month, defined by positive responses against at least three of five target serotypes (ie, 1, 3, 5, 7F, and 19A). Responders were defined according to a 2 or more-fold increase in IgG concentrations with ELISA or opsonophagocytic assay compared with baseline. The main analysis was performed in the modified intention-to-treat population, including all randomly assigned patients with a valid measure of the primary endpoint, analysed in their assigned group. There was no involvement of people with lived experience in the study design or implementation. The trial was registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT01942174</span><svg><path></path></svg></span>) and is completed.</div></div><div><h3>Findings</h3><div>Between Sept 27, 2013, and Oct 10, 2019, 276 patients with rheumatoid arthritis were randomly assigned. 27 patients were excluded, of whom four patients dropped out, and 249 patients were included in the modified intention-to-treat population (126 [51%] in the delay group and 123 [49%] in the immediate group). 174 (70%) patients were female and 75 (30%) were male, the mean age at enrolment was 55·6 year","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"7 10","pages":"Pages e675-e686"},"PeriodicalIF":16.4,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765676","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}
引用次数: 0
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