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International Map of Axial Spondyloarthritis (IMAS): results from the perspective of 5557 patients from 27 countries around the globe. 轴性脊柱关节炎国际地图(IMAS):来自全球 27 个国家的 5557 名患者的研究结果。
IF 6.2 2区 医学
RMD Open Pub Date : 2024-06-08 DOI: 10.1136/rmdopen-2023-003504
Marco Garrido-Cumbrera, Denis Poddubnyy, Fernando Sommerfleck, Christine Bundy, Souzi Makri, José Correa-Fernández, Shashank Akerkar, Jo Lowe, Elie Karam, Laura Christen, Victoria Navarro-Compan
{"title":"International Map of Axial Spondyloarthritis (IMAS): results from the perspective of 5557 patients from 27 countries around the globe.","authors":"Marco Garrido-Cumbrera, Denis Poddubnyy, Fernando Sommerfleck, Christine Bundy, Souzi Makri, José Correa-Fernández, Shashank Akerkar, Jo Lowe, Elie Karam, Laura Christen, Victoria Navarro-Compan","doi":"10.1136/rmdopen-2023-003504","DOIUrl":"10.1136/rmdopen-2023-003504","url":null,"abstract":"<p><strong>Background: </strong>The International Map of Axial Spondyloarthritis (IMAS) is a global initiative aimed to assess the impact and burden of axial spondyloarthritis (axSpA) and identify the unmet needs from the patient's perspective.</p><p><strong>Method: </strong>IMAS is a collaboration between the Axial Spondyloarthritis International Federation (ASIF), the University of Seville, Novartis Pharma AG and steered by a scientific committee. IMAS collected information through an online cross-sectional survey (2017-2022) from unselected patients with axSpA from Europe, Asia, North America, Latin America and Africa who completed a comprehensive questionnaire containing over 120 items.</p><p><strong>Results: </strong>5557 patients with axSpA participated in IMAS. Mean age was 43.9 ±12.8 years, 55.4% were female, 46.2% had a university education and 51.0% were employed. The mean diagnostic delay was 7.4 ±9.0 years (median: 4.0), and the mean symptom duration was 17.1 ±13.3 years. 75.0% of patients had active disease (Bath Ankylosing Spondylitis Disease Activity Index ≥4), and 59.4% reported poor mental health (12-item General Health Questionnaire ≥3). In the year before the survey, patients had visited primary care physicians 4.6 times and the rheumatologist 3.6 times. 78.6% had taken non-steroidal anti-inflammatory drug ever, 48.8% biological disease-modifying antirheumatic drugs and 43.6% conventional synthetic disease-modifying antirheumatic drugs. Patients's greatest fear was disease progression (55.9%), while the greatest hope was to be able to relieve pain (54.2%).</p><p><strong>Conclusions: </strong>IMAS shows the global profile of patients with axSpA, highlighting unmet needs, lengthy delays in diagnosis and high burden of disease in patients with axSpA worldwide. This global information will enable more detailed investigations to obtain evidence on the critical issues that matter to patients around the world to improve their care and quality of life.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11163687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Inflammation in the posterior elements, in particular the facet joint and facet joint ankylosis over 2-year follow-up in radiographic axial spondyloarthritis. 放射性轴性脊柱关节炎患者两年随访中的后部炎症,尤其是面关节和面关节强直。
IF 6.2 2区 医学
RMD Open Pub Date : 2024-06-08 DOI: 10.1136/rmdopen-2024-004199
Manouk de Hooge, Roos Stal, Alexandre Sepriano, Xenofon Baraliakos, Monique Reijnierse, Jürgen Braun, Désirée van der Heijde, Floris A van Gaalen, Sofia Ramiro
{"title":"Inflammation in the posterior elements, in particular the facet joint and facet joint ankylosis over 2-year follow-up in radiographic axial spondyloarthritis.","authors":"Manouk de Hooge, Roos Stal, Alexandre Sepriano, Xenofon Baraliakos, Monique Reijnierse, Jürgen Braun, Désirée van der Heijde, Floris A van Gaalen, Sofia Ramiro","doi":"10.1136/rmdopen-2024-004199","DOIUrl":"10.1136/rmdopen-2024-004199","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the association of posterior element (PE) and facet joint (FJ) inflammation with subsequent new FJ ankylosis (FJA) on MRI, in patients with radiographic axial spondyloarthritis (r-axSpA).</p><p><strong>Methods: </strong>Patients from the Sensitive Imaging in Ankylosing Spondylitis cohort, inclusion criteria r-axSpA and ≥1 radiographic spinal syndesmophyte, were studied. MRI of the full spinal was performed at baseline, 1 and 2 years. PE/FJ inflammatory lesions and FJA were assessed per vertebral unit (VU) level by three readers. With multilevel time-lagged autoregressive generalised estimated equations, the association between PE/FJ inflammation and the subsequent development of FJA was investigated, taking the reader and VU levels into account.</p><p><strong>Results: </strong>Out of the 58 patients with at least 2 reader scores available, mean age 49 (SD 10) years, 84% men, 59% had baseline PE inflammation, 24% had FJ inflammation and 26% had FJA. PE inflammation was more prevalent in the lower thoracic spine and FJ inflammation in the upper thoracic spine. VU with PE or FJ inflammation showed subsequent new FJA in two and one VU levels, respectively. The probability of developing FJA doubled with prior FJ inflammation. In multilevel analysis, FJ inflammation was associated with subsequent FJA (OR=3.8, 95% CI: 1.5 to 9.8), while no association was found between PE inflammation and new FJA (OR=1.2 (0.6-2.4)).</p><p><strong>Conclusions: </strong>FJ inflammation is rare in severe r-axSpA, but when present, the likelihood of developing subsequent FJA is over three times higher compared with FJ without inflammation. This finding contributes to the understanding of the relationship between inflammation and ankylosis at the same anatomical location in patients with axSpA.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11163638/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies. 改善轴性脊柱关节炎患者的身体功能、睡眠、工作效率和整体健康相关生活质量:两项三期研究的结果。
IF 5.1 2区 医学
RMD Open Pub Date : 2024-06-04 DOI: 10.1136/rmdopen-2024-004202
Maureen Dubreuil, Victoria Navarro-Compán, Annelies Boonen, Karl Gaffney, Lianne S Gensler, Christine de la Loge, Thomas Vaux, Carmen Fleurinck, Ute Massow, Vanessa Taieb, Michael F Mørup, Atul Deodhar, Martin Rudwaleit
{"title":"Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies.","authors":"Maureen Dubreuil, Victoria Navarro-Compán, Annelies Boonen, Karl Gaffney, Lianne S Gensler, Christine de la Loge, Thomas Vaux, Carmen Fleurinck, Ute Massow, Vanessa Taieb, Michael F Mørup, Atul Deodhar, Martin Rudwaleit","doi":"10.1136/rmdopen-2024-004202","DOIUrl":"10.1136/rmdopen-2024-004202","url":null,"abstract":"<p><strong>Objective: </strong>To assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2.</p><p><strong>Methods: </strong>Patients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL).</p><p><strong>Results: </strong>At Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p<0.001), and numerically greater improvements in MOS-Sleep-R Index II and WPAI:axSpA scores. Higher proportions of bimekizumab-randomised versus placebo-randomised patients at Week 16 achieved increasingly stringent thresholds for improvements in BASFI (0 to ≤4), and thresholds for meaningful improvements in SF-36 PCS (≥5-point increase from baseline) and ASQoL (≥4-point decrease from baseline). Responses were sustained or further improved to Week 52, where 60%-70% of bimekizumab-treated patients achieved BASFI ≤4 and meaningful improvements in SF-36 PCS and ASQoL, regardless of whether originally randomised to bimekizumab or placebo.</p><p><strong>Conclusion: </strong>Bimekizumab treatment led to early improvements in physical function, sleep, work productivity and overall HRQoL at Week 16 in patients across the full axSpA disease spectrum. Improvements were sustained to Week 52.</p><p><strong>Trial registration numbers: </strong>NCT03928704; NCT03928743.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11163688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141248458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
PERFECTRA: a pragmatic, multicentre, real-life study comparing treat-to-target strategies with baricitinib versus TNF inhibitors in patients with active rheumatoid arthritis after failure on csDMARDs. PERFECTRA:一项务实、多中心、真实生活研究,比较巴利昔尼与 TNF 抑制剂对 csDMARDs 治疗失败的活动性类风湿关节炎患者的靶向治疗策略。
IF 5.1 2区 医学
RMD Open Pub Date : 2024-05-30 DOI: 10.1136/rmdopen-2024-004291
Celine J van de Laar, Martijn A H Oude Voshaar, Peter Ten Klooster, Danyta I Tedjo, Reinhard Bos, Tim Jansen, A Willemze, Grada A Versteeg, Y P M Goekoop-Ruiterman, Eric-Jan Kroot, Mart van de Laar
{"title":"PERFECTRA: a pragmatic, multicentre, real-life study comparing treat-to-target strategies with baricitinib versus TNF inhibitors in patients with active rheumatoid arthritis after failure on csDMARDs.","authors":"Celine J van de Laar, Martijn A H Oude Voshaar, Peter Ten Klooster, Danyta I Tedjo, Reinhard Bos, Tim Jansen, A Willemze, Grada A Versteeg, Y P M Goekoop-Ruiterman, Eric-Jan Kroot, Mart van de Laar","doi":"10.1136/rmdopen-2024-004291","DOIUrl":"10.1136/rmdopen-2024-004291","url":null,"abstract":"<p><strong>Objective: </strong>To compare the effectiveness of a strategy administering baricitinib versus one using TNF-inhibitors (TNFi) in patients with rheumatoid arthritis (RA) after conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) failure in a real-life treat-to-target (T2T) setting.</p><p><strong>Methods: </strong>Patients with biological and targeted synthetic DMARD (b/tsDMARD) naïve RA with disease duration ≤5 years without contraindications to b/tsDMARD were randomised to either TNFi or baricitinib when csDMARD failed to achieve disease control in a T2T setting. Changes in clinical and patient-reported outcome measures (PROMs) were assessed at 12-week intervals for 48 weeks. The primary endpoint was non-inferiority, with testing for superiority if non-inferiority is demonstrated, of baricitinib strategy in the number of patients achieving American College of Rheumatology 50 (ACR50) response at 12 weeks. Secondary endpoints included 28-joint count Disease Activity Score with C reactive protein (DAS28-CRP) <2.6, changes in PROMs and radiographic progression.</p><p><strong>Results: </strong>A total of 199 patients (TNFi, n=102; baricitinib, n=97) were studied. Both study groups were similar. Baricitinib was both non-inferior and superior in achieving ACR50 response at week 12 (42% vs 20%). Moreover, 75% of baricitinib patients achieved DAS28-CRP <2.6 at week 12 compared with 46% of TNFi patients. On secondary outcomes throughout the duration of the study, the baricitinib strategy demonstrated comparable or better outcomes than TNFi strategy. Although not powered for safety, no unexpected safety signals were seen in this relatively small group of patients.</p><p><strong>Conclusion: </strong>Up to present, in a T2T setting, patients with RA failing csDMARDs have two main strategies to consider, Janus Kinases inhibitor versus bDMARDs (in clinical practice, predominantly TNFi). The PERFECTRA study suggested that starting with baricitinib was superior over TNFi in achieving response at 12 weeks and resulted in improved outcomes across all studied clinical measures and PROMs throughout the study duration in these patients.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11328659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141180640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Dysregulation of circulating collagen turnover markers in very early systemic sclerosis. 早期系统性硬化症中循环胶原蛋白周转标志物的失调。
IF 6.2 2区 医学
RMD Open Pub Date : 2024-05-28 DOI: 10.1136/rmdopen-2023-003306
Rucsandra Dobrota, Suzana Jordan, Pernille Juhl, Nicoletta Del Papa, Britta Maurer, Mike Becker, Carina Mihai, Anne-C Bay-Jensen, Morten Asser Karsdal, Anne Sofie Siebuhr, Oliver Distler
{"title":"Dysregulation of circulating collagen turnover markers in very early systemic sclerosis.","authors":"Rucsandra Dobrota, Suzana Jordan, Pernille Juhl, Nicoletta Del Papa, Britta Maurer, Mike Becker, Carina Mihai, Anne-C Bay-Jensen, Morten Asser Karsdal, Anne Sofie Siebuhr, Oliver Distler","doi":"10.1136/rmdopen-2023-003306","DOIUrl":"10.1136/rmdopen-2023-003306","url":null,"abstract":"<p><strong>Objective: </strong>Clinical observation suggests that vascular activation and autoimmunity precede remodelling of the extracellular matrix (ECM) in systemic sclerosis (SSc). We challenge this paradigm by hypothesising that ECM biomarkers are already disturbed in patients with very early SSc (veSSc) when fibrosis is not yet clinically detectable.</p><p><strong>Methods: </strong>42 patients with veSSc, defined as the presence of Raynaud's phenomenon and at least one of puffy fingers, positive antinuclear antibodies or pathological nailfold capillaroscopy, not meeting the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for SSc, were compared with healthy controls (HCs, n=29). ECM degradation (BGM, C3M, C4M and C6M) and ECM formation biomarkers (PRO-C3, PRO-C4 and PRO-C5) were measured in serum using ELISAs. A cross-sectional analysis at baseline and a longitudinal analysis was performed.</p><p><strong>Results: </strong>Compared with HC, veSSc patients showed a strongly dysregulated turnover of type III and IV collagens (higher C3M, C4M, both p<0.0001 and PRO-C3, p=0.004, lower turnover ratios PRO-C3/C3M and PRO-C4/C4M, both p<0.0001). The biglycan degradation biomarker BGM was higher in veSSc than in HC (p=0.006), whereas the degradation biomarker for type VI collagen, C6M, was lower (p=0.002). In an ROC analysis, biomarkers of type III and IV collagen excellently distinguished between veSSc and HC: C3M, AUC=0.95, p<0.0001; C4M, AUC=0.97, p<0.0001; turnover ratios PRO-C3/C3M, AUC=0.80, p<0.0001; PRO-C4/C4M, AUC=0.97; p<0.0001.</p><p><strong>Conclusion: </strong>These findings indicate ECM remodelling as a very early phenomenon of SSc occurring in parallel with microvascular and autoimmune changes. Biomarkers of type III and IV collagens distinguished between veSSc patients and HC, indicating them as potential biomarkers for the detection of veSSc.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11138262/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141162096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Increased risk of adverse gestational outcomes in pregnant women with primary Sjögren's syndrome. 原发性斯约格伦综合征孕妇不良妊娠结局风险增加。
IF 6.2 2区 医学
RMD Open Pub Date : 2024-05-28 DOI: 10.1136/rmdopen-2023-003616
Zhen Tan, Meilin Shao, Yingbo Zhou, Li Wang, Yan Ma, Nan Xiang, Xiang Yuan, Bin Wang, Xiangliang Xie, Mingtao Zhou, Yumin Wang, Sidong Li, Xiaomei Li
{"title":"Increased risk of adverse gestational outcomes in pregnant women with primary Sjögren's syndrome.","authors":"Zhen Tan, Meilin Shao, Yingbo Zhou, Li Wang, Yan Ma, Nan Xiang, Xiang Yuan, Bin Wang, Xiangliang Xie, Mingtao Zhou, Yumin Wang, Sidong Li, Xiaomei Li","doi":"10.1136/rmdopen-2023-003616","DOIUrl":"10.1136/rmdopen-2023-003616","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to identify risk factors contributing to diverse pregnancy outcomes in primary Sjögren's syndrome (pSS) cases.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on pregnant individuals with pSS, who received outpatient or inpatient care across multiple hospitals in Anhui Province, China, from January 2015 to December 2022.</p><p><strong>Results: </strong>This study included 164 pregnant women with pSS and 328 control subjects, with no statistically significant difference in average age between the two groups. Analysis of pregnancy outcomes revealed that, compared with the control group, pregnant women in the pSS group were more likely to experience miscarriages, both spontaneous (12.80% vs 1.52%, p<0.001) and therapeutic (6.10% vs 0.91%, p<0.05). The proportion of placental abnormalities detected during prenatal ultrasound in women from the pSS group was higher (14.63% vs 6.40%, p<0.05). In the analysis of pregnancy outcomes for live-born neonates, a higher incidence of congenital heart abnormalities was observed in the pSS group (27.34% vs 12.03%, p<0.05). While there were no significant differences between the pSS pregnancies in terms of both normal and adverse pregnancy outcomes, a comparison of fetal survival and fetal loss in pSS pregnancies revealed a greater use of prophylactic anticoagulant therapy in the fetal survival group. Notably, the application of low molecular weight heparin (LMWH) emerged as an independent protective factor for fetal survival.</p><p><strong>Conclusions: </strong>Compared with non-autoimmune controls, pregnancy in women with pSS presents more challenges. Importantly, we observed that the use of LMWH as anticoagulant therapy is an independent protective measure for fetal survival.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11138269/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141162098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Role of technology-based innovation in chronic disease management in rheumatology. 基于技术的创新在风湿病学慢性病管理中的作用。
IF 6.2 2区 医学
RMD Open Pub Date : 2024-05-28 DOI: 10.1136/rmdopen-2024-004264
Tanguy Guillotin, Alain Saraux
{"title":"Role of technology-based innovation in chronic disease management in rheumatology.","authors":"Tanguy Guillotin, Alain Saraux","doi":"10.1136/rmdopen-2024-004264","DOIUrl":"10.1136/rmdopen-2024-004264","url":null,"abstract":"","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11138263/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141162137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study. 类风湿性关节炎患者服用乌达帕替尼与阿达木单抗的长期安全性和疗效:SELECT-COMPARE 三期随机研究的 5 年数据。
IF 5.1 2区 医学
RMD Open Pub Date : 2024-05-28 DOI: 10.1136/rmdopen-2023-004007
Roy Fleischmann, Jerzy Swierkot, Sara K Penn, Patrick Durez, Louis Bessette, Xianwei Bu, Nasser Khan, Yihan Li, Charles G Peterfy, Yoshiya Tanaka, Eduardo Mysler
{"title":"Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study.","authors":"Roy Fleischmann, Jerzy Swierkot, Sara K Penn, Patrick Durez, Louis Bessette, Xianwei Bu, Nasser Khan, Yihan Li, Charles G Peterfy, Yoshiya Tanaka, Eduardo Mysler","doi":"10.1136/rmdopen-2023-004007","DOIUrl":"10.1136/rmdopen-2023-004007","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the safety and efficacy of upadacitinib versus adalimumab from SELECT-COMPARE over 5 years.</p><p><strong>Methods: </strong>Patients with rheumatoid arthritis and inadequate response to methotrexate were randomised to receive upadacitinib 15 mg once daily, placebo or adalimumab 40 mg every other week, all with concomitant methotrexate. By week 26, patients with insufficient response to randomised treatment were rescued; patients remaining on placebo switched to upadacitinib. Patients completing the 48-week double-blind period could enter a long-term extension. Safety and efficacy were assessed through week 264, with radiographic progression analysed through week 192. Safety was assessed by treatment-emergent adverse events (TEAEs). Efficacy was analysed by randomised group (non-responder imputation (NRI)) or treatment sequence (as observed).</p><p><strong>Results: </strong>Rates of TEAEs were generally similar with upadacitinib versus adalimumab, although numerically higher rates of herpes zoster, lymphopenia, creatine phosphokinase elevation, hepatic disorder and non-melanoma skin cancer were reported with upadacitinib. Numerically greater proportions of patients randomised to upadacitinib versus adalimumab achieved clinical responses (NRI); Clinical Disease Activity Index remission (≤2.8) and Disease Activity Score based on C reactive protein <2.6 were achieved by 24.6% vs 18.7% (nominal p=0.042) and 31.8% vs 23.2% (nominal p=0.006), respectively. Radiographic progression was numerically lower with continuous upadacitinib versus adalimumab at week 192.</p><p><strong>Conclusion: </strong>The safety profile of upadacitinib through 5 years was consistent with the known safety profile of upadacitinib, with no new safety risks. Clinical responses were numerically higher with upadacitinib versus adalimumab at 5 years. Upadacitinib demonstrates a favourable benefit-risk profile for long-term rheumatoid arthritis treatment.</p><p><strong>Trial registration number: </strong>NCT02629159.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11138271/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141162136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Urinary methotrexate dosage in rheumatoid arthritis, in patients treated for at least 6 months: a potential marker of adherence. 治疗至少 6 个月的类风湿性关节炎患者的尿甲氨蝶呤剂量:坚持治疗的潜在标志。
IF 5.1 2区 医学
RMD Open Pub Date : 2024-05-20 DOI: 10.1136/rmdopen-2023-004024
Noémie Théate, Marion Geoffroy, Lukshe Kanagaratnam, Claire Gozalo, Isabelle Charlot, Lois Bolko, Ambre Hittinger-Roux, Zoubir Djerada, Jean-Hugues Salmon
{"title":"Urinary methotrexate dosage in rheumatoid arthritis, in patients treated for at least 6 months: a potential marker of adherence.","authors":"Noémie Théate, Marion Geoffroy, Lukshe Kanagaratnam, Claire Gozalo, Isabelle Charlot, Lois Bolko, Ambre Hittinger-Roux, Zoubir Djerada, Jean-Hugues Salmon","doi":"10.1136/rmdopen-2023-004024","DOIUrl":"10.1136/rmdopen-2023-004024","url":null,"abstract":"<p><strong>Objectives: </strong>Non-adherence to rheumatoid arthritis (RA) treatments must be identified. A methotrexate (MTX) urinary dosage (METU) was recently developed. The aim of our study was to assess adherence to MTX in RA using METU in real-life conditions and to compare it with indirect adherence measurement technics.</p><p><strong>Methods: </strong>We performed a cross-sectional study at Reims University Hospital. We included over 18-year-old patients with RA treated by MTX for more than 6 months. Patients were invited to complete demographic, clinical and psychological questionnaires and adherence measurement technics (Compliance Questionnaire of Rheumatology (CQR) and Medication Possession Ratio (MPR)). A urinary sample was collected to measure MTX and information about tolerance was evaluated through Methotrexate Intolerance Severity Score.</p><p><strong>Results: </strong>84 patients were included, 26 using oral MTX, 58 subcutaneous (SC) MTX. Among them, 73% were female, mean age was 61.5 years, MTX mean dose was 15 mg/week and 61.9% were treated by biological DMARDs (Disease Modifying Antirheumatic Drugs). 77 patients (91.7%) were adherent to treatment according to METU, whereas MPR and CQR reported less adherence (69.5% and 61.9%, respectively). MPR and METU were not significantly different in SC MTX users (p=0.059). Non-adherent patients had a higher number of tender joints and C reactive protein value (p<0.05).</p><p><strong>Conclusion: </strong>This is the first largest study evaluating MTX adherence in patients with RA using a urinary dosage. We identified that indirect adherence measurements did not reflect real-life adherence. It would be appreciable to realise METU, in a new study, in patients with RA with unexplained response to treatment, to consider it before escalating therapeutic strategy.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11328664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141076833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Machine learning identifies risk factors associated with long-term opioid use in fibromyalgia patients newly initiated on an opioid. 机器学习可识别与新开始使用阿片类药物的纤维肌痛患者长期使用阿片类药物相关的风险因素。
IF 5.1 2区 医学
RMD Open Pub Date : 2024-05-20 DOI: 10.1136/rmdopen-2024-004232
Carlos Raúl Ramírez Medina, Mengyu Feng, Yun-Ting Huang, David A Jenkins, Meghna Jani
{"title":"Machine learning identifies risk factors associated with long-term opioid use in fibromyalgia patients newly initiated on an opioid.","authors":"Carlos Raúl Ramírez Medina, Mengyu Feng, Yun-Ting Huang, David A Jenkins, Meghna Jani","doi":"10.1136/rmdopen-2024-004232","DOIUrl":"10.1136/rmdopen-2024-004232","url":null,"abstract":"<p><strong>Objectives: </strong>Fibromyalgia is frequently treated with opioids due to limited therapeutic options. Long-term opioid use is associated with several adverse outcomes. Identifying factors associated with long-term opioid use is the first step in developing targeted interventions. The aim of this study was to evaluate risk factors in fibromyalgia patients newly initiated on opioids using machine learning.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted using a nationally representative primary care dataset from the UK, from the Clinical Research Practice Datalink. Fibromyalgia patients without prior cancer who were new opioid users were included. Logistic regression, a random forest model and Boruta feature selection were used to identify risk factors related to long-term opioid use. Adjusted ORs (aORs) and feature importance scores were calculated to gauge the strength of these associations.</p><p><strong>Results: </strong>In this study, 28 552 fibromyalgia patients initiating opioids were identified of which 7369 patients (26%) had long-term opioid use. High initial opioid dose (aOR: 31.96, mean decrease accuracy (MDA) 135), history of self-harm (aOR: 2.01, MDA 44), obesity (aOR: 2.43, MDA 36), high deprivation (aOR: 2.00, MDA 31) and substance use disorder (aOR: 2.08, MDA 25) were the factors most strongly associated with long-term use.</p><p><strong>Conclusions: </strong>High dose of initial opioid prescription, a history of self-harm, obesity, high deprivation, substance use disorder and age were associated with long-term opioid use. This study underscores the importance of recognising these individual risk factors in fibromyalgia patients to better navigate the complexities of opioid use and facilitate patient-centred care.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11308899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141076821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
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