RMD Open最新文献

{"title":"Use of risk chart algorithms for the identification of psoriatic arthritis patients at high risk for cardiovascular disease: findings derived from the project CARMA cohort after a 7.5-year follow-up period","authors":"Jessica Polo y La Borda, Santos Castañeda, Elena Heras-Recuero, Fernando Sánchez-Alonso, Zulema Plaza, Carmen García Gómez, Ivan Ferraz-Amaro, Jesús Tomás Sanchez-Costa, Olga Carmen Sánchez-González, Ana Isabel Turrión-Nieves, Ana Perez-Alcalá, Carolina Pérez-García, Carlos González-Juanatey, Javier Llorca, Miguel Angel Gonzalez-Gay","doi":"10.1136/rmdopen-2024-004207","DOIUrl":"https://doi.org/10.1136/rmdopen-2024-004207","url":null,"abstract":"Objective To assess the predictive value of four cardiovascular (CV) risk algorithms for identifying high-risk psoriatic arthritis (PsA) patients. Methods Evaluation of patients with PsA enrolled in the Spanish prospective project CARdiovascular in RheuMAtology. Baseline data of 669 PsA patients with no history of CV events at the baseline visit, who were followed in rheumatology outpatient clinics at tertiary centres for 7.5 years, were retrospectively analysed to test the performance of the Systematic Coronary Risk Assessment (SCORE), the modified version (mSCORE) European Alliance of Rheumatology Associations (EULAR) 2015/2016, the SCORE2 algorithm (the updated and improved version of SCORE) and the QRESEARCH risk estimator version 3 (QRISK3). Results Over 4790 years of follow-up, there were 34 CV events, resulting in a linearised rate of 7.10 per 1000 person-years (95% CI 4.92 to 9.92). The four CV risk scales showed strong correlations and all showed significant associations with CV events (p<0.001). SCORE, mSCORE EULAR 2015/2016 and QRISK3 effectively differentiated between low and high CV risk patients, although the cumulative rate of CV events observed over 7.5 years was lower than expected based on the frequency predicted by these risk scales. Additionally, model improvement was observed when combining QRISK3 with any other scale, particularly the combination of QRISK3 and SCORE2, which yielded the lowest Akaike information criterion (411.15) and Bayesian information criterion (420.10), making it the best predictive model. Conclusions Risk chart algorithms are very useful for discriminating PsA at low and high CV risk. An integrated model featuring QRISK3 and SCORE2 yielded the optimal synergy of QRISK3’s discrimination ability and SCORE2’s calibration accuracy. No data are available.","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140612759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Computable phenotype for real-world, data-driven retrospective identification of relapse in ANCA-associated vasculitis","authors":"Jennifer Scott, Arthur White, Cathal Walsh, Louis Aslett, Matthew A Rutherford, James Ng, Conor Judge, Kuruvilla Sebastian, Sorcha O’Brien, John Kelleher, Julie Power, Niall Conlon, Sarah M Moran, Raashid Ahmed Luqmani, Peter A Merkel, Vladimir Tesar, Zdenka Hruskova, Mark A Little","doi":"10.1136/rmdopen-2023-003962","DOIUrl":"https://doi.org/10.1136/rmdopen-2023-003962","url":null,"abstract":"Objective ANCA-associated vasculitis (AAV) is a relapsing-remitting disease, resulting in incremental tissue injury. The gold-standard relapse definition (Birmingham Vasculitis Activity Score, BVAS>0) is often missing or inaccurate in registry settings, leading to errors in ascertainment of this key outcome. We sought to create a computable phenotype (CP) to automate retrospective identification of relapse using real-world data in the research setting. Methods We studied 536 patients with AAV and >6 months follow-up recruited to the Rare Kidney Disease registry (a national longitudinal, multicentre cohort study). We followed five steps: (1) independent encounter adjudication using primary medical records to assign the ground truth, (2) selection of data elements (DEs), (3) CP development using multilevel regression modelling, (4) internal validation and (5) development of additional models to handle missingness. Cut-points were determined by maximising the F1-score. We developed a web application for CP implementation, which outputs an individualised probability of relapse. Results Development and validation datasets comprised 1209 and 377 encounters, respectively. After classifying encounters with diagnostic histopathology as relapse, we identified five key DEs; DE1: change in ANCA level, DE2: suggestive blood/urine tests, DE3: suggestive imaging, DE4: immunosuppression status, DE5: immunosuppression change. F1-score, sensitivity and specificity were 0.85 (95% CI 0.77 to 0.92), 0.89 (95% CI 0.80 to 0.99) and 0.96 (95% CI 0.93 to 0.99), respectively. Where DE5 was missing, DE2 plus either DE1/DE3 were required to match the accuracy of BVAS. Conclusions This CP accurately quantifies the individualised probability of relapse in AAV retrospectively, using objective, readily accessible registry data. This framework could be leveraged for other outcomes and relapsing diseases. Data are available on reasonable request. We would invite any potential research collaborations or data requests through the corresponding author, MAL (mlittle@tcd.ie), on reasonable request, as agreed by participants in their written informed consent (detailed on page 3: <https://www.tcd.ie/medicine/thkc/assets/pdf/RKD-Vasculitis-Patient-PIL-ICF-Version-5-07AUG19.pdf>). Requests will be considered on a case-by-case basis.","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140829435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Significance of structural changes in the axial skeleton in patients with axial spondyloarthritis: how important are lesions in the sacroiliac joint?","authors":"EULAR","doi":"10.1136/rmdopen-2022-002822corr1","DOIUrl":"https://doi.org/10.1136/rmdopen-2022-002822corr1","url":null,"abstract":"Braun J. Significance of structural changes in the axial skeleton in patients with axial spondyloarthritis: how important are lesions in the sacroiliac …","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140595263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Diagnostic utility of serum IgG4 level in IgG4-related diseases: a comprehensive systematic review and meta-analysis","authors":"EULAR","doi":"10.1136/rmdopen-2023-003498corr1","DOIUrl":"https://doi.org/10.1136/rmdopen-2023-003498corr1","url":null,"abstract":"Chang C, Chan T, Yu H, et al . Diagnostic utility of serum IgG4 level in IgG4-related diseases: a comprehensive systematic …","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140595268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disease evolution and organ damage accrual in patients with stable UCTD: a long-term monocentric inception cohort","authors":"Chiara Tani, Francesca Trentin, Alice Parma, Dina Zucchi, Chiara Cardelli, Chiara Stagnaro, Elena Elefante, Viola Signorini, Linda Carli, Maria Laura Manca, Marta Mosca","doi":"10.1136/rmdopen-2023-003967","DOIUrl":"https://doi.org/10.1136/rmdopen-2023-003967","url":null,"abstract":"Objectives Undifferentiated connective tissue diseases (UCTDs) are systemic autoimmune conditions that cannot be diagnosed nor classified as defined CTD; the majority maintains an undifferentiated profile (stable UCTD, sUCTD) over time. Data on long-term outcomes of sUCTD are lacking. Methods Retrospective longitudinal analysis of an inception cohort of 141 patients with sUCTD. Disease evolution and damage accrual were evaluated at 1, 5 and 10 years. Partial least square (PLS) regression was used to identify the basal variables contributing to damage accrual at 1, 5 and 10 years of follow-up. Trend of damage over time was compared with a cohort of age-matched and sex-matched patients with systemic lupus erythematosus (SLE) by means of Nelson-Aalen analysis. Results 11.3% of patients evolved to a definite CTD after a median 11 years (IQR 6–25) from the first symptom. At last visit, 10% were on glucocorticoids and 6% on immunosuppressive therapy. In 27.3%, at least one item of organ damage was recorded according to the SLICC/DI score (mean score 1.19±0.46). At PLS analysis, age at diagnosis and age at first symptoms were related to damage at 1 year, not taking antimalarials and taking immunosuppressants were associated with damage at 5 years. The mean survival without damage was 9.3 years in sUCTD and 8.4 years in SLE. The 10-year probability without damage was 62% and 23% in SLE and sUCTD, respectively (p=0.015). Conclusions Although less significantly impacted than in patients with SLE, in the long-term UCTDs can accumulate organ damage and evolve into defined connective tissue diseases. Data are available on reasonable request. The data that support the findings of this study are available on request from the corresponding author on reasonable request.","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140802040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Myocardial infarction in a population-based cohort of patients with biopsy-confirmed giant cell arteritis in southern Sweden","authors":"Pavlos Stamatis, Moman Aladdin Mohammad, Karl Gisslander, Peter A Merkel, Martin Englund, Carl Turesson, David Erlinge, Aladdin J Mohammad","doi":"10.1136/rmdopen-2023-003960","DOIUrl":"https://doi.org/10.1136/rmdopen-2023-003960","url":null,"abstract":"Objectives To determine the incidence rate (IR) of myocardial infarction (MI), relative risk of MI, and impact of incident MI on mortality in individuals with biopsy-confirmed giant cell arteritis (GCA). Methods MIs in individuals diagnosed with GCA 1998–2016 in Skåne, Sweden were identified by searching the SWEDEHEART register, a record of all patients receiving care for MI in a coronary care unit (CCU). The regional diagnosis database, with subsequent case review, identified GCA patients receiving care for MI outside of a CCU. A cohort of 10 reference subjects for each GCA case, matched for age, sex and area of residence, was used to calculate the incidence rate ratio (IRR) of MI in GCA to that in the general population. Results The GCA cohort comprised 1134 individuals. During 7958 person-years of follow-up, 102 were diagnosed with incident MI, yielding an IR of 12.8 per 1000 person-years (95% CI 10.3 to 15.3). The IR was highest in the 30 days following GCA diagnosis and declined thereafter. The IRR of MI in GCA to that of the background population was 1.29 (95% CI 1.05 to 1.59). Mortality was higher in GCA patients who experienced incident MI than in those without MI (HR 2.8; 95% CI 2.2 to 3.6). Conclusions The highest incidence of MI occurs within the 30 days following diagnosis of GCA. Individuals with GCA have a moderately increased risk of MI compared with a reference population. Incident MI has a major impact on mortality in GCA. No data are available. Raw data are protected by confidentiality laws in Sweden and cannot be shared. All data relevant to the study are included in the article. For further information contact the corresponding author.","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140595856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding the psychosocial determinants of effective disease management in rheumatoid arthritis to prevent persistently active disease: a qualitative study","authors":"Nkasi Stoll, Mrinalini Dey, Sam Norton, Maryam Adas, Ailsa Bosworth, Maya H Buch, Andrew Cope, Heidi Lempp, James Galloway, Elena Nikiphorou","doi":"10.1136/rmdopen-2024-004104","DOIUrl":"https://doi.org/10.1136/rmdopen-2024-004104","url":null,"abstract":"Background According to epidemiological studies, psychosocial factors are known to be associated with disease activity, physical activity, pain, functioning, treatment help-seeking, treatment waiting times and mortality in people with rheumatoid arthritis (RA). Limited qualitative inquiry into the psychosocial factors that add to RA disease burden and potential synergistic interactions with biological parameters makes it difficult to understand patients’ perspectives from the existing literature. Aim This study aimed to gather in-depth patient perspectives on psychosocial determinants that drive persistently active disease in RA, to help guide optimal patient care. Methods Patient research partners collaborated on the research design and materials. Semistructured interviews and focus groups were conducted online (in 2021) with patients purposively sampled from diverse ethnicities, primary languages, employment status and occupations. Data were analysed using inductive thematic analysis. Results 45 patients participated across 28 semistructured interviews and three focus groups. Six main themes on psychosocial determinants that may impact RA management were identified: (1) healthcare systems experiences, (2) patient education and health literacy, (3) employment and working conditions, (4) social and familial support, (5) socioeconomic (dis)advantages, and (6) life experiences and well-being practices. Conclusion This study emphasises the importance of clinicians working closely with patients and taking a holistic approach to care that incorporates psychosocial factors into assessments, treatment plans and resources. There is an unmet need to understand the relationships between interconnected biopsychosocial factors, and how these may impact on RA management. All data relevant to the study are included in the article or uploaded as supplemental information.","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140595526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence of collagen-induced arthritis is elevated by a high-fat diet without influencing body weight in mice","authors":"Jianhui Liang, Kuangyang Yang, Yanni Shen, Xiao Peng, Hao Tan, Lichu Liu, Qian Xie, Yan Wang","doi":"10.1136/rmdopen-2023-003869","DOIUrl":"https://doi.org/10.1136/rmdopen-2023-003869","url":null,"abstract":"Obesity is recognised as a risk factor for triggering rheumatoid arthritis (RA), and it can worsen joint deformities1 and diminish the quality of life in patients with RA.2 The reduction of body weight in obese individuals is believed to alleviate RA symptoms.3 Body mass index (BMI) serves as the primary standard for evaluating obesity.4 An increase in BMI by 1 SD notably elevates the incidence rate of RA, suggesting a causal link between higher BMI and an increased risk of developing RA.5 The association between BMI and obesity is straightforward, as a higher BMI typically indicates a greater risk of obesity.4 Obesity is clinically defined as having a BMI of 30 kg/m2 or greater.4 Here, we established collagen-induced arthritis (CIA) models in mice using both regular and high-fat diets (HFDs) to see if HFD can induce severe RA symptoms in mice. CIA mice develop arthritis symptoms, including joint swelling, redness and stiffness, mirroring the clinical features of human RA.6 Therefore, the CIA model has become the prevailing animal model for RA research. Our observations indicated that mice in the HFD sham group exhibited significantly higher body weights compared with regular diet group, in line with previous reports.7 However, the HFD …","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140595669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Obesity is a risk factor for poor response to treatment in early rheumatoid arthritis: a NORD-STAR study","authors":"Violetta Dubovyk, Georgios K Vasileiadis, Tahzeeb Fatima, Yuan Zhang, Meliha Crnkic Kapetanovic, Alf Kastbom, Milad Rizk, Annika Söderbergh, Sizheng Steven Zhao, Ronald F van Vollenhoven, Merete Lund Hetland, Espen A Haavardsholm, Dan Nordström, Michael T Nurmohamed, Bjorn Gudbjornsson, Jon Lampa, Mikkel Østergaard, Marte Schrumpf Heiberg, Tuulikki Sokka-Isler, Gerdur Gröndal, Kristina Lend, Kim Hørslev-Petersen, Till Uhlig, Anna Rudin, Cristina Maglio","doi":"10.1136/rmdopen-2024-004227","DOIUrl":"https://doi.org/10.1136/rmdopen-2024-004227","url":null,"abstract":"Objective This report from the NORD-STAR (Nordic Rheumatic Diseases Strategy Trials and Registries) trial aimed to determine if obesity is associated with response to conventional and biological antirheumatic treatment in early rheumatoid arthritis (RA). Methods This report included 793 participants with untreated early RA from the randomised, longitudinal NORD-STAR trial, all of whom had their body mass index (BMI) assessed at baseline. Obesity was defined as BMI ≥30 kg/m2. All participants were randomised 1:1:1:1 to one of four treatment arms: active conventional treatment, certolizumab-pegol, abatacept and tocilizumab. Clinical and laboratory measurements were performed at baseline and at 8, 12, 24 and 48-week follow-up. The primary endpoint for this report was response to treatment based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) remission and Disease Activity Score with 28 joints using C-reactive protein (DAS28-CRP) <2.6 stratified by BMI. Results Out of 793 people included in the present report, 161 (20%) had obesity at baseline. During follow-up, participants with baseline obesity had higher disease activity compared with those with lower BMI, despite having similar disease activity at baseline. In survival analyses, obesity was associated with a lower likelihood of achieving response to treatment during follow-up for up to 48 weeks (CDAI remission, HR 0.84, 95% CI 0.67 to 1.05; SDAI, HR 0.77, 95% CI 0.62 to 0.97; DAS28-CRP <2.6, HR 0.78, 95% CI 0.64 to 0.95). The effect of obesity on response to treatment was not influenced by the treatment arms. Conclusion In people with untreated early RA followed up for up to 48 weeks, obesity was associated with a lower likelihood of good treatment response, irrespective of the type of randomised treatment received. Trial registration number [NCT01491815][1]. Data are available upon reasonable request. Data are available on reasonable request. Nordic Rheumatic Diseases Strategy Trials and Registries (NORD-STAR) data will not be shared publicly. Access to the NORD-STAR data is organised according to a strict data access procedure. For all types of access, a research proposal must be submitted for evaluation by the NORD-STAR Steering Committee. The evaluation is performed to align the goals of the researchers with the goals of NORD-STAR (which are in turn aligned with the informed consent form signed by NORD-STAR participants). Further information on NORD-STAR data can be obtained by contacting the NORD-STAR Steering Committee (mail to nordstar@ki.se). [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01491815&atom=%2Frmdopen%2F10%2F2%2Fe004227.atom","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140595267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Induction of regulatory T cells and efficacy of low-dose interleukin-2 in systemic sclerosis: interventional open-label phase 1–phase 2a study","authors":"François Barde, Roberta Lorenzon, Eric Vicaut, Sébastien Rivière, Patrice Cacoub, Carlotta Cacciatore, Michelle Rosenzwajg, Anne Daguenel-Nguyen, Olivier Fain, David Klatzmann, Arsène Mekinian","doi":"10.1136/rmdopen-2023-003500","DOIUrl":"https://doi.org/10.1136/rmdopen-2023-003500","url":null,"abstract":"Background Systemic sclerosis (SSc) is a chronic autoimmune disease, with impaired immune response, increased fibrosis and endothelial dysfunction. Regulatory T cells (Tregs), which are essential to control inflammation, tissue repair and autoimmunity, have a decreased frequency and impaired function in SSc patients. Low-dose interleukin-2 (IL-2LD) can expand and activate Tregs and has, therefore, a therapeutic potential in SSc. Objective We aimed to assess the safety and biological efficacy of IL-2LD in patients with SSc. Methods As part of the TRANSREG open-label phase IIa basket trial in multiple autoimmune diseases, we studied nine patients with SSc without severe organ involvement. Patients received 1 million international units (MIU)/day of IL-2 for 5 days, followed by fortnightly injections for 6 months. Laboratory and clinical evaluations were performed between baseline and month 6. Results At day 8, the primary endpoint (Treg frequency) was reached with a 1.8±0.5-fold increase of Treg levels among CD4+ T lymphocytes (p=0.0015). There were no significant changes in effector T cells nor in B cells. IL-2LD was well tolerated, and no serious adverse events related to treatment occurred. There was a globally stable measurement in the modified Rodnan skin score and Valentini score at month 6. Disease activity and severity measures, the quality of life evaluated by EuroQL-5D-5L and pulmonary function test parameters remained stable during the study period. Conclusion IL-2LD at a dosage of 1 MIU/day safely and selectively activates and expands Tregs. Clinical signs remain stable during the study period. This opens the door to properly powered phase II efficacy trials investigating IL-2LD therapeutic efficacy in SSc. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information.","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140595329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}