RMD OpenPub Date : 2024-07-01DOI: 10.1136/rmdopen-2024-004180
Maryam Adas, Mrinalini Dey, Sam Norton, Heidi Lempp, Maya H Buch, Andrew Cope, James Galloway, Elena Nikiphorou
{"title":"What role do socioeconomic and clinical factors play in disease activity states in rheumatoid arthritis? Data from a large UK early inflammatory arthritis audit","authors":"Maryam Adas, Mrinalini Dey, Sam Norton, Heidi Lempp, Maya H Buch, Andrew Cope, James Galloway, Elena Nikiphorou","doi":"10.1136/rmdopen-2024-004180","DOIUrl":"https://doi.org/10.1136/rmdopen-2024-004180","url":null,"abstract":"Background Persistently active rheumatoid arthritis (pactiveRA) may be due to the interplay between biological and non-biological factors. The role of socioeconomic factors remains unclear. Objectives To explore which biological and non-biological factors associate with pactiveRA. Methods Adults with early RA in the National Early Inflammatory Arthritis Audit, recruited from May 2018 to October 2022, were included if having pactiveRA or persistently low RA (plowRA). The pactiveRA was defined as three consecutive Disease Activity Score-28 joints (DAS28) of >3.2 at baseline, 3 and 12 months. The plowRA was defined as DAS28 ≤3.2 at 3 and 12 months. Stepwise forward logistic regression was used to explore associations with pactiveRA (outcome). Age and gender were included a priori, with socioeconomic factors and comorbidities as exposure variables. Results 682 patients with pactiveRA and 1026 plowRA were included. Compared with plowRA, patients with pactiveRA were younger (58, IQR: 49–67) versus (62, IQR: 52–72), and included more women (69% vs 59%). The pactiveRA was associated with worse scores in patient-reported outcomes at baseline, and anxiety and depression screens. Overall, there was clear social patterning in pactiveRA, with age-by-gender interaction. Logistic regression indicated age, gender, social deprivation and previous or current smoking, were independently associated with pactiveRA, after controlling for disease severity markers (seropositivity). Depression, lung disease, gastric ulcers and baseline corticosteroid use, were also associated with pactiveRA (p<0.05 for all). Conclusion Socioeconomic factors and deprivation were associated with pactiveRA, independent of clinical and disease characteristics. Identifying ‘adverse’ socioeconomic drivers of pactiveRA can help tailor interventions according to individual need. Data are available upon reasonable request. Data used in this study were collected for the National Early Inflammatory Arthritis Audit and are available on request to the data controllers (the Healthcare Quality Improvement Partnership). Data are available upon reasonable request by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. All data relevant to the study are included in the article. All figures and tables included in this article are original.","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"22 1","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141609160","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}
RMD OpenPub Date : 2024-06-28DOI: 10.1136/rmdopen-2024-004278
Peter C Taylor, Georg Schett, Tom Wj Huizinga, Qingmin Wang, Fowzia Ibrahim, Bei Zhou, Sophia G Liva, Jafar Sadik B Shaik, Yuan Xiong, Jocelyn H Leu, Rohit A Panchakshari, Matthew J Loza, Keying Ma, Harman Dhatt, Ricardo Rojo Cella, Chetan S Karyekar, Carolyn A Cuff, Sheng Gao, Kaiyin Fei
{"title":"Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study.","authors":"Peter C Taylor, Georg Schett, Tom Wj Huizinga, Qingmin Wang, Fowzia Ibrahim, Bei Zhou, Sophia G Liva, Jafar Sadik B Shaik, Yuan Xiong, Jocelyn H Leu, Rohit A Panchakshari, Matthew J Loza, Keying Ma, Harman Dhatt, Ricardo Rojo Cella, Chetan S Karyekar, Carolyn A Cuff, Sheng Gao, Kaiyin Fei","doi":"10.1136/rmdopen-2024-004278","DOIUrl":"10.1136/rmdopen-2024-004278","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of nipocalimab in participants with moderate to severe active rheumatoid arthritis (RA) and inadequate response or intolerance to ≥1 antitumour necrosis factor agent.</p><p><strong>Methods: </strong>In this phase 2a study, participants with RA seropositive for anticitrullinated protein antibodies (ACPA) or rheumatoid factors were randomised 3:2 to nipocalimab (15 mg/kg intravenously every 2 weeks) or placebo from Weeks 0 to 10. Efficacy endpoints (primary endpoint: change from baseline in Disease Activity Score 28 using C reactive protein (DAS28-CRP) at Week 12) and patient-reported outcomes (PROs) were assessed through Week 12. Safety, pharmacokinetics and pharmacodynamics were assessed through Week 18.</p><p><strong>Results: </strong>53 participants were enrolled (nipocalimab/placebo, n=33/20). Although the primary endpoint did not reach statistical significance for nipocalimab versus placebo, a numerically higher change from baseline in DAS28-CRP at Week 12 was observed (least squares mean (95% CI): -1.03 (-1.66 to -0.40) vs -0.58 (-1.24 to 0.07)), with numerically higher improvements in all secondary efficacy outcomes and PROs. Serious adverse events were reported in three participants (burn infection, infusion-related reaction and deep vein thrombosis). Nipocalimab significantly and reversibly reduced serum immunoglobulin G, ACPA and circulating immune complex levels but not serum inflammatory markers, including CRP. ACPA reduction was associated with DAS28-CRP remission and 50% response rate in American College of Rheumatology (ACR) criteria; participants with a higher baseline ACPA had greater clinical improvement.</p><p><strong>Conclusions: </strong>Despite not achieving statistical significance in the primary endpoint, nipocalimab showed consistent, numerical efficacy benefits in participants with moderate to severe active RA, with greater benefit observed for participants with a higher baseline ACPA.</p><p><strong>Trial registration number: </strong>NCT04991753.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141470585","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}
RMD OpenPub Date : 2024-06-28DOI: 10.1136/rmdopen-2024-004367
Vincenzo Venerito, Florenzo Iannone
{"title":"Large language model-driven sentiment analysis for facilitating fibromyalgia diagnosis.","authors":"Vincenzo Venerito, Florenzo Iannone","doi":"10.1136/rmdopen-2024-004367","DOIUrl":"10.1136/rmdopen-2024-004367","url":null,"abstract":"<p><strong>Background: </strong>Fibromyalgia (FM) is a complex disorder with widespread pain and emotional distress, posing diagnostic challenges. FM patients show altered cognitive and emotional processing, with a preferential allocation of attention to pain-related information. This attentional bias towards pain cues can impair cognitive functions such as inhibitory control, affecting patients' ability to manage and express emotions. Sentiment analysis using large language models (LLMs) can provide insights by detecting nuances in pain expression. This study investigated whether open-source LLM-driven sentiment analysis could aid FM diagnosis.</p><p><strong>Methods: </strong>40 patients with FM, according to the 2016 American College of Rheumatology Criteria and 40 non-FM chronic pain controls referred to rheumatology clinics, were enrolled. Transcribed responses to questions on pain and sleep were machine translated to English and analysed by the LLM Mistral-7B-Instruct-v0.2 using prompt engineering targeting FM-associated language nuances for pain expression ('prompt-engineered') or an approach without this targeting ('ablated'). Accuracy, precision, recall, specificity and area under the receiver operating characteristic curve (AUROC) were calculated using rheumatologist diagnosis as ground truth.</p><p><strong>Results: </strong>The prompt-engineered approach demonstrated accuracy of 0.87, precision of 0.92, recall of 0.84, specificity of 0.82 and AUROC of 0.86 for distinguishing FM. In comparison, the ablated approach had an accuracy of 0.76, precision of 0.75, recall of 0.77, specificity of 0.75 and AUROC of 0.76. The accuracy was superior to the ablated approach (McNemar's test p<0.001).</p><p><strong>Conclusion: </strong>This proof-of-concept study suggests LLM-driven sentiment analysis, especially with prompt engineering, may facilitate FM diagnosis by detecting subtle differences in pain expression. Further validation is warranted, particularly the inclusion of secondary FM patients.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141470584","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}
RMD OpenPub Date : 2024-06-28DOI: 10.1136/rmdopen-2024-004187
Ivan Ferraz-Amaro, Fernanda Genre, Ricardo Blanco, Vanesa Calvo-Rio, Cristina Corrales-Selaya, Virginia Portilla, Elena Aurrecoechea, Ricardo Batanero, Vanesa Hernández-Hernández, Juan Carlos Quevedo-Abeledo, Carlos Rodríguez-Lozano, Clementina López-Medina, Lourdes Ladehesa-Pineda, Santos Castañeda, Esther F Vicente-Rabaneda, Cristina Fernández-Carballido, María Paz Martínez Vidal, David Castro Corredor, Joaquín Anino Fernández, Diana Peiteado, Chamaida Plasencia-Rodriguez, Rosa Expósito, Maria Luz Garcia Vivar, Eva Galíndez-Agirregoikoa, Nuria Vegas, Irati Urionagüena, Esther Montes-Perez, Miguel A Gonzalez-Gay, Javier Rueda-Gotor
{"title":"Sex-specific impact of inflammation on traditional cardiovascular risk factors and atherosclerosis in axial spondyloarthritis. A multicentre study of 913 patients.","authors":"Ivan Ferraz-Amaro, Fernanda Genre, Ricardo Blanco, Vanesa Calvo-Rio, Cristina Corrales-Selaya, Virginia Portilla, Elena Aurrecoechea, Ricardo Batanero, Vanesa Hernández-Hernández, Juan Carlos Quevedo-Abeledo, Carlos Rodríguez-Lozano, Clementina López-Medina, Lourdes Ladehesa-Pineda, Santos Castañeda, Esther F Vicente-Rabaneda, Cristina Fernández-Carballido, María Paz Martínez Vidal, David Castro Corredor, Joaquín Anino Fernández, Diana Peiteado, Chamaida Plasencia-Rodriguez, Rosa Expósito, Maria Luz Garcia Vivar, Eva Galíndez-Agirregoikoa, Nuria Vegas, Irati Urionagüena, Esther Montes-Perez, Miguel A Gonzalez-Gay, Javier Rueda-Gotor","doi":"10.1136/rmdopen-2024-004187","DOIUrl":"10.1136/rmdopen-2024-004187","url":null,"abstract":"<p><strong>Introduction: </strong>The nature of the relationship between inflammation, cardiovascular (CV) risk factors and atherosclerosis in axial spondyloarthritis (axSpA) remains largely unknown and sex differences in this regard are yet to be assessed.</p><p><strong>Methods: </strong>Study including 611 men and 302 women from the Spanish multicentre AtheSpAin cohort to assess CV disease in axSpA. Data on CV disease risk factors were collected both at disease diagnosis and at enrolment, and data on disease activity, functional indices and carotid ultrasonography only at enrolment.</p><p><strong>Results: </strong>After a median disease duration of 9 years, patients of both sexes who at disease diagnosis had elevated acute phase reactants (APRs), more frequently had hypertension and obesity. The same occurred with dyslipidaemia in men and with diabetes mellitus in women. At enrolment, CV risk factors were independently associated with APR and with activity and functional indices, with various sex differences. C reactive protein (CRP) values were inversely associated with HDL-cholesterol in men (β coefficient: -1.2 (95% CI: -0.3 to -0.07) mg/dL, p=0.001), while erythrocyte sedimentation rate values were positively associated with triglycerides in women (β coefficient: 0.6 (95% CI: 0.04 to 1) mg/dL, p=0.035). Furthermore, only women showed an independent relationship between insulin resistance parameters and APR or disease activity. Both men and women with high-very high CV risk according to the Systematic Assessment of Coronary Risk Evaluation 2 and CRP levels higher than 3 mg/L at diagnosis of the disease presented carotid plaques significantly more frequently than those with normal CRP levels at disease diagnosis.</p><p><strong>Conclusion: </strong>Inflammation is associated with atherosclerosis and CV disease in axSpA. A gender-driven effect is observed in this relationship.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141470586","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}
RMD OpenPub Date : 2024-06-28DOI: 10.1136/rmdopen-2024-004255
Marie Himbert, Noémie Jourde-Chiche, Léa Chapart, Nicolas Charles, Karine Baumstarck, Eric Daugas
{"title":"Anti-dsDNA IgE: a potential non-invasive test for prediction of lupus nephritis relapse.","authors":"Marie Himbert, Noémie Jourde-Chiche, Léa Chapart, Nicolas Charles, Karine Baumstarck, Eric Daugas","doi":"10.1136/rmdopen-2024-004255","DOIUrl":"10.1136/rmdopen-2024-004255","url":null,"abstract":"<p><strong>Objectives: </strong>Discontinuation or continuation of maintenance immunosuppressive therapy (MIST) after a severe lupus nephritis (LN) requires measuring the risk of relapse but reliable clinical and biological markers are lacking. The WIN-IgE study assesses the value of serum anti-dsDNA IgE autoantibodies as a biomarker for the prediction of relapse in severe LN.</p><p><strong>Methods: </strong>WIN-IgE is an ancillary study of the WIN-Lupus study (NCT01284725), a prospective controlled clinical trial which evaluated the discontinuation of MIST after 2-3 years in class III or IV±V LN with active lesions. WIN-IgE included all patients with available serum collected at randomisation for continuation or discontinuation of MIST. In these sera, anti-dsDNA antibodies, IgE and IgG, were quantified by ELISA and compared between patients who experienced LN relapse and those who did not during the 24 months of follow-up.</p><p><strong>Results: </strong>52 patients were included, 25 in the MIST continuation group and 27 in the MIST discontinuation group, 12 experienced a biopsy-proven relapse of LN. Initial anti-dsDNA IgE antibodies levels were higher in patients with subsequent LN relapse. Anti-dsDNA IgG was not associated with relapse. Survival without LN relapse was lower in patients with anti-dsDNA IgE levels above vs below a threshold of 1.9 arbitrary units (p=0.019), particularly in the subgroup of patients randomised to discontinue MIST (p=0.002). In all patients, anti-dsDNA IgE above 1.9 arbitrary units had a positive predictive value of 0.8 for severe LN relapse.</p><p><strong>Conclusions: </strong>These results suggest blood anti-dsDNA IgE as a non-invasive predictive marker of LN relapse.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141470583","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}
RMD OpenPub Date : 2024-06-21DOI: 10.1136/rmdopen-2024-004382
Joy Ardjuna van der Pol, Cornelia F Allaart, Tom W J Huizinga, Sytske Anne Bergstra
{"title":"Are poor prognostic factors a realistic basis for treatment decisions in patients with rheumatoid arthritis? Lessons from the IMPROVED study.","authors":"Joy Ardjuna van der Pol, Cornelia F Allaart, Tom W J Huizinga, Sytske Anne Bergstra","doi":"10.1136/rmdopen-2024-004382","DOIUrl":"10.1136/rmdopen-2024-004382","url":null,"abstract":"","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11191757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141437436","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}
RMD OpenPub Date : 2024-06-17DOI: 10.1136/rmdopen-2024-004273
Maja Schlereth, Melek Yalcin Mutlu, Jonas Utz, Sara Bayat, Tobias Heimann, Jingna Qiu, Chris Ehring, Chang Liu, Michael Uder, Arnd Kleyer, David Simon, Frank Roemer, Georg Schett, Katharina Breininger, Filippo Fagni
{"title":"Deep learning-based classification of erosion, synovitis and osteitis in hand MRI of patients with inflammatory arthritis.","authors":"Maja Schlereth, Melek Yalcin Mutlu, Jonas Utz, Sara Bayat, Tobias Heimann, Jingna Qiu, Chris Ehring, Chang Liu, Michael Uder, Arnd Kleyer, David Simon, Frank Roemer, Georg Schett, Katharina Breininger, Filippo Fagni","doi":"10.1136/rmdopen-2024-004273","DOIUrl":"10.1136/rmdopen-2024-004273","url":null,"abstract":"<p><strong>Objectives: </strong>To train, test and validate the performance of a convolutional neural network (CNN)-based approach for the automated assessment of bone erosions, osteitis and synovitis in hand MRI of patients with inflammatory arthritis.</p><p><strong>Methods: </strong>Hand MRIs (coronal T1-weighted, T2-weighted fat-suppressed, T1-weighted fat-suppressed contrast-enhanced) of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients from the rheumatology department of the Erlangen University Hospital were assessed by two expert rheumatologists using the Outcome Measures in Rheumatology-validated RA MRI Scoring System and PsA MRI Scoring System scores and were used to train, validate and test CNNs to automatically score erosions, osteitis and synovitis. Scoring performance was compared with human annotations in terms of macro-area under the receiver operating characteristic curve (AUC) and balanced accuracy using fivefold cross-validation. Validation was performed on an independent dataset of MRIs from a second patient cohort.</p><p><strong>Results: </strong>In total, 211 MRIs from 112 patients (14 906 region of interests (ROIs)) were included for training/internal validation using cross-validation and 220 MRIs from 75 patients (11 040 ROIs) for external validation of the networks. The networks achieved high mean (SD) macro-AUC of 92%±1% for erosions, 91%±2% for osteitis and 85%±2% for synovitis. Compared with human annotation, CNNs achieved a high mean Spearman correlation for erosions (90±2%), osteitis (78±8%) and synovitis (69±7%), which remained consistent in the validation dataset.</p><p><strong>Conclusions: </strong>We developed a CNN-based automated scoring system that allowed a rapid grading of erosions, osteitis and synovitis with good diagnostic accuracy and using less MRI sequences compared with conventional scoring. This CNN-based approach may help develop standardised cost-efficient and time-efficient assessments of hand MRIs for patients with arthritis.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420682","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}
{"title":"Increased risk of cardiovascular events under the treatments with Janus kinase inhibitors versus biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: a retrospective longitudinal population-based study using the Japanese health insurance database.","authors":"Ryoko Sakai, Eiichi Tanaka, Eisuke Inoue, Masayoshi Harigai","doi":"10.1136/rmdopen-2023-003885","DOIUrl":"10.1136/rmdopen-2023-003885","url":null,"abstract":"<p><strong>Objectives: </strong>To compare the risk of cardiovascular events among Janus kinase inhibitors (JAKIs), biological disease-modifying antirheumatic drugs (bDMARDs) (tumour necrosis factor inhibitors (TNFIs) and non-TNFIs) and methotrexate (MTX) in Japanese patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>Using Japanese claims data, patients with RA were enrolled in this study if they had at least one ICD-10 code (M05 or M06), were new users of JAKIs, bDMARDs or MTX between July 2013 and July 2020 and being 18 years old or older. The incidence rate (IR), IR ratio and adjusted hazard ratio (aHR (95% CI)) of cardiovascular events including venous thromboembolism, arterial thrombosis, acute myocardial infarction and stroke were calculated. A time-dependent Cox regression model adjusted for patient characteristics at baseline was used to calculate aHR.</p><p><strong>Results: </strong>In 53 448 cases, IRs/1000 patient-years of the overall cardiovascular events were 10.1, 6.8, 5.4, 9.1 and 11.3 under the treatments with JAKIs, bDMARDs, TNFIs, non-TNFIs and MTX, respectively. The adjusted HRs of JAKIs for overall cardiovascular events were 1.7 (1.1 to 2.5) versus TNFIs without MTX and 1.7 (1.1 to 2.7) versus TNFIs with MTX.</p><p><strong>Conclusions: </strong>Among patients with RA, individuals using JAKIs had a significantly higher risk of overall cardiovascular events than TNFIs users, which was attributed to the difference in the risk between JAKIs and TNFIs versus MTX. These data should be interpreted with caution because of the limitations associated with the claims database.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420683","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}
RMD OpenPub Date : 2024-06-17DOI: 10.1136/rmdopen-2024-004315
Simranpreet K Mann, Jeffrey N Bone, Else S Bosman, David A Cabral, Kimberly A Morishita, Kelly L Brown
{"title":"Predictive utility of ANCA positivity and antigen specificity in the assessment of kidney disease in paediatric-onset small vessel vasculitis.","authors":"Simranpreet K Mann, Jeffrey N Bone, Else S Bosman, David A Cabral, Kimberly A Morishita, Kelly L Brown","doi":"10.1136/rmdopen-2024-004315","DOIUrl":"10.1136/rmdopen-2024-004315","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of this study is to evaluate whether anti-neutrophil cytoplasmic antibody (ANCA) seropositivity and antigen specificity at diagnosis have predictive utility in paediatric-onset small vessel vasculitis.</p><p><strong>Methods: </strong>Children and adolescents with small vessel vasculitis (n=406) stratified according to the absence (n=41) or presence of ANCA for myeloperoxidase (MPO) (n=129) and proteinase-3 (PR3) (n=236) were compared for overall and kidney-specific disease activity at diagnosis and outcomes between 1 and 2 years using retrospective clinical data from the ARChiVe/Paediatric Vasculitis Initiative registry to fit generalised linear models.</p><p><strong>Results: </strong>Overall disease activity at diagnosis was higher in PR3-ANCA and MPO-ANCA-seropositive individuals compared with ANCA-negative vasculitis. By 1 year, there were no significant differences, based on ANCA positivity or specificity, in the likelihood of achieving inactive disease (~68%), experiencing improvement (≥87%) or acquiring damage (~58%). Similarly, and in contrast to adult-onset ANCA-associated vasculitis, there were no significant differences in the likelihood of having a relapse (~11%) between 1 and 2 years after diagnosis. Relative to PR3-ANCA, MPO-ANCA seropositivity was associated with a higher likelihood of kidney involvement (OR 2.4, 95% CI 1.3 to 4.7, p=0.008) and severe kidney dysfunction (Kidney Disease Improving Global Outcomes (KDIGO) stages 4-5; OR 6.04, 95% CI 2.77 to 13.57, p<0.001) at onset. Nonetheless, MPO-ANCA seropositive individuals were more likely to demonstrate improvement in kidney function (improved KDIGO category) within 1 year of diagnosis than PR3-ANCA seropositive individuals with similarly severe kidney disease at onset (p<0.001).</p><p><strong>Conclusions: </strong>The results of this study suggest important paediatric-specific differences in the predictive value of ANCA compared with adult patients that should be considered when making treatment decisions in this population.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420684","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}
RMD OpenPub Date : 2024-06-17DOI: 10.1136/rmdopen-2023-004032
Mandeep Sekhon, Annette de Thurah, George E Fragoulis, Jan Schoones, Tanja A Stamm, Theodora P M Vliet Vlieland, Bente Appel Esbensen, Heidi Lempp, Lindsay Bearne, Marios Kouloumas, Polina Pchelnikova, Thijs Willem Swinnen, Chris Blunt, Ricardo J O Ferreira, Loreto Carmona, Elena Nikiphorou
{"title":"Synthesis of guidance available for assessing methodological quality and grading of evidence from qualitative research to inform clinical recommendations: a systematic literature review.","authors":"Mandeep Sekhon, Annette de Thurah, George E Fragoulis, Jan Schoones, Tanja A Stamm, Theodora P M Vliet Vlieland, Bente Appel Esbensen, Heidi Lempp, Lindsay Bearne, Marios Kouloumas, Polina Pchelnikova, Thijs Willem Swinnen, Chris Blunt, Ricardo J O Ferreira, Loreto Carmona, Elena Nikiphorou","doi":"10.1136/rmdopen-2023-004032","DOIUrl":"10.1136/rmdopen-2023-004032","url":null,"abstract":"<p><strong>Objective: </strong>To understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative research to inform recommendations within European Alliance of Associations for Rheumatology (EULAR).</p><p><strong>Methods: </strong>A systematic literature review was performed in multiple databases including PubMed/Medline, EMBASE, Web of Science, COCHRANE and PsycINFO, from inception to 23 October 2020. Eligible studies included primary articles and guideline documents available in English, describing the: (1) development; (2) application of validated tools (eg, checklists); (3) guidance on assessing methodological quality of qualitative research and (4) guidance on grading levels of qualitative evidence. A narrative synthesis was conducted to identify key similarities between included studies.</p><p><strong>Results: </strong>Of 9073 records retrieved, 51 went through to full-manuscript review, with 15 selected for inclusion. Six articles described methodological tools to assess the quality of qualitative research. The tools evaluated research design, recruitment, ethical rigour, data collection and analysis. Seven articles described one approach, focusing on four key components to determine how much confidence to place in findings from systematic reviews of qualitative research. Two articles focused on grading levels of clinical recommendations based on qualitative evidence; one described a qualitative evidence hierarchy, and another a research pyramid.</p><p><strong>Conclusion: </strong>There is a lack of consensus on the use of tools, checklists and approaches suitable for appraising the methodological quality of qualitative research and the grading of qualitative evidence to inform clinical practice. This work is expected to facilitate the inclusion of qualitative evidence in the process of developing recommendations at EULAR level.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"10 2","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184179/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420686","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}