OBJECTIVES:To build on existing evidence regarding single-item measurement instruments of patient-reported bother or trouble from medical side effects in individuals with rheumatic and musculoskeletal diseases (RMDs). Further, to collect input from the OMERACT community through a structured survey that rated and ranked available options and to seek agreement to advance one or more of these measures for use as exploratory outcomes in future clinical trials. METHODS:At OMERACT 2025 we presented and discussed survey results for domain match, feasibility and ranking of six candidate instruments of bother or trouble from side effects. Collaborator feedback - including comments from patients, clinicians, and researchers - was synthesized with a large-language-model (LLM) to identify key concerns and guide refinement of the instrument's relevance, clarity, and acceptability. The LLM-assisted synthesis of participant comments resulted in a new, single-item instrument designed to improve patient safety reporting from the patient's perspective. RESULTS:The merged and modified version of the instrument was presented at the OMERACT 2025 meeting, where 33 participants approved it as a reasonable approach to incorporate collaborator input. The proposed instrument is feasible (32 [97%]) and voting supported advancing its further assessment (30 [91%]) as an exploratory outcome measurement instrument in coming RMD trials. CONCLUSION:We developed a novel single-item instrument. This is the first known application of LLMs in refining a patient-reported outcome instrument for clinical trials. It is designed to capture the patient perspective on symptomatic treatment-related side effects in RMDs and is supported for exploratory use in trials.
Objectives Concerns are growing regarding the relationship of air pollution (especially fine particulate matter, PM2.5) in diseases like systemic lupus erythematosus (SLE). It is unclear which chemical components of ambient PM2.5 may be most harmful, and whether other air pollutants play additional roles. We aimed to evaluate the association between the mixture of PM2.5 components and SLE onset, quantifying their relative contributions to SLE risk, and potential effect modification by ambient ozone levels. Methods Using MarketScan® administrative health data, we assembled an urban open cohort of all enrollees ≥18-year-old (without prior SLE) with residential core-based statistical area (CBSA) information. Each year after 2013, eligible individuals entered the cohort and were followed until SLE onset, death, insurance disenrollment, or study end (Dec. 2023). SLE incident cases were identified by ≥1 hospitalization or ≥2 physician billing diagnostic codes. From the cohort, all SLE cases and a 20% random baseline sub-cohort were combined into a case-cohort sample. Concentrations of PM2.5 components (ammonium, black carbon, mineral dust, sulfate, nitrate, organic matter, sea salt) and ambient ozone for 2 years before cohort entry were estimated by satellite- and ground-based models and assigned based on CBSAs at cohort entry. Extended quantile g-computation models assessed potential associations of SLE onset with the mixture of PM2.5components, ozone and their interaction, adjusting for sex, age, baseline chronic obstructive pulmonary disease (as a proxy for smoking), geographic region, and year of cohort entry. Index weights estimated by quantile g-computation models quantified the relative contributions of individual PM2.5 components to SLE risk. Results Our case-cohort sample numbered 8,345,067 individuals including 21,485 new SLE cases. At the median ozone referent level (ie, 36.1 parts per billion), the adjusted hazard ratio for SLE onset was 1.142 (95% confidence interval, CI 1.107-1.179) per every quartile increase in all PM2.5 components (Table 1). Ozone was also associated with increased risk of SLE (HR 1.009, 95% CI 1.001-1.017). There was effect modification such that the HR for PM2.5 was highest when ozone level was lowest (Table 1). Similar results were seen in sub-groups stratified by sex or age. Mineral dust consistently had the largest index weight across different sub-groups and ozone levels. Table 1. Systemic Lupus Erythematosus Risk: Hazard Ration (HR) estimates for effects of PM 2.5 component mixture, ozone, and the interaction between the exposures, at different referent levels of ozone. Conclusion PM2.5 and ozone were associated with SLE onset; mineral dust was an important contributor. Mineral dust triggers pulmonary inflammation and is a plausible trigger of autoimmunity and SLE onset. Addressing sources of ambient mineral dust (road traffic, construction, farming) may help reduce SLE incidence.
BACKGROUND:Gender disparities in rheumatology persist despite increasing female representation. This comprehensive global survey, conducted by the Coalition for Health and Gender Equity (CHANGE) group, examined preferences for gender equity interventions among rheumatology professionals. METHODS:A cross-sectional online survey of rheumatologists and allied health professionals was conducted across 105 countries (January 2023-May 2024). Intervention preferences spanned four domains: conference-based, organizational, skills training, and work-based strategies. Gender differences were evaluated using logistic regression adjusted for years of work experience, with subgroup analyses by Human Development Index (HDI), Gender Inequality Index (GII), professional role, and caregiving responsibilities. Multiple comparisons were adjusted using Benjamini- Hochberg correction for false discovery rate. RESULTS:Among 1945 respondents (66.4% female), the most widely endorsed interventions overall were family- and child-friendly conference policies (71.4%), communication and scientific writing training (52.6%), and engagement of national rheumatology groups (46.9%). Women demonstrated significantly stronger support for increasing the visibility of female role models (11.89% vs 5.81%, OR = 3.29, p < 0.01), establishing gender-balanced committees (17.66% vs 16.01%, OR = 1.76, p < 0.01), and gender-sensitive editorial board policies (12.70% vs 10.66%, OR = 1.77, p < 0.01). Respondents from higher-GII countries prioritised scientific writing masterclasses (OR = 4.58, p < 0.05) and career planning training (OR = 3.90, p < 0.05) but showed lower endorsement of unconscious bias training (OR = 0.48, p < 0.05) and male allyship programmes (OR = 0.42, p < 0.05). Women in low/middle-HDI countries more frequently selected grant writing support (40.3% vs 26.4%, p < 0.01). CONCLUSION:Gender equity intervention preferences vary systematically across contexts. These findings provide empirical foundations for developing culturally responsive, evidence-informed intervention frameworks to advance gender equity in rheumatology.
Objectives To identify disparities in the access to and use of biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in inflammatory rheumatic and musculoskeletal diseases (iRMDs). Methods A systematic search of literature was conducted in Embase, Medline (to 30 May 2023), and relevant congress databases (to June 2023). Interventional and observational studies reporting measures of disparity in access to, receipt of, or utilisation of b/tsDMARDs in iRMDs were eligible. Outcomes included access to b/tsDMARDs, likelihood to receive treatment, time to first initiation, treatment adherence, and treatment persistence. Disparities across these outcomes are reported. Reporting follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews guidance. Results Of 4218 publications identified, 104 were included in this scoping review. All studies were observational; 70% reported data from patients with rheumatoid arthritis, and 65% were from North America or Europe. Gender (58%) and age (54%) were commonly investigated factors. Lower gross domestic product/capita (n = 7 publications) was associated with reduced access to b/tsDMARDs, whereas older age (n = 20 publications) and receiving government-funded health insurance (eg, Medicare/Medicaid) (n = 6 publications) were negatively associated with the likelihood of receiving b/tsDMARDs. No clear association was identified for any disparity factors and time to the initiation of b/tsDMARDs. Conclusions Disparities in access to and use of b/tsDMARDs are reported in the literature along with the role of commonly studied social determinants of health (SDoH). More research is needed to identify the full spectrum of existing disparities and to reveal the role of SDoH, including the lesser-studied ones.
Gender equity is increasingly recognized as essential to integrity and sustainability of the medical workforce, yet significant disparities remain. This study aims to evaluate longitudinal trends in gender equity within Brazilian rheumatology, focusing on career advancement, work-family interface, and workplace safety. This comparative cross-sectional study analyzed two self-administered, web-based surveys conducted at different moments among members of the Brazilian Society of Rheumatology (SBR), to assess temporal changes. The surveys included Reuma Equity (2022, n = 459, 67.1
Background: In British Columbia, based on Medical Services Commission reports, male rheumatologists earn on average 31.2% more than female rheumatologists. The reasons for this disparity are not completely understood. Methods: The Department of Medicine Rheumatology Equity Committee at the University of British Columbia developed a survey that the BC Society of Rheumatologists (BCSR) distributed to its members. Survey questions included domains such as demographics, career stage, remuneration, time allocation, work hours, duration of consult and follow-up appointments, hours spent on indirect care, and patient population. Results: Forty-nine rheumatologists (67% of BCSR members) responded. Women and men worked the same number of hours per week (42.5 and 42.6 hours, respectively). However, 71% of women earned less than $400 000 annually, compared with 33.5% of men. Women spent longeron an initial consult (50.4 minutes versus 40.8 minutes for men) and had more patients with complex connective tissue disease and fewer with mechanical concerns than did men. Conclusions: There are significant differences in the way that female and male rheumatologists practise. Changing time-based billing codes for complex initial consultations may be one way to address these disparities.
Objectives Systemic lupus erythematosus (SLE) is associated with significant morbidity and healthcare burden. Estimates of SLE incidence help inform research and public health initiatives, including rheumatology workforce planning. SLE incidence estimates may be affected by health care access or care-seeking behavior (impacted by COVID-19 pandemic years, 2020-2022) and/or by environmental factors (eg, viral triggers, climate change). We estimated annual SLE incidence rates over time, using real-world US data. Methods Using the Merative™ MarketScan® Commercial (±Medicare Supplemental) databases, we identified adults (18+) with >2 years of continuous enrollment and no SLE diagnoses during those 2 years between Jan. 2016-Dec. 2022. Among these, a 20% random sample was selected for analysis. Time zero was first qualifying date for cohort entry. Incident SLE was defined by International Classification of Diseases diagnostic codes, based on ≥2 physician visits ≥8 weeks apart within 2 years and/or ≥1 hospitalization. Individuals were followed from time zero until earliest SLE diagnosis, health plan disenrollment, or end of follow-up. Annual SLE incidence rates were calculated with 95% confidence intervals (CI). We report incidence overall and stratified by sex. Female-specific rates were further stratified according to whether person-time was contributed during reproductive age (age < 52). We assessed age (continuous) and sex in a multivariate hazard regression predicting SLE onset, controlling for calendar year. Results We analyzed 4.6 million individuals followed an average of 2.8 years (standard deviation, SD 2.2); 52.6% were female, mean age at time zero was 43.1 years (SD 14.8). During this period, 1,593 new SLE cases (89.2% female) were identified across 12.9 million person-years (12.3 events per 100,000 person-years). No clear difference in incidence comparing 2020-2022 (12.6 events /100,000 person-years) vs 2016-2019 (12.2 events/100,000 person-years). In any given calendar year, incidence was much greater among females, with a higher incidence during reproductive years (23.3 events/100,000 person-years; 95% CI 21.9-24.9) vs later (16.8 events/100,000 person-years; 95% CI 15.3-18.5) (Table 1). In multivariate models, hazard ratios (HR) for female sex was 7.47 (95% CI 6.38-8.75) and for age (continuous),1.00 (95% CI 1.00, 1.01). Table 1: Annual SLE incidence by 10,000 person-years with 95% CI, US MarketScan, 2016-2022* Conclusion These clinically relevant real-world data suggest SLE incidence in the US is holding steady, during the period 2016-2022. Limitations of our analyses include selection bias (all individuals had private insurance), short average follow-up time, and possible outcome misclassification (eg, prevalent SLE cases mischaracterized as incident). Ongoing analyses will consider other factors, such as urban-vs-rural residence, race/ethnicity, and environmental exposures over longer periods.
Objective:To assess the psychosocial impact of axial spondyloarthritis (axSpA). Methods:A literature search was conducted in two stages: stage 1 included all patients with axSpA and stage 2 focused on patients with inadequate response to prior TNF inhibitor treatment. Selection criteria included population (adults with axSpA), outcomes of interest (psychosocial factors potentially impacted by axSpA, e.g. quality of life, mental health and work productivity) and context [disease-related (disease activity, pain) and -unrelated (gender, race, ethnicity, behaviour) factors potentially affecting psychosocial outcomes). Search results were categorized based on the core domains of disease activity, pain, morning stiffness, fatigue, physical function and overall functioning and health in patients with axSpA. Results:A total of 197 articles were included in this review, most of which were observational, with only one randomized controlled trial (RCT). The evidence suggests an association between greater disease burden and poorer psychosocial outcomes as well as a bidirectional relationship between disease components and psychosocial outcomes, both contributing to the overall disease burden. However, while many studies reported on psychosocial outcomes, potential relationships with disease domains or activity were not evaluated. Furthermore, there were inconsistencies across studies in how these outcomes were measured, such as the use of different tools and/or scales. Conclusion:Given the paucity of RCTs examining psychosocial outcomes in axSpA, future research should focus on standardizing assessment of psychosocial impairments experienced by patients and establishing appropriate interventions and management strategies to ensure the holistic treatment of patients with axSpA and to optimize treatment response and outcomes.
ObjectiveTo increase awareness and understanding of the principles of Equity, Diversity, and Inclusivity (EDI) within Outcome Measures in Rheumatology's (OMERACT) members. For this, we aimed to obtain ideas on how to promote and foster these principles within the organization and determine the diversity of the current membership in order to focus future efforts.MethodsWe held a plenary workshop session at OMERACT 2023 with roundtable discussions on barriers and solutions to increased diversity within OMERACT. We conducted an anonymous, web-based survey of members to record characteristics including population group, gender identity, education level, age, and ability.ResultsThe workshop generated ideas to increase diversity of participants across the themes of building relationships [ 12 topics], materials and methods [5 topics], and conference-specific [6 topics]. Four hundred and seven people responded to the survey (25% response rate). The majority of respondents were White (75%), female (61%), university-educated (94%), Christian (42%), spoke English at home (60%), aged 35 to 55 years (50%), and did not report a disability (64%).ConclusionOMERACT is committed to improving its diversity. Next steps include strategic recruitment of members to the EDI working group, drafting an EDI mission statement centering equity and inclusivity in the organization, and developing guidance for the OMERACT Handbook to help all working groups create actionable plans for promoting EDI principles.
Objectives The primary aim of the CHANGE survey is to determine the current state of gender equity within rheumatology, and secondarily, to review the physician perspective on bullying, harassment and equipoise of opportunities within rheumatology.Methods The CHANGE e-survey is a cross-sectional self-reported questionnaire adapted from EULAR's gender equity in academic rheumatology task force. The survey was launched in January 2023; it is available in six languages and distributed widely via rheumatology organizations and social media. Eligible participants include rheumatologist physicians and rheumatology health-care professionals. Survey responses will undergo descriptive analysis and inter-group comparison aiming to explore gender-based discrimination using logistic regression, with subgroup analyses for country/continent variations.Conclusion This e-survey represents a comprehensive global initiative led by an international consortium, aimed at exploring and investigating the gender-related disparities and obstacles encountered by rheumatologists and rheumatology health-care professionals across diverse communities and health-care environments. By pursuing this initiative, we aim to take the broader rheumatology community a step closer to understanding the underlying origins of inequities and their determinants. Such insights are pivotal in identifying viable interventions and strategies to foster gender equity within the field. Ultimately, our collective objective is to ensure equitable access to opportunities for every individual, irrespective of gender, thereby promoting inclusivity and fairness across the entire spectrum of professional practice and career development. What does this mean for patients?The CHANGE Study, led by a team of rheumatology professionals worldwide, is working to make health care more equal for everyone. We are focusing on challenges faced by rheumatologists, such as fair pay and career opportunities. To understand these issues better, the team is gathering information through a global survey of rheumatology professionals. The goal is to find out why there are differences and come up with solutions. Ultimately, the aim is to create a fair and inclusive environment in rheumatology, ensuring that everyone has the same chances to grow in their careers, regardless of their gender. The findings of the study will help to create better guidelines, promoting fairness and equality for health-care professionals in rheumatology.
ObjectiveQuality of care (QoC) delivery in rheumatoid arthritis (RA) continues to suffer from various challenges (eg, delay in diagnosis and referral) that can lead to poor patient outcomes. This study aimed to identify good practice interventions that address these challenges in RA care in North America.MethodsThe study was conducted in three steps: (1) literature review of existing publications and guidelines (April 2005 to April 2021) on QoC in RA; (2) in‐person visits to >50 individual specialists and health care professionals across nine rheumatology centers in the United States and Canada to identify challenges in RA care and any corresponding good practice interventions; and (3) collation and organization of findings of the two previous methods by commonalities to identify key good practice interventions, followed by further review by RA experts to ensure key challenges and gaps in RA care were captured.ResultsSeveral challenges and eight good practice interventions were identified in RA care. The interventions were prioritized based on the perceived positive impact on the challenges in care and ease of implementation. High‐priority interventions included the use of technology to improve care, streamlining specialist treatment, and facilitating comorbidity assessment and care. Other interventions included enabling patient access to optimal medication regimens and improving patient self‐management strategies.ConclusionLearnings from the study can be implemented in other rheumatology centers throughout North America to improve RA care. Although the study was completed before the COVID‐19 pandemic, the findings remain relevant.
Dermatomyositis (DM) is a rare and debilitating, systemic, autoimmune disease. While heterogenous in presentation and severity, DM is primarily characterised by a spectrum of skin and muscle disease, which may include proximal muscle weakness and recalcitrant cutaneous eruptions. DM may also be associated with joint pain and stiffness, inflammatory arthritis, dysphagia, fatigue, and calcinosis. The current standard of care for DM includes glucocorticoids, immunosuppressants, and intravenous immunoglobulin (IVIg). Unfortunately, these medications are not uniformly effective and can lead to adverse events, particularly with chronic use, necessitating discontinuation of therapy. Therefore, a substantial unmet need exists for more tailored and efficacious therapies that target DM pathogenesis. Brepocitinib is an oral, once-daily, novel, and specific TYK2/JAK1 inhibitor. Brepocitinib's potent inhibition of TYK2 and JAK1 reduces the signalling of pro-inflammatory cytokines, including IFN-α/β, IL-12, IL-23, and IFNγ, that have been implicated in the pathogenesis of DM. Other JAK inhibitors have been used off-label in both case series and open-label clinical trials in patients with DM; and brepocitinib has demonstrated efficacy in phase 2 clinical trials of several other autoimmune diseases, including plaque psoriasis, psoriatic arthritis, Crohn's disease, hidradenitis suppurativa, and ulcerative colitis. Therefore, there is a strong scientific and clinical rationale for the utility and potential effectiveness of brepocitinib in the treatment of DM patients. Currently, the safety, tolerability, and efficacy of brepocitinib is being evaluated in the largest (n=225) double-blind placebo-controlled phase 3 trial in DM patients to date (VALOR - NCT0543726).
Racial disparities in disease activity, clinical outcomes, and treatment survival persist despite advancements in rheumatoid arthritis (RA) therapies and clinical management. In this post hoc analysis of pooled data from the tofacitinib global clinical program, we evaluated the impact of race on the efficacy and safety of tofacitinib in patients with RA. Data were pooled from 15 phase 2–3b/4 studies of patients with RA treated with tofacitinib 5 or 10 mg twice daily, adalimumab, or placebo. Outcomes were stratified by self-reported patient race (White/Black/Asian/Other). Efficacy outcomes to month 12 included: American College of Rheumatology (ACR)20/50/70 responses, Clinical Disease Activity Index (CDAI)/Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4(ESR)] low disease activity (LDA) rates, least squares (LS) mean change from baseline (∆) in CDAI, DAS28-4 (ESR), Health Assessment Questionnaire-Disability Index (HAQ-DI), and Pain [Visual Analog Scale (VAS)]. Odds ratios (ORs; 95
OBJECTIVE:To evaluate the regional variation of cost sharing and associations with rheumatoid arthritis (RA) disease burden in the US.METHODS:Patients with RA from rheumatology practices in Northeast, South, and West US regions were evaluated. Sociodemographics, RA disease status, and comorbidities were collected, and Rheumatic Disease Comorbidity Index (RDCI) score was calculated. Primary insurance types and copay for office visits (OVs) and medications were documented. Univariable pairwise differences between regions were conducted, and multivariable regression models were estimated to evaluate associations of RDCI with insurance, geographical region, and race.RESULTS:In a cohort of 402 predominantly female, White patients with RA, most received government versus private sponsored primary insurance (40% vs. 27.9%). Disease activity and RDCI were highest for patients in the South region, where copays for OVs were more frequently more than $25. Copays for OVs and medications were less than $10 in 45% and 31.8% of observations, respectively, and more prevalent in the Northeast and West patient subsets than in the South subset. Overall, RDCI score was significantly higher for OV copays less than $10 as well as for medication copays less than $25, both independent of region or race. Additionally, RDCI was significantly lower for privately insured than Medicare individuals (RDCI -0.78, 95% CI [-0.41 to -1.15], P < 0.001) and Medicaid (RDCI -0.83, 95% CI [-0.13 to -1.54], P = 0.020), independent of region and race.CONCLUSION:Cost sharing may not facilitate optimum care for patients with RA, especially in the Southern regions. More support may be required of government insurance plans to accommodate patients with RA with a high disease burden.