搜索结果：Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases

Upadacitinib (UPA), an oral Janus kinase inhibitor, has shown efficacy with an acceptable safety profile in rheumatoid arthritis (RA) clinical trials. To assess the real-world effectiveness and safety of UPA in adults with moderate-to-severe RA in the UPHOLD observational study. Co-primary endpoints were: (i) proportion of patients achieving disease activity score in 28 joints using C-reactive protein (DAS28[CRP]) remission (<&#x2009;2.6) at 6 months; and (ii) proportion of those patients maintaining remission at 12 months. Additional analyses included proportions of patients achieving and maintaining DAS28(CRP) low disease activity (LDA; &#x2264; 3.2), other composite measures of disease activity, and subgroup analyses by therapy strategy and prior treatment. Treatment-emergent adverse events (TEAEs) in the full analysis set (FAS; patients receiving&#x2009;&#x2265;&#x2009;1 UPA dose) were reported through August 10, 2023. Co-primary and selected secondary endpoints were analyzed by modified non-responder imputation (mNRI) in modified (m)FAS1 (FAS patients who completed 6 months of treatment and had DAS28[CRP] data available, and those who discontinued before 6 months) and mFAS2 (mFAS1 patients who achieved remission at 6 months, completed 12 months of treatment, and had DAS28[CRP] data available, and those who discontinued between 6 and 12 months); and as observed (AO) in patients with non-missing data. Of 1719 participants, 1717 were enrolled; 1701 comprised the FAS. Overall, 400/1719 (23.3%) patients discontinued before 12 months. Of mFAS1 patients, 499 (mNRI: 499/1074 [46.5%]; AO: 499/902 [55.3%]) achieved DAS28(CRP) remission at 6 months; of mFAS2 patients, 269 (mNRI: 269/340 [79.1%]; AO: 269/317 [84.9%]) maintained remission at 12 months. DAS28(CRP) remission or LDA rates were consistent regardless of whether UPA was initiated and maintained as monotherapy or combination therapy. Similar responses were observed across prior treatment subgroups. Among selected TEAEs of special interest, herpes zoster and serious infection occurred at 3.12 and 2.62 events/100 patient-years, respectively. No new safety signals were identified. UPA demonstrated real-world effectiveness in moderate-to-severe RA, with approximately half of patients achieving DAS28(CRP) remission at 6 months and most maintaining remission through 12 months. The real-world benefit-risk profile of UPA remains favorable and is consistent with phase 3 clinical trial data. NCT04497597.

Rheumatoid arthritis (RA) impacts quality of life causing disability and increased mortality. Treatment decisions are complex and require individualization. Shared decision making (SDM) is the first principle of RA treat-to-target guidelines, but uptake is suboptimal. We aim to evaluate the effectiveness of a multicomponent SDM intervention on RA disease activity and explore the early implementation of the intervention within three geographically diverse rheumatology services. The RAiSeD trial uses a stepped-wedge, cluster-randomized trial design at three U.S. Veterans Health Administration rheumatology clinics, targeted to enroll more than 400 patients and over 45 clinicians. The multicomponent SDM intervention consists of three parts: (1) rheumatology clinician training and a pocket card on SDM and fostering choice awareness ("acknowledging when there is more than one sensible option available to address a patient's situation"), (2) RA patient activation using the AskShareKnow questions, and (3) a point-of-care decision aid (RA Choice) and medication summary guide. We will conduct a mixed-methods outcomes and process evaluation. Outcomes will be evaluated during a pre-intervention (usual care) and intervention period. The primary outcome is disease activity as measured by the validated Clinical Disease Activity Index (CDAI), with secondary outcomes of RA knowledge and medication adherence. SDM will be measured by two brief, validated patient-reported measures. A subgroup of clinic visits will be audio-recorded and clinicians' efforts to involve patients in SDM will be assessed. The implementation process will be evaluated using stakeholder interviews and field notes at each of the three sites. This study is the first multi-site trial of a multicomponent intervention to facilitate SDM among veterans with RA. We expect to improve uptake of SDM across geographically distinct rheumatology clinics and hypothesize that patients exposed to the interventions will have a greater decrease in disease activity and an increase in knowledge of RA medications compared to usual care. Insights gained from this study will inform broader dissemination and implementation of SDM across VA rheumatology clinics and beyond, with the goal of improving quality of care for all persons with RA. ClinicalTrials.gov NCT05530694. Registered on September 7, 2022.

To investigate the practices of doctors in the diagnosis and treatment of adult SAPHO syndrome. A cross-sectional study was conducted by distributing online questionnaires to physicians across five hospitals, specifically targeting departments involved in the diagnosis and treatment of adult SAPHO syndrome, including rheumatology, dermatology, and orthopedics. A total of 103 clinical physicians participated in the survey.The three most commonly observed clinical features of adult SAPHO syndrome were elevated ESR and CRP (82/84), focal swelling and fever (73/84), and new lesions found on imaging (70/84). The primary diagnostic tools utilized were Whole body bone imaging (76.2%) and CT scans (60.1%), with less frequent use of MRI (22.6%) and positron emission tomography-computed tomography (PET-CT) (9.6%). Notably, only 14% of physicians reported never performing disease activity monitoring. Nearly all respondents (98%) selected nonsteroidal anti-inflammatory drugs (NSAIDs) as the first-line treatment. Additionally, 81% of physicians opted for target synthetic disease-modifying antirheumatic drugs (tsDMARDs), 78.6% for steroids, 71.4% for biological disease-modifying antirheumatic drugs (bDMARDs), 66.7% for conventional synthetic disease-modifying antirheumatic drugs (csDMARDs, and only 18.5% chose bisphosphonates (pamidronate and zoledronate). While Whole body bone imaging and CT scans are widely used for the early diagnosis of adult SAPHO syndrome, there is a gap in the utilization of MRI and the practice of disease activity monitoring. Physicians prefer commonly used rheumatic drugs, but there remains limited application of bisphosphonates. Highlight &#x2022; Our study first systematically investigated Chinese physicians' perspectives on the diagnosis and treatment of adult SAPHO syndrome. &#x2022; We pointed out that the utilization of imaging tools (such as MRI) and bisphosphonates was low, suggesting that the diagnostic strategy needs to be optimized. &#x2022; This study may aid the research of SAPHO syndrome at home and abroad, providing references.

Dissemination and implementation of socially prescribed community-based programmes for individuals with rheumatic conditions remain rare. However, such programmes can help overcome key barriers, including limited access to evidence-based psychological interventions, individuals' preference for psychosocial care outside of rheumatology clinics and the prevention of isolation and loneliness. This study presents a qualitative process evaluation of a community-based Acceptance and Commitment Therapy (ACT) group intervention, delivered as part of a psychosocial service within a support organization for individuals with rheumatic conditions. We conducted 12 semi-structured qualitative interviews following participants' completion of five in-person ACT group sessions. Reflexive thematic analysis was used to assess acceptability and explore how participants conceptualized ACT's processes of change. Four key themes emerged, offering practical considerations for planning and delivering ACT groups for individuals with rheumatic conditions: (1) the process of finding peace through mindfulness while managing practice-related difficulties, (2) recognizing the importance of making values-consistent choices, (3) navigating an ambivalent relationship with pain and (4) the dual nature of the group experience-both comforting and awkward. Findings highlight the implications of programme duration in planning ACT groups for individuals with rheumatic conditions in the community. The study suggests that acceptance and mindfulness may be time-bound and context-sensitive processes, influenced by the fluctuating symptomatology of rheumatic conditions. Mindfulness is best developed step by step, starting with body awareness, understanding symptoms and slowly bringing mindfulness into daily life. Pain acceptance should focus more on facilitating momentary patterns of activity engagement, rather than willingness towards the fluctuating symptoms.

The previously developed FLARE questionnaire assesses the multidimensional aspects of a flare of psoriatic arthritis (PsA). We aimed to further validate this questionnaire. Reanalysis of data from the ReFLAP study (ClinicalTrials.gov: NCT03119805), a longitudinal observational study carried out in 14 countries. Demographic, clinical, and patient-reported data were collected at baseline and 1 follow-up visit. The FLARE questionnaire (range 0-10) was completed at both timepoints (mean interval 4.5 months). Using a patient anchor question for perceived flare (yes/no), the optimal cutoff for defining a flare was obtained using receiver-operating characteristic curve analysis. Based on this cutoff, patients were compared for flare (yes/no) using clinical and patient-reported data, including composite measures of disease activity. The magnitude of score differences in patients experiencing a new flare at second visit were compared with independent samples t-scores. Of 147 patients, 61 (41%) reported a flare at baseline; the optimal score cutoff from the FLARE questionnaire was 4 (sensitivity 0.86, specificity 0.76) and, using this cutoff, patients in flare had significantly worse clinical and patient-reported outcomes. Of those patients reporting a flare, the most frequently affirmed items from the questionnaire referred to pain, mobility, frustration, and fatigue. Those with a new flare at the second visit had patient-reported and clinical change scores significantly worse than those not reporting a flare. This study has provided further data on the FLARE questionnaire performance and validity. The questionnaire is ready for use in clinical trials and longitudinal observational studies. PLAIN LANGUAGE SUMMARYPeople with psoriatic arthritis sometimes experience a flare of their disease. This can cause more pain in the joints, more inflamed skin, more fatigue, and worse mood. We have developed a questionnaire to measure these changes. In this study of 147 patients in 14 countries, we looked at how the questionnaire compared to other measurements of disease activity, including other patient-reported measures of disease impact. We found that patients reporting a flare of their disease, as defined by this questionnaire, reported worsening in all aspects of their disease, including in physical, emotional, and functional aspects. These results mean that the questionnaire can now be used in clinical practice and clinical trials for patients to indicate if they are having a flare.

Needs assessments in patients with juvenile idiopathic arthritis (JIA) have revealed a need for disease information, self-management skills, and peer support. We previously developed and tested the acceptability of an in-person and videoconference-based self-management program (SMP) to address these needs. The aim of this pilot randomized controlled trial (RCT; the VISTA-JIA trial) is to evaluate the feasibility and preliminary effectiveness of a virtual group-based SMP for adolescents with JIA in comparison to a waitlist control group. A total of 100 participants with confirmed JIA (aged 12-17 years) will be recruited from 5 Canadian pediatric rheumatology centers and randomized 1:1 to the intervention or waitlist control groups. Adolescents in the intervention group will receive the virtual SMP. Those randomized to the control group will receive standard of care alone and will later be eligible for the SMP. The SMP includes JIA disease education, self-management strategies, and peer support. Four 60- to 90-minute sessions will be conducted over 8 weeks with a group size of 4-6 participants. The primary feasibility outcome will be adherence to the SMP (defined as completion of all 4 sessions by at least 80% of participants). Other secondary feasibility outcomes will include recruitment and withdrawal rates, the proportion of completed questionnaires, engagement and satisfaction with the SMP measured through a semistructured virtual interview, and intervention fidelity (consistent content and technology delivery). Secondary preliminary effectiveness outcomes will be assessed by completing 5 validated questionnaires at pre- and postprogram time points: (1) the Medical Issues, Exercise, Pain, and Social Support Questionnaire to assess perceived ability to manage JIA (self-management); (2) the Children's Arthritis Self-Efficacy Scale to assess self-efficacy; (3) the Pediatric Quality of Life Inventory 3.0 Rheumatology-Teen Module to assess health-related quality of life; (4) the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference Scale to assess pain interference; and (5) Readiness for Adult Care in Rheumatology to assess transition readiness. Descriptive statistics and nonparametric tests will be used to analyze the data. The study setup is complete at all centers, including training of the facilitators, revising and finalizing education sessions, participant's handout guide, and fidelity checklist. Recruitment began in January 2024 and is expected to conclude by December 2025. Feasibility outcomes, including adherence and engagement, as well as preliminary effectiveness, will be analyzed post intervention. This is the first evidence-based, virtual, interactive, group-structured JIA SMP in Canada. This SMP will address needs for disease information, self-management skills, and peer support in adolescents with JIA. The results of this pilot study will inform a full-scale RCT focused on the efficacy and cost-effectiveness of the program with the goal of integration in routine clinical practice across Canada. ClinicalTrials.gov NCT06184100; https://clinicaltrials.gov/study/NCT06184100. DERR1-10.2196/69539.

Golimumab is a safe and effective treatment for patients with rheumatoid arthritis. Biosimilars to the reference product (RP; Simponi&#xae;) may make treatment more accessible. The aim of this study was to assess the efficacy of AVT05, a golimumab biosimilar, and RP, each used in combination with methotrexate, in participants with moderate-to-severe rheumatoid arthritis. This was a 52-week, randomized, double-blind, two-arm, parallel-group, active-controlled study. Participants were randomized 1:1 to receive AVT05 (n = 251) or RP (n = 251), 50 mg subcutaneously once every 4 weeks to Week 12 inclusive. Randomization was stratified by the baseline Disease Activity Score-28 for Rheumatoid Arthritis using C-Reactive Protein (DAS28-CRP) [&#x2264; 5.1 and > 5.1]. The primary endpoint was the change from baseline in DAS28-CRP at Week 16. At Week 16, responder participants (DAS28-CRP decreased by > 0.6 from baseline and disease activity DAS28-CRP &#x2264; 5.1) initially enrolled in the AVT05 arm continued to receive AVT05 every 4 weeks. Responder participants initially randomized to RP were re-randomized 1:1 to either continue receiving RP or switch to AVT05. Non-responders were discontinued from the study drug. Change from baseline in DAS28-CRP response criteria at weeks 4, 8, 12, 24, 32, 40, 48, and 52 and percentage of subjects achieving American College of Rheumatology 20/50/70 at weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 were assessed as secondary endpoints. Safety and immunogenicity endpoints were also assessed. At Week 16, the least squares mean (standard error) change from baseline in DAS28-CRP in AVT05 and RP was -&#xa0;2.89 (0.058) and -&#xa0;2.98 (0.058), respectively. The two-sided 95% confidence interval of the least squares mean difference (0.09; standard error 0.082) was entirely contained within the prespecified equivalence margin of -&#xa0;0.6, 0.6 (-&#xa0;0.07, 0.25), supporting a demonstration of comparative efficacy. Two sensitivity analyses (one [S1] without exclusion of any data because of intercurrent events, and one [S2] excluding data following intercurrent events or relevant protocol deviations) supported the robustness of the primary endpoint estimates (S1 95% confidence interval -&#xa0;0.07, 0.25; S2 95% confidence interval -&#xa0;0.07, 0.25). There were no notable differences in subgroup analyses. Secondary efficacy analyses were consistent with the primary endpoint, including in participants who switched treatments. Overall safety profiles showed no clinically meaningful differences between treatments, including in participants who switched treatments. Immunogenicity profiles were comparable between treatment arms at all timepoints, including in participants who switched treatments. Analysis of the change in DAS28-CRP from baseline to Week 16 supported the assessment of comparative efficacy between AVT05 and RP golimumab. Secondary efficacy endpoints were consistent with this, including in participants who switched. AVT05 had a safety and immunogenicity profile similar to that observed for RP at all timepoints, including in participants who switched&#xa0;treatments. The trial is registered at ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT05842213) and the EU Clinical Trials Register (EudraCT Number: 2022-001825-63).

Managing rheumatic diseases requires teamwork, but referral patterns and challenges remain poorly understood. This study explored rheumatologists' perspectives on referral patterns in the Gulf countries. We conducted a web-based, 21-question cross-sectional survey between November and December 2024, collecting data on rheumatologists' demographics, referral patterns, influencing factors, and satisfaction. Participants were recruited through email invitations, WhatsApp groups and snowball sampling. Statistical analyses included descriptive and inferential methods, such as subgroup comparisons and logistic regression, to identify predictors of referral frequency and satisfaction. A total of 149 rheumatologists participated, with 58.4% being consultants. Approximately 55% had up to 10 years of post-training experience. The primary referral method was electronic health records (EHR) (84.8%). In the three months preceding the survey, 36.3% made 0-10 referrals, while 35.6% made over 20. Dermatology (85.5%) and physiotherapy (79.5%) were the most referred specialties, aligning with psoriatic arthritis and systemic lupus erythematosus as the most referred diseases. Most rheumatologists (78%) often or always followed up on referrals, and 37.4% reported moderate changes in their referral decision-making over time. Key influences on referral decisions included patient-, practice-, and diagnostic-related factors. Patient gender preference had no impact. Multidisciplinary meetings (78.2%), access to updated clinical guidelines (76.5%), attending multidisciplinary continuing medical education or training programs (67.2%), and improved EHR referral systems (64.7%) were the top resources for improving referrals. Satisfaction post-referral was affected by various factors such as patients' experiences post-referral (61.5%), and healthcare professionals' responsiveness to their questions (54.2%). Logistic regression analysis showed that age, employment status, practice setting, and geographical location were associated with referral decisions. This study is the first to provide valuable insights into referral practices among Gulf rheumatologists, identifying key influencing factors and areas for improvement. Findings suggest that enhancing EHR systems, multidisciplinary meetings, and clinical guidelines can optimize referrals and interdisciplinary care.

OBJECTIVE: To provide the first nationwide description of biologic and targeted synthetic DMARD (b/tsDMARD) use among Estonian patients with rheumatoid arthritis (RA), focusing on treatment effectiveness, persistence, and reasons for discontinuation across sequential lines of therapy. METHODS: Data were obtained from the Estonian Biologic Therapy Registry covering years 2006&#x2013;2022. All adult RA patients who had received at least one dose of a b/tsDMARD were included. Effectiveness at 6 months was evaluated using DAS28-CRP as a continuous measure (&#x394;DAS28) and categorical response definitions: remission (DAS28&#x2009;&#x2264;&#x2009;2.6), low disease activity (LDA; DAS28&#x2009;>&#x2009;2.6 and &#x2264;&#x2009;3.2), and EULAR response criteria. Treatment persistence was analyzed using Kaplan&#x2013;Meier estimates, and reasons for discontinuation were categorized systematically. RESULTS: A total of 1,074 patients were analysed (78% female, mean age 53.7 years, 85% seropositive). Mean baseline DAS28-CRP was 5.1. The mean 6-month reduction in DAS28-CRP during first-line therapy was ~&#x2009;2.2 points. Remission was achieved in 35&#x2013;46% of patients across treatment lines 1&#x2013;5, with overlapping confidence intervals, while LDA occurred in about 12&#x2013;22% of patients. Drug survival was comparable between treatment lines: 60% of patients remained on therapy at 2 years, and the median time to discontinuation for first-line therapy was 1.66 years. Most patients initiated therapy with a TNF inhibitor and many continued within the same class before switching to IL-6 inhibitors, rituximab, or JAK inhibitors. The main reasons for discontinuation were loss or lack of efficacy (~&#x2009;50%) and adverse events (~&#x2009;27%), predominantly allergic reactions and infections. CONCLUSIONS: In real-world Estonian RA practice, biologic and targeted therapies were effective across multiple treatment lines, with the greatest improvement observed during first-line therapy and sustained clinical benefit in later lines. Treatment persistence remained stable despite multiple switches, and the distribution of discontinuation causes mirrored other European registries. These findings support the continued value of sequential b/tsDMARD therapy in achieving disease control among patients with difficult-to-treat RA.

Patients with RA are at an increased risk for serious infections, but less is known about more common, non-serious infections. We aimed to assess the frequency and characteristics of non-serious infections and their effect on medication interruptions, quality of life, and disease flares. We remotely recruited adults with RA from July 2022 to July 2023 through a community rheumatology practice-based research network. Participants joined the ArthritisPower Registry (now PatientSpot) and completed a baseline survey and up to six monthly follow-up surveys, focused on patient-reported outcomes (PROs), infections, medication interruptions, and disease flares. The impact of infections was evaluated by comparing survey measures in those with vs without an infection. We recruited 351 patients with RA who contributed 1674 monthly observations. Patients reported 523 infections (31% of observations), most frequently upper respiratory infections. Although few infections led to emergency department visits or hospitalizations, infections frequently led to missed work (37%) or RA treatment interruptions (26%). RA treatment interruptions were more common in those with vs without health-care encounters or antibiotic use (38% vs 12%) and in more severe vs less severe infections (47% vs 20%). Infections were associated with worse scores for fatigue but not function, depression, or social participation. Frequency of disease flares was greater in those with an infection who interrupted RA treatment, especially in patients receiving tumor necrosis factor (TNF) inhibitors. Infections are common in patients with RA and frequently lead to medication interruptions. These infections are associated with greater fatigue and impaired work productivity and may contribute to more disease flares.

Idiopathic inflammatory myopathies (IIM) are a heterogeneous group of rare systemic autoimmune rheumatic diseases. Despite advances in treatment, the definition of remission and low disease activity (LDA) in IIM remains inconsistent and lacks consensus and validation. This review summarizes existing published definitions, achievement rates, and predictive factors of remission/LDA in adult IIM, focusing on dermatomyositis (DM), polymyositis (PM), anti-synthetase syndrome (ASyS), and immune-mediated necrotizing myopathies (IMNM). Our literature review revealed a wide variability in remission definitions, incorporating physician assessment, muscle strength, laboratory normalization, and medication tapering or discontinuation. Some studies defined "remission on medication", while others required complete treatment cessation. Most definitions required a minimum duration of six months. Organ-specific remission (including for the skin, lung, and muscle domains) was inconsistently addressed. LDA has been less extensively studied in IIM, with the myositis disease activity assessment visual analog scales (MYOACT) being the only measure applied to DM. Remission rates varied widely, with stricter criteria yielding lower rates. Factors associated with remission included younger age, early immunosuppressive treatment, non-severe muscle involvement, the absence of myositis-specific autoantibodies (MSA), although some studies reported positivity for certain MSA were associated with remission. Conversely, remission was less likely for patients with PM, overlap myositis, and those positive for anti-TIF1-&#x3b3; or Ku autoantibodies. Standardized remission criteria incorporating physician assessment, patient assessment, organ-specific parameters, laboratory assessments, and sustained remission duration are essential for harmonizing clinical and research evaluations in IIM. Establishing uniform definitions will improve therapeutic outcome assessments and facilitate meaningful comparisons in clinical trials and real-world practice.

Inflammatory rheumatic diseases (IRDs) are chronic autoimmune conditions that affect a variety of organs and systems. These disorders have a major impact on hand function, restricting independence in daily activities and lowering quality of life. They are characterized by significant reductions in the hand's fine motor skills, grip strength, and coordination capacities. These impairments in hand function have a detrimental influence on physical capability, psychological adjustment, and occupational productivity. Since IRDs are chronic and progressive, early detection, continuous follow-up, and multifaceted rehabilitation strategies are essential. Self-report measures and performance-based assessments are utilized to evaluate hand function. Furthermore, imaging techniques, including ultrasonography, magnetic resonance imaging, and dual-energy computed tomography, provide an objective evaluation of subclinical inflammation and structural damage. Rehabilitation approaches, as a complement to medical care, play an important role in maintaining and enhancing hand function. Multicomponent therapies, including exercise, splinting, occupational therapy, manual therapy, massage, and patient education, are beneficial for preserving functional gains. Future research is anticipated to concentrate on discovering biomarkers for early diagnosis, creating sensor-based digital evaluation tools and telerehabilitation programs, and developing individualized, AI-powered rehabilitation procedures. These developments will make a substantial contribution to preserving hand function and enhancing the quality of life for IRD patients.

To evaluate the relative strength of clinical and sociodemographic predictors of health-related quality of life (HRQoL) in patients with rheumatoid arthritis (RA) under real-life conditions. This cross-sectional, observational study included adult patients fulfilling the 2010 American College of Rheumatology-European Alliance of Associations for Rheumatology classification criteria for RA, recruited from 11 public tertiary rheumatology centres in Brazil. To reflect real-life clinical practice, no restrictions were applied regarding disease stage or treatment status. HRQoL was assessed using the 12-item Short Form Health Survey (SF-12). Physical disability was measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI). Clinical and epidemiological variables were evaluated as candidate predictors. Associations were explored using bivariate analyses and multiple linear regression models. Standardised beta coefficients (z&#x3b2;) were used to estimate the relative strength of independent predictors. 1079 patients were included; 89.4% were women and 56.0% were white, with a mean (SD) age of 57.0 (11.4) years and a median (IQR) disease duration of 152 (84.0-242.0)&#x2009;months.In multivariate analysis, the following remained independently associated with physical score: HAQ-DI score (&#x3b2;=-3.92, 95% CI (-4.56 to -3.28), z&#x3b2;=-0.44, p<0.001), non-white race (&#x3b2;=-0.97, 95% CI (-1.80 to -0.14), z&#x3b2;=-0.71, p=0.022) and absence of regular physical activities (&#x3b2;=0.56, 95% CI (0.04 to 1.09), z&#x3b2;=-0.07, p=0.036).For mental score, remaining independent predictors were HAQ-DI (&#x3b2;=-5.00, 95% CI (-6.17 to -3.83), z&#x3b2;=-0.31, p<0.001), fibromyalgia (&#x3b2;=-5.52, 95% CI (-7.76 to -3.26), z&#x3b2;=-0.15, p<0.001), white race (&#x3b2;=3.32, 95% CI (1.79 to 4.84), z&#x3b2;=0.13, p<0.001), current smoking (&#x3b2;=-4.95, 95% CI (7.42 to -2.48), z&#x3b2;=-0.12, p<0.001), female biological sex (&#x3b2;=3.91, 95% CI (-6.36 to -1.46), z&#x3b2;=-0.10, p=0.002) and Simplified Disease Activity Index (&#x3b2;=-0.91, 95% CI (-0.17 to -0.02), z&#x3b2;=-0.09, p=0.018). Physical disability was the strongest determinant of impaired HRQoL in both physical and mental domains among participants with RA. Other relevant determinants of poorer physical HRQoL in descending order of relative strength were non-White race and absence of regular physical activity, while for poorer mental HRQoL, fibromyalgia, race, smoking status, female sex and disease activity. These findings reinforce functional preservation as a key therapeutic target in routine RA care.

Patient-reported outcomes (PROs) in systemic rheumatic diseases (SRDs) are in the forefront of clinical research. However, a comprehensive evaluation of PROs in pivotal trials supporting SRD drug approval is lacking. This study aims to systematically characterize the use of PROs in pivotal trials supporting the US Food and Drug Administration (FDA) approval of SRDs treatments and to assess the quality of reporting. We reviewed the pivotal trials supporting the approval of SRD indications by FDA since July 2013 to assess the use of PROs, including specific PRO measures (PROMs) and types of endpoints designated. Quality of PRO reporting was assessed according to a modified ISOQoL criteria. From July 1st, 2013, to June 30th, 2024, the FDA approved 43 new SRD indications based on 67 pivotal trials, with 58 trials included in the final analysis. PROs served as multiple types of endpoints in most trials. All 58 reviewed trials utilized PROs as secondary or exploratory endpoints. The numbers of trials that employed PROs as components of primary endpoints, co-primary endpoints, and key secondary endpoints, were 47(81.0%), 4(6.9%), 45(77.6%), respectively. Notably, the inclusion of PROs as components of composite primary endpoints or co-primary endpoints (100% vs. 8.3%, P&#x2009;<&#x2009;0.001) and key secondary endpoints (93.5% vs. 16.7%, P&#x2009;<&#x2009;0.001) were significantly higher in inflammatory arthritis compared to other SRDs. Regarding PROM types, 37 trials (63.8%) reported both generic and disease-specific PROMs, covering a broad range of domains. Quality of PRO reporting, influenced by disease type and the presence of additional PRO reports, was moderate to poor in 45 trials (81.8%). Key reporting elements, such as the PRO hypothesis, mode of PROMs completion, and extent and reasons for missing PRO data, were documented in fewer than 30% of the trials. PROs significantly impact SRDs drug approval decisions, especially for inflammatory arthritis. However, the overall quality of PRO reporting in pivotal trials of SRDs is suboptimal and needs improvement. Our study provides a comprehensive summary of PRO application in SRDs trials, highlighting the need for strengthening PRO utilization in non-arthritis SRDs and improving PRO reporting quality in future studies.

Radiographic joint space width (JSW) and MRI-based cartilage thickness are key imaging biomarkers in knee osteoarthritis (OA), yet their weak correlation complicates cross-modality interpretation. This mismatch may potentially be explained by differences in patient posture and joint loading, as radiographs are typically obtained in a weight-bearing and flexed position, whereas MRI scans are acquired in a non-weight-bearing and extended position. Using a 0.25&#xa0;T rotatable MRI scanner, 21 individuals with OA were scanned in four positions, extended and flexed in non-weight-bearing and weight-bearing conditions, to reflect typical clinical imaging conditions and functional joint motion and loading. Three-dimensional JSW and cartilage thickness maps of the tibia and femur were generated, registered to canonical surfaces, and analyzed vertex-wise using statistical parametric mapping. Spearman correlations between JSW and cartilage thickness were calculated for each position. JSW narrowed under weight-bearing, particularly medially, and showed a posterior shift with flexion, especially laterally. Femoral cartilage responded more to positional changes than tibial cartilage, showing posterior thinning and anterior thickening under weight-bearing flexion. Correlations between JSW and cartilage thickness strengthened while weight-bearing, especially posteriorly, but weakened anteriorly and laterally during flexion. Overall, moving from non-weight-bearing extension (MRI positioning) to weight-bearing flexion (radiograph positioning) improved JSW-cartilage correlations in the tibia and posterior femur. JSW and cartilage thickness are strongly influenced by joint loading and flexion. Weight-bearing flexion improves JSW-cartilage correspondence posteriorly but reduces it anteriorly. These findings primarily inform interpretation and standardization of imaging endpoints across modalities and imaging conditions; translation to routine clinical practice is currently limited by scanner availability and the modest magnitude of cartilage thickness differences.

Rheumatoid arthritis (RA) is a global health concern with increasing prevalence. Despite recommendations for regular disease activity assessments, their implementation in routine clinical practice remains challenging. The Medical Support System for Rheumatoid Arthritis (MiRAi) is an offline, semi-automated system that calculates disease activity indices by integrating patient and clinician inputs from electronic health records (EHRs). This study evaluated the association between MiRAi implementation and the frequency of disease activity assessments in patients with RA. We conducted a retrospective cohort study of patients with RA treated at a tertiary hospital in Japan between April 2022 and March 2023. We included all adult outpatients (aged &#x2265;18 years) with RA diagnosed according to the 2010 ACR/EULAR [American College of Rheumatology/European Alliance of Associations for Rheumatology] classification criteria. The hospital introduced MiRAi in June 2022 and achieved full deployment by October 2022. MiRAi calculated the clinical disease activity index (CDAI) and the modified health assessment questionnaire (mHAQ) through automated extraction of joint counts, patient global assessment, and functional status from structured EHR fields. Primary outcomes included the frequency of CDAI and mHAQ assessments. We administered a structured post-implementation survey to assess rheumatologists' perceptions of MiRAi. Physicians used MiRAi for 236/884 (26.7%) patients with RA. Patients with documented CDAI and mHAQ scores increased from 29 (5.9%) in June 2022 to 81 (19.0%) in November 2022, representing a 3.2-fold increase. Among surveyed rheumatologists (n=10), 5 (50%) reported the regular use of MiRAi. Physicians who regularly used MiRAi (n=5) cited improved accuracy in disease assessment and enhanced treatment decision-making. Non-users and occasional users (n=5) identified three primary barriers: limited familiarity with MiRAi, time constraints, and discrepancies between clinical judgment and MiRAi-generated outputs. Despite MiRAi's availability, only 168 (19%) patients underwent quantitative disease activity assessment by the study end. Among 15 patients with high disease activity (CDAI >22), physicians recorded 3 treatment modifications and 2 intra-articular steroid injections. MiRAi implementation increased disease activity assessment frequency by 3.2-fold over 6 months; however, physician adoption remained at 26.7%, below the 80% target for routine care. Future implementation strategies should address identified barriers through system integration, structured user training, and workflow optimization to achieve guideline-concordant care for patients with RA.

To develop evidence-based Pan American League of Associations for Rheumatology (PANLAR) recommendations for the treatment of oligoarthritis category in juvenile idiopathic arthritis (oligo-JIA) patients. A panel of pediatric rheumatologists from Latin-America (LATAM) generated clinically meaningful questions related to the treatment of oligo-JIA patients, using Population, Intervention, Comparator, and Outcome (PICO) format. Following Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, a team of methodologists conducted a systematic literature review, extracted, summarized intervention effect estimates, and graded the evidence quality. LATAM pediatric rheumatology experts' panel voted each PICO question, which required a minimum agreement of 70% among the voting members and developed recommendations. Seven recommendations and 4 expert opinion were developed. Short-term course of NSAID and intra-articular corticosteroids was recommended as initial therapy in those with minimal disease activity with no risk factors for poor prognosis. The initiation of a nbDMARD was recommended in patients with high disease activity and risk factors for poor prognosis. For patients who achieve inactive disease state, treatment with DMARD should be maintained for a minimum of 12 months after remission. We proposed sulfasalazine or leflunomide in patients with methotrexate intolerance, or in the presence of contraindication or unavailability of bDMARD. For oligo-JIA patients with high disease activity or uveitis, anti-TNF agents are recommended as the first choice among bDMARD. Regular physical activity was also recommended for these patients. The first PANLAR oligo-JIA treatment guidelines provide evidence-based guidance for health care providers, treating patients with oligo-JIA in LATAM.

Enthesitis is increasingly recognized as a key manifestation of psoriatic disease (PsD). However, how best to assess enthesitis remains a point of discussion due to limitations of the existing assessment tools, including their inability to differentiate between inflammatory and noninflammatory enthesitis as well as a high placebo response in clinical trials. At the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2024 annual meeting, a debate was held to address whether traditional clinical enthesitis indices should be discontinued for PsD. Dr. Sibel Aydin advocated for their discontinuation, emphasizing that clinical indices often capture "enthesalgia" (pain at the entheseal sites overlapping with pain disorders like fibromyalgia) rather than true inflammatory enthesitis. These clinical indices may lack specificity for detecting inflammation, which can lead to inaccurate assessments. Further, studies show high reports of placebo response when using clinical indices, suggesting their limitations in discriminating active disease from noninflammatory pain mechanisms. Aydin advocated for prioritizing emerging imaging tools over traditional clinical indices. Dr. Atul Deodhar argued against discontinuation of traditional clinical enthesitis indices, highlighting that despite limitations, these indices have been used successfully in multiple randomized controlled trials, leading to approval of numerous treatment options for psoriatic arthritis. Although promising, alternative imaging modalities like ultrasound to evaluate inflammation come with their own challenges, including operator dependency, variability in interpretation, and lack of regulatory approval as a standardized outcome measure. This report presents both perspectives, analyzing the evidence and implications for the future of enthesitis assessment in clinical practice.

Knee osteoarthritis (OA) is the most common chronic arthritis and is a leading cause of pain and disability. Chronic care model (CCM) has been proved successful in Hong Kong primary care setting. This study aims to assess the clinical effectiveness of a CCM, named Assessment and Management Program on Knee Osteoarthritis (RAMP-Knee OA), compared to usual care in adults with knee OA. The study is a 52-week, two-arm, parallel, open-label randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N&#x2009;=&#x2009;114) versus usual care (N&#x2009;=&#x2009;114) on self-reported knee pain and other secondary outcomes. Measurement instruments will be tested at baseline, 16, 32, and 52&#xa0;weeks. The primary outcome will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; 5-point Likert) pain at 52&#xa0;weeks. Secondary outcomes include a set of biopsychosocial parameters: Physical function will be measured subjectively by WOMAC function subscale and objectively by the 30-second chair and stand performance test. Lower limb muscle mass will be measured by bioimpedance analysis. Physical activity level will be measured by the Chinese International Physical Activity Questionnaire (Short form). Self-management efficacy will be measured by Pain-Self Efficacy questionnaire. Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) will be used to measure anxiety and depression, respectively. Insomnia will be measured by the 7-item Insomnia Severity Index (ISI), and loneliness will be measured by the 6-item De Jong Gierveld Loneliness Scale. EuroQuol-5D questionnaire will be used to measure health-related quality of life. Both primary and secondary outcomes at different points will be conducted using analysis of covariance, adjusting for baseline values. Secondary analyses include adjustments for potential confounders and exploration of interaction effects of treatment and the potential moderators. The findings will address the evidence-to-practice gap for the implementation of a CCM that incorporates a comprehensive risk assessment, care protocol, self-management support, and scheduled health assessments in Hong Kong. ClinicalTrials.gov, 1 NCT06283147. Registered on 22 February 2024.