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ObjectivesSince the 2007 recommendations for the management of early arthritis have been presented, considerable research has been published in the field of early arthritis, mandating an update of the 2007 European League Against Rheumatism (EULAR) recommendations for management of early arthritis.MethodsIn accordance with the 2014 EULAR Standardised Operating Procedures, the expert committee pursued an approach that was based on evidence in the literature and on expert opinion. The committee involved 20 rheumatologists, 2 patients and 1 healthcare professional representing 12 European countries. The group defined the focus of the expert committee and target population, formulated a definition of ‘management’ and selected the research questions. A systematic literature research (SLR) was performed by two fellows with the help of a skilled librarian. A set of draft recommendations was proposed on the basis of the research questions and the results of the SLR. For each recommendation, the categories of evidence were identified, the strength of recommendations was derived and the level of agreement was determined through a voting process.ResultsThe updated recommendations comprise 3 overarching principles and 12 recommendations for managing early arthritis. The selected statements involve the recognition of arthritis, referral, diagnosis, prognostication, treatment (information, education, pharmacological and non-pharmacological interventions), monitoring and strategy. Eighteen items were identified as relevant for future research.ConclusionsThese recommendations provide rheumatologists, general practitioners, healthcare professionals, patients and other stakeholders with an updated EULAR consensus on the entire management of early arthritis.

ObjectivesThis post hoc analysis assessed speed, magnitude and maintenance of pain improvement in patients with early rheumatoid arthritis (RA) receiving baricitinib, baricitinib and methotrexate (MTX), or MTX over 1 year. Cumulative pain and quality of life benefits were also assessed.MethodsRandomised, double-blind, phase 3 study RA-BEGIN (NCT01711359) compared baricitinib 4 mg (N=159), baricitinib 4 mg +MTX (N=215) and MTX (N=210) in patients with RA who had no or limited prior disease-modifying antirheumatic drug treatment. Pain was assessed on a 0–100 mm Visual Analogue Scale (VAS). Proportion of patients with ≥30%, ≥50% and ≥70% pain improvement from baseline; ≤20 mm and ≤10 mm on the pain VAS; and time to achieve pain improvement thresholds were assessed over 52 weeks, as were Patient Global Assessment (PtGA) and 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS) outcomes.ResultsBaricitinib monotherapy or combination with MTX provides greater (least square mean changes (LSM) from baseline −40 mm and −43 mm, respectively) and more rapid (median 12 and 8 weeks to ≥70% improvement, respectively) pain relief than MTX alone (LSM −31 mm, median 20 weeks to ≥70% improvement) over 52 weeks. Baricitinib, alone or combination, provides 9–10 additional weeks of limited to no pain, similar gain in achievable wellness measured through PtGA, and 5–7 additional weeks with change in SF-36 PCS ≥5 vs MTX over 1 year.ConclusionsPatients treated with baricitinib reported significantly greater and more rapid pain relief, more weeks with limited to no pain, and clinically meaningful improvements in physical health than patients treated with MTX alone over 1 year.

Background While risk factors for difficult-to-treat rheumatoid arthritis (D2TRA) have been studied in recent years, no studies have determined if there are differences between early and late developers of D2TRA. This study investigates whether patients can be classified by time to D2TRA development and examines risk factors for earlier onset. Patients and methods Observational study involving D2TRA patients whose reason for switching b/tsDMARD therapy was inefficacy (D2TRA-Inneficacy). Demographic data, comorbidities and disease characteristics, acute phase reactants and Disease Activity Score-28 [DAS28-ESR]) at baseline and 6 months after initiation of the first b/tsDMARD, and duration of each treatment were recorded. Using LASSO (Least Absolute Shrinkage and Selection Operator) Cox-regression feature-selection strategy, we identified those factors influencing the time to D2TRA-Inneficacy. DBSCAN clustering was conducted to identify subgroups based on time to D2TRA. Finally, we used ROC and Precision-Recall curves in tandem with the Youden index to establish a cutoff point for differentiating early and late-D2TRA. Results Of the 131 patients with D2TRA, 96 (72.7%) were classified as D2TRA-inefficacy. The variables presence of anxiety-depressive syndrome (ADS) at first b/tsDMARD, CRP at 6 months after starting the first b/tsDMARD and age at disease diagnosis were selected based on their contracted scores from the LASSO Cox-regression model, following the criterion of minimizing the cross-validated error. DBSCAN clustering based on selected variables identified three clusters. These clusters, differentiated by time to D2TRA, classified patients into early and late D2TRA groups. Finally, an optimal cut-off point of 44.5 months was determined using the Youden index to distinguish between the two groups. Conclusion In our cohort, the cut-off time for defining early developers of D2TRA-inefficacy was 44.5 months. The presence of ADS diagnosis, a higher CRP 6 months after the first b/tsDMARD, and being older at diagnosis were predictors of early development of D2TRA.

ObjectiveTo examine the performance of the new 2022 American College of Rheumatology (ACR)/EULAR giant cell arteritis (GCA) classification criteria for diagnosis in routine clinical care.MethodsMulticentric retrospective observational study of patients referred to two ultrasound (US) fast track clinics. Patients with GCA were compared with unselected controls with suspected GCA. The gold standard for GCA diagnosis has been clinical confirmation after 6 months of follow-up. All patients underwent an US exam of temporal and extracranial arteries (carotid, subclavian and axillary) at baseline. Fluorodeoxyglucose-positron emission tomography/CT was performed according to standard clinician criteria. The performance of the new 2022 ACR/EULAR GCA classification criteria was evaluated in all patients with GCA across different subsets of the disease.ResultsA total of 319 patients (188 cases, 131 controls) were included for analysis (mean age 76 years, 58.9% females). Overall, the 2022 EULAR/ACR GCA classification criteria had a sensitivity of 92.6% and a specificity of 71.8%, using GCA clinical diagnosis as external criterion and the area under the curve (AUC) was 0.928 (95% CI 0.899 to 0.957). Isolated large vessel-GCA showed a sensitivity of 62.2% and a specificity of 71.8% (AUC 0.691 (0.592 to 0.790)), while biopsy‐proven GCA showed a sensitivity of 100% and a specificity of 71.8% (AUC 0.989 (0.976 to 1)). Overall sensitivity and specificity of the 1990 ACR criteria was 53.2% and 80.2%, respectively.ConclusionsThe new 2022 ACR/EULAR GCA classification criteria showed adequate diagnostic accuracy in patients with suspected GCA under routine care, and an improvement on the sensitivity and specificity of the 1990 ACR classification criteria in all patient subsets.

Objective To determine the usefulness of power Doppler (PD) ultrasound (US) to predict rheumatoid arthritis (RA) development in patients with clinically suspect arthralgia (CSA). Methods Retrospective analysis of a US unit cohort over a 1-year period. Patients with CSA and no previous diagnosis of inflammatory arthritis (IA) were included for analysis. All underwent bilateral US examination of the hands and/or feet according to the EULAR guidelines. Active US inflammation was defined as PD synovitis and/or tenosynovitis ≥1 at any location. RA diagnosis according to clinician criteria 6 months after the US examination was checked. Univariate and multivariate logistic regression models were employed to investigate possible predictive factors of RA development. Results A total of 110 CSA patients (80 females, mean age 53.6 years) were included for analysis. After 6 months of follow-up, 14 (12.7%) developed RA and 34 (30.9%) IA. US active inflammation was present in 38 (34.5%) patients (28.2% showed PD synovitis and 18.2% PD tenosynovitis). Multivariate analysis showed that ACPA ( OR 1.0003; 95% CI 1.002–1.006) and ESR ( OR 1.054; 95% CI 1.016–1.094) were significantly associated with the detection of US active inflammation at baseline. Only PD tenosynovitis was found to be an independent predictive factor of an evolution towards RA ( OR 6.982; 95% CI 1.106–44.057) and IA ( OR 5.360; 95% CI 1.012–28.390). Conclusion US is able to detect features of subclinical inflammation in CSA patients, especially in those with higher ESR and ACPA values. Only PD tenosynovitis at baseline US assessment was found to be an independent predictor of RA and IA development in CSA patients.

Background Opioids are not recommended for fibromyalgia. Objective To investigate the frequency of opioid use in a large cohort of fibromyalgia patients and to identify factors associated with opioid consumption. Methods A retrospective, observational study of a large fibromyalgia cohort in a tertiary care center. We assessed fibromyalgia severity, functional capacity, anxiety, depression, drugs consumption and the patient’s impression of change. We compared strong opioid consumers (SOC) and non-SOC. Inferential statistical and logistic regression analysis were used to identify factors associated with opioid consumption, and ANOVA for repeated measurements. Results We found a prevalence of 9.2% of SOC (100 patients) among 1087 patients in the cohort. During the last four years there was a significant increase on the incidence of SOC up to 12.8% ( p  = 0.004). There were no differences in demographic variables between SOC and non-SOC. Clinical variables were significantly more severe in SOC, and they consumed more non-opioid drugs ( p  < 0.0001). Opioid consumption was independently associated with other non-opioid drugs (Odds ratio 1.25, CI: 1.13–1.38), but not with the fibromyalgia severity. At three months, 62% of the patients had opioid withdrawal. There were no statistical differences in the fibromyalgia severity at the initial evaluation, or the patient’s impression of change compared with those patients who continued opioids. Coping strategies were better in those patients who withdrew opioids ( p  = 0.044). Conclusions We observed an increase in opioid prescriptions during the last four years. Opioid consumption was associated with concomitant use of non-opioid drugs, but it was not associated with fibromyalgia severity.

ObjectivePatients with severe refractory systemic lupus erythematosus (srSLE) exhibit failure to respond to treatments, progressive organ damage, and high mortality. Traditionally manufactured CD19-directed CAR T-cell therapies have potential to promote full clinical remission in srSLE. YTB323 (rapcabtagene autoleucel) is a novel, rapidly manufactured, autologous CD19-directed CAR T-cell therapy. The objective of this study is to determine the safety, efficacy and cellular kinetics of YTB323 in patients with srSLE.MethodsAn open-label, single-arm, multicentre phase 1/2 study (NCT05798117) to assess the safety, efficacy and cellular kinetics of YTB323 in patients with srSLE is currently ongoing. Safety data including adverse events (AEs), severe AEs, deaths, vital signs, electrocardiogram and laboratory assessments and preliminary efficacy data including SLE Disease Activity Index (SLEDAI) and Physician’s Global Assessment (PhGA) were collected. Pharmacokinetics (PK) data monitored by quantitative polymerase chain reaction and flow cytometry, and biomarker data including levels of B cells, T cells, immunoglobulin (Ig)G, IgA, IgM, complement C3 and C4 and anti-dsDNA were also collected.ResultsWe present safety, preliminary efficacy and biomarker data for six patients (data cutoff: December 2023), and available PK data for two patients who received YTB323 treatment (data cutoff: August 2023). Transient lymphodepletion-related cytopenia (grade 3 or 4) was observed in all six patients, as expected. Hypogammaglobulinaemia, which did not require intravenous immunoglobulin treatment, was a common AE. Cytokine release syndrome (grade 1 [n=1] or 2 [n=3]) was observed in four of six patients, and all events resolved following treatment with tocilizumab. No events of immune cell-associated neurotoxicity syndrome were reported. Infectious complications included pneumonia in one patient (grade 2). Preliminary efficacy and biomarker data for six patients indicated considerable reductions in SLEDAI (figure 1a) and PhGA (figure 1b) accompanied by improvements in relevant disease biomarkers such as anti-dsDNA (figure 1c), complement levels (figure 2a-b), and proteinuria, as well as deep B-cell depletion with subsequent B-cell recovery. PK assessment confirmed CAR T-cell expansion for the two patients with evaluable PK data.Abstract LBP1 Figure 1Individual efficacy parameters over timeAbstract LBP1 Figure 2Complement levels over timeConclusionsInterim data from this clinical trial suggest favourable safety, CAR T-cell expansion, B-cell depletion and initial efficacy of YTB323 in srSLE, supporting its continued evaluation.

Objective To evaluate the impact of cardiovascular risk (CVR) on the diagnostic accuracy of the ultrasonographic (US) Halo Score in patients with suspected giant cell arteritis (GCA). Methods Retrospective observational study of patients referred to our US fast track clinic with suspected GCA for a 2-year period. The intima-media thickness (IMT) of cranial and extra-cranial arteries and the Halo Score was determined to assess the extent of vascular inflammation. The European Society of Cardiology Guidelines on CV Disease Prevention were used to define different categories of CVR and patients were classified according to the Systemic Coronary Risk Evaluation (SCORE). The gold standard for GCA diagnosis was clinical confirmation after a 6-month follow-up. Results Of the 157 patients included, 47 (29.9%) had GCA after a 6-month follow-up. Extra-cranial artery IMT was significantly higher in patients with high/very high CVR than in those with low/moderate CVR, but only among patients without GCA. Non-GCA patients with high/very high CVR had also a significantly higher Halo Score in contrast with low/moderate CVR [9.38 (5.93) vs 6.16 (5.22); p  = 0.007]. The area under the ROC curve of the Halo Score to identify GCA was 0.835 (95% CI 0.756–0.914), slightly greater in patients with low/moderate CVR (0.965 [95% CI 0.911–1]) versus patients with high/very high CVR (0.798 [95% CI 0.702–0.895]). A statistically weak positive correlation was found between the Halo Score and the SCORE ( r 0.245; c  = 0.002). Conclusions Elevated CVR may influence the diagnostic accuracy of the US Halo Score for GCA. Thus, CVR should be taken into consideration in the US screening for GCA.