OBJECTIVES:To characterize the longitudinal evolution of B-cell biomarkers in patients with primary Sjögren's disease (SjD) and analyse their association with the clinical disease course. METHODS:We analysed data from the French multicentre prospective ASSESS cohort. Patients fulfilling AECG criteria with ≥2 visits including both immunological assessments and ClinESSDAI scores over a 5 years follow-up were included. Baseline B-cell biomarkers included immunoglobulin levels, monoclonal component, cryoglobulinaemia, complement fractions, RF and β2-microglobulin. Disease activity was assessed using ClinESSDAI score. Associations between the number of abnormal B-cell markers and disease activity were analysed using ANOVA and Kruskal-Wallis tests. Changes in IgG were evaluated according to the biological domain of the STAR index, defined as a relative decrease ≥10%. RESULTS:Among the 395 ASSESS participants, 362 met inclusion criteria. Mean follow-up was 56.4 months (±10.6), with a mean of 5.3 visits per patient (±0.5). B-cell biomarkers remained stable in 80.5%. According to STAR criteria, 43.1% were classified as biological responders to the biological domain of STAR based on IgG decrease, occurring mostly within the first year, without correlation with changes in ClinESSDAI or ESSPRI. Although baseline ClinESSDAI did not differ by the number of B-cell abnormalities (P = 0.096), patients with multiple B-cell activity markers-particularly ≥5-had an increased risk of persistent or worsening disease (OR 4.6, 95% CI 1.2-17.8; P = 0.002). CONCLUSION:B-cell biomarkers profile in SjD is largely stable over time. However, a high baseline 'B-cell burden' identifies patients at risk of poorer outcomes, supporting their use for stratification and monitoring.
OBJECTIVES:Ultrasound (US) is a valuable tool to detect inflammation in peripheral psoriatic arthritis (pPsA). This multicentre study assessed the intra- and inter-reader reliability of US-detected elementary lesions in peripheral psoriatic arthritis (pPsA) and evaluated the impact of standardized training on reliability, as a first step to guide multicentre assessment in the APACHE cohort. METHODS:A cross-sectional study was conducted to analyse the reliability of pPsA US lesions, as a first step in an ongoing predictive cohort (APACHE, NCT03768271) study. Three web-based reliability exercises were carried out between 2020 and 2024. Inter-rater and intra-rater reliability were assessed using Light's kappa (κ). During the third reliability exercise, a reference atlas of elementary US lesions in dactylitis was developed. RESULTS:Experienced and trainee sonographers from 30 recruiting centres participated into the study. In step 1, intra-reader kappas were moderate-to-good for synovitis (0.50-0.80), tenosynovitis (0.51-0.63), enthesitis (0.62-0.73), and poor for dactylitis (0.31-0.47); inter-reader kappas were lower for synovitis (0.32-0.70), tenosynovitis (0.40-0.49), enthesitis (0.47-0.60) and dactylitis (0.13-0.24). In Step 2, reliability improved notably in expert and trainees except for dactylitis [intra-reader: synovitis (0.81-0.90), tenosynovitis (0.66-0.83), enthesitis (0.61-0.81), dactylitis (0.37-0.47); inter-reader: synovitis c(0.72-0.84), tenosynovitis (0.55-0.76), enthesitis (0.37-0.59), dactylitis (0.12-0.30)]. Step 3 achieved moderate-to-good reliability for dactylitis (intra 0.69-0.80, inter 0.46-0.68). An atlas was produced based on expert consensus and lesion identification rates among sonographers. CONCLUSION:Standardized training was associated with a marked improvement in intra- and inter-reader reliability for the assessment of elementary pPsA lesions. The consensus-based US atlas provides practical guidance for identifying challenging dactylitis-related lesions in clinical and research settings.
Objective The field of rheumatoid arthritis (RA) is moving towards identification of and intervention in people at risk of RA, but a validated risk stratification method is lacking. This work was undertaken to develop a risk stratification method for persons presenting with arthralgia considered to be at risk of RA. Methods A joint EULAR/American College of Rheumatology (ACR) expert committee was established. Risk factor and outcome data from 10 arthralgia cohorts (including clinically suspect arthralgia and autoantibody-positive arthralgia) were studied. The work focused on differentiating the risk of progression to clinically apparent inflammatory arthritis (IA) within 1 year, using clinical and serologic variables, without and with subclinical joint inflammation detected by ultrasound (US) or magnetic resonance imaging (MRI). Developing RA according to the 2010 EULAR/ACR criteria within 1 year was a secondary outcome. A set of validated risk stratification criteria was developed. Results Using data from 2,293 symptomatic at-risk individuals, a stratification method was derived consisting of 6 clinical and serologic variables (morning stiffness, patient-reported joint swelling, difficulty making a fist, C-reactive protein, rheumatoid factor, and anti-citrullinated peptide antibody) yielding an area under the curve (AUC) of 0.80 (95% confidence interval [CI] 0.77-0.83) for IA development. The inclusion of US variables did not increase the discriminative ability. When MRI-detected subclinical inflammation variables were included, the AUC was 0.87 (95% CI 0.82-0.90). In the presence of clinical, serologic, and MRI variables, a sensitivity and specificity of >75% was achieved. For RA development, the AUC of the criteria with MRI was 0.93 (95% CI 0.90-0.97). Conclusions EULAR/ACR risk stratification criteria have been developed for people with arthralgia in secondary care who are considered at risk for RA. The criteria can be applied in the absence or presence of imaging data and have been developed to define homogeneous risk groups for future prevention trials.
OBJECTIVE:The objective of this study was to assess whether polypharmacy (PP) was associated with treatment response and serious adverse events (SAEs) in early rheumatoid arthritis (RA). Additionally, we aimed to investigate whether PP could serve as a surrogate marker for comorbidities. METHODS:We used data from the French cohort ESPOIR, a prospective study of early RA. PP was defined as a categorical variable stratified into two or three categories according to median of distribution in the cohort. A logistic regression model was used. We assessed the occurrence of SAEs (severe infections, hospitalizations, deaths) throughout a 10-year follow-up period. RESULTS:The proportion of patients who achieved DAS 28 remission (REM) one year after the initiation of the first disease-modifying antirheumatic drug (DMARD) was 32.1% in the PP group versus 67.9% in the non-PP group (P = 0.07) from 497 patients included. At five years, the proportion with REM was 45.0% in the PP group versus 56.3% in the non-PP group (P = 0.03). Patients taking two or more medications (excluding RA therapy) had a 40% lower likelihood of achieving REM at five years (adjusted odds ratio [OR] 0.60 [95% confidence interval (CI) 0.38-0.94], P = 0.03). At 10 years, patients receiving multiple medications had a 43% lower probability of achieving REM (adjusted OR 0.57 [95% CI 0.34-0.94], P = 0.02). The incidence of SAEs was 61 per 1,000 person-years. Among patients who developed SAEs, 86.4% were in the PP group and 49.8% were in the non-PP group (P = 0.03). CONCLUSION:PP is associated with a poorer treatment response and increased risk of SAEs. PP may serve as a good surrogate marker of comorbidities in epidemiologic studies.
There is accumulating evidence that inflammation is a key driver of atherosclerosis development and thrombotic complications. This pathophysiological mechanism explains, at least in part, the increased cardiovascular risk of patients with immune-mediated arthritis. Experimental and clinical studies have shown that tumour necrosis factor (TNF) plays a pathological role in both vascular and joint diseases, suggesting that TNF inhibitors (TNFis) may limit cardiovascular events in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SpA). This review summarizes studies exploring the effects of TNFis on cardiovascular outcomes in patients with RA, PsA or SpA. Clinical studies suggest that TNFis reduce vascular inflammation and may improve (or prevent worsening of) endothelial dysfunction and arterial stiffness. There is evidence that TNFis reduce the incidence of cardiovascular events in patients with inflammatory arthritis compared with non-biological treatments, particularly in patients with rheumatoid arthritis. Fewer studies have compared the effects of different classes of biological therapy on outcomes, but found no significant difference in the risk of cardiovascular events between patients taking TNFis and other biological therapy. In contrast, patients at high cardiovascular risk may derive greater benefit from a TNFi than from a Janus kinase inhibitor (JAKi). The cardiovascular impact of JAKis is still under debate, with a recent safety warning. Targeted control of inflammation is a key strategy to reduce the risk of major adverse cardiovascular events in patients with inflammatory arthritis. Cardiovascular evaluation and risk stratification, using a multidisciplinary approach involving rheumatology and cardiology teams, are recommended to guide optimal immunomodulatory treatment. Inflammation in blood vessel walls can lead to serious cardiovascular conditions, such as heart attacks, strokes or sudden death. Excess inflammation in autoimmune arthritic conditions like rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (SpA) places people with these conditions at high risk of developing cardiovascular disease (CVD). Treatments for inflammatory arthritis suppress inflammation, so they may also reduce the risk of CVD. Potent anti-inflammatory drugs called biologicals (injected into the blood vessels [intravenous] or beneath the skin [subcutaneous]) are used when conventional drugs cannot control symptoms. This review evaluates research into the effects of biologicals called tumour necrosis factor inhibitors (TNFis) on CVD in people with RA, PsA or SpA. TNFis suppress some of the changes to the structure and function of blood vessels that can lead to CVD. TNFis also reduce the incidence of cardiovascular events in people with inflammatory arthritis compared with non-biological treatments, particularly in people with RA. Less is known about whether TNFis reduce the risk of CVD compared with other types of biological treatment or Janus kinase inhibitors (JAKis), but people at high cardiovascular risk may derive greater benefit from a TNFi than a JAKi. Assessing and managing cardiovascular risk is important when caring for people with inflammatory arthritis. Effective control of inflammation relieves arthritic symptoms and reduces the CVD risk. People with inflammatory arthritis and CVD may also need treatment for other cardiovascular risk factors (e.g. high blood pressure or cholesterol), requiring effective communication between different healthcare providers (e.g. rheumatologists and cardiologists).
OBJECTIVES:The field of rheumatoid arthritis (RA) is moving towards identification of and intervention in people at risk of RA, but a validated risk stratification method is lacking. This work was undertaken to develop a risk stratification method for persons presenting with arthralgia considered to be at risk of RA. METHODS:A joint European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) expert committee was established. Risk factor and outcome data from 10 arthralgia cohorts (including clinically suspect arthralgia and autoantibody-positive arthralgia) were studied. The work focused on differentiating the risk of progression to clinically apparent inflammatory arthritis (IA) within 1 year, using clinical and serologic variables, without and with subclinical joint inflammation detected by ultrasound (US) or magnetic resonance imaging (MRI). Developing RA according to the 2010 EULAR/ACR criteria within 1 year was a secondary outcome. A set of validated risk stratification criteria was developed. RESULTS:Using data from 2293 symptomatic at-risk individuals, a stratification method was derived consisting of 6 clinical and serologic variables (morning stiffness, patient-reported joint swelling, difficulty making a fist, C-reactive protein, rheumatoid factor, and anti-citrullinated peptide antibody) yielding an area under the curve (AUC) of 0.80 (95% CI, 0.77-0.83) for IA development. The inclusion of US variables did not increase the discriminative ability. When MRI-detected subclinical inflammation variables were included, the AUC was 0.87 (95% CI, 0.82-0.90). In the presence of clinical, serologic, and MRI variables, a sensitivity and specificity of >75% was achieved. For RA development, the AUC of the criteria with MRI was 0.93 (95% CI, 0.90-0.97). CONCLUSIONS:EULAR/ACR risk stratification criteria have been developed for people with arthralgia in secondary care who are considered at risk for RA. They can be applied in the absence or presence of imaging data and have been developed to define homogeneous risk groups for future prevention trials.
OBJECTIVES:To describe the design and methodology of APACHE, a cohort of patients with early peripheral psoriatic arthritis (pPsA), and to assess the main baseline clinical characteristics of the first included patients. METHODS:APACHE is an ongoing prospective multicentre national cohort (NCT03768271) with a planned follow-up of 10years. Included patients have recent-onset (<12months) peripheral arthritis, a personal and/or family history of psoriasis, pPsA diagnosed by a rheumatologist, and no history of targeted disease-modifying antirheumatic drug therapy. At inclusion, demographic data, disease activity, comorbidities, and imaging results (not reported here) are collected. A descriptive analysis of these data was performed. RESULTS:The first 186 study patients had a mean age of 44±11years and mean arthritis duration of 6±4months; 84 (45%) were women; 169 (91%) had a history of psoriasis (mean duration, 14years) and 71 (38%) were receiving methotrexate. Disease activity was moderate with a mean DAPSA score of 19±14 and mean swollen and tender joint counts of 2.1±3.2 and 6.0±8.0, respectively. The initially involved joints were mainly the hands (40%) and knees (28%). Entheseal pain (39%) was more prevalent than dactylitis (27%). Comorbidities were common, with obesity in 27% and at least one cardiovascular risk factor or disease in 49% of patients. CONCLUSION:Patients with early peripheral PsA had moderate disease activity, a predominant oligoarticular profile, and a high prevalence of entheseal pain.
Background:Few real-life long-term data depending on patient age are available in patients starting tocilizumab (TCZ) treatment for rheumatoid arthritis (RA). Objectives:This study aimed to compare patient characteristics and long-term management with TCZ in RA patients over and under 75 years of age. Methods:This real-world study was based on secondary data from the French National administrative Healthcare database (SNDS). Eligible adult patients were diagnosed with a RA, and had a first TCZ delivery between 2015/01/01 and 2016/12/31 (index date). Patient data were extracted for the 4 years prior to the index date, and until 2019/12/31. All data were described according to patient age at the index date (<75 and ≥75 years). Therapeutic lines were described from the index date. Maintenance of TCZ therapy was analyzed using the Kaplan Meier method. Adverse events were described using adjusted Hazard Ratios (aHR; reference: age <75 years). Results:Among the 4,290 analyzed patients (mean age: 57 ± 14 years; female: 77.4%), 3,888 (90.6%) were aged <75 years and 402 (9.4%) were older. Most patients were treated with disease-modifying antirheumatic drugs (DMARDs) for more than 1 year prior to TCZ initiation (<75 years: 83.6%, ≥75 years: 69.9%). At the index date, 48.5% of elderly received SC TCZ (<75 years: 58.1%), 66.2% had TCZ monotherapy (vs. 51.2%), and 83.3% corticosteroids (vs. 76.1%). The median time of TCZ maintenance was similar in both groups [ <75 years: 17.9 months, 95% CI (16.6-19.5); ≥75 years: 14.9 months (11.6-18.6)]. Over follow-up, patients aged at least 75 years experienced more severe and opportunistic infections than younger patients [17.7 vs. 6.9 events per 100 patient-year, aHR: 1.80; 95% CI (1.53-2.13)], acute cardiovascular events [5.6 vs. 1.4; 2.13 (1.60-2.83)], hematological complications [2.0 vs. ≤ 1.0; 1.88 (1.22-2.91)], and deaths [4.7 vs. ≤ 1.0; 3.71 (2.64-5.21)], but no differences were observed for hepatitis, cancer, allergic reaction, and digestive perforation. Conclusion:This large French nationwide study conducted in patients who initiated TCZ for RA provide reassuring results for patients aged at least 75 years compared to younger patients, in particular regarding treatment maintenance. No new safety signals were identified in elderly patients.
Objectives: This study aimed to evaluate the 10-year clinical outcome of patients with recent-onset axial spondyloarthritis (axSpA). Methods study design: The DESIR cohort is an inception cohort of axSpA patients. Methods diagnosis and management: The diagnosis and management of patients were based on the decision of the treating rheumatologist. Methods statistical analysis: Both complete cases and imputed data analyses were conducted. Results: Of the 708 enrolled patients, 45 were excluded due to a change in the baseline diagnosis, 3 patients died, and 300 were lost to follow-up over the 10 years. In the completer population, one patient required bilateral total hip replacement, and 56 patients received a pension due to invalidity. The prevalence of main extra-musculoskeletal features increased from baseline to year 10: psoriasis from 18% to 30%, acute anterior uveitis from 10% to 18%, and inflammatory bowel disease from 5% to 10%. The most frequent comorbidity was hypertension, with an increase from 5% to 15% from baseline to year 10. In the imputed data analysis the estimated proportions of patients with an acceptable status at year 10 were 70% [95% CI: 63; 77] for acceptable PASS, 43% [95% CI: 37; 49] for BASDAI < 3, and 48% [95% CI: 41; 56] for ASDAS < 2.1. Conclusion: These findings suggest that despite a quite favorable 10-year outcome exists for severe outcomes, a large proportion of patients present with an important disease burden reflected by patientreported outcomes. This information can be valuable for providing patients with information at the time of diagnosis.
Background: We aimed to evaluate the value of the Fibrosis-4 (FIB-4) score as a prognostic factor in RA in the prospective ESPOIR cohort. Methods: We included patients from the ESPOIR cohort with a diagnosis of RA according to ACR/EULAR criteria. The formula for the FIB-4 score is as follows: [age (years) × aspartate transaminase level (U/L)]/[platelet count (109/L) × alanine aminotransferase level (U/L)1/2]. We used a linear mixed-effects model with a random effect of patient to account for repeated measures over time. Results: Overall, 647 of the 813 patients included met the ACR/EULAR criteria for RA, with no differential diagnosis during the first 10 years of follow-up. Of these patients, at baseline, 633 had a calculable FIB-4 score. Median FIB-4 score was 0.75 (interquartile range 0.53–0.99). On multivariate analysis, FIB-4 score was not independently associated with progression of Disease Activity Score in 28 joints over 10 years of follow-up, unlike baseline C-reactive protein level and SJC. Baseline FIB-4 score was not associated with the modified Sharp score at 5-year follow-up, unlike age and ACPAs. FIB-4 score was not associated with mortality (hazard ratio 1.1 [95% CI 0.46; 2.8], p = 0.77) or major adverse cardiovascular events (0.46 [0.13; 1.6], p = 0.22) over the 10-year follow-up. No significant change in FIB-4 score over time was related to treatments. Conclusions: The present prospective cohort study did not find a prognostic role of FIB-4 score in RA. Reassuringly, FIB-4 score was not increased with DMARD treatment after 10 years of follow-up.
BackgroundJanus kinase inhibitors are an effective option for achieving sustained remission or low disease activity in patients with rheumatoid arthritis (RA) following inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs. Filgotinib is a Janus kinase 1–preferential inhibitor available in two doses for moderate-to-severe RA. We report the long-term efficacy and safety of filgotinib.MethodsIn the ongoing long-term extension study FINCH 4 (NCT03025308), patients continue filgotinib 200 mg or 100 mg from FINCH 1, 2 or 3 or receive filgotinib 200 mg or 100 mg de novo. Efficacy assessments up to week 156 include American College of Rheumatology 20% response (ACR20), Disease Activity Score 28 using C-reactive protein of <2.6, Clinical Disease Activity Index of ≤2.8, Simplified Disease Activity Index of ≤3.3 and Boolean remission (1.0 and 2.0) with non-responder imputation.ResultsIn patients with an inadequate response to methotrexate, 60.2% and 54.6% receiving de novo filgotinib 200 mg and 100 mg had an ACR20 at week 156, respectively, as did 67.3% and 59.5% of those who continued filgotinib 200 mg and 100 mg. At week 156, Boolean remission 1.0 was achieved by 18.8% and 15.4% of patients treated with de novo filgotinib 200 mg and 100 mg, respectively, and by 21.1% and 18.5% when Boolean 2.0 criteria were applied. Similar efficacy data were seen in patients from FINCH 2 and 3. Safety data were consistent with the known safety profile of filgotinib.ConclusionIn FINCH 4, filgotinib 200 mg and 100 mg (continuous or de novo) demonstrated sustained efficacy up to week 156 in patients enrolled from FINCH 1, 2 or 3, with no unexpected safety results.
La pneumopathie interstitielle diffuse associée à la polyarthrite rhumatoïde (PID-PR) et la fibrose pulmonaire idiopathique (FPI) présentent des facteurs de risque communs (le sexe masculin, l’exposition tabagique, l’âge avancé et certaines prédispositions génétiques). Plusieurs études ont mis en évidence le rôle de la pollution atmosphérique dans l’incidence de la FPI. À partir de données nationales de codage, une étude américaine a montré que l’exposition aux PM2,5 est un facteur de risque de développer une PID-PR mais l’exposition tabagique était inconnue et les autres polluants n’ont pas été étudiés. L’objectif de l’étude était de comparer les niveaux d’exposition à la pollution atmosphérique au long cours des patients ayant une PID-PR à ceux des patients ayant une PR sans PID. Il s’agit d’une étude rétrospective multicentrique incluant des patients ayant eu un scanner thoracique et suivis pour une PR ou une PID-PR dans les centres d’Avicenne, de Bichat ou au sein de la cohorte nationale ESPOIR. Les niveaux d’expositions moyens aux NO2, O3, PM10 et PM2,5 ont été estimés au code postal de la ville de résidence à partir du modèle de dispersion chimie transport CHIMERE. La période d’exposition cumulée à la pollution a été étudiée sur les 5 années précédant le scanner thoracique. Une régression logistique a été utilisée pour étudier l’influence de l’exposition à la pollution de l’air sur l’apparition de la PID-PR. Six cent huit patients présentant une PR et ayant eu un scanner thoracique ont été inclus. Deux cent trente (39 %) présentaient une PID au scanner. L’âge moyen était de 56,8 (± 13,4), 171 (41 %) d’entre eux étaient des hommes et 263 (50 %) étaient fumeurs anciens ou actuels. Les anticorps anti-CCP étaient positifs dans 79 % des cas avec un taux moyen de 221. L’exposition moyenne des sujets dans les 5 années précédant le scanner thoracique était pour les PM2,5 de 16,3 (± 4,74) μg/m3; les PM10 de 22,3 (±3,80) μg/m3; l’O3de 44,9 (±7,43) μg/m3; NO2 = 27,0 (± 9,40) μg/m3. En analyse uni-variée, le fait de présenter une PID-PR au scanner était associé au sexe masculin, à l’âge, à une exposition tabagique et une exposition au long cours aux PM2,5 (OR: 1,05 IC95 %[1,01; 1,08] p = 0,013), aux PM10 (OR 1,07 IC95 %[1,02; 1,12] p = 0,004) et au NO2 (OR:1,03 IC95 %[1,01; 1,05] p = 0,003). L’exposition chronique aux PM2,5, PM10 et au NO2 augmente le risque de PID chez les personnes atteintes de PR. Une analyse multivariée est en cours avec l’ensemble des données de la cohorte ESPOIR en tenant compte de l’âge, du sexe et du tabagisme.
Objectives We evaluated the risk of severe infection in patients with immune-mediated inflammatory disease (IMID) treated with RTX and with Ig deficiency.Methods This was an observational, retrospective single-centre study of patients undergoing treatment with at least one rituximab (RTX) infusion for an IMID until 31 May 2020. Patients were followed up for at least 12 months after the last infusion or until severe infection or death. Ig deficiency was classified as prevalent (before RTX) or acquired (normal Ig assay results before RTX but Ig deficiency during a follow-up).Results Of 311 patients, 10.6% had prevalent and 19.6% acquired Ig deficiency. Prevalent Ig deficiency was related to concomitant treatment with glucocorticoids (GCs), in particular with a high daily dose at baseline; and acquired Ig deficiency to cumulative dose of RTX, mean Disease Activity Score in 28 joints (DAS28), immunosuppressor or GCs therapy at baseline, diabetes mellitus and obesity. Overall, 14.5% of patients had a severe infection during follow-up, which was numerically but not statistically more frequent in patients with prevalent Ig deficiency than normal Ig level. On multivariate analysis, risk of severe infection was associated with chronic pulmonary disease, GCs dose and mean DAS28-C reactive protein. In a time-dependent analysis, risk of severe infection was not associated with Ig deficiency, either acquired or prevalent (adjusted HR 1.04 (95% CI 0.5 to 2.3), p=0.92).Conclusion Risk of severe infection was not associated with RTX-induced Ig deficiency in patients with an IMID. RTX management should be discussed according to an individual assessment of the infectious risk, especially in patients with GC therapy or chronic lung disease.
Objectives(1) To assess the progression of ultrasonography-detected synovitis in a cohort of patients with rheumatoid arthritis (RA) in remission during 1 year of follow-up (2) to evaluate the ability of consecutive examinations of ultrasonography to predict relapse (R) or radiographic progression (RP) at 1 year.MethodsPatients with RA (2010 American College of Rheumatology-European Alliance of Associations for Rheumatology criteria) in clinical remission (Disease Activity Score in 28 joints (DAS28)<2.6 without clinically active synovitis) were included. An independent investigator performed ultrasonography every 3 months for 1 year. Ultrasonography-detected synovitis was defined as power Doppler-positive ultrasonography synovitis (PDUS) grade ≥1 in at least one joint. PDUS at ≥2 consecutive visits during the follow-up defined persistent PDUS. An increase of ≥1 point in the modified total Sharp score defined RP. An increase in DAS28-C-reactive protein (CRP)>0.6 or DAS28-CRP>3.2 and any modification of disease-modifying anti-rheumatic drugs or glucocorticoids defined relapse. Univariate and multivariate Cox regression analyses were used to evaluate factors associated with R/RP at 1 year.ResultsPDUS was detected in 75 (65.2%), 66, 60, 46 and 29 of the 115 patients with RA at baseline and at months 3, 6, 9 and 12, respectively. 58 (50.4%) patients exhibited persistent PDUS. After 1 year, 22/85 (25.9%) experienced relapse and 12 (14.1%) showed RP. On multivariate analysis, factors predicting R/RP at 1 year were persistent PDUS (HR=2.98, p=0.014) and an increase in DAS28-CRP level at the visit before relapse (HR=4.36, p=0.004).ConclusionPersistent PDUS during follow-up, rather than at baseline, predicted worse outcome at 1 year and requires careful monitoring.
Objectives: This study aimed to estimate the prevalence of ANCA-associated vasculitis (AAV). That is, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA), in Southern France in 2018, and evaluate differences among Europeans and non-Europeans. Methods: This population-based, cross-sectional study used four sources (hospitals, community-based physicians, laboratories, National Health Insurance) to identify adults >= 15years diagnosed with GPA, MPA or EGPA, living in Herault and Gard in 2018. Cases were defined using the ACR/EULAR classification criteria, and if necessary, the European Medicines Agency algorithm. Prevalence estimates were standardised to the world population and capture-recapture analysis was used to assess the comprehensiveness of the estimation. The influence of geographical origin was evaluated. Results: A total of 202 patients were selected, with 86 cases of GPA (42.6%), 85 cases of MPA (42.1%) and 31 cases of EGPA (15.3%). The standardised prevalence estimates per million inhabitants for 2018 were: 103 (95%CI 84-125) for AAV, 48 (95%CI 35-64) for GPA, 39 (95%CI 28-53) for MPA and 16 (95%CI 9-26) for EGPA, 36 (95%CI 25-50) for anti-PR3 positive AAV, 46 (95%CI 34-61) for anti-MPO positive AAV, and 16 (95%CI 9-26) for ANCA-negative AAV. The global estimation of comprehensiveness by capture-recapture analysis was 80.5%. The number of AAV cases was higher for non-European residents (P 1/4 0.001), particularly for MPA (P < 0.0001). Conclusion: We provide a new estimate of AAV prevalence in France and show a higher prevalence of MPA in non-European patients.
Introduction Objectif 1) explorer l’étendue et les raisons de la discordance entre l’évaluation globale du patient (PGA) et l’évaluation globale du médecin (PhGA) de l’activité de la polyarthrite rhumatoïde (PR)2) déterminer l’impact de la discordance répétée sur l’évolution de la PR au cours des cinq premières années. Patients et méthodes -Patients : de la cohorte française d’arthrite précoce ESPOIR (2 articulations gonflées pendant<6 mois, non traités par DMARD), répondant aux critères ACR-EULAR pour la PR à l’inclusion.– Analyse : la concordance entre PGA et PhGA (Bland-Altman plot) a été évaluée. Une régression logistique multivariée a été utilisée pour déterminer les variables indépendamment associées à la discordance définie par une différence entre PGA et PhGA≥20 à l’inclusion.Des modèles logistiques multivariés ont été utilisés pour déterminer si la discordance répétée (discordance |PGA – PhGA|≥20 à plus de la moitié des visites précédentes) était associée aux rémissions (booléennes, SDAI et DAS28), à la stabilité fonctionnelle (HAQ≤0,5 et deltaHAQ≤0,25), à la qualité de vie (EQ5D) et à l’absence de progression radiographique (delta Sharp score<1) à 1, 2 et 5ans de suivi. Résultats Chez 645 patients atteints de PR débutante (âge moyen=48,8±12,2ans, 77 % des femmes, 48,7 % d’ACPA+), la concordance à l’inclusion était meilleure aux deux extrémités du spectre, en particulier pour une activité élevée de la maladie. Une discordance entre les patients et leurs médecins s’est produite dans 30 % de notre cohorte : 24 % avaient des scores PGA plus élevés et 6 %, des scores PhGA plus élevés. Dans les régressions logistiques multivariées, un faible NAG, une faible composante mentale du SF-36, vivre seul, des niveaux plus élevés de fatigue étaient associés à la discordance. Dans les analyses multivariées, la discordance répétée était significativement associée à une moindre rémission, une moindre stabilité fonctionnelle, une moindre qualité de vie à 1,2 et 5ans et plus de progression radiographique à 1 et 2ans. Conclusion Des évaluations patient-médecin discordantes et répétées de l’activité de la maladie ont un impact négatif sur la rémission, la fonction et la progression structurale de la PR sur une période de 5ans.
Introduction De nombreux domaines du rhumatisme psoriasique (RPso) débutant restent mal connus. La SFR a mis en place une cohorte multicentrique nationale de RPso articulaires périphériques (pRPso) très récents, destinés à être suivis de façon standardisée pendant 10 ans (APACHE). Dans cette analyse intermédiaire d’APACHE, nous avons analysé l’effet du sexe sur les caractéristiques cliniques à l’inclusion des 193 premiers patients inclus. Patients et méthodes Les patients inclus doivent avoir au moins une arthrite périphérique depuis maximum 12 mois ; un psoriasis personnel ou familial ; un diagnostic de RPso retenu par leur rhumatologue (indice de confiance d’au moins 7 sur 10), et doivent être naïfs de traitements ciblés. Lors de la visite d’inclusion (M0), les données collectées incluent : des données démographiques, d’histoire/activité/sévérité de la maladie, de comorbidités, biologiques, socioéconomiques ; également les traitements actuels et passés, des radiographies des mains/poignets, pieds, bassin et toute autre articulation atteinte, un examen ultrasonographique complet des 4 extrémités, une IRM main/poignet ou pied (CIC Brest) et des échantillons biologiques (ADN, ARN, sérum/plasma, urines – CRB Toulouse). L’analyse intermédiaire décrit les principales caractéristiques à M0, en dehors de l’imagerie, des 193 patients inclus au 29/02/2024. Une différence entre les hommes et les femmes a été recherchée avec les tests statistiques usuels : Wilcoxon, Chi2, Fisher. Les analyses n’ont pas été ajustées. Résultats Des 193 patients inclus, 186 étaient analysables. L’âge moyen à M0 était de 44±11 ans, 45 % étaient des femmes, 21 % (34/161) étaient porteurs du HLA-B27, 26 % étaient fumeurs, et en termes de traitements, 41 % étaient sous anti-inflammatoires non stéroïdiens, 5 % sous stéroïdes, et 38 % sous méthotrexate. Les principales caractéristiques démographiques et clinico-biologiques de ces patients sont résumées dans le Tableau 1 ; aucune n’est apparue statistiquement différente en fonction du sexe. Les principales comorbidités sont présentées dans le Tableau 2 ; une plus grande fréquence globale de facteurs de risque ou comorbidités cardiovasculaires (p=0,026), notamment d”HTA (p=0,029) et, en tendance, de goutte (p=0,065), a été notée chez les hommes. Discussion Il s’agit à notre connaissance de la première description de pRPso très récents (moins d’un an). Le phénotype articulaire périphérique obligatoire et ce caractère très récent permettent de distinguer les informations fournies par APACHE de celles disponibles dans la littérature et constituent donc une grande force de cette cohorte. Conclusion Cette étude fournit pour la première fois une description clinique de ce que sont les patients ayant un pRPso très récent. Il est à noter, qu’à ce stade débutant de la maladie, les seules différences observées entre les femmes et les hommes sont la plus grande fréquence de facteurs de risque ou comorbidités cardiovasculaires chez les hommes.
Objectives The aim of this article is to describe the safety and efficacy of filgotinib 200 mg (FIL200) or FIL 100 mg (FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (NCT03025308).Methods Patients who completed any of three parent studies (NCT02889796: inadequate response to methotrexate; NCT02873936: inadequate response to biologic disease-modifying antirheumatic drugs; NCT02886728: methotrexate-na & iuml;ve) without rescue therapy could enter the long-term extension; patients taking FIL continued their dosage, and those who received comparators were rerandomised to FIL200 or FIL100. This analysis includes Week 156 interim results.Results Among Japanese patients, 110 received FIL200, and 97 received FIL100. Mean (SD) FIL200 and FIL100 exposure was 157.0 (51.49) and 156.0 (52.45) weeks. The exposure-adjusted incidence rates (95% confidence interval) for FIL200/FIL100 were 2.7 (1.4, 5.2)/2.4 (1.2, 5.1) for herpes zoster, 0.9 (0.3, 2.8)/1.0 (0.3, 3.2) for malignancy (excluding nonmelanoma skin cancer), and 0.6 (0.2, 2.4)/0.3 (0.0, 2.4) for major adverse cardiovascular events. More patients receiving FIL200 with prior FIL200 exposure achieved clinical remission vs other groups (including Clinical Disease Activity Index remission in 40% vs <= 27% at Week 156).Conclusions FIL200 and FIL100 were generally well tolerated by Japanese patients, without new, unexpected adverse events.
BACKGROUND:Inception cohorts aim to describe chronic diseases from diagnosis and over years of follow-up. Axial spondyloarthritis (axSpA) diagnosis might be challenging during the first years of the disease. Thus, identifying the features that will be associated with a confirmed diagnosis over time is key. OBJECTIVES:To assess the frequency and the predisposing factors for a change of an initial diagnosis in an inception axSpA cohort. METHODS:DESIR is an ongoing national multicentre inception axSpA cohort with currently 12.5 years of follow-up. At the entry visit and confirmed at each visit, the diagnosis of axSpA was based on the opinion of the treating rheumatologist. Follow-up was interrupted in case of a change in this initial diagnosis. Multiple imputation was used to estimate the probability of a change in the initial diagnosis of axSpA for each patient lost to follow-up. Factors predisposing to an unchanged diagnosis of axSpA were then assessed using a multivariate logistic regression model on the imputed data sets. RESULTS:Of the 708 patients included, over 10 years of follow-up, 45 (6.4%) were excluded due to a diagnosis change and 300 (42.4%) patients were lost to follow-up. Based on the imputation of these 300 patients, a change in their initial axSpA diagnosis was estimated in 42 (14.0%). Factors predisposing to an unchanged initial axSpA diagnosis during follow-up were (ORs (95% CIs)): radiographic sacroiliitis: 17.0 (4.1 to 71.0); psoriasis: 5.3 (2.0 to 14.3); CRP≥6 mg/L: 2.7 (1.3 to 5.3); good NSAID response: 2.5 (1.5 to 4.2); HLA B27+: 2.0 (1.3 to 3.3); anterior chest wall pain: 2.0 (1.2 to 3.3) and female sex: 1.9 (1.2 to 3.0). CONCLUSION:These data suggest that a change in diagnosis in recent onset axSpA exists, but is not frequent, and is less likely to occur in the presence of objective features at baseline.