Composite Disease Activity Index Research Articles

The Psoriatic Arthritis 5-Thermometer Scales (PsA-5Ts): Measurement Properties of a New Multidimensional Composite Tool for the Quick Assessment of the Overall Health Status in Psoriatic Arthritis.

Psoriatic arthritis (PsA) is a heterogeneous condition that is difficult to assess. The goal of this research was to evaluate the clinimetric properties of the Psoriatic Arthritis 5-Thermometer Scales (PsA-5Ts), a new patient-reported outcome (PRO) to measure the overall health status in PsA patients. The PsA-5Ts were compared to composite measures of disease activity (DAPSA, PASDAS, CPDAI) and PROs (PsAID-12 and SF-36). The convergent validity was assessed through the Spearman's correlation coefficient and the discriminant validity through the receiver operating characteristic (ROC) curve analysis, applying the Minimal Disease Activity (MDA) as an external criterion. The cross-sectional assessment included 155 patients. Significant high correlations were observed when comparing PsA-5Ts to composite indices of disease activity and PROs (all at significance levels of p < 0.0001). The PsA-5Ts subscales were highly significantly different in terms of MDA status (all at p < 0.0001). The PsA-5Ts had good discriminant validity like that of the DAPSA, CPDAI, PASDAS, and PsAID-12, and better than that of the SF-36, with an area under the ROC curve of 0.944 (65% CI 0.895-0.974). The PsA-5Ts are an easy-to-use PRO that can be integrated with disease activity indices in the assessment of PsA in daily clinical practice.

Comprehensive evaluation of the influence of sex differences on composite disease activity indices for rheumatoid arthritis: results from a nationwide observational cohort study

BackgroundThe effects and their magnitudes of sex on disease activity indices for rheumatoid arthritis are not clear. We aimed to comprehensively evaluate the influence of sex on disease activity indices in the real-world setting using a large observational database.MethodsWe analyzed 14,958 patients registered in the National Database of Rheumatic Diseases in Japan (NinJa) in 2017. We evaluated the sex differences in the 28-joint disease activity score (DAS28) using erythrocyte sedimentation rate (ESR), DAS28 using C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index by disease activity category using Cliff’s delta and regression analysis. Differences in the share of components of indices were evaluated using permutational multivariate analysis of variance. Correction equations were constructed to estimate the number of misclassification in male patients who achieve DAS28-ESR remission.ResultsDAS28-ESR showed higher values in female patients than male patients in remission despite no obvious difference in other indices or disease activity categories. Among the components of DAS28-ESR, only ESR was higher in female patients than male patients in remission. In DAS28-CRP and SDAI, 28-tender joint count was higher and CRP was lower in female patients than male patients. In addition, the profiles in the components were different between female and male patients, especially among those with high disease activity. Using correction equations, almost 12% of male patients with DAS28-ESR remission were estimated to be misclassified, mainly due to differences in ESR.ConclusionAmong the disease activity indices, significant sex difference was observed only in DAS28-ESR remission. The degree of misclassification in DAS28-ESR remission would be unignorable.

Validation of UVEDAI: An Index for Evaluating the Level of Inflammatory Activity in Uveitis.

Uveitis is the inflammation of the middle layer of the eye, the uvea, and is a major cause of blindness. None of the instruments used in clinical practice are, in themselves, sufficient to evaluate the course of uveitis. Therefore, it is necessary to develop instruments enabling standardized measurement of inflammatory activity. We developed a composite disease activity index for patients with uveitis known as UVEDAI, which considers the overall activity of the eye. The objective of this study was to validate the composite index of ocular inflammation, UVEDAI. A multicenter cross-sectional study involving eight Spanish tertiary hospitals. Sixty-two patients aged ≥ 18years with acute uveitis were recruited. Participants gave informed consent before participating in the study. A full ophthalmological examination was performed by two ophthalmologists to determine inflammatory activity: one used the UVEDAI score and the other used clinical judgment. The ophthalmologists did not share their findings with each other to avoid introducing bias into the analysis. Construct validity was established by means of factor analysis. The criterion validity of the index was determined using an ordinal multivariate regression model, in which the dependent variable was the degree of uveal inflammation (mild, moderate, or high/severe). Cut-off points were determined for the UVEDAI and for the receiver operating characteristic (ROC) curves. Sixty-two patients were included. Total variance with the three components accounted for 80.32% of the construct validity. Each of the three components identified one type of eye involvement. The discriminatory capacity of UVEDAI was 0.867 (95% CI 0.778; 0.955 p < 0.001) for mild versus moderate-high and 0.946 (95% CI 0.879; 1.000 p < 0.001) for high versus mild-moderate. The variables included in UVEDAI enable ocular inflammatory activity to be described with a high degree of accuracy. The index may be used to evaluate and classify this activity with considerable discriminatory power.

Relation of some clinical composite indices of disease activity in rheumatoid arthritis to a simplified 12 joint power Doppler ultrasound activity index

Aim of the workTo assess the association of some clinical composite disease activity indices with a simplified 12 joint power Doppler ultrasound (PDUS) activity index in rheumatoid arthritis (RA). Patients and methodsOne hundred RA patients who fulfilled the 2010 European league against rheumatism/American college of Rheumatology (EULAR/ACR) classification criteria for RA were recruited from the Rheumatology outpatient clinic, Cairo University Hospitals. Disease activity score (DAS28), the simplified disease activity index (SDAI), clinical disease activity index (CDAI) as well as mean overall index for RA (MOI-RA) were assessed. Grey Scale Ultrasonography (GSUS) and PDUS activity assessment was performed using a simplified 12-joint score. ResultsThe 100 patients were 80 females and 20 males (F:M 4:1). Their mean age was 44.4 ± 10.8 years with disease duration of 6.3 ± 4.7 years. Rheumatoid factor was positive in 77 %. DAS28 was 4.5 ± 1.3, SDAI 27.7 ± 22.7, CDAI 17.5 ± 13.2 and MOI-RA 86.8 ± 25.1. On US, tenosynovitis was present in 10 %, irregularity in 23 % and erosion in 62 %. The mean 12-point PDUS was 3.53 ± 4.16 and the overall US score 10.34 ± 9.3. A significant correlation was found between the US findings of overall synovitis, degree of PD and US score with DAS28 (r = 0.3, p < 0.0001; r = 0.4, p < 0.0001 and r = 0.3, p < 0.0001) with SDAI (r = 0.3, p < 0.0001; r = 0.4,p < 0.0001; r = 0.4, p < 0.0001) and with MOI-RA score (r = 0.3, p < 0.0001; r = 0.4, p < 0.0001 and r = 0.4, p < 0.0001 respectively) but the highest correlations was with CDAI (r = 0.4, p < 0.0001; r = 0.5, p < 0.0001 and r = 0.4, p < 0.0001 respectively). ConclusionSimplified 12 -joint PDUS score is well correlated with activity indices in RA patients.

Cross-cultural and clinical validation of the MDHAQ/RAPID3 questionnaire in electronic format for a Brazilian population of patients with rheumatoid arthritis

BackgroundPatients with rheumatologic diseases are monitored fundamentally through metric tools or index calculated from clinical data and patient exams, which allow us to assess the severity of the disease and guide the therapeutic decision. In rheumatoid arthritis (RA), for treatment to be optimized and considered effective, periodic assessment with composite disease activity index and a 'treat-to-target' approach is required. The Routine Assessment of Patient Index Data 3 (RAPID3) in the Multidimensional Health Assessment Questionnaire (MDHAQ) includes only three measures based on the central patient self-reported dataset and can be used in a 'treat-to-target' approach analogous to the Clinical Disease Activity Index (CDAI) and the Disease Activity Score 28-joints (DAS28). This tool, however, has not undergone cross-cultural or clinical validation in Brazil. In this research, we performed the MDHAQ cross-cultural and clinical validation for the Brazilian population of RA patients.MethodsThe Portuguese version of the MDHAQ was created identically in an electronic questionnaire and underwent a cross-cultural validation process with 38 participants. Test–retest was performed in 29 patients. Further, a clinical validation with 129 Rheumatoid Arthritis patients was performed. Electronic MDHAQ was answered through an online platform. We also collected socioeconomic data as well as other clinical (CDAI, SDAI, DAS28) and functional (HAQ) scores during the face-to-face assessment of patients.ResultsMDHAQ/RAPID3 maintained semantic, idiomatic, as well as conceptual and experience equivalence for the Brazilian population, with 92% acceptance of participants. It showed test–retest reliability, adequate internal consistency (Cronbach's α 0.85) and correlation of the scores obtained with adequate association with the DAS28 gold standard. RAPID3 also had high sensitivity (98%), adequate specificity (48%), high negative predictive value (92%) and negative post-test probability of 8%, attributes expected for a test tool for population screening.ConclusionThe use of MDHAQ/RAPID3 associated with traditional clinical measures can adequately allow for remote follow-up based on the 'treat-to-target' approach with performance comparable to the gold standard DAS28, being a viable tool in the sample of Brazilian patients with RA in the current context of telehealth.

Treat to target in Behcet's disease: Should we follow the paradigm of other systemic rheumatic diseases?

During the last decades the efficacy of biologic agents, mainly of anti-TNFs, in controlling the activity of serious manifestations of Behcet's Disease (BD) has been established. On the other hand, the clinical heterogeneity of BD has precluded the validation of a widely-accepted composite index for disease assessment and for target disease-state definitions, such as low disease activity and remission, and the testing of their implementation in clinical practice. Therefore, in contrast to other systemic rheumatic diseases, a treat-to-target strategy has not yet been developed in BD. There are several challenges towards this approach, including standardization of outcome measures for assessing the disease activity in each-affected organ and construction of a composite disease activity index. The challenges for the development of a treat-to-target strategy and possible solutions are discussed in this position paper, which stemmed from a round table discussion that took place in the 19th International Conference on BD.

Comparison of rheumatoid arthritis composite disease activity indices and residual activity in a Brazilian multicenter study- REAL study.

IntroductionRheumatoid arthritis (RA) composite disease activity indices have become handy tools in daily clinical practice and crucial in defining remission or low disease activity, the main target of the RA treatment. However, there is no definition of the best index to assess disease activity in clinical practice.ObjectivesTo compare the residual activity among the indices with the ACR/EULAR remission criteria (Boolean method) to identify the most feasible for assessing remission in daily practice, also considering correlation and concordance, sensibility, and specificity.Patients and methodsWe selected 1116 patients with established RA from the real-life rheumatoid arthritis study database—REAL. The composite disease activity indices—DAS28-ESR, DAS28-CRP, SDAI, and CDAI–and their components were compared to the Boolean method to identify residual activity using binomial regression. The indices were analyzed for correlation and agreement using the Spearman index and weighted kappa. The chi-square test evaluated sensibility and specificity for remission based on the Boolean method.ResultsDAS28-CRP overestimated remission and confirmed higher residual activity than SDAI and CDAI. The indices showed good correlation and agreement, with a better relationship between SDAI and CDAI (k:0,88). CDAI and SDAI showed higher sensitivity and specificity for remission based on the Boolean method. CDAI was performed in 99% of patients, while DAS28 and SDAI were completed in approximately 85%.ConclusionsAlthough all composite indices of activity can be used in clinical practice and showed good agreement, CDAI and SDAI have better performance in evaluating remission based on the Boolean method, showing less residual activity and higher sensibility and specificity. In addition, CDAI seems to be more feasible for disease activity evaluation in daily clinical practice, especially in developing countries.

P080 ADS024 attenuates weight loss and decreases disease activity in DSS-induced colitis

Abstract Background Ulcerative colitis (UC) is a chronic, idiopathic inflammatory disease characterised by a dysregulated innate and adaptive immune response to gut microbiota that contributes to the perpetuation of colonic inflammation. ADS024 is an orally administered live biotherapeutic product (LBP), comprised of a single strain of Bacillius velezensis, being developed for potential application in the treatment of patients with UC. Methods Colitis was induced in 39 mice by exposure to 3% dextran sodium sulfate (DSS)-treated drinking water from Day 0 to Day 5; 6 control animals did not receive DSS. Animals were then dosed with vehicle (PBS; n=15) or ADS024 (n=12) twice daily for 14 days via oral gavage or with comparator anti-p40 mAb (n=12) once daily (IP) on Days 6, 9, 12, 15. All animals were monitored daily for body weight loss, diarrhea, blood in stool, and activity level. Each of these parameters was individually scored according to the disease activity index (DAI) scoring scheme. Animals underwent video endoscopy on Day 19 to assess colitis severity and stool consistency was scored during endoscopy. Following endoscopy on Day 19, all surviving animals were sacrificed, and blood was collected and processed for serum and analysed for metabolomic profile. Results Animals in which colitis was induced by exposure to 3% DSS demonstrated significant weight loss, most profoundly from Days 8 to 11, an increase in the composite DAI and increased mean colon weight:length ratios as compared to control animals. Animals treated with ADS024 had improved body weight, starting at 72 hours post-treatment and decreased DAI scoring over the course of the study compared to the vehicle control group (p&amp;lt;0.01 and p&amp;lt;0.05 respectively), comparable to treatment with anti-p40 mAb which has a mechanism of action similar to ustekinumab (Stelara®) approved for the treatment of UC. A trend towards a decrease in the mean colon weight:length ratio was observed in animals treated with ADS024, but there was no difference in mean endoscopy scoring compared to the vehicle control group. DSS treatment altered the serum biochemical profile at day 19 and ADS024 induced changes suggesting a reversion towards the control state. Conclusion Oral treatment with ADS024 improved body weight loss, reduced DAI, and resulted in a trend towards reduction in mean colon weight:length ratios in the DSS-induced mouse colitis model. In addition, ADS024 treatment led to a rebalancing of the systemic metabolomic shift caused by DSS exposure.

Normal C-reactive protein in active psoriatic arthritis: results from real-world clinical practice.

Background:The value of normal C-reactive protein (CRP) in psoriatic arthritis (PsA) is debatable.Objectives:To test the hypothesis that CRP is frequently normal in contemporary real-world PsA patients, despite active disease.Design:In this cross-sectional study, patients were divided into two groups: CRP ⩽ 0.5 mg/dl (normal) and CRP > 0.5 mg/dl (increased). Having as dependent variable the CRP status, these groups were compared for disease-related features, including composite disease activity indices [clinical Disease Activity in PSoriatic Arthritis (cDAPSA) and minimal disease activity (MDA)] and patient-reported outcomes (PROs). Agreement between CRP status and cDAPSA/MDA scores was calculated (Cohen’s kappa).Methods:Data from consecutive PsA patients attending two outpatient rheumatology clinics (January 2019–June 2021) were analysed.Results:From 128 patients enrolled (51.6% females; mean ± standard deviation age: 53.4 ± 11.7 years; 23.4%, 48.4% and 64.1% treated with glucocorticoids, conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biologic DMARDs, respectively), two-thirds (66.4%, n = 85) had normal CRP values. CRP status was not associated with any of the disease-related parameters and PROs, but only with ESR [odds ratio: 1.04 (95% confidence interval: 1.01–1.06), p = 0.005]. Among patients with normal CRP, 45.9% (39/85) were on non-MDA state, while 21.2% (18/85) had cDAPSA-moderate and 5.9% (5/85) had cDAPSA-high disease activities. Conversely, 54.2% (39/72) of patients on non-MDA state and 52.3% (23/44) of those with cDAPSA-moderate or cDAPSA-high disease activity had normal CRP values. Cohen’s kappa between normal CRP and MDA, cDAPSA-remission, and cDAPSA-remission/low disease activity was –0.26, –0.21 and –0.22, respectively, displaying total disagreement.Conclusion:Normal CRP in PsA should not be used as surrogate marker of remission or low/MDA, therefore needs to be interpreted with caution in clinical decision-making.

Large joints are progressively involved in rheumatoid arthritis irrespective of rheumatoid factor status\u2014results from the early rheumatoid arthritis study

This study aimed to examine the progression of large joint involvement from early to established RA in terms of range of movement (ROM) and time to joint surgery, according to the presence of rheumatoid factor (RF). We used a historical longitudinal cohort of early RA patients. Patients were deemed RF negative if all repeated assessments were negative. The rate of progression from normal to any loss of range of movement (ROM) from years 3 to 14 were modelled using generalized estimating equations, for elbows, wrists, hips, knees and ankle, adjusting for confounders. Time to joint surgery was analysed using multivariable Cox models. A total of 1458 patients were included (66% female, mean age 55 years) and 74% were RF-positive. The prevalence of any loss of ROM, from year 3 through to 14 was highest in the wrist followed by ankle, knee, elbow and hip. Odds of loss of ROM increased over time in all joint regions assessed, at around 7–13% per year from year 3 to 14. Time to surgery was similar according to RF-status for the wrist and ankle, but RF-positive cases had a lower hazard of surgery at the elbow (HR 0.37, 0.15–0.90), hip (HR 0.69, 0.48–0.99) and after 10 years at the knee (HR 0.41, 0.25–0.68). Large joints become progressively involved in RA, most frequently affecting the wrist followed by ankle, which is overlooked in composite disease activity indices. RF-negative and positive cases progressed similarly. Treat-to-target approaches should be followed irrespective of RF status.

Measuring Inflammatory Foot Disease in Rheumatoid Arthritis: Development and Validation of the Rheumatoid Arthritis Foot Disease Activity Index-5.

Omission of foot joints from composite global disease activity indices may lead to underestimation of foot and overall disease in rheumatoid arthritis (RA) and under-treatment. The aim of this study was to evaluate the measurement properties of the Rheumatoid Arthritis Foot Disease Activity Index-5 (RADAI-F5), a newly developed patient-reported outcome measure for capturing foot disease activity in people with RA. Participants with RA self-completed the RADAI-F5, modified Rheumatoid Arthritis Disease Activity Index (mRADAI-5), Foot Function Index (FFI), and Foot Impact Scale (FIS) impairment/footwear and activity/participation subscales. The 28-joint Disease Activity Score using the erythrocyte sedimentation rate (DAS28-ESR) was also recorded. Subgroups completed the RADAI-F5 at 1 week and 6 months. Psychometric properties, including construct, content and longitudinal validity, internal consistency, 1-week reproducibility, and responsiveness over 6 months were evaluated. Of 142 respondents, 103 were female, with a mean ± SD age of 55 ± 12.5 years and median RA disease duration of 10 (interquartile range 3.6-20.8) months. Theoretically consistent associations confirming construct validity were observed with mRADAI-5 (0.789 [95% confidence interval (95% CI) 0.73, 0.85]), FFI (0.713 [95% CI 0.62, 0.79]), FIS impairment/footwear (0.695 [95% CI 0.66, 0.82], P < 0.001), FIS activity/participation (0.478 [95% CI 0.37, 0.63], P < 0.001), and the DAS28-ESR (0.379 [95% CI 0.26, 0.57], P < 0.001). The RADAI-F5 demonstrated high internal consistency (Cronbach's α = 0.90) and good reproducibility (intraclass correlation coefficient = 0.868 [95% CI 0.80, 0.91], P < 0.001, smallest detectable change = 2.69). Content validity was confirmed, with 82% rating the instrument relevant and easy to understand. The RADAI-F5 is a valid, reliable, responsive, clinically feasible patient-reported outcome measure for measuring foot disease activity in RA.

Disease Activity Indices for Pouchitis: A Systematic Review.

Several indices exist to measure pouchitis disease activity; however, none are fully validated. As an initial step toward creating a validated instrument, we identified pouchitis disease activity indices, examined their operating properties, and assessed their value as outcome measures in clinical trials. Electronic databases were searched to identify randomized controlled trials including indices that evaluated clinical, endoscopic, or histologic pouchitis disease activity. A second search identified studies that assessed the operating properties of pouchitis indices. Eighteen randomized controlled trials utilizing 4 composite pouchitis disease activity indices were identified. The Pouchitis Disease Activity Index (PDAI) was most commonly used (12 of 18; 66.7%) to define both trial eligibility (8 of 12; 66.7%), and outcome measures (12 of 12; 100%). In a separate search, 21 studies evaluated the operating properties of 3 pouchitis indices; 90.5% (19 of 21) evaluated validity, of which 42.1% (8 of 19) evaluated the construct validity of the PDAI. Criterion validity (73.7%; 14 of 19) was evaluated through correlation of the PDAI with fecal calprotectin (FCP; r = 0.188 to 0.71), fecal lactoferrin (r = 0.570 to 0.582), and C-reactive protein (CRP; r = 0.584). Two studies assessed correlation of the modified PDAI (mPDAI) with FCP (r = 0.476 and r = 0.565, respectively). Fair to moderate inter-rater reliability of the PDAI (k = 0.440) and mPDAI (k = 0.389) was reported in a single study. Responsiveness of the PDAI pre-antibiotic and postantibiotic treatment was partially evaluated in a single study of 12 patients. Development and validation of a specific pouchitis disease activity index is needed given that existing instruments are not valid, reliable, or responsive.

AB0704 TELEMEDICINE AT THE TIME OF COVID-19: THE EXPERIENCE WITH RA PATIENTS TREATED WITH JAK-INHIBITORS

Background:The spread of COVID-19, the lockdown, the limited access to care reevaluated the role of tele-consultation and self-assessment.Objectives:Our aim was to evaluate in a cohort of Rheumatoid Arthritis (RA) patients treated with JAK-inhibitors (JAKi): the self-assessed disease activity during lockdown, the lockdown impact on fatigue, anxiety, depression and the prevalence of Covid-19.Methods:We enrolled RA patients treated with baricitinib or tofacitinib. At baseline (BL) and follow-up we collected: patients’ demographic data, composite disease activity indices (CDAI, DAS28CRP), global assessment (PGA), pain visual analogue scale (VAS), FACIT (functional assessment of chronic illness therapy) and a self-rating scale for disease impact on anxiety and depression (Zung-A/D). Patients were instructed on how to perform self-assessment through video-material and fulfilled the online form of “Rheumatoid Arthritis Impact of Disease” (RAID)1 and “RA Disease Activity Index” (RADAI). To capture the pandemic effect, we compared patients in different status (remission, low, moderate and high-disease activity) at the last in-person visit (preCoV) through the DAS28CRP and CDAI, to the tele-health visit (THV), measured by the RAID. BL and pre-CoV ZUNG-A, ZUNG-D, FACIT questionnaires were compared with the online results during the pandemic. Exposure, tests and symptoms of Covid-19 were recorded. Data were expressed as mean±standard deviation or median(IQR) according to distribution.Results:Twenty patients (median age 58.2±11.9 and mean disease duration 153.5 ± 112.7 months) were treated with tofacitinib and 27 with baricitinib. The median time-lapse between the pre-CoV visit and the THV was 12 (IQR 4) weeks. DAS28CRP and CDAI significantly decreased from BL to pre-CoV visit. During the last in-person visit, 21 patients (48.83%) were in remission, 9 (20.93%) in low disease activity; according to the RAID, 15 (31.91%) and 7 (14.89%) patients were respectively in remission and low disease activity during the THV (Table A). PGA and pain significantly decreased from BL to pre-Cov visit but worsened during the lockdown (Table A). FACIT remaining stable during THV. At THV, we detected a significant improvement of anxiety from BL (Zung-A) and a tendency to lower depression scores compared to BL (Table A). JAKi showed a good safety profile considering Covid-19 symptoms, none of the patients was diagnosed with SarsCoV2 infection.Conclusion:This is the first study on virtual assessment in RA patients treated with JAKi. The unique social experiment of the pandemic impaired the clinical response already achieved before the lockdown, without a collateral worseling of FACIT, anxiety and depression.

Rheumatoid Arthritis disease activity assessment in routine care: performance of the most widely used composite disease activity indices and patient-reported outcome measures.

Background and aim:To evaluate the convergent and discriminative validity of many continuous composite disease activity indices and patient-reported outcome measures (PROMs) in rheumatoid arthritis (RA).Methods:In consecutive RA patients in moderate or high disease activity, according to the Simplified Disease Activity Index (SDAI) definition, were computed four additional composite disease activity indices, the 28-joint Disease Activity Score – erythrocyte sedimentation rate (DAS28-ESR), the Clinical Disease Activity Index (CDAI), the Chronic Arthritis Systemic Index (CASI), and the Mean Overall Index for RA (MOI-RA), and five PROMs, the Patients’ Activity Scale (PAS), the Rheumatoid Arthritis Impact of Disease (RAID), the 5-item RA Disease Activity Index (RADAI-5), the Routine Assessment of Patient Index Data (RAPID3), and the Clinical Arthritis Activity (PRO-CLARA). Spearman’s rho correlation coefficients were determined to assess their convergent validity, and discriminative performance was calculated by the area under the receiver-operating curve (AUC-ROC). The patients’ opinion of their symptomatic status (PASS) was used as the external criterion.Results:246 RA patients with moderate (29.3%) or high disease activity (70.7%) have been assessed. The indices all showed a significant correlation (p <0.0001 for all). Among the composite disease activity indices, the CDAI was the one that showed the best discriminating ability compared to the PASS (AUC = 0.962), while among the PROMs the RAID was the most performing (AUC = 0.879).Conclusions:CDAI as composite index of disease activity, and RAID as PROM, are the two instruments with the best performances in relation to PASS. The use of validated disease activity measures can help in clinical practice to adopt treat-to-target strategies in RA patients. (www.actabiomedica.it)

Validation of the HAQ-UP-A (Health Assessment Questionnaire-Upper Limbs-Argentine Version) in Patients With Rheumatoid Arthritis.

To validate HAQ-UP-Argentine version in patients with RA. Cross-sectional study. Consecutive patients ≥18years with diagnosis of RA (ACR/EULAR 2010) were included. Socio-demographic data and RA characteristics were recorded. Questionnaires were administered: HAQ-A, HAQ-UP-A, FIHOA, Quick-DASH. The reproducibility of the questionnaire was assessed. A total of 100 patients were included, 83% women, mean age 57.9years (SD 11.6). Cronbach's alpha test was 0.94. The intra-item correlation did not show redundant questions. HAQ-UP-A showed excellent correlation with HAQ-A (r=.93); FIHOA (r=.89) and Quick-DASH (r=.91). It also showed good correlation with DAS28-ESR (r=.68) and other composite disease activity indices as well as with other parameters of the disease. There was no correlation between HAQ-UP-A and disease duration. The reproducibility of the questionnaire was 0.82. Multiple linear regression adjusted for age and sex showed patient global VAS as the main determinant of HAQ-UP-A, followed by the presence of morning stiffness. HAQ-UP-A was found to be reliable, valid and reproducible in patients with RA, representing a useful tool for the evaluation of the functional capacity of the upper limbs in these patients.

High Remission Rates in a Brazilian Cohort of Initial Rheumatoid Arthritis after 15 Years of Follow-Up

Introduction: Rheumatoid arthritis (RA) is a chronic systemic rheumatic disease which is usually treated with corticosteroids and immunobiologicals. The goal of this article is to carry out an assessment of disease activity indices in a cohort of patients with rheumatoid arthritis. Patients and Methods: This is a prospective cohort study. Individuals from the Initial Rheumatoid Arthritis Brasilia Cohort, which is an incident cohort of early RA diagnosed patients, were monitored at the Rheumatology Service of the Hospital Universitario de Brasilia (HUB), University of Brasilia (UnB), Brazil. A cross-sectional analysis was carried out from 2017 to 2018 to evaluate patients with 15 or more years of follow-up, through a direct interview and review of medical records. The main focus of the study is on the assessment of disease activity, based on the indices: 28-joint Disease Activity Score based on Creactive protein (DAS 28 CPR) and based on erythrocyte sedimentation rate (DAS 28 ESR), Clinical Disease Activity Index (CDAI), and Simple Disease Activity Index (SDAI). The reference remission criteria used were the Composite Disease Activity Indices. Results: 107 patients were evaluated, mostly women, mean age of 55.1 years. Concerning the disease characteristics, 75.5% of the patients were positive for rheumatoid factor and 12 (11.3%) had documented erosive disease. The mean Health Assessment Questionnaire (HAQ) at the time of assessment was 0.6 (median 0.35). The indices analyzed showed: DAS28-ESR 48.6% of patients were in remission and 12.1% had low activity levels, DAS28-CRP 55.1% and 11.2%, SDAI 42% and 26.1%, CDAI 41.1% and 27.1%. These remission and low disease activity levels are higher than those generally found in the literature. Conclusion: This study presents a cohort of patients with RA who started treatment at an early stage of the disease and who achieved higher rates of remission and lower disease activity than those reported in the literature.

Validation of the HAQ-UP-A (Health Assessment Questionnaire-Upper Limbs-Argentine Version) in patients with rheumatoid arthritis

HAQ is considered the gold standard for the evaluation of functional capacity in patients with rheumatoid arthritis (RA), even though it does not focus in any particular anatomical region. With the objective of assessing functional disability of the hand in elderly patients with osteoarthritis, Baron et al. used a modified version of the HAQ which was calculated as the mean value for those categories involving mostly upper extremities and named it ‘HAQ-UP’. This instrument has not been validated in patients with RA. ObjetiveTo valídate HAQ-UP argentine version in patients with RA. MethodsCross-sectional study. Consecutive patients ≥ 18 years with diagnosis of RA (ACR/EULAR 2010) were included. Socio-demographic data and RA characteristics were recorded. Questionnaires were administered: HAQ-A, HAQ-UP-A, FIHOA, Quick DASH. The reproducibility of the questionnaire was assessed. ResultsA total of 100 patients were included, 83% women, mean age 57.9 years (SD 11.6). Cronbach's alpha test was 0.94. The intra-item correlation did not show redundant questions. HAQ-UP-A showed excellent correlation with HAQ-A (r=0.93); FIHOA (r=0.89) and Quick DASH (r=0.91). It also showed good correlation with DAS28-ESR (r=0.68) and other composite disease activity indices as well as with other parameters of the disease. There was no correlation between HAQ-UP-A and disease duration. The reproducibility of the questionnaire was 0.82. Multiple linear regression adjusted for age and sex showed patient global VAS as the main determinant of HAQ-UP-A, followed by the presence of morning stiffness. ConclusionHAQ-UP-A was found to be reliable, valid and reproducible in patients with RA, representing a useful tool for the evaluation of the functional capacity of the upper limbs in these patients.

NEMO score in nailfold videocapillaroscopy is a good tool to assess both steady state levels and overtime changes of disease activity in patients with systemic sclerosis: a comparison with the proposed composite indices for this disease status entity

BackgroundIn previous studies, we demonstrated that the NEMO score, i.e. the cumulative number of microhaemorrhages (MHEs) and microthromboses (MTs), observed in nailfold videocapillaroscopy was a good indicator of the steady state level of disease activity (DA) in patients with systemic sclerosis (SSc) when the European Scleroderma Study Group (EScSG) index was considered the gold standard.Aim of the studyTo verify whether the NEMO score could be (i) a valid tool to assess DA, even when the modified European Scleroderma Trials and Research (EUSTAR) index was considered to be the comparator, and (ii) a sensitive method to capture the DA overtime changes.Patients and methodsThe NEMO score and the EScSG and EUSTAR indices were contemporarily assessed at baseline (T0) and after a follow-up of 4–56 months (T1) in 98 patients with SSc. The differences (Δ) between the T1 and T0 values of the NEMO score and the EScSG and EUSTAR indices were calculated and compared to each other.ResultsNEMO score values were very closely correlated with the corresponding values of the EScSG and EUSTAR indices both at T0 and T1 observations (p < 0.0001 in all cases with the exception of the correlation with EScSG values at T1 (p < 0.03)). The values of the two composite DA indices were also strictly related to each other in both T0 and T1 observations (p < 0.0001).Receiver operating characteristic (ROC) curve analysis showed the NEMO score had a good sensitivity and specificity in classifying patients with a predefined level of DA (scores ≥ 3.0 and ≥ 2.5 for the EScSG and EUSTAR indices, respectively, p < 0.0001 in both cases).Δ values of the NEMO score were significantly correlated with the corresponding values of both the EScSG and EUSTAR indices. Weighted Cohen’s k level of agreement between Δ values of the NEMO score and those of the EScSG and EUSTAR indices was moderate (0.55 and 0.59, respectively).ConclusionsNEMO score proves to be a feasible, non-invasive, and valid tool to assess steady state levels and changes over time of DA in patients with SSc. Thus, it can represent an alternative or complementary method to measure this disease status entity in this disorder.

Body mass index as a driver of selection of biologic therapy in rheumatoid arthritis. Results from the US-CLARA study

PurposeBody mass index (BMI) demonstrated to influence the clinical response to different drugs in rheumatoid arthritis (RA). The aim of this study was to investigate the role of BMI in the achievement of remission in active RA patients starting the treatment with abatacept. MethodsData regarding 130 RA patients enrolled in the UltraSound-CLinical ARthritis Activity (US-CLARA) study were retrospectively analyzed. Patients were assessed at baseline (when starting abatacept treatment) and at 3- and 6-months. An extensive clinimetric evaluation, including a new ultrasound (US)/clinical composite disease activity index, termed US-CLARA, was performed at every timepoints. Outcome of interest of the study was the impact of BMI on the achievement of the Disease Activity Score 28-joints erythrocyte sedimentation rate (DAS28-ESR) or the ACR/EULAR Boolean remission criteria at 6 month. ResultsAt 6-month 26 out of 130 patients were defined as responders to abatacept. Comparing the baseline characteristics of responders to non-responders, US-CLARA showed a statistically significant difference between the two groups. The logistic regression analysis showed that the two indipendent variables, predictive of treatment response (keeping the DAS28-ESR and/or Boolean remission criteria as dependent variable), were the self-tender joint count assessment (p = 0.0412) and the ultrasound score (p = 0.0211). No other baseline variable, notably BMI, was associated to 6-month abatacept response. ConclusionsBMI does not influence the abatacept response in RA patients with active disease. During abatacept treatment, the clinical response can be achieved despite a condition of overweight or obesity.

PROMIS Fatigue short forms are reliable and valid in adults with rheumatoid arthritis

BackgroundFatigue is prevalent and impactful in rheumatoid arthritis (RA). There is no standardized measure for its assessment nor data concerning the performance of PROMIS-Fatigue short forms (SFs) in people with RA. We evaluated the construct validity of 4-, 7-, and 8-item PROMIS-Fatigue SFs in RA patients across the range of disease activity.MethodsAdult RA patients were recruited from an online patient community and an observational cohort from three academic medical centers. Measures included PROMIS-Fatigue SFs, other PROMIS measures, and other patient reported outcomes including RAND-36 Vitality, Fatigue NRS, and patient global assessment of disease activity. Other measures from the observational cohort included 28-joint swollen and tender joints, physician global assessment, and the composite RA clinical disease activity index (CDAI).ResultsTwo-hundred online participants and 348 participants from the observational cohort were included. PROMIS Fatigue SF scores spanned the measurement continuum and correlated highly with each other (r’s ≥ 0.91) and other fatigue measures (r’s ≥ 0.85). PROMIS-Fatigue SF scores were highly and inversely associated with Physical Function and Participation (r’s − 0.77 to − 0.78), and moderately-highly and positively correlated with pain, sleep disturbance, anxiety, and depression (r’s 0.60 to 0.75). PROMIS-Fatigue SF scores showed dose-response relationships across fatigue severity descriptors and CDAI categories.ConclusionsThese results provide robust evidence supporting the construct validity of the 4, 7, and 8-item PROMIS-Fatigue SFs. They capture fatigue across the spectrum of RA disease activity in diverse groups of individuals and should be considered for use as patient-centered assessments of disease control and treatment efficacy.