Simplified Disease Activity Index Research Articles

Validity of Remission Criteria in Rheumatoid Arthritis Compared to Ultrasound-Defined Remission.

Remission is the ultimate purpose of treatment in rheumatoid arthritis (RA). However, even when the most stringent composite scores are used, structural damages can occur; hence, ultrasonography (US) appears to be the best way to assess real remission. This study aimed to investigate the validity of different RA remission scores using US as a reference. An analytic diagnostic study, of 30 RA patients in remission (according to the Disease Activity Score in 28 Joints [DAS28]) and a control group with active RA, was conducted between January and October 2018 at Mongi Slim Hospital in Tunis, Tunisia. Among them, patients in remission were identified according to their Simple Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI) and the Boolean American College of Rheumatology/European League against Rheumatism activity index (ACR/EULAR) remission scores. The validity of each activity score for remission was calculated by considering the absence of power Doppler (PD) signals as a gold standard. All patients were in remission according to the DAS28, with an average score of 2.03 (1.1-2.6). US examination showed PD signals in 57% of patients. A total of 26 patients were in remission according to the CDAI; a Doppler signal was detected in 58% of those cases. SDAI remission was accomplished in 19 patients, with PD activity in 53% of cases. Of the 14 patients in remission according to the Boolean ACR/EULAR criteria, synovial hyper-vascularisation was found in 64%. Considering true remission as the absence of PD signals, the most sensitive and specific score was the DAS28 (93% and 68%, respectively). Considering remission in RA as the absence of vascularised synovitis, the DAS28 is the most sensitive and most specific score.

Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two Trials.

We conducted a post hoc analysis of efficacy and safety of filgotinib stratified by estimated radiographic progression rate before baseline (BL) in patients with rheumatoid arthritis (RA) who had inadequate response to methotrexate (MTX; FINCH 1; NCT02889796) or were naïve to it (FINCH 3; NCT02886728). Radiographic progression rate was BL-Modified Total Sharp Score (mTSS) divided by RA duration (BL mTSS/year); estimated rapid radiographic progression (e-RRP) was BL change in mTSS/year ≥ 5; and estimated nonrapid radiographic progression (e-NRRP) was BL mTSS/year < 5. Efficacy and safety were compared between subgroups. All p-values are nominal. In FINCH 1 and FINCH 3, 558/1755 (31.8%) and 787/1249 (63.0%) patients, respectively, had BL e-RRP. BL characteristics were generally similar between subgroups within each trial. At week (W) 24, in FINCH 1, proportions achieving a Disease Activity Score 28 for rheumatoid arthritis with C-reactive protein < 2.6 were significantly greater with filgotinib 200 (FIL200) and 100mg (FIL100) versus placebo among e-RRP and e-NRRP subgroups. In each study, proportions of FIL-treated patients achieving Clinical Disease Activity Index ≤ 2.8 and Simple Disease Activity Index ≤ 3.3 were similar between subgroups. In FINCH 3, disease activity measures were at least numerically improved among patients receiving FIL versus MTX monotherapy. At W24, mTSS changes from BL (CFB) were greater among patients with e-RRP in FINCH 1 and FINCH 3 versus e-NRRP (0.81 versus 0.19, p = 0.001; 0.67 versus 0.25, p = 0.31, respectively). At W52, in FINCH 1, mTSS CFBs were smaller among e-RRP patients treated with FIL200 (0.40; p < 0.001) and FIL100 (0.77; p = 0.024) versus adalimumab (ADA; 1.46). In FINCH 3 at W52, mTSS CFBs were significantly smaller with FIL200 versus MTX among e-RRP patients. Rates of treatment-emergent adverse events (AEs) were comparable between subgroups and across treatment arms. Patients with previous e-RRP who received standard care tended to progress radiographically. FIL200 demonstrated persistent, consistent benefit for disease activity control among e-RRP and e-NRRP subgroups, and AE profiles were similar between subgroups. Although filgotinib efficacy was somewhat reduced among patients with e-RRP, filgotinib treatment slowed radiographic progression in both subgroups. Clinicaltrials.gov NCT02889796, NCT02886728.

American College of Rheumatology/EULAR Remission Criteria for Rheumatoid Arthritis: 2022 Revision.

In 2011, the American College of Rheumatology (ACR) and EULAR endorsed provisional criteria for remission in rheumatoid arthritis (RA), both Boolean- and index-based. Based on recent studies indicating that a higher threshold for the patient global assessment (PtGA) may improve agreement between the 2 sets of criteria, our goals were to externally validate a revision of the Boolean remission criteria using a higher PtGA threshold and to validate the provisionally endorsed index-based criteria. We used data from 4 randomized trials comparing biologic disease-modifying antirheumatic drugs to methotrexate or placebo. We tested the higher proposed PtGA threshold of 2 cm (Boolean2.0) (range 0-10 cm) compared to the original threshold of 1 cm (Boolean1.0). We analyzed agreement between the Boolean- and index-based criteria (Simplified Disease Activity Index [SDAI] and Clinical Disease Activity Index [CDAI]) for remission and examined how well each remission definition predicted later good physical function (Health Assessment Questionnaire [HAQ] score ≤0.5) and radiographic nonprogression. Data from 2,048 trial participants, 1,101 with early RA and 947 with established RA, were included. The proportion of patients with disease in remission at 6 months after treatment initiation increased when using Boolean2.0 compared to Boolean1.0, from 14.8% to 20.6% in early RA and 4.2% to 6.0% in established RA. Agreement between Boolean2.0 and the SDAI or CDAI remission criteria was better than for Boolean1.0, particularly in early disease. Boolean2.0, SDAI, and CDAI remission criteria had similar positive likelihood ratios (LRs) to predict radiographic nonprogression and a HAQ score of ≤0.5 (positive LR 3.8-4.3). The omission of PtGA (BooleanX) worsened the prediction of good functional outcomes. Using the Boolean 2.0 criteria classifies more patients as achieving remission and increases the agreement with index-based remission criteria without jeopardizing predictive value for radiographic or functional outcomes. This revised Boolean definition and the previously provisionally endorsed index-based criteria were endorsed by ACR and EULAR.

Citrullinated and carbamylated proteins in extracellular microvesicles from plasma of patients with rheumatoid arthritis.

To investigate the expression of citrullinated and carbamylated proteins in extracellular microvesicles (EMVs) from RA patients. We enrolled 24 RA naïve for biological therapy and 20 healthy donors (HD), matched for age and sex. For each patient, laboratory and clinical data were recorded and clinical indexes were measured (Clinical Disease Activity Index, Simplified Disease Activity Index, DAS28). EMVs in RA patients and HD were purified from plasma and measured by nanoparticle tracking analysis (NanoSight). Further, EMVs were incubated with anti-citrullinated/carbamylated proteins antibodies and processed by flow cytometry and western blot to evaluate the expression of citrullinated/carbamylated antigens. NanoSight revealed a significant increase of EMVs in RA compared with HD. Moreover, cytofluorimetric analysis showed a significative higher expression of citrullinated antigens on EMVs' surface in RA than donors, while no substantial difference was found in the expression of carbamylated antigens. These data were confirmed by western blot which identified vimentin, glycolytic enzyme alpha-enolase 1 and collagen type II as the main citrullinated and carbamylated proteins carried by EMVs. Finally, a relevant correlation between the expression of citrullinated antigens and disease activity was found. The results of this study suggest an involvement of EMVs in the pathogenesis of RA by inducing autoimmunity.

Withdrawal of MTX in rheumatoid arthritis patients on bDMARD/tsDMARD plus methotrexate at target: a systematic review and meta-analysis.

To evaluate the effect of MTX withdrawal on disease activity and remission rate in patients at target after treatment with biologic DMARDs (bDMARDs)/targeted synthetic DMARDs (tsDMARDs) plus MTX. We searched the PubMed, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) databases for all randomized controlled trials (RCTs) on MTX withdrawal in patients with RA at target after combination therapy from inception to 7 March 2022 in order to extract data, including: the change from withdrawal in DAS28 at the endpoint; proportion of low disease activity (LDA) assessed by DAS28, Simplified Disease Activity Index (SDAI) or Clinical Disease Activity Index (CDAI); proportion of remission assessed by DAS28, SDAI CDAI or ACR/EULAR Boolean remission. The Cochrane Q test and I2 test were used to assess heterogeneity, and random-effects models were used for data synthesis. This study is registered with PROSPERO (CRD42022303891). Six articles were included for qualitative and quantitative analysis, all of which were noninferior RCTs involving 1430 patients (734 in the withdrawal group and 696 in the continuation group). Compared with continuing combination therapy, tapering off or discontinuing MTX increased DAS28 by 0.20 (95% CI 0.09, 0.32, I2 = 0%) and decreased the percentage of patients with LDA assessed by DAS28 to <3.2 [risk ratio (RR) 0.88 (0.80, 0.97), I2 = 0%]. However, MTX withdrawal did not decrease remission rates assessed by DAS28, SDAI, CDAI or ACR/EULAR Boolean remission [RR 0.90 (0.81, 1.01), 0.93 (0.77, 1.11), 0.90 (0.74, 1.11), 0.95 (0.70, 1.29), respectively]. Withdrawing MTX slightly increases the RA disease activity in patients treated at target with bDMARDs/tsDMARDs plus MTX and has limited effects for patients with deep remission.

Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials.

IntroductionThe Routine Assessment of Patient Index Data 3 (RAPID3) is a patient-reported outcome tool recommended for the assessment of disease activity in patients with rheumatoid arthritis (RA) in clinical practice. This analysis evaluated the long-term effect of upadacitinib vs. comparators on RAPID3 scores in patients with RA in the phase 3 SELECT clinical trial program.MethodsThis post hoc analysis included data from five randomized controlled trials (RCTs) in patients receiving upadacitinib 15 mg or 30 mg once daily (QD) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). The proportions of patients reporting RAPID3 remission (scores ≤ 3) were assessed at week 60. Correlations between absolute scores for RAPID3 and Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and 28-joint Disease Activity Score with C-reactive protein (DAS28[CRP]) at week 60 were assessed using Spearman correlation coefficients.ResultsA total of 3117 patients were included from the SELECT-NEXT, -BEYOND, -MONOTHERAPY, -COMPARE, and -EARLY trials. By week 60, 32–52% of methotrexate-naïve and csDMARD inadequate responder (IR) patients treated with either upadacitinib 15 mg QD or upadacitinib 30 mg QD reported RAPID3 scores consistent with remission. The proportions were slightly lower in the biologic DMARD-IR SELECT-BEYOND population (19–28%). RAPID3 scores highly correlated (Spearman correlation values ≥ 0.58) with CDAI, SDAI, and DAS28(CRP) scores through week 60 (all p < 0.001).ConclusionsUpadacitinib, as monotherapy or in combination with csDMARDs, was associated with patient-reported remission assessed by RAPID3 over 60 weeks across the SELECT RCTs in patients with RA.Trial registrationSELECT-BEYOND (NCT02706847); SELECT-NEXT (NCT02675426); SELECT-MONOTHERAPY (NCT02706951); SELECT-EARLY (NCT02706873); SELECT-COMPARE (NCT02629159).Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-022-00483-4.

Chinese registry of rheumatoid arthritis (CREDIT) V: sex impacts rheumatoid arthritis in Chinese patients.

The impact of sex on the clinical manifestations of rheumatoid arthritis (RA) were diversely reported in the literature. The Chinese Registry of rhEumatoiD arthrITis provides a platform for the investigation of this issue in Chinese patients. Demographic and clinical parameters were collected from all enrolled patients with RA and from patients with early RA (disease duration ≤6 months). The differences in data regarding disease activity, comorbidities, and medications for RA were compared between men and women. The proportions of patients who achieved remission and low disease activity were compared at enrollment and during 3-, 6-, and 12-month follow-up visits. A total of 11,564 patients were enrolled, 83.6% of whom were female. In all the enrolled patients and patients with early RA, C-reactive protein (CRP, 12.0 vs . 6.7 mg/L), pain visual analogue scale (4.8 vs . 4.5), patient's and physician's global assessment (4.9 vs . 4.5 and 4.9 vs . 4.5), 28-joint disease activity score using DAS28-CRP (4.3 vs . 4.0) simplified disease activity index (21.9 vs . 19.9), and clinical disease activity index (19.3 vs . 18.0) were significantly higher in men than in women. Additionally, the swollen joint count/tender joint count and DAS28 using erythrocyte sedimentation rate were higher in male patients than in female patients with early RA. More female patients with early RA reached the treatment target at baseline than male patients (23.4% vs . 18.2%, assessed by CDAI). At 3 months, 6 months, and 12 months, the proportion of remission and treatment target achievement was similar in both sexes. Coronary artery disease (CAD) and stroke were more frequent in men than in women. In Chinese patients with RA, men were found to have more active disease, as well as more cases of CAD and stroke. Therefore, sex should be carefully considered during the personalization of RA treatment.

Efficacy and safety of a mobile app intervention in patients with inflammatory arthritis: a prospective pilot study

EULAR highlighted the essential role of digital health in increasing self-management and improving clinical outcomes in patients with arthritis. The objective of this study was to evaluate the efficacy and safety of the digital health application (DHA) in patients with inflammatory arthritis. We assessed demographic parameters, treatment regimen, disease activity, and other patient-reported outcomes at baseline and after 4 weeks of DHA use added to standard care treatment. Of 17 patients, who completed the study, 7 (41.2%) patients were male, ranging from 19 to 63 (40.5 ± 12.2) years. No significant change in antirheumatic treatment was observed during the study. Statistically significant improvements (p < 0.05) were noted for health-related quality of life (increase in Physical Component Summary of Short Form-36 (SF-36) by 23.6%) and disease activity (decrease of Clinical Disease Activity Index and Simple Disease Activity Index by 38.4% and 39.9%, respectively). Clinically significant improvement was demonstrated for SF-36 Total Score (+ 14.4%), disease activity (Rheumatoid Arthritis Disease Activity Index− 5 to 15.9%), and depression (Patient Health Questionnaire− 9 to 13.5%). None of the efficacy parameters showed negative trends. No adverse events were reported throughout the study. The usability level was high i.e., the mean mHealth Application Usability Questionnaire Score of 5.96 (max.: 7.0) demonstrated a high level of application usability. This suggests that using a personalized disease management program based on DHA significantly improves several measures of patient-reported outcomes and disease activity in patients with inflammatory arthritis in a timely manner. These findings highlight the potential of complementary digital therapy in patients with inflammatory arthritis.

Association between patient-reported outcomes and impairments in work and activity in patients with rheumatoid arthritis in clinical remission: A retrospective analysis using the IORRA database.

To explore the patient-reported outcomes (PROs) associated with work productivity and activity impairment (WPAI) in patients with rheumatoid arthritis (RA) in clinical remission. We enrolled patients with RA ≥18 years and with a simplified disease activity index ≤3.3 from the Institute of Rheumatology, Rheumatoid Arthritis data set collected in October 2017. The pain-visual analogue scale, patients' global assessment visual analogue scale (VAS), Japanese version of the Healthcare Assessment Questionnaire (J-HAQ) Disability Index, and duration of morning joint stiffness were selected as the PROs. To evaluate work productivity and activity, the WPAI for RA instrument (WPAI-RA) was used. To assess the contribution of each PRO to the WPAI-RA score, an analysis of variance model was constructed. The mean age of the 2614 patients was 62.4 years; 85.1% were female. Median values of the WPAI-RA score were 1.1% for absenteeism, 6.5% for presenteeism, 7.4% for work impairment, and 10.2% for activity impairment. Morning joint stiffness contributed the most to absenteeism (18.0%), while pain-VAS contributed the most to presenteeism (57.4%), work productivity loss (51.1%), and daily activity impairment (53.7%). J-HAQ was the second most contributing factor to presenteeism (17.4%), work productivity loss (16.3%), and daily activity impairment (26.0%). The pain-VAS and J-HAQ highly contributed to WPAI in patients with RA in clinical remission.

Dynamics of patient reported outcomes during the use various biological disease-modifying antirheumatic drugs for rheumatoid arthritis

One of the main tasks of modern complex therapy of rheumatoid arthritis (RA) is to improve the quality of life of patients. To do this, it is necessary not only to achieve remission or low activity, but also to successfully control the main, most painful, manifestations of the disease. Therefore, when evaluating the results of RA treatment, the dynamics of not only standard indices (DAS28 (Disease Activity Score 28), CDAI (Clinical Disease Activity Index), SDAI (Simplified Disease Activity Index)), but also the so-called “patient reported outcomes” (PRO) – a patient’s global assessment of disease activity (PGA), pain, functional disorders and fatigue.This review examines the effect of one of the main classes of anti–rheumatic drugs - biological disease-modifying antirheumatic drugs (bDMARDs) on the PROs. The results of a series of randomized controlled trials are presented, in which changes in PROs were studied using various tumor necrosis factor α (TNF-α) inhibitors, abatacept T-lymphocyte co-stimulation inhibitor, rituximab CD20 inhibitor and interleukin (IL) 6 inhibitors.The use of bDMARDs in combination with methotrexate (MTX) provides a reduction in PGA and pain by 50-60%, functional disorders according to HAQ (Health Assessment Questionnaire) and fatigue according to FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) – by 15-30%. B DMARDs monotherapy (with the exception of the effect of tocilizumab on HAQ) does not exceed MTX monotherapy in its effect on PROs. Monotherapy with tocilizumab provides more favorable dynamics of PGA and pain than monotherapy with TNF-α inhibitors. An important advantage of IL-6 inhibitors is the rapid achievement of a clinical effect, which is noted already in the first 2 weeks after the first administration of the drug.

Mindfulness-based stress reduction to improve depression, pain and high patient global assessment in controlled rheumatoid arthritis

ObjectiveThe aim was to improve distressing patient-reported outcomes (PROs) that persisted in RA patients with clinically controlled inflammation (controlled RA).MethodsIn a pragmatic pilot study, we offered mindfulness-based stress reduction (MBSR), a group intervention, to controlled RA patients who had high (≥16) Centre for Evaluation Studies depression (CES-D) scores and/or patient general assessment of disease activity (PGA) at least 2/10 larger than evaluator general assessment (EGA) (PGA-EGA: Delta). Evaluations before, 6 and 12 months after MBSR included CES-D, PGA, modified HAQ, simple disease activity index (SDAI), anxiety (general anxiety disorder 7; GAD-7), coping strategies (coping with health injuries and problems; CHIP), sleep disturbance and pain. Facilitators and obstacles to recruitment and participation were identified. A subset of patients was interviewed for qualitative analysis of their experience.ResultsOut of 306 screened patients, 65 were referred, 39 (60%) agreed and 28 (43%) completed MBSR. Anticipated burden, timing and frequency of group meetings, commuting issues, age extremes and co-morbidities were barriers to participation. Up to 12 months after MBSR, anxiety, depression, emotion-oriented coping, sleep and function significantly improved. Nonetheless, no significant impact was observed on pain, PGA, Delta or SDAI. The interviews revealed that benefits, including integration of effective coping strategies, were maintained.ConclusionWe addressed MBSR feasibility issues and selection of outcomes in controlled RA patients with distressing PROs. For patients who chose to participate in MBSR, lasting benefits were evident for anxiety, depression, sleep and function. Larger studies are required to evaluate the weaker impact of MBSR on RA-related pain and PGA.

Articular 18Fluorodeoxyglucose Uptake Is Associated With Clinically Assessed Swollen Joint Count in Patients With Rheumatoid Arthritis.

Examination and conventional radiography of joints are unable to precisely evaluate and measure disease activity in rheumatoid arthritis (RA). We quantified joint inflammation using 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) in people with RA to determine if PET-derived uptake variables were correlated with RA disease activity measures. We cross-sectionally studied 34 patients with RA in a substudy of the Rheumatoid Arthritis Study of the Myocardium (RHYTHM). All patients underwent 18F-FDG-PET scanning with CT for attenuation correction and anatomic co-registration. Linear regression was used to model the associations of disease activity scores with articular FDG uptake, calculated as standardized uptake values (SUVs). Weighted joint volume SUVs (wjSUV) representing 25%, 50%, 75%, and maximum (100%) uptake (wj25SUV, wj50SUV, wj75SUV, and wjMaxSUV, respectively) were calculated as global variables of the total volume of joint inflammation in each patient. Calculated wj25SUV (Spearman ρ = 0.39, P = 0.04), wj50SUV (ρ = 0.39, P = 0.04), and wj75SUV (ρ = 0.37, P = 0.045) measures were significantly correlated with the number of swollen joints. Similar significant correlations were found for the Simplified Disease Activity Index but not Clinical Disease Activity or Disease Activity Score in 28 joints. No associations were found between articular FDG uptake and nonarticular RA-related variables (ie, disease duration, seropositivity, or RA treatments). Articular FDG uptake in patients with RA was significantly correlated with the number of swollen joints but not with biochemical measures of inflammation.

Development and validation of equations for conversion from DAS28ESR and DAS28CRP to the SDAI in patients with rheumatoid arthritis.

Disease Activity Score-28 (DAS28) with erythrocyte sedimentation rate (DAS28ESR), DAS28 with C-reactive protein (DAS28CRP), and simplified disease activity index (SDAI) are widely used to assess disease activity as low, moderate, or high or in remission in patients with rheumatoid arthritis (RA). However, these indicators can generate inconsistent results, influencing treatment decisions and limiting comparisons across studies. We aimed to establish equations for conversion from DAS28ESR and DAS28CRP to SDAI. We conducted a retrospectivestudy, including 933 outpatients who were simultaneously assessed using DAS28ESR, DAS28CRP, and SDAI. The patients were divided into a training set (70%) and a validation set (30%). We developed equations to convert DAS28ESR and DAS28CRP values into SDAI values by bisquare-weighted robust regression to obtain SDAI-DAS28ESR and SDAI-DAS28CRP. In addition to using kappa values to assess consistency, differences in disease activity classification between SDAI-DAS28ESR and SDAI-DAS28CRP were examined by the Stuart-Maxwell test and the Bowker test. Two quadratic equations were developed as follows: SDAI-DAS28ESR = 1.168 × (DAS28ESR)^2 - 2.432 × (DAS28ESR) + 2.649 and SDAI-DAS28CRP = 1.2 × (DAS28CRP)^2 - 0.3522 × (DAS28CRP) - 0.6014. After applying the equations, the Stuart-Maxwell test and the Bowker test were no longer significant between SDAI-DAS28ESR and SDAI or between SDAI-DAS28CRP and SDAI. The kappa values increased from 0.57 to 0.73 between SDAI-DAS28ESR and SDAI and 0.76 to 0.86 between SDAI-DAS28CRP and SDAI. SDAI-DAS28ESR and SDAI-DAS28CRP are interchangeable with the SDAI on the group level, which will facilitate comparisons among studies. In addition, the equations improved consistency between indicators. Key Points • There is disagreement in assessing disease activity in patients with rheumatoid arthritis between Disease Activity Score-28 (DAS28) with erythrocyte sedimentation rate (DAS28ESR), DAS28 with C-reactive protein (DAS28CRP), and simplified disease activity index (SDAI). • We developed and validated two quadratic equations to convert DAS28ESR and DAS28CRP into SDAI. We found there was no longer significant difference in disease activity between indicators after applying the equations. • This work may allow comparisons across studies which use different indicators.

Rheumatoid arthritis and nutritional profile: A study in Brazilian females.

Patients with rheumatoid arthritis (RA) may have nutritional impairment. In RA, muscle loss is associated with an increase in fat tissue, and the patients may not have body mass index (BMI) alterations. To study the nutritional status in a sample of patients with RA in Brazil through mini nutritional assessment (MNA) and electric bioimpedance and its relationship to BMI, functionality, disease activity, and treatment. Seventy-one RA females were included. Chart review was used to obtain epidemiological, clinical, and treatment data. Patients answered the MNA and were submitted to electrical bioimpedance and anthropometric measurements. Disease activity was assessed through simple disease activity index (SDAI), clinical disease activity index (CDAI), and function, through health assessment questionnaire (HAQ). According to MNA, 23 (32.4%) patients were at risk for malnutrition and 1 (1.4%) was malnourished. MNA were associated with disease activity and function impairment (SDAI P=.02; CDAI P=.02, and HAQ P=.002) but not with used medications. According to BMI, 76% were overweight or obese. An increased percentage of body fat was found in 98.7% and a lower percentage of lean mass in 95.7%. Disease activity and function were not associated with the percentage of body fat of any used medications, with a lower percentage of body fat in those using abatacept (P=.01). Almost one-third of patients had nutritional impairment according to MNA which was associated with disease activity and loss of function. Almost the whole sample had an increased percentage of fat mass and a diminished percentage of muscle mass that could not be linked with disease activity, function or used medications.

The correlation of ultrasound-detected synovitis in an individual small joint with overall clinical disease activity in patients with rheumatoid arthritis.

To explore the correlation between the ultrasound-detected synovitis in each individual joint at metacarpophalangeal (MCP), proximal interphalangeal (PIP), and metatarsophalangeal (MTP) regions and the clinical disease activity in patients with rheumatoid arthritis (RA). Clinical disease activity was assessed by disease activity score (DAS) based on 28-joint count and erythrocyte sedimentation rate (DAS28-ESR), C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI). Gray scale (GS) and power Doppler (PD) synovitis was assessed by ultrasound semi-quantitatively. The correlation between clinical disease activity indices and synovitis score in each joint was assessed using Spearman's rank correlation test. 211 RA patients were included in this study. The whole GS scores of all MCP joints showed the highest correlation with each Clinical Disease Activity Index (r = 0.403-0.452, p < 0.01). Likewise, the whole PD scores of all MCP joints also showed the highest correlation with clinical disease activity (r = 0.332-0.396, p < 0.01). At individual joint level,the highest correlation of GS score with DAS28-ESR (r = 0.411, p < 0.01), DAS28-CRP (r = 0.459, p < 0.01), and SDAI (r = 0.444, p < 0.01) was observed in MCP3 joint while with CDAI (r = 0.421, p < 0.01) in MCP2 joint. The highest correlation of PD score with DAS28-ESR (r = 0.353, p < 0.01), DAS28-CRP (r = 0.399, p < 0.01), CDAI (r = 0.368, p < 0.01), and SDAI (r = 0.377, p < 0.01) was observed in MCP5 joint. The ultrasound-detected synovitis at MCP joints, especially MCP2, MCP3, and MCP5 joints, was best correlated with clinical disease activity in most RA cases, in contrast to PIP and MTP joints. Key Points • The correlation of ultrasound-detected synovitis in each individual joint with the clinical disease activity in RA patients is diverse among joint regions. MCP joints showed the best, in contrast to PIP and MTP joints.

Lower hand grip in rheumatoid arthritis patients is associated with low finite element analysis using high resolution peripheral quantitative computed tomography scan of the 2nd metacarpophalangeal joint.

To evaluate hand function by hand grip test in rheumatoid arthritis (RA) patients, and its association with bone erosions and the estimated bone strength (finite element - FE analysis) through the analysis of the 2nd metacarpal head of the dominant hand using high resolution peripheral quantitative computed tomography (HR-pQCT). Eighty-two female RA patients between 18-50 years old were selected. Demographic data, Health Questionnaire Assessment Disability Index (HAQ), Disease Activity Score of 28 joints (DAS)-28, simplified disease activity index (SDAI) and the hand grip test were set. The HR-pQCT scans of 2nd metacarpophalangeal joints of the dominant hand of all patients were performed according to SPECTRA group protocols. The images were used to assess bone erosions and FE analysis. The hand grip test was categorized in 2 groups and separately compared (< 18 vs ≥18 kgf). A logistic regression was performed using hand grip test <18 kgf as a dependent variable. A significant difference was found between the 2 groups regarding HAQ, inflammatory markers (erythrocyte sedimentation rate, C-reactive protein), DAS-28, SDAI, total volume of erosion and bone strength parameter (FE analysis - Failure Load [F.Load]). The logistic regression analysis showed that the risk factors associated with hand grip test <18 kgf were higher SDAI (odds ratio [OR] 0.912; 95% CI 0.837-0.993) and lower values of bone strength parameter (F.Load) (OR 1.007; 95% CI 1.002-1.012). Lower values of hand grip test were associated with higher disease activity score-SDAI and lower bone strength of 2nd metacarpal bone head of the dominant hand evaluated here through a FE analysis using HR-pQCT scan.

Female reproductive status and exogenous sex hormone use in rheumatoid arthritis patients treated with tocilizumab and csDMARDs.

Sex is well known to influence risk, severity and treatment outcomes of RA, although the underlying causes are uncertain. The aim of this research was to examine whether factors influencing female sex hormones (reproductive status and exogenous sex hormone use) are associated with the efficacy of DMARDs. Individual participant data were pooled from five phase 3 clinical trials where RA patients were treated with tocilizumab and/or conventional synthetic DMARDs. The primary outcome was the time to first remission according to the Simplified Disease Activity Index. The relationship between menopausal status or use of exogenous sex hormones and the time of first remission was assessed via Cox proportional analysis. Analysed data included sex, baseline menopausal status (premenopausal, perimenopausal, early postmenopausal and postmenopausal), participant age, body mass index, race, number of previous DMARDs and baseline disease activity. Analysis included 4474 female patients, of whom 2817 (62.9%) were postmenopausal, 202 (4.5%) were early postmenopausal, 1021 (22.8%) were premenopausal and 414 (9.2%) were perimenopausal. Of these, 221 (7.8%), 13 (6.4%), 255 (25%) and 47 (11.4%), respectively, were taking exogenous sex hormones. In the pooled analysis, perimenopausal status was associated with reduced remission compared with premenopausal status [adjusted HR 0.78 (95% CI 0.61, 0.99)]. Sex hormone use was associated with significantly higher remission [adjusted HR 1.20 (95% CI 1.01, 1.43)]. Perimenopausal women were less likely to achieve remission compared with premenopausal RA patients. The use of exogenous sex hormones appeared to be associated with more frequent remission in female RA patients, particularly those who were perimenopausal and early postmenopausal, although further research is required to confirm and identify the drivers for this observation and how it interacts with menopausal status.

Longitudinal trajectories of fatigue in early RA: the role of inflammation, perceived disease impact and early treatment response

ObjectiveFatigue is common in rheumatoid arthritis (RA). We aimed to explore its longitudinal course, predictors and association with disease activity in early RA.MethodsData came from the 2-year treat-to-target trial CareRA...

Pereklad, kros-kulturalna adaptatsiia i validyzatsiia ankety tsentralnoi sensytyzatsii (Central Sensitization Inventory) dlia khvorykh na revmatoidnyi artryt

Introduction. Pain syndrome is one of the leading disabilitating factors in patients with rheumatoid arthritis (RA). Recently the heterogeneity of pathogenetic mechanisms of pain formation in the patients with joints inflammatory diseases has been demonstrated. The phenomenon of central sensitization is among the leading mechanisms of pain perception. In 2012 T. G. Mayer et al. created the Central Sensitization Inventory (CSI), which makes it possible rapid identification of patients whose symptoms may be related to the phenomenon of central sensitization. Currently the Ukrainian version of this questionnaire is not available. The aim of the study. Our investigation was directed towards translation, cross-cultural adaptation, validation, and testing of Central Sensitization Inventory Ukrainian version in rheumatoid arthritis patients. Materials and methods. Translation and cross-cultural adaptation of CSI were carried out according to the standard Guidelines for the process of cross-cultural adaptation of self-report measures. 75 patients diagnosed with RA according to ACR/EULAR (2010) criteria and 15 control group patients were involved in the study. RA activity was determined due to Disease Activity Score – 28 (DAS-28), the Simplified Disease Activity Index (SDAI), the Clinical Disease Activity Index (CDAI), and the functional ability of patients – by Health Assessment Questionnaire – Disability Index (HAQ-DI). Visual analog scoring (VAS) from 0 to 10 points were used to evaluate the intensity of pain. Statistical analysis of the results was performed using the methods of variation statistics in the application package SPSS22 (© SPSS Inc.). The results are presented as the mean value with standard deviation (M ± SD). Results. According to DAS-28, patients had a predominance of moderate and high disease activity (4.99 ± 0.87). Also, high RA activity in most patients was confirmed by CDAI (32.96 ± 9.46) and SDAI (35.90 ± 9.56). Impairment of functional ability in the examined patients according to the HAQ-DI index was 1.36 ± 0.70 points. Severe functional impairment (HAQ-DI value more than 2 points) was observed in 19.0 % of patients. The intensity of pain assessed in patients was 6,92 ± 1,55 points. The reliability of the Ukrainian-language version of the CSI questionnaire was evaluated by a “test-retest” with an interval of 7 days in 65 patients with RA. The obtained data demonstrated the high reliability of the CSI questionnaire – intraclass correlation coefficient was 0.914, and the L. Cronbach’s alpha coefficient was 0.914. The CSI questionnaire in RA patients demonstrated the phenomenon of central sensitization in this category of patients. The CSI value in our patients was 36.32 ± 14.67 versus 15.60 ± 12.10 in controls. At the same time, an indicator of more than 40 (central sensitization present) was detected in 40.0 % of patients. Conclusions. Translation, cross-cultural adaptation and validation of the Central Sensitization Inventory questionnaire were accomplished. The Ukrainian version of the questionnaire showed sufficient reliability and internal consistency. This questionnaire can be useful in both – scientific purposes and clinical practice – regarding the Ukrainian-speaking population with rheumatoid arthritis.

Predictors of Remission and Low Disease Activity in Rheumatoid Arthritis Patients: Results From the Follow-up of a Real-World Peruvian Cohort.

Clinical remission is the goal in rheumatoid arthritis (RA) management; however, this can be difficult to achieve in several parts of the world. Our objective was to determine predictors of remission and remission/low disease activity (LDA) in RA. A longitudinal real-setting RA cohort was followed up (January 2016-2020). Predictors examined were sex, age at diagnosis, disease duration, socioeconomic status, tobacco use, rheumatoid factor titer, comorbidities (Charlson index), Simple Disease Activity Index (SDAI) score, disability (Multidimensional Disease Health Assessment Questionnaire), health-related quality of life (Short Form-36 questionnaire), glucocorticoid dose, biological/target synthetic disease-modifying antirheumatic drugs, and conventional DMARD (c-DMARD) use. Univariable and multivariable generalized estimating equation models were done to determine predictors of remission (at a given visit) and sustained remission (2 consecutives visits), using the SDAI definition (0 or <3.3). Similarly, remission/LDA (SDAI <11) predictors were examined. Five hundred thirty RA patients included the following: 160 patients (30.2%) achieved remission in at least 1 visit, and 126 patients (23.77%) achieved sustained remission. On the multivariable analysis glucocorticoid dose (odds ratio [OR], 1.060; 95% confidence interval [CI], 1.027-1.094; p = 0.004) and current (OR, 2.293; 95% CI, 1.811-2.903; p < 0.001) or past (OR, 1.383; 95% CI, 1.127-1.698; p = 0.002) use of c-DMARDs predicted remission/LDA in at least 1 visit, whereas the SDAI (OR, 0.951; 95% CI, 0.942-0.959; p < 0.001), Multidimensional Disease Health Assessment Questionnaire (OR, 0.648; 95% CI, 0.549-0.764; p < 0.001), and age at diagnosis (OR, 0.994; 95% CI, 0.990-0.998; p = 0.004) were negative predictors. As to sustained remission/LDA, current (OR, 2.012; 95% CI, 1.458-2.776: p < 0.001) or past (OR, 1.517; 95% CI, 1.155-1.993; p = 0.003) use of c-DMARDs, having a better Short Form-36 questionnaire physical component summary (OR, 1.022; 95% CI, 1.014-1.029; p < 0.001), and older age at diagnosis (OR, 1.013; 95% CI, 1.003-1.022; p = 0.008) predicted it, whereas SDAI (OR, 0.949; 95% CI, 0.933-0.965; p < 0.001) and medium low/low socioeconomic status (OR, 0.674; 95% CI, 0.500-0.909; p = 0.010) were negative predictors. During follow-up of this real-world RA cohort, c-DMARD use predicted remission and remission/LDA. In contrast, disease activity was a negative predictor.