Rheumatoid Arthritis Disease Activity Score Research Articles

Effect of Integrated Naturopathy Interventions on Systemic Inflammatory Markers and Quality of Life in Patients With Active Rheumatoid Arthritis: A Randomized Controlled Trial.

Rheumatoid arthritis (RA) is a chronic, systemic, polyarticular autoimmune inflammatory disease that destroys the capsule and synovial lining of joints. Antirheumatic treatment reduces disease activity and inflammation, but not all patients respond to treatment. Naturopathy, a research-based complementary and alternative medicine, may be useful in these patients, but there is little data on the effect of Naturopathy interventions on inflammation and disease activity in RA. To explore the effect of 12 weeks of integrated naturopathy interventions on disease-specific inflammatory markers and quality of life in RA patients. A total of 100 RA patients were randomized into two groups: the naturopathy group (integrated naturopathy interventions with routine medical therapy) and the control group (only with routine medical therapy). Blood samples were collected pre- and post-intervention for primary outcome measurements of systemic inflammatory markers (ESR, CRP, and IL-6). Disease activity score (DAS-28) and quality of life were used to assess disease activity and functional status using SF-36, respectively, at pre- and post-intervention time points. The results of the present study show a notable decrease in disease activity after 12 weeks of naturopathy intervention. As such, a significant decrease was found in levels of systemic inflammatory markers such as ESR (p = 0.003)and IL-6 (p < 0.001), RA disease activity score (DAS-28) (p = 0.02), and most of the components of health-related quality of life (SF 36 scores) (p < 0.05) except in vitality (p = 0.06). Conclusions: The findings of the present study suggest that integrated naturopathy treatments may have the ability to control persistent inflammation, maintain immune homeostasis, and lower disease activity.

Comparison of safety and effectiveness between etanercept biosimilar LBEC0101 and reference in patients with rheumatoid arthritis in real-world data using the KURAMA cohort.

Biosimilars are anticipated to be widely used in the treatment of rheumatoid arthritis (RA), owing to their cost efficiency; LBEC0101 was the first etanercept (ETN) biosimilar approved in Japan. However, there are limited real-world data comparing its safety and effectiveness with those of a reference product. This study used data from the Kyoto University Rheumatoid Arthritis Management Alliance cohort, including patients with RA who received ETN therapy-ETN reference product (ETN-RP) or LBEC0101-between 2015 and 2021. Serum ETN levels were measured using liquid chromatography-tandem mass spectrometry. The 1-year continuation rates of ETN-RP and LBEC0101 were 58.7% and 74.4%, respectively. Effectiveness of treatment was evaluated in 18 patients; both products significantly reduced the 28-joint RA disease activity score and erythrocyte sedimentation rate (DAS28-ESR). Moreover, to determine equivalence, we analysed 11 patients who switched from ETN-RP to LBEC0101; the DAS28-ESR and serum ETN levels before and after switching were not significantly different. This real-world cohort study confirmed that the biosimilar of ETN, LBEC0101, was comparable to the reference product in terms of continuation rate, effectiveness at initiation of introduction, and effect persistence before and after switching in clinical practice.

Demographic, Clinical Profile of Rheumatoid Arthritis Patients and Their Association with Disease Severity in Ghana.

Rheumatoid arthritis (RA) is one of the frequent chronic, systemic, inflammatory autoimmune disorders with an estimated global prevalence of 1%. RA leads to joint destruction and disability if left untreated. Ghana has seen very few studies on RA, and little is known about the disease's severity and related variables. This study sought to characterize the clinical presentation and determine disease severity and associated risk factors with disease severity among RA patients in a tertiary hospital in Ghana. This cross-sectional study was conducted between September 2020 and August 2021. This study included 56 consecutively consenting RA patients from the Komfo Anokye Teaching Hospital orthopaedic unit. Diagnosis of RA was based on the updated American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2022 rheumatoid arthritis classification criteria by a rheumatologist. A study questionnaire was used to gather participant demographics and clinical features, and results from the laboratory were taken from the patients' charts and medical records. The patients' disease severity was evaluated based on the rheumatoid arthritis disease activity score, which is based on a 28-joint count (DAS28), and their functioning was evaluated using the modified health assessment questionnaire. The participants' mean age was 51.25 ± 13.22 years. Out of the total participants, 46 were females, and 10 were males (female-to-male ratio 4.6 : 1). Moreover, 37.50% had arthritis of the hand; 5.30% had severe disease, and 94.60% were not severe. A majority (76.80%) were on methotrexate medication. The most frequently involved joints were the knee (42.90%), wrist (32.10%), and elbow (12.50%). There was no statistically significant association with disease severity and a functional status score of >0.5 (cOR: 10.60, 95% CI (0.52-217.30); p = 0.124). In addition, marital status (p = 0.04), disease duration (p = 0.04), family complaints (p = 0.02), and ESR (p = 0.03) were significantly associated with disease severity. RA is predominant among elder populations and females. Disease duration, family complaints, and ESR are associated with disease severity. The findings of this study call for interventions towards ensuring early diagnosis of RA among high-risk populations to enhance good management practices.

The impact of concomitant Sjögren's disease on rheumatoid arthritis disease activity: a systematic review and meta-analysis.

Rheumatoid arthritis (RA) and Sjögren's syndrome (SS) frequently co-exist but the consequence for RA disease activity of having concomitant SS (RA/SS) is not well established. We conducted a systematic review and meta-analysis to investigate the impact of SS on disease outcomes in individuals with RA. We searched Web of Science (Core Collection, FSTA, Medline), PubMed and Cochrane databases, without language restriction. Studies reporting RA disease activity scores, joint counts, visual analogue scales (VAS), disability and joint damage, and comparing RA and RA/SS were selected. Outcomes reported in at least 3 studies in which the diagnosis of SS fulfilled classification criteria underwent meta-analysis, using a random effects model where heterogeneity was detected. The literature search identified 2991 articles and abstracts; 23 underwent full-text review and 16 were included. The studies included a total of 29722 patients (8614 with RA/SS and 21108 with RA). Using studies eligible for meta-analysis (744 patients with RA/SS and 4450 with RA), we found higher DAS-28 ESR scores (mean difference 0.50, 95% CI -0.008-1.006; p=0.05), higher swollen joint count scores (mean difference 1.05, 95% CI 0.42-1.67; p=0.001), and greater functional disability as measured by HAQ (mean difference 0.19, 95% CI 0.05-0.34; p=0.009) in RA/SS compared to RA alone. Other outcome measures (tender joint count, fatigue VAS) showed a numerical trend towards higher scores in RA/SS but were not statistically significant. RA/SS patients appear to have higher disease activity and more functional disability than patients with RA alone. The aetiology and clinical implications of this are unclear and warrant further investigation.

Seluang Fish (Rasbora sp.) Oil Improves Interleukin-17 Levels and Disease Activity in Rheumatoid Arthritis

BACKGROUND: Vitamin D has a role in downregulating the proinflammatory cytokines as well as promoting the antiinflammatory pathway in rheumatoid arthritis (RA). Seluang fish (Rasbora sp.) has potency as a new source of vitamin D. Previous study had proven Seluang fish oil efficacy in systemic lupus erythematosus. However, there are no trials that prove its efficacy in RA yet. Hence, this study was conducted to find out the ability of Seluang fish oil to improve proinflammatory cytokines, vitamin D levels, and disease activity in RA.METHODS: A clinical trial with a randomized and double-blind method was done in two groups, each one consisting of 17 RA subjects. One group was given 500 mL of a Seluang fish oil capsule (contains 665 IU cholecalciferol), while the other group was given a placebo daily, for 12 consecutive weeks. Measurements of the RA disease activity score 28 erythrocyte sedimentation rate (DAS28-ESR) and DAS28 C-reactive protein (DAS28-CRP), as well as measurement of interleukin (IL)-6, IL-17, and vitamin D levels by using immunoassay method were performed before and after the supplementation.RESULTS: Significant alterations in the lower levels of IL-17 were observed in the Seluang fish oil group (p=0.031), but not in the placebo group (p=0.320). Reduction of DAS28-ESR (p=0.000) and DAS28-CRP (p=0.000) score demonstrated that the Seluang fish oil supplementation was useful in reducing RA disease activity. No significant shift was observed in either vitamin D (p=0.967) or IL-6 levels (p=0.076) after Seluang Fish Oil supplementation.CONCLUSION: Seluang fish oil is effective in lowering IL-17 levels, DAS28-ESR, and DAS28-CRP, but not in improving vitamin D level or lowering IL-6 level in RA patients.KEYWORDS: rheumatoid arthritis, seluang fish oil, interleukin-6, interleukin-17, vitamin D, DAS28

Oral health-related quality of life in rheumatoid arthritis: a comparative analysis

BackgroundCompared to the healthy population, the psychological impact of rheumatoid arthritis(RA) on patients' lives could dramatically lower their oral health-related quality of life (OHRQoL). Our goal is to analyze OHRQoL in RA patients and look into the role of disease activity, dental health index, and Temporomandibular disorders score in maintaining their oral health.MethodsIn a cross-sectional comparative study, we compared a sample of 40 RA patients with 40 age- and gender-matched healthy controls in terms of oral health and OHRQoL. Temporomandibular disorders (TMD), number of decayed, filled, or missing teeth (DMFT), and Oral Health Impact Profile (OHIP) were among the oral health factors studied (OHIP-14). This study also looked at the link between the RA disease activity score (DAS28) and oral health factors.ResultsRA patients had a significantly higher mean (poorer OHRQol) than healthy controls in total oral function, total psychosocial impact, OHIP-14 sum score, OHIP-14 extent score, TMD score and the number of missed teeth (Mann–Whitney U test, P-value < 0.05). After adjustment for DMFT, only the oral function score of OHIP-14 had a significant correlation with disease activity (Mann–Whitney U test, P-value < 0.05). The TMD sum score significantly correlated with disease activity regardless of adjustment for DMFT (Spearman's Correlation test, P-value < 0.05 for both). The number of decayed teeth and missed teeth showed a positive correlation with increased disease activity (Coefficient = 0.239 and 0.245, P-value < 0.05 for both).ConclusionsPatients with RA are less satisfied with their oral health than healthy controls. In RA patients, the number of missing teeth and temporomandibular disorders was substantially greater, and the number of missing teeth and temporomandibular diseases increased significantly with increased disease activity. Although OHRQoL was inversely connected with RA activity, after correcting for decaying, missing, and filled teeth, only the oral function score of OHIP-14 exhibited a slight connection to DAS28.

The Clinical Presentation and Factors Associated with Disease Severity of Rheumatoid Arthritis in Uganda: A Cross-Sectional Study.

BackgroundRheumatoid arthritis (RA) is a chronic, debilitating disease that leads to joint destruction and disability if left untreated. Few studies on RA have been conducted in Uganda, and there is limited information on disease severity and associated factors. This study sought to characterize the clinical presentation and to determine disease severity and the factors associated with disease severity among participants with RA in Uganda.MethodsBetween August 2018 and February 2019, patients presenting to the rheumatology outpatient clinic in Mulago National Referral Hospital were enrolled into the study using a cross-sectional design. Participants’ demographics and clinical characteristics were collected using a study questionnaire, and laboratory results were extracted from their charts. The patients’ functionality was assessed using the Modified Health Assessment Questionnaire and their disease severity was assessed using the RA Disease Activity Score based on 28-joint count (DAS28).ResultsA total of 170 participants were enrolled, of whom 81.2% were female. Nearly two-thirds (111/170) were classified as having severe disease. Having a functional status score of >0.5 (adjusted odds ratio 1.7, 95% confidence interval 1.4–2.2, p<0.001) was significantly associated with severe disease.ConclusionIn this population, the majority of the patients seen at the rheumatology outpatient clinic had severe disease, suggesting that patients may be presenting late, with limited early detection of the disease. Impaired functional status was associated with increased disease severity and may be used by clinicians to highlight disease severity when it is not possible to assess the RA DAS28.

Reduction of peripheral regulatory T cells in active rheumatoid arthritis patients with coronary artery disease

ObjectiveTo identify lymphocyte and CD4 + T cell subset characteristics, particularly regulatory T cells (Tregs), in active rheumatoid arthritis (RA) patients with coronary artery disease (CAD).MethodsA total of 54 RA patients with CAD (RA-CAD group), 43 RA patients without CAD (pure RA group), and 43 healthy controls (HC group) were enrolled. The absolute number and frequency of lymphocyte subpopulations and CD4 + T cell subsets were analyzed by flow cytometry. Serum levels of cytokines were analyzed using a cytometric bead array. Clinical and laboratory data were collected retrospectively and their correlation with CD4 + T subsets were analyzed.ResultsThere was a significant decrease in the absolute number of Treg cells (CD4 + CD25 + Foxp3 + T cells) in the RA-CAD group compared to the pure RA group (p < 0.001). Similarly, both the absolute number (p = 0.001) and frequency (p = 0.011) of Tregs in the RA-CAD group were decreased compared to the HCs, causing a Th17/Treg imbalance (p = 0.044). No difference was found in the absolute number and frequency of Treg cells between the pure RA and HC groups. However, the absolute Th17 cell count was increased in the pure RA group (p = 0.032). The serum level of cytokine IL-17 was lower in the RA-CAD group than in the pure RA group (p = 0.023). In the RA-CAD group, the Treg number was negatively correlated with the RA disease activity score and ESR value, and LDL and ApoB100 levels were negatively correlated with the number of Th17 cells.ConclusionsActive RA patients with CAD sustain more severe immune tolerance damage and Th17/Treg disorder. Monitoring of lymphocyte and CD4 + T cell subsets, particularly Treg cells, is crucial to understanding immune status in this group. Focusing on RA activity and CAD risk control, immune-regulatory therapy based on the Treg level may be more beneficial for RA patients with CAD.

Lower Urinary Tract Symptoms Among Females with Rheumatoid Arthritis: A Prospective Cross-Sectional Study.

PurposeTo assess the presence of lower urinary tract symptoms (LUTS) in rheumatoid arthritis (RA) female patients with assessment of LUTS and its impact on quality of life (QoL).Patients and MethodsA prospective, cross-sectional study of female patients with RA was conducted. Demographics and clinical data, Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS), and the RA Disease Activity Score 28 (DAS28) were all collected. A correlation has been made between all variables to assess the factors that induce LUTS in RA and the impact on QoL.ResultsEighty-nine patients were enrolled. About 94.4% of RA patients had at least one symptom of LUTS. Concerning DAS28, 55.1% had moderate disease activity and 16.9% had high disease activity, which was not significantly associated with BFLUTS or QoL. The prevalence of overactive bladder syndrome symptoms (OAB: frequency, urgency, nocturia, and urgency incontinence) were found to be 65.2%, 59.6%, 56.2%, and 30.3%, respectively. Stress incontinence was prevalent in 40.4% of patients. The overall interference with life was evident in 27 (30.3%) patients secondary to LUTS. Body mass index (BMI) was positively and significantly correlated with the presence of storage symptoms (r = 0.306, p = 0.004) and with the total BFLUTS (r = 0.251, p = 0.018). BFLUTS subdomains and total scores were significantly correlated to poor QoL. The correlation of the BFLUTS QoL was found to be r = 0.584, p < 0.001 with storage symptoms, r = 0.399, p < 0.001 with voiding symptoms, and r = 0.757, p < 0.001 with incontinence.ConclusionLUTS is a prominent and significant disability that directly affects QoL in RA. BMI is an independent factor that is linked to LUTS in RA patients.

Association between sarcopenia, physical performance and falls in patients with rheumatoid arthritis: a 1-year prospective study

BackgroundPatients with rheumatoid arthritis (RA) are at increased risk of falls and fractures. Sarcopenia occurs more frequently in RA patients due to the inflammatory processes. Early diagnosis and prevention programmes are essential to avoid serious complications. The present study aims to identify risk factors for falls related to sarcopenia and physical performance.MethodsIn a 1-year prospective study, a total of 289 patients with RA, ages 24–85 years, were followed using quarterly fall diaries to report falls. At the baseline, medical data such as RA disease duration and Disease Activity Score (DAS28CRP) were collected. Self-reported disability was assessed using the Health Assessment Questionnaire (HAQ). Appendicular skeletal mass was determined by Dual X-ray-Absorptiometry (DXA). Physical performance was evaluated by handgrip strength, gait speed, chair rise test, Short Physical Performance Battery, and FICSIT-4. Muscle mechanography was measured with the Leonardo Mechanograph®. Sarcopenia was assessed according to established definitions by the European Working Group on Sarcopenia in Older People (EWGSOP2) and The Foundation for the National Institutes of Health (FNIH). Univariate and multiple logistic regression analysis were used to explore associations with falling. Receiver-operating characteristics (ROC) were performed, and the area under the curve is reported.ResultsA total of 238 subjects with RA completed the 1-year follow-up, 48 (20.2%) experienced at least one fall during the observational period. No association was found between sarcopenia and prospective falls. Age (OR = 1.04, CI 1.01–1.07), HAQ (OR = 1.62, 1.1–2.38), and low FICSIT-4 score (OR = 2.38, 1.13–5.0) showed significant associations with falls.ConclusionsIn clinical practice, a fall assessment including age, self-reported activities of daily life and a physical performance measure can identify RA patients at risk of falling.Trial registrationThe study has been registered at the German Clinical Trials Register and the WHO International Clinical Trials Registry Platform (ICTRP) since 16 March 2017 (DRKS00011873).

Rheumatoid arthritis activity scores in patients with and without fibromyalgia syndrome.

BACKGROUND: Fibromyalgia syndrome (FM) is a systemic disease of unknown etiology, which can cause widespread musculoskeletal pain. In patients with rheumatoid arthritis (RA), FM can cause an additional symptom burden, which can affect some variables on the RA disease activity score 28 (DAS28), a tool that evaluates 28 joints in RA patients.OBJECTIVE: Compare the results of four different versions of the DAS28 and the parameters used to determine disease activity scores in RA patients with and without FM, and determine whether there are treatment differences between RA patients with and without FM.DESIGN: Retrospective, cross-sectional.SETTING: Tertiary hospital.PATIENTS AND METHODS: We identified patients diagnosed with RA between 1 September 2016 and 1 February 2020 and identified patients with and without FM.MAIN OUTCOME MEASURES: Differences between variables in the DAS28 calculations (tender joint count [TJC], patient global assessment [PGA], and others), between patients with and without FM, and differences between patients with and without FM who were using or not using biological agents.SAMPLE SIZE: 381, including 322 females (84.5%).RESULTS: The frequency of FM in RA patients was 25.7% (89 females, 24.6%). In RA patients with FM, the TJC and PGA median values were significantly higher than in patients without FM (P<.05). The use of corticosteroids and biological therapy in patients with FM was more frequent than in patients without FM (P<.05). Compared to patients without FM, patients with FM switched treatment more often because of non-response to treatment (P=.01) Median values of the DAS28 scores (calculated by four different versions of the instrument) in RA patients with FM were higher than in patients without FM (P<.05).CONCLUSION: The presence of FM in RA patients may affect the subjective variables in different versions of DAS28 scores, causing the disease activity to score higher on the instrument, erroneously indicating worse disease than is actually present.LIMITATIONS: A single center, retrospective study.CONFLICTS OF INTEREST: None.

Altered skeletal muscle metabolic pathways, age, systemic inflammation, and low cardiorespiratory fitness associate with improvements in disease activity following high-intensity interval training in persons with rheumatoid arthritis

BackgroundExercise training, including high-intensity interval training (HIIT), improves rheumatoid arthritis (RA) inflammatory disease activity via unclear mechanisms. Because exercise requires skeletal muscle, skeletal muscle molecular pathways may contribute. The purpose of this study was to identify connections between skeletal muscle molecular pathways, RA disease activity, and RA disease activity improvements following HIIT.MethodsRA disease activity assessments and vastus lateralis skeletal muscle biopsies were performed in two separate cohorts of persons with established, seropositive, and/or erosive RA. Body composition and objective physical activity assessments were also performed in both the cross-sectional cohort and the longitudinal group before and after 10 weeks of HIIT. Baseline clinical assessments and muscle RNA gene expression were correlated with RA disease activity score in 28 joints (DAS-28) and DAS-28 improvements following HIIT. Skeletal muscle gene expression changes with HIIT were evaluated using analysis of covariance and biological pathway analysis.ResultsRA inflammatory disease activity was associated with greater amounts of intramuscular adiposity and less vigorous aerobic exercise (both p < 0.05). HIIT-induced disease activity improvements were greatest in those with an older age, elevated erythrocyte sedimentation rate, low cardiorespiratory fitness, and a skeletal muscle molecular profile indicative of altered metabolic pathways (p < 0.05 for all). Specifically, disease activity improvements were linked to baseline expression of RA skeletal muscle genes with cellular functions to (1) increase amino acid catabolism and interconversion (GLDC, BCKDHB, AASS, PYCR, RPL15), (2) increase glycolytic lactate production (AGL, PDK2, LDHB, HIF1A), and (3) reduce oxidative metabolism via altered beta-oxidation (PXMP2, ACSS2), TCA cycle flux (OGDH, SUCLA2, MDH1B), and electron transport chain complex I function (NDUFV3). The muscle mitochondrial glycine cleavage system (GCS) was identified as critically involved in RA disease activity improvements given upregulation of multiple GCS genes at baseline, while GLDC was significantly downregulated following HIIT.ConclusionIn the absence of physical activity, RA inflammatory disease activity is associated with transcriptional remodeling of skeletal muscle metabolism. Following exercise training, the greatest improvements in disease activity occur in older, more inflamed, and less fit persons with RA. These exercise training-induced immunomodulatory changes may occur via reprogramming muscle bioenergetic and amino acid/protein homeostatic pathways.Trial registrationClinicalTrials.gov, NCT02528344. Registered on 19 August 2015.

P140 As we move to using short-acting drugs for the treatment of RA in the time of a pandemic, does baricitinib live up to its trial data in clinical practice?

Background/Aims Baricitinib is an oral, reversible and selective inhibitor of JAK1 and JAK2 tyrosine kinases. It was approved for use in 2017 by NICE for the treatment of moderate to severe rheumatoid arthritis (RA). Considering the current risk of COVID-19, the BSR have advocated the use of short-acting drugs such as baricitinib when escalating treatment in RA. As real-world data is limited, we aimed to explore the efficacy of baricitinib in clinical practice. Methods Observational data was collected retrospectively for patients at the Dudley Group NHSFT with RA (ACR/EULAR criteria) who had received at least one dose of baricitinib prior to 1st October 2019, with a follow up period to 1st October 2020. Patients were identified from a local biologics database. Further data was identified from patients’ medical records including, demographics, features of RA, previous RA therapy history and disease activity scores (DAS28) at 0, 6 and 12 months. Data was input into an Excel spreadsheet with subsequent analysis conducted using SPSS Version26. Results We identified 26 RA patients (77% female) treated with baricitinib; mean age 61.6 (SD 14.6) years and median disease duration of 12.1 (IQR 5.8-18.4) years. Rheumatoid factor and anti-CCP antibody were positive in 73% and 65% respectively. 35% (n = 9) of patients were biologically naïve, in whom baricitinib was chosen due to needle-phobia (n = 7), or where anti-TNF drugs were considered inappropriate (bronchiectasis, ANA positivity). Mean DAS28 (SD) scores at baseline, 6 and 12 months were 5.9(0.8), 2.8(0.9) and 2.7(1.3) respectively, with significant reduction from baseline to both 6 and 12 months (P < 0.001). A drop of ≥ 1.2 in DAS28 was recorded in 94% of patients with complete data at 6 months (n = 18, 4 missing, 4 discontinued). At 6 and 12 months, 85% and 81% of patients remained on Baricitinib. In total five patients discontinued Baricitinib due to side effects or tolerability issues. Reasons for discontinuation did not include thromboembolic events, zoster or serious infections. When comparing naïve and non-naïve groups, there was no significant difference in age, sex or disease duration. The number of previous biologics used by patients were 1(n = 6), 2(n = 3), ≥3(n = 8). Biologically naive compared to non-naïve patients had a higher DAS28 at baseline, (Mean [SD]) (6.2[0.9] versus 5.7[0.8] NS) but lower at 6 months (2.1[1.6] versus 3.1[1.1] P = 0.023) and greater DAS improvement at 6months (-4.4[1.2] versus -2.5[0.9] P < 0.002). Conclusion We observed that up to 94% of patients responded to baricitinib with a mean DAS improvement at 6 months of -3.1, biologic naïve patients doing best. Drug survival at 12 months was 81%. These trends are comparable to findings in clinical trials. However, due to our small sample size, the findings are vulnerable to type 1 and 2 errors and should be interpreted with caution. Disclosure H.J.S. Vardon: None. K.M.J. Douglas: None.

Urinary sodium-to-potassium ratio associates with hypertension and current disease activity in patients with rheumatoid arthritis: a cross-sectional study

BackgroundExcessive salt intake is thought to exacerbate both development of hypertension and autoimmune diseases in animal models, but the clinical impact of excessive salt in rheumatoid arthritis (RA) patients is still unknown. We performed a cross-sectional study to clarify the associations between salt load index (urinary sodium-to-potassium ratio (Na/K ratio)), current disease activity, and hypertension in an RA population.MethodsThree hundred thirty-six participants from our cohort database (KURAMA) were enrolled. We used the spot urine Na/K ratio as a simplified index of salt loading and used the 28-Joint RA Disease Activity Score (DAS28-ESR) as an indicator of current RA disease activity. Using these indicators, we evaluated statistical associations between urinary Na/K ratio, DAS28-ESR, and prevalence of hypertension.ResultsUrinary Na/K ratio was positively associated with measured systolic and diastolic blood pressure and also with prevalence of hypertension even after covariate adjustment (OR 1.34, p < 0.001). In addition, increased urinary Na/K ratio was significantly and positively correlated with DAS28-ESR in multiple regression analysis (estimate 0.12, p < 0.001), as was also the case in gender-separated and prednisolone-separated sub-analyses.ConclusionUrinary Na/K ratio was independently associated with current disease activity as well as with prevalence of hypertension in RA patients. Thus, dietary modifications such as salt restriction and potassium supplementation should be investigated as a potential candidate for attenuating both disease activity and hypertension in RA patients.

Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial

Objective No evidence has shown the efficacy of Sodium Risedronate (Risedronate) for glucocorticoid-induced osteoporosis (GIO) in patients with Rheumatoid arthritis (RA). The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA. Methods This was a six-month randomized, double-blind, placebo-controlled trial of 95 patients with GIO complicated with RA from 19 centers. The primary endpoint was the change from baseline in lumbar spine bone mineral density (L-BMD). Secondary endpoints included changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts. Incident of non-traumatic spine fractures and adverse events were tracked as safety endpoints. Results Increase in L-BMD was significantly greater in the Risedronate group compared to the Placebo group (Risedronate: 3.49% [95% CI: 1.92–5.05] vs Placebo: 0.12% [95% CI: −2.07 to 2.30], p < .0001). No significant difference was found in the femoral neck and total hip BMD. Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients. Conclusion Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.

Anti-carbamylated Protein Antibodies and Serum Level of 14-3-3 Protein for Early Detection of Rheumatoid Arthritis Patient in Correlation with Rheumatoid Factor, Anti-CCP Antibodies, Disease Activity and Joint Damage using High Frequency Musculoskeletal Ultrasound

Background: Rheumatoid arthritis (RA) is a common progressive chronic inflammatory autoimmune disease which affects mostly small joints, causing pain, swelling, deformity, and disability. Although progress has been made in exploring RA nature, still there is a lot to know about the disease pathogenesis, diagnosis, and treatment. Aim of the Work: To investigate the role of serum anti-carbamylated protein antibodies and 14-3-3η in the diagnosis of RA compared to rheumatoid factor (RF), anti-CCP antibodies, and highfrequency musculoskeletal ultrasound used to assess the disease activity and joint damage. Methods: Serum anti-carbamylated protein antibodies and 14-3-3η were measured using ELISA in 61 RA patients and 26 normal controls. RA Disease Activity Score (DAS 28), X-ray and musculoskeletal ultrasound (hands and feet), carotid ultrasound (Intima-Media Thickness IMT) were used in assessing the RA disease. Results: Anti-carbamylated protein antibodies were significantly elevated in RA patients 4.5 (4.1- 8.9 U⁄ml) compared to the control 3.2(1.9- 4.3 U⁄ml) (p&lt; 0.001) but 14-3-3η showed no significant difference. There was a significant positive correlation between anti-carbamylated protein antibodies, 14-3-3η levels and disease activity score assessed by DAS 28, increased IMT measured by carotid duplex, total synovitis and total erosion score were assessed by musculoskeletal ultrasound. There was no correlation between RF and anti-CCP antibodies. Anti-carbamylated protein antibodies were found to have 66.7% sensitivity and 85.2% specificity in RA diagnosis, while 14- 3-3η had 51.9% sensitivity and 72.1% specificity. Conclusion: Anti-carbamylated protein antibodies and 14-3-3η have a high sensitivity and specificity in RA diagnosis and had a correlation with the disease activity and joint damage.

Reweighting to address nonparticipation and missing data bias in a longitudinal electronic health record study

PurposeWe examined whether weighting techniques could account for longitudinal differences in disease activity by race/ethnicity between research participants and nonparticipants with rheumatoid arthritis (RA). MethodsWe included 377 patients with RA from a public hospital in San Francisco, CA. We estimated the probability of not enrolling in a research study by constructing weights using inverse probability weighting. Disease activity over time by race/ethnicity was analyzed across the entire patient population and among research participants only using multivariable mixed-effects models. ResultsThere were no differences in RA disease activity scores between research participants and nonparticipants at baseline; however, longitudinal differences in disease activity between research participants and nonparticipants were found by race/ethnicity. Weighting research participants in accordance with sociodemographic and clinical characteristics of the nonparticipant population did not result in any meaningful changes in disease activity by race/ethnicity over time. ConclusionsIn our study of patients with RA, inverse probability weighting using select sociodemographic and clinical variables was not sufficient to account for longitudinal disease activity differences by race/ethnicity between research participants and nonparticipants.

OP0035 EXAMINATION OF INTERSTITIAL LUNG DISEASE IN PATIENTS WITH RHEUMATOID ARTHRITIS – PREVALENCE, TIME TO ONSET, AND CLINICAL CHARACTERISTICS

Background:Interstitial lung disease (ILD) is a known extraarticular manifestation of rheumatoid arthritis (RA). Previous studies have shown variability in the prevalence of RA-ILD, as well as clinical characteristics and risk factors of RA-ILD.Objectives:To evaluate the prevalence and time to onset of ILD and compare the clinical characteristics between RA patients (pts) with or without ILD using a large US electronic medical record (EMR)-based dataset.Methods:Pts with an initial RA diagnosis (ICD-9-CM code: 714.0; ICD-10-CM codes: M05 &amp; M06) during the study period (01JAN2009-20SEP2019) were included from the Discus Analytics JointMan database. The initial RA diagnosis date was defined as the index date. Pts with ILD were identified by ICD diagnosis codes or by provider indication in the JointMan record. Pts who developed ILD before RA were excluded from this analysis. The prevalence and time to onset of ILD were reported. Pt demographics, comorbidities, RA characteristics and disease activity scores were compared for 6 months prior to or on the index date (baseline period) for selected adult RA pts with available information.Results:Among 8,963 identified RA pts, 337 (3.8%) were diagnosed with ILD on or after RA diagnosis. The median time to ILD onset post-RA was 2.3 years, and 47% had ILD within 2 years after RA diagnosis. RA-ILD pts were significantly older than those without ILD (65.8 years vs. 59.1 years; p&lt;0.001; Table 1). At baseline, a higher percentage of RA-ILD pts had history of chronic obstructive pulmonary disease, positive rheumatoid factor, rheumatoid nodules, erosive joint disease, positive anti-cyclic citrullinated peptide antibody, and joint swelling compared to RA-only pts (Table 2). The mean ESR and RA disease activity scores were also significantly higher for RA-ILD pts.Table 1.Patient DemographicsPatient demographicsRA-ONLY COhort(N = 5,612)RA-ild coHORT(N = 205)P-valueAge, Mean ± SD, years59.1 ± 14.265.8 ± 11.8&lt;.001Male, N (%)1,375 (24.5%)72 (35.1%)0.001Race, N (%) White4,014 (71.5%)165 (80.5%)0.005 African American365 (6.5%)9 (4.4%)0.226 Other/Missing1,233 (22.0%)31 (15.1%)0.020Table 2.Baseline Clinical CharacteristicsClinical CharacteristicsRA-ONLY COhort(N = 3,846)RA-ild coHORT(N = 115)P-valueHistory of Chronic Obstructive Pulmonary Disease, N (%)102 (2.7%)8 (7.0%)0.006Hypertension, N (%)900 (23.4%)23 (20.0%)0.395Serious Infection, N (%)38 (1.0%)3 (2.6%)0.091Rheumatoid Factor Positive, N (%)1,388 (36.1%)69 (60.0%)&lt;.001Joint Stiffness, N (%)1,092 (28.4%)39 (33.9%)0.197Rheumatoid Nodules, N (%)153 (4.0%)17 (14.8%)&lt;.001Erosive Joint Disease, N (%)459 (11.9%)23 (20.0%)0.009Anti-CCP Antibody Positive, N (%)858 (22.3%)45 (39.1%)&lt;.001Joint Swelling*, N (%)2,861 (58.0%)123 (68.0%)0.008Joint Tenderness*, N (%)3,728 (75.6%)138 (76.2%)0.851ESR**, Mean ± SD, mm/hr22.0 ± 22.630.1 ± 25.5&lt;.001CRP**, Mean ± SD, mg/L22.5 ± 13.060.6 ± 25.00.086CDAI, Mean ± SD16.4 ± 12.318.9 ± 15.70.044DAS28-CRP, Mean ± SD2.6 ± 1.23.1 ± 1.4&lt;.001DAS28-ESR, Mean ± SD3.3 ± 1.43.9 ± 1.5&lt;.001SDAI, Mean ± SD20.2 ± 29.328.6 ± 40.20.048* A total of 4,929 non-ILD and 181 ILD patients had joint swelling and tenderness data.** Variables were calculated among patients who had available information.Conclusion:This large real-world RA population provides insight into the burden of ILD in RA pts. Pts with ILD had a higher proportion of comorbidities and RA-related conditions and higher RA activity. Further analysis is warranted to assess the risk factors of ILD and its prognosis.Disclosure of Interests:Joe Zhuo Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Qisu Zhang Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Keith Knapp Consultant of: In the last year, I was a paid consultant to Bristol Myers-Squibb Company., Employee of: I am a paid employee of Discus Analytics., Yuexi Wang Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Cynthia Gutierrez Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Ding He Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Lin Xie Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Sonie Lama Shareholder of: I own shares of Bristol-Myers Squibb Company., Employee of: I am a paid employee of Bristol-Myers Squibb Company., Gary Craig Consultant of: I have served as a consultant to Bristol-Myers Squibb Company., Employee of: I am a paid employee of Arthritis Northwest and VP of Discus Analytics., Speakers bureau: I am a member of the speakers bureau for Bristol-Myers Squibb Company.

THU0134 COGNITIVE IMPAIRMENT IN RHEUMATOID ARTHRITIS

Background:Increasing evidence suggests that systemic inflammation may be associated with an increased risk of developing cognitive dysfunction and Alzheimer’s disease (AD). Some studies have found an association between rheumatoid arthritis (RA) and neurodegeneration with several finding increased incidence of mild cognitive impairment (MCI) in those with RA compared to healthy controls.Objectives:This study aims to use preliminary data from theRheumatoid arthritis, medication and memorystudy (RESIST) to investigate the prevalence of MCI in a population of patients with RA and explore the relationship between MCI and specific demographic and clinical characteristics.Methods:The Montreal Cognitive Assessment (MoCA) was used as a cognitive screening tool and was administered to subjects ≥55 years of age who had been diagnosed with RA according to the ACR/EULAR criteria. Demographic and clinical data was recorded at screening in face-to-face interviews and included age, gender, date of RA diagnosis and RA medication. RA disease activity score from 28 joints (DAS28), rheumatoid factor (RF) level, anti-cyclic citrullinated peptide (anti-CCP) level, erythrocyte sedimentation rate (ESR) were recorded. 260 participants completed both screening and baseline visits as part of the RESIST longitudinal study, MoCA scores from baseline were analysed for these participants. Statistical analysis was used to provide descriptive statistics and explore possible predictors of cognitive impairment.Results:A total of 636 participants (mean age 68.1 yrs, female 67.5%) were screened between May 2018 and December 2019. The mean MoCA for screened participants was 25.4; 45.3% scored &lt;26 in the MoCA and were considered to have mild cognitive impairment. Age was negatively correlated with MoCA score and was the only significant predictor of cognitive impairment. For each year of increase in age the MoCA score reduced by a mean of 0.08 points (p&lt;0.05). There was little evidence of a difference in mean MoCA score by gender, RA medication, duration of disease, DAS28 score, ESR, anti-CCP or RF levels. The mean MoCA scores increased by 0.4 points between screening and baseline (P&lt;0.001).Conclusion:A large proportion of participants scored below the proposed cut-off for normal cognition in the MoCA suggesting a high prevalence of MCI in adults &gt;55 years with moderately active RA. This provides further support for the role of chronic inflammation in cognitive dysfunction and AD. Screening for MCI in rheumatology clinics might be clinically useful.DemographicsOutcomeAge mean years (+/-SD) (n=633)68.1 (8.01)Gender (n=636)Female n (%)429 (67.5)RA Medication (n=636)csDMARD n (%)TNFi n (%)368 (57.9)268 (42.1)Duration of RA mean years (+/-SD) (n=484)14.4 (13.9)DAS28 mean (+/-SD) (n=306)3.5 (2.04)ESR mean (+/-SD) (n=501)23.4 (22.0)Anti-CCP (n=387)Positive n (%)236 (61)Rheumatoid Factor (n=377)Positive n (%)277 (73.5)MoCA Score points (n=636)≥26, n (%)&lt;26 n (%)348 (54.7)288 (45.3)Subjective memory concerns (n=430)Yes n (%)No n (%)95 (22.1)335 (77.9)Disclosure of Interests:Christopher Edwards Grant/research support from: Abbvie, Biogen, Roche, Consultant of: Abbvie, Samsung, Speakers bureau: Abbvie, BMS, Biogen, Celgene, Fresenius, Gilead, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB, Bethany McDowell: None declared, Chris Holroyd: None declared, Chris Cardwell: None declared, Michelle McHenry Speakers bureau: Novartis, Pfizer, AbbVie, Celgene, Lilly, Gary Meenagh: None declared, Clive Holmes: None declared, Bernadette McGuiness: None declared

PMS68 PROMONITOR FOR THERAPEUTIC DRUG MONITORING IN PATIENTS WITH SEVERE RHEUMATOID ARTHRITIS TREATED WITH ADALIMUMAB IN ENGLAND AND WALES

Adalimumab is used for severe rheumatoid arthritis (RA), but its efficacy is hampered by the presence of low drug levels and anti-drug antibodies (ADAs). Although not currently part of standard National Health Service (NHS) practice, patients who achieve remission may be eligible for supervised dose tapering. This could be done through the use of enzyme-linked immunosorbent assay (ELISA) tests, capable of measuring both drug and ADAs concentrations, alongside conventional clinical assessment. In this study, the economic outcomes of adding therapeutic drug monitoring (TDM) using Promonitor (Grifols–Progenika) assays to standard care in people with severe RA (Disease Activity Score 28>5.1) treated with adalimumab who had either achieved remission or low disease activity were evaluated. A cost-utility analysis based on a decision tree model was informed by a non-randomised trial INGEBIO identified following a systematic review. Since there is a substantial variation in clinical practice for TDM testing, dose-tapering and flare-management strategies in people with RA, and the actual cost of adalimumab to the NHS, incremental cost-effectiveness ratios (ICERs) were estimated for various clinically plausible scenarios and discounts for the list price of adalimumab (Humira®, AbbVie). Costs and resource use were considered from the NHS and Personal Social Services perspective. No discounting was applied to costs and effects due to the short-term time horizon of 18 months. ICERs in all except two scenarios were located in the north-east quadrant of the cost-effectiveness plane and ranged from £4,230 to £164,009 per quality-adjusted life-year gained. When the frequency of testing was one test per year or the cost of phlebotomy appointments to collect trough samples was excluded, the intervention dominated standard care. The cost-effectiveness of TDM with Promonitor for optimizing adalimumab treatment in people with RA is highly uncertain due to data limitations. Thus, future clinical studies are warranted.