Patients In Low Disease Activity Research Articles

Patients with axial spondyloarthritis reported willingness to use remote care and showed high adherence to electronic patient-reported outcome measures: an 18-month observational study

Remote monitoring using electronic patient reported outcomes (ePROs) in axial spondyloarthritis (axSpA) may improve self-management and reduce the need for consultations. However, knowledge regarding patients’ willingness to use remote care and adherence to reporting ePROs is scarce. The objective of this study was to assess axSpA patients’ willingness to use remote care and adherence to reporting of ePROs. The study was part of a three-armed randomized controlled trial testing digital follow-up strategies (The ReMonit study, NCT: 05031767). AxSpA patients in low disease activity were randomized to usual care, remote monitoring, or patient-initiated care. Demographics, clinical data, and patients’ willingness to use remote care were collected at baseline. EPROs were reported either monthly or quarterly by the remote monitoring- and patient-initiated care group over 18 months, respectively. Adherence to reporting was calculated as number of ePROs completed divided by the total number requested. Mixed model logistic regression was utilized to assess factors associated with adherence to reporting of ePROs. In total 242 patients (median age 43 years, 75% males) were included. The majority (96%) reported high willingness to use remote care. Adherence to reporting ePROs remained high over 18 months by remote monitoring and patient-initiated care groups [median (IQR): 88% (77–100) vs. 83% (66–100)]. No patient characteristics were significantly associated with adherence to reporting of ePROs. The high degree of willingness and adherence to reporting ePROs over time indicates that the majority of axSpA patients with low disease activity are motivated to use remote care.

Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial.

Patients with chronic inflammatory joint diseases such as axial spondyloarthritis have traditionally received regular follow-up in specialist health care to maintain low disease activity. The follow-up has been organized as prescheduled face-to-face visits, which are time-consuming for both patients and health care professionals. Technology has enabled the remote monitoring of disease activity, allowing patients to self-monitor their disease and contact health care professionals when needed. Remote monitoring or self-monitoring may provide a more personalized follow-up, but there is limited research on how these follow-up strategies perform in maintaining low disease activity, patient satisfaction, safety, and cost-effectiveness. The Remote Monitoring in Axial Spondyloarthritis (ReMonit) study aimed to assess the effectiveness of digital remote monitoring and self-monitoring in maintaining low disease activity in patients with axial spondyloarthritis. The ReMonit study is a 3-armed, single-site, randomized, controlled, open-label noninferiority trial including patients with axial spondyloarthritis with low disease activity (Ankylosing Spondylitis Disease Activity Score <2.1) and on stable treatment with a tumor necrosis factor inhibitor. Participants were randomized 1:1:1 to arm A (usual care, face-to-face visits every sixth month), arm B (remote monitoring, monthly digital registration of patient-reported outcomes), or arm C (patient-initiated care, self-monitoring, no planned visits during the study period). The primary end point was disease activity measured with the Ankylosing Spondylitis Disease Activity Score, evaluated at 6, 12, and 18 months. We aimed to include 240 patients, 80 in each arm. Secondary end points included other measures of disease activity, patient satisfaction, safety, and cost-effectiveness. The project is funded by the South-Eastern Norway Regional Health Authority and Centre for the treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Norway. Enrollment started in September 2021 and was completed with 242 patients by June 2022. The data collection will be completed in December 2023. To our knowledge, this trial will be among the first to evaluate the effectiveness, safety, and cost-effectiveness of remote digital monitoring and self-monitoring of patients with axial spondyloarthritis compared with usual care. Hence, the ReMonit study will contribute important knowledge to personalized follow-up strategies for patients with axial spondyloarthritis. These results may also be relevant for other patient groups with inflammatory joint diseases. ClinicalTrials.gov NCT05031767; hpps://www.clinicaltrials.gov/study/NCT05031767. DERR1-10.2196/52872.

Dose reduction of rituximab in clinical practice: a retrospective cohort study of rheumatoid arthritis patients in low disease activity on rituximab.

To determine the effects of dose reduction of rituximab (RTX) on rheumatoid arthritis (RA) disease activity in clinical practice. Retrospective cohort study of RA patients using RTX, in stable low disease activity (i.e. Disease Activity Score 28-joint count CRP (DAS28-CRP) ≤3.5 for ≥6 consecutive months) and ≥2 DAS28-CRP measurements. We identified three treatment periods: 1) full dose RTX, 2) RTX dose reduction, and 3) stable RTX dose (and interval) after tapering. Linear mixed-model analysis was used to estimate mean DAS28-CRP during these periods. Rituximab use was assessed as the median percentage of the RTX Daily Defined Dose (%DDD) per period, with 1 x 1000 mg/6 months as reference. 387 patients were included in the cohort with a median of 8 DAS28-CRP measurements (Q1-Q3:4-13) available per patient and median follow-up time of 44 months (Q1-Q3: 23-76). 299 patients tapered RTX and entered period 2 at least once, of whom 226 also entered period 3. Mean DAS28-CRP were 2.37 (95% CI: 2.29, 2.44) for period 1, 2.33 (95% CI: 2.25, 2.40) for period 2, and 2.27 (95% CI: 2.18, 2.35) for period 3, the latter significantly lower compared to period 1 (p=0.025). %DDD for the three time periods were 96%, 57% and 49%, respectively. Dose reduction of RTX in clinical practice is effective for many RA patients and leads to relevant dose reduction. Together with other previously proven benefits of ultra-low dose RTX, wider implementation of ultra-low dose RTX in RA patients should be considered.

Correlation Between Rheumatoid Arthritis Activity with Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio: A Case-Control Study

Background: Patients with Rheumatoid arthritis (RA) may suffer from joint deformity, due to the inflammatory process in active disease. Inflammation may lead to disability in patients with RA. The neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) have been emerged as markers of many inflammatory diseases including RA. The aim of this study was to evaluate the role of NLR and PLR ratios in the evaluation of RA activity and their relation with DAS-28 that is already used for the assessment of RA disease activity. Our patients were divided into group A (patients with active disease, DAS-28 &gt; 2.6) and group B (patients with remission, DAS-28 &lt; 2.6). The patients with active disease were subdivided into three subgroups (patients with high disease activity with DAS-28 &gt; 5.1, moderate disease activity patients with DAS-28 &gt; 3.2, and low disease activity patients with DAS-28 &lt;3.2 and &gt;2.6). Results: NLR and PLR are significantly higher in patients with RA than in healthy people and higher in patients with active disease than those in remission and significantly positively correlated with RA activity. Conclusion: Both NLR and PLR are two inflammatory markers that are useful in evaluating RA disease activity as they are simple, cheap, and objective markers.

Ten-year radiographic and functional outcomes in rheumatoid arthritis patients in remission compared to patients in low disease activity

BackgroundTo compare the 10-year structural and functional prognosis between patients in sustained remission versus patients in sustained low disease activity (LDA) in early rheumatoid arthritis (RA).MethodsWe included 256 patients from the ESPOIR cohort who fulfilled the 2010 ACR/EULAR criteria for RA and who were in sustained remission using the Simple Disease Activity Index (SDAI) score (n = 48), in sustained LDA (n = 139) or in sustained moderate to high disease activity (MDA or HDA, n = 69) over 10 years. The mTSSs progression over 10 years and the 10-year HAQ-DI scores were compared between the 3 groups. A longitudinal latent process mixed model was used to assess the independent effect of SDAI status over time on 10-year mTSS progression and HAQ-DI at 10 years.ResultsPatients in sustained remission group were younger, had lower baseline HAQ-DI and mTSS scores and were less exposed to glucocorticoids, methotrexate or biologic disease-modifying anti-rheumatic drugs over 10 years. Patients in sustained remission had lower 10-year structural progression (variation of mTSS in the remission group: 4.06 (± 4.75) versus 14.59 (± 19.76) in the LDA group and 21.04 (± 24.08), p < 0.001 in the MDA or HDA groups) and lower 10-year HAQ-DI scores (10-year HAQ-DI in the remission group: 0.14 (± 0.33) versus 0.53 (± 0.49) in the LDA group and 1.20 (± 0.62) in the MDA or HDA groups, p < 0.001). The incidence of serious adverse events over 10 years was low, about 3.34/100 patient years, without any difference between the three groups.ConclusionRA patients in sustained SDAI remission have better long-term structural and functional outcomes in comparison to patients in sustained LDA.

Telemedicine for follow-up of systemic lupus erythematosus during the 2019 coronavirus pandemic: A pragmatic randomized controlled trial.

Patients with systemic lupus erythematous were vulnerable to severe coronavirus disease 2019 infection and the negative impact of disrupted healthcare delivery. Telemedicine has been a popular alternative to standard in-person care during the pandemic despite the lack of evidence. This was a 1-year pragmatic randomized-controlled trial. Patients followed at the lupus nephritis clinic were randomized to either telemedicine or standard follow-up in a 1:1 ratio. Patients in the telemedicine group were followed up via videoconferencing. Standard follow-up group patients continued conventional in-person outpatient care. The primary outcome of the study was the proportion of patients in low disease activity after 1 year. Secondary outcomes included cost-of-illness, safety, and various patient-reported outcomes. From 6/2020 to 12/2021, 144 patients were randomized and 141 patients (telemedicine: 70, standard follow-up: 71) completed the study. At 1 year, 80.0% and 80.2% of the patients in the telemedicine group and standard follow-up group were in lupus low disease activity state or complete remission, respectively (p = 0.967). Systemic lupus erythematous disease activity indices, number of flares and frequency of follow-ups were also similar. There were no differences in the cost-of-illness, quality of life or mental health scores. However, significantly more patients in the telemedicine group (41.4% vs 5.6%; p < 0.001) required switch of mode of follow-up and higher proportion of them had hospitalization during the study period (32.9% vs 15.5%; p = 0.016). Being in the telemedicine group or not in low disease activity at baseline were the independent predictors of hospitalization (odds ratio: 2.6; 95% confidence interval: 1.1-6.1, odds ratio: 2.7, 95% confidence interval: 1.1-6.7, respectively) in the post hoc analysis. In patients with systemic lupus erythematous, telemedicine predominant follow-up resulted in similar 1-year disease control compared to standard care. However, it needed to be complemented by in-person visits, especially in patients with unstable disease.

Cytokines and chemokines multiplex analysis in patients with low disease activity rheumatoid arthritis

Rheumatoid arthritis is a severe chronic autoimmune disorder that results from pathological activation of immune cells and altered cytokine/chemokine network. The aim of our study was to evaluate concentrations of chosen cytokines and chemokines in blood sera and synovial fluid samples isolated from low disease activity rheumatoid arthritis (RA) patients and osteoarthritis (OA) sufferers. Blood sera and synovial fluid samples have been obtained from 24 OA and 14 RA patients. Cytokines/chemokines levels have been determined using a Milliplex® Map 38-plex human cytokine/chemokine magnetic bead-based panel (Merck Millipore, Germany) and Luminex® MAGPIX® platform (Luminex USA). Low disease activity RA patients showed altered concentration of numerous cytokine/chemokine when compared to OA controls—they were characterized by, inter alia, increased: eotaxin/CCL11 (p = 0.037), GRO/CXCL1 (p = 0.037), IL-2 (p = 0.013), IL-4 (p = 0.017), IL-7 (p = 0.003), IL-8 (p = 0.0007) and GM-CSF (p = 0.037) serum levels, whilst MDC/CCL22 concentration was decreased in this group (p = 0.034). Eotaxin/CCL11 (p = 0.001), GRO/CXCL1 (p = 0.041), IL-10 (p = 0.003), GM-CSF (p = 0.01), IL-1RA (p = 0.0005) and VEGF (p = 0.01) concentrations in synovial fluid of RA females were also increased. Even with low disease activity score, RA patients exhibited increased concentrations of cytokines with pro- and anti-inflammatory activities, as well as numerous chemokines, growth factors and regulators of angiogenesis. Surprisingly, RA subjects also shown decreased concentration of CCL22 chemokine. The attempt to restore cytokine balance and tolerogenic environment is ineffective in RA sufferers even with good disease management. Distinguished factors could serve as possible indicators of disease progression even in low disease activity patients.

Histological activity despite normal ALT and IgG serum levels in patients with autoimmune hepatitis and cirrhosis

Background & AimsIn autoimmune hepatitis (AIH), normal levels of transaminases and IgG define biochemical remission and are considered the best surrogate markers for histological remission. This study assessed whether this also applies to patients with AIH cirrhosis.MethodsIn this European multicentric study, we included 125 biopsies from 113 patients with AIH and histologically proven cirrhosis; 105 biopsies from 104 patients with AIH without cirrhosis served as controls. Biochemical parameters were available within 4 weeks of biopsy. AIH activity was graded according to the modified Hepatitis Activity Index (mHAI), with mHAI ≥4/18 considered to indicate risk of disease progression.ResultsIn total, 47 out of 125 liver biopsies were obtained from patients with AIH cirrhosis and normal ALT levels at time of biopsy. Only 26% (12/47) of those livers showed histological remission (mHAI <4/18), whereas 36% (17/47) showed moderate to high histological activity (mHAI ≥6/18). In patients with noncirrhotic AIH, 88% (46/52 biopsies) of cases with normal ALT levels had histological remission and only 4% (2/52) had an mHAI ≥6/18 (p <0.001). The addition of IgG to define complete biochemical remission only slightly improved the association with histological remission in the limited number of patients with AIH cirrhosis available for analysis [29% (5/17) of biopsies with mHAI <4/18]. ALT correlated closely with mHAI in AIH without cirrhosis but poorly in AIH with cirrhosis.ConclusionsIn contrast to patients with noncirrhotic AIH, in patients with AIH cirrhosis, who are at risk of disease progression, normal ALT levels and potentially also complete biochemical remission are poor surrogate markers of histological remission. Thus, new biomarkers are needed to monitor disease activity and progression in patients with AIH cirrhosis.Lay summaryAutoimmune hepatitis (AIH) is an inflammatory disease of the liver that usually responds to immunosuppressive therapy. Serum transaminases and IgG levels within the normal ranges define complete biochemical remission and are considered as surrogate markers for histological disease activity. Here, we show that those biochemical markers are not sufficient to indicate low disease activity in patients with AIH and already established cirrhosis. Consequently, until better biomarkers for disease activity are found, only liver biopsy can reliably indicate disease activity in the presence of cirrhosis. Additional investigations, such as measurements of liver stiffness, should be undertaken to monitor non-invasively for disease progression in patients with AIH and established cirrhosis.

Change in dietary inflammatory index score is associated with control of long-term rheumatoid arthritis disease activity in a Japanese cohort: the TOMORROW study

BackgroundThe dietary inflammatory index (DII®), a quantitative measure of the inflammatory potential of daily food and nutrient intake, and associations between a variety of health outcomes have been reported. However, the association between DII score and disease activity of rheumatoid arthritis (RA) is unclear. Therefore, this study was designed to test whether higher DII score contributes to disease activity and as a corollary, whether reducing DII score helps to achieve or maintain low disease activity or remission in patients with RA.MethodsWe performed a cross-sectional and longitudinal analysis using 6 years of data (from 2011 to 2017) in TOMORROW, a cohort study consisting of 208 RA patients and 205 gender- and age-matched controls started in 2010. Disease activity of RA patients was assessed annually using DAS28-ESR (disease activity score 28 joints and the erythrocyte sedimentation rate) as a composite measure based on arthritic symptoms in 28 joints plus global health assessment and ESR. Dietary data were collected in 2011 and 2017 using the brief-type self-administered diet history questionnaire (BDHQ). Energy-adjusted DII (E-DII™) score was calculated using 26 nutrients derived from the BDHQ. Data were analyzed with two-group comparisons, correlation analysis, and multivariable logistic regression analysis.ResultsOne hundred and seventy-seven RA patients and 183 controls, for whom clinical and dietary survey data were available, were analyzed. RA patients had significantly higher E-DII (pro-inflammatory) score compared to controls both in 2011 and 2017 (p < 0.05). In RA patients, E-DII score was not a factor associated with significant change in disease activity. However, anti-inflammatory change in E-DII score was associated maintaining low disease activity (DAS28-ESR ≤ 3.2) or less for 6 years (OR 3.46, 95% CI 0.33–8.98, p = 0.011).ConclusionsThe diets of RA patients had a higher inflammatory potential than controls. Although E-DII score was not a factor associated with significant disease activity change, anti-inflammatory change in E-DII score appeared to be associated with maintaining low disease activity in patients with RA.Trial registrationUMIN Clinical Trials Registry, UMIN000003876. Registered 7 Aug 2010—retrospectively registered.

TIPE2 and PCNP expression abnormalities in peripheral blood mononuclear cells associated with disease activity in rheumatoid arthritis: a meta-analysis.

Rheumatoid arthritis (RA) is a prevalent chronic autoimmune disease posing a considerable burden on both individuals and society. Tumor necrosis induced protein 8-like 2 (TIPE2), closely related to PEST-containing nuclear protein (PCNP) expression, is an immune-related protein potentially involved in the pathogenesis of autoimmune diseases. In this study, we aimed to assess differential expressions of TIPE2 and PCNP in peripheral blood mononuclear cells (PBMCs) between active and inactive RA patients. Relevant studies were selected from Medline, Google Scholar, Web of Science, and China National Knowledge Infrastructure (CNKI). Only observational studies (irrespective of publication status, language, or blinding), which compared patients in high disease activity, irrespective of the sample size, with patients in low disease activity of RA were evaluated. Four studies were included with 248 patients, 138 in the active group and 110 in the inactive group. Three studies provided data on TIPE2 expression levels, where 106 patients were divided into the active group and 88 patients were divided into the inactive group. The pooled analysis revealed a statistically significant difference between the two groups (WMD: 5.60; 95% CI: 5.02-6.18). Two studies provided data on PCNP expression levels, where 64 patients were divided into the active group and 44 patients were divided into the inactive group. The pooled analysis revealed a statistically significant difference between the two groups (WMD: 7.76; 95% CI: 3.09-12.43). The expression levels of TIPE2 and PCNP are significantly increased in PBMCs of active RA patients.

Challenges in Applying Treat to Target Strategy in Sample of Iraqi Patients with Rheumatoid Arthritis.

Objective:To identify barriers and factors that might hamper RA patients from achieving clinical target.Patients and methods:A total of 100 consecutive RA patients (95 females: 5 males) were included in this retrospective cross-sectional study. Data were collected at one point in time using questionnaire and interview. Demographic data, disease duration, functional classes, medications, and compliance assessment on the current treatments by using the Compliance Questionnaire Rheumatology (CQR19) were recorded for all patients. Achievement of clinical target was defined using the Clinical Disease Activity Index (CDAI; score ≤ 10). The main barriers preventing reaching the clinical target were reported for all the patients with moderate to high disease activity.Results:Among 100 patients with a recorded CDAI, 58 patients (58%) had not achieved the clinical target (CDAI > 10), for whom the barriers to disease control were recorded. The recorded barriers were drug unavailability/interruption (34.5%), under-treatment (20.7%), insufficient time to assess treatment response to recently initiated DMARDs (12.1%), non- inflammatory musculoskeletal pain (10.3%), had no further drug option available (10.3%), irreversible joint damage (5.2%), and other or non- identified barriers (6.9%). All patients completed CQR-19 items and poor compliance was identified as a predictor of high disease activity (P=0.001). Disease duration had a strong effect on the likelihood of patient response (P=0.035). There was a lower response rate among current smokers (P=0.007). Additionally, functional impairment appeared to be associated with high disease activity (P=0.0001). A significantly larger portion of low disease activity patients were presently on biological treatments (P=0.037) while steroid use had been associated with high disease activity (P=0.03). Age, gender, and Body Mass Index did not predict response to treatment.Conclusions:This study identified interruption of biologic drugs supply as a large barrier to RA treatment target. The data supported improved outcomes among patients receiving biological treatments. Additionally, certain factors were associated with high disease activity including longer disease duration, functional impairment, smoking, non-adherence, and steroid use.

Serum Calcium and Serum Alkaline Phosphatase Levels and their Correlations with Disease Activity in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis is a systemic autoimmune disease, characterized by chronic synovial inflammationleading to joint destruction and bone erosion. Metabolic changes have been studied in rheumatoid arthritis,with several studies reported decrease in serum calcium, and increase in serum alkaline phosphatase inrheumatoid arthritis patients in comparison to healthy individuals. This study has been undertaken toevaluate serum calcium and serum alkaline phosphatase levels in patients with rheumatoid arthritis, andtheir correlation with disease activity. A total of 100 patients with rheumatoid arthritis were enrolled in thestudy and compared with 50 healthy controls (46 female: 4 male) matched for age and sex. No significantdifferences have been noticed in mean values of serum calcium, corrected calcium, and serum alkalinephosphatase in patients with rheumatoid arthritis and healthy controls. The mean values of serum calcium,corrected calcium and serum alkaline phosphatase levels were slightly higher with moderate and high diseaseactivity in comparison to low disease activity in patients with rheumatoid arthritis, but the differences didnot reach the statistical significance.

Extensive fragmentation and re-organization of transcription in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is the prototype of autoimmune diseases, characterized by extensive gene expression perturbations in peripheral blood immune cells. Circumstantial evidence suggests that these perturbations may be due to altered epigenetic profiles and chromatin accessibility but the relationship between transcriptional deregulation and genome organization remains largely unstudied. In this work we propose a genomic approach that leverages patterns of gene coexpression from genome-wide transcriptome profiles in order to identify statistically robust Domains of Co-ordinated gene Expression (DCEs). Application of this method on a large transcriptome profiling dataset of 148 SLE patients and 52 healthy individuals enabled the identification of significant disease-associated alterations in gene co-regulation patterns, which also correlate with SLE activity status. Low disease activity patient genomes are characterized by extensive fragmentation leading to overall fewer DCEs of smaller size. High disease activity genomes display extensive redistribution of co-expression domains with expanded and newly-appearing (emerged) DCEs. The dynamics of domain fragmentation and redistribution are associated with SLE clinical endophenotypes, with genes of the interferon pathway being highly enriched in DCEs that become disrupted and with functions associated to more generalized symptoms, being located in domains that emerge anew in high disease activity genomes. Our results suggest strong links between the SLE phenotype and the underlying genome structure and underline an important role for genome organization in shaping gene expression in SLE.

Economic evaluation of low-dose SKA cytokines in patients with rheumatoid arthritis in maintaining low disease activity or remission

Introduction. The administration of low-dose SKA cytokines allows to maintain remission or low disease activity in patients with rheumatoid arthritis. This analysis aims to estimate the maintenance treatment cost of low-dose SKA cytokines versus DMARDs in patients with rheumatoid arthritis.&#x0D; Methods and Results. Rather than evaluating the cost-effectiveness of individual therapeutic agents, it becomes recommendable for decision-makers to identify an optimal sequencing of such agents. A one-year cost consequence analysis (CCA) was conducted, comparing two alternative strategies to maintain remission or low disease activity in patients with rheumatoid arthritis: i) first line with low-dose SKA cytokines and second line with antitumor necrosis factor-α (TNF-α), ii) first line with DMARDs and second line with TNF-α. The CCA was conducted from the perspective of the Italian National Health Service (iNHS). Only direct medical costs (drugs cost) were considered. We performed a sensitivity analysis to test the robustness of the results. The sequence using cytokines in first line showed the lower mean annual cost of treatment: the mean annual cost per patient was €1,280.96 with cytokines and €1,987.21 with DMARDs. Sensitivity analyses confirmed the base case result.&#x0D; Conclusion. From the iNHS’s perspective low-dose, SKA cytokines, as first line treatment appears a cost-saving strategy to maintain remission or low disease activity in patients with rheumatoid arthritis. (HTA &amp; Market Access)

THU0108 REAL-WORLD RADIOGRAPHIC PROGRESSION IN RA WITH BIOLOGIC DMARDS

Background:As structural damage is irreversible and strongly associated with functional disability1, it is an important outcome to be prevented in rheumatoid arthritis (RA). Acute phase markers, rheumatoid factor (RF) and anti-citrullinated protein (anti-CCP) positivity are important predictors of erosive disease2. Previous studies conducted in real life setting have divergent results regarding the role of disease activity in radiographic progression3,4.Objectives:To evaluate the impact of disease activity and biologic disease modifying anti-rheumatic drugs (bDMARDs) on radiographic progression of established RA in clinical practice in southern Brazilian public health system.Methods:Longitudinal retrospective study including patients with RA (1987 ACR criteria) treated with bDMARDs and followed from 2015 to 2019. Clinical and demographic data were collected at baseline. Radiographs of hands and feet were performed yearly. X-rays were scored according to the van der Heijde-modified total Sharp method (vdH-mTSS) in known chronological order. Clinical relevant radiographic progression (CRRP) was defined as an increase ≥3 units on the score per year5.Demographic, clinical, and radiographic characteristics of RA patients with or without relevant progression were compared with Fisher exact and Mann-Whitney test.Results:Seventy-five patients were included. The patients’ characteristics are shown in table 1. Twenty three (30%) patients presented CRRP at any time point of the follow up (figure 1). Mean DAS28-ESR at baseline was higher in patients who progressed radiographically, than those who did not progress (4.8±1.1 vs 3.5±1.1; p &lt; 0.001). No patient in remission at baseline presented with CRRP. Radiographic progression occurred in 15% of patients in low disease activity, 34% of patients in moderate disease activity and 57% of patients in high disease activity at baseline, depicting a linear relation between categories of disease activity and CRRP. RF, anti-CCP, disease duration, educational level, smoking status, total vdH-mTSS at baseline, number and duration of biologic DMARDs were not associated with CRRP. No single biologic DMARD was associated with worse radiological prognosis.Table 1.Baseline characteristics and bDMARD treatment during 5 years of follow upCharacteristicsN = 75Age, yrs, mean ± SD58.1 ± 10.1Female, n (%)65 (86.6)Disease duration, yrs, mean ± SD16.2 ± 7.6IgM RF positivity, n (%)69 (92)Anti-CCP positivity, n (%)27 (75) *DAS28-ESR, mean ± SD4.2 ± 1.0Educational level, n(%) Elementary school (≤ 8years)49 (65) Intermediate school (9-12 years)23 (30,6) University/college degree3 (4)SmokingCurrent or former31 (41.3)Never44 (58,7)vdH-mTSS, median (IQR)21 (5-53)Number of bDMARD, mean ± SD2.4 ± 1.1Duration of bDMARD, yrs, mean ± SD7.4 ± 2.6Methotrexate use, n, %61 (81)Biologic DMARD184**TNF inhibitors, n, %106 (57.6)Tocilizumab, n, %30 (16.3)Abatacept, n, %25 (13.6)Rituximab, n, %23 (12.5)RF rheumatoid fator anti-CCP anti-citrullinated protein bDMARD biologic disease-modifying anti-rheumatic drug ESR erythrocyte sedimentation rate DAS28 disease activity in 28 joints vdH-mTSS van der Heijde-modified total Sharp score IQR interquartile range *information available from 36 patients **all bDMARD treatmentsConclusion:In contrast to controlled clinical trials, real-world studies have shown that patients with RA treated with bDMARD still develop radiological progression. We observed that despite prognostic factors, achievement of treatment target is the most important factor to prevent articular damage in RA.

Modifiable Lifestyle Factors Associated With Response to Treatment in Early Rheumatoid Arthritis.

ObjectiveWe aimed to evaluate the associations between response to algorithm‐directed treat‐to‐target conventional synthetic disease‐modifying antirheumatic drug therapy and potentially modifiable lifestyle factors, including dietary fish oil supplementation, body mass index (BMI), and smoking history in a rheumatoid arthritis (RA) inception cohort.MethodsPatients with RA with a duration of less than 12 months were reviewed every 3 to 6 weeks to adjust therapy according to disease response. All patients received advice to take fish oil supplements, and omega‐3 status was measured as plasma levels of eicosapentaenoic acid (EPA). Lifestyle factors and other variables potentially prognostic for 28‐joint Disease Activity Score (DAS28) remission and DAS28 low disease activity (LDA) at the 12‐month visit were included in multivariable logistic regression models.ResultsOf 300 participants, 57.7% reached DAS28 LDA, and 43.7% were in DAS28 remission at 1 year. Increase in plasma EPA was associated with an increase in the odds of being in LDA (adjusted odds ratio [OR] = 1.27; P < 0.0001) and remission (adjusted OR = 1.21; P < 0.001). There was some evidence that the effect of BMI on LDA might be modified by smoking history. An increase in BMI was associated with a decrease in the odds of being in LDA in current and former smokers but had no impact on LDA in patients who had never smoked. There were no meaningful associations between BMI or smoking history and remission.ConclusionOmega‐3 status, BMI, and smoking history are potential predictors of outcome in early RA. The possibility of an effect modification by smoking on the predictive value of BMI merits further investigation.

P227 Remote monitoring of patients with RA: a user-centred design approach

Abstract Background Patients with rheumatoid arthritis are generally seen at arbitrary intervals in secondary care. Patients with active disease may not always be seen at the most appropriate time and those with low disease activity may be seen more frequently than necessary. The NHS Long Term Plan expects outpatient appointments to be reduced by up to a third, with digital transformation a key enabler. The remote capture of patient-reported outcome measures (PROMs) has the potential to facilitate more flexible and responsive outpatient services. Methods This project aimed to design a digital remote monitoring platform to test the hypothesis that PROMs can be used to proactively monitor and trigger consultations when patients need them most. The Rheumatoid Arthritis Impact of Disease (RAID) questionnaire, a validated multidimensional PROM, was used. Waiting room testing with patients informed the design of an acceptable mobile device format of the RAID. Recruitment criteria and acceptable cut-offs for defining flare were agreed by the rheumatology multidisciplinary team. Patients in low disease activity or remission (DAS &amp;lt;3.2) were invited to the service via SMS. All patients were informed regarding the governance of handling patient data and an opt-out option was offered. Patients were sent an automated monthly SMS with a PROM link and weekly reminder SMS if required. They also had the option to send in SMS messages at other times or add free text comments. Patients submitting a RAID score of ≥ 4 received a SMS with a link to the rheumatology advice service advising a remote consultation. The SMS-based service went live in January 2019 and all incoming communication was monitored on a daily basis. Results 104 RA patients are currently using the remote monitoring service with 10.3% (13/117) opting-out. 847 monthly PROMs have been sent via SMS. The PROM completion rate has been 68.9% (range 59.0-85.1%). 120 RAID (21.8%) scored 2-≤4 indicating low disease activity and 136 RAID (24.7%) ≤ 2 indicating disease remission. 480 SMS have been sent manually to patients who have engaged in two-way communication or returned a RAID score ≥4. 44 telephone advice appointments were triggered through the remote monitoring service by patients in disease flare. 80% (35/44) of remote consultation were considered to have to have averted a face to face consultation with the remaining 20% providing advice alone. Interviews have been conducted with PROM ‘non-completers’ to learn and inform further service design. Conclusion This project has demonstrated how a user-centred design approach to utilising technology can support access to rheumatology care when patients need it most, such as disease flare. The identification of patients self-reporting low disease activity using multidimensional PROMs may enable more efficient utilisation of clinical capacity through patient-initiated appointment deferment and lead to improved patient-centred care. Disclosures M.J. Martin: Honoraria; Novartis, Abbvie. Grants/research support; National Ankylosing Spondylitis Society. N. Ng None. L. Blackler None. T. Garrood None.

P14 Using NHS resources wisely: A Snapshot of biologic and small molecule agent prescribing at the Peter Maddison Rheumatology Centre

Abstract Background Pharmacological management of rheumatological conditions has transformed in the past two decades. A range of targeted therapies are available to manage conditions such as rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Careful governance and management is required to ensure patients receive the most appropriate drug and dose for their condition. Methods Patients diagnosed with RA, PsA and SpA/AS treated with a biologic or small molecule agent during the period of April 2018 - March 2019 for &amp;gt;6 months duration were eligible for inclusion. Patients were identified using biologic patient registers maintained by the Rheumatology department. Results One hundred and eighty-one patients were eligible for inclusion. Ninety-two patients (51%) were female, age range: 21 - 85 years, median = 54 years. The most prescribed biologic was etanercept (n = 71, 39.2%) followed by rituximab (n = 31, 17.1%) and adalimumab (n = 23, 12.7%) of which 98.4% were prescribed a biosimilar formulation. A breakdown of prescribing is illustrated below. Over a third of patients were maintained on a reduced dose of biologic, resulting in significant cost efficiencies (£20,000 cost avoidance with etanercept dose reduction). Twenty-eight patients in the RA cohort were not on a DMARD; of these 25 patients (89.2%) had achieved remission/ low disease activity. Average annual drug cost per patient was higher for psoriatic arthritis (£6,719.33 vs. £4731.00 for RA and £3,417.27 for SpA). Patients treated with rituximab had a dosing interval of 12 months or longer between cycles, as dosing was influenced by clinical symptoms. As a result, the percentage of patients in low disease activity is lower. Conclusion This study has shown marked variance in cost per head (range= £1,769- £9,303) depending on the disease, type of targeted therapy and disease response rate. The PMRC multidisciplinary team approach to introducing biosimilar medicine prescribing and actively maintaining patients in remission/low disease activity on reduced biologic therapy, has enabled patients to access medicines and deliver value-based healthcare with positive patient outcomes in line with NICE guidelines and clinical reasoning. Disclosures A.R. Jones None. A. Batty None. L.A. Lloyd None. A. Breslin None. C. Owen None. Y. Ahmad: None.

Comorbidity burden and clinical characteristics of patients with difficult-to-control rheumatoid arthritis.

Difficult-to-treat rheumatoid arthritis (RA) is a significant clinical problem despite no clear definition. We aimed to provide clinical characteristics and associated comorbidities of RA patients in relation to disease control. RA characteristics and physician-recorded comorbidities were analyzed in a sample of 1937 RA patients. Patients treated for RA for 5.2y (IQR, 2.1-11.3) were classified as difficult-to-control when presenting with DAS28-ESR > 3.2 despite previous use of at least 2 csDMARDs. A comparison of demographic and RA-related characteristics between difficult-to-treat and low disease activity patients (DAS28-ESR ≤ 3.2) was performed. Comorbidity burden was assessed by calculating Rheumatic Diseases Comorbidity Index (RDCI). Logistic regression model was constructed for difficult-to-control disease. Hypertension (46.9% (95%CI, 44.7-49.2)), coronary artery disease (CAD) (18.5% (95%CI, 16.8-20.3)), and diabetes (14.4% (95%CI, 12.9-16.0)) were the most prevalent conditions in RA patients. When compared with the adequate control group, difficult-to-control patients were increasingly burdened with hypertension (52.7% (95%CI, 47.5-57.8) vs. 42.0% (95%CI, 36.6-47.6); p = 0.006), cardiovascular diseases (24.2% (95%CI, 20.1-28.9) vs. 11.1% (95%CI, 8.0-15.1); p < 0.001), respiratory system diseases (7.0% (95%CI, 4.8-10.2) vs. 3.3% (95%CI, 1.8-5.9); p = 0.03) and gastroduodenal ulcers (2.3% (95%CI, 1.2-4.4) vs. 0.3% (95%CI, 0.1-1.8); p = 0.04). Patients with higher RDCI had lower chance to obtain low disease activity (OR 0.69 (95%CI, 0.61-0.79); p < 0.001). In multivariate analysis, RDCI was independently associated with difficult-to-control disease (OR 1.46 (95%CI, 1.21-1.76); p < 0.001). RA patients suffer from a variety of comorbidities. Cardiovascular and respiratory system diseases occur twice as often in difficult-to-control patients. RDCI may provide a valuable tool in evaluating a risk for difficult-to-control RA. Key Points • Hypertension, coronary artery disease and diabetes are the most prevalent comorbidities in rheumatoid arthritis. • Cardiovascular and respiratory tract diseases as well as gastroduodenal ulcers are more common among difficult-to-control patients, when compared with subjects with adequately controlled RA. • Rheumatic Diseases Comorbidity Index is an independent predictor for difficult-to-control RA.

Effectiveness of etanercept biosimilar SB4 in maintaining low disease activity in patients with psoriatic arthritis switched from etanercept originator: an open-label one year study

Background: Currently, there are no studies specifically aimed at investigating the effectiveness of etanercept biosimilar SB4 in psoriatic arthritis (PsA).Objectives: Our primary objective was to verify the ability of SB4 to maintain low disease activity in patients switching from reference etanercept to SB4 after 1 year of treatment with this last drug.Methods: Eighty-seven PsA patients with low disease activity at baseline measured by using the clinical Disease Activity Index for Psoriatic Arthritis ≤ 13 (cDAPSA; range 0–154) were prospectively evaluated after 6 and 12 months when switching from the reference etanercept to SB4.Results: One year after switching from the reference etanercept to SB4, 76 (87.3%) out of 87 patients maintained a cDAPSA ≤ 13.Conclusions: SB4 was effective in maintaining a state of low disease activity in the majority of patients switched from the reference etanercept. However, the proportion of patients (11 subjects) who failed to maintain a state of low disease activity at the end of the study was statistically significant. Loss of effectiveness in the above subjects was mainly due to subjective evaluations given by the patients, rather than an objectifiable exacerbation of disease.