Patients In Low Disease Activity Research Articles

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.

Evaluation of the activity of RA and sustained remission in patients ongoing biological therapy

The aim of the study is to establish the frequency and sustained remission and low disease activity in patients with RA in the course of long-term treatment with synthetic and biological means (DMARDs) in real conditions. In the conditions of retrospective data analysis of real clinical practice, there were included 209 patients suffering from RA. Activity indexes of RA in all patients were analyzed in the last year of treatment with bDMARDs. The average age of the patients is 59,01 years old. The dominants sex is female (84.6%). The beginning of treatment with biological therapy is delayed with the average of 8.21 year. In all activity indexes of RA, which were monitored in the beginning of the 6th and the 12th months, there was established a significant difference in their variation for the periods surveyed. There is a general trend towards lowering the values of our indicators. In the beginning of the monitored period, the patients going into remission (DAS28 CRP) are approximately 3 times less – 11% (n = 23) in comparison with those in the end of the study – 32.99% (n = 64) (p &lt; 0.001). In 10% of the cases a sustained remission is observed by both combined indexes (DAS28 ESR and DAS28 CRP) (p &lt; 0.001). Today the accurate way is the “treat to target” strategy. The purpose is lowering the activity of the disease to very low levels (or remission) and achieving a long-term remission which is now real and achievable.

The frequency of remission and low disease activity in patients with rheumatoid arthritis, and their ability to identify people with low disability and normal quality of life

ObjectiveTreat-to-target in rheumatoid arthritis (RA) recommends targeting remission, with low disease activity (LDA) being an alternative goal. When deciding to target remission or LDA, important considerations are the likelihood of attaining them, and their impacts on function and health-related quality of life (HRQoL). We have addressed this by studying: (a) the frequency of remission and LDA/remission; (b) DAS28-ESR trends after remission; (c) ability of remission vs. LDA to identify patients with normal function (HAQ ≤ 0.5) and HRQoL (EQ-5D ≥ the normal population). MethodsWe studied 571 patients in two clinical trials, and 1693 patients in a 10-year routine care cohort. We assessed the frequency and sustainability of remission and LDA/remission, variability in DAS28-ESR after remission, and sensitivity/specificity of remission and LDA/remission at identifying patients with low disability levels and normal HRQoL using Receiver Operator Characteristic (ROC) curves. Results:Point remission and remission/LDA were common (achieved by 35–58% and 49–74% of patients, respectively), but were rarely sustained (sustained remission and remission/LDA achieved by 5–9% and 9–16% of patients, respectively). Following attaining remission, DAS28-ESR levels varied substantially. Despite this, of those patients attaining point remission, the majority (53–61%) were in remission at study end-points. Whilst remission was highly specific at identifying patients with low disability (85–91%) it lacked sensitivity (51–57%); similar findings were seen for normal HRQoL (specificity 78–86%; sensitivity 52–59%). The optimal DAS28-cut-off to identify individuals with low disability and normal HRQoL was around the LDA threshold. ConclusionsOur findings support both the treat-to-target goals. Attaining remission is highly specific for attaining low disability and normal HRQoL, although many patients with more active disease also have good function and HRQoL. Attaining a DAS28-ESR ≤ 3.2 has a better balance of specificity and sensitivity for attaining these outcomes, with the benefit of being more readily achievable. Although sustaining these targets over time is rare, even attaining them on a one-off basis leads to better function and HRQoL outcomes for patients.

PMS32 - Effectiveness and Costs of Conventional Dmard Therapy in Patients with Rheumatoid Arthritis

Biological therapy for rheumatoid arthritis (RA) is still associated with high costs and has impacted the budget in the Colombian Health System in the last decade. We aimed to describe the costs and the effectiveness of conventional therapy in patients with RA using Disease Activity Score 28 (DAS28). During 12-month we followed patients with RA receiving conventional therapy, under a T2T model. Clinical follow-up was defined according to DAS28: every 3-5 weeks (DAS28>5.1), every 7-9 weeks (DAS28≥.1 and ≤5.1), and every 11-13 weeks (DAS28<3.1). We stratified patients in four groups: remission, low disease activity (LDA), moderate disease activity (MDA) and severe disease activity (SDA). Means and standard deviations were calculated for continuous variables and categorical variables were presented as percentages. We assessed the overall drug expenses using US Dollars at the official rate of exchange for December 2017. In a 12 month period 1310 patients were followed, 85% were women. Mean age was 60 ±11, mean DAS28 was 3.69 ±0.98. After 12 months we achieved remission in 42.2%, and LDA in 24.73% of our patients (at overall response of 67%). The most used medication was methotrexate 42%, followed by prednisone 18%, sulfasalazine 16%, chloroquine 10%, aziatropine 8% and leflunomide 7%. The costs for conventional DMARD therapy were USD $281.173, saving approximately for all patients USD$10.795.659 (mean biological therapy cost $8.458 per patient/year) through avoiding early use of biological therapy, using a T2T approach and patient multidisciplinary patient centered care (PCC) model. To achieve remission or LDA in patients with RA at a low cost is possible using conventional DMARDs and a PCC model. Other studies have shown the importance to establish clear criteria for the use of biological therapy in order to use it with economic rationality.

Remaining local subclinical joint inflammation is associated with deteriorated metacarpeal head bone microarchitecture in rheumatoid arthritis patients low disease activity

ObjectivesBone alterations at the subchondral level during rheumatoid arthritis (RA) remain under investigation. It remains unknown whether subchondral bone damage might still occur in RA patients in clinical remission, which could then infer suggesting that even minor subclinical inflammatory changes in the joint can induce local bone loss. MethodsThirty-two RA patients treated with biological disease-modifying anti-rheumatic drugs (bDMARDs) with low disease activity since at least 6 months and having erosion on the second or third metacarpeal head were enrolled in this pilot cross-sectional study. They were divided in two groups according to local inflammation assessed by Doppler-ultrasound exam surrounding the site of erosion. Cortical and trabecular parameters of the metacarpeal head were then assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) and compared in both groups. ResultsTwenty and twelve RA patients were enrolled in the “Doppler positive erosion” (DE+) group and Doppler negative erosion (DE−) group, respectively. No difference was observed in their clinical or biological RA characteristics. Both cortical density and thickness were similar among groups. Within the trabecular network, while no difference in bone volume was observed, trabecular density as well as trabecular number were decreased (P<0.001 and P<0.05 respectively), whereas trabecular separation and distribution of trabecular separation were increased in DE+ compared to DE− (P<0.05). ConclusionIn RA patients in low disease activity under bDMARDs, persistence of local inflammation was associated with alteration of the trabecular compartment. Trabecular density was the most strongly altered parameter and could be a candidate to assess drug effect on periarticular bone damage.

Efficacy of embedded nurse-led versus conventional physician-led follow-up in rheumatoid arthritis: a systematic review and meta-analysis

ObjectiveTo compare the efficacy of embedded nurse-led versus conventional physician-led follow-up on disease activity in patients with rheumatoid arthritis (RA).MethodsIn a systematic literature search, we identified randomised controlled trials (RCTs)...

Higher Levels of Secretory IgA Are Associated with Low Disease Activity Index in Patients with Reactive Arthritis and Undifferentiated Spondyloarthritis.

Both reactive arthritis (ReA) and undifferentiated spondyloarthritis (uSpA) belong to the group of autoinflammatory diseases called spondyloarthritis (SpA). Hypotheses have been proposed about a relationship between the intestinal mucosa and inflammation of joint tissues. The role of immunoglobulin IgA or secretory immunoglobulin A (SIgA) in the inflammatory and/or clinical activity of patients with SpA remains poorly understood. To evaluate the status of total IgA and SIgA, and the association among the levels of SIgA, IgA, IgA anti-Chlamydia trachomatis, and anti-Shigella spp. with the disease activity measures, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels, was compared in a cohort of patients with ReA and uSpA and healthy subjects. This was a cross-sectional study. The serum concentrations of SIgA, IgA anti-C. trachomatis, anti-Shigella spp., and total IgA were measured. Disease activity was measured in each patient by means of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS). Statistical analysis did include as bivariate evaluation, comparisons by Student's t-test, Kruskal-Wallis test, and U Mann-Whitney test, with a multivariate evaluation by principal components analysis (PCA). A correlation analysis was carried out using the Pearson correlation coefficient and a linear regression models. All analysis were made using Stata version 11.2® for Windows, R V3.3.21. Statistical significance was defined a p-value <0.05. In all, 46 patients (78.2% men; mean age, 34.8 ± 12.3 years) and 53 controls (41% men; mean age, 32 ± 11.4 years) were included in the study. The mean serum levels of SIgA were higher in SpA patients than in healthy subjects (p < 0.001). Only SIgA levels correlated with disease activity: BASDAI (r = -0.42, p = 0.0046), ASDAS-CRP (r = -0.37, p = 0.014), and ASDAS-ESR (r = -0.45, p = 0.0021). The negative correlation between SIgA and all activity indices was higher in HLA-B27-positive patients (BASDAI r = -0.70, p = 0.0009, ASDAS-CRP r = -0.58, p = 0.0093, and ASDAS-ESR r = -0.57, p = 0.0083). The PCA showed three factors: the first component was constituted by variables referred as clinical activity measures, the second did include the serological activity markers, and the last component was compounded by age and symptoms time. Elevated serum levels of SIgA were found to be related with low disease activity in patients with ReA and uSpA.

Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study.

To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA). RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib.

Maintenance treatment using abatacept with dose reduction after achievement of low disease activity in patients with rheumatoid arthritis (MATADOR) – A prospective, multicenter, single arm pilot clinical trial

Objectives: To preliminarily evaluate the feasibility of maintenance therapy with reduced dose of intravenous abatacept (ABT) to 250 mg/body/month after achieving remission or low disease activity (LDA).Patients and methods: RA patients treated with ABT at 13 sites were enrolled in this prospective interventional pilot study during the period between March 2013 and March 2015. Inclusion criteria were (1) age at 20 years or older, (2) under treatment with monthly intravenous ABT at approved doses, (3) DAS28-CRP lower than 2.7 at least for 6 months, (4) agreed to join this trial with written informed consent and (5) body weight under 125 kg. Enrolled patients were maintained with intravenous monthly ABT at a reduced dose of 250 mg/body (MATADOR protocol). The primary end point was the proportion of the patients continued with MATADOR protocol at week 48. MATADOR protocol was discontinued upon disease flare or other reasons such as patients’ request or severe adverse event (AE). Disease activities and structural changes were also evaluated.Results: Fifty-three patients fulfilled the entry criteria and were followed for 1-year. MATADOR protocol was continued for 1-year in 43 (81%) of the evaluated patients. Three patients experienced severe AEs. Mean DAS28-CRP and remission rate were 1.56 and 88% when ABT reduced and 1.80 and 81% at 1-year, respectively. Structural remission was achieved in 34 out of 42 evaluated patients.Conclusions: Reduced dose of intravenous ABT was proposed as a feasible choice for maintenance therapy for RA after achievement of remission/LDA, although further randomized trials would be awaited.

Structural and functional outcomes of a therapeutic strategy targeting low disease activity in patients with elderly-onset rheumatoid arthritis: a prospective cohort study (CRANE).

The aim of this study was to evaluate structural damage and physical disability in patients with elderly-onset RA (EORA) who were treated in clinical practice with a therapeutic strategy targeting low disease activity (LDA). Data from 151 MTX-naive patients (mean age 74.9 years) with EORA from a prospective, monocentric registry were analysed. Treatment was adjusted every 3 months targeting LDA [28-joint DAS using ESR (DAS28-ESR) <3.2]. Treatment was initiated with non-biologic DMARDs (nbDMARDs), followed by TNF inhibitors (TNFis) or tocilizumab. The primary outcome was change from week 0 to week 52 in the modified total Sharp score (ΔmTSS). Secondary outcomes were derived from the HAQ Disability Index (HAQ-DI) and DAS28 at week 52. Predictors of clinically relevant radiographic progression [CRRP; ΔmTSS/year more than the smallest detectable change (2.1 points)] were examined using multivariate logistic regression models. Adherence to the treat-to-target strategy was observed in 83.4% of the 151 patients at week 24 and in 75.5% at week 52. At week 52, 67.6% of the patients were receiving a nbDMARD alone, 31.0% a TNFi with or without MTX and 1.4% tocilizumab. At week 52, structural remission (ΔmTSS/yr ≤0.5) was achieved in 49.7% of the patients, functional remission (HAQ-DI ≤0.5) in 63.4% and LDA in 51.0%. Clinical responses at weeks 12 and 24 were significant independent predictors of CRRP. Cumulative disease activity during the first 12 weeks predicted CRRP with a C-statistic of 0.888. Achieving structural remission, functional remission and LDA in clinical practice in EORA patients are realistic goals. Our results indicate significant benefits for a therapeutic strategy targeting LDA for EORA patients in clinical practice.

FRI0003 Quality of Life and Economic Benefits of Remission/Low Disease Activity in Patients with Rheumatoid Arthritis in Clinical Practice Setting

BackgroundRecent studies, primarily in clinical trial settings, have suggested that attaining remission/low disease activity (LDA) in patients with early-stage RA contributes to improved clinical outcomes.ObjectivesEvaluate the associations between achievement of...

THU0228 Validity of Omeract Preliminary Flare Questions in a Randomized Controlled Trial, that Assesses Impact of Disease Activity Guided Down-Titration of Anti-TNF Treatment in Rheumatoid Arthritis Patients in Low Disease Activity

BackgroundThe OMERACT RA flare group developed a preliminary set of questions to detect and measure flares in rheumatoid arthritis (RA) patients (preliminary flare questions, PFQs). Domains identified to potentially characterise...

Measurement of stiffness in patients with rheumatoid arthritis in low disease activity or remission: a systematic review.

BackgroundRecent qualitative research has shown that stiffness is an important symptom for patients to identify remission. However, it is unclear how to measure stiffness in low disease activity. This systematic review aims to summarise the existing literature on validity of patient reported outcomes to measure stiffness in RA low disease activity states, to aid the choice for a measurement instrument.MethodsAn extensive pubmed-search was undertaken, identifying measurement instruments for patient perceived stiffness used in low disease activity. Eligible studies reported on 1) stiffness as an outcome in relation to other core set measures, 2) development of a patient reported tool to measure stiffness, or 3) comparison of two different tools to measure aspects of stiffness, all in low disease activity.ResultsOf 788 titles, only two studies report on validity of stiffness measures within low disease activity. Morning stiffness (MS) is reported in 44 to 80% of patients in low disease activity. A difference of 40 to 60 minutes in duration until maximum improvement is observed between active and inactive patients. Severity of MS might discriminate better between high and low disease activity compared to measurement of duration of MS.ConclusionsThere is insufficient data on measurement of stiffness in the spectrum of low disease activity or remission.

Blood monocyte subsets and selected cardiovascular risk markers in rheumatoid arthritis of short duration in relation to disease activity.

Objectives. To evaluate blood monocyte subsets and functional monocyte properties in patients with rheumatoid arthritis (RA) of short duration in the context of cardiovascular (CV) risk and disease activity. Methods. We studied conventional markers of CV risk, intima media thickness (IMT), and blood monocyte subsets in 27 patients aged 41 ± 10 years with RA of short duration (median 12 months) and 22 healthy controls. The RA subjects were divided into low (DAS28: 2.6–5.1) and high (DAS28 > 5.1) disease activity. Results. RA patients exhibited increased levels of intermediate (CD14++CD16+) monocytes with decreased CD45RA expression compared to controls, increased counts of classical (CD14++CD16−) monocytes, and decreased percentages of nonclassical (CD14+CD16++) monocytes. Patients with high disease activity had lower HLA DR expression on classical monocytes compared to low disease activity patients. There were no differences in monocyte subsets between subjects with DAS > 5.1 and DAS ≤ 5.1. There were no significant intergroup differences in IMT and the majority of classical CV risk factors. Conclusions. Patients with RA of short duration show alteration in peripheral blood monocyte subsets despite the fact that there is no evidence of subclinical atherosclerosis. Disease activity assessed with DAS28 was associated with impaired functional properties but not with a shift in monocyte subpopulations.

SAT0157 Discontinuation of etanercept in rheumatoid arthritis patients in clinical remission: Two-year outcome

BackgroundTumor necrosis factor (TNF) inhibitors enable tight control of disease activity in patients with rheumatoid arthritis (RA). Discontinuation of TNF inhibitors after achievement of clinical remission is important for safety...

AB0296 Discontinuation of tocilizumab after attaining remission in patients with rheumatoid arthritis

BackgroundEfficacy and safety of biologic agents against refractory rheumatoid arthritis (RA) patients have been proved, however expensive cost is still a serious problem. Biologic free study about infliximab (RRR study)...

THU0155 The addition of another disease-modifying anti-rheumatic drug to methotrexate in place of infliximab improves the rate of infliximab-free sustained remission

BackgroundAnti-tumor necrosis factor (TNF) biological agent, infliximab, (IFX) has been successfully withdrawn in at least a half of patients with rheumatoid arthritis (RA) in sustained remission with IFX plus methotrexate...

AB0297 Dose reduction in patients with rheumatoid arthritis responding to the standard rituximab regimen.

BackgroundRituximab (RTX), a chimeric anti-CD20 monoclonal antibody, safe and effective in rheumatoid arthritis (RA) patients with inadequate response orintolerant to tumor necrosis factor (TNF) inhibitorshas been approved at dose of...

AB1459-HPR Despite low disease activity patients with poly- and dermatomyositis perceive activity limitation, reduced grip force and quality of life longitudinally

BackgroundPolymyositis (PM) and dermatomyositis (DM) are idiopathic inflammatory myopathies with muscle weakness and reduced muscle endurance. The impairments lead to activity limitation, participation restriction and reduced quality of life.ObjectivesTo investigate...