Composite Disease Activity Measures Research Articles

Can quantitative MRI be used in the clinical setting to quantify the impact of intra-articular glucocorticoid injection on synovial disease activity in juvenile idiopathic arthritis?

BackgroundJuvenile idiopathic arthritis (JIA), the most common chronic rheumatic disease of childhood, is characterised by synovitis. Clinical assessments of synovitis are imperfect, relying on composite and indirect measures of disease activity including clinician-reported measures, patient-reported measures and blood markers. Contrast-enhanced MRI is a more sensitive synovitis assessment technique but clinical utility is currently limited by availability and inter-observer variation. Improved quantitative MRI techniques may enable future development of more stringent MRI-defined remission criteria.The objective of this study was to determine the utility and feasibility of quantitative MRI measurement of synovial volume and vascularity in JIA before and twelve weeks after intra-articular glucocorticoid injection (IAGI) of the knee and to assess the acceptability of MRI to participating families.MethodsChildren and young people with JIA and a new episode of knee synovitis requiring IAGI were recruited from the Great North Children’s Hospital in Newcastle upon Tyne. Quantitative contrast-enhanced MRI was performed prior to and twelve weeks after IAGI, in addition to standard clinical assessment tools, including the three-variable clinical juvenile arthritis disease activity score (cJADAS) and active joint count.ResultsEleven young people (5 male, median age 13 years, range 7–16) with JIA knee flare were recruited and 10 completed follow-up assessment. Following IAGI, the median (interquartile range) cJADAS improved from 8.5 (2.7) to 1.6 (3.9), whilst the median synovial volume improved from 38.5cm3 (82.1cm3) to 0.0cm3 (0.2cm3). Six patients presented with frank synovitis outside normal limits on routine MRI reporting. A further three had baseline MRI reports within normal limits but the quantitative measurements identified measurable synovial uptake. Post-IAGI quantitative measurements highlighted significant improvements in 9 patients.ConclusionsIAGI led to a marked reduction in synovial volume, with quantitative MRI identifying more patients with an improved synovial volume than routine qualitative clinical reporting. Improvements in cJADAS scores were more variable with the patient/parent global assessment component contributing most to the scores. Further work is indicated, exploring the utility of quantitative MRI in the assessment of less accessible joints and comparing the impact of different treatment modalities.

Correlation of the Multi-Biomarker Disease Activity Score With Rheumatoid Arthritis Disease Activity Measures: A Systematic Review and Meta-Analysis.

There are conflicting reports on the validity of the multi-biomarker disease activity (MBDA) score for assessing rheumatoid arthritis (RA) disease activity. Our aim was to perform a systematic review of the MBDA and a meta-analysis of the correlation between the MBDA and other RA disease activity measures. A systematic review was performed by searching Medline, Embase, Scopus, Google Scholar, and the Cochrane Library from inception to March 7, 2017. Study details, MBDA performance, and study quality were assessed by independent reviewers. Correlations of the MBDA with composite RA disease activity measures were pooled using random-effects meta-analyses. A total of 22 studies were identified in the systematic review, of which 8 (n = 3,242 assays) reported correlations of the MBDA with RA disease activity measures. Pooling results from these 8 studies in the meta-analysis, the MBDA demonstrated modest correlations with the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP; r = 0.41, 95% confidence interval [95% CI] 0.36-0.46) and the Disease Activity Score using the erythrocyte sedimentation rate (DAS28-ESR; r = 0.48, 95% CI 0.38-0.58), with weaker correlations observed with the Simplified Disease Activity Index (SDAI; r = 0.35, 95% CI 0.26-0.43), Clinical Disease Activity Index (CDAI; r = 0.26, 95% CI 0.19-0.33), and Routine Assessment of Patient Index Data 3 (RAPID3; r = 0.23, 95% CI 0.19-0.27). Correlations between change in MBDA and change in disease activity measures ranged from r = 0.53 for the DAS28-ESR to r = 0.26 for the CDAI. The MBDA demonstrates moderate convergent validity with the DAS28-CRP and the DAS28-ESR but weaker correlations with the SDAI, CDAI, and RAPID3. While it appears to complement existing RA disease activity measures, further assessment of the performance characteristics of the MBDA is warranted.

The relationship between patient acceptable symptom state and disease activity in patients with psoriatic arthritis.

The Psoriatic Arthritis Disease Activity Score (PASDAS) and Disease Activity Index for Psoriatic Arthritis (DAPSA) are composite PsA disease activity measures. We sought to identify the PASDAS and DAPSA cut-off points consistent with patient acceptable symptom state (PASS), the threshold of symptoms beyond which patients consider themselves well, and examine PASS across published PASDAS and DAPSA thresholds for low, moderate and high disease activity. We used a standard protocol including physician assessment and patient-reported outcomes to prospectively record measures required to calculate PASDAS and DAPSA. We identified PASS thresholds for the PASDAS and DAPSA using receiver operating characteristics curve analyses. We assessed the frequency of reporting acceptable symptom state across disease activity thresholds for PASDAS and DAPSA scores. A total of 229 patients (58.5% male, mean age 55.5 years, mean disease duration 17.1 years) were recruited. The PASS threshold for the PASDAS was 3.79 [area under the curve (AUC) 0.86, sensitivity 0.75, specificity 0.82] and for the DAPSA was 11.10 (AUC 0.91, sensitivity 0.89, specificity 0.82). With the PASDAS, 90% of patients defined as having low disease activity considered their symptom state acceptable, compared with 55% and 17% among those with moderate and high disease activity, respectively. With the DAPSA, 98% of patients in disease remission considered their symptom state acceptable compared with 85, 22 and 18% among those with low, moderate and high disease activity, respectively. We have defined PASS thresholds for PASDAS and DAPSA. The PASDAS target for low disease activity and DAPSA targets of low disease activity or remission align well with PASS.

Assessing Disease Activity in Psoriatic Arthritis: A Literature Review.

Psoriatic arthritis (PsA) is a multifaceted disease, with a high impact on patients’ psychological and physical well-being. There is increasing recognition that assessment of both clinical aspects of disease and patient identified concerns, such as fatigue, work disability, and treatment satisfaction need to be addressed. Only then can we fully understand disease burden and make well-informed treatment decisions aimed at improving patients’ lives. In recent years, there has been much progress in the development of unidimensional and composite measures of disease activity, as well as questionnaires capturing the patient’s perspective in psoriatic disease. Despite these advances, there remains disagreement amongst clinicians as to which instruments should be used. As a consequence, they are yet to receive widespread implementation in routine clinical practice. This review aims to summarize currently available clinical and patient-derived assessment tools, which will provide clinicians with a practical and informative resource.

Conceptual model for the health technology assessment of current and novel interventions in rheumatoid arthritis.

The objective of this study was to evaluate current approaches to economic modeling in rheumatoid arthritis (RA) and propose a new conceptual model for evaluation of the cost-effectiveness of RA interventions. We followed recommendations from the International Society of Pharmacoeconomics and Outcomes Research-Society of Medical Decision Making (ISPOR-SMDM) Modeling Good Research Practices Task Force-2. The process involved scoping the decision problem by a working group and drafting a preliminary cost-effectiveness model framework. A systematic literature review (SLR) of existing decision-analytic models was performed and analysis of an RA registry was conducted to inform the structure of the draft conceptual model. Finally, an expert panel was convened to seek input on the draft conceptual model. The proposed conceptual model consists of three separate modules: 1) patient characteristic module, 2) treatment module, and 3) outcome module. Consistent with the scope, the conceptual model proposed six changes to current economic models in RA. These changes proposed are to: 1) use composite measures of disease activity to evaluate treatment response as well as disease progression (at least two measures should be considered, one as the base case and one as a sensitivity analysis); 2) conduct utility mapping based on disease activity measures; 3) incorporate subgroups based on guideline-recommended prognostic factors; 4) integrate realistic treatment patterns based on clinical practice/registry datasets; 5) assimilate outcomes that are not joint related (extra-articular outcomes); and 6) assess mortality based on disease activity. We proposed a conceptual model that incorporates the current understanding of clinical and real-world evidence in RA, as well as of existing modeling assumptions. The proposed model framework was reviewed with experts and could serve as a foundation for developing future cost-effectiveness models in RA.

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis/Outcome Measures in Rheumatology Consensus-Based Recommendations and Research Agenda for Use of Composite Measures and Treatment Targets in Psoriatic Arthritis.

A meeting was convened by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) to further the development of consensus among physicians and patients regarding composite disease activity measures and targets in psoriatic arthritis (PsA). Prior to the meeting, physicians and patients completed surveys on outcome measures. A consensus meeting of 26 rheumatologists, dermatologists, and patient research partners reviewed evidence on composite measures and potential treatment targets plus results of the surveys. The meeting consisted of plenary presentations, breakout sessions, and group discussions. International experts including members of GRAPPA and OMERACT were invited to the meeting, including the developers of all of the measures discussed. After discussions, participants voted on proposals for use, and consensus was established in a second survey. Survey results from 128 health care professionals and 139 patients were analyzed alongside a systematic literature review summarizing evidence. A weighted vote was cast for composite measures. For randomized controlled trials, the most popular measures were the PsA disease activity score (40 votes) and the GRAPPA composite index (28 votes). For clinical practice, the most popular measures were an average of scores on 3 visual analog scales (45 votes) and the disease activity in PsA score (26 votes). After discussion, there was no consensus on a composite measure. The group agreed that several composite measures could be usedand that future studies should allow further validation and comparison. The group unanimously agreed that remission should be the ideal target, with minimal disease activity (MDA)/low disease activity as a feasible alternative. The target should include assessment of musculoskeletal disease, skin disease, and health-related quality of life. The group recommended a treatment target of very low disease activity (VLDA) or MDA. Consensus was not reached on a continuous measure of disease activity. In the interim, the group recommended several composites. Consensus was reached on a treatment target of VLDA/MDA. An extensive research agenda was composed and recommends that data on all PsA clinical domains be collected in ongoing studies.

Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles

ObjectivesSystemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease associated with diffuse immune cell dysfunction. CD40–CD40 ligand (CD40L) interaction activates B cells, antigen-presenting cells and platelets. CD40L blockade might provide...

Apps for People With Rheumatoid Arthritis to Monitor Their Disease Activity: A Review of Apps for Best Practice and Quality.

BackgroundRheumatoid arthritis (RA) is a chronic inflammatory arthritis requiring long-term treatment with regular monitoring by a rheumatologist to achieve good health outcomes. Since people with RA may wish to monitor their own disease activity with a smartphone app, it is important to understand the functions and quality of apps for this purpose.ObjectiveThe aim of our study was to assess the features and quality of apps to assist people to monitor their RA disease activity by (1) summarizing the available apps, particularly the instruments used for measurement of RA disease activity; (2) comparing the app features with American College of Rheumatology and European League against Rheumatism (ACR and EULAR) guidelines for monitoring of RA disease activity; and (3) rating app quality with the Mobile App Rating Scale (MARS).MethodsSystematic searches of the New Zealand iTunes and Google Play app stores were used to identify all apps for monitoring of RA disease activity that could be used by people with RA. The apps were described by both key metadata and app functionality. App adherence with recommendations for monitoring of RA disease activity in clinical practice was evaluated by identifying whether apps included calculation of a validated composite disease activity measure and recorded results for future retrieval. App quality was assessed by 2 independent reviewers using the MARS.ResultsThe search identified 721 apps in the Google Play store and 216 in the iTunes store, of which 19 unique apps met criteria for inclusion (8 from both app stores, 8 iTunes, and 3 Google Play). In total, 14 apps included at least one validated instrument measuring RA disease activity; 7 of 11 apps that allowed users to enter a joint count used the standard 28 swollen and tender joint count; 8 apps included at least one ACR and EULAR-recommended RA composite disease activity (CDA) measure; and 10 apps included data storage and retrieval. Only 1 app, Arthritis Power, included both an RA CDA measure and tracked data, but this app did not include the standard 28 tender and swollen joint count. The median overall MARS score for apps was 3.41/5. Of the 6 apps that scored ≥4/5 on the overall MARS rating, only 1 included a CDA score endorsed by ACR and EULAR; however, this app did not have a data tracking function.ConclusionsThis review found a lack of high-quality apps for longitudinal assessment of RA disease activity. Current apps fall into two categories: simple calculators primarily for rheumatologists and data tracking tools for people with RA. The latter do not uniformly collect data using validated instruments or composite disease activity measures. There is a need for appropriate, high-quality apps for use by rheumatologists and patients together in co-management of RA.

Impact of Obesity on Remission and Disease Activity in Rheumatoid Arthritis: A Systematic Review and Meta-Analysis.

To summarize the relationship between obesity and remission in rheumatoid arthritis (RA); secondary objectives were to summarize other measures of treatment response and mortality in RA. Medline and Embase searches were performed in March 2016 using relevant MeSH and keyword terms for obesity and RA. Articles were selected if they reported estimates for achieving remission in obese subjects relative to other body mass index (BMI) categories, or changes in composite or individual disease activity measures or patient-reported outcomes during therapy, or mortality rates, in relation to BMI category or on a continuous scale. Remission outcomes were conducive to meta-analysis, and all other outcomes were summarized. A total of 3,368 records were screened; we included 8 reporting remission rates, 9 reporting disease activity measures or patient-reported outcomes, and 3 examining mortality by obesity status or BMI. Obese patients attain remission less frequently than nonobese and/or normal-weight patients. In adjusted models, obese patients demonstrated lower odds of achieving remission (pooled odds ratio [OR] 0.57 [95% confidence interval (95% CI) 0.45, 0.72]) and sustained remission (pooled OR 0.49 [95% CI 0.32, 0.74]) relative to nonobese subjects. Most studies found obese patients to have worse Disease Activity Scores or Disease Activity Scores in 28 joints, tender joint counts, inflammatory markers, patient global evaluation scores, pain scores, and physical function scores during followup, but not worse swollen joint counts. Obesity was not associated with increased mortality. Obesity decreases the odds of achieving remission in RA and negatively impacts disease activity and patient-reported outcomes during therapy. Interventions to reduce BMI should be investigated for their ability to improve disease outcomes.

Development and First Validation of a Disease Activity Score for Gout.

ObjectiveTo develop a new composite disease activity score for gout and provide its first validation.MethodsDisease activity has been defined as the ongoing presence of urate deposits that lead to acute arthritis and joint damage. Every measure for each Outcome Measures in Rheumatology core domain was considered. A 3‐step approach (factor analysis, linear discriminant analysis, and linear regression) was applied to derive the Gout Activity Score (GAS). Decision to change treatment or 6‐month flare count were used as the surrogate criteria of high disease activity. Baseline and 12‐month followup data of 446 patients included in the Kick‐Off of the Italian Network for Gout cohort were used. Construct‐ and criterion‐related validity were tested. External validation on an independent sample is reported.ResultsFactor analysis identified 5 factors: patient‐reported outcomes, joint examination, flares, tophi, and serum uric acid (sUA). Discriminant function analysis resulted in a correct classification of 79%. Linear regression analysis identified a first candidate GAS including 12‐month flare count, sUA, visual analog scale (VAS) of pain, VAS global activity assessment, swollen and tender joint counts, and a cumulative measure of tophi. Alternative scores were also developed. The developed GAS demonstrated a good correlation with functional disability (criterion validity) and discrimination between patient‐ and physician‐reported measures of active disease (construct validity). The results were reproduced in the external sample.ConclusionThis study developed and validated a composite measure of disease activity in gout. Further testing is required to confirm its generalizability, responsiveness, and usefulness in assisting with clinical decisions.

Impact of tofacitinib on patient outcomes in rheumatoid arthritis - review of clinical studies.

Rheumatoid arthritis is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient’s quality of life and function. Tofacitinib was approved for the treatment of rheumatoid arthritis in the USA in 2012 and subsequently in other countries, but not by the European Medicines Agency. The goal of this review was to evaluate the impact of tofacitinib on patient-reported and patient-specific outcomes from prior clinical studies, focusing on quality of life, functionality, pain, global disease assessment, major adverse consequences, and withdrawals. A total of 13 reports representing 11 clinical studies on tofacitinib in rheumatoid arthritis were identified through PubMed and reference lists in meta-analyses and other reviews. Data on improvements in patient-driven composite tools to measure disease activity in rheumatoid arthritis, such as the Health Assessment Questionnaire, served as a major outcome evaluated in this review and were extracted from each study. Additional data extracted from those clinical studies included patient assessment of pain (using a 0–100 mm visual analog scale), patient global assessment of disease (using a 0–100 mm visual analog scale), patient withdrawals, withdrawals due to adverse effects or lack of effect, and risk of serious adverse effects, serious infections, and deaths. Tofacitinib 5 mg bid appears to have a favorable impact on patient outcomes related to efficacy and safety when compared with baseline values and with comparator disease-modifying antirheumatic drugs and placebo. Improvements were seen in the composite and individual measures of disease activity. Serious adverse effects, other adverse consequences, overall withdrawals, and withdrawals due to adverse effects and lack of efficacy are similar or more favorable for tofacitinib versus comparator disease-modifying antirheumatic drugs and placebo. At this point, tofacitinib appears to have an important role in the treatment of rheumatoid arthritis through improvement in these patient outcomes. However, it may require years of additional clinical studies and postmarketing surveillance to fully characterize the benefit-to-risk ratio of tofacitinib in a larger and diverse patient population.

Rheumatoid factor, not antibodies against citrullinated proteins, is associated with baseline disease activity in rheumatoid arthritis clinical trials.

IntroductionAlthough the prognostic value of rheumatoid factor (RF) and autoantibodies against citrullinated proteins (ACPAs) in patients with rheumatoid arthritis (RA) is well established, their association with RA disease activity remains unclear. Here, we investigate this association in a large study using data from clinical trials.MethodsWe used baseline data from four recent randomized controlled clinical trials of RA. We investigated individual and composite measures of disease activity. The relationship of RF and ACPAs with these measures was investigated by using stratified analysis (comparing four groups of patients according to the presence or absence of RF and ACPAs) and matched analysis (disease activity levels compared between patients negative and patients highly positive for one autoantibody who were matched for levels of the other autoantibody as well as for age, gender, and duration of RA).ResultsA total of 2118 patients were analysed in the different cohorts. In the stratified analysis, RF+ patients, regardless of ACPA status, had the highest levels of disease activity, whereas ACPA+ patients had disease activity that was similar to or lower than that of ACPA− patients, both in the presence and in the absence of RF. When matched for ACPA levels, patients with highly positive RF had significantly higher disease activity for all composite indices compared with patients who were RF− (P = 0.0067), whereas ACPA-highly-positive and ACPA-negative patients matched for RF levels had similar disease activity, again even with the tendency toward lower disease activity for ACPA+ patients (P = 0.054).ConclusionThe data presented suggest that the presence of RF has a clear association with higher levels of disease activity but that the presence of ACPAs has not and even appears to be associated with lower disease activity.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-015-0736-9) contains supplementary material, which is available to authorized users.

Advances in the management of rheumatoid arthritis

Modern early rheumatoid arthritis strategies are usually based upon a number of important overarching principles: 1. early diagnosis facilitates early commencement of disease modifying anti-rheumatic therapy; 2. early commencement of treatment reduces the long-term risk of erosive damage and functional decline; 3. composite disease activity measures should be used to quantify global rheumatoid arthritis disease activity; and 4. therapy should be intensified until a predefined disease activity target has been achieved. A substantial minority of rheumatoid arthritis patients (approximately 40%) will experience an adequate response to methotrexate monotherapy; however, the remainder may require disease modifying anti-rheumatic combination therapy, and/or biologic therapy, to achieve disease activity targets. Importantly, short term trials of methotrexate monotherapy do not appear to disadvantage outcomes provided treatment continues to be intensified if disease activity targets are not achieved.

Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force

BackgroundReaching the therapeutic target of remission or low-disease activity has improved outcomes in patients with rheumatoid arthritis (RA) significantly. The treat-to-target recommendations, formulated in 2010, have provided a basis for...

Disease characteristics and treatment patterns in veterans with rheumatoid arthritis and concomitant hepatitis C infection.

To assess disease characteristics, disease activity, and treatment patterns in rheumatoid arthritis (RA) patients with comorbid hepatitis C virus (HCV) infection. RA patients with concomitant HCV were identified within the Veterans Affairs Rheumatoid Arthritis Registry. HCV was defined as at least 1 diagnostic code present in medical record databases. Generalized estimating equations in linear regression models compared component and composite measures of disease activity between HCV-positive and HCV-negative patients over the study period, accounting for within-subject correlations. Similar analysis of pharmacy databases evaluated medication use within each group. Ninety-two of 1,706 registry participants (5.1%) were identified with concomitant HCV. At enrollment, HCV-positive patients were younger (mean ± SD 61.7 ± 7.1 years versus 67.5 ± 11.2 years; P < 0.001), more often African American (35% versus 15%; P < 0.001), and smokers (48% versus 26%; P < 0.001). In unadjusted and adjusted analyses incorporating all study visits, patient-reported outcomes (pain, tender joints, and patient global scores) were higher in HCV-positive patients, contributing to higher disease activity scores. There was no difference in physician-reported outcomes (swollen joints or physician global scores). HCV-positive patients had lower C-reactive protein levels (β -0.30 [95% confidence interval (95% CI) -0.53, -0.07], P = 0.01). Over all visits, HCV-positive patients were less likely to receive methotrexate (odds ratio [OR] 0.27 [95% CI 0.17, 0.40], P < 0.001), and more likely to receive prednisone (OR 1.41 [95% CI 1.02, 1.97], P = 0.04) and anti-tumor necrosis factor α (anti-TNFα) therapies (OR 1.51 [95% CI 1.04, 2.19], P = 0.03). RA patients with concomitant HCV have higher disease activity scores, driven primarily by higher patient-reported measures. HCV-positive patients were more likely to be treated with prednisone and anti-TNFα therapies and less likely to receive methotrexate compared to HCV-negative patients.

Outcome Measures for Gout Clinical Trials: a Summary of Progress

Gout is the most common form of inflammatory arthritis. With the development of new agents for the treatment of gout in the last decade, the lack of validated outcome measures for clinical trials in gout has become apparent. Gout has been a topic of discussion at Outcomes in Rheumatology Clinical Trials (OMERACT) meetings since 2002. This work has included identification of core domains for outcome measures for both acute and chronic gout studies. More recently, OMERACT have endorsed a number of these domains and measurement instruments for these domains. The domains appear to be largely relevant to patients with gout but additional issues have been identified, including the absence of an endorsed disease-specific measure of health-related quality of life. Concurrently, a preliminary definition of flare has been developed and leading from this, early versions of composite measures of disease activity and response criteria. With the ability for excellent serum urate control, remission should be possible and preliminary remission criteria have been proposed. Flare definition, response criteria and remission criteria require further validation. The role of serum urate as a biomarker for chronic gout studies is promising, but further work is required to show that serum urate is a biomarker of relevant clinical outcomes.

Clinical Composite Measures of Disease Activity and Damage Used to Evaluate Patients With Systemic Lupus Erythematosus: A Systematic Literature Review

ObjectivesTo determine the most appropriate indices to evaluate the disease activity and damage in patients with systemic lupus erythematosus (SLE). MethodsA systematic literature search was performed to identify validation studies of indices used to evaluate disease activity and damage. We collected information for each instrument on every aspect of validation including feasibility, reliability, validity and sensitivity to change using ad hoc forms. ResultsA total of 38 articles were included addressing the validation of 6 composite indices to evaluate disease activity (BILAG, ECLAM, SLAM, SLEDAI, LAI and SLAQ); and 3 indices to evaluate damage (SLICC/ACE-DI, LDIQ and BILD). Only the SLAQ, LIDIQ and the BILD were self-administered. Feasibility and internal consistency was only studied in 3 indices (BILAG, SLAQ and SDI) with a Cronbach α ranging from 0.35 to 0.87. The intra-observer reliability was examined by the intraclass correlation coefficient for BILAG with a result of 0.48 (95% CI: 0.23–0.81) and using analysis of variance for SLAM-R (0.78), SLEDAI (0.33) and the LAI (0.81). The inter-observer feasibility was evaluated using the correlation coefficient for ECLAM (0.90–0.93), the SLAM (0.86) and MEX-SLEDAI (0.97–0.89). The construct validity was examined by means of convergence with other instruments, specifically with global assessment by the physician, with similar results between indices (0.48–0.75). Lastly, responsiveness was tested in all indices except LAI, SDI and LDIQ, with a standardized response mean ranging from 0.12 to 0.75. ConclusionsAlthough multiple instruments have been validated for use in SLE it was not possible to find direct evidence of which is the most appropriate. BILAG and SLEDAI, with moderate feasibility and low responsiveness, are the 2 indices with a most complete validation and more extensively used.

Further optimization of the reliability of the 28-joint disease activity score in patients with early rheumatoid arthritis.

BackgroundThe 28-joint Disease Activity Score (DAS28) combines scores on a 28-tender and swollen joint count (TJC28 and SJC28), a patient-reported measure for general health (GH), and an inflammatory marker (either the erythrocyte sedimentation rate [ESR] or the C-reactive protein [CRP]) into a composite measure of disease activity in rheumatoid arthritis (RA). This study examined the reliability of the DAS28 in patients with early RA using principles from generalizability theory and evaluated whether it could be increased by adjusting individual DAS28 component weights.MethodsPatients were drawn from the DREAM registry and classified into a “fast response” group (N = 466) and “slow response” group (N = 80), depending on their pace of reaching remission. Composite reliabilities of the DAS28-ESR and DAS28-CRP were determined with the individual components' reliability, weights, variances, error variances, correlations and covariances. Weight optimization was performed by minimizing the error variance of the index.ResultsComposite reliabilities of 0.85 and 0.86 were found for the DAS28-ESR and DAS28-CRP, respectively, and were approximately equal across patients groups. Component reliabilities, however, varied widely both within and between sub-groups, ranging from 0.614 for GH (“slow response” group) to 0.912 for ESR (“fast response” group). Weight optimization increased composite reliability even further. In the total and “fast response” groups, this was achieved mostly by decreasing the weight of the TJC28 and GH. In the “slow response” group, though, the weights of the TJC28 and SJC28 were increased, while those of the inflammatory markers and GH were substantially decreased.ConclusionsThe DAS28-ESR and the DAS28-CRP are reliable instruments for assessing disease activity in early RA and reliability can be increased even further by adjusting component weights. Given the low reliability and weightings of the general health component across subgroups it is recommended to explore alternative patient-reported outcome measures for inclusion in the DAS28.

AB0950 Concordance between Joint Symptoms and Ultrasonography Findings in Patients with Rheumatoid Arthritis

ObjectivesRecently ultrasonography (US) has been prevalent as a valid and objective modality of joint examination. As a result, accumulating findings of the association between joint US observations and physical examination...

SAT0146 Dissecting the Impact of Comorbidities on Disease Activity in Rheumatoid Arthritis: Ancillary Analysis from the COMORA Study

BackgroundSuppression of disease activity is the goal of the treatment of rheumatoid arthritis (RA). Therefore the use of validated composite measures of disease activity is needed in order to treat...