Disease Activity Outcome Measures Research Articles

Three Distinct Transcriptional Profiles of Monocytes Associate with Disease Activity in Scleroderma Patients.

Patients with diffuse cutaneous systemic sclerosis (dcSSc) display a complex clinical phenotype. Transcriptional profiling of whole blood or tissue from patients are affected by changes in cellular composition that drive gene expression and an inability to detect minority cell populations. We undertook this study to focus on the 2 main subtypes of circulating monocytes, classical monocytes (CMs) and nonclassical monocytes (NCMs) as a biomarker of SSc disease severity. SSc patients were recruited from the Prospective Registry for Early Systemic Sclerosis. Clinical data were collected, as well as peripheral blood for isolation of CMs and NCMs. Age-, sex-, and race-matched healthy volunteers were recruited as controls. Bulk macrophages were isolated from the skin in a separate cohort. All samples were assayed by RNA sequencing (RNA-seq). We used an unbiased approach to cluster patients into 3 groups (groups A-C) based on the transcriptional signatures of CMs relative to controls. Each group maintained their characteristic transcriptional signature in NCMs. Genes up-regulated in group C demonstrated the highest expression compared to the other groups in SSc skin macrophages, relative to controls. Patients from groups B and C exhibited worse lung function than group A, although there was no difference in SSc skin disease at baseline, relative to controls. We validated our approach by applying our group classifications to published bulk monocyte RNA-seq data from SSc patients, and we found that patients without skin disease were most likely to be classified as group A. We are the first to show that transcriptional signatures of CMs and NCMs can be used to unbiasedly stratify SSc patients and correlate with disease activity outcome measures.

The BILAG2004-Pregnancy Index is a valid disease activity outcome measure for pregnant SLE patients.

ObjectivesThis study was to determine whether the BILAG2004-Pregnancy Index (BILAG2004-P) has construct/criterion validity and is sensitive to change.MethodsThis was an observational multicentre study that recruited pregnant SLE patients. Data were collected on disease activity [using the BILAG2004-P and Physician Global Assessment (PGA)], investigations and therapy at each assessment. The overall BILAG2004-P score as determined by the highest score achieved by any system was used in the analysis. Cross-sectional analysis was used for construct and criterion validity. The comparison was with C3, C4 and anti-dsDNA for construct validity, while it was with change in therapy and PGA in criterion validity. Sensitivity to change was assessed by determining the relationship between the change in BILAG2004-P and the change in therapy between two consecutive visits.ResultsA total of 97 patients with 112 pregnancies were recruited. There were 610 assessments available for construct/criterion validity analysis (98.2% of pregnancies had more than one assessment) and 497 observations for sensitivity to change analysis. Increasing BILAG2004-P scores were associated with low C3. The active BILAG2004-P score (grade A or B) was associated with an increase in therapy and the PGA of active disease. There was an increasing likelihood of higher overall scores with an increase in therapy and the PGA of active disease. In the sensitivity to change analysis, an increase in the BILAG2004-P score was associated with an increase in therapy and inversely associated with a decrease in therapy. A decrease in the BILAG2004-P score was associated with a decrease in therapy and inversely associated with an increase in therapy.ConclusionThe BILAG2004-P has criterion validity and is sensitive to change.

Peroxisome proliferator activated receptor-γ agonist pioglitazone improves vascular and metabolic dysfunction in systemic lupus erythematosus

ObjectivesPremature cardiovascular events in systemic lupus erythematosus (SLE) contribute to morbidity and mortality, with no effective preventive strategies described to date. Immune dysregulation and metabolic disturbances appear to play prominent...

Disease activity outcome measures are only available in half of the electronic medical files of patients with axial spondyloarthritis followed in an outpatient clinic: the results of an audit of a tertiary-care rheumatology department.

Current recommendations for management of patients with axial spondyloarthritis (axSpA) include regular collection of validated disease activity outcomes. This study aimed at evaluating the proportion of patients for whom validated outcome measures were available on their electronic medical reports (EMR), and the factors associated with the presence of such information on the EMR. We performed a cross-sectional monocentric observational study, including patients with an axSpA diagnosis who attended an outpatient visit between February, 2018 and February, 2019. Patients (demographics, disease characteristics, treatment) and physician characteristics (age, gender) and the disease activity outcome measures (BASDAI, CRP and ASDAS, and the items allowing to calculate them) were retrieved from the EMR. The proportion of patients in which disease activity outcome measures were available in the EMR was calculated, and the association between the presence of such outcomes and patients and physician's characteristics was evaluated. 320 EMR of axSpA patients seen in the outpatient clinic were examined. Among them, 131 (41%) and 123 (38.4%) had a BASDAI + CRP and an ASDAS reported, respectively, but at least one was available in 178 (55.6%) of the EMR. The most frequently reported disease activity items were duration of morning stiffness (n = 230, 72%) and CRP (n = 224, 70%). Only previous participation on a systematic holistic review was independently associated with a reported disease activity outcome. Thus,implementation of recommendations with regard to regularly collecting disease activity outcome measures is not optimal. The participation in educational programs including self-assessment educational programs might be a key to improve such implementation.

Performance of 3 Composite Measures for Disease Activity in Peripheral Spondyloarthritis.

To investigate concurrent validity and discrimination of the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, Psoriatic Arthritis Disease Activity Score (PASDAS), and Ankylosing Spondylitis Disease Activity Score (ASDAS) in peripheral spondyloarthritis (pSpA) in clinical practice. Data from a Dutch registry for SpA (SpA-Net) were used. Predefined hypotheses on concurrent validity of the composite measures with 15 other outcome measures of disease activity, physical function, and health-related quality of life were tested. Concurrent validity was considered acceptable if ≥ 75% of the hypotheses were confirmed. Discrimination was assessed by stratifying patients in DAPSA, PASDAS, and ASDAS predefined disease activity states and studying mean differences in health outcomes by 1-way ANOVA. Further, the concordance in disease activity states was determined. All analyses were repeated in subgroups with and without psoriasis (PsO). DAPSA, PASDAS, and ASDAS scores were available for 191, 139, and 279 patients with pSpA, respectively. The concurrent validity and discrimination of all composite measures were acceptable, as the strength of correlations were as hypothesized in ≥ 75% of the studied correlations. With increasing disease activity states, scores in nearly all outcome measures worsened significantly. The DAPSA, PASDAS, and ASDAS classified 22%, 56%, and 48% of the patients, respectively, in the 2 highest disease activity states. Stratified analyses for concomitant PsO revealed no relevant subgroup differences. The performance of DAPSA, PASDAS, and ASDAS in pSpA was acceptable, and independent of concomitant PsO. Due to discrepancy in classification, the validity of existing thresholds for disease activity states warrants further study in pSpA.

The erratic C-reactive protein: a novel outcome measure for longitudinal disease activity in rheumatoid arthritis.

There is a relationship between both the magnitude and variability of C-reactive protein (CRP) levels and disease activity level in rheumatoid arthritis (RA). It seems that CRP levels remain low and stable in clinical remission then increase and become erratic in active disease. The purpose of this research was to determine if there is a difference in the variability of CRP levels over time in patients in clinical remission versus those with active disease. Patients with a diagnosis of RA with a minimum of 3 CRP readings in the previous 12-month period were included at a single site. At each visit the patient was evaluated by an experienced rheumatologist to determine current disease activity - remission versus active disease. The primary outcome measure was the difference between the coefficient of variation of the CRP (CRP-COV) in patients in remission versus those with active disease. 272 patients were enrolled into the study. The mean CRP and CRP-COV was significantly smaller for patients in clinical remission versus active disease, for patients in CDAI remission (<2.6), and for those who did not require a change in treatment. Smokers, on average, had higher mean CRP readings regardless of clinical status. We have identified a new clinical outcome measure of disease activity in RA that captures longitudinal variability in disease activity and identifies those patients with clinically active disease despite a "normal" CRP level due to the higher variability of CRP if not in remission.

Developing outcome measures of disease activity in pediatric myasthenia

Pediatric myasthenia encompasses juvenile myasthenia gravis (JMG) and congenital myasthenic syndrome (CMS), which are chronic disorders with fluctuating symptoms amenable to medical therapy. Disease activity and treatment response may be difficult to assess, but, unlike adults, outcome measures have not been developed in children. The study was performed in children (0-18 years of age) at the neuromuscular center of a pediatric hospital over a 3-year period. Patients were recruited prospectively as part of their routine clinical care. Demographic data, diagnosis (JMG/CMS), and the following scales were recorded at each visit: Myasthenia Gravis Foundation of America (MGFA) class, Myasthenia Gravis Composite (MGC), and Pediatric Myasthenia-Quality of Life 15 (PM-QOL15). Thirty-three patients (24 JMG, 9 CMS) were included in the study, 22 had two or more visits. We established known-groups validity of the MGC and PM-QOL15 scores as compared with the MGFA class. To establish concurrent validity, we constructed a receiver-operating characteristic curve and calculated threshold values of MGC and PM-QOL15 with optimal sensitivity and specificity for identifying a patient with more severe (MGFA III or higher) disease. Finally, we demonstrated the concordance between the MGC and PM-QOL15 by their statistically significant positive Pearson and Spearman correlations. Our study suggests that MGC and PM-QOL15 are important disease outcome measures in pediatric myasthenia that are easy to administer and provide reliable assessment of disease activity in the clinic setting. Further studies are needed to validate their use for pediatric clinical research trials.

THU0165 PROSARA - A PROSPECTIVE, MULTICENTER, NON-INTERVENTIONAL STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF SARILUMAB FOR THE TREATMENT OF ACTIVE RHEUMATOID ARTHRITIS IN REGULAR CARE IN GERMANY

Background: Blockade of IL-6 signaling by sarilumab has been demonstrated to be an effective treatment approach for rheumatoid arthritis. Due to strict inclusion and exclusion criteria, randomized controlled trials may not represent the heterogeneous RA patient population encountered in regular care. Objectives: The current study investigated the safety and effectiveness of sarilumab in the treatment of RA in regular care in Germany. Methods: The prospective, observational, single-arm 24-months PROSARA study (SARILL08661) is currently running in Germany at 79 sites, aiming to include up to 750 RA patients treated with sarilumab. RA patients are selected at physician discretion and treated according to the label. Study objectives include the documentation of safety and various effectiveness outcomes. This interim analysis included patients with data available up to 12 weeks. All analyses are descriptive only. Results: To date 348 patients were included in the study; of which 265 patients had post-baseline data. The mean age of the patients analyzed was 58.6 years (24-83); 76.3% are female. The mean disease duration was 10.3 years; comorbidities were present in 80.7% of patients. At baseline, 32.5% were biologic naive. Most common pretreatment with b/ts DMARDs included TNF-inhibitors (TNFi, 56.2%), non-TNFi biologics (29.1%) or JAK-inhibitors (JAKi, 17.4%). At baseline, 49% received sarilumab as monotherapy and 29% in combination with conventional DMARDs (not specified for 22%). After 12 weeks of treatment with sarilumab, the mean DAS28-ESR decreased from 5.0±1.46 to 3.0±1.44 and CDAI from 26.7±13.79 to 13.6±11.4, respectively. DAS28-ESR remission/ low disease activity was achieved in 42.8% [n=77/180 patients with valid data on this parameter]/ 59.4% [n=107/180] of patients; 13.6% [n=28/206] and 49% [n=101/206] of patients reached CDAI remission and low disease activity. Boolean remission was observed in 9.5% [n=19/201] of patients at week 12. HAQ-DI improved from 1.3 at baseline to 1.1 at week 12 (n=195). The mean CDAI improvement was similar for autoantibody-positive (RF and/or ACPA; CDAI -12.5 at week 12) compared to -negative patients (CDAI -15.4 at week 12). Patients switching from JAKi to sarilumab (n=32), were more severely affected, had longer disease duration and received more prior treatments than patients switched from another compound. Of note, similar efficacy was observed among patients that switched from JAKi to sarilumab vs patients switched from other DMARDs; disease activity outcome measures including DAS28, CDAI, TJC, SJC and global assessments improved consistently (Figure 1). Safety was consistent with the anticipated profile of IL-6-R-inhibition and no new safety signals occurred. Adverse events and serious adverse events were described in 33.9% and 6.3% of patients, respectively. Conclusion: Sarilumab administered in regular care demonstrated rapid and clinically meaningful improvement in a general RA patient population including patients switching from JAKi. The safety profile was consistent with data reported from controlled clinical trials. Disclosure of Interests: Eugen Feist Consultant of: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi, Speakers bureau: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi, Peer-Malte Aries Consultant of: Sanofi, Speakers bureau: Sanofi, Silke Zinke: None declared, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Inka Albrecht Employee of: Sanofi, Oliver Bley Employee of: Sanofi, Michael Obermeier: None declared, Patrizia Sternad: None declared, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Cornelia Kuhne Grant/research support from: Novartis, Amgen, Roche/Chugai, Pfizer, Celgene, AbbVie, Sanofi, Ann-Dorthe Holst: None declared, Niklas Thomas Baerlecken: None declared, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

AB0785 REAL LIFE EXPERIENCE OF METHOTREXATE BASED DUAL COMBINATION DMARDS IN PSORIATIC ARTHRITIS- RESULTS FROM KARNATAKA PSORIATIC ARTHRITIS COHORT (KPsAC)

Background:Biologics have been the focus of recent treatment guidelines and ‘Treat to Target’ strategies for both psoriasis (PsO) &amp; psoriatic Arthritis (PsA). However, in day-today practice, combination DMARDs anchored around methotrexate are mainstay in majority of patients.Objectives:To describe experience and effectiveness of Methotrexate in combination with conventional DMARDs in Karnataka Psoriatic Arthritis Cohort.Methods:Treatment information was extracted from KPsAC (n=549) which is a cross sectional, non-interventional study conducted across 17 rheumatology practicing centres in Karnataka, India using a structured proforma. This study was approved by respective Ethical committee. Information on efficacy was extracted for various csDMARDs in combination with methotrexate. Standard disease activity outcome measures were used for assessing the response to therapy (DAPSA, PASI, HAQ, MDA5). All participating rheumatologists underwent training to calculate PASI and other outcome scores.Results:Nearly half of the patients in our cohort were on methotrexate (44%) monotherapy. Proportion of patients who received combination csDMARD anchored on methotrexate were 29%. The choice of add on csDMARD was as per clinician discretion or subject preference. Patients were divided in to three groups based on treatments they were receiving at the time of study: Methotrexate (Mtx)+Leflunomide (Lef), Mtx+Sulfasalazine (SSz) and Mtx+Apremilast(Apr). Their characteristics along with outcome measures are depicted in table 1. In Mtx+Apr group: remission or low disease activity was present in 42%, HAQ score of &lt;0.5 was seen in 82%, and only one patient had a PASI of &gt; 10. PASI was significantly lower in the Mtx+Apr group compared to Mtx+Lef group (p&lt;0.009) and Mtx +Ssz group (p &lt; 0.020)Conclusion:Apremilast is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4)**. In this observational study, 3 groups of methotrexate plus csDMARD- leflunomide, sulphasalazine and apremilast fared similarly for articular domain of PsA. However, in cutaneous domain, PASI was significantly lower in apremilast + methotrexate group. To our knowledge, this is the first real life report of the use of combination DMARDs in unselected PsA patients demonstrating effectiveness of apremilast in cutaneous domain. Methotrexate remains anchor DMARD for treatment of PsA in 2/3rdof PsA patients. Addition of apremilast to methotrexate inadequate responders appears to be beneficial in PsA with persistent cutaneous disease. However, being an observational study, this needs to be confirmed in controlled clinical trials.

P104 Longitudinal patient reported outcome data collected from a smartphone app can map group level trajectories of disease activity over time

Abstract Background Patient-reported outcome measures are a cornerstone of the current early inflammatory arthritis audit and part of the best practice tariff. However, outcome data are collected infrequently meaning longitudinal changes in disease activity cannot be accurately examined. We report results of a twelve-month clinical pilot of a cloud-enabled commercial smartphone app to record patient self-reported disease activity outcome measures to evaluate trends of disease activity in a routine rheumatology setting. Methods Patients with a clinical diagnosis of inflammatory arthritis attending routine rheumatology clinic were offered the opportunity to use a smartphone app to record their disease activity between hospital appointments using the RAPID3. Data from the first twelve months (July 2018 - July 2019) was extracted and latent class modelling using aggregate data was undertaken to explore the trends of disease activity experienced by our patients at a group level. Standard analysis recommendations were followed. Results Over the course of twelve-months, 58 patients used the app to record their disease activity using the RAPID3. These patients had a mean age of 53 and were 76% female. 35 patients had rheumatoid arthritis, 15 patients had psoriatic arthritis and 8 had another inflammatory arthritis. The median number of RAPID3 scores completed per patient was 8 (interquartile range 14), and a total of 706 RAPID3 scores were submitted over the 12 months. Three different trajectories of disease activity were identified among our cohort of patients. The first trajectory showed a low stable plateau of disease activity for six months before further improvement (27 patients:47%) over six months. The second trajectory (23 patients; 40%) showed an initial moderate disease activity which gradually declined over six months before improving markedly in the last three months, returning to moderate disease activity. The final trajectory (8 patients; 14%) identified patients with the highest disease activity which showed a gradual but slow improvement of disease activity over twelve months. These different trajectories show the changing burden of inflammatory arthritis over time. Conclusion Regular longitudinal data collection of patient-reported outcomes via a smartphone app can be used to show distinct group level trajectories of disease activity and could be used to examine changes in outcomes of patients over time. Data such as these could be used at a departmental level to examine the burden of inflammatory arthritis experienced by patients, assist planning future service requirements, and help anticipate the timings of future appointments more accurately for patients. Disclosures P.D.H. Hamann Consultancies; Living With Ltd. Royalties; PH has provided consultancy for and has an options and limited royalty agreement with, Living With Ltd. software company for the development of the smartphone application described in this abstract. N. Minaur None. J.H. Tobias None. E.M. Clark None.

Idiopathic Inflammatory Myopathies.

Major advances have been made in the field of idiopathic inflammatory myopathies (IIM), or myositis, that are likely to facilitate development of new therapeutic strategies that have not yet been applied in this group of diseases. These advances include new classification criteria to better identify the patients with IIM, detection of several new myositis-specific autoantibodies that facilitates subgrouping of patients into more specific clinical phenotypes, development of outcome measures for disease activity, and new response criteria. We have learned from clinical studies that exercise is an important part of treatment and that pharmacologic treatment should be combined with exercise.

Outcome measures of disease activity for rare autoimmune rheumatic diseases.

Systemic lupus erythematosus, scleroderma, myositis and Sjögren's syndrome are rare, complex, multi-systemic rheumatic diseases associated with significant morbidity and mortality. Thorough assessments of disease activity are required to guide clinical management and assess response to new therapies in clinical trials. This article reviews the commonly used outcome measures to assess this group of diseases and discusses the limitations of their use.

Outcome measures of disease activity in inflammatory arthritis.

The most common types of chronic inflammatory arthritis are rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. In order to assess the activity of these diseases and tailor therapy, several outcome measures have been developed. They include composite scores based on clinical findings, biochemical markers and patient questionnaires. This article discusses the most commonly used outcome measures and looks at their limitations in quantifying the complex clinical features of different types of inflammatory arthritis, focusing in particular on rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Identifying Relapses in Multiple Sclerosis Patients through Administrative Data: A Validation Study in the Lazio Region, Italy

Background: Relapse is frequently considered an outcome measure of disease activity in relapsing-remitting multiple sclerosis (MS). The objectives of this study were to identify relapse episodes in patients with MS in the Lazio region using health administrative databases and to evaluate the validity of the algorithm using patients enrolled at MS treatment centers. Methods: MS cases were identified in the period between January 1, 2006 and December 31, 2009 using data from regional Health Information Systems (HIS). An algorithm based on HIS was used to identify relapse episodes, and patients recruited at MS centers were used to validate the algorithm. Positive and negative predictive values (PPV, NPV) and the Cohen's kappa coefficient were calculated. Results: The overall MS population identified through HIS consisted of 6,094 patients, of whom 67.1% were female and the mean age was 41.5. Among the MS patients identified by the algorithm, 2,242 attended the centers and 3,852 did not. The PPV was 58.9%, the NPV was 76.3%, and the kappa was 0.36. Conclusions: The proposed algorithm based on health administrative databases does not seem to be able to reliably detect relapses; however, it may be a helpful tool to detect healthcare utilization, and therefore to identify the worsening condition of a patient's health.

Beneficial effect of n-3 polyunsaturated fatty acids on inflammation and analgesic use in psoriatic arthritis: a randomized, double blind, placebo-controlled trial

Objective: This study aimed to investigate the effects of marine n-3 polyunsaturated fatty acids (PUFAs) on disease activity, use of analgesics, and inflammatory biomarkers in patients with psoriatic arthritis (PsA).Method: Patients with established PsA (n = 145) were investigated in a randomized, double-blind, placebo-controlled study. The participants received a supplement of 3 g n-3 PUFA/day or 3 g olive oil/day (control) for 24 weeks. Outcome measures for disease activity, use of analgesics, and leukotriene formation from activated granulocytes were assessed at baseline and at study end.Results: In total, 145 patients were included and 133 completed the study. After 24 weeks, the n-3 PUFA group showed a decrease in Disease Activity Score (DAS28-CRP), 68 tender joint count, enthesitis score, and psoriasis area and severity index, although not significantly different from the controls. There was a significant reduction in non-steroidal anti-inflammatory drug (NSAID) and paracetamol use compared with controls (p = 0.04). In addition, the participants in the n-3 PUFA group had significantly lower formation of leukotriene B4 (p = 0.004) from stimulated granulocytes and significantly higher formation of leukotriene B5 (p < 0.001) compared with controls.Conclusion: The n-3 PUFA-supplemented group showed improvement in outcome measures for disease activity, although the difference between the groups was not statistically significant. However, use of NSAIDs and paracetamol was significantly reduced in the n-3 PUFA group compared to the control group. Finally, there was a significant decrease in leukotriene B4 formation in the n-3 PUFA group compared with controls.

Selected aspects of the current management of myositis.

The idiopathic inflammatory myopathies (IIM) are a rare and heterogeneous group of acquired autoimmune muscle disorders, often referred to as 'myositis'. Clinical assessment, together with muscle biopsy findings and autoantibody status are key factors to consider when making a diagnosis of IIM, and in stratification of the 'IIM spectrum' into disease subgroups. Treatment stratified according to serotype (and in the future, likely also genotype) is increasingly being used to take account of the heterogeneity within the IIM spectrum. Subgroup classification is also important in terms of monitoring for complications, such as malignancy and interstitial lung disease. Disease monitoring should include the use of standardized tools such as the IMACS disease activity outcome measures. Other tools such as muscle MRI can be useful in identifying areas of active muscle inflammation. Treatment outcomes in IIM remain unsatisfactory. The evidence base to guide treatment decisions is remarkably limited. In addition to muscle inflammation, a number of noninflammatory cell-mediated mechanisms may contribute to weakness and disability, and for which no specific treatments are currently available.

Year in review: imaging

Purpose: Imaging biomarker of disease activity, treatment response and prognostic value continues to plays a crucial role within the field of osteoarthritic (OA) research. An overview of major publication available on www.pubmed.com from April 2015 to March 2016 within the OA field using imaging as outcome measures of disease activity will be presented with emphasis on longitudinal trials, correlation to histology and predictive value of imaging for the clinical course of osteoarthritis.

Outcome Measures in Psoriatic Arthritis.

In the last decade, there have been significant advances in outcome measure research in psoriatic arthritis (PsA). In this article, the outcome measures for disease activity in individual key domains of PsA are reviewed, followed by the key patient-reported outcome measures of function, quality of life, fatigue, and a new measure for disease impact, the psoriatic arthritis impact of disease. New research into composite measures of psoriatic disease is summarized, including response measures and proposed cutoff points for disease activity. Finally, the key future issues in outcome measurement in PsA are addressed.

Peripheral blood cytokine and chemokine profiles in juvenile localized scleroderma: T-helper cell-associated cytokine profiles

ObjectiveTo evaluate peripheral blood T-helper (TH) cell-associated cytokine and chemokine profiles in localized scleroderma (LS), and correlate them with clinical disease features, including disease activity parameters. MethodsA 29-plex Luminex platform was used to analyze the humoral profile of plasma samples from 69 pediatric LS patients and 71 healthy pediatric controls. Cytokine/chemokine levels were compared between these two groups and within LS patients, focusing on validated clinical outcome measures of disease activity and damage in LS. ResultsPlasma levels of IP-10, MCP-1, IL-17a, IL-12p70, GM-CSF, PDGF-bb, IFN-α2, and IFN-γ were significantly higher in LS subjects compared to healthy controls. Analysis within the LS group demonstrated IP-10, TNF-α, and GM-CSF correlated with clinical measures of disease activity. Several cytokines/chemokines correlated with anti-histone antibody, while only a few correlated with positive ANA and single-stranded DNA antibody. ConclusionThis is the first time that multiple cytokines and chemokines have been examined simultaneously in LS. In general, a TH1 (IFN-γ) and TH17 (IL-17a) predominance was demonstrated in LS compared to healthy controls. There is also an IFN-γ signature with elevated IP-10, MCP-1, and IFN-γ, which has been previously demonstrated in systemic sclerosis, suggesting a shared pathophysiology. Within the LS patients, those with active disease demonstrated IP-10, TNF-α, and GM-CSF, which may potentially serve as biomarkers of disease activity in the clinical setting.

SAT0212 Can We Use Enthesis Ultrasound as an Outcome Measure of Disease Activity in Spondyloarthritis? A Study at Achilles Level

BackgroundSpondyloarthritis (SpA) is a group of disorders that are characterized by inflammatory involvement of the enthesis and the adjacent bone. Enthesitis is regarded as the primary lesion and is observed...