Physician Assessment Of Disease Activity Research Articles

FRI0504 Reliability and Validity of Patients Reported Outcomes in Poly/Dermatomyositis: A Pilot Study Using an Italian Version of Myositis Activity Profile (MAP) in A Monocentric Cohort of Patients

Backgroundthe evaluation of disease activity in patients with polymyositis (PM) and dermatomyositis (DM) still represents a challenge. International Myositis Assessment & Clinical Studies Group (IMACS) has performed a consensus on...

The Brigham Scalp Nail Inverse Palmoplantar Psoriasis Composite Index (B-SNIPI): a novel index to measure all non-plaque psoriasis subsets.

Psoriasis is a chronic inflammatory disease that encompasses a large spectrum of clinically distinct subtypes. Although chronic plaque psoriasis is reported as the most common form of psoriatic skin disease, there is growing evidence that other variants including scalp, nail, inverse, and palmoplantar psoriasis are prevalent, undertreated, and associated with significant impairment in quality of life. Currently, the Psoriasis Area and Severity Index (PASI) is the standard to assess psoriasis severity as well as response to treatment; however, the PASI has several limitations. In response to this need and as a complementary objective measure to the PASI, we created the Brigham Scalp Nail Inverse Palmoplantar Psoriasis Composite Index (B-SNIPI), based on patient-surveyed, patient-reported outcomes equally weighted with physician assessment of disease activity. Herein we summarize the B-SNIPI as presented at the 2013 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

A99: Symptom and Treatment Characteristics of Juvenile Primary Fibromyalgia Syndrome in the CARRA Registry: Are Males and Females Created Equal?

Background/Purpose:Children and adolescents with juvenile primary fibromyalgia syndrome (JPFS) often present to pediatric rheumatologists for evaluation. Limited data are available on the characteristics of and treatments used for JPFS, particularly in males.Methods:We evaluated deidentified data from baseline visits of JPFS patients entered in the Childhood Arthritis & Rheumatology Research Alliance (CARRA) registry between May 2010 and September 2013. Data regarding demographics, symptoms, functional measures and treatment are compared as a function of gender.Results:There were 172 patients (27 males), ages 8–21 years (Mean (M) = 15.4 +/− 2.3). Patients were symptomatic for a mean of 1.7 +/− 2.2 years prior to their first visit, with no significant difference between males and females (M = 2.2 vs. 1.6 respectively, t(169) = 1.19, p = .2). Widespread pain (89%), fatigue (83%), disordered sleep (77%), headaches (61%), and extremity numbness/tingling (32%) were the most commonly reported symptoms. Females had more numbness and tingling (35% vs. 13% respectively, χ2 = 4.4, p = 0.04). Table lists treatments used. Males were significantly more likely to have used gabapentin (26% vs. 8%, χ2 = 7.6, p <0.01). Of the 63 patients using non‐pharmacologic treatment, females were significantly more likely to have used massage and yoga. Over 50% of patients received education on JPFS, sleep hygiene, and general counseling. Graded aerobic activity and physical therapy were commonly prescribed. Less then 10% of patients tried opioids, serotonin norepinephrine reuptake inhibitors, craniosacral therapy, hypnosis, and biofeedback. Univariable analysis on APPLE data at baseline to 3 years Percent of Patients Treatment Females (N = 146) Males (N = 26) Pharmacological treatments tried (N = 115) Daily non‐steroidal anti‐inflammatory drugs 42% 50% Selective serotonin reuptake inhibitors 29% 15% Tri‐cyclic antidepressants 26% 25% Gabapentin 13% 35% Non‐pharmacological treatments tried (N=63) Physical therapy 60% 62% Dietary supplements 22% 46% Therapeutic massage 30% 8% Mindfulness/meditation 18% 23% Chiropractic 18% 8% Acupuncture/acupressure 16% 8% Yoga 12% 0% Significant gender difference, p<.05.Mean pain scores were moderate to severe (6.3 +/− 2.5/10) and were significantly positively related to Childhood Health Assessment Questionnaire (CHAQ) scores (r = .3, p <.01), patient ratings of impairment in health‐related quality of life (HRQOL) (r = .4, p < .01), and patient ratings of impairment in overall well‐being (r = .6, p < .01) both for males and females. Males were more disabled based on subjective (patient/parent report) functioning measures (HRQOL and CHAQ), although no differences were observed on physician report measures (physician global assessment and ACR functional class).Conclusion:Based on data from the largest known cohort of JPFS patients, there are few significant gender differences in physician assessment of disease activity. However, higher levels of disability reported by male patients suggest the need to consider gender when evaluating and treating JPFS patients. Possible explanations for the discrepancies in treatment include effects of gender on physician's perception of patient's pain leading to more medication use among males or females being more willing to try non‐pharmacologic modes of treatment. Future studies on gender and treatment outcomes are needed to improve care for these patients.

SAT0478 Assesment of the Validity of the Juvenile Arthritis Functionality Scale (JAFS) on Children with Juvenile Idiopathic Arthritis

BackgroundThe physical function is very important component in clinical evaluation of the activity of juvenile idiopathic arthritis (JIA). The most widely used questionnaire for functional assessment is the Childhood Health...

Effective Control of Recalcitrant Pruritus by Bevacizumab: A Possible Role for Vascular Endothelial Growth Factor in Chronic Itch?

Prurigo is a difficult to treat condition characterized by severe pruritus presenting with chronic secondary scratch lesions. We report here a dramatic improvement in pruritus in a patient with prurigo simplex who was being treated with bevacizumab, a monoclonal vascular endothelial growth factor (VEGF) antibody. On the basis of the increased VEGF expression measured in the skin of this patient, serum levels of VEGF were subsequently analysed in 27 consecutive patients with prurigo and 19 healthy controls. VEGF levels were significantly increased in the serum of patients with prurigo. Moreover, VEGF concentrations correlated with physician-assessed disease activity. Based on these observations, we speculate that VEGF is involved in the pathophysiology of prurigo.

Rheumatoid arthritis disease measurement: a new old idea

In many medical treatment areas, the use of treatment targets has led to improved outcomes, including a reduction in end-organ damage. In rheumatology, appropriate targets appear elusive, although preventing joint damage, minimizing disability and improving mortality are end results on which most clinicians would agree. Sophisticated measures of disease activity, particularly in early disease, have only recently been objectively evaluated. Swollen joint count, tender joint count, acute-phase reactants, citrullinated antibody titres (ACPAs), patient and physician assessment of disease activity, radiographs and other imaging modalities such as US and MRI may all be appropriate to measure. A number of composite measures have been proposed as possible or practical methods for defining RA disease activity. Some require testing of acute-phase reactants, but several do not. ACR20/50/70 scores are useful for measuring change from visit to visit, while others (DAS28, HAQ, Simplified Disease Activity Index, Clinical Disease Activity Index and Routine Assessment of Patient Index Data) assess disease activity at a single point. Disease measures have now been used in myriad clinical trials and studies. The FIN-RACo, TICORA, CAMERA and BeSt trials employed measures of disease activity at predetermined points to guide treatment decisions. These trials supported the consistent use of objective measures to derive significant benefits from treat-to-target strategies. The concept that objective measures can guide aggressive treatment to reach a defined optimal end point or target is a strategy that rheumatologists hopefully might now agree is critically important.

Novel automated system for magnetic resonance imaging quantification of the inflamed synovial membrane volume in patients with juvenile idiopathic arthritis

To introduce a novel automated method for the quantification of the inflamed synovial membrane volume (SV) using magnetic resonance imaging (MRI), and to investigate its feasibility and validity in patients with juvenile idiopathic arthritis (JIA). The tool was tested on 58 patients with JIA and wrist involvement. Thirty-six patients had a 1-year MRI followup. MRI of the clinically more affected wrist was performed using a 1.5T scanner and a Flex small coil. An algorithmic approach, based on supervised voxel classification for automatic estimation of SV in a 3-dimensional MRI, was developed. The SV was estimated as the number of positively classified voxels and then normalized by the patient's body surface (NSV). Validation procedures included the analysis of reliability, construct validity, responsiveness to change, discriminant validity, and the predictive value. The agreement between the automated estimation of NSV and the manual measurements was excellent (intraclass correlation coefficient 0.93, 95% confidence interval 0.79-0.98). The automatic NSV demonstrated good construct validity by yielding strong correlations with local signs of disease activity and a moderate correlation with global physician assessment of disease activity and with the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system synovitis score. NSV showed a strong responsiveness to clinical change (standardized response mean values >1) and satisfactory discriminant validity. High baseline NSV (>4.6) had high predictive value (100%) with respect to erosive progression. The proposed automated method allowed reliable quantification of NSV, which represents a promising imaging biomarker of disease activity in JIA. The automated system has the potential to improve the longitudinal assessment of JIA and to predict progressive joint destruction.

Validation of the Cutaneous Lupus Disease Area and Severity Index (CLASI) using physician- and patient-assessed health outcome measures

The Cutaneous Lupus Disease Area and Severity Index (CLASI) has not been validated using rheumatologist-conducted disease activity and damage assessments, especially cutaneous assessments. Active skin disease and skin damage may have substantial effects on patient-reported outcomes and on body image. We sought to validate the CLASI against: (1) physician-assessed disease activity and damage measures; and (2) patient-reported assessment of quality of life and body image. Cross-sectional data were collected from 31 patients with cutaneous lupus erythematosus. Cutaneous disease activity and damage were measured by using the CLASI. Disease activity (using the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus [SLE] Disease Activity Index [SLEDAI}), damage (Systemic Lupus International Collaboration Clinics-American College of Rheumatology Damage Index [SDI]), quality of life (LupusPRO), and body image (Body Image Quality of Life Inventory) were obtained. Descriptive statistics and Spearman correlations were ascertained. Mean (SD) age was 42.3 (12.8) years; 97% were women. The mean (SD) CLASI activity and damage scores were 10.5 (7.4) and 9.9 (9.5). Correlations noted were: total CLASI activity and SLEDAI-rash (r = 0.42, P = .02), CLASI-mucosal and SLEDAI-mucosal (r = 0.65, P = .001), CLASI-recent hair loss and SLEDAI-alopecia (r = 0.61, P = .001), and total CLASI activity and LupusPRO symptoms domain (r = -0.38, P = .04). Total CLASI-damage correlated with SDI-scarring/alopecia (r = 0.51, P = .004), SDI-extensive scarring/panniculum (r = 0.55, P = .003), and SDI-skin ulceration (r = 0.36, P = .05). CLASI scalp scarring correlated with SDI-skin scarring/alopecia (r = 0.94, P = .001). CLASI activity on the face and nose was associated with significant concerns on the Body Image Quality of Life Inventory. Limitations include small sample size. CLASI activity and damage scores correlate with physician-assessed cutaneous activity and damage in cutaneous lupus erythematosus in patients with SLE. Cutaneous activity in visible areas may generate body image concerns.

Comparative effectiveness and predictors of response to tumour necrosis factor inhibitor therapies in rheumatoid arthritis

Adalimumab, etanercept and infliximab are effective TNF inhibitors (TNFis) in the treatment of RA, but no randomized clinical trials have compared the three agents. Prior observational data are not consistent. We compared their effectiveness over 1 year in a prospective cohort. Analyses were performed on subjects' first episode of TNFi use in the Rheumatic Diseases Portuguese Register, Reuma.pt. The primary outcome was the proportion of patients with European League Against Rheumatism good response sustained at two consecutive observations separated by 3 months during the first year of TNFi use. Comparisons were performed using conventional adjusted logistic regression, as well as matching subjects across the three agents using a propensity score. In addition, baseline predictors of treatment response to TNFi were identified. The study cohort included 617 RA patients, 250 starting etanercept, 206 infliximab and 161 adalimumab. Good response was achieved by 59.6% for adalimumab, 59.2% for etanercept and 51.9% for infliximab (P = 0.21). The modelled probability of good response did not significantly differ across agents (etanercept vs adalimumab OR = 0.97, 95% CI 0.55, 1.71; etanercept vs infliximab OR = 1.25, 95% CI 0.74, 2.12; infliximab vs adalimumab OR = 0.80, 95% CI 0.47, 1.36). Matched propensity score analyses also showed no significant treatment response differences. Greater educational attainment was a predictor of better response, while smoking, presence of ACPA, glucocorticoid use and worse physician assessment of disease activity at baseline each predicted a reduced likelihood of treatment response. Over 1 year, we found no difference in effectiveness between adalimumab, etanercept and infliximab.

Disease Activity, Proteinuria, and Vitamin D Status in Children with Systemic Lupus Erythematosus and Juvenile Dermatomyositis

To evaluate relationships among vitamin D, proteinuria, and disease activity in pediatric systemic lupus erythematosus (SLE) and juvenile dermatomyositis (JDM). Multiple linear regression was used to associate subject-reported race, sunscreen use, and vitamin D intake with physician-assessed disease activity and serum 25-hydroxyvitamin D (25[OH]D) in 58 subjects with pediatric SLE (n=37) or JDM (n=21). Serum 25(OH)D was correlated with urinary vitamin D binding protein/creatinine ratio (DBP/C) and other indicators of proteinuria. Serum 25(OH)D levels in subjects with SLE were inversely associated with the natural log of urinary DBP/C (r=-0.63, P<.001) and urine protein to creatinine ratio (r=-0.60, P<.001), with an adjusted mean 10.9-ng/mL (95% CI, 5.1-16.8) decrease in 25(OH)D for those with proteinuria. Excluding subjects with proteinuria, serum 25(OH)D levels were inversely associated with disease activity in JDM, but not in SLE. Overall, 66% of all subjects were taking concurrent corticosteroids, but this was not associated with 25(OH)D levels. Low serum 25(OH)D in patients with SLE is associated with proteinuria and urinary DBP. Vitamin D deficiency is associated with disease activity in patients with JDM and SLE; this relationship in SLE may be confounded by proteinuria.

Physician assessment of disease activity in JIA subtypes. Analysis of data extracted from electronic medical records

ObjectiveAlthough electronic medical records (EMRs) have facilitated care for children with juvenile idiopathic arthritis (JIA), analyses of treatment outcomes have required paper based or manually re-entered data. We have started EMR discrete data entry for JIA patient visits, including joint examination and global assessment, by physician and patient. In this preliminary study, we extracted data from the EMR to Xenobase™ (TransMed Systems, Inc., Cupertino, CA), an application permitting cohort analyses of the relationship between global assessment to joint examination and subtype.MethodsDuring clinic visits, data were entered into discrete fields in ambulatory visit forms in the EMR (EpicCare™, Epic Systems, Verona, WI). Data were extracted using Clarity Reports, then de-identified and uploaded for analyses to Xenobase™. Parameters included joint examination, ILAR diagnostic classification, physician global assessment, patient global assessment, and patient pain score. Data for a single visit for each of 160 patients over a 2 month period, beginning March, 2010, were analyzed.ResultsIn systemic JIA patients, strong correlations for physician global assessment were found with pain score, joint count and patient assessment. In contrast, physician assessment for patients with persistent oligoarticular and rheumatoid factor negative patients showed strong correlation with joint counts, but only moderate correlation with pain scores and patient global assessment. Conversely, for enthesitis patients, physician assessment correlated strongly with pain scores, and moderately with joint count and patient global assessment. Rheumatoid factor positive patients, the smallest group studied, showed moderate correlation for all three measures. Patient global assessment for systemic patients showed strong correlations with pain scores and joint count, similar to data for physician assessment. For polyarticular and enthesitis patients, correlation of patient global assessment with pain scores was strong. Moderate correlations were found between patient global assessment and joint count in oligoarticular and polyarticular patients.ConclusionData extraction from the EMR is feasible and useful to evaluate JIA patients for indicators of treatment responsiveness. In this pilot study, we found correlates for physician global assessment of arthritis differed, according to disease subtype. Further data extraction and analyses will determine if these findings can be confirmed, and will assess other outcome measures, compare longitudinal responses to treatment, and export extracted data to multi-center databases.

Discordant assessment of lupus activity between patients and their physicians: the Singapore experience

Patients with systemic lupus erythematosus often assess their disease activity differently from their physicians. We studied the factors associated with this discordance. The data provided by 534 systemic lupus erythematosus patients were analyzed. We compared the physician and patient assessments of lupus activity on a visual-assessment scale from the same visit. We collected clinical data and scores from MOS 36-Item Short-Form Health Survey, Systemic Lupus Erythematosus Quality-of-Life Questionnaire, Rheumatology Attitudes Index, Systemic Lupus Erythematosus Disease Activity Index, and revised Systemic Lupus Activity Measure. Patients tended to score their disease activity higher than do their physicians, when these factors were present: poorer general health assessment, presence of thrombocytopenia, hypertension and urinary sediments, and difficulty in carrying groceries. Physicians tended to score the disease activity higher than do the patients in these circumstances proteinuria, hemolysis, use of azathioprine or cyclophosphamide, tiredness, photosensitivity, higher revised Systemic Lupus Activity Measure score, casturia, and patient report of being more easily ill than are other patients. There was only moderate correlation between the discordance in the baseline and the subsequent visits. The physician assessment of disease activity at baseline correlated better with an objective measure of disease activity (revised Systemic Lupus Activity Measure) in the subsequent visit than the patient assessment. In conclusion, discordance in the perception of disease activity between patients and physicians may be amenable to intervention.

Monitoring disease activity of rheumatoid arthritis in clinical practice: contributions from clinical trials

Rheumatoid arthritis is a heterogeneous and progressive autoimmune disease, and patients with this condition show varied responses to treatment. Practical, reliable, individually tailored measures of disease activity and treatment responses are needed. Outcome measures used in randomized, controlled trials, including American College of Rheumatology response criteria and Disease Activity Scores, identify when treatment should be initiated or changed, but can be time consuming and impractical in daily practice. Simplified disease activity indices, abbreviated joint counts and patient-report questionnaires are more-convenient ways to assess therapeutic responses in the clinic. Patient-reported measures of physical function, pain and global disease activity best differentiate the results of active treatment from those of placebo treatment in randomized, controlled trials. Improvements in physical function closely reflect changes in health-related quality of life. Recent trials have demonstrated limited correlations between clinical responses and radiographically demonstrated responses; both should be assessed on a regular basis. It is recommended that three domains be assessed in the clinic for therapeutic responses: patient-reported measures of physical function and/or global disease activity; physician assessment of disease activity; and imaging of the hands and/or feet on a biannual basis. Problematic joints and cervical spine involvement should be followed as clinically indicated. Measures of improvement for individually relevant physical activities need to be defined for each patient.

Analgesic and disease modifying effects of interferential current in psoriatic arthritis

Interferential current (IFC) was suggested to improve the skin manifestations of psoriasis vulgaris, possibly by enhancing the intracellular concentration of cyclic AMP. We assessed the efficacy of IFC on psoriatic arthritis (PsA). Nine consecutive patients were analyzed at baseline and after 16 weeks of IFC therapy. Bipolar IFC was applied twice daily to hands, feet plus all affected joints. IFC improved SF-36 assessed body pain, but not other SF-36 subscales. Morning stiffness, tender joint counts, and physician assessed disease activity improved. In contrast, visual analogue scale assessed pain, CRP and ESR measurements were unchanged. MRI of the most affected hand or foot documented a tendency towards worsened tendinitis, soft tissue swelling, and new joint space narrowing and erosions. Bone scintigraphy showed a trend towards deterioration. New joints became inflamed within treated sites. Thus IFC has analgesic effects in PsA, but does not have a satisfactory disease modifying effect.

Psychosocial contributors to mental and physical health in patients with systemic lupus erythematosus.

To delineate psychosocial and systemic lupus erythematosus (SLE)-related medical factors that contribute to the mental and physical health of SLE patients. In a cross-sectional study, 44 women completed standardized instruments assessing daily hassles, social support, psychologic distress, and quality of life and underwent a physician examination to assess disease activity and disease damage. Four multiple linear regression analyses were computed to identify factors associated with the following outcomes: patient-perceived psychologic distress and global physical health and physician-assessed disease activity and damage. Variables entered into the regression analyses were: hassles severity, types of social support, SLE disease activity and damage, age, disease duration, education, ethnicity, and global psychologic distress (for the outcomes of self-perceived global physical health and disease activity and damage). The best model explaining global psychologic distress included hassles severity and self-esteem social support. The best model explaining patients' perceptions of their global physical health included hassles severity and tangible social support. Psychologic distress accounted for a significant proportion of variance in both disease activity and damage. High stress (assessed by hassles severity), poor social support, and psychologic distress--potentially modifiable variables--are associated with the mental and physical health of SLE patients.

Disease severity in rheumatoid arthritis: relationships of plasma tumor necrosis factor-alpha, soluble interleukin 2-receptor, soluble CD4/CD8 ratio, neopterin, and fibrin D-dimer to traditional severity and functional measures.

Rheumatoid arthritis is a complex inflammatory disease of unknown cause. Although various laboratory and clinical measurements are useful in managing these patients, there is a need for better tests to quantitatively assess disease activity. The purpose of this study was to investigate the association of certain immune and inflammation (I-I) parameters with four traditional disease severity measures and a functional measure in rheumatoid arthritis patients. A single set of patient blood samples was analyzed, and four traditional disease severity measures and patient functional statuses were determined from 64 consecutive outpatients with rheumatoid arthritis. Plasma tumor necrosis factor-alpha (TNF), soluble interleukin-2 receptor (sIL-2R), sCD4 and sCD8 (and the sCD4/sCD8 ratio), neopterin, and fibrin D-dimer were analyzed in relationship to Westergren erythrocyte sedimentation rate (ESR), physician assessment of disease activity, joint pain count, grip strength, and Arthritis Impact Measurement Scale (AIMS) scores. Rheumatoid arthritis patients had higher mean levels of all I-I measures (except sCD4) compared to healthy subjects. Initial significant correlations between TNF, sIL-2R, and D-dimer and several disease severity and functional measures were detected. When we controlled for the covariates age, gender, race, and medications, regression analyses indicated that, as a group, the I-I measures were significantly related to grip strength, physician disease severity rating, ESR, and total joint pain. When the predictive values of the I-I measures were tested controlling for the covariates and ESR, D-dimer was independently and significantly associated with variability in grip strength, physician disease severity, and AIMS physical disability, while TNF was associated with a significant amount of variability in total joint pain.(ABSTRACT TRUNCATED AT 250 WORDS)

An Analysis of Crohn’s Disease Activity Indices from a Registry of Patients in Eastern Pennsylvania

The objectives of this report were to compare Crohn’s disease patients’ assessment of disease activity and its effect on their well-being to their physician’s assessment of the disease activity and the patient’s well-being; and to use existing Crohn’s disease indices in comparing the severity of Crohn’s disease across various indices. The indices included in this study were the National Cooperative Crohn’s Disease Study index, the Harvey and Bradshaw Index, the Oxford Index, the Modified Organisation Mondiale de Gastroentérologie Index, the Cape Town Index, the Bristol Index, and the St Marks Index. The comparison of Crohn’s disease patient self-evaluation and physician evaluation of the patient indicates a significant agreement between patient and physician assessment of disease activity (Χ241.68, P=0.00001). Cohen’s weighted kappa, a chance-corrected coefficient of agreement for nominal scales, was also used to evaluate the quality of agreement between physician and patient assessment of well-being. The weighted kappa (0.2322, P=0.0002) indicates a significant level of agreement.

Which traditional measures should be used in rheumatoid arthritis clinical trials?

It is standard practice to use multiple outcome measures in rheumatoid arthritis (RA) clinical trials. Because of this, multiple testing is usually done, and there is confusion in the interpretation of the results. It is not clear which measures are the most sensitive to detecting improvement and which provide independent information. To address these questions, we conducted an analysis of pooled raw data from 3 placebo-controlled RA trials: one of methotrexate, another of oral and injectable gold, and the third of low-dose and high-dose D-penicillamine. The results show that the joint tenderness count, erythrocyte sedimentation rate, grip strength, and physician assessment of disease activity perform best in RA clinical trials and cover the domain of change measured by traditional outcome measures. Other clinical measures may provide little additional useful information for a standard therapeutic trial of up to 6 months duration, and some measures, such as the proximal interphalangeal joint circumference, hemoglobin level, and 50-foot walking time, can be eliminated from such trials.