Patient-reported Disease Activity Research Articles

AB1453-HPR Investigation of clinical pilates exercises on disease activity, functional status and mobility in female patients with ankylosing spodylitis

BackgroundThe benefical effects of exercise on symptom severity or spinal mobility has been shown in many studies about Ankylosing Spondylitis (AS). But the studies including the effects of clinical pilates...

SAT0551 What is the Real World Relationship between Patient-Reported Pain or Patient Global Assessment and Disease Activity Indices in Rheumatoid Arthritis? An Analysis from the Prospective, Observational Registry, Biotrac

BackgroundPatient-reported outcomes such as pain and patient global assessment of disease activity (PtGA) have been critiqued for not accurately assessing RA disease activity as they may reflect aspects not directly...

OP0082 Short term effect of 2-weeks rehabilitation on disease activity and health status in patients with ankylosing spondylitis

BackgroundApart from pharmacological treatment (NSAIDs and anti-TNF-α treatment), exercise and physiotherapy are cornerstones in the management of ankylosing spondylitis (AS) (1).ObjectivesTo evaluate the effect of a 2-weeks rehabilitation program on...

AB0647 Arthritis in systemic lupus erythematosus: A patient’s perspective

BackgroundJoint involvement in systemic lupus erythematosus (SLE) is common and occurs in over 80% of patients. Even if traditionally considered mild and non erosive, joint involvement may cause chronic pain,...

Pain and depression predict self-reported fatigue/energy in lupus

This study examined the contribution of pain and psychological distress to fatigue. One-hundred and twenty-five adult Caucasian and Hispanic lupus patients participated in this study. Demographic data, patient- and physician-reported disease activity, as well as psychological functioning, were collected. Fatigue, pain, and vitality were measured using visual analogue scales as well as a subscale of the SF-36 questionnaire. Linear and hierarchical regression analyses were conducted. In the regression analysis, ethnicity was entered at the first step, followed by age, income and education at step 2, pain and disease activity measures at step 3, and psychological measurements at step 4. In the linear regression analysis, Caucasians reported more fatigue. Fatigue positively correlated with income, education, pain, patient-reported disease activity, helplessness, and depression, and negatively with internality, and the energy analysis mirrored the results of the fatigue analysis. In the first regression analysis, fatigue was the dependent variable. At step 1, Caucasians reported more fatigue. At step 2, no other demographic variables were significant. At step 3, pain and disease activity measures were significant when entered as a block; however, pain independently explained a large amount of variance. At step 4, psychological factors were significant as a block, with depression being the strongest predictor. In the second analysis, energy was the dependent variable. At step 1, Hispanics reported more energy. At step 2, demographic variables were not significant. At step 3, pain and disease activity were significant when entered as a block; however, only pain uniquely predicted energy. At step 4, psychological factors were significant as a block, with depression as the major contributor. Both pain and depression were found to be strong predictors of fatigue, and negatively correlated with energy. Disease activity did not appear to play a significant role in lupus fatigue. These findings support the importance of managing depression and pain in order to reduce fatigue in patients with systemic lupus erythematosus.

Evaluation of spondylarthritis activity by patients and physicians: ASDAS, BASDAI, PASS, and flares in 200 patients

ObjectivesIn patients with spondyloarthritis, to determine Ankylosing Spondylitis Disease Activity Score (ASDAS) cutoffs matching the patient-acceptable symptom state (PASS) and patient-reported levels of disease activity, to assess associations between disease activity levels and presence of depression, and to identify ASDAS and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) cutoffs indicating a flare and indicating a remission. MethodsProspective single-center study of patients meeting ASAS criteria for spondyloarthritis receiving follow-up at the Besançon teaching hospital, France, between February 2011 and February 2012. In each patient, the BASDAI, ASDAS, Bath Ankylosing Spondylitis Functional Index (BASFI), patient-acceptable symptom state (PASS) and signs of depression were assessed. Receiver-operating characteristic (ROC) curves were drawn to identify the ASDAS cutoffs separating different levels of disease activity. The kappa coefficient was computed to evaluate agreement between patients and physicians regarding the presence of flares. ResultsTwo hundred patients with a mean age of 44.4±12.5years and mean disease duration of 12.9±10.5years were included. Mean BASDAI was 4.1±2.2, mean ASDAS-C-reactive protein (CRP) was 2.4±1, mean BASFI was 3.3±2.7, and 58.9% of patients reported being in the PASS. The PASS was associated with BASDAI values inferior or equal to 4.1 and ASDAS-CRP values inferior or equal to 2.3. Mild patient-reported disease activity was associated with BASDAI values inferior or equal to 3.8 and ASDAS-CRP values inferior or equal to 2.3; corresponding values for high patient-reported disease activity were superior to 5.2 and superior to 3.1. Among patients reporting high disease activity, 64.5% had Beck Depression Inventory scores consistent with severe depression. At the time of the visit, 36.9% of the patients and 28.3% of the physicians felt there was a flare. Cutoffs indicating a flare were superior or equal to 5.2 for the BASDAI and superior or equal to 2.3 for the ASDAS-CRP. Agreement between patients and physicians regarding flares was good (Kappa, 0.61). An evaluation in 43 patients indicated that an ASDAS-CRP cutoff inferior or equal to 2.2 separated the 25.6% of patients who reported being in remission from the other patients. ConclusionOur results show a significant association between disease activity and depression severity, as well as good agreement between BASDAI and ASDAS. The ASDAS cutoffs for the various levels of patient-reported disease activity differed from the cutoffs suggested by ASAS; a 2.3 cutoff was found for both patient-reported absence of disease activity and PASS, indicating that achieving PASS should be included among our treatment objectives.

Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis–associated uveitis: A consensus effort from the multinational interdisciplinary working group for uveitis in childhood

To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis. The literature relating to outcome measures used in studies of uveitis in childhood and adolescence was reviewed. A set of core outcomes and domains was established using the Delphi process. This was reviewed by a representative multinational interdisciplinary working group. Nominal group technique consensus was reached on face and content validity of the range and content of the domains. The outcomes and the appropriate instruments for uveitis trials were adapted to the age ranges of patients with JIA-associated uveitis. Consensus was reached that data should be reported at defined time points in longitudinal studies with patients stratified by prognostic markers. Visual acuity testing should be age appropriate. The severity of uveitis (measured as anterior chamber cell grade) and duration of active inflammation should be documented. Visually significant structural complications should be recorded and quantified with standard measures. The responses to treatment and corticosteroid-sparing effects of treatment should be documented. Patient-reported disease activity and age-specific uveitis-related quality of life should be reported using appropriate questionnaires. The proposed outcome measures in JIA-associated uveitis should aid in the standardization and comparison of future RCTs of the treatment regimens for this disease. The proposed outcome measures will be verified in a prospective validation study.

A Multidimensional Model of Fatigue in Patients with Rheumatoid Arthritis

To evaluate a multidimensional model testing disease activity, mood disturbance, and poor sleep quality as determinants of fatigue in patients with rheumatoid arthritis (RA). The data of 106 participants were drawn from baseline of a randomized comparative efficacy trial of psychosocial interventions for RA. Sets of reliable and valid measures were used to represent model constructs. Structural equation modeling was used to test the direct effects of disease activity, mood disturbance, and poor sleep quality on fatigue, as well as the indirect effects of disease activity as mediated by mood disturbance and poor sleep quality. The final model fit the data well, and the specified predictors explained 62% of the variance in fatigue. Higher levels of disease activity, mood disturbance, and poor sleep quality had direct effects on fatigue. Disease activity was indirectly related to fatigue through its effects on mood disturbance, which in turn was related to poor sleep quality. Mood disturbance also indirectly influenced fatigue through poor sleep quality. Our findings confirmed the importance of a multidimensional framework in evaluating the contribution of disease activity, mood disturbance, and sleep quality to fatigue in RA using a structural equation approach. Mood disturbance and poor sleep quality played major roles in explaining fatigue along with patient-reported disease activity.

Development and validation of a short form of the valued life activities disability questionnaire for rheumatoid arthritis

To develop and validate a shortened version of the Valued Life Activities disability and accommodations scale (VLA) for individuals with rheumatoid arthritis (RA). To shorten the existing VLA measure, item response theory analyses were conducted using data from 449 patients with RA. Next, the resulting 14-item shortened version of the VLA scale (S-VLA) was evaluated by structured interviews among 20 RA patients. Lastly, the S-VLA was administered to 150 RA patients along with other measures, including the Health Assessment Questionnaire (HAQ) and Short Form 36 (SF-36). A random sample of 50 patients completed the S-VLA 2 weeks later to assess reliability. Item statistics were calculated to evaluate correlations between individual items and the S-VLA total score. Correlations between the S-VLA and other measures were used to evaluate validity. Test-retest reliability was 0.91, while Cronbach's alpha for the S-VLA was 0.95. None of the 14 items was associated with improved alpha coefficients when omitted. All of the items were strongly correlated with the S-VLA total score. S-VLA scores were highly positively correlated with the HAQ (r = 0.81, P ≤ 0.001), patient-reported disease activity (r = 0.71, P ≤ 0.001), satisfaction with abilities (r = 0.82, P ≤ 0.001), and number of days with activity limitations (r = 0.65, P ≤ 0.001). In addition, as hypothesized, the S-VLA was inversely correlated with the SF-36 physical component summary score (r = -0.78, P ≤ 0.001) and the physical functioning (r = -0.80, P ≤ 0.001), role physical (r = -0.67, P ≤ 0.001), and social functioning (r = -0.72, P ≤ 0.001) subscales. The S-VLA is a short, valid, and reliable instrument that may prove useful for monitoring disability among individuals with RA.

The Patient Reported Outcomes in Lupus (PATROL) study: role of depression in health-related quality of life in a Southern California lupus cohort

This study examines the relationship between psychosocial factors, ethnicity, disease activity and quality of life in systemic lupus erythematosus. One hundred and twenty-five adult Caucasian and Hispanic lupus patients were recruited from four Southern California medical centers. Linear regression analysis was performed to assess the correlation of ethnicity, socioeconomic factors (age, income), and disease activity (patient and physician reported), as well as psychological (depression, internality, helplessness) variables with quality of life (QOL) as measured by the Short Form (SF)-36. Hierarchical multiple regression analysis was then used to determine the stepwise contribution of the above determinants on the eight domains of the SF-36 questionnaire. Depression negatively correlated with QOL in both Caucasians (r -0.488 to -0.660) and Hispanics (r -0.456 to -0.723). Patient-reported disease activity was moderately related (r -0.456 to -0.698) to seven of the eight SF-36 domains in Hispanics, and none in Caucasians. Physician-reported disease activity, measured by SLEDAI, did not correlate with QOL among Hispanics or Caucasians. When linear and hierarchical regression was used, depression significantly correlated (p < 0.0001) with the majority of the SF-36 domains, except general health, while age had a significant effect in only one domain of the SF-36, physical functioning (p < 0.0001). Depression, and not disease activity, appears to have a major influence on quality of life in both Hispanic and Caucasian patients in this lupus cohort.

P061 - Reduction in extraintestinal manifestations of Crohn's disease is associated with improvements in patient-reported and disease activity outcomes in patients treated with adalimumab

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S35 P061 Reduction in extraintestinal manifestations of Crohn’s disease is associated with improvements in patient-reported and disease activity outcomes in patients treated with adalimumab W. Reinisch1 *, R. Lofberg2, E. Louis3, A.P. Yu4, J. McHale4, N. Beaulieu4, P. Mulani5, J. Chao5. 1Medical University of Vienna, Vienna, Austria, 2Karolinska Institutet, Stockholm, Sweden, 3University of Liege, Liege, Belgium, 4Analysis Group, Boston, MA, USA, 5Abbott, Abbott Park, IL, USA Introduction: Adalimumab is approved for treatment of adults with active Crohn’s disease (CD) and has been shown to induce and maintain remission in patients who have had an inadequate response to conventional therapy. CD is associated with extraintestinal manifestations (EIMs) in approximately 25% of patients.1 The objective of this analysis was to assess the impact of EIMs on patient-reported outcomes (PROs) and disease activity in patients with CD. Methods: The Crohn’s Patients Treated With Adalimumab: Results of a Safety and Efficacy Study (CARE) enrolled 945 patients with moderate to severe CD (Harvey Bradshaw Index [HBI] score 7). CARE was a multicenter, open-label, European, Phase IIIb trial evaluating the efficacy and safety of adalimumab in a large population of patients whose treatment approximated usual clinical practice. Outcomes included Short Inflammatory Bowel Disease Questionnaire (SIBDQ), 4 components of the Work Productivity and Activity Impairment (WPAI) questionnaire (total activity impairment [TAI], total work productivity impairment [TWPI], absenteeism, and presenteeism), and HBI. Presence of EIMs was assessed clinically as part of the baseline physical examination, and healing and development of new EIMs were evaluated at each scheduled visit at 2, 4, 8, 12, and 20 weeks after initiation of adalimumab therapy. A comparison of patients with and without EIMs at baseline was conducted to assess differences in demographics, PROs, and CD-related outcomes. Multivariate regression analyses were used to assess the impact of a reduction in EIMs on outcomes at Week 20, controlling for baseline characteristics. Results: At baseline, 52.6% (n = 497) of patients reported having 1 EIM, with an average of 1.4. EIMs reported in the patient population included erythema nodosum, pyoderma gangrenosum, eye involvement, arthritis, arthralgia, sacroiliitis, ankylosing spondylitis, hepatic disease, thrombosis, and nephrolithiasis. Patients with EIMs had more disease activity (ie, greater HBI), poorer SIBDQ, more impairment in daily activity as measured by TAI, and more CD-related symptoms at baseline than those without EIMs (p < 0.001). Patients who had longer duration of CD had, on average, more EIMs at baseline. Of the 497 patients with EIMs at baseline, 63.4% (n = 315) experienced a decrease in the number of EIMs at Week 20 of treatment with adalimumab. Regression analysis demonstrated that a decrease in the number of EIMs at Week 20 was a statistically significant predictor of improvements in patient-reported and disease activity outcomes, after controlling for baseline characteristics (table). Coefficients of reductions in number of EIMs in predicting HRQOL and disease activity scores at Week 20 in CARE: Results of linear regression analysis SIBDQ estimate 2.40**

Physical function in ankylosing spondylitis is independently determined by both disease activity and radiographic damage of the spine

Aim:To study the relationship between disease activity, radiographic damage and physical function in patients with ankylosing spondylitis (AS)Patients and methods:Baseline and 2-year data of the Outcome in Ankylosing Spondylitis International...

Oxidative stress in systemic lupus erythematosus: relationship to disease activity and symptoms

Oxidative stress may play a role in the pathogenesis of systemic lupus erythematosus (SLE). We examined the hypothesis that oxidative stress was associated with indices of lupus disease activity and severity of symptoms. Urinary F2 isoprostane excretion, a validated marker of oxidative stress, was measured in 95 patients with SLE and 103 healthy controls. Outcome measures included SLEDAI and SLICC scores, the modified health assessment questionnaire, the fatigue severity scale (FSS), and visual analogue scales (VAS) for fatigue, pain and overall disease activity. F2 isoprostane excretion was compared in patients and controls, and its relationship with clinical variables in SLE examined. F2 isoprostane excretion did not differ significantly among patients with lupus (2.7 +/- 2.3 ng/mg Cr) and control subjects (2.2 +/- 1.4 ng/mg Cr) (P = 0.70). In patients with lupus, F2 isoprostane concentrations were independently associated with higher patient reported disease activity (VAS) (OR = 1.52, P = 0.01), fatigue (FSS, OR = 1.52, P = 0.03) and lower quality of life (OR = 0.73, P = 0.05), but not with objective markers or inflammation or disease activity. In conclusion, F2 isoprostane excretion is associated with patient-reported symptoms in SLE but not with measures of inflammation, SLEDAI or SLICC. Oxidative stress may contribute to debilitating symptoms such as fatigue in SLE.