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Objective: This was an exploratory analysis to develop a new way of representing BILAG-2004 system scores longitudinally that would be clinically meaningful and easier to analyse in comparison with multiple categorical variables., Methods: Data from a multicentre longitudinal study of SLE patients (the BILAG-2004 index and therapy collected at every visit) were used. External responsiveness analysis of the index suggested the possibility of using counts of systems with specified transitions in scores as a basis to analyse the system scores. Exploratory analyses with multinomial logistic regression were used to examine the appropriateness of this new method of analysing BILAG-2004 system scores. Receiver operating characteristic (ROC) curve analysis was used to assess the performance of this approach., Results: There were 1414 observations from 347 patients. A novel method was devised based on counts of systems with defined transitions in score (BILAG-2004 systems tally, BST). It has six components (systems with major deterioration, systems with minor deterioration, systems with persistent significant activity, systems with major improvement, systems with minor improvement and systems with persistent minimal or no activity). This was further simplified (simplified BST, sBST) into three components (systems with active/worsening disease, systems with improving disease and systems with persistent minimal or no activity). Both versions had expected associations with change in therapy. ROC curve analyses demonstrated that both versions had similar good performance characteristics (areas under the curve >0.80) in predicting increase in therapy., Conclusion: The BST and sBST provide alternative approaches to representing BILAG-2004 disease activity longitudinally. Further validation of their use is required.

Objectives: To examine SLEDAI-2000 cut-off scores for definition of active SLE and to determine the sensitivity to change of SLEDAI-2000 for the assessment of SLE disease activity and minimal clinically meaningful changes in score., Methods: Data from two multi-centre studies were used in the analysis: in a cross-sectional and a longitudinal fashion. At every assessment, data were collected on SLEDAI-2000 and treatment. The cross-sectional analysis with receiver operating characteristic (ROC) curves was used to examine the appropriate SLEDAI-2000 score to define active disease and increase in therapy was the reference standard. In the longitudinal analysis, sensitivity to change of SLEDAI-2000 was assessed with multinomial logistic regression. ROC curves analysis was used to examine possible cut-points in score changes associated with change in therapy, and mean changes were estimated., Results: In the cross-sectional analysis, the most appropriate cut-off scores for active disease were 3 or 4. In the longitudinal analysis, the best model for predicting treatment increase was with the change in SLEDAI-2000 score and the score from the previous visit as continuous variables. The use of cut-points was less predictive of treatment change than the use of continuous score. The mean difference in the change in SLEDAI-2000 scores, adjusted for prior score, between patients with treatment increase and those without was 2.64 (95% CI 2.16, 3.14)., Conclusions: An appropriate SLEDAI-2000 score to define active disease is 3 or 4. SLEDAI-2000 index is sensitive to change. The use of SLEDAI-2000 as a continuous outcome is recommended for comparative purposes.

Objective: To develop a recommended measure of response for use in psoriatic arthritis (PsA) clinical trials and observational cohort studies reflecting joint involvement., Methods: Previously, we used data from phase III randomized placebo-controlled trials of anti-tumor necrosis factor (TNF) agents to determine models, based primarily on statistical considerations but with some clinical input when necessary, that best distinguish drug-treated from placebo-treated patients. For the same data, we examine response criteria currently used for PsA and logistic regression models based on the individual components of these response criteria. Comparison with our previously developed models, based primarily on statistical consideration, is made., Results: A simplified score, the PsA Joint Activity Index (PsAJAI), based on components of the ACR30, performed better than the ACR20 and PsARC, and comparable to our previously developed models. The PsAJAI is a weighted sum of 30% improvement in core measures with weights of 2 given to the joint count measure, the C-reactive protein laboratory measure, and the physician global assessment of disease activity measure. Weights of 1 should be given to the remaining 30% improvement measures including pain, patient global assessment of disease activity, and the Health Assessment Questionnaire., Conclusion: We recommend the PsAJAI be used as an outcome measure for assessing joint disease response in PsA clinical trials.

Objective: In a preliminary attempt to develop a drug responder index for patients with systemic lupus erythematosus (SLE), 2 validated disease activity instruments were studied for their responsiveness and compared to a physician visual analog scale (VAS) assessment of disease activity. We attempted to determine whether these validated instruments were useful components in characterizing response in the setting of a clinical trial., Methods: Eighty paper patients were assessed using the British Isles Lupus Assessment Group (BILAG) and Systemic Lupus Disease Activity Index (SLEDAI) and by physician's assessment of global activity. The cases were arranged in random order and divided into groups of 20 patients and each group was assessed by 20 lupus experts; change in disease activity was recorded at 3 and 6 months compared to baseline using a physician VAS., Results: Four different lupus experts assessed disease activity in all 80 patients at baseline and 3 and 6 months after initiation of therapy using the BILAG and SLEDAI instruments. BILAG and SLEDAI scores correlated well over time; however, in a regression analysis where average physician VAS were chosen as the outcome variable, a significant amount of variation in the average physician VAS not related to the SLEDAI and BILAG scores was noted., Conclusion: The physician VAS may be too blunt to assess response in SLE, because even among experienced lupus assessors, there were considerable differences in what influenced scoring decisions.

Objective: To examine the relationship of the Arthritis Impact Measurement Scales (AIMS) to changes in articular status and functional performance in a group of patients with psoriatic arthritis (PsA)., Methods: The AIMS was administered to 65 patients attending the University of Toronto Psoriatic Arthritis Clinic in 1989 and in 1993. Clinical and laboratory assessments of function, active inflammation, and damage were also performed at these 2 clinic visits. Linear regression analysis was performed to relate changes in the number of actively inflamed joints and number of deformed joints to AIMS measurements, while logistic regression was used to relate the American College of Rheumatology (ACR) functional class and the AIMS scores taken at the 2 clinic visits., Results: There were 27 women and 38 men with a mean age of 46 years and arthritis duration of 13 years. Based only on information derived from the AIMS questionnaire, the maximum percentage of variation explained was 21 and 9% for the number of active joints and deformed joints, respectively. The strongest relationship was between the pain component scales measured at the 2 visits and the number of active joints. In all cases the initial clinical value made a significant additional contribution to the regression., Conclusion: The finding that the AIMS was sensitive to articular changes that occurred in patients over a 4 year period provides further support for the utility of the AIMS as an outcome measure in clinical studies of PsA. However, changes in the AIMS did not capture the full extent of the changes in both articular status and ACR functional class. This suggests that the AIMS and traditional measures of disease activity and function assess somewhat different aspects of clinical status and that it may be beneficial to use both types of measures in monitoring the course of PsA.

Objective: To assess the validity of the revised and expanded version of the Arthritis Impact Measurement Scales (AIMS2) in patients with psoriatic arthritis (PsA)., Methods: The AIMS2 was administered to all patients attending our Psoriatic Arthritis Clinic between June and December 1993. Clinical and radiological assessments were performed during the clinic visits., Results: The patient population included 124 patients, 75 men and 49 women with a mean age of 48.4 years and a mean arthritis duration of 14.6 years. Most of the physical function scales as well as the pain and work scales were moderately to highly correlated with clinical measures of function (r = 0.27-0.64) and disease activity (r = 0.28-0.50), but they were not correlated with measures of disease severity. The psychosocial scales were poorly correlated with all clinical measures., Conclusion: Our data suggest that, like the original AIMS, the AIMS2 is valid for use as an adjunct outcome measure for clinical trials in PsA.

The Arthritis Impact Measurement Scales (AIMS) consists of 9 scales that measure physical function, pain and psychosocial function. It has been validated for use in various forms of arthritis, but not in psoriatic arthritis (PsA). The AIMS was administered to 145 patients attending our PsA clinic. We carried out simultaneous assessment of clinical measures of function, measures of disease activity, and measures of disease severity. Most scales of physical function were moderately to highly correlated with clinical measures of function (r = 0.33-0.57; p = 0.0001), measures of disease activity (r = 0.24-0.53, p = 0.003-0.0001), and measures of disease severity (r = 0.23-0.6; p = 0.02-0.0001). The pain scale was highly correlated with clinical measures of function and measures of disease activity (r = 0.38-0.58; p = 0.0001) but not with measures of disease severity. Of the psychosocial scales, the depression scale was moderately correlated with clinical measures of function (r = 0.27-0.3; p = 0.001-0.0001). Our data suggest that the physical function and pain scales are good indicators of overall function and disease activity and are valid for use in PsA.