Ross Maclean

Responsiveness of patient reported outcomes including fatigue, sleep quality, activity limitation, and quality of life following treatment with abatacept for rheumatoid arthritis

Objective: To evaluate the responsiveness of patient reported outcomes (PROs), including fatigue, sleep, activity limitation, and quality of life, in patients with rheumatoid arthritis (RA). Methods: Data were considered from a randomised controlled trial comparing abatacept (n = 258) with placebo (n = 133) on a background of DMARD treatment in RA patients who were inadequate responders to anti-TNF therapy (ATTAIN study). PROs assessed included SF-36, activity limitation, fatigue, and sleep. For each outcome the treatment difference, relative per cent improvement, standardised response mean (SRM), and relative efficiency for assessing an outcome’s ability to detect a treatment effect relative to tender joint count (TJC) were calculated. A relative efficiency >1 suggests a measure that is more efficient than TJC in detecting treatment effect. Results: Moderate to large SRMs (⩾0.6) were observed for the PRO measures. In particular, SRMs (95% confidence interval) were: physician global, 0.72 (0.51 to 0.94); HAQ, 0.63 (0.42 to 0.85); SF-36 physical component score, 0.62 (0.40 to 0.83); SF-36 bodily pain, 0.68 (0.46 to 0.90); and fatigue, 0.59 (0.38 to 0.81). Relative efficiencies for physician global (1.6), SF-36 bodily pain domain (1.4), pain intensity (1.4), HAQ (1.2), SF-36 physical component score (1.2), fatigue (1.1), and patient global assessment (1.04) were all more responsive than TJC. The SF-36 mental component score (0.3), swollen joint count (0.6), activity limitation (0.8), sleep (0.7), and C reactive protein (0.9) were less responsive. Conclusions: Using PROs for evaluating treatments for RA can detect improvements and will identify changes that are important to patients. In general, physical assessments are more responsive to an effective treatment than mental assessments.

The direct and indirect cost burden of Crohn's disease and ulcerative colitis.

Objective: To estimate the direct medical and indirect (absenteeism and short-term disability) cost burden of Crohns Disease (CD) and Ulcerative Colitis (UC). Methods: Data were obtained from 1999 to 2005 MarketScan databases. Twelve-month expenditures for patients with CD and UC were compared to expenditures among an equal number of propensity score matched comparison group patients. Regression analysis controlled for demographics and case-mix. Results: Annual medical expenditures were significantly higher for commercially insured CD and UC patients compared to matched comparison group patients (

The impact of rheumatoid arthritis on medical expenditures, absenteeism, and short-term disability benefits

18,963 vs

Abatacept improves both the physical and mental health of patients with rheumatoid arthritis who have inadequate response to methotrexate treatment

5300 for CD patients,

Item Response Theory Methods can Improve the Measurement of Physical Function by Combining the Modified Health Assessment Questionnaire and the SF-36 Physical Function Scale

15,020 vs

Peripheral Arterial Disease and Renal Transplantation

4982 for UC patients, respectively, all P < 0.001). Indirect costs were also high for employed patients with these conditions. Conclusions: CD and UC are costly diseases with a significant cost burden related to health care utilization and productivity loss.

Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDS and anti-TNF inadequate responders for the management of moderate to severe rheumatoid arthritis

Objectives: The objectives of this study were to estimate medical expenditures, absenteeism, and short-term disability costs for workers with rheumatoid arthritis (RA) and to estimate the relative costs of RA over a 12-month period. Methods: Using data from nine U.S. employers, direct and indirect costs for 8502 workers with RA were compared with costs for a matched group without RA. Regression analyses controlled for factors that were different even after propensity score matching. Results: Average total costs for workers with RA were

The direct and indirect cost burden of acutecoronary syndrome

4244 (2003 dollars) greater than for workers without RA. RA was the fourth most costly chronic condition per employee compared with cancers, asthma, bipolar disorder, chronic obstructive pulmonary disease, depression, diabetes, heart disease, hypertension, low back disorders, and renal failure. Conclusions: RA is a costly disorder and merits consideration as interventions are considered to improve workers’ health and productivity.

Proposed severity and response criteria for Routine Assessment of Patient Index Data (RAPID3): results for categories of disease activity and response criteria in abatacept clinical trials.

Objective: To examine the impact of added abatacept treatment on health related quality of life (HRQoL) in patients with rheumatoid arthritis (RA) who have inadequate response to methotrexate (MTX). Methods: The impact of abatacept treatment on HRQoL was examined in a longitudinal, randomised double blind, placebo controlled clinical trial. Effects of treatment on HRQoL were examined using repeated measures analysis of covariance and comparing rates of change in HRQoL across treatment groups. The relationship between American College of Rheumatology (ACR) clinical markers and disease duration with changes in HRQoL indicators was also examined. Finally, a responder analysis was used to examine the percentage of patients who improved by 0.5 SD in 12 months or who reached the normative levels seen in the US general population. Results: Statistically significant improvements in the abatacept group relative to controls were observed across a range of HRQoL measures, including physical function, fatigue, all eight domains of the SF-36, and the physical and mental component summaries (PCS and MCS). Improvements were seen as early as day 29 for fatigue and for five out of eight SF-36 domains. By day 169, all HRQoL measures were significantly better with abatacept than with placebo. HRQoL gains were associated with greater ACR clinical improvement, and the effects were consistent for patients with different disease duration. A significantly greater percentage of patients treated with abatacept reached normative levels of PCS, MCS, physical functioning, and fatigue compared with patients treated with MTX alone. Conclusion: Combined abatacept and MTX treatment produces significant improvements across a wide range of HRQoL domains in patients with RA.

Indirect cost-effectiveness analyses of abatacept and rituximab in patients with moderate-to-severe rheumatoid arthritis in the United States

Objective:To compare the measurement properties of the Modified Health Assessment Questionnaire [MHAQ], the SF-36® Health Survey 10 item Physical Functioning scale [PF10], and scores from an item response theory (IRT) based scale combining the two measures.Study Design:Rheumatoid arthritis (RA) patients (n = 339) enrolled in a multi-center, randomized, double-blind, placebo-controlled trial completed the MHAQ and the SF-36 pre- and post-treatment. Psychometric analyses used confirmatory factor analysis and IRT models. Analyses of variance were used to assess sensitivity to changes in disease severity (defined by the American College of Rheumatism (ACR)) using change scores in MHAQ, PF10, and IRT scales. Analyses of covariance were used to assess treatment responsiveness.Results:For the entire score range, the 95% confidence interval around individual patient scores was smaller for the combined (total) IRT based scale than for other measures. The MHAQ and PF10 were about 70% and 50% as efficient as the total IRT score of physical functioning in discriminating among ACR groups, respectively. The MHAQ and PF10 were also less efficient than the total IRT score in discriminating among treatment groups.Conclusions:Combining scales from the two short forms yields a more powerful tool with greater sensitivity to treatment response.