[Show abstract][Hide abstract] ABSTRACT: Individuals with systemic lupus erythematosus (SLE) often experience symptoms that affect family relationships, which are important components of quality of life. To assess the impact of SLE on family role functioning, we developed a 6-domain (Fatigue, Activity participation, Mental health, Isolation, Love and intimacy, and You/fulfilling family roles [FAMILY]) measure. The objectives of this study were to pilot test and achieve preliminary validation for the SLE-FAMILY questionnaire.
This was a 3-phase study. In phase 1 (development), domains were identified and items were generated for evaluation. During phase 2 (pilot test), a pilot test was conducted to assess the performance of candidate items. In phase 3 (initial validation), 52 individuals with SLE completed questionnaires, including the 6-item SLE-FAMILY. Data were analyzed for internal consistency reliability, and validity was assessed using correlations between the SLE-FAMILY questionnaire and well-validated measures.
The SLE-FAMILY had good test-retest reliability (0.82) and internal consistency (0.67). Reliability analysis of individual items revealed weakness in the performance of item 5. We reviewed raw data and determined that 9 individuals likely overlooked the reverse scoring of item 5, thus explaining its poor reliability. When these 9 individuals were excluded from analysis, Cronbach's alpha increased to 0.71, while test-retest reliability remained acceptable (0.75). Spearman's rho correlations supported the validity of the SLE-FAMILY measure. A pilot test of the SLE-FAMILY questionnaire without the reverse-scored item was conducted; results suggested that the modified version is superior to the initial form.
The SLE-FAMILY questionnaire is a promising new instrument for robust measurement of family role functioning.
[Show abstract][Hide abstract] ABSTRACT: To evaluate abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX).
Patients randomised to abatacept or placebo (+MTX) during the 1-year double-blind period of the Abatacept in Inadequate responders to Methotrexate (AIM) trial received open-label abatacept (+MTX) in the long-term extension (LTE). Safety was assessed for patients who received ≥ 1 dose of abatacept, regardless of randomisation group. Efficacy was assessed for patients randomised to abatacept who entered the LTE.
433 and 219 patients were randomised and treated with abatacept or placebo, respectively; 378 and 161 entered the LTE. At year 3, 440/539 patients were ongoing. No unexpected safety events were observed in the LTE. By year 3, incidence rates of adverse event and serious adverse events were 249.8/100 and 15.1/100 patient-years, respectively. Incidence rates were generally stable over time. At year 3, 84.8%, 63.4% and 37.5% of patients achieved American College of Rheumatology (ACR) criteria of 20, 50 and 70, respectively, compared with 82.3%, 54.3% and 32.4% of patients at year 1. Mean changes in Genant-modified Sharp scores were reduced progressively over 3 years, with significantly greater inhibition during year 3 compared with year 2 (p=0.022 for total score).
In MTX-inadequate responders with RA, abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.
Annals of the rheumatic diseases 10/2011; 70(10):1826-30. · 8.11 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To examine changes in activity participation following abatacept treatment for rheumatoid arthritis (RA), and which factors contributed to such changes.
Data were analyzed from the Abatacept in Inadequate responders to Methotrexate (AIM) and Abatacept Trial in Treatment of Anti-TNF INadequate responders (ATTAIN) clinical trials of abatacept in patients with RA. Activity participation was evaluated by the validated Activity Participation Questionnaire (APaQ), along with measures of clinical response and health-related quality of life. Changes in the APaQ during the two study periods were compared between treatment groups. Multiple regression analyses were performed to investigate the determinants of change in activity participation. The relationship between clinical efficacy measures (including low disease activity state [LDAS], Disease Activity Score 28-defined remission, and European League Against Rheumatism [EULAR] responses) and changes in activity participation were investigated.
Statistically significant, substantive improvements in activity participation were observed over the entire study period in patients treated with abatacept. Abatacept-treated patients showed improvements from baseline of 8.4 and 7.3 days in activity participation, compared with 4.5 and 1.4 days in the placebo group (P < 0.005 vs. placebo in both trials), at the end of AIM and ATTAIN, respectively. The Short Form-36 physical and mental component scores, patient global assessment, and the Health Assessment Questionnaire-Disability Index score were found to be the strongest determinants of changes in activity participation. Patients who achieved LDAS, disease remission and good EULAR responses experienced greater improvements in activity participation measures.
Abatacept treatment substantively and significantly improved patients' ability to participate in their usual activities. The gain in activity was closely related to improvements in clinical status, physical function and quality of life.
Value in Health 02/2011; 14(2):361-70. · 2.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To assess the impact of abatacept on sleep quality in patients with rheumatoid arthritis (RA), and the validity of the sleep disturbance scale of the Medical Outcomes Study Sleep Questionnaire (MOS-Sleep).
Data from two randomised, double-blind, placebo-controlled abatacept trials (Abatacept Trial in Treatment of Antitumor necrosis factor IN adequate responders (ATTAIN) and Abatacept in Inadequate responders to Methotrexate (AIM)) were analysed. Sleep quality was assessed using the MOS-Sleep. Changes in the Sleep Disturbance Scale were assessed according to clinical responses (including American College of Rheumatology (ACR) and Disease Activity Score 28 C-reactive protein criteria). Correlations between sleep disturbance and patient-reported outcomes were assessed. The sensitivity to change of sleep disturbance was assessed by calculating the standardised response means (SRMs).
258 abatacept- and 133 placebo-treated patients in ATTAIN and 433 abatacept- and 219 placebo-treated patients in AIM were analysed. In ATTAIN, mean improvements to month 6 were significantly greater for patients treated with abatacept than for placebo patients in sleep disturbance (11.3 vs 2.9, p<0.001), sleep adequacy (9.0 vs 0.6, p<0.05), somnolence (10.5 vs 1.6, p<0.001) and Sleep Problems Index (SPI) I (9.5 vs 1.4, p<0.0001) and II (9.8 vs 2.1, p<0.001); mean improvements in AIM to year 1 were statistically significant for sleep disturbance (12.9 vs 8.9, p<0.05) and SPI I (9.4 vs 6.7, p<0.05) and II (10.4 vs 7.3, p<0.05). Associations between mean improvements in sleep disturbance and clinical responses were statistically significant (3.8, 12.7, 18.0, p<0.001 and 5.0, 11.5, 15.7, p<0.001 for European League Against Rheumatism responses, none, moderate and good in ATTAIN and AIM, respectively; 10.2, 14.4, 22.8, p=0.007 and 10.9, 14.9, 17.7, p=0.006 for ACR 20, 50 and 70 responses in ATTAIN and AIM, respectively). SRMs for sleep disturbance were 0.38 (ATTAIN) and 0.19 (AIM).
Abatacept treatment provides significant improvements in multiple aspects of sleep in patients with RA. The Sleep Disturbance Scale of the MOS-Sleep shows validity, reliability and sensitivity to change.
Annals of the rheumatic diseases 10/2010; 69(10):1768-73. · 8.11 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The Medical Outcomes Study Short-form 36 (SF-36) provides numerical measurement of patient health, but does not include preferences for health states and cannot be used directly in cost-effectiveness analyses. By contrast the Euroqol EQ-5D can be used for cost-effectiveness analyses. The EQ-5D has rarely been used in systemic lupus erythematosus (SLE). We compared SF-36 and EQ-5D values across rheumatic diseases.
We studied 1316 patients with SLE, 13,722 with rheumatoid arthritis (RA), 3623 with non-inflammatory rheumatic disorders (NIRD), and 2733 with fibromyalgia (FM).
The mean EQ-5D, physical (PCS) and mental (MCS) component summary scores were 0.72, 36.3, and 44.3, respectively, in SLE. There was essentially no difference among EQ-5D and PCS scores for patients with SLE, RA, or NIRD. MCS was lower in SLE compared with RA and NIRD (44.3, 49.1, 50.8, respectively). All scores were more abnormal in FM (0.61, 31.9, 41.9). Within SF-36 domains, physical function was better, but general health, vitality, social function, role-emotional, and mental health were more impaired in SLE compared with RA and NIRD. In SLE, quality of life (QOL) was predicted by damage, comorbidity, income, education, and age. Fifteen percent of patients with SLE were very satisfied with their health, and their QOL scores (0.84, 45.4, 50.1) were similar to those found in the US population for EQ-5D and MCS, but were slightly reduced for PCS.
EQ-5D and PCS are at the same levels in SLE as in RA and NIRD, but are more abnormal in SLE in the MCS and mental health domains. EQ-5D values allow preference-based comparisons with other chronic conditions.
The Journal of Rheumatology 02/2010; 37(2):296-304. · 3.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To describe and compare the prevalence of lifetime and current self-reported comorbidity and associated quality of life in 4 rheumatic diseases, and to investigate comorbid conditions in light of the overlap between the index condition and comorbid conditions (CC), and in the context of symptom-type diagnoses.
We studied comorbidity in 11,704 patients with fibromyalgia (FM), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and noninflammatory rheumatic disorders (NIRD). Patients completed semiannual self-reports relating to 22 present and past illnesses and completed the EuroQol (EQ-5D) utility index.
CC were most common in FM, followed by SLE. FM comorbidity was dominated by depression, mental illness, and symptom-type comorbidity (e.g., gastrointestinal and genitourinary disorders). In SLE, there were substantial increases in hypertension, depression, cataract, fractures, and cardiovascular and cerebrovascular, neurologic, lung, gall bladder and endocrine disorders compared with RA. Any current CC reduced the EQ-5D utility by 0.08 to 0.16 units. The lowest EQ-5D score was noted for current psychiatric illness (0.55) and current depression (0.60).
Four patterns of comorbidity emerged: that associated with aging; that associated with aging but enhanced by the index condition, as in SLE and cardiovascular disease; comorbidity that is part of the symptoms complex of the index condition; and CC that represent lifetime traits or manifestations of the underlying illness. Depression was the most strongly associated correlate of EQ-5D quality of life, and current depression was present in about 15% of patients with RA or NIRD and 34% to 39% of those with SLE and FM.
The Journal of Rheumatology 02/2010; 37(2):305-15. · 3.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We sought to identify instruments assessing sleep quality that measure the domains of sleep applicable to rheumatoid arthritis (RA) patients and are feasible to use and have appropriate reliability, validity, and responsiveness properties. A systematic review of sleep instruments was conducted. In particular, domains related to sleep that were assessed in the instruments were identified and evaluated. Feasibility characteristics and psychometric properties of instruments were reviewed. At OMERACT 9, the preparatory work was described at the plenary session of the Patient Perspective Workshop, and the tasks of 3 breakout groups in ranking and scoring the domains and sleep instruments were outlined. Each breakout group considered different aspects of sleep: sleep domains, feasibility, and psychometric properties. The rapporteur for each breakout group reported back to the plenary on the domains and sleep instruments that achieved the highest rank/score. The systematic review identified 45 sleep instruments of interest. Based on these instruments, 14 domains of sleep were identified. The top ranked domains were: Sleep Adequacy (1), Sleep Maintenance (2), Sleep Initiation (3) and Daytime Functioning (4). The top ranked instruments on feasibility were: Athens Insomnia Scale (2.3), Medical Outcome Study (MOS) Sleep (4.0), Insomnia Severity Index (4.9), and Women's Health Insomnia Rating Scale (5.5). The highest scored instruments on psychometric properties were: Athens Insomnia Scale (13.6), Sleep Assessment Questionnaire (13), Pittsburgh Sleep Diary (12), and MOS Sleep (11). Sleep domains have been reviewed, and several sleep instruments have been identified. These instruments should be considered for use in planned clinical trials of RA patients to assess their applicability.
The Journal of Rheumatology 10/2009; 36(9):2077-86. · 3.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To estimate the long-term direct medical costs and health care utilization for patients with systemic lupus erythematosus (SLE) and a subset of SLE patients with nephritis.
Patients with newly active SLE were found in the MarketScan Medicaid Database (1999-2005), which includes all inpatient, outpatient, emergency department, and pharmaceutical claims for more than 10 million Medicaid beneficiaries. The date a patient became newly active was defined as the earliest observed SLE diagnosis code, with a 6-month clean period prior to the diagnosis. This method identified 2,298 patients with a consecutive followup of 5 years. A reference group of patients without SLE was constructed using propensity score matching. Nephritis was assessed based on diagnosis and procedure codes involving the kidney.
Mean annual medical costs for SLE patients totaled $16,089 at year 1, which is significantly greater (by $6,831) than that for reference patients. Costs decreased slightly at year 2 but then increased yearly at an average rate of 16% through year 5, to $23,860. SLE patients without nephritis (n = 1,809) had costs $967-3,756 higher than the reference patients. SLE patients with nephritis (n = 489) had costs $13,228-34,907 greater than the reference group. Inpatient visits for the nephritis subgroup were 0.6-1.0 per capita, which are approximately twice the rate for all SLE patients and 3 to 4 times higher than the reference group.
SLE is a costly condition to treat. Medical expenses incurred by SLE patients increase steadily over time, particularly for patients with nephritis.
[Show abstract][Hide abstract] ABSTRACT: To evaluate the safety and efficacy of abatacept plus methotrexate (MTX) over 5 years in patients with rheumatoid arthritis.
Patients were randomized to abatacept 10 or 2 mg/kg or placebo, plus MTX. Patients completing the 1-year, double-blind period entered the longterm extension, where all patients received a fixed dose of abatacept ~10 mg/kg. We describe safety analyses for all patients who received at least 1 dose of abatacept and efficacy analyses for the original ~10 mg/kg abatacept-treated group, over 5 years.
Of the 235 abatacept- or placebo-treated patients completing the double-blind period, 219 entered the longterm extension; 130 (59.4%) were continuing at Year 5. No unexpected safety events were observed during the longterm extension compared with the double-blind period. Incidence rates of adverse events (AE) and serious AE were 489.7 and 20.0/100 patient-years in Year 1 versus 374.9 and 18.9/100 patient-years in the cumulative period, respectively. Using exploratory analyses, improvements observed at Year 1 in the 10 mg/kg group were maintained at Year 5, as assessed by ACR responses (ACR20=77.1% vs 82.7%; ACR50=53.0% vs 65.4%; ACR70=28.9% vs 40.4% at Years 1 and 5, respectively) and disease activity (Low Disease Activity State=48.2% vs 58.5%; Disease Activity Score-28-defined remission=25.3% vs 45.3% at Years 1 and 5, respectively).
Abatacept maintained the efficacy observed at Year 1 over 5 years of treatment, and demonstrated consistent safety and tolerability. These data, along with relatively high retention rates, support the longterm clinical benefit provided by selective T cell costimulation modulation. Clinical trial registry: ClinicalTrials.gov; clinical trial registration number: NCT00254293.
The Journal of Rheumatology 05/2009; 36(4):736-42. · 3.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate the relationship between renal activity and quality of life (QOL) in patients with systemic lupus erythematosus (SLE).
Three hundred eighty-six patients completed annual Medical Outcomes Study Short Form-36 questionnaires and physicians completed the SLE Disease Activity Index and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index. Concurrent association between renal activity and QOL was evaluated through regression models that adjusted for demographics and nonrenal disease activity and nonrenal damage. To characterize the longitudinal relationship between change in renal activity and change in QOL, all renal activity and QOL data over the entire study were used to estimate a linear trend within each individual patient through hierarchical modeling.
In the regression model that assessed the association between renal activity and QOL, on average, each additional renal activity item fulfilled was associated with a 2.04-unit (95% CI 0.88, 3.24) decrease in the physical function subscale, a 5.28-unit (95% CI 2.76, 7.76) decrease in the role-physical subscale, a 2.24-unit (95% CI 0.72, 3.80) decrease in the social function subscale, and a 1.16-unit (95% CI 0.60, 1.72) decrease in the physical component summary score. In the hierarchical model, no association was observed between changes in renal activity and QOL.
Patients with SLE and active renal disease concurrently experience a slightly poorer QOL than those without renal disease, especially in the physical domains. Because the confidence intervals were wide, we could not accurately estimate whether a longitudinal change in renal activity was associated with a change in QOL.
The Journal of Rheumatology 05/2009; 36(5):947-52. · 3.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To validate the definitions of minimal disease activity (MDA) in patients with rheumatoid arthritis (RA) and to compare abatacept to control with respect to patients attaining a state of MDA.
Two randomized controlled trials comparing abatacept to control in patients with RA were considered: ATTAIN and AIM. Core set measures, Disease Activity Score 28-joint count (DAS28), and, for AIM, radiographic scores were available. The core set and DAS-based definitions for MDA were calculated and the number of patients in the treatment groups meeting the definitions was compared to determine sensitivity of the criteria to treatment differences and patient severity. The number of times achieving MDA was compared to the change in Health Assessment Questionnaire (HAQ), and for the AIM study compared to change in radiographic scores.
For both definitions of MDA, the change in radiographic scores showed a continual decrease in progression the more often a patient was in MDA. The change in HAQ, for both studies, showed a similar consistent improvement - the longer a patient was in MDA, then the better the HAQ score. Significantly more patients in the abatacept group met the core set and DAS-based definition of MDA than in the control group.
The presence and persistence of MDA was associated with slowing of radiographic progression and improvement in the HAQ, providing support for discriminative and predictive validity of the measure. The MDA results were consistent with other efficacy analyses indicating a treatment advantage for abatacept.
The Journal of Rheumatology 03/2009; 36(2):260-5. · 3.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To estimate the medical- and productivity-related cost burden of systemic lupus erythematosus (SLE) and SLE with nephritis in an employee population.
Using administrative data, annual costs were calculated for SLE patients, a subset with nephritis, and a matched control group of patients without SLE. These costs were compared with the cost of other chronic conditions.
Mean annual medical expenditures and short term disability costs for SLE patients were $12,238 and $1184 greater (2005 dollars), respectively, than those of controls. Mean medical expenditures for SLE/nephritis patients were $46,862 greater than for controls. When compared with other chronic health conditions faced by employees, SLE/nephritis was the most costly condition.
SLE, particularly with nephritis, is associated with substantial costs. Therapies that can better manage SLE may provide opportunities for savings to employers.
Journal of occupational and environmental medicine / American College of Occupational and Environmental Medicine 02/2009; 51(1):66-79. · 1.88 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: An important aspect of general health is subjective well-being (SWB), which is defined as happiness and overall satisfaction with life. Herein we examined the reliability and validity of observation-based ratings of SWB in patients with rheumatoid arthritis (RA). Ten RA patients experiencing a disease flare (period of increased symptoms) completed two semi-structured interviews (baseline and 4 weeks later) that were digitally recorded. Twelve healthcare professionals watched the 20 brief videos in random order and scored them using the Well-Being Coding System (WBCS) for observer-reported SWB. Patient-reported SWB scores and scores from the Medical Outcomes Study: 36-Item Short Form Survey (SF-36) were compared to observer-reported scores for SWB. We found inter-rater reliability to be extremely high and a significant relationship between observer SWB composite scores and patient SWB composite scores. Observer SWB composite scores and other scores associated with SWB from the SF-36 were also related significantly. There was also some evidence supporting the ability of observers to detect change in SWB. Taken together, we found preliminary evidence suggesting that when using information gleaned from brief patient interviews clinicians can make reliable and valid evaluations of patients' SWB.
Applied Psychology Health and Well-Being 01/2009; 1(1):46 - 61. · 1.75 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To assess cost-effectiveness of abatacept in patients with rheumatoid arthritis (RA) with inadequate response to tumor necrosis factor-alpha antagonists (anti-TNF).
We developed a simulation model to depict progression of disability [in terms of Health Assessment Questionnaire Disability Index (HAQ-DI)] in women aged 55-64 years with moderately to severely active RA and inadequate response to anti-TNF. At model entry, patients were assumed to receive either oral disease modifying antirheumatic drugs (DMARD) only or oral DMARD plus abatacept. Patients were then tracked from model entry until death. Future health-state utilities and medical-care costs (except study therapy) were estimated based on predicted values of the HAQ-DI. The model was estimated using data from a Phase III clinical trial of abatacept plus secondary sources. Cost-effectiveness was expressed in terms of incremental cost (2006 US$) per quality-adjusted life-year (QALY) gained alternatively over 10 years and a lifetime. Future costs and health effects were discounted at 3% annually.
Over 10 years, abatacept would yield 1.0 additional QALY (undiscounted) per patient (4.0 vs 3.0 for oral DMARD) at an incremental (discounted) cost of $45,497 (100,648 vs $55,151) respectively; over a lifetime, corresponding figures were 1.6 QALY (5.8 vs 4.2) and $64,978 ($140,714 vs $82,489). Cost-effectiveness was [mean (95% CI)] $50,576 ($47,056, $54,944) per QALY gained over 10 years, and $45,979 ($42,678, $49,932) per QALY gained over a lifetime. Findings were robust in sensitivity analyses.
Abatacept is cost-effective by current standards of medical practice in patients with moderately to severely active RA and inadequate response to an anti-TNF.
The Journal of Rheumatology 09/2008; 35(9):1745-53. · 3.26 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To consider the feasibility of assessing multiple facets of independence in rheumatoid arthritis (RA) using a measure developed from existing items and examining its face validity, construct validity and responsiveness to change.
The ATTAIN (Abatacept Trial in Treatment of Anti-tumor necrosis factor [TNF] Inadequate responders) database was used. Patients with RA were randomized 2:1, abatacept (n = 258) and placebo (n = 133). A multi-faceted scale to measure physical and psychosocial independence was constructed using items from the Health Assessment Questionnaire (HAQ) and Short Form 36 Health Survey (SF-36). Questions assessing activity limitations and need for outside caregiver help were also examined. Interviews with 20 RA patients assessed face validity.
Item Response Theory analysis yielded two traits - 'Psychosocial Independence', derived from the number of days with activity limitations plus the Role Emotional, Social Functioning and Role Physical subscale items from the SF-36; and 'Physical Independence', derived from 15 HAQ items assessing need for help from another. The two traits showed no significant differential item functioning for age or gender and demonstrated good face validity. Changes over 169 days on Psychosocial Independence were greater (mean 0.46 units, 95% confidence interval [CI]: 0.17-0.75) for the abatacept group than for placebo (p = 0.002). Changes in Physical Independence were greater (mean 0.59 units, 95% CI: 0.35-0.82) for the abatacept group than for placebo (p < 0.001).
The multi-faceted assessment of independence in RA based on items from commonly used instruments is feasible suggesting promise for evaluating independence in future clinical trials. This approach demonstrated good face and construct validity and responsiveness in RA patients who had previously failed anti-TNF therapy. However, we caution against an interpretation that these data suggest that abatacept improves independence because the component parts of this assessment came from instruments used in the ATTAIN trial where data had been previously analyzed.
Current Medical Research and Opinion 05/2008; 24(5):1443-53. · 2.37 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate the efficacy, radiographic changes, and safety of abatacept and methotrexate therapy through 2 years in a long-term extension of a previously published 1-year study.
Patients who received placebo during year 1 were switched to abatacept. Patients taking abatacept continued to take it. Efficacy and safety were assessed through 2 years.
Of 539 patients enrolled in the initial 1-year study, 488 completed 1 year of the long-term extension (2% discontinued for lack of efficacy). At 2 years, patients taking abatacept had maintained their responses on the American College of Rheumatology (ACR) improvement criteria and the Disease Activity Score in 28 joints (DAS28; using the C-reactive protein [CRP] level), as well as their physical function (according to the Health Assessment Questionnaire [HAQ] disability index [DI]) and health-related quality of life (HRQOL; assessed with the Short Form 36 [SF-36] health survey), that were observed at the end of the double-blind period (year 1 versus year 2 values were 81.9% versus 80.3% for ACR 20% improvement, 25.4% versus 30.9% for a DAS28 [CRP] of <2.6, 71.8% versus 66.8% for the HAQ DI, and 9.7 versus 10.6 and 7.3 versus 7.2, respectively, for the mean change in the physical and mental components summary scores of the SF-36). In the abatacept group, post hoc analysis demonstrated further inhibition of radiographic progression during year 2 (57% reduction in mean change of total score in year 2 versus year 1; P<0.0001), and minimal radiographic progression was observed (mean change in total score from baseline was 1.1 and 1.6 at year 1 and 2, respectively). Rates of adverse events (AEs) and severe AEs were consistent throughout the cumulative period.
The improvements in signs and symptoms, physical function, and HRQOL observed after 1 year of abatacept treatment were maintained through 2 years of treatment. This durability was accompanied by a safety profile consistent with that in the double-blind portion of the study. Radiographic progression was further inhibited in year 2 compared with year 1, suggesting an increasing effect of abatacept on the inhibition of structural damage in year 2.
[Show abstract][Hide abstract] ABSTRACT: The aims of this study were to examine the relationship between external home help (EHH) use (ie, help provided by someone other than family or friends) and clinical response and patient-reported outcomes in patients with rheumatoid arthritis (RA), and to determine whether abatacept treatment in addition to methotrexate reduces the need for EHH.
EHH use was recorded monthly in the Abatacept in Inadequate responders to Methotrexate (AIM) trial, a 12-month, randomized, double-blind, placebo-controlled trial of abatacept in patients with active RA also receiving methotrexate. Clinical response was defined using American College of Rheumatology (ACR) criteria, European League Against Rheumatism (EULAR) criteria, and Disease Activity Scale (DAS)-28 score. Patient-reported outcomes included the Health Assessment Questionnaire (HAQ), 100-mm visual analog scales (VASs) for pain and fatigue, and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) for health-related quality of life. Analysis of covariance and regression analysis were performed to investigate the relationship between change in EHH use and both clinical response and patient-reported outcomes.
Of 590 patients enrolled in the study, 232 (39.3%) were receiving EHH at baseline (mean age, 50.2 years; 88% female; 85% white; mean duration of RA, 8.8 years; mean [SD] EHH use, 15.6 [11.3] days). The level of EHH use was consistently higher with poorer scores on the HAQ, pain and fatigue VASs, DAS28, and SF-36. At 12 months, the mean reduction from baseline in EHH use was significantly greater in patients with ACR-50 or ACR-70 clinical response, EULAR good or moderate response, DAS28 remission, and clinically meaningful improvements in patient-reported outcomes. On multiple regression analysis, change in SF-36 Physical Functioning subscale score was the most important contributor to change in EHH after adjustment for other variables. The mean reduction from baseline in EHH use was significantly greater with abatacept compared with placebo over the study period (all, P<0.001).
In this exploratory analysis of data from patients with active RA from the AIM trial, EHH use was decreased significantly with improvements in clinical response, disease activity, and patient-reported outcomes. Treatment with abatacept in addition to methotrexate was associated with significantly decreased EHH use, suggesting that abatacept may have been associated with improved function and increased physical independence in these patients with RA.
[Show abstract][Hide abstract] ABSTRACT: The cost of the biological drug abatacept may be partly offset by reductions in the cost of productivity losses due to employee absences and reduced effectiveness at work because of rheumatoid arthritis (RA).
This was a 1-year productivity cost model based on epidemiologic and economic data. The setting was private industry in the US and the primary outcome measure was the difference in the costs of lost productivity and drug treatment with and without abatacept ('cost difference').
The lost productivity cost of RA for a firm of 10,000 was $1.69 million, largely due to the cost of RA-related absenteeism ($1.55 million) rather than to worker displacement ($0.12 million) or care-giving for spouses with RA ($0.02 million). In the base case analysis (excluding presenteeism), 37% of the acquisition cost of abatacept was offset by reductions in the cost of RA-related productivity losses. In some industry groups (Utilities and Finance), and in models that included presenteeism, reductions in lost productivity costs exceeded the abatacept cost.
Much of the acquisition cost of abatacept may be offset by reductions in the cost of productivity losses due to RA. Abatacept treatment could be cost saving in some industry groups.
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to assess annual changes in the continuous summary physical performance score (CSPPS) and the quartile summary physical performance (QSPPS) score, evaluate how these changes relate to self-reported changes in physical function and to examine clinically meaningful changes in CSPPS and QSPPS.
This was a longitudinal study of an elderly cohort of men and women (age>65) reporting at least two domains of disability from 5 centers in the US and Europe. Subjects completed assessments of mobility, ability to perform activities of daily living (ADLs), and the physical component of the SF-36 at both baseline and at 1- year, as well as a self-report of change in function over the year. Timed physical performance tests including walking speed, repeated chair stands and balance were used to calculate QSPPS and CSPPS at baseline and one year.
Regardless of the tool used to evaluate clinical significance (ADL, SF- 36 PF, mobility disability, self-rating of physical performance) or a determination of the small meaningful change estimates based on effect size, it appears that a change of approximately 3 points in the CSPPS or 0.6 points in the QSPPS is clinically meaningful.
In this cohort with moderate to severe disability, an annual change of approximately 3 points in CSPPS and 0.6 points in QSPPS are clinically meaningful and these changes are evident at one year.
Aging clinical and experimental research 12/2007; 19(6):484-91. · 1.01 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To compare the measurement properties of the Modified Health Assessment Questionnaire [MHAQ], the SF-36((R)) Health Survey 10 item Physical Functioning scale [PF10], and scores from an item response theory (IRT) based scale combining the two measures.
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.
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.
Combining scales from the two short forms yields a more powerful tool with greater sensitivity to treatment response.
Quality of Life Research 06/2007; 16(4):647-60. · 2.41 Impact Factor