Objective. To assess the impact of certolizumab pegol (CZP), a novel PEGylated anti-tumor necrosis factor, in combination with methotrexate (MTX) on productivity outside and within the home, and on participation in family, social, and leisure activities in adult patients with rheumatoid arthritis (RA). Methods. The efficacy and safety of CZP (200 mg and 400 mg) plus MTX were assessed in 2 phase III, multicenter, double-blind, placebo-controlled trials (Rheumatoid Arthritis Prevention of Structural Damage [RAPID] 1 and RAPID 2). The novel, validated, RA-specific Work Productivity Survey (WPS-RA) was used to assess work place and home productivity. WPS-RA responses were collected at baseline and every 4 weeks until withdrawal/study completion. Results. At baseline, 41.6% and 39.8% of subjects were employed outside the home in RAPID 1 and RAPID 2, respectively. Compared with placebo plus MTX, CZP plus MTX significantly reduced work absenteeism and presenteeism among patients working outside the home. Significant reductions in number of household days lost, household days with productivity reduced by >50%, and days lost due to RA for participation in family, social, and leisure activities were reported by patients in active treatment relative to placebo plus MTX. Improvements in all measures were observed with CZP plus MTX as early as week 4, and maintained until the study end (12 months in RAPID 1, 6 months in RAPID 2). Findings were consistent with clinical improvements with CZP plus MTX in both trials. Conclusion. CZP plus MTX improved productivity outside and within the home and resulted in more participation in social activities compared with placebo plus MTX. These observations suggest that considerable indirect cost gains might be achieved with this therapeutic agent in RA.

Introduction The rheumatoid arthritis-specific Work Productivity Survey (WPS-RA) measures the impact of rheumatoid arthritis (RA) and treatment on patient productivity within and outside the home. It contains nine questions addressing employment status, productivity within and outside the home, and daily activities. The objective of this paper was to evaluate the discriminant validity, responsiveness, and reliability of the WPS-RA in patients with active RA. Methods Two hundred twenty subjects (mean age was 53.8 years, 83.6% were female, mean disease duration was 9.54 years, mean number of disease-modifying anti-rheumatic drugs failed was 2, and 38.6% were employed outside the home) in a phase III, 24-week, double-blind, placebo-controlled trial completed the WPS-RA at baseline and every 4 weeks until withdrawal/study completion. Validity was evaluated via known groups using baseline data (first and third quartiles of subjects' Health Assessment Questionnaire – Disability Index [HAQ-DI] scores and Short Form-36 health survey [SF-36] scores). To evaluate responsiveness, mean changes in WPS-RA at week 24 were compared between American College of Rheumatology 20% improvement criteria (ACR20) (or HAQ-DI) responders and non-responders. Standardized response mean (SRM) was also used to quantify responsiveness. All group comparisons were conducted using a non-parametric bootstrap-t method. Results Subjects with lower HAQ-DI or SF-36 scores generally had statistically greater RA-associated losses in productivity within and outside the home compared with subjects with higher scores (25 of 32 evaluations were statistically significant). Smallest differences between groupswere seen in work absenteeism and days with outside help. At week 24, ACR20 and HAQ-DI responders reported large improvements in productivity within and outside the home; non-responders reported mainly a worsening in productivity ( P ≤ 0.05). Effect size for productivity changes in ACR20 or HAQ-DI responders was moderate to large for six out of eight items (SRM = 0.48 to 1.12). The effect size was small for work absenteeism and days with outside help. (SRM = 0.4 and 0.24, respectively). In non-responders, the magnitude of change was negligible (SRM < 0.1) or small (SRM < 0.3). Conclusions The WPS-RA has demonstrated properties of discriminative validity, reliability, and responsiveness for the measurement of productivity within and outside the home in subjects with active RA.

ObjectivesThis study evaluated the association of body mass index (BMI) with health-related quality of life (HRQoL), health utilities, health care resource utilization, productivity, activity impairment, and the associated costs.MethodsResults were from the 2013 EU5 (France, Germany, Italy, Spain, UK) National Health and Wellness Survey, a nationally representative, online survey of respondents aged ≥18 years. Analyses focused on normal weight (BMI ≥18.5 kg/m2 and BMI <25 kg/m2), overweight (BMI ≥25 kg/m2 and BMI <30 kg/m2), Obese Class (OC) I (BMI ≥30 kg/m2 and BMI <35 kg/m2), OC II (BMI ≥35 kg/m2 and BMI <40 kg/m2), and OC III (BMI ≥40 kg/m2) respondents. Outcomes included HRQoL (Short Form [SF]-36v2), health utilities (SF-six dimension [6D]), productivity loss (Work Productivity and Activity Impairment questionnaire), and resource utilization (provider visits, emergency room visits, and hospitalizations) in the past 6 months. Direct and indirect costs were estimated from the literature. Generalized linear regression models predicted outcomes as a function of BMI, adjusting for covariates (age, sex, comorbidities).ResultsAmong 58,364 respondents, 46.9% were normal weight, 34.5% were overweight, 12.5% were OC I, 4.0% were OC II, and 2.1% were OC III. Metabolic comorbidities increased as BMI increased. After adjustments, all three OC respondents exhibited significantly lower HRQoL than normal weight respondents. Health utilities (normal weight: 0.720; overweight: 0.718; OC I: 0.703; OC II: 0.683; OC III: 0.662) declined with an increase in BMI (all P<0.05 vs normal). Among employed respondents (57.7%), overall work impairment increased as BMI increased. Normal (vs all OCs) had lower activity impairment and fewer provider visits, lower indirect costs (normal weight: €7,974; overweight: €7,825; OC I: €8,465; OC II: €9,394; OC III: €10,437), and lower total direct costs (normal weight: €516; overweight: €553; OC I: €583; OC II: €605; OC III: €717), all P<0.05.ConclusionIncreased BMI was associated with worse HRQoL, greater comorbidities, higher direct and indirect costs, and worse health utilities. Weight management may improve patient outcomes.

The aims of this study were (1) to compare health outcomes (i.e., health-related quality of life [HRQoL], productivity at work, and healthcare resource use visits) between those with insomnia and non-insomnia controls, (2) to compare health outcomes between those treated for insomnia and non-insomnia controls, and (3) to assess the prevalence of side effects of insomnia medications and their relationship with health outcomes. Data from the 2013 US (N = 75,000) and 5EU (N = 62,000) National Health and Wellness Survey (NHWS) were used. The NHWS is a patient-reported survey administered to a demographically representative sample of adults. Those who met DSM-V criteria for insomnia and, separately, those treated for insomnia were compared with equivalently sized control groups who were identified using a propensity score matching method. Outcomes included HRQoL (Short Form 36v2), productivity at work (Work Productivity and Activity Impairment—General Health questionnaire), and healthcare resource use visits in the past 6 months and were analyzed using one-way ANOVAs. Among those with treated insomnia, those with and without side effects were compared on health outcomes using general linear models controlling for confounding variables. Patients with insomnia (n = 4147) and treated insomnia (n = 2860) in the 5EU reported significantly worse HRQoL than controls (health utilities: 0.60 vs. 0.74; 0.60 vs. 0.74, respectively), greater overall work impairment (38.74% vs. 14.86%; 39.50% vs. 15.66%), and more physician visits in the past 6 months (9.10 vs. 4.08; 9.58 vs. 4.11). Similar findings were observed in the US. Among those treated for insomnia, 13.56% and 24.55% in the US and 5EU, respectively, were non-adherent due to side effects. In the US, non-adherence was associated with significantly worse HRQoL (health utilities: 0.60 vs. 0.64, p <.05) and greater overall work impairment (37.71% vs. 29.08%, p <.05), among other significant differences. These relationships were not significant in the 5EU. A significant burden of insomnia was observed in both the US and 5EU, and the association remained even after treatment. Non-adherence due to side effects was common and, in the case of the US, associated with significantly poorer health outcomes.

Background: Up to 50% of essential tremor patients are refractory to medication and require alternative treatment to achieve tremor relief. This study aimed to identify and analyze evidence supporting the use of the emerging magnetic resonance-guided focused ultrasound (MRgFUS) compared to alternative stimulatory and ablative interventions for the treatment of medication-refractory essential tremor: radiofrequency thalamotomy, unilateral deep brain stimulation (DBS), and stereotactic radiosurgery. Methods: A systematic literature review was conducted to identify clinical, health-related quality of life (HRQoL), and economic evidence for each intervention. Because of the lack of comparative evidence captured, a feasibility assessment was performed to determine possible comparisons between interventions, and newly established matchingadjusted indirect comparison and simulated treatment comparison techniques were used to conduct a comparison between unilateral DBS aggregate data and MRgFUS individual patient data. Results: The systematic literature review identified 1,559 records, and screening yielded 46 relevant articles. The captured studies demonstrated that radiofrequency thalamotomy, DBS, stereotactic radiosurgery, and MRgFUS all exhibit clinical efficacy, with variation in onset and duration of tremor relief, and are each associated with a unique safety profile. The matching-adjusted indirect comparison and simulated treatment comparison results demonstrated no evidence of a difference in efficacy (measured by Clinical Rating Scale for Tremor Total) and HRQoL (measured by Clinical Rating Scale for Tremor Part C) outcomes between MRgFUS and unilateral DBS in the short term (r12 months). Conclusions: This study provides preliminary evidence that MRgFUS could elicit similar short-term tremor-and HRQoL-related benefits to DBS, the current standard of care, and allowed for the first robust statistical comparison between these interventions.