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Purpose: Many hospital-based infusion centers treat patients with rheumatoid arthritis (RA) with intravenous biologic agents, yet may have a limited understanding of the overall costs of infusion in this setting. The purposes of this study were to conduct a microcosting analysis from a hospital perspective and to develop a model using an activity-based costing approach for estimating costs associated with the provision of hospital-based infusion services (preparation, administration, and follow-up) in the United States for maintenance treatment of moderate to severe RA., Methods: A spreadsheet-based model was developed. Inputs included hourly wages, time spent providing care, supply/overhead costs, laboratory testing, infusion center size, and practice pattern information. Base-case values were derived from data from surveys, published studies, standard cost sources, and expert opinion. Costs are presented in year-2017 US dollars. The base case modeled a hospital infusion center serving patients with RA treated with abatacept, tocilizumab, infliximab, or rituximab., Findings: Estimated overall costs of infusions per patient per year were $36,663 (rituximab), $36,821 (tocilizumab), $44,973 (infliximab), and $46,532 (abatacept). Of all therapies, the biologic agents represented the greatest share of overall costs, ranging from 87% to $91% of overall costs per year. Excluding infusion drug costs, labor accounted for 53% to 57% of infusion costs., Implications: Biologic agents represented the highest single cost associated with RA infusion care; however, personnel, supplies, and overhead costs also contributed substantially to overall costs (8%-16%). This model may provide a helpful and adaptable framework for use by hospitals in informing decision making about services offered and their associated financial implications., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To estimate economic impact resulting from increased biologics use for treatment of rheumatoid arthritis (RA) and Crohn's disease (CD) in Argentina, Brazil, Colombia, and Mexico., Methods: The influence of increasing biologics use for treatment of RA during 2012-2022 and for treatment of CD during 2013-2023 was modeled from a societal perspective. The economic model incorporated current and projected medical, indirect, and drug costs and epidemiologic and economic factors. Costs associated with expanded biologics use for RA were compared with non-expanded use in Argentina, Brazil, Colombia, and Mexico. A similar analysis was conducted for CD in Brazil, Colombia, and Mexico., Results: Accounting for additional costs of biologics and medical and indirect cost offsets, the model predicts that expanded use of biologics for patients with RA from 2012 to 2022 will result in cumulative net cost savings of ARS$2.351 billion in Argentina, R$9.004 billion in Brazil, COP$728.577 billion in Colombia, and MXN$18.02 billion in Mexico; expanded use of biologics for patients with CD from 2013 to 2023 will result in cumulative net cost savings for patients with CD of R$0.082 billion in Brazil, COP$502.74 billion in Colombia, and MXN$1.80 billion in Mexico. Indirect cost offsets associated with expanded biologics use were a key driver in reducing annual per-patient net costs for RA and CD., Limitations: Future economic projections are limited by the potential variance between projected and actual future values of biologic prices, wages, medical costs, and gross national product for each country., Conclusions: Increasing biologics use to treat RA and CD may limit cost growth over time by reducing medical and indirect costs. These findings may inform policy decisions regarding biologics use in Argentina, Brazil, Colombia, and Mexico.

Objectives: To evaluate the effects of adalimumab plus MTX (ADA + MTX) vs MTX monotherapy on work-related outcomes in early RA patients with elevated risk of employment loss., Methods: A post hoc analysis at weeks 26 and 24 from the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab (OPTIMA) and PRevention Of Work Disability (PROWD) trials, respectively, was conducted in MTX-naïve RA patients randomized to ADA + MTX or placebo (PBO) + MTX. Work instability was assessed using the RA-Work Instability Scale (RA-WIS) and work productivity was measured with the Work Productivity and Activity Impairment Questionnaire. Employed patients with a baseline RA-WIS score ⩾10, indicating medium to high risk for job loss, were included (OPTIMA, n = 320; PROWD, n = 124)., Results: Patients receiving ADA + MTX in OPTIMA had significantly greater improvements in RA-WIS compared with PBO + MTX (mean change -7.22 vs -5.23, respectively). Significantly higher percentages of patients in the ADA + MTX group experienced improvements in one or more risk category (58 vs 47%) and ⩾5 (55 vs 43%), ⩾7 (47 vs 35%) and ⩾9 (42% vs 26%) points in their RA-WIS score. These trends were seen in PROWD but were not significant. In OPTIMA, patients receiving ADA + MTX showed significant changes in percentage points from baseline vs PBO + MTX in activity impairment, presenteeism and overall work impairment (-32.0 vs -23.7, -24.6 vs -17.1, -27.3 vs -18.3, respectively)., Conclusions: Among early RA patients with elevated risk of employment loss, ADA + MTX therapy was associated with a significant reduction in work instability vs PBO + MTX. Significantly greater percentages of patients receiving ADA + MTX therapy achieved clinically meaningful improvements in their RA-WIS scores., (© The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: To assess trends and predictors of mechanical devices/aids use by rheumatoid arthritis (RA) patients since the introduction of biologic disease-modifying antirheumatic drugs (DMARDs)., Methods: Sociodemographic characteristics, disease characteristics, and mechanical aid use (assessed using the Health Assessment Questionnaire) were compared among RA patients ages >17 years at diagnosis, enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) registry during January 2001 to December 2003 and January 2010 to December 2012. Univariate and multivariate logistic regression analyses were used to identify predictors of mechanical aid use among patients in both cohorts., Results: Sociodemographic characteristics were similar between 1,096 patients in the 2001-2003 cohort and 11,140 patients in the 2010-2012 cohort. Disease activity was significantly lower among patients in the 2010-2012 cohort (mean ± SD Clinical Disease Activity Index score 10.1 ± 11.1 versus 17.0 ± 13.8; P < 0.001). A greater proportion of patients in the 2010-2012 cohort received biologic DMARDs (50.7% versus 32.5%; P < 0.001) and fewer were biologic-naive (39.1% versus 61.6%; P < 0.001). Fewer patients in the 2010-2012 cohort used any mechanical devices/aids (31.1% versus 40.8%; P < 0.001). In multivariate analysis, patients in the 2010-2012 cohort and those with a history of biologic agent use were less likely to use devices/aids (odds ratio [OR] 0.77 [95% confidence interval (95% CI) 0.66-0.90] and OR 0.68 [95% CI 0.62-0.75], respectively). Predictors of greater devices/aids usage included older age, female sex, higher disease activity, and less employment. Effect sizes were greatest for disease activity and employment., Conclusion: Mechanical devices/aids use among patients with RA was significantly lower during 2010-2012 versus 2001-2003 and among biologic-experienced patients, suggesting reduced disability., (© 2016, American College of Rheumatology.)

Objectives: To compare income growth over time between employees with RA treated with anti-TNFs and those treated with methotrexate (MTX)., Methods: Privately insured employees (aged ≥18) with ≥1 RA diagnosis (ICD-9: 714.0) were identified from a large-scale US employer claims database (1998-2011). Patients were stratified into treatment groups (anti-TNF-treated patients and MTX-monotherapy patients) based on their treatment history. The anti-TNF-treated patients comprised patients who filled ≥1 prescription for anti-TNFs, with or without MTX (index date defined as the date of the first anti-TNF prescription). The MTX-treated patients comprised patients who filled ≥1 prescription for MTX-monotherapy (index date randomly selected). The primary study outcome was the annual income growth rate (US dollars). Patients were followed from their index date to health plan disenrollment or the end of data availability (maximum follow-up of 5 years). The effect of treatment type on income growth was assessed using a multivariable generalized estimating equation model, adjusting for key baseline characteristics. Income growth was compared to that of the general employed population using Social Security data (1998-2011)., Results: The regression-adjusted annual growth rate in income for anti-TNF-treated patients (n = 1848) was 2.8% (CI = 1.9-3.6%), significantly greater (p < 0.05) than the 0.6% (CI = -0.2-1.4%) for MTX-monotherapy patients (n = 1866). Compared to the general employed population, income growth was lower (p < 0.05) for MTX-monotherapy patients and comparable for anti-TNF-treated patients., Conclusions: Compared to MTX-monotherapy, anti-TNF treatment is associated with a higher income growth rate among employees with RA. Anti-TNF-treated patients experienced comparable income growth to the general employed population norm.

Introduction: Biologic therapies have demonstrated efficacy and safety in several chronic systemic disorders. The authors indirectly compared response rates and costs per responder associated with biologic treatments for moderate-to-severe Crohn's disease (CD), psoriasis (Ps), and/or rheumatoid arthritis (RA)., Methods: A systematic literature search was performed to identify phase 3 randomized controlled trials of biologics for CD (adalimumab, infliximab), Ps (adalimumab, etanercept, infliximab, ustekinumab 45 mg, ustekinumab 90 mg), or methotrexate-refractory RA (abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab). Food and Drug Administration-approved dosing schedules were evaluated. Published response rates were extracted, with response defined in CD, Ps, and RA as: ≥70-point reduction in CD Activity Index at 12 months; ≥75% improvement in Psoriasis Area and Severity Index at 3 months; and ≥50% improvement in American College of Rheumatology component scores at 6 months. Within each indication, mixed-treatment comparison meta-analyses were conducted to derive pooled estimates and 95% CIs of response rate difference versus placebo for each biologic, adjusting for cross-trial variation in control-arm response rates. Cost per responder was estimated for each biologic as projected per patient drug costs (2011 US$) divided by response rate difference., Results: Altogether, 23 publications were selected. In CD, 12-month cost per responder was estimated at $116,291 (95% CI $71,637-208,348) for adalimumab and $125,169 (95% CI $60,532-267,101) for infliximab. Among biologics approved in Ps, 3-month cost per responder was lowest for adalimumab ($9,756; 95% CI $8,668-11,131), infliximab ($12,828; 95% CI $11,772-13,922), and ustekinumab 45 mg ($13,821; 95% CI $12,599-15,167). In RA, biologics with the lowest 6-month cost per responder were adalimumab ($27,853; 95% CI $19,284-40,270), etanercept ($29,140; 95% CI $14,170-61,030), and tocilizumab ($31,363; 95% CI $14,713-64,232)., Conclusion: Meta-analyses of clinical trials found considerable variation in cost-effectiveness of biologic therapies for CD, Ps, and RA. These results may help determine biologic utilization in these chronic diseases.

Background: Rates and impacts of worsening symptoms in patients with psoriasis have not been well characterized., Objectives: To assess the risk of clinically relevant worsening of psoriasis symptoms in patients treated with adalimumab versus placebo and to determine the health-related quality-of-life (HRQOL) impacts of such worsening., Methods: The cumulative incidence of worsening was compared for adalimumab (40 mg every other week following an 80 mg induction dose) versus placebo using data from two phase III randomized, placebo-controlled trials (CHAMPION and REVEAL). Clinically relevant worsening of psoriasis was defined as a follow-up visit with a ≥25% increase in the Psoriasis Area and Severity Index (PASI) from baseline or a ≥5-unit increase in the Dermatology Life Quality Index from baseline during the initial 16-week double-blind treatment periods. Patients with versus without worsening were compared in terms of pain, work productivity and activity impairment (WPAI) and the mental and physical component summary (MCS and PCS) scores of the Short-Form 36 Health Survey. A subgroup analysis was performed for patients with PASI 10-20 at baseline., Results: The 17-week risk of clinically relevant worsening was 37.0% (95% CI 26.1, 46.3) for placebo (n = 445) and 4.2% (95% CI 2.0, 6.3) for adalimumab-treated patients (n = 914) [p < 0.0001]. Patients with versus without worsening experienced substantially increased pain, increased WPAI and greater impairment in MCS and PCS. Results were similar for patients with PASI 10-20 at baseline., Limitations: The short study duration may not reflect long-term outcomes., Conclusion: Clinically relevant worsening of psoriasis symptoms was associated with substantial worsening of HRQOL. Adalimumab treatment was associated with a substantially reduced risk of clinically relevant worsening.

Background: Psoriasis is associated with health-related quality-of-life impairment and depression., Objective: We sought to determine the effect of adalimumab on depression symptoms in patients with psoriasis., Methods: Patients with moderate to severe psoriasis in a randomized, placebo-controlled, double-blind clinical trial were assessed for depression symptoms at baseline and week 12 or early termination (ET) using the Zung Self-rating Depression Scale (ZDS). The effects of adalimumab (40 mg every other week) versus placebo on ZDS score at week 12/ET were assessed using analysis of covariance. Relationships between ZDS and the Psoriasis Area and Severity Index (PASI), the Dermatology Life Quality Index, and the Short Form 36 Health Survey were assessed using Pearson correlations. Changes in ZDS score were compared for patients with and without a 75% or greater reduction in baseline PASI score., Results: Compared with the placebo group (n = 52), the adalimumab group (n = 44) experienced an additional 6-point reduction in ZDS score (95% confidence interval: 2.5-9.5; P < .001) by week 12/ET. Depression improvement was correlated with improvement in PASI (r = 0.5; P < .0001) and Dermatology Life Quality Index (r = 0.5; P < .0001). Greater ZDS score improvement was observed at week 12/ET in responders with a 75% or greater reduction in baseline PASI score than in nonresponders (10.6 [SD = 9.4] vs 1.4 [SD = 9.6]; P < .001)., Limitations: This analysis cannot distinguish whether adalimumab has a direct or indirect effect on depression., Conclusions: Adalimumab treatment reduced psoriasis symptoms, reduced depression symptoms, and improved health-related quality of life in patients with moderate to severe psoriasis., (Copyright 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)

Background: Psoriatic arthritis often affects patients with psoriasis., Objective: To examine the effect of adalimumab on psoriatic arthritis in patients with moderate to severe psoriasis., Methods: Data from patients with psoriasis and a reported history of comorbid psoriatic arthritis in 3 randomized, placebo-controlled psoriasis trials of adalimumab were analyzed., Results: Adalimumab (n = 274) reduced the risk of psoriatic arthropathy adverse events by 75% versus placebo (1.1 vs. 4.8%; p = 0.025). Psoriasis/psoriatic arthritis-related pain was significantly reduced (-31.3 vs. -5.6 visual analog scale units; p < 0.0001). At week 16, adalimumab-treated patients were more likely to respond (56.9 vs. 4.5%; p < 0.001) and responded for a greater percentage of follow-up time (39.3 vs. 2.9%; p< 0.0001) than placebo-treated patients (regression model for PASI 75 and ACR 20 responses)., Conclusion: Adalimumab treatment of moderate to severe psoriasis reduced symptoms of comorbid psoriatic arthritis., (Copyright 2009 S. Karger AG, Basel.)

Background: This study assessed the impact of simultaneous achievement of clinical, functional and structural efficacy, herein referred to as comprehensive disease control (CDC), on short-term and long-term work-related outcomes, health-related quality of life (HRQoL), pain and fatigue.Methods: Data were pooled from three randomised trials of adalimumab plus methotrexate for treatment of early-stage or late-stage rheumatoid arthritis (RA). CDC was defined as 28-joint Disease Activity Score using C reactive protein <2.6, Health Assessment Questionnaire <0.5 and change from baseline in modified Total Sharp Score ≤0.5. Changes in scores at weeks 26 and 52 for work-related outcomes, Short Form 36 (SF-36) physical (PCS) and mental component scores (MCS), a Visual Analogue Scale measuring pain (VAS-Pain) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were compared between patient groups defined by achievement of CDC at week 26 using linear regression with adjustment for baseline scores.Results: Patients with RA who achieved CDC at week 26 (n=200) had significantly greater improvements in VAS-Pain (46.9 vs 26.9; p<0.0001), FACIT-F (13.3 vs 7.5; p<0.0001), SF-36 PCS (19.7 vs 8.9; p<0.0001) and SF-36 MCS (8.1 vs 5.0; p=0.0004) than those who did not (n=1267). Results were consistent at week 52 and among methotrexate-naive patients with early RA, methotrexate-experienced patients with late-stage RA and patients with inadequate response to methotrexate.Conclusions: Patients with RA who achieved CDC at week 26 had improved short-term and long-term HRQoL, pain, fatigue and work-related outcomes compared with patients who do not. These results demonstrate that the joint achievement of all CDC components provides meaningful benefits to patients.Trial Registration Numbers: DE019: NCT00195702, PREMIER: NCT00195702, OPTIMA: NCT00195702. [ABSTRACT FROM AUTHOR]