Association of Inadequately Controlled Disease and Disease Severity With Patient-Reported Disease Burden in Adults With Atopic Dermatitis.

Importance: Real-world data are limited on the patient-reported burden of adult atopic dermatitis (AD). Objective: To characterize the patient-reported burden of AD with regard to impact of disease severity and inadequate control in adults from clinical settings. Design, Setting, and Participants: In this cross-sectional study using data from 6 academic medical centers in the United States collected by a self-administered internet-based questionnaire, 1519 adult patients with AD were stratified by AD severity as mild or moderate/severe using the Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD). Patients with moderate/severe disease using systemic immunomodulators/phototherapy were further stratified as having adequate or inadequate disease control. Strata were compared for all outcomes. Main Outcomes and Measures: Outcomes included validated measures and stand-alone questions assessing itch (pruritus numerical rating scale; PO-SCORAD itch visual analog scale), pain (numerical rating scale), sleep (PO-SCORAD sleep visual analog scale; sleep interference with function), anxiety and depression (Hospital Anxiety and Depression Scale), and health-related quality of life (Dermatology Life Quality Index). Results: Among the 1519 adult patients with AD, relative to mild AD (n = 689, 64% women; mean [SD] age, 46.5 [18.0] years), patients with moderate/severe AD (n = 830, 66.8% women; mean [SD] age, 45.1 [16.9] years) reported more severe itching and pain, greater adverse effects on sleep, higher prevalence of anxiety and depression (417 [50.2%] vs 188 [27.3%]), and greater health-related quality-of-life impairment. The 103 patients with moderate/severe AD with inadequate disease control despite treatment with systemic immunomodulators or phototherapy (55.7%) reported higher burdens of itch and sleeping symptoms vs patients with controlled disease including more days per week with itchy skin (5.7 vs 2.7) and higher proportions with itch duration greater than half a day (190 [22.8%] vs 20 [2.9%]). Sleep symptoms included trouble sleeping (3.9 vs 1.1 on the PO-SCORAD VAS), longer sleep latency (38.8 vs 21.6 minutes), more frequent sleep disturbances (2.6 vs 0.4 nights in past week), and greater need for over-the-counter sleep medications (324 [39%] vs 145 [21%]). Conclusions and Relevance: Inadequate disease control was common among patients with moderate/severe AD, and was associated with a higher patient-reported burden than patients with controlled disease. Regardless of disease control, the burden of moderate/severe AD was higher than mild AD, suggesting a need for more effective therapies for moderate/severe disease.

Health Care Resource Utilization and Costs Among Adults with Atopic Dermatitis in the United States: A Claims-Based Analysis.

BACKGROUND: Data on health care resource utilization (HCRU) and costs for patients with atopic dermatitis (AD) are lacking. OBJECTIVE: The objective of this study was to determine HCRU and costs associated with AD in US adults. METHODS: This retrospective study identified patients with AD from the Truven Health Marketscan Commercial Claims and Encounters database during 2013 based on ≥2 claims with International Classification of Diseases, Ninth Revision code 691.8 (n = 10,533; first claim = index event); 1-year continuous enrollment before and after index was required. Patients were age- and gender-matched in a 1:3 ratio to controls without AD (n = 31,599). Patients with AD were further categorized into 2 groups, with treatment regimens as surrogates for increasing disease severity: claim for phototherapy or systemic immunomodulatory agents (more severe) or no claim for either (less severe). Incremental differences in resource use and costs were evaluated using multivariate analysis. RESULTS: AD was associated with higher utilization and costs across resource categories (all P < .0001); adjusted total incremental annual costs were $3,302. Resource utilization and costs were higher in the more severe group, with adjusted total incremental annual costs of $4,463. CONCLUSION: AD is associated with significant incremental health care utilization and costs, which are higher in patients with more severe disease.

Economic impact of expanded use of biologic therapy for the treatment of rheumatoid arthritis and Crohn's disease in Argentina, Brazil, Colombia, and Mexico.

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.

Increased risk of venous thromboembolic events with corticosteroid vs biologic therapy for inflammatory bowel disease.

BACKGROUND & AIMS: We investigated whether treatment of active inflammatory bowel disease with biologic agents is associated with a reduced risk of venous thromboembolic events (VTEs) compared with corticosteroid therapy. METHODS: We performed a retrospective analysis of 15,100 adults with inflammatory bowel disease who were identified from the Truven Health MarketScan databases. We analyzed data from patients who received 6 months of continuous medical and prescription coverage before and 12 months after their first diagnosis and had no VTE during the 6 months before they first received biologic or corticosteroid therapy. The outcome assessed was any VTE that occurred during the 12-month follow-up period. A multivariate logistic regression model was used to evaluate the effects of biologic, corticosteroid, and combination therapies (biologics and corticosteroids) on VTE risk. RESULTS: Three hundred twenty-five VTEs occurred during the study period (in 2.25% of patients receiving only corticosteroids, in 0.44% of patients receiving biologics, and in 2.49% of patients receiving combination therapy). Compared with patients receiving only corticosteroids, the odds ratio for VTE in patients receiving only biologics was 0.21 (95% confidence interval, 0.05-0.87) in the multivariate model, and the odds ratio for VTE in patients on combination therapy was 1.01. CONCLUSIONS: Compared with treatment with only a biologic agent, corticosteroid therapy is associated with a nearly 5-fold increase in risk for VTE. Combination therapy with corticosteroids and biologic agents was associated with the same risk for VTE as that of corticosteroids alone. Corticosteroids therefore appear to increase risk for VTE.

Risk-benefit analysis of adalimumab versus traditional non-biologic therapies for patients with Crohn's disease.

BACKGROUND: Adalimumab is indicated for the treatment of moderately to severely active Crohn's disease (CD). A systematic analysis of risks and benefits of adalimumab versus traditional non-biologic therapies for patients refractory to non-biologic therapy is lacking. METHODS: A base-case analysis compared expected benefits of adalimumab therapy with a 12-week stopping rule for non-responders versus non-biologic therapies using data from clinical trials (CHARM, CLASSIC I). Adverse events (AEs) recorded in clinical trials (CHARM, CLASSIC I, CLASSIC II, GAIN, open-label extensions) were compiled. Sensitivity analyses incorporated all observed benefits of adalimumab and placebo (CHARM, CLASSIC I, GAIN) and observed AEs from a systematic literature review of non-biologic therapies (MEDLINE search of randomized trials 1990-2007). Distributional information from maintenance clinical trial observations and benefit model predictions were used in a probabilistic simulation. Incremental net benefits were estimated based on utility estimates from the literature. RESULTS: Average time in remission (i.e., CDAI <150) over 1 year of therapy was 39.9% for adalimumab versus 6.6% for traditional non-biologic therapies. Adalimumab was associated with fewer expected hospitalizations, better fistula closure rates, and lower AE rates. These findings were robust in sensitivity analyses. In the probabilistic simulation, with serious AEs as a composite of risks, adalimumab provided greater benefits with fewer AEs versus non-biologic therapies (P < 0.01). Adalimumab demonstrated greater incremental net quality-adjusted life-years (0.12) versus non-biologic therapies. CONCLUSIONS: Adalimumab demonstrated greater benefits and lower rates of AEs versus traditional non-biologic therapies for patients with moderately to severely active CD who were refractory to non-biologic therapies.

Adherence to infliximab maintenance therapy and health care utilization and costs by Crohn's disease patients.

INTRODUCTION: Studies suggest infliximab decreases hospitalization and surgery rates in Crohn'fs disease (CD). The aim of this analysis was to evaluate adherence to infliximab maintenance therapy and the impact of medication adherence on health care utilization and costs by patients with CD. METHODS: Patients with CD who had at least four infliximab infusions (with the time between consecutive infusions < or =12 weeks for the first four infusions) during the first year following infliximab initiation (index date) were identified from the Integrated Health Care Information Service claims database (2002-2006). Nonadherence was defined as fewer than seven infliximab infusions in the first year. One-year health care resource utilization and costs (excluding infliximab drug and administration costs) were compared between adherent and nonadherent patients, with adjustment for baseline characteristics. RESULTS: A total of 571 patients with CD who were receiving infliximab maintenance therapy were identified. The infusion-based nonadherence rate was 34.3% during the first year of therapy. The multivariate analysis demonstrated that compared with adherent patients, nonadherent patients were more likely to have been hospitalized (odds ratio [OR]=2.7 [all-cause] and OR=2.5 [CD-related]; both P<0.001). Compared with infliximab-adherent patients, adjusted medical costs by nonadherent patients were 73% ($6,692) and 90% ($4,961) greater for all-cause and CD-related medical costs, respectively (both P<0.001), and adjusted hospitalization costs were 115% ($11,450) and 115% ($9,570) greater for all-cause and CD-related hospitalization costs, respectively (both P<0.001). CONCLUSION: More than one-third of patients on infliximab maintenance therapy were nonadherent to recommended maintenance. Further, nonadherence was associated with increased medical costs and a greater rate of hospitalization.