The effects of adalimumab treatment and psoriasis severity on self-reported work productivity and activity impairment for patients with moderate to severe psoriasis.

BACKGROUND: Psoriasis significantly impairs work productivity and daily activities. OBJECTIVES: We sought to examine the effects of adalimumab on psoriasis-related work productivity and activity impairment and associations between the impairment and psoriasis severity in patients with moderate to severe psoriasis. METHODS: Data were from the first 16 weeks of the Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis TriAL (REVEAL). Outcomes as measured by the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-Psoriasis) included employment status, total work productivity impairment, and total activity impairment. Logistic regression and analyses of covariance were used to assess the effects of adalimumab and treatment response (≥ 75% improvement in Psoriasis Area and Severity Index responders) on WPAI-Psoriasis outcomes. Longitudinal generalized estimating equations and Pearson correlation coefficients were used to assess associations between WPAI outcomes and psoriasis severity. RESULTS: Greater improvements in total work productivity impairment and total activity impairment were observed with adalimumab treatment versus placebo (15.5 and 11.1 percentage points, respectively; P < .001). Unemployment rate, total work productivity impairment, and total activity impairment were significantly associated with greater baseline psoriasis severity. Changes in WPAI outcomes were significantly correlated with greater psoriasis severity. The Dermatology Life Quality Index had stronger associations with changes in WPAI outcomes compared with clinical severity measures (Psoriasis Area and Severity Index and Physician Global Assessment). LIMITATIONS: REVEAL only included WPAI data for 16 weeks. Therefore, long-term impact of adalimumab treatment on productivity outcomes could not be assessed. In addition, information on occupational job title or industry was not collected and data were not adjusted for psoriatic arthritis. CONCLUSIONS: Adalimumab reduced psoriasis-related work productivity and activity impairment in patients with moderate to severe psoriasis.

Risks of developing psychiatric disorders in pediatric patients with psoriasis.

BACKGROUND: Symptoms of psoriasis can be embarrassing and distressing, and may increase risk of developing psychiatric disorders in young people. OBJECTIVE: We sought to compare incidences of psychiatric disorders between pediatric patients with psoriasis and psoriasis-free control subjects. METHODS: Patients (<18 years) with continuous health plan enrollment 6 months before and after first psoriasis diagnosis (index date) were selected (Thomson Reuters MarketScan database, 2000-2006 [Thomson Reuters, New York, NY]). Patients with psoriasis (N = 7404) were matched 1:5 on age and sex to psoriasis-free control subjects (N = 37,020). Patients were followed from index date to first diagnosis of a psychiatric disorder (ie, alcohol/drug abuse, depression, anxiety disorder, bipolar disorder, suicidal ideation, eating disorder), end of data availability, or disenrollment. Patients with psychiatric diagnoses or psychotropic medication use before the index date were excluded. Cox proportional hazard models controlling for age, sex, and comorbidities were used to estimate the effect of psoriasis on risks of developing psychiatric disorders. RESULTS: Patients with psoriasis were significantly more at risk of developing psychiatric disorders versus control subjects (5.13% vs 4.07%; P = .0001; hazard ratio = 1.25; P = .0001), especially depression (3.01% vs 2.42%; P = .0036; hazard ratio = 1.25; P = .0053) and anxiety (1.81% vs 1.35%; P = .0048; hazard ratio = 1.32; P = .0045). LIMITATIONS: Retrospective, observational studies of medical claims data are typically limited by overall quality and completeness of data and accuracy of coding for diagnoses and procedures. CONCLUSIONS: Pediatric patients with psoriasis had an increased risk of developing psychiatric disorders, including depression and anxiety, compared with psoriasis-free control subjects.

Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: efficacy and safety results from an open-label study.

BACKGROUND: Strategies for transitioning patients with psoriasis from suboptimal therapy have not been delineated. OBJECTIVE: We sought to determine the efficacy and safety of transitioning to adalimumab for the treatment of psoriasis in patients with suboptimal response to prior therapy with etanercept, methotrexate (MTX), or narrowband (NB)-ultraviolet (UV)B phototherapy. METHODS: In this 16-week, open-label, phase IIIb trial, patients with chronic plaque psoriasis discontinued suboptimal therapy between 11 and 17 days (etanercept) or between 4 and 10 days (MTX and NB-UVB) before initiating adalimumab (80 mg at week 0, then 40 mg every other week from week 1). The primary end point was the percentage of patients achieving a Physician Global Assessment of "clear" or "minimal" at week 16. RESULTS: At week 16, Physician Global Assessment of "clear" or "minimal" was achieved by 52% of all enrolled patients (79 of 152) and 49%, 61%, and 48% in the etanercept, MTX, and NB-UVB subgroups, respectively. Four patients (2.6%) experienced at least 125% worsening of Psoriasis Area and Severity Index score relative to screening value at any study visit. The adalimumab safety profile was consistent with results from other psoriasis clinical trials. LIMITATIONS: This study is limited by its relatively short 16-week duration, small patient enrollment, and open-label design. CONCLUSION: Patients who had a suboptimal response to etanercept, MTX, or NB-UVB phototherapy experienced a similar, approximately 50% likelihood of achieving a clinically relevant response to adalimumab. Immediate transition to adalimumab from prior suboptimal therapy, with no dosage tapering or overlap, had a low risk of psoriasis flare.

Effects of adalimumab versus placebo on risk of symptom worsening in psoriasis and subsequent impacts on health-related quality-of-life: analysis of pooled data from two randomized, double-blind, placebo-controlled, multicentre clinical trials.

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.

Benefit-risk analysis of adalimumab versus methotrexate and placebo in the treatment of moderate to severe psoriasis: comparison of adverse event-free response days in the CHAMPION trial.

BACKGROUND: The Comparative Study of Humira versus Methotrexate (MTX) versus Placebo in Psoriasis Patients (CHAMPION) demonstrated superior efficacy of biologic over conventional systemic immunosuppressant therapy in psoriasis. OBJECTIVE: We sought to compare the risk-benefit profile of adalimumab (ADA), MTX, and placebo using data from CHAMPION. METHODS: Patients randomized to ADA (n = 107), MTX (n = 110), or placebo (n = 53) were followed up for 16 weeks. Response (≥75% improvement in Psoriasis Area and Severity Index), days free of adverse events (AEs), moderate to severe AEs, infection-related AEs, and study drug-related AEs were analyzed. RESULTS: ADA treatment was associated with substantially more days (SD) of AE-free response compared with MTX or placebo treatment, respectively: 36.9 (31.1) versus 8.3 (15.9) or 6.7 (18.1) days of response free of any AEs, 43.8 (31.9) versus 11.1 (19.9) or 7.9 (19.9) days of response free of moderate to severe AEs, 48.5 (29.2) versus 12.4 (21.7) or 9.2 (21.8) days of response free of infection-related AEs, and 44.6 (31.4) versus 11.8 (21.1) or 10.0 (24.0) days free of study drug-related AEs (all P < .0001 for ADA vs MTX or placebo). LIMITATIONS: This clinical trial-based analysis may not have captured the full spectrum of AEs in the actual clinical setting. The short (16-week) duration of the trial limited the ability to capture some important but uncommon AEs associated with long-term ADA or MTX use. CONCLUSION: With 4 times as many AE-free response days, ADA demonstrated a superior benefit-risk profile.

The effect of adalimumab on reducing depression symptoms in patients with moderate to severe psoriasis: a randomized clinical trial.

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.

Impact of adalimumab on symptoms of psoriatic arthritis in patients with moderate to severe psoriasis: a pooled analysis of randomized clinical trials.

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.

High prevalence of potential drug-drug interactions for psoriasis patients prescribed methotrexate or cyclosporine for psoriasis: associated clinical and economic outcomes in real-world practice.

BACKGROUND: Methotrexate (MTX) and cyclosporine (CYC) may adversely interact with common medications in patients with psoriasis. OBJECTIVE: Our purpose was to investigate the prevalence and outcomes of MTX/CYC polypharmacy. METHODS: We evaluated rates of events that may be associated with drug-related toxicity, health care resource utilization and costs for patients with psoriasis in the Ingenix(R) Impact National Managed Care Database (1999-2007) who were exposed or not exposed to potential drug-drug interactions. RESULTS: Among 4,583 (57.6%) exposed and 3,372 (42.4%) nonexposed patients, nonsteroidal anti-inflammatory drugs and antibiotics were the most common drugs with potential interactions. The exposed patients had significantly greater risks of developing renal [adjusted odds ratio (OR): 2.58; p = 0.0145], gastrointestinal (OR: 1.36; p = 0.0197) and pulmonary events (OR: 1.20; p = 0.0470), and significantly greater health care resource utilization (e.g. OR for inpatient and emergency department visits: 1.47; p < 0.0001) and costs (adjusted incremental cost: USD 1,722; p < 0.0001). CONCLUSIONS: MTX/CYC polypharmacy is prevalent in patients with psoriasis and associated with significant risks.

Guidelines for pharmacoeconomic and outcomes research fellowship training programs: joint guidelines from the american college of clinical pharmacy and the international society of pharmacoeconomics and outcomes research.

Abstract Pharmacoeconomics and outcomes research (PEOR) demonstrates the added value of health services and treatments and is used by a variety of individuals in numerous settings to optimize patient care. Currently, 51 PEOR fellowship programs are publicized on Web sites from organizations such as the American College of Clinical Pharmacy (ACCP), the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and the Academy of Managed Care Pharmacy. These programs demonstrate the diversity of PEOR fellowships, as they are offered by sponsors in a variety of environments (e.g., academia, industry, consulting services, United States managed care, and government). Although the program sponsors vary, all fellowships should have the common goal of providing directed, highly individualized postgraduate training designed to prepare participants to become independent PEOR researchers. Like any health discipline, advancements in knowledge and technology along with changes in health care systems require refinement of existing training programs, including PEOR fellowships. Members of ACCP and ISPOR developed a survey instrument to assess structure, educational objectives, and outcome measures of PEOR fellowship programs. The survey objectives were to determine PEOR researchers' beliefs regarding qualifications of the training site, program, and preceptors(s) as well as fellowship applicant requirements, research commitment, didactic coursework and evaluation of fellows' research skills; and to develop PEOR fellowship guidelines based on data obtained from the survey. Pharmacoeconomics and outcomes research fellowship guidelines were originally published in 1999; this document outlines the revised PEOR fellowship guidelines based on recent literature and results of the ACCP-ISPOR survey described above. These guidelines are intended to assist PEOR researchers design, refine, and self-assess their fellowship program and to serve as a tool for prospective PEOR fellowship candidates to evaluate programs.

Association between hospital size and pharmacy department productivity.

PURPOSE: The purposes of this study were to characterize and quantify workload and productivity in hospitals according to their size, to establish comparative statistics useful for pharmacy administrators as a means to contrast their efficiency to that of other hospitals of similar sizes, and to provide data to enable policymakers to better assess staffing and resource needs. METHODS: A 50-item Web-based survey designed to illicit information about pharmacy department staffing, workload, and productivity was sent electronically to 242 members of Consorta, Inc., a group-purchasing organization. Responses were received from 110 organizations, a response rate of 45.5%. The responses were categorized into three groups according to the number of staffed beds and were profiled and compared using descriptive and inferential statistics. RESULTS: Pharmacy department workload and expenditures were primarily a function of hospital size: Hospital volume statistics, pharmacy expenditures, hours of operation, pharmacy full-time equivalents (FTEs), and dispensing workload all are highly dependent on the size of the facility. The range of clinical services provided by small, medium, and large hospitals did not differ with the exception of a few services provided more often in larger hospitals. Overall productivity ratios demonstrated greater efficiency among larger hospitals. In terms of costs, pharmacy and hospital expenditures per occupied bed and per admission generally decreased as hospital size increased. CONCLUSION: Results of a survey suggested consistency in clinical services provided by hospitals of varying size and increased productivity with increasing hospital size. Respondents employed fewer FTEs than those in other national surveys.

Monitoring of pharmacy staffing, workload, and productivity in community hospitals.

PURPOSE: The purpose of this survey was to identify and characterize pharmacy productivity monitoring systems used in community hospitals that were part of a national group purchasing organization (GPO). METHODS: A 50-item questionnaire was developed, pretested, and sent electronically to the directors of pharmacy at 242 member hospitals of Consorta, Inc., a national GPO. The questionnaire was designed to elicit information on (1) hospital pharmacy demographics, (2) systems used to measure hospital pharmacy productivity, and (3) staffing levels and workload. Hospital demographic data were also obtained for respondent and nonrespondent hospitals from the American Hospital Association's AHA Guide. Descriptive statistics, Student's t tests, and chi-square tests were used to characterize the data and compare respondents with nonrespondents. RESULTS: Responses were received from 110 hospitals (45.5%). No clinically significant differences were found when respondent and nonrespondent hospitals were compared based on AHA Guide data. The productivity workload ratios monitored most often by respondent hospitals were full-time equivalents (FTEs) per adjusted patient day, FTEs per dose dispensed, and FTEs per dose billed. Respondents reported a mean +/- S.D. of 21.90 +/- 18.83 actual FTEs and total doses dispensed, billed, or administered per year of 111,391.4 +/- 111,538.0. A major limitation of the productivity systems used in the hospitals was the inability of the systems to account for clinical services performed by the pharmacy staff. CONCLUSION: A survey of community hospitals indicated that although most engaged in productivity monitoring, systems for such measurement often failed to capture all relevant clinical workload data.

Economic evaluation of biologic therapies for the treatment of moderate to severe psoriasis in the United States.

BACKGROUND: New biologic therapies are available for moderate to severe psoriasis. OBJECTIVE: To determine the most cost-effective sequence of biologic treatments. METHODS: Through modeling of the clinical pathway of biologic agents, adalimumab, alefacept, efalizumab, etanercept, and infliximab, the costs and benefits (quality-adjusted life-years [QALYs]) were determined. A decision rule determined the optimal treatment sequence comparing costs and QALYs. RESULTS: While infliximab was found to provide the most incremental QALY and etanercept was found to be the least costly, on balance, the incremental cost-effectiveness ratio of adalimumab was the most favorable (ICER = $544/QALY). Consequently, the optimal sequence would begin with adalimumab and be followed by etanercept, infliximab, efalizumab, and alefacept, respectively. The limitations of this study are that evidence was based on indirect comparisons of biologic effectiveness, and toxicities were not included in the model. CONCLUSIONS: In consideration of cost-effectiveness in prescribing biologics for moderate to severe psoriasis, the optimal sequence would begin with adalimumab.

Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial.

OBJECTIVE: To determine the efficacy, safety, and sustainability of response to adalimumab therapy for moderate to severe chronic plaque psoriasis involving hands and/or feet. DESIGN: Sixteen-week, randomized, double-blind, placebo-controlled evaluation of adalimumab therapy for moderate to severe chronic plaque psoriasis involving the hands and/or feet with a 12-week open-label extension (Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet [REACH]). SETTING: Multicenter outpatient study in the United States and Canada. PARTICIPANTS: Patients with chronic plaque psoriasis on the hands and/or feet with a Physician's Global Assessment of hands and/or feet (hfPGA) score of "moderate" or above. INTERVENTION: Patients were randomized 2:1 to adalimumab (80 mg at week 0, then 40 mg every other week starting at week 1) or to matching placebo. MAIN OUTCOME MEASURE: Percentage of patients achieving an hfPGA score of "clear" or "almost clear" at week 16. RESULTS: Seventy-two patients (adalimumab [n = 49];placebo [n = 23]) were evaluated. Baseline percentages of patients with moderate and severe hfPGA scores were 76% and 24%, respectively, for the adalimumab group and 74% and 26%, respectively, for the placebo group. At week 16, 31% and 4% of patients randomized to adalimumab and placebo, respectively, achieved an hfPGA score of clear or almost clear (P = .01). At week 28, 80% of the hfPGA clear or almost clear response was maintained from week 16 (25% for patients randomized to adalimumab). Adverse events in both groups were generally mild to moderate. In both periods combined, nasopharyngitis (27% and 13% for adalimumab- and placebo-treated patients, respectively) was most frequently reported. CONCLUSION: Adalimumab is efficacious and well tolerated for treatment of chronic plaque psoriasis of hands and/or feet, with efficacy largely maintained to 28 weeks. Trial Registration clinicaltrials.gov Identifier: NCT00735787.

Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial.

BACKGROUND: Psoriasis is associated with a variety of major physical and mental co-morbidities. OBJECTIVE: To assess the incremental burden of co-morbidities on patient-reported outcomes and evaluate the efficacy and safety of adalimumab in psoriasis patients with co-morbidities. STUDY DESIGN: Data were obtained from the initial 16-week, double-blind treatment period of REVEAL (Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis triAL), a randomized, multicenter, phase III clinical trial. INTERVENTION: Patients with moderate to severe psoriasis were randomized in a 2 : 1 ratio to receive adalimumab 80 mg (two 40 mg injections administered subcutaneously) at baseline followed by one 40 mg injection every other week from week 1 to week 15 or placebo. MAIN OUTCOME MEASURES: Clinical severity (Psoriasis Area and Severity Index [PASI]) and patient-reported outcomes (Dermatology Life Quality Index [DLQI], Short Form 36 [SF-36] health survey, Work Productivity and Activity Impairment [WPAI] questionnaire) were assessed during the trial. The effect of selected co-morbidities (i.e. hypertension, psoriatic arthritis, hyperlipidemia, obesity, depression, other forms of arthritis, diabetes mellitus, and other cardiovascular diseases) on patient-reported outcomes was evaluated using multivariate analysis of covariance models. Subgroup analyses were performed by co-morbidity type to statistically compare the clinical efficacy, patient-reported outcome benefits, and safety of adalimumab with placebo in the presence of these conditions. RESULTS: Study co-morbidities were each independently associated with significantly greater impairment on at least one general patient-reported outcome measured at baseline (all p < 0.05), with the exception of hyperlipidemia. During the 16-week study, adalimumab patients demonstrated significantly greater PASI 75 response rates (defined as a reduction of at least 75% in PASI scores from baseline) compared with placebo patients for all co-morbidity subgroups. Adalimumab provided consistent improvements in DLQI, SF-36 Physical Component Summary and Mental Component Summary scores, and WPAI total scores from baseline to week 16 within co-morbidity subgroups. Rates of serious adverse events (AEs), serious infectious AEs, and AEs leading to discontinuation were comparable between adalimumab and placebo for patients with co-morbidities. CONCLUSIONS: Co-morbidities were associated with additionally impaired health-related quality of life and work productivity in patients with psoriasis. Adalimumab significantly improved efficacy and patient-reported outcomes and was well tolerated in patients with co-morbidities.

Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept.

The absence of head-to-head trials is a common challenge in comparative effectiveness research and health technology assessment. Indirect cross-trial treatment comparisons are possible, but can be biased by cross-trial differences in patient characteristics. Using only published aggregate data, adjustment for such biases may be impossible. Although individual patient data (IPD) would permit adjustment, they are rarely available for all trials. However, many researchers have the opportunity to access IPD for trials of one treatment, a new drug for example, but only aggregate data for trials of comparator treatments. We propose a method that leverages all available data in this setting by adjusting average patient characteristics in trials with IPD to match those reported for trials without IPD. Treatment outcomes, including continuous, categorical and censored time-to-event outcomes, can then be compared across balanced trial populations. The proposed method is illustrated by a comparison of adalimumab and etanercept for the treatment of psoriasis. IPD from trials of adalimumab versus placebo (n = 1025) were re-weighted to match the average baseline characteristics reported for a trial of etanercept versus placebo (n = 330). Re-weighting was based on the estimated propensity of enrolment in the adalimumab versus etanercept trials. Before matching, patients in the adalimumab trials had lower mean age, greater prevalence of psoriatic arthritis, less prior use of systemic treatment or phototherapy, and a smaller mean percentage of body surface area affected than patients in the etanercept trial. After matching, these and all other available baseline characteristics were well balanced across trials. Symptom improvements of ≥75% and ≥90% (as measured by the Psoriasis Area and Severity Index [PASI] score at week 12) were experienced by an additional 17.2% and 14.8% of adalimumab-treated patients compared with the matched etanercept-treated patients (respectively, both p < 0.001). Mean percentage PASI score improvements from baseline were also greater for adalimumab than for etanercept at weeks 4, 8 and 12 (all p < 0.05). Matching adjustment ensured that this indirect comparison was not biased by differences in mean baseline characteristics across trials, supporting the conclusion that adalimumab was associated with significantly greater symptom reduction than etanercept for the treatment of moderate to severe psoriasis.

Economic burden of psoriasis compared to the general population and stratified by disease severity.

OBJECTIVE: To evaluate health care utilization and costs for patients with psoriasis vs. the general population and by psoriasis severity. RESEARCH DESIGN AND METHODS: Claims data were analyzed for adult patients with > or =1 diagnosis of psoriasis and continuous enrollment during the year of 2003 (case sample). A control sample was matched 2:1 on baseline demographic characteristics to the case sample. Case samples were further stratified by psoriasis severity based on treatment patterns. Outcomes were compared descriptively and by a multivariate two-part model to evaluate differences between the case vs. control groups and by psoriasis severity. MAIN OUTCOME MEASURES: Outcomes included health care resource utilization and health care costs. RESULTS: A total of 56,528 patients with psoriasis met the inclusion criteria. Patients with psoriasis had significantly greater total health care resource utilization, total medical resource utilization, and total drug utilization vs. the control sample (p < 0.0001). Compared with control patients, patients with psoriasis had significantly greater total health care costs ($5529 vs. $3509), including greater medical costs ($3925 vs. $2687) and drug costs ($1604 vs. $822; all p < 0.0001). Patients with moderate to severe psoriasis (n = 5248) had greater total health care costs vs. patients with mild psoriasis (n = 51,280) ($10,593 vs. $5011), including greater medical costs ($5854 vs. $3728) and drug costs ($4738 vs. $1283; all p < 0.0001). Multivariate analyses confirmed the increased utilization and costs in all comparisons. LIMITATIONS: The study limitations included limited generalizability of the findings beyond the study population, classification of disease severity based on treatment instead of clinical measures, and exclusion of out-of-pocket costs and indirect costs in the study. CONCLUSIONS: Patients with psoriasis incur greater health care resource utilization and costs compared with the general population. Psoriasis severity is positively associated with increased health care resource utilization and costs.

Utilization pattern of etanercept and its cost implications in moderate to severe psoriasis in a managed care population.

OBJECTIVE: To describe the utilization patterns, particularly dosage-escalation patterns, and economic implications of etanercept in the treatment of moderate to severe psoriasis in a real-world setting. METHODS: Patients with psoriasis receiving etanercept were identified from the Integrated Health Care Information Services database and were observed for 12 months or until etanercept discontinuation (defined as gap of >60 days between prescriptions). Patients were excluded if they had other autoimmune conditions or received TNF antagonists within 6 months of the index date. Ratios of patients with dosage increase to total sample were calculated. Among patients continuing treatment for 1 year, etanercept dosage and drug costs (measured by average wholesale price) were compared for patients with and without dosage increase using the Wilcoxon signed rank test. RESULTS: 55.2% of patients discontinued during the study year; 51.6% of patients initiated at 100 mg/week; and 34.8% who initiated at 50 mg/week required dosage increases. Among patients continuously treated for 1 year, dosage increase resulted in incremental annual drug costs of $8,440 and $9,313 for 100 and 50 mg/week, respectively (both p < 0.0001). The annual dosage of etanercept in excess of the labeled amount translated into $2,040 and $3,032 greater etanercept costs per patient in the 100 and 50 mg/week groups, respectively. CONCLUSION: In this analysis, 33-50% of patients with psoriasis required dosage increases during their first year of etanercept therapy, resulting in increased annual treatment costs as compared with expected costs imputed from label indications. Because of patient selection criteria, the findings may not be representative of the entire population of patients with psoriasis.

Cost analysis of divalproex sodium extended-release compared to valproic acid in the treatment of bipolar disorder.

OBJECTIVES: To analyze, from a payer perspective, the net pharmaceutical and medical costs of prescribing divalproex sodium extended-release (DVPX-ER) versus valproic acid (VPA) in patients with bipolar disorder. METHODS: The study used a decision analytic framework to compare the total costs associated with DVPX-ER relative to VPA in the treatment of bipolar disease. The decision model incorporated two primary outcomes: GI side effects and treatment success. Levels of health service utilization and probability values were obtained from an expert panel comprised of 15 psychiatrists. Unit costs were obtained from an academic medical center. Two-way sensitivity analysis and a Monte Carlo simulation were conducted to examine the stability of the results. RESULTS: The average probability of GI side effects associated with VPA and DVPX-ER estimated by the expert panel was 0.36 and 0.10 respectively. The average probability of treatment success for VPA and DVPX-ER was estimated to be 0.45 and 0.58 respectively. In the base case analysis, the expected total cost per patient was $34 208.84 and $25 336.13 for VPA and DVPX-ER respectively, a difference (incremental cost) of -$8188.87. Probabilistic sensitivity analysis using Monte Carlo simulation indicated a negative incremental cost of using DVPX-ER relative to VPA in a majority (approximately 70%) of cases. CONCLUSIONS: The results from this decision analysis, based on probabilities of major events and associated utilization from an expert panel, suggest that divalproex sodium extended-release results in lower total costs than valproic acid in the treatment of bipolar disorder. Limitations of this study primarily involved the sources of data used in the model, including that derived from expert opinion.