Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: results from a randomized, controlled Phase III study.

OBJECTIVE: To evaluate the impact of adalimumab on health-related quality of life (HRQOL) for patients with moderate to severe plaque psoriasis. BACKGROUND: Psoriasis is a chronic, inflammatory, immune-mediated disease that has a significant impact on patients' HRQOL. Adalimumab is a fully human monoclonal antibody that blocks tumor necrosis factor, a pro-inflammatory cytokine, and is effective and well-tolerated for patients with moderate to severe psoriasis. METHODS: Data were obtained for a secondary analysis of patients in a randomized, controlled Phase III trial evaluating the effect of adalimumab in patients with psoriasis (N = 1,205). Patients with moderate to severe psoriasis were randomized in a 2:1 ratio to 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. Short Form-36 (SF-36) Health Survey scores of psoriasis patients were used to assess HRQOL and were compared with United States (US) population norms at baseline and Week 16. RESULTS: Baseline Physical Component Summary (PCS) scores for the placebo and adalimumab groups were similar to the general US population. Baseline mean Mental Component Summary (MCS) scores were significantly lower for the adalimumab and placebo groups compared with the general population (47.4, 47.7, and 50.8 points, respectively; p < 0.0001). PCS scores at Week 16 for patients receiving adalimumab had improved and were significantly greater than scores for the general US population (52.7 vs 48.9; p < 0.001). Compared with the general US population, MCS scores at Week 16 were similar for patients receiving adalimumab (51.2 vs 50.8; p = 1.000) and lower for patients receiving placebo (50.8 vs 48.7; p < 0.0001). CONCLUSION: Psoriasis has a broad impact on patient functioning and well-being. Improvement in skin lesions and joint symptoms associated with adalimumab treatment was accompanied by improvements in HRQOL to levels that were similar to or greater than those of the general US population. TRIAL REGISTRATION: Clinicaltrials.gov NCT00237887.

Relationship between clinical response to therapy and health-related quality of life outcomes in patients with moderate to severe plaque psoriasis.

BACKGROUND: Health-related quality of life (HRQOL) outcomes are associated with clinical response to treatment in psoriasis. However, the association between HRQOL outcomes and more substantial degrees of Psoriasis Area and Severity Index (PASI) response and physician and patient global ratings remains ill defined. OBJECTIVE: This study examined the relationship between achieving a 75% or > or =90% improvement in PASI and HRQOL outcome measures. METHODS: Secondary analyses were completed using data for 1,469 patients with moderate to severe plaque psoriasis from two adalimumab clinical trials. HRQOL was measured via the Dermatology Life Quality Index (DLQI) and the Short Form 36 (SF 36) Health Survey. Clinical response was assessed by the PASI, physician's global assessment and patient's global assessment status scores. Clinical response was categorized into 6 groups based on PASI response: <25% (n = 332); 25 to <50% (n = 137); 50 to <75% (n = 170); 75 to <90% (n = 288); 90 to <100% (n = 255), and 100% (n = 192). Analysis of covariance models compared baseline measures and 16-week changes in HRQOL scores. RESULTS: Statistically significant differences were observed between PASI response groups in DLQI total scores and in SF 36 summary and scale scores (p < 0.0001). The PASI 100 and PASI 90 to <100 groups demonstrated a >10-point decrease in DLQI total scores. Moreover, these changes were statistically significantly greater than those observed for the PASI 75 to <90 group (p < 0.001) and the other PASI response groups (p < 0.001). For the SF 36, the greatest changes were observed in the PASI 75 to <90, PASI 90 to <100 and PASI 100 groups, which all had improvements of >4 points in the Mental Component and Physical Component Summary (MCS and PCS) scores. Statistically significantly greater differences in DLQI total and SF 36 summary and scale scores were also observed between patient's global assessment categories (p < 0.0001) and between physician's global assessment categories (p < 0.0001). CONCLUSION: Improvement in PASI response of >75% corresponded to improvements in HRQOL outcome measures for patients with moderate to severe psoriasis. PASI 90 or 100 responders had greater improvements in DLQI total score than PASI 75 responders.

Adalimumab treatment is associated with improvement in health-related quality of life in psoriasis: patient-reported outcomes from a phase II randomized controlled trial.

BACKGROUND: Psoriasis substantially impairs the health-related quality of life (HRQOL) of patients, and a comprehensive evaluation of treatment includes HRQOL measures. OBJECTIVE: To assess the impact of adalimumab on patient-reported outcomes (PROs) of patients with moderate to severe psoriasis. METHODS: In a Phase II, randomized, controlled trial, the efficacy and safety of two dosages of adalimumab (40 mg weekly or every other week) versus placebo were assessed for 12 weeks in the treatment of moderate to severe plaque psoriasis. Patients completed the Dermatology Life Quality Index (DLQI), Short-Form 36 (SF-36) Health Survey, and EuroQOL-5D (EQ-5D) at baseline and 12 weeks. The primary endpoint was the percentage of patients achieving a > or =75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Investigators assessed PASI and Physician's Global Assessment (PGA) scores. RESULTS: Adalimumab patients (either dosage) displayed significantly greater improvements versus placebo patients in DLQI, EQ-5D, and SF-36 Mental Component Summary scores, as well as in Bodily Pain, Vitality, Social Functioning, Role-Emotional, and Mental Health domains. The adalimumab 40-mg weekly group also reported significantly greater improvements in SF-36 Physical Component Summary scores versus the placebo group. CONCLUSION: Both adalimumab dosages were efficacious in improving dermatology-specific and general PROs in patients with moderate to severe psoriasis.

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.

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.