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Background: Psoriasis adversely affects health-related quality of life (HRQoL) in adults; however, little information exists about its impact on children and adolescents., Objective: The effect of etanercept therapy on HRQoL compared with placebo was evaluated in children and adolescents with moderate to severe plaque psoriasis., Methods: HRQoL data were collected from patients 4 to 17 years of age in a randomized, double-blind, placebo-controlled, North American, phase III study of etanercept. Instruments for assessing HRQoL included the Children's Dermatology Life Quality Index (CDLQI), Pediatric Quality of Life Inventory (PedsQL), Stein Impact on Family Scale, and Harter Self-Perception Profile for Children., Results: Baseline CDLQI and PedsQL scores revealed reduced HRQoL in patients with psoriasis relative to comparative populations. Patients treated with etanercept demonstrated significantly higher mean percentage improvement in total CDLQI scores from baseline to week 12 compared with those treated with placebo (52.3% etanercept vs 17.5% placebo [P = .0001]). At week 12, patients who achieved 75% improvement in their Psoriasis Area and Severity Index score had higher percentage improvements from baseline in total CDLQI scores than those who did not have 75% improvement in Psoriasis Area and Severity Index score., Limitations: The PedsQL, Stein scale, and Harter profile demonstrated limited improvement in patients' HRQoL, suggesting that these scales may not be sensitive to issues that are relevant to children with psoriasis and their families., Conclusion: Etanercept therapy had a clinically and statistically meaningful impact on disease-specific quality of life (CDLQI) and a clinically meaningful impact on general quality of life (PedsQL) in children and adolescents with moderate to severe plaque psoriasis., (Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)

Background: The tumor necrosis factor (TNF) inhibitor etanercept has been demonstrated to be safe and effective for treating chronic plaque psoriasis in 3 clinical trials., Objectives: To refine efficacy results for etanercept on the basis of a larger population size through the integration of the 3 studies, and to determine if the efficacy profile across all 3 studies is consistent with efficacy profiles observed for individual trials., Methods: In these integrated analyses, data for 1187 patients from 3 blinded treatment groups were pooled to compare efficacy at 12 weeks: etanercept 50 mg weekly (equivalent to 25 mg twice weekly) subcutaneously, etanercept 50 mg twice weekly subcutaneously, and placebo. The primary efficacy end point in all 3 studies was at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Other measurements included PASI 50, PASI 90, patient's and dermatologist's global assessments, and Dermatology Life Quality Index., Results: In the integrated analyses, statistically significant, dose-dependent improvements in PASI 75 at 12 weeks were observed in patients treated with etanercept 50 mg weekly (33%) and 50 mg twice weekly (49%), compared with the placebo group (3%; P < .05). Significant improvements also were seen in all secondary end points (PASI 50 and PASI 90 responses, patient's and dermatologist's global assessments, and Dermatology Life Quality Index) at 12 weeks. Subgroup analyses of baseline patient characteristics demonstrated that there were no statistically significant treatment-by-covariate interactions., Limitations: A limitation of these integrated analyses is the relatively short (12-week) time frame., Conclusion: The efficacy profile of etanercept in patients with psoriasis was consistent across multiple studies as shown in the integrated analyses of the primary and secondary end points. Etanercept demonstrated rapid, dose-dependent improvements in disease severity and quality of life consistently over all studies.

Background: Etanercept, a tumor necrosis factor antagonist, is an approved treatment in the United States and Europe for plaque psoriasis., Objective: To further examine the safety profile of etanercept in patients with chronic, moderate to severe plaque psoriasis., Methods: Safety data from an integrated database of 1347 patients from 3 randomized, double-blind, placebo-controlled clinical trials were analyzed. Safety end points included incidence rates of adverse events, serious adverse events, infections, serious infections, injection site reactions, and routine laboratory assessments. Pooled safety results from the first 12 weeks of each trial are reported here., Results: Rates of adverse events, serious adverse events, infections, and serious infections in the first 12 weeks of the 3 trials were similar among all active groups as well as each active group, compared with the placebo group. No dose-related toxicities were reported., Limitations: This report includes a relatively short (12-week) time frame; data from patients exposed to etanercept for longer periods are needed., Conclusions: Etanercept was generally safe in a large cohort of patients with moderate to severe plaque psoriasis.

Background: Etanercept provides rapid, significant improvement in psoriatic symptoms and disease., Objective: The effectiveness of continued etanercept treatment beyond 24 weeks in patients who initially did not achieve at least a 50% improvement from baseline in the Psoriasis Area and Severity Index (PASI 50) was assessed., Methods: Patients with moderate to severe plaque psoriasis received 50 mg open-label, subcutaneous etanercept per week after completing blinded therapy with placebo or 1 of 3 doses of etanercept. The PASI was measured., Results: Irrespective of prior dosing regimens, 43% of 157 patients who did not attain PASI 50 responses at week 24 achieved PASI 50 responses at week 36; 55% achieved PASI 50 responses at week 60. Etanercept was safe and well tolerated., Limitations: Interpretation of these results is limited by the open-label design of the analysis., Conclusion: More than half of patients who initially had an inadequate response to treatment achieved satisfactory responses with continued etanercept therapy. The safety profile of etanercept in these patients and in patients who had more immediate responses was similar.

In this randomized, double-blind, phase III trial, patients with psoriasis received etanercept for 24 weeks or placebo for 12 weeks followed by etanercept for 12 weeks. At week 12, improvement in Dermatology Life Quality Index was 47% to 61% with etanercept compared with 11% with placebo (P < .0001). Etanercept rapidly and substantially improved patients' health-related quality of life.