Patient-reported outcomes in pediatric patients with psoriasis undergoing
etanercept treatment: 12-week results from a phase III randomized controlled
Author(s): Langley RG, Paller AS, Hebert AA, Creamer K, Weng HH, Jahreis A, Globe D, Patel
V, Orlow SJ.
Affiliation(s): Dalhousie Medical School, Halifax, Halifax, Nova Scotia, Canada. email@example.com
Publication date & source: 2011, J Am Acad Dermatol. , 64(1):64-70
BACKGROUND: Psoriasis adversely affects health-related quality of life (HRQoL) in
adults; however, little information exists about its impact on children and
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.