Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase III randomized controlled trial

• Published in: Journal of the American Academy of Dermatology Vol. 64; no. 1; pp. 64 - 70
• Main Authors: Langley, Richard G., MD, Paller, Amy S., MD, Hebert, Adelaide A., MD, Creamer, Kara, MS, Weng, Haoling H., MD, Jahreis, Angelika, MD, PhD, Globe, Denise, PhD, Patel, Vaishali, PharmD, MS, Orlow, Seth J., MD, PhD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.01.2011; Elsevier
• Subjects: Adolescent; Age Factors; Biological and medical sciences; Child; Child, Preschool; Children's Dermatology Life Quality Index; Dermatologic Agents - therapeutic use; Dermatology; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Etanercept; Female; Follow-Up Studies; General aspects; Harter Self-Perception Profile for Children; health-related quality of life; Humans; Immunoglobulin G - therapeutic use; Male; Maximum Tolerated Dose; Medical sciences; Patient Satisfaction; pediatric plaque psoriasis; Pediatric Quality of Life Inventory; Psoriasis - diagnosis; Psoriasis - drug therapy; Psoriasis - psychology; Psoriasis. Parapsoriasis. Lichen; Quality of Life; Receptors, Tumor Necrosis Factor - therapeutic use; Risk Assessment; Severity of Illness Index; Sex Factors; Stein Impact on Family Scale; Time Factors; Treatment Outcome; Pediatric Quality of Life Inventory; DLQI; PASI; Harter Self-Perception Profile for Children; PASI 75; Children's Dermatology Life Quality Index; MID; health-related quality of life; 75% improvement in Psoriasis Area and Severity Index score; Psoriasis Area and Severity Index; pediatric plaque psoriasis; CDLQI; Stein Impact on Family Scale; Dermatology Life Quality Index; HRQoL; minimally important difference; PedsQL; Phase III trial; Human; Skin disease; Prognosis; Psoriasis; Dermatology; Antipsoriatic agent; Case study; Immunomodulator; Chemotherapy; Treatment; Etanercept; Child
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2010.02.060

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.