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

  • Richard G. Langley, MD

      Affiliations

    • Dalhousie Medical School, Halifax, Halifax, Nova Scotia, Canada
    • Corresponding Author InformationReprint requests: Richard G. Langley, MD, Division of Dermatology, Dalhousie University, QE2 Health Science Center, 4195 Dixon Bldg, 5820 University, Halifax, NS, Canada, B3H1V8.
    • ,
  • Amy S. Paller, MD

      Affiliations

    • Children's Memorial Hospital and Northwestern University Medical School, Chicago, Chicago, Illinois
    • ,
  • Adelaide A. Hebert, MD

      Affiliations

    • University of Texas Dermatology Clinical Research Center, Houston, Texas
    • ,
  • Kara Creamer, MS

      Affiliations

    • Amgen Inc, Thousand Oaks, Thousand Oaks, California
    • ,
  • Haoling H. Weng, MD

      Affiliations

    • Amgen Inc, Thousand Oaks, Thousand Oaks, California
    • ,
  • Angelika Jahreis, MD, PhD

      Affiliations

    • Amgen Inc, Thousand Oaks, Thousand Oaks, California
    • ,
  • Denise Globe, PhD

      Affiliations

    • Amgen Inc, Thousand Oaks, Thousand Oaks, California
    • ,
  • Vaishali Patel, PharmD, MS

      Affiliations

    • Amgen Inc, Thousand Oaks, Thousand Oaks, California
    • ,
  • Seth J. Orlow, MD, PhD

      Affiliations

    • New York University Langone Medical Center, New York, New York

Accepted 14 February 2010. published online 09 July 2010.
Corrected Proof

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.

Key words: Children's Dermatology Life Quality Index, Harter Self-Perception Profile for Children, health-related quality of life, pediatric plaque psoriasis, Pediatric Quality of Life Inventory, Stein Impact on Family Scale

Abbreviations used: CDLQI, Children's Dermatology Life Quality Index, DLQI, Dermatology Life Quality Index, HRQoL, health-related quality of life, MID, minimally important difference, PASI, Psoriasis Area and Severity Index, PASI 75, 75% improvement in Psoriasis Area and Severity Index score, PedsQL, Pediatric Quality of Life Inventory

 

 Drs Jahreis and Patel are former employees of Amgen Inc; they are currently employed by Genentech and Allergan, respectively.

 This analysis was designed by Amgen Inc and funded by Immunex Corp, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc in October 2009. Financial support for the preparation of the manuscript was provided by Amgen Inc.

 Disclosure: Dr Langley has received investigator grants from Amgen, Schering, Abbott, Centocor, LEO Pharma, Novartis, Celgene, Pfizer, NanoBio, Serono, Bristol-Myers Squibb, and Isotechnika, and has received honoraria from serving on the scientific advisory boards for Amgen, Schering, and Abbott. Dr Paller has served as an investigator for Amgen without compensation, but has received honoraria from Amgen and Centocor/Johnson & Johnson as a consultant. Dr Hebert has received compensation from Amgen as a consultant and has served as a researcher for Amgen without compensation. Dr Orlow has been an investigator for Amgen without compensation, but has received honoraria from Amgen and Centocor/Johnson & Johnson as a consultant, and his department has been the recipient of an unrestricted educational grant from Amgen. Ms Creamer and Drs Weng and Globe are Amgen employees and have Amgen stock and stock options. Drs Jahreis and Patel were Amgen employees at the time this manuscript was drafted and held Amgen stock and stock options.

PII: S0190-9622(10)00365-8

doi:10.1016/j.jaad.2010.02.060

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