Journal of the American Academy of Dermatology
Volume 64, Issue 1 , Pages 64-70 , January 2011

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, Illinois
    • ,
  • Adelaide A. Hebert, MD

      Affiliations

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

      Affiliations

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

      Affiliations

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

      Affiliations

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

      Affiliations

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

      Affiliations

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

      Affiliations

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

,Accepted 14 February 2010.

References 

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  2. Rogers M. Childhood psoriasis. Curr Opin Pediatr. 2002;14:404–409
  3. Leman J, Burden AD. Recognition and treatment of psoriasis in children. Curr Paediatr. 2003;13:418–422
  4. Raychaudhuri SP, Gross J. A comparative study of pediatric onset psoriasis with adult onset psoriasis. Pediatr Dermatol. 2000;17:174–178
  5. Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001;137:280–284
  6. Paller AS, Siegfried EC, Langley RG, Gottlieb AB, Pariser D, Landells I, et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008;358:241–251
  7. US Food and Drug Administration. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. Available from: URL:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed January 14, 2010.
  8. Lewis-Jones MS, Finlay AY. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;132:942–949
  9. Holme SA, Man I, Sharpe JL, Dykes PJ, Lewis-Jones MS, Finlay AY. The children's dermatology life quality index: validation of the cartoon version. Br J Dermatol. 2003;148:285–290
  10. Wales College of Medicine Department of Dermatology. Dermatology life quality index questionnaire. Available from: URL:http://www.dermatology.org.uk/index.asp?portal/quality/dlqi.html. Accessed December 9, 2008.
  11. Varni JW, Seid M, Smith Knight T, Burwinkle T, Brown J, Szer IS. The PedsQL in pediatric rheumatology: reliability, validity, and responsiveness of the pediatric quality of life inventory generic core scales and rheumatology module. Arthritis Rheum. 2002;46:714–725
  12. Stein RE, Riessman CK. The development of an impact-on-family scale: preliminary findings. Med Care. 1980;18:465–472
  13. Stein RE, Jessop DJ. The impact on family scale revisited: further psychometric data. J Dev Behav Pediatr. 2003;24:9–16
  14. Williams AR, Piamjariyakul U, Williams PD, Bruggeman SK, Cabanela RL. Validity of the revised impact on family (IOF) scale. J Pediatr. 2006;149:257–261
  15. Wichstrom L. Harter's self-perception profile for adolescents: reliability, validity, and evaluation of the question format. J Pers Assess. 1995;65:100–116
  16. Harter S. Manual for the self-perception profile for children. Denver (CO): University of Denver; 1985;
  17. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582–592
  18. Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003;3:329–341
  19. Beattie PE, Lewis-Jones MS. A comparative study of impairment of quality of life in children with skin disease and children with other chronic childhood diseases. Br J Dermatol. 2006;155:145–151
  20. Feldman SR, Kimball AB, Krueger GG, Woolley JM, Lalla D, Jahreis A. Etanercept improves the health-related quality of life of patients with psoriasis: results of a phase III randomized clinical trial. J Am Acad Dermatol. 2005;53:887–889
  21. Gottlieb AB, Matheson RT, Lowe N, Krueger GG, Kang S, Goffe BS, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol. 2003;139:1627–1632
  22. Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349:2014–2022
  23. Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomized phase III trial. Lancet. 2006;367:29–35

 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

Journal of the American Academy of Dermatology
Volume 64, Issue 1 , Pages 64-70 , January 2011

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