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.

  • Image Result

    Study schema for double-blind period. PASI, Psoriasis Area and Severity Index; PASI 50, 50% improvement in PASI score; W, week.

    Study schema for double-blind period. PASI, Psoriasis Area and Severity Index; PASI 50, 50% improvement in PASI score; W, week.

  • Image Result

    Improvements in Children's Dermatology Life Quality Index (CDLQI) total scores over time. Data represent median (solid line) and mean (broken line) percentage improvements in total CDLQI score in pati

    Improvements in Children's Dermatology Life Quality Index (CDLQI) total scores over time. Data represent median (solid line) and mean (broken line) percentage improvements in total CDLQI score in patients receiving etanercept (dark black line) versus placebo (light gray line) during double-blind portion of study. Error bars represent SEM. Placement of data points has been skewed to enhance visibility. aMedian total CDLQI scores at baseline were 7 for etanercept group and 10 for placebo group. bMean total CDLQI scores at baseline were 9 for etanercept group and 10 for placebo group. cDuring double-blind period, patients who entered the escape arm at or after week 4 were imputed as treatment failures through week 12. dSlope was interpolated between weeks 4 and 12 as measurements were not taken at weeks 6, 8, and 10.

  • Image Result
    Children's Dermatology Life Quality Index (CDLQI) total score percentage improvements for etanercept group by 75% improvement in Psoriasis Area and Severity Index score (PASI 75) response. Data repres

    Children's Dermatology Life Quality Index (CDLQI) total score percentage improvements for etanercept group by 75% improvement in Psoriasis Area and Severity Index score (PASI 75) response. Data represent median (solid line) and mean (broken line) percentage improvements in total CDLQI score over time for patients who did (dark black line) and did not (light gray line) achieve PASI 75 during double-blind portion of study. Error bars represent SEM. Placement of data points has been skewed to enhance visibility. aMedian total CDLQI scores at baseline were 9 for PASI 75 achievers and 6 for PASI 75 nonachievers. bMean total CDLQI scores at baseline were 10 for PASI 75 achievers and 8 for PASI 75 nonachievers. cSlope was interpolated between weeks 4 and 12 as measurements were not taken at weeks 6, 8, and 10.

 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