Journal of the American Academy of Dermatology
Volume 63, Issue 3 , Pages 457-465, September 2010

Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of life in patients with moderate-to-severe psoriasis: Results from a randomized, double-blind, placebo-controlled phase III trial

Limited portions of these data were presented at the 13th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Toronto, Ontario, Canada, May 3-7, 2008, and the Fifth International Congress on Psoriasis: From Gene to Clinic, London, United Kingdom, December 4-6, 2008.

  • Richard G. Langley, MD

      Affiliations

    • Dalhousie University, Halifax, Nova Scotia, Canada
  • ,
  • Steven R. Feldman, MD

      Affiliations

    • Wake Forest University School of Medicine, Winston-Salem, North Carolina
  • ,
  • Chenglong Han, PhD

      Affiliations

    • Worldwide Health Economics, Johnson & Johnson Pharmaceutical Services LLC, Horsham, Pennsylvania
  • ,
  • Brad Schenkel, MS

      Affiliations

    • Worldwide Health Economics, Johnson & Johnson Pharmaceutical Services LLC, Horsham, Pennsylvania
  • ,
  • Philippe Szapary, MD, MSCE

      Affiliations

    • Centocor, Inc, Malvern, Pennsylvania
  • ,
  • Ming-Chun Hsu, PhD

      Affiliations

    • Centocor, Inc, Malvern, Pennsylvania
  • ,
  • Jean-Paul Ortonne, MD

      Affiliations

    • Hôpital L'Archet, Nice, France
  • ,
  • Kenneth B. Gordon, MD

      Affiliations

    • Northwestern University Feinberg School of Medicine and Evanston Northwestern Healthcare, Chicago, Illinois
  • ,
  • Alexa B. Kimball, MD, MPH

      Affiliations

    • Harvard Medical School, Boston, Massachusetts
    • Corresponding Author InformationReprint requests: Alexa B. Kimball, MD, MPH, Department of Dermatology, Harvard Medical School, 50 Staniford St, #246, Boston, MA 02114.

Accepted 15 September 2009. published online 12 May 2010.

Background

Anxiety, depression, and impaired health-related quality of life (HRQoL) are common in patients with psoriasis.

Objective

We sought to analyze the effect of ustekinumab on these conditions in patients with moderate-to-severe psoriasis.

Methods

Patients with moderate-to-severe psoriasis (n = 1230) were randomized 1:1:1 to receive 45 mg of ustekinumab, 90 mg of ustekinumab, or placebo. The Hospital Anxiety and Depression Scale was used to measure anxiety and depression, and the Dermatology Life Quality Index to measure HRQoL.

Results

At baseline, 40.3% and 26.7% of patients reported symptoms of anxiety and depression, respectively, and 54.6% reported Dermatology Life Quality Index scores greater than 10, indicating a very high impact of disease on HRQoL. Greater improvements at week 12 in mean Hospital Anxiety and Depression Scale-Anxiety (13.9%), Hospital Anxiety and Depression Scale-Depression (29.3%), and Dermatology Life Quality Index (76.2%) scores were reported in ustekinumab groups compared with placebo (P < .001 each).

Limitations

Results for these measures are reported only through 24 weeks.

Conclusion

Patients receiving ustekinumab reported significant improvements in symptoms of anxiety, depression, and HRQoL.

Key words: anxiety, depression, Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, psoriasis, quality of life, ustekinumab

Abbreviations used: AE, adverse event, DLQI, Dermatology Life Quality Index, HADS, Hospital Anxiety and Depression Scale, HADS-A, Hospital Anxiety and Depression Scale-Anxiety, HADS-D, Hospital Anxiety and Depression Scale-Depression, HRQoL, health-related quality of life, PASI, Psoriasis Area and Severity Index, QoL, quality of life

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 Supported by Centocor, Inc.

 Disclosures can be found in the Appendix.

PII: S0190-9622(09)01197-9

doi:10.1016/j.jaad.2009.09.014

Journal of the American Academy of Dermatology
Volume 63, Issue 3 , Pages 457-465, September 2010