Journal of the American Academy of Dermatology
Volume 61, Issue 5 , Pages 793-798, November 2009

Randomized, double-blind, placebo-controlled evaluation of the efficacy of oral psoralen plus ultraviolet A for the treatment of plaque-type psoriasis using the Psoriasis Area Severity Index score (improvement of 75% or greater) at 12 weeks

  • S. Priya Sivanesan, MD, MPH

      Affiliations

    • Department of Dermatology, Pittsburgh University, Pittsburgh, Pennsylvania
    • ,
  • Shilpa Gattu, BS

      Affiliations

    • University of California, Irvine, California
    • ,
  • Judith Hong, MD

      Affiliations

    • Department of Dermatology, University of California, San Francisco, California
    • ,
  • Arianne Chavez-Frazier, MD

      Affiliations

    • Department of Dermatology, University of Texas Health Science Center, Houston, Texas
    • ,
  • Grace D. Bandow, MD

      Affiliations

    • Albert Einstein College of Medicine, New York, New York
    • ,
  • Farah Malick, MD

      Affiliations

    • Department of Dermatology, Wayne State University, Dearborn, Michigan
    • ,
  • Greg Kricorian, MD

      Affiliations

    • Amgen Pharmaceuticals, Orange County, California
    • ,
  • John Koo, MD

      Affiliations

    • Department of Dermatology, University of California, San Francisco, California
    • Corresponding Author InformationReprint requests: John Koo, MD, 515 Spruce St, San Francisco, CA 94118.

Accepted 22 April 2009. published online 22 September 2009.

Background

Psoralen plus ultraviolet A (PUVA) for the treatment of psoriasis has never been evaluated using the Psoriasis Area Severity Index (PASI) in a randomized, double-blind, placebo-controlled trial. The lack of such data limits our capacity to estimate PUVA's efficacy relative to other treatment options that are available today.

Objectives

The purpose of this study was to evaluate the efficacy of PUVA therapy for patients with plaque-type psoriasis.

Methods

This study involved 40 patients with psoriasis; 30 received PUVA and 10 received UVA with placebo. PASI scores were assessed at baseline and every 4 weeks thereafter for 12 weeks.

Results

By nonresponder imputation, 60% (18 of 30) in the PUVA group achieved 75% or more improvement in PASI score after 12 weeks of treatment compared with 0% (0 of 10) in the UVA plus placebo group (P < .0001). Using intent to treat with last observation carried forward analysis, 63% (19 of 30) in the PUVA group achieved 75% or more improvement in PASI score compared with 0% (0 of 10) in the UVA plus placebo group (P < .0001). By per protocol analysis, 86% (18 of 21) in the PUVA group as compared with 0% (0 of 7) in the UVA plus placebo group reached 75% or more improvement in PASI score after 12 weeks (P < .0001).

Limitations

The study was relatively small with only 40 patients enrolled and 28 patients who completed the protocol. Further studies that involve head-to-head comparison of PUVA with other treatment modalities are needed. Nonresponder imputation, last observation carried forward with intent to treat, and per protocol analyses each have separate advantages and limitations when determining clinical significance.

Conclusions

This study supports the observation that PUVA is a highly efficacious treatment for chronic plaque psoriasis.

Key words: PASI 75, psoriasis, PUVA

Abbreviations used: CI, confidence interval, LOCF, last observation carried forward, NB, narrowband, NRI, nonresponder imputation, PASI, Psoriasis Area and Severity Index, PASI 50, 50% or greater improvement in Psoriasis Area and Severity Index score, PASI 75, 75% or greater improvement in Psoriasis Area and Severity Index score, PP, per protocol, PUVA, psoralen plus ultraviolet A, UV, ultraviolet

 

 Supported by Valeant Pharmaceuticals.

 Disclosure: Dr Koo has been a clinical researcher and/or consultant and/or speaker for Valeant, Allergan, Warner-Chilcott, Amgen, Biogen, Bristol-Myers Squibb, Centacor, Connetics, Elan, Astellas, Galderma, Genentech, GlaxoSmithKlein, Novartis, Roche, and Serono. Ms Gattu is a consultant for Coria Labs. Dr Kricorian was an employee at Amgen Pharmaceuticals. Drs Sivanesan, Hong, Chavez-Frazier, Bandow, and Malick have no conflicts of interest to declare.

 Interim data were presented orally at the American Academy of Dermatology 63rd Annual Meeting, New Orleans, LA, February 18-22, 2005.

PII: S0190-9622(09)00533-7

doi:10.1016/j.jaad.2009.04.053

Journal of the American Academy of Dermatology
Volume 61, Issue 5 , Pages 793-798, November 2009