American Journal of Clinical Dermatology

, Volume 8, Issue 2, pp 93–102 | Cite as

Placebo Response in Two Long-Term Randomized Psoriasis Studies that were Negative for Rosiglitazone

  • Charles N. Ellis
  • Jonathan N. Barker
  • Ann E. Haig
  • Christine A. Parker
  • Susan Daly
  • Deepthi A. Jayawardene
Original Research Article American journal of Clinical Dermatology

Abstract

Background:Previous research has suggested that the thiazolidinedione rosiglitazone may possess antipsoriatic activity.

Objective:To compare the efficacy and safety of rosiglitazone with that of placebo in the treatment of chronic plaque psoriasis.

Methods:Two large-scale, randomized, double-blind, multicenter studies (study A, n = 1563; study B, n = 1032) were conducted over 52 weeks (plus optional 44 weeks safety extension) in an outpatient setting. The subjects (aged 18–75 years) had moderate-to-severe chronic plaque psoriasis affecting ≥10% body surface area (BSA) with plaques of any elevation above normal-appearing skin (or ≥6% BSA involvement with marked elevation) and had not used phototherapy during the previous month or thiazolidinediones within the previous 3 months. Rosiglitazone was administered as 2, 4, or 8mg tablets once daily. The main outcome measure was the proportion of subjects achieving ≥75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at week 26. both studies for subjects receiving placebo, the PASI 75 was 9% (48/506) and the PASI 50 (proportion of subjects who achieved at least 50% improvement from baseline) was 27% (135/506). In addition, few subjects withdrew from placebo or rosiglitazone treatment because of ‘lack of efficacy’ and the majority persisted in the year-long study.

Conclusion: While these large-scale, robust studies demonstrated that rosiglitazone is not active in psoriasis, they also showed that for a large proportion of subjects receiving placebo, the expectation of a successful treatment, the favorable adverse effect profile of the drug, and the supportive environment of a clinical study conferred beneficial effects. These results may have implications for the design of future placebo-controlled studies in patients with psoriasis.

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Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  • Charles N. Ellis
    • 1
  • Jonathan N. Barker
    • 2
  • Ann E. Haig
    • 3
  • Christine A. Parker
    • 4
  • Susan Daly
    • 4
  • Deepthi A. Jayawardene
    • 3
  1. 1.Department of DermatologyUniversity of Michigan Medical SchoolAnn ArborUSA
  2. 2.St John’s Institute of DermatologySt Thomas’ HospitalLondonUK
  3. 3.Medicine Development Centre, GlaxoSmithKlinePhiladelphiaUSA
  4. 4.Medicine Development Centre, GlaxoSmithKlineGreenfordUK

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