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
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.
Reprint requests: John Koo, MD, 515 Spruce St, San Francisco, CA 94118.
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.
ABSTRACT