A global phase III randomized controlled trial of etanercept in psoriasis: Safety, efficacy, and effect of dose reduction

Kim A. Papp, S. Tyring, M. Lahfa, J. Prinz, C. E M Griffiths, A. M. Nakanishi, R. Zitnik, P. C M Van De Kerkhof

    Research output: Contribution to journalArticlepeer-review


    Background: In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated. Objectives: To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept. Methods: In this multicentre 24-week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double-blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks. Results: Five hundred and eighty-three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P <0.0001 for each etanercept group compared with placebo). At week 24 (after 12 weeks of open-label 25 mg etanercept BIW), a PASI 75 was achieved by 54% of patients whose dose was reduced from 50 mg BIW to 25 mg BIW, by 45% of patients in the continuous 25 mg BIW group, and by 28% in the group that received placebo followed by etanercept 25 mg BIW. Etanercept was well tolerated throughout the study. Conclusions: Etanercept provided clinically meaningful benefit to patients with chronic plaque psoriasis, with no apparent decrease in efficacy after dose reduction. © 2005 British Association of Dermatologists.
    Original languageEnglish
    Pages (from-to)1304-1312
    Number of pages8
    JournalBritish Journal of Dermatology
    Issue number6
    Publication statusPublished - Jun 2005


    • Cytokine
    • Etanercept
    • Phase III study
    • Psoriasis
    • Randomized controlled trial
    • Tumour necrosis factor


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