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

Abstract

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.

• Authors: K A Papp, S Tyring, M Lahfa, J Prinz, C E M Griffiths, A M Nakanishi, R Zitnik, P C M van de Kerkhof, Linda Melvin, Etanercept Psoriasis Study Group
• Journal: The British journal of dermatology (Br J Dermatol) Vol. 152 Issue 6 Pg. 1304-12 (Jun 2005) ISSN: 0007-0963 [Print] England
• PMID: 15948997 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Immunoglobulin G
• Immunosuppressive Agents
• Receptors, Tumor Necrosis Factor
• Recombinant Fusion Proteins
• Etanercept

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Etanercept
• Female
• Humans
• Immunoglobulin G (administration & dosage, therapeutic use)
• Immunosuppressive Agents (administration & dosage, therapeutic use)
• Injections, Subcutaneous
• Male
• Middle Aged
• Psoriasis (drug therapy)
• Receptors, Tumor Necrosis Factor (administration & dosage, therapeutic use)
• Recombinant Fusion Proteins (administration & dosage, therapeutic use)
• Statistics as Topic