A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol 2003 Dec;139(12):1627-32; discussion 1632
Date
12/17/2003Pubmed ID
14676082DOI
10.1001/archderm.139.12.1627Scopus ID
2-s2.0-10744221697 (requires institutional sign-in at Scopus site) 454 CitationsAbstract
OBJECTIVE: To determine safety and efficacy of monotherapy with etanercept.
DESIGN: Randomized, double-blind, placebo-controlled, multicenter study.
SETTING: Outpatient, ambulatory; private practice and university dermatology research centers.
PATIENTS: Patients aged at least 18 years, with plaque psoriasis involving 10% or more of body surface area; 148 were screened and 112 were randomly assigned to treatment groups and received study drug.
INTERVENTIONS: Patients received placebo or etanercept, 25 mg, subcutaneously twice a week for 24 weeks. Other psoriasis therapies were limited during the study.
MAIN OUTCOME MEASURES: Safety measurements included tracking of adverse events and laboratory values. Efficacy was evaluated using the Psoriasis Area and Severity Index (PASI); the primary end point was a 75% improvement in PASI. Other efficacy measurements included patient and physician global assessments and quality-of-life measures.
RESULTS: After 12 weeks of treatment, 17 (30%) of the 57 etanercept-treated patients and 1 (2%) of the 55 placebo-treated patients had achieved PASI 75%, and after 24 weeks, 32 (56%) of etanercept-treated patients and 3 (5%) of placebo-treated patients had reached this level (P<.001 for both time points). By 24 weeks, psoriasis was clear or minimal by physician's global assessment in more than 50% of patients who received etanercept. Treatment failure (PASI response <50) occurred in 23% of patients at week 24. All other measures confirmed the efficacy of etanercept. Adverse events were similar among etanercept and placebo groups.
CONCLUSION: Etanercept monotherapy provided significant benefit to patients with psoriasis and had a favorable safety profile.
Author List
Gottlieb AB, Matheson RT, Lowe N, Krueger GG, Kang S, Goffe BS, Gaspari AA, Ling M, Weinstein GD, Nayak A, Gordon KB, Zitnik RAuthor
Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Computer Graphics
Double-Blind Method
Etanercept
Female
Humans
Immunoglobulin G
Immunosuppressive Agents
Male
Middle Aged
Psoriasis
Receptors, Tumor Necrosis Factor
Retrospective Studies
Statistics, Nonparametric
