A Randomized Trial of Etanercept as Monotherapy for Psoriasis

Alice B. Gottlieb, Robert T. Matheson, Nicholas Lowe, Gerald G. Krueger, Sewon Kang, Bernard S. Goffe, Anthony A. Gaspari, Mark Ling, Gerald D. Weinstein, Anjuli Nayak, Kenneth B. Gordon, Ralph Zitnik, Luigi Naldi

Research output: Contribution to journalArticle

Abstract

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

Original languageEnglish (US)
Pages (from-to)1627-1632
Number of pages6
JournalArchives of Dermatology
Volume139
Issue number12
DOIs
StatePublished - Dec 2003
Externally publishedYes

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Psoriasis
Placebos
Safety
Etanercept
Private Practice
Body Surface Area
Dermatology
Multicenter Studies
Outpatients
Therapeutics
Quality of Life
Outcome Assessment (Health Care)
Physicians
Research
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Dermatology

Cite this

Gottlieb, A. B., Matheson, R. T., Lowe, N., Krueger, G. G., Kang, S., Goffe, B. S., ... Naldi, L. (2003). A Randomized Trial of Etanercept as Monotherapy for Psoriasis. Archives of Dermatology, 139(12), 1627-1632. https://doi.org/10.1001/archderm.139.12.1627

A Randomized Trial of Etanercept as Monotherapy for Psoriasis. / Gottlieb, Alice B.; Matheson, Robert T.; Lowe, Nicholas; Krueger, Gerald G.; Kang, Sewon; Goffe, Bernard S.; Gaspari, Anthony A.; Ling, Mark; Weinstein, Gerald D.; Nayak, Anjuli; Gordon, Kenneth B.; Zitnik, Ralph; Naldi, Luigi.

In: Archives of Dermatology, Vol. 139, No. 12, 12.2003, p. 1627-1632.

Research output: Contribution to journalArticle

Gottlieb, AB, Matheson, RT, Lowe, N, Krueger, GG, Kang, S, Goffe, BS, Gaspari, AA, Ling, M, Weinstein, GD, Nayak, A, Gordon, KB, Zitnik, R & Naldi, L 2003, 'A Randomized Trial of Etanercept as Monotherapy for Psoriasis', Archives of Dermatology, vol. 139, no. 12, pp. 1627-1632. https://doi.org/10.1001/archderm.139.12.1627
Gottlieb AB, Matheson RT, Lowe N, Krueger GG, Kang S, Goffe BS et al. A Randomized Trial of Etanercept as Monotherapy for Psoriasis. Archives of Dermatology. 2003 Dec;139(12):1627-1632. https://doi.org/10.1001/archderm.139.12.1627
Gottlieb, Alice B. ; Matheson, Robert T. ; Lowe, Nicholas ; Krueger, Gerald G. ; Kang, Sewon ; Goffe, Bernard S. ; Gaspari, Anthony A. ; Ling, Mark ; Weinstein, Gerald D. ; Nayak, Anjuli ; Gordon, Kenneth B. ; Zitnik, Ralph ; Naldi, Luigi. / A Randomized Trial of Etanercept as Monotherapy for Psoriasis. In: Archives of Dermatology. 2003 ; Vol. 139, No. 12. pp. 1627-1632.
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