ReportA randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis
Section snippets
Patients and methods
Institutional Review Board approval and written informed consent were obtained before study-related procedures were done. Eligible patients were 18 years of age or older with stable, active plaque psoriasis involving 10% body surface area (BSA) or more. For entry criteria, the reader is directed to the Web site www.clinicaltrials.gov (study NCT00111111).4
Patients were randomly assigned 1:1 into two groups, continuous and interrupted therapy. During the first 12 weeks, all patients received
Results
At baseline, the groups were well balanced in terms of demographics and disease characteristics. Most were men (62%) and white (85%). Mean age was 45.4 years, mean duration of psoriasis was 18.2 years, and mean BSA involvement was 29%. A majority of the 2546 randomized patients who received 1 dose or more of etanercept completed the study (88% continuous, 85% interrupted) (Fig 1). The most common reasons for study withdrawal were as follows: lost to follow-up (4.9%), AEs (2.7%), withdrawn
Discussion
To our knowledge, Etanercept Assessment of Safety and Effectiveness represents the largest interventional study in psoriasis patients to date. The results demonstrated that etanercept was effective and generally well tolerated when administered continuously or after discontinuation and re-treatment. Although continuous etanercept therapy provided optimal benefits, patients who respond well to etanercept may discontinue and reinitiate treatment, with a high probability of recapturing similar
References (13)
- et al.
Quality-of-life issues in psoriasis and psoriatic arthritis: outcome measures and therapies from a dermatological perspective
J Am Acad Dermatol
(2006) - et al.
Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial
Lancet
(2000) Enbrel® (etanercept)
(2006)- et al.
Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy
J Dermatolog Treat
(2006) - ClinicalTrials.gov Web site. Available at: http://www.clinicaltrials.gov/. Study identifier NCT00111111. Accessed April...
- et al.
Etanercept as monotherapy in patients with psoriasis
N Engl J Med
(2003)
Cited by (0)
Funding sources: Amgen Inc. and Wyeth Research.
Disclosures: Dr Moore has received honoraria or funding from Abbott, Allergan, Amgen, Astellas, Biogen, Centocor, Connetics, Dermik, Galderma, Genentech, GlaxoSmithKline, Healthpoint, 3M, Medicis, Novartis, and Warner Chilcott. Dr Gordon has received support and honoraria from the following companies: Abbott, Amgen, Biogen, Centocor, and Genentech. Dr Kang has received research funding from Amgen. Dr Gottlieb is a consultant for several companies (Amgen Inc; BiogenIdec, Inc; Centocor, Inc.; Wyeth Pharmaceuticals; Schering-Plough Corporation; Eisai; Celgene Corp; Bristol Myers Squibb Co; Beiersdorf, Inc; Warner Chilcott; Abbott Labs; Roche; Sankyo; Medarex; Kemia; Celera; TEVA; Actelion; UCB; Novo Nordisk; Almirall; Immune Control) and is on the speaker's bureau for Amgen Inc. and Wyeth Pharmaceuticals. Dr Freundlich is an employee of Wyeth. Drs Xia and Stevens are employees of Amgen.
The data in this article have been presented at the 2005 AAD Academy meeting in Chicago, Ill, July 20-24, 2005 and the 2006 AAD annual meeting in San Francisco, Calif, March 3-7, 2006.