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A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis

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Background

Although etanercept is used as a continuous therapy for moderate to severe plaque psoriasis, intermittent use may be necessary in some instances.

Objective

In this randomized, open-label study, we evaluated the effectiveness and safety of continuous versus interrupted etanercept therapy.

Methods

All patients received uninterrupted etanercept 50 mg twice weekly during the first 12 weeks, followed by either continuous (n = 1272) or interrupted (n = 1274) etanercept 50 mg once weekly in the next 12 weeks. The primary effectiveness end point was the proportion of responders (those who achieved a Physician's Global Assessment [PGA] score ≤2 and improvement from baseline) at week 24. Secondary end points included the PGA “clear/almost clear” status, the PGA Scalp Psoriasis score, and the Dermatology Life Quality Index. A modified intent-to-treat analysis was performed.

Results

At week 12, comparable high proportions of responders were reported in the continuous (71.3%) and interrupted (72.0%) arms. However, the proportion of responders at week 24 was greater in the continuous group than in the interrupted group (71.0% vs 59.5%; P < .0001). Similar results were observed in secondary end points. The mean number of etanercept doses (1 dose = 50 mg) received by patients in the continuous group was 33.4, compared with 28.0 in the interrupted group. Etanercept was well tolerated in both treatment arms.

Limitations

We examined one round of discontinuation and re-treatment; interrupted therapy provided less total medication to responding patients.

Conclusions

Continuous and interrupted etanercept therapy was effective and generally well tolerated in patients with psoriasis, with greater improvements observed in the continuous arm at week 24. Most patients regained their response after reinitiation of etanercept.

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)

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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.

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