Journal of the American Academy of Dermatology
Efficacy of etanercept in an integrated multistudy database of patients with psoriasis
Section snippets
Patient population
The institutional review boards of the participating medical centers approved the protocols. All patients gave written informed consent before initiation of the clinical trials. Patients included in the integrated analyses were eligible if they were 18 years of age or older; had active, stable plaque psoriasis involving at least 10% of body surface area (BSA); and were candidates for or had received previous phototherapy or systemic therapy for psoriasis. Patients in the phase 2 study required
Patient demographics and baseline characteristics
Across all studies, 773 patients received at least 1 dose of etanercept (50 mg weekly [n = 415] or 50 mg twice weekly [n = 358]), compared with 414 patients who received placebo. The severity of psoriasis in the patient population was consistent with moderate to severe psoriasis. Baseline patient demographics and characteristics were comparable between all 3 treatment groups (Table I). Patients were predominantly white men with severe psoriasis, 25% of whom had a prior diagnosis of psoriatic
Discussion
Psoriasis is a debilitating disease associated with major morbidity and negative impact on patients' lives. Etanercept therapy has been shown to significantly improve the physical and psychological burdens of the disease, as well as to improve the quality of life of affected individuals, in 3 placebo-controlled, double-blind clinical trials. In our integrated analyses, the results from these 3 studies were remarkably consistent with respect to efficacy within each study and across all studies
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Supported by Amgen Inc and Wyeth Research. Funded by Immunex Corporation, Seattle, Wash, a wholly owned subsidiary of Amgen Inc, Thousand Oaks, Calif, and by Wyeth. Data were collected by Amgen and stored in a central repository. Amgen provided statistical and editorial support.
Conflicts of interest: Dr Gordon has received support and honoraria from the following companies: Abbott, Amgen, Biogen, Centocor, and Genentech. He received an honorarium for this work. Dr Korman has received grants from Amgen, has served as a clinical investigator for Amgen, and is on the Amgen speakers bureau. Dr Frankel serves on a speakers bureau for Amgen. Drs Wang, Jahreis, Zitnik, and Chang are employees of and have been granted stock options in Amgen, Inc.
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