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| |  Etanercept Provides Sustained Efficacy and Safety Benefits in Patients With Psoriasis: Presented at AAD By Jill Stein SAN FRANCISCO -- March 10, 2009 -- Etanercept maintains good efficacy and safety when used as long-term treatment for psoriasis, researchers said here at the at the American Academy of Dermatology (AAD) 67th Annual Meeting. Etanercept is a soluble tumour necrosis factor-alpha approved for treatment of moderate to severe plaque psoriasis. Kim Papp, MD, Probity Medical Research, Waterloo, Ontario, and colleagues presented results on March 8 for patients with moderate to severe plaque psoriasis who were treated with etanercept for up to 4.2 years. The 383 patients included in the analysis were enrolled at 17 Canadian sites in a 1- to 2- year open-label extension study after they had completed 1 of 3 prior trials of 1 to 2.5 years during which they received placebo, etanercept 25 or 50 mg once weekly, or 50 mg twice weekly. Mean duration of psoriasis in the cohort was 23.2 years; 35.5% of patients had psoriatic arthritis. Participants in the extension trial used etanercept for a range of 2.0 to 4.6 years. During the extension period, 8.4% of patients received etanercept for 50 mg once weekly and 91.6% received 50 mg twice weekly. Results data showed that 85.6% of patients achieved a score of 0, 1, or 2 on the Physician's Status Global Assessment after 6 months of treatment, and 67.1% achieved a score of 0, 1, or 2 after 3.5 cumulative years of treatment. Adverse events occurred in 67.1% of patients. No difference in the percentage or type of adverse events was observed between treatment groups. The subject incidence of infectious adverse events was 42.3%. Noninfectious adverse events occurred in 48.6% of subjects and most often included hypertension, hypercholesterolaemia, back pain, and skin lacerations. Twenty-two patients (5.7%) had serious noninfectious adverse events; only chest pain in 1 patient was thought to be drug-related. Four subjects each experienced 1 infectious serious adverse event but none was considered to be drug-related. One sudden death of unknown cause occurred during the study period. Overall, the data show that etanercept once or twice weekly has sustained efficacy and a favourable safety profile, the investigators said. In fact, there was no cumulative toxicity, and no new safety signals were observed during up to 4.2 years, the investigators said. Funding for this study was provided by Amgen Canada Inc. and Wyeth Pharmaceuticals. [Presentation title: Assessment of Long-Term Safety and Efficacy of Etanercept for the Treatment of Psoriasis in an Adult Canadian Population. Abstract P3314]
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