Efficacy

The efficacy of etanercept for the treatment of plaque psoriasis has been evaluated in four placebo-controlled studies, one of which evaluated psoriasis in the setting of psoriatic arthritis. This study by Mease and colleagues which evaluated etanercept in the treatment of psoriatic arthritis also examined a subset of 38 patients who had more than 3 % of their body surface area (BSA) covered with plaque psoriasis. Of the 38 patients, 19 received etanercept, 25 mg subcutaneous twice weekly, while the remaining 19 received placebo. After 12 weeks of therapy, 26% of those subjects receiving etanercept achieved PASI-75 compared to 0% of those receiving placebo.

A larger, phase 2, randomized, double-blind and placebo controlled study by Gottlieb and colleagues (Gottlieb, Chaudhari, et al. 2003) examined the efficacy and safety of etanercept, 25 mg subcutaneously twice a week compared to placebo, as monotherapy for moderate to severe plaque psoriasis. After 12 weeks of therapy, 30 % of patients achieved a PASI-75 compared to 2 % in the placebo group. After 24 weeks of continuous therapy, 56 % of patients receiving etanercept achieved PASI-75 compared to 5% in the control group. In addition, by 24 weeks, psoriasis was clear or minimal by the physician's global assessment in more than 50% of patients who received etanercept.

Leonardi and colleagues later conducted a phase 3, placebo-controlled, double blind study that evaluated etanercept for psoriasis. Patients with moderate to severe psoriasis who were not receiving any other therapies including systemic, phototherapy or topical treatments, were enrolled. Six hundred and seventy-two patients underwent randomization and 652 received either placebo or received etanercept subcutaneously at low dose (25 mg once weekly), medium dose (25 mg twice weekly), or high dose (50 mg twice weekly). After 12 weeks, patients who were in the placebo group began twice weekly treatment with 25 mg of etanercept. After 12 weeks of therapy, 4%, 14%, 32%, and 47% of patients achieved a PASI-75 on placebo, 25 mg once weekly, 25 mg twice weekly, and 50 mg twice weekly, respectively. After 24 weeks of continuous therapy, the PASI-75 score in the low dose group was 21 %, 41 % in those receiving 25 mg twice weekly, and 54% in those receiving the high dose of 50 mg twice weekly.

A second large, phase 3, double-blind study evaluating etanercept for moderate to severe plaque psoriasis was conducted in the US, Europe, and Canada by Papp and colleagues. The study involved three groups of patients, each receiving placebo twice weekly, etaner-cept 25 mg twice weekly, or etanercept 50 mg twice weekly, for the first 12 weeks. After 12 weeks, all three groups were continued on etanercept 25 mg twice weekly for 12 weeks. After the first 12 weeks of therapy, 3 %, 34 %, and 49 % of patients receiving placebo, 25 mg twice weekly, and 50 mg twice weekly, achieved PASI-75 respectively, findings consistent with those results seen in the US studies. During the second 12-week period during which all patients received 25 mg, those patients who were previously receiving 25 mg twice weekly continued to improve, with 45% achieving PASI-75 at week 24. The high dose group (50 mg twice weekly) who were then placed on 25 mg twice weekly maintained their previous improvements, with 54 % achieving PASI-75 at week 24, and of those patients who were previously receiving placebo, 28 % achieved a PASI-75. These finds suggested that induction with high-dose etanercept can then be maintained with a lower dose and still preserve PASI-75 scores.

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