Efficacy and safety of etanercept in patients with psoriasis: results of a global phase iii study

Abstract

In previous psoriasis and psoriatic arthritis studies including a US phase III study, etanercept produced significant improvement in psoriatic skin disease. This second global phase III study was performed to confirm the efficacy and safety of etanercept monotherapy in patients with psoriasis. In this multicenter, blinded, randomized study, patients received either etanercept at 25 mg twice weekly (25BIW) or 50 mg twice weekly (50BIW), or placebo, by SC injection for 12 weeks. The primary endpoint was the proportion of patients achieving at least a 75% improvement in Psoriasis Area and Severity Index (PASI) at 12 weeks. 583 patients were randomized and dosed in the study. Groups (n = 196 and 194 for etanercept 25BIW, and 50BIW, respectively; n = 193 for placebo) were balanced for patient age, psoriasis duration, and disease severity. The percent of patients achieving the primary endpoint of PASI 75 at 12 weeks was significantly higher in the etanercept groups (25BIW, 50BIW) vs. the placebo group (34%, and 49% vs. 3%, respectively; p-value < 0.0001 vs. placebo for both doses). The percent of patients achieving clear or almost clear status on physician’s static global assessment at 12 weeks was also significantly higher in the etanercept groups vs. the placebo group (39%, and 57% vs. 4%, respectively; p-value < 0.0001 vs. placebo for both doses). Statistically significant improvements in patient static global assessment and Dermatology Life Quality Index also confirmed efficacy of etanercept therapy. Etanercept was well tolerated. Numbers of patients reporting adverse events and infections were similar between etanercept and placebo groups at 12 weeks. In this second phase III study, etanercept monotherapy was efficacious and well tolerated in the treatment of psoriasis.