Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomized controlled trial with open-label extension

P C M van de Kerkhof, S Segaert, M Lahfa, T A Luger, Z Karolyi, A Kaszuba, G Leigheb, F M Camacho, D Forsea, C Zang, M P Boussuge, L Paolozzi, J Wajdula
British Journal of Dermatology 2008, 159 (5): 1177-85

BACKGROUND: In previous studies, etanercept 25 mg twice weekly (BIW) or 50 mg BIW significantly reduced disease severity in patients with plaque psoriasis and demonstrated a favourable safety profile.

OBJECTIVES: To assess the efficacy and safety of etanercept 50 mg administered once weekly (QW) compared with placebo in patients with moderate-to-severe plaque psoriasis over 24 weeks.

METHODS: This study was conducted in two parts: (i) a 12-week, double-blind, placebo-controlled phase, in which patients received etanercept 50 mg QW or placebo QW; and (ii) a 12-week, open-label extension phase, in which all patients received etanercept 50 mg QW. Primary endpoint was a 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included percentage PASI improvement and Physician's Global Assessment (PGA).

RESULTS: One hundred and forty-two patients were analysed in the double-blind phase; 126 patients entered the open-label phase. At week 12, significantly more patients receiving etanercept 50 mg QW (37.5%) achieved PASI 75 response than patients receiving placebo (2.2%; P < 0.0001). At week 24, 71.1% in the etanercept-etanercept group and 44.4% in the placebo-etanercept group achieved PASI 75. Mean percentage of PASI improvement from baseline was 55.4% with etanercept vs. 9.4% worsening with placebo at week 12 (P < 0.0001), with 77.4% and 57.7% improvement in the etanercept-etanercept and placebo-etanercept groups at week 24. A PGA score of 0-1 (clear-almost clear) was achieved by 64% and 42% in the etanercept-etanercept and placebo-etanercept groups at week 24, respectively. Etanercept 50 mg QW was well tolerated. No deaths, serious infections, opportunistic infections (including tuberculosis), demyelinating disorders, malignancies or new safety signals were reported.

CONCLUSIONS: Nearly three-quarters of patients with moderate-to-severe psoriasis receiving etanercept 50 mg QW achieved significant improvement in disease severity over 24 weeks. This study also showed a favourable tolerability and safety profile with etanercept 50 mg QW.

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