Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis

It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.

Inclusion Criteria:

• Men aged 18-70
• Women in postmenopausal
• Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA
• PASI > 10 e/o BSA (Body Surface Area) > 10

Exclusion Criteria:

• Drug induced psoriasis
• Pustular or erythrodermic psoriasis
• Fertile women
• Pregnancy or lactation
• cholesterol > 230mg/dL e triglyceride > 200 mg/dL
• Known intolerance to efalizumab and acitretin
• Serious infection at enrollement
• History of previous neoplasia