The FDA has approved Stelara (ustekinumab injection, from Centocor Ortho Biotech), a monoclonal antibody, for the treatment of moderate to severe psoriasis in patients ≥18 years of age who are candidates for phototherapy of systemic therapy. This approval was based on data from a clinical development program that included two Phase 3 trials and enrolled more than 2,200 patients. Patients were randomized to receive either a subcutaneous injection of Stelara or placebo, given at weeks 0 and 4, followed by every-12-week dosing. In each trial, a significantly higher proportion of patients receiving Stelara achieved at least a 75% reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI), or PASI 75, at week 12 compared to patients receiving placebo. With every-12-week Stelara maintenance therapy, the majority of patients achieving a PASI 75 improvement maintained substantial skin clearance for one year.
Stelara is expected to be available in October 2009.