Centocor, Inc, of Horsham, Pennsylvania, presented the results from its phase III EXPRESS II study of Remicade® (infliximab) in the treatment of moderate to severe plaque psoriasis at the 64th Annual American Academy of Dermatology meeting on March 3 in San Francisco, California.

A multicenter, randomized, double-blind, dose-ranging, placebo-controlled trial, EXPRESS II examined the safety and efficacy of Remicade in 835 patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of 3 mg/kg or 5 mg/kg Remicade or placebo at weeks 0, 2, and 6. Patients in the active induction treatment groups were randomized again at week 14 to receive either scheduled or "as-needed" maintenance treatment at the same dose administered during the induction phase. Patients in the placebo group crossed over at week 16 to receive 5 mg/kg Remicade at weeks 16, 18, and 22, and every 8 weeks thereafter for maintenance therapy through week 46.

The findings from EXPRESS II showed that every 8-week maintenance therapy resulted in greater long-term skin clearance compared with "as-needed" therapy regimens within each dose. For example, at week 10, after infusions at weeks 0, 2, and 6, 70% of patients treated with 3 mg/kg Remicade and 75% of patients receiving 5 mg/kg Remicade achieved at least a 75% improvement in psoriasis as measured by Psoriasis Area Severity Index (PASI 75), compared with 2% of patients receiving placebo (P <.001). At week 50, patients receiving 5 mg/kg Remicade for maintenance therapy every 8 weeks achieved the highest level of sustained PASI improvement, with the majority of patients achieving PASI 75 vs the 3 mg/kg Remicade 8-week maintenance therapy and the 3 mg/kg and 5 mg/kg Remicade "as-needed" therapy regimens.

In November 2005, Centocor announced that the US Food and Drug Administration accepted its filing of a supplemental Biologics License Application (sBLA) for the use of Remicade in the treatment of moderate to severe plaque psoriasis. In September 2005, Centocor received European Commission approval of Remicade for the treatment of moderate to severe plaque psoriasis in adults who either failed to respond to, have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate, or psoralen plus ultraviolet light A (PUVA). Remicade is approved in the US and European Union for the treatment of active psoriatic arthritis.

—A. Techman