New analyses reinforce efficacy of Remicade in treatment of severe psoriasis

In September 2006, REMICADE was approved in the U.S. for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter.

About EXPRESS

The European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study (EXPRESS) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE induction and maintenance therapy in 378 adult patients with chronic, stable plaque psoriasis involving at least 10 percent body surface area (BSA), a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients received either REMICADE 5 mg/kg or placebo administered at weeks 0, 2 and 6, followed by maintenance treatment every eight weeks. The REMICADE group continued on maintenance treatments every eight weeks. Patients in the placebo group were crossed over at week 24 to receive REMICADE 5 mg/kg at weeks 24, 26 and 30, then every eight weeks through week 46.

In EXPRESS, through week 24, adverse events (AEs) occurred at a higher incidence in the REMICADE group (82 percent) compared with the placebo group (71 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzyme tests. There were more serious AEs (six percent), including one fatal infection, in the REMICADE group than in the placebo group (three percent). AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.

About EXPRESS II