Remicade therapy shown to improve productivity in patients treated for chronic plaque psoriasis

"This research further illustrates the correlation and impact of psoriasis on work productivity and demonstrates the substantial physical and emotional burdens faced by those living with this life-altering disease," says Gail Zimmerman, president and CEO, National Psoriasis Foundation. "We at the National Psoriasis Foundation encourage continued research and stress the importance of access to effective therapies, which may help manage a disease that often interferes with work and life activities."

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 II

The Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE in 835 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of REMICADE 3 mg/kg or 5 mg/kg 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 were crossed over at week 16 to receive REMICADE 5 mg/kg at weeks 16, 18 and 22, then every 8 weeks through week 46.

In EXPRESS II, through week 14 (the placebo-controlled period), adverse events (AEs) occurred at a higher incidence in the REMICADE groups (63 percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared with the placebo group (56 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzymes. Serious AEs occurred at rates of two percent in the placebo group, three percent in the 5 mg/kg group and one percent in the 3 mg/kg group. AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.