REMICADE-treated patients experienced substantial improvement in psoriasis in critical body regions

Marked improvement in 4 regions of body

SAN ANTONIO, TX, February 1, 2008 -- Data from an integrated analysis of three randomized, placebo-controlled trials showed patients with moderate to severe plaque psoriasis receiving REMICADE (infliximab) achieved a consistently high level of skin clearance in each of the four body regions (head, trunk, lower and upper extremities) as measured by the Psoriasis Area Severity Index (PASI). At week 10 of the analysis, which included nearly 1,500 subjects, 71 percent of patients receiving REMICADE 3 mg/kg and 79 percent of patients receiving REMICADE 5 mg/kg achieved a PASI 75, or at least a 75 percent improvement in the chronic inflammatory condition, compared with three percent of patients receiving placebo (both P<0.001). Additionally, 39 percent and 52 percent of patients receiving REMICADE 3 mg/kg and 5 mg/kg, respectively, achieved a PASI 90, or nearly complete skin clearance, versus one percent of patients receiving placebo (both P<0.001). Investigators reported these findings at the 66th Annual Meeting of the American Academy of Dermatology.

In September 2006, the U.S. Food and Drug Administration (FDA) approved REMICADE (5 mg/kg) for the treatment of chronic severe plaque psoriasis. Following an initial three infusion treatments (induction regimen), REMICADE is given once every eight weeks, or as few as six times a year.

“This analysis shows that treatment with REMICADE resulted in a consistently high level of clinical response in each quadrant of the body evaluated by PASI, and the results were consistent with patients’ overall psoriasis improvement,” said Alan Menter, MD, dermatologist, Baylor Research Institute, Dallas. “REMICADE remains an important advancement and biologic treatment option for a broad spectrum of patients with severe psoriasis.“

According to findings presented by investigators, in each of the three psoriasis clinical trials evaluated, the Study of Psoriasis with Infliximab [REMICADE] Induction Therapy (SPIRIT), the European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study (EXPRESS), and the Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II), a substantial proportion of REMICADE-treated patients experienced dramatic improvements in head- and neck-related psoriasis, trunk psoriasis and psoriasis of the lower and upper extremities as compared with the placebo group. Additionally, the improvements in each body region were generally consistent with the overall PASI response. At week 10, the proportions of patients achieving at least a 75 percent improvement or at least a 90 percent improvement of head and neck-related psoriasis in the combined REMICADE groups (3 mg/kg and 5 mg/kg) versus placebo were as follows: SPIRIT, 86 percent versus 22 percent achieved at least 75 percent improvement and 69 percent versus 12 percent achieved at least 90 percent improvement; EXPRESS, 85 percent versus 13 percent achieved at least 75 percent improvement and 73 percent versus 8 percent achieved at least 90 percent improvement; EXPRESS II, 79 percent versus 10 percent achieved at least 75 percent improvement and 67 percent versus 6 percent achieved at least 90 percent improvement.