New analyses reinforce efficacy of Remicade in treatment of severe psoriasis

Data show patients with severe psoriasis affecting the nails experienced significant improvements with Remicade therapy

WASHINGTON, DC, February 2, 2007 -- Findings from an integrated analysis of data from three pivotal, randomized, placebo-controlled trials showed that at week 10 more than three-quarters of patients with severe psoriasis receiving REMICADE® (infliximab) 3 mg/kg or 5 mg/kg achieved a 75 percent improvement in the chronic, inflammatory skin disease as measured by the Psoriasis Area Severity Index (PASI 75). In addition, in a separate analysis, investigators presented findings from a Phase 3 study, which showed that patients treated with REMICADE experienced significant and progressive improvements in psoriasis affecting the nails. Nail disease occurs in up to 50 percent of people with psoriasis. These findings were presented today at the 65th Annual Meeting of the American Academy of Dermatology.

"The integrated data show the substantial efficacy of REMICADE and present great hope for patients with severe psoriasis, particularly those patients burdened with this chronic disease who previously failed phototherapy or systemic therapy," said Alan Menter, MD, dermatologist, Baylor Research Institute, Dallas, and lead study investigator.

In the analysis of 1462 randomized patients, 991 patients (68 percent) met criteria for severe disease as defined by a body surface area (BSA) of at least 20 percent. Out of the 991 patients, 73 percent and 69 percent of study patients had received previous phototherapy or systemic therapy, respectively. At week 10, among patients with severe psoriasis treated with REMICADE (combined 3 mg/kg and 5 mg/kg groups), 79 percent of patients who had received prior phototherapy and 76 percent who had been previously treated with one or more systemic agents achieved PASI 75, compared with three percent and one percent, respectively, of placebo patients (P < 0.001, for both). In a separate analysis from the Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II), among patients with severe psoriasis who were either dissatisfied with or were intolerant to phototherapy, 73 percent of those treated with REMICADE achieved PASI 75 at week 10, compared with two percent of patients receiving placebo (P < 0.001). Sixty-nine percent of patients who were dissatisfied with or were intolerant to one or more systemic therapies prior to starting REMICADE achieved PASI 75 at week 10, compared with zero patients in the placebo group (P < 0.001).