New analyses reinforce efficacy of Remicade in treatment of severe psoriasis

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 eight weeks through week 46.

In EXPRESS II, through week 14 (the placebo-controlled period), 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 enzyme tests. 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.

About SPIRIT

Study of Psoriasis with Infliximab [REMICADE] Induction Therapy (SPIRIT) was a Phase 2, multi-center, double-blind, placebo-controlled study evaluating the use of REMICADE induction therapy in 249 people with severe plaque psoriasis who had previously received psoralen plus ultraviolet light A (PUVA) or systemic therapy for psoriasis. Trial participants were randomized to receive REMICADE 3 mg/kg, REMICADE 5 mg/kg or placebo at weeks 0, 2, and 6 and were assessed biweekly for 10 weeks. At week 26, 114 patients whose Physician Global Assessment (PGA) score indicated moderate to severe disease were eligible for one additional infusion of their assigned treatment to assess the safety of re-treatment after a 20-week treatment-free period.