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

PASI responses for trunk psoriasis in the combined REMICADE groups (3 mg/kg and 5 mg/kg) versus placebo were as follows: SPIRIT, 86 percent versus 12 percent achieved at least 75 percent improvement and 66 percent versus 4 percent achieved at least 90 percent improvement; EXPRESS, 87 percent versus 5 percent achieved at least 75 percent improvement and 72 percent versus 1 percent achieved at least 90 percent improvement; EXPRESS II, 79 percent versus 7 percent achieved at least 75 percent improvement and 59 percent versus 4 percent achieved at least 90 percent improvement.

Patients in the combined REMICADE groups (3mg/kg and 5 mg/kg) experienced similar improvement in PASI scores of the upper and lower extremities. For the upper extremities the proportions of patients achieving at least 75 percent improvement or at least 90 percent improvement versus placebo were as follows: SPIRIT, 77 percent versus 6 percent achieved at least 75 percent improvement and 49 percent versus 2 percent achieved at least 90 percent improvement; EXPRESS, 82 percent versus 4 percent achieved at least 75 percent improvement and 56 percent versus 1 percent achieved at least 90 percent improvement; EXPRESS II, 72 percent versus 2 percent achieved at least 75 percent improvement and 46 percent versus 0.5 percent achieved at least 90 percent improvement. Results for the lower extremities were: SPIRIT, 72 percent versus 8 percent achieved at least 75 percent improvement and 49 percent versus 2 percent achieved at least 90 percent improvement; EXPRESS, 75 percent versus 3 percent achieved at least 75 percent improvement and 50 percent versus 1 percent achieved at least 90 percent improvement; EXPRESS II, 65 percent versus 4 percent achieved at least 75 percent improvement and 35 percent versus 0.5 percent achieved at least 90 percent improvement.

Further results from the integrated analysis were published in the summer 2007 issue of the Psoriasis Forum, a journal of the National Psoriasis Foundation, and showed the consistency of REMICADE response across subgroups defined by a variety of baseline demographic and disease characteristics in patients with psoriasis. REMICADE was similarly effective regardless of previous use of phototherapy or major conventional systemic therapies.

About EXPRESS

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 8 weeks. The REMICADE group continued on maintenance treatments every 8 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 8 weeks through week 46.