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Infliximab Study Demonstrates High Level of Clinical Response Throughout Body

SAN ANTONIO, Feb. 4 /PRNewswire/ -- Data from an integrated analysis of three randomized, placebo-controlled trials showed patients with moderate to severe plaque psoriasis receiving REMICADE(R) (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 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, and lead study investigator. "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.

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.

In EXPRESS, through week 24, adverse events (AEs) occurred at a higher incidence in the Remicade group (82 percent) compared with the placebo group (71 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. There were more serious AEs (6 percent), including one fatal infection, in the Remicade group than in the placebo group (3 percent). AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.

About EXPRESS II
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), 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 2 percent in the placebo group, 3 percent in the 5 mg/kg group and 1 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
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, patients whose Physician Global Assessment (PGA) score indicated moderate to severe disease (n=114) were eligible for one additional infusion of their assigned treatment to assess the safety of retreatment after a 20-week treatment-free period.

In the SPIRIT trial, the percentage of patients with one or more AE was higher in the Remicade groups compared with placebo. Through week 30 of the SPIRIT trial, 63 percent, 78 percent and 79 percent of patients in the placebo, Remicade 3 mg/kg and 5 mg/kg groups, respectively, reported one or more AE. The most commonly reported side effects versus placebo were upper respiratory tract infection (15 percent versus 14 percent), headache (15 percent versus 8 percent) and itching (12 percent versus 0 percent). A total of 6 percent of REMICADE-treated patients reported serious AEs, compared with zero patients in the placebo group. Overall, the AEs were consistent with those seen in previous trials. Please see "Important Safety Information" below.

Source: Centocor

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