REMICADE 5 mg/kg and 10 mg/kg than placebo-treated patients (P less than or equal to 0.003 for all comparisons with placebo). The rates of clinical response were similar between the corticosteroid-refractory and corticosteroid-responsive subgroups. The proportions of patients with sustained clinical response or sustained clinical remission were significantly higher in each REMICADE group than in the placebo group (P less than or equal to 0.002 for all comparisons with placebo). Additionally, the proportion of patients treated with REMICADE 5 mg/kg and 10 mg/kg who achieved mucosal healing at weeks 8 and 30 (in ACT 1 and ACT 2) and at week 54 (in ACT 1) was significantly greater than that for the placebo-treated patients (P less than or equal to 0.009 for all comparisons with placebo).

Furthermore, 61 percent of the patients in ACT 1 and 51 percent of the patients in ACT 2 were receiving corticosteroids at baseline. The baseline median daily corticosteroid dose was 20 mg/day in both studies. Of the patients who were receiving corticosteroids at baseline, the proportion of patients who were in clinical remission and had discontinued corticosteroids was significantly greater in the 5 mg/kg REMICADE group versus the placebo group at week 30 (P = 0.030 for ACT 1 and P = 0.010 for ACT 2); and at week 54 (P = 0.006 for ACT 1), an important factor for patients with UC who may experience considerable morbidity as a result of corticosteroids.

The serious adverse events reported in these trials were similar to those reported in previous REMICADE clinical trials. See Important Safety Information below.

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Contact: Michael Parks
215-325-4010
Centocor, Inc.
8-Dec-2005

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