Patients with moderate-to-severe active ulcerative colitis treated with Infliximab ( Remicade ) at weeks 0, 2, and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8, 30, and 54 than were those receiving placebo.
Data from two Phase III trials, ACT 1 and ACT 2, show Remicade met primary and secondary endpoints of clinical response, clinical remission and mucosal healing.

The ACT 1 and ACT 2 clinical trials were conducted to evaluate the safety and efficacy of Remicade 5 mg/kg and 10 mg/kg at weeks zero, two and six and then every eight weeks in people with active ulcerative colitis.

The primary endpoint for these trials was a clinical response at week eight, defined as a decrease from baseline in the Mayo score by greater than or equal to 30 percent and greater than or equal to three points, accompanied by a decrease in the rectal bleeding subscore of greater than or equal to one or a rectal bleeding subscore of zero or one at week eight.
Secondary endpoints also included a clinical response at week 30, clinical remission at week eight and week 30 and mucosal healing at week eight. The serious adverse events reported in these trials were similar to those reported in previous Remicade clinical trials.

In ACT 1, 69 percent of patients who received 5 mg of Infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo ( P<0.001 for both comparisons with placebo ).

In ACT 2, 64 percent of patients who received 5 mg of Infliximab and 69 percent of those who received 10 mg had a clinical response at week 8, as compared with 29 percent of those who received placebo ( P<0.001 for both comparisons with placebo ).

In both studies, patients who received Infliximab were more likely to have a clinical response at week 30 ( P 0.002 for all comparisons ).

In ACT 1, more patients who received 5 mg or 10 mg of Infliximab had a clinical response at week 54 ( 45 percent and 44 percent, respectively ) than did those who received placebo ( 20 percent, P<0.001 for both comparisons ).

Source: The New England Journal of Medicine, 2005


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