CENTOCOR PRESENTS NEW DATA ON REMICADE

Patients with ulcerative colitis (UC) treated with Remicade (infliximab) had an approximate 50 percent reduction in mean number of hospitalizations per year compared with placebo, according to an analysis of long-term data from a Phase III clinical trial, the ACT 1 trial, presented by Centocor at the American College of Gastroenterology meeting. Patients who responded and those who were in remission at one year had lower mean number of hospitalizations (no hospitalizations) than non-responders through one year of treatment.

Reduction of hospitalizations was sustained through one year in ACT 1 with approximately 50 percent lower mean number of hospitalizations for Remicade-treated patients (12 per 100 patients) compared with placebo (22 per 100 patients). Furthermore, the time to the first hospitalization among Remicade patients was longer compared with patients who received placebo.

Combined long-term data from ACT 1 and ACT 2 indicate that at week 30, patients who were treated with Remicade experienced fewer hospitalizations requiring high-dose corticosteroids than those treated with placebo. Among 484 Remicade-treated patients, there were 13 hospitalizations. Among 244 patients in the placebo group there were 19 hospitalizations.

Remicade was approved by the FDA for the treatment of UC last year based on positive results from two randomized, placebo-controlled, pivotal Phase III clinical trials, ACT 1 and ACT 2. Fifty-four-week results from the ACT 1 trial further demonstrated the long-term safety and efficacy of Remicade in patients with moderately to severely active UC and found that Remicade therapy not only induces clinical remission, but also maintains remission of symptoms up to one year.