At week 8, in both the 54-week ACT 1 trial and the 30-week ACT 2 trial, statistically significant differences in the proportion of patients in clinical response, clinical remission, and with mucosal healing were shown in UC patients treated with REMICADE versus those receiving placebo. In particular, approximately two-thirds of UC patients treated with REMICADE achieved the primary endpoint of clinical response, defined as improvement in signs and symptoms. Moreover, more than half had mucosal healing and more than one-third were in clinical remission. Furthermore, in both ACT 1 and ACT 2, nearly one-quarter of REMICADE patients receiving corticosteroids at baseline were in remission and steroid-free by week 30. In both ACT 1 and ACT 2, a significantly greater proportion of patients treated with REMICADE compared with placebo achieved clinical response, clinical remission, and mucosal healing from week 8 through the end of each trial (week 54 in ACT 1 and week 30 in ACT 2).
A major advance in the treatment of UC, REMICADE is the first and only biologic indicated in the United States for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately-to-severely active UC who have had an inadequate response to conventional therapy. This approval was based on the 30-week data from both trials.
"These long term results highlight the benefits of REMICADE for the treatment of UC," said William J. Sandborn, MD, professor of medicine, Mayo Clinic College of Medicine, head of the Inflammatory Bowel Disease (IBD) Interest Group, director of the IBD Clinical Research Unit at Mayo Medical Center, and lead study investigator. "These data
Contact: Michael Parks