Remicade shows promise in treating ulcerative colitis

May 16 2005

Results from two Phase III, placebo-controlled clinical trials found that approximately two-thirds of patients with moderate to severe, active ulcerative colitis (UC) treated with Remicade (infliximab, 5mg/kg) demonstrated a significant improvement in symptoms.

In addition, one-third of patients achieved clinical remission. Data from the ACT I and ACT II clinical trials show Remicade achieved all primary and secondary endpoints of clinical response accompanied by decreases in rectal bleeding, and improvement in mucosal healing. Patients also were able to meaningfully reduce or eliminate steroid medications. The results were presented today at the 36th annual Digestive Disease Week meeting.

Currently, there are no biologic therapies approved to treat moderate to severe UC, a chronic disease with significant impact on quality of life that affects over 700,000 people in Europe. Alternative treatments are limited and, if conventional treatments do not control the symptoms of the disease, many patients may have to face surgical removal of the colon.

"The positive results of these studies showed significant improvement in patients suffering with the debilitating symptoms of ulcerative colitis. Currently, there are limited options for patients with UC and Remicade has the potential to represent a significant treatment advance," said Paul Rutgeerts, MD, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium.

Schering-Plough Corporation has rights to market Remicade in all countries outside of the United States, except in Japan, China (including Hong Kong), Taiwan and Indonesia, where Tanabe Seiyaku, Ltd. markets the product. Centocor discovered Remicade and has exclusive marketing rights to the product in the United States.