WASHINGTON, DC, May 23, 2007 Findings presented today at Digestive Disease Week 2007 (DDW), from long-term extensions of the ACT trials (Active Ulcerative Colitis 1 & 2) show that subjects with moderately to severely active ulcerative colitis (UC) who had responded to REMICADE (infliximab) in the blinded phase of the trials maintained improvement in their clinical symptoms for up to two years.
The ACT extension trials were conducted in both the United States and Europe, under co-principle investigators William Sandborn, M.D. of the Mayo Clinic and Walter Reinisch, M.D., of the University Hospital Vienna, Austria. The data show that for patients who completed follow-up through week 56 of the extension trials, 92 percent reported mild or no disease activity, as measured by the Physician's Global Assessment (PGA). For patients followed through week 104, 97 percent reported mild or no disease activity.
At week 0 of the ACT extension trials, 76 percent of 229 responder patients enrolled had mild or no disease activity, as indicated by a PGA score of 0 or 1, and 41 percent had no disease activity (PGA score of 0). At week 56, 92 percent of those patients remaining in the extension trials (n=181) had mild or no disease activity, and 61 percent had no disease activity. At week 104, 97 percent of those patients remaining in the extension trials (n=97) had mild or no disease activity, and 75 percent had no disease activity.
"The data demonstrate the sustained efficacy of REMICADE for many patients with UC," said co-principle investigator Walter Reinisch, M.D., of the University Hospital Vienna, Austria. "Because UC is a chronic condition, many patients live with cycles of recurring flares. This can greatly hinder a person's social and professional life. The availability of therapies that quickly reduce symptoms and maintain response and remission long term is a significant benefit to patients."