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| |  Infliximab Effective for Ulcerative Colitis By W. A. Thomasson, PhD CHICAGO, IL -- May 17, 2005 -- Infliximab (IFX) appears to be an effective and well-tolerated treatment for ulcerative colitis, researchers reported here on May 16th at Digestive Disease Week (DDW). The findings of the ACT 2 study, which evaluated the safety and efficacy of IFX for treatment of active ulcerative colitis, were presented by William J. Sandborn, MD, professor of medicine, Mayo College of Medicine, head, Inflammatory Bowel Disease (IBD) Interest Group, and director, IBD Clinical Research Unit, Mayo Medical Center, Rochester, Minnesota. Infliximab, a monoclonal antibody that neutralizes proinflammatory tumor necrosis factor alpha, is currently approved for treatment of Crohn's disease. The study enrolled 364 patients with ulcerative colitis refractory to at least 1 standard therapy. These patients were randomized to receive infliximab at a dose of 5 or 10 mg/kg, or placebo, administered on weeks 0, 2, and 6, then every 8 weeks thereafter. This dosing regimen is the same as for treatment of Crohn's disease. Clinical response was defined as a decrease in the Mayo ulcerative colitis score of 30% or greater and 3 points or greater, and a decrease in the rectal bleeding score of 1 or greater or a rectal bleeding score of 0 or 1 at week 8. Clinical remission was defined as a Mayo score below 2. Mucosal healing was defined as an endoscopy subscore of 0 or 1. At week 8, 64.5% of patients on the 5-mg/kg dose and 69.2% on 10 mg/kg achieved a clinical response, compared with 29.3% with placebo (P < .001 for both). At week 30, 47.1%, 60%, and 26% achieved clinical response, respectively (P < .001 for both). Clinical remission was achieved in 33.9%, 27.5%, and 5.7% at week 8, respectively (P < .001 for both). At week 30, these were 25.6%, 35.8%, and 10.6% (P = .003 and P < .001). Mucosal healing at week 8 was seen in 60.3%, 61.7%, and 30.9%, respectively (P < .001 for both). At week 30, it was seen in 46.3%, 56.7%, and 30.1% (P = .009 and P < .001). The rate of corticosteroid discontinuation at week 30 was significantly greater in both infliximab groups than in the placebo group (18.3%, 27.3%, 3.3%; P < .001 and P = .010, respectively). Infliximab was generally well tolerated, with a safety profile similar to those reported in previous studies, Dr. Sandborn said in a prepared statement released on May 16th following presentation of the 2 studies. "The remission and response rates and mucosal healing rates, and the steroid sparing rates, are nearly identical to what we see in Crohn's disease," he said. "I think the results are clear an unequivocal." Grant/research support was obtained from Schering-Plough and Centocor. Results from an essentially identical study -- ACT 1, which evaluated patients treated with corticosteroids and/or 6-mercaptopurine/azathioprine -- were also presented at DDW. Paul Rutgeerts, MD, PhD, professor of medicine, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium, who presented the study, said the results show that infliximab is effective in treating active ulcerative colitis by reducing signs and symptoms, inducing remission, attaining mucosal healing, and facilitating corticosteroid withdrawal while maintaining remission.
[Presentation title: Infliximab Induction and Maintenance Therapy for Ulcerative Colitis: the ACT 2 Trial. Abstract 688. A Randomized Placebo-Controlled Trial Of Infliximab Therapy for Active Ulcerative Colitis: Act I Trial. Abstract 689]
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