New Orleans, LA Crohns disease, which currently affects up to one million people in the U.S., causes inflammation in the lining of the small intestine that can lead to pain and discomfort. Though the condition usually occurs in the lower part of the small intestine, it can affect any part of the digestive tract. New studies presented today at Digestive Disease Week show the commitment of gastroenterology researchers to this population that is in need of new treatment options. Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
These studies present confirming evidence that we are getting closer to finding an absolute cause for Crohns disease, said Jim Lewis, M.D., of the University of Pennsylvania. We hope that until we can find a cure for Crohns, these new options will improve the quality of life for sufferers.
All of the studies below analyzed patient response based on the Crohns Disease Activity Index (CDAI), which measures the severity of a patients disease.
A Phase III, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Tolerability of AntegrenTM (natalizumab) in Maintaining Clinical Response and Remission in Crohns Disease (ENACT-2) (Abstract 900030*)
AntegrenTM (natalizumab) has undergone a successful phase III induction of response/remission study (ENACT-1). In this multi-center, international trial, researchers conducted a randomized, controlled study (ENACT-2) to determine whether a six-month regimen of the drug could maintain the clinical response/remission achieved by the previous study.
ENACT-2 studied 339 adult subjects with Crohns disease (CD) from ENACT-1 who had achieved a response on the drug (* 70-point reduction in CDAI) and/or remission (CDAI score of less than 150) and had a CDAI score of less than 220 after receiving three infusions of
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18-May-2004
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