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Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission
Date:5/21/2008

Three of Four HUMIRA Patients from CHARM Study in Remission at One Year

Maintained Remission at Two Years

ABBOTT PARK, Ill., May 21 /PRNewswire-FirstCall/ -- Results from an open-label extension study of two Abbott pivotal studies, CHARM and GAIN, demonstrate that adult moderate-to-severe Crohn's patients treated with HUMIRA(R) (adalimumab) achieved long-term clinical remission and clinical response, respectively, according to data presentations today at Digestive Disease Week(R) (DDW) in San Diego. DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Patients from CHARM and GAIN were followed through into a non-placebo controlled, ongoing open-label extension (OLE) trial. Patients from CHARM were followed a total of two years, and patients from the 4-week GAIN study were followed a total of one year.

The CHARM extension data demonstrated that three out of four patients (77 percent) taking HUMIRA, who were in remission at the end of the one-year pivotal study, maintained clinical remission for an additional year. The GAIN data showed that, of patients with a clinical response at four weeks, approximately 65 percent remained in clinical response at one year, and 40 percent were in clinical remission at one year. Response was measured by change in Crohn's Disease Activity Index (CDAI), a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well-being and other measures. Clinical remission was measured as a score of less than 150 and clinical response was measured as a decline of at least 70 points from baseline.

Crohn's disease is a serious, chronic, inflammatory bowel disease that affects more than 500,000 Americans. It affects people of all ages but it is primarily a disease
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