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Natalizumab Improves Quality of Life for Patients with Crohn's Disease: Presented at DDW
By Ed Susman
ORLANDO, FL -- May 23, 2003 -- Natalizumab, the investigational monoclonal antibody to alpha-4 integrin, appears to improve the quality of life in patients with active Crohn's Disease, researchers noted on May 20th here at Digestive Disease Week 2003.
In a Phase II, randomised, double-blind study of natalizumab, doctors analysed responses of 248 patients to the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a validated psychological instrument that measures four quality-of-life domains: bowel and systemic symptoms, and emotional and social function.
"Significant improvements in all four domains of the questionnaire were seen in patients receiving two infusions of natalizumab compared to those receiving placebo," said Dr. Stephen Donoghue, PhD, head of the European Clinical Research Group of Elan Pharmaceuticals, Stevenage, United Kingdom.
Dr. Donoghue explained that the quality-of-life improvements were assessed six weeks after the beginning of treatment with natalizumab.
Bowel symptoms increased from an IBDQ score of 41 to 44 points in the placebo group; from 38 to 47 points in patients on a low-dose 3 mg/kg infusion of natalizumab; from 42 to 50 points in patients receiving two 3 mg/kg infusions of natalizumab; and from 37 to 47 points in patients receiving two 6 mg/kg infusions of natalizumab (P<0.005 vs. placebo).
Similar differences were seen for systemic symptoms (P<0.05), emotional function (P<0.005) and social function (P<0.05).
"These results further suggest that natalizumab may hold promise for treatment of Crohn's disease," Dr. Donoghue stated.
Digestive Disease Week 2003 is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract.
This study was funded by Elan Pharmaceuticals.
[Study title: Quality of Life Improvements in a Phase 2 Study of Natalizumab for Active Crohn's Disease. Abstract 105724]
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