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Results from an open-label extension study of two clinical trials, CHARM and GAIN, demonstrate that adult moderate-to-severe Crohn’s patients treated with Humira® (adalimumab) achieved long-term clinical remission and clinical response, respectively.
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 four-week GAIN study were followed a total of one year.
The CHARM extension data demonstrated that three out of four patients (77%) 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% remained in clinical response at one year, and 40% 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 life-long condition with no known cure. One of the goals of treatment is to induce and maintain remission, which can help patients with their chronic symptoms,” said Remo Panaccione, MD, Associate Professor, and Director of the Inflammatory Bowel Disease Clinic at the University of Calgary and study author.
Humira is manufactured by Abbott.