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Title: Sustained Clinical Remission and Response in Crohn's Disease With Extended Adalimumab Therapy: Presented at ACG

"Sustained Clinical Remission and Response in Crohn's Disease With Extended Adalimumab Therapy: Presented at ACG"

By Paula Moyer LAS VEGAS, NV -- October 30, 2006 -- Patients with Crohn's disease have continued clinical remission and response when they continue on treatment with adalimumab (Humira) therapy, according to investigators who presented their findings here at the American College of Gastroenterology Annual Scientific Meeting (ACG). "There was no significant difference between the results of every-other-week and weekly treatment," said principal investigator William J. Sandborn, MD, professor of medicine, Mayo College of Medicine, Rochester, Minnesota. The safety profile seen in this study was consistent with results seen in previous studies of patients with rheumatoid arthritis and Crohn's disease, he said. In an extension of the fully Human antibody Adalimumab for Remission Maintenance (CHARM) study, Dr. Sandborn and colleagues randomized 499 patients to placebo or adalimumab; those on active treatment received 80 mg subcutaneously at the beginning of treatment and 40 mg at week 2. The active treatment group was further randomized to treatment every other week or weekly. Week-26 results, presented on October 22[^nd, show remission rates of 40% and 46% for the every-other-week and weekly adalimumab groups, respectively, compared with 17% for the placebo group. At week 56, the remission rates were 36% and 43%, respectively, and 12% for placebo (P < .001 for all).

Clinical response, as measured by the percent of patients that had a decrease of at least 100 (CR100) in the Crohn's Disease Activity Index, were 52% in each adalimumab group at week 26, and 26% in the placebo group. At week 56, CR100 rates were 41% in the every-other-week group, 48% in the weekly group, and 16% in the placebo group.

The CR70 rates at week 26 were 54% for the every-other-week group, 56% for the weekly group, and 28% for the placebo group. At week 56, those rates were 43%, 49%, and 18% (P < .001 for all).

The study was funded by Abbott, which manufactures Humira.

[Presentation title: Adalimumab Maintains Clinical Remission and Response in Patients With Active Crohn's Disease: Results of the CHARM Trial. Abstract P297]

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