Regardless of dosing regimen, adalimumab is superior to placebo in maintaining clinical remission for one year in patients with moderately to severely active Crohn's disease, according to a presentation at the annual Digestive Disease Week.
Data from the CHARM trial (Crohn's trial of the fully Human antibody Adalimumab for Remission Maintenance) showed that remission rates were maintained through 56 weeks in patients who demonstrated response to adalimumab during a four-week open-label induction phase. Clinical remission was measured by a decrease in the Crohn's Disease Activity Index (CDAI). The index is 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, level of general well-being and other measures.

The trial included 854 patients who received open-label induction therapy with adalimumab 80 mg at week zero and 40 mg at week two. Seventy-six patients withdrew prior to randomization. All of the remaining 778 patients at week four were randomized to receive 40 mg adalimumab every other week, adalimumab 40 mg weekly, or placebo through week 56. The 499 patients (58 percent) with week four clinical response to adalimumab (an index decrease equal to or greater than 70 from baseline) made up the primary efficacy analysis group.

At week eight, steroid tapering was permitted for those responding to treatment. All patients with active fistulas at both screening and baseline visits, regardless of their response to adalimumab during the open-label induction period, were assessed for fistula closure.

Co-primary endpoints were clinical remission rates at week 26 and week 56. The data showed significantly higher remission rates (index <150) at weeks 26 and 56 versus placebo, among patients with a decrease in index > 70 points at week four.

In addition, the percent of patients in clinical remission on the two dosing regimens was comparable. Of the 172 patients treated with adalimumab every other week, 40 percent were in clinical remission at week 26 and 36 percent were in remission at week 56. Of the 157 patients taking the drug weekly, 46 percent achieved clinical remission from Crohn's disease at week 26 and 41 percent maintained remission at week 56. In comparison, of the 170 patients receiving placebo, 17 percent achieved clinical remission at week 26 and 12 percent maintained remission at week 56.

"Hundreds of thousands of people, many of whom are young and active adults, suffer from this chronic condition and, to this point, have had limited effective, long-term treatment options," said trial investigator William J. Sandborn, MD, Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Mayo Clinic and Mayo Medical School, Rochester, Minn. "The findings from CHARM add to the growing body of scientific evidence supporting adalimumab as a potential treatment for moderate to severely active Crohn's disease."