New Analysis of Data Shows Treatment with Abbott’s HUMIRA® (adalimumab) Significantly Reduced Disease-Related Hospitalization for Patients with Crohn’s Disease

HUMIRA Data Showed 57 Percent Reduction in Risk of Hospitalization from Crohn’s Disease vs. Placebo at One Year

Abbott today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn’s disease treated with HUMIRA® (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalized due to their disease at one year (5.9 percent versus 13.9 percent.

Crohn’s disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. It affects people of all ages but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn’s disease, so maintenance of remission from disease flares is one of the primary goals of treatment.

People with Crohn’s disease may be hospitalized for a variety of reasons, from fever and vomiting to intestinal obstruction and infections, sometimes leading to surgery. Previous studies have shown that hospitalization is responsible for approximately 60 percent of the direct cost of Crohn’s disease and that the average cost per hospital stay is estimated (based on published cost data from 1997) to be about $37,000 per patient in 2006 dollars. Hospitalization is also associated with a negative impact on health-related quality of life in patients with Crohn’s disease.

Data from the Phase III, pivotal study, called CHARM, were evaluated to assess the effect of ongoing treatment with HUMIRA on the risk of hospitalization. At one year, this analysis showed that patients taking placebo (13.9 percent) were more than twice as likely as patients on HUMIRA (5.9 percent) to be hospitalized from Crohn’s disease.

“Patients on HUMIRA throughout the one-year analysis were significantly less likely to be hospitalized because of their Crohn’s disease. Maintaining treatment with HUMIRA was the only independent factor in this analysis that helped patients reduce the risk of Crohn’s related hospitalization,” said Brian G. Feagan, M.D., lead investigator of the analysis, Department of Medicine, Epidemiology and Biostatistics, University of Western Ontario, London Health Sciences Centre, London, ON, Canada.