Multi-center Study Finds Monoclonal Antibody May Reduce Need for Steroid Use in Children with Crohn's Disease

05/8/2003

PHILADELPHIA, May 8 /PRNewswire/ -- A monoclonal antibody shows promising results in treating children with Crohn's disease (CD), a painful inflammation of the digestive tract, according to a multi-center study conducted at five medical centers. The clinical benefits provided by the treatment may reduce the need for steroid drugs in children, which carry risks of impaired growth and osteoporosis.

The multi-center study, led by researchers from The Children's Hospital of Philadelphia, reinforces findings from a larger, single-center study, of the same agent at Children's Hospital, published earlier this year.

The most recent study demonstrates that infliximab, a monoclonal antibody used to treat adults with Crohn's disease, is also effective and safe in treating children with the disorder. It appears in the current issue of the American Journal of Gastroenterology.

"Crohn's disease is becoming a common chronic pediatric disease with the average age of onset occurring much younger than before," said Robert Baldassano, M.D., director of the Center for Inflammatory Bowel Disease at The Children's Hospital of Philadelphia and primary investigator of the study. "Biological agents, like infliximab, are potential future treatment regimens for a host of chronic illnesses, including pediatric Crohn's disease."

In the study, 21 pediatric CD patients at five study centers in the U.S. and Europe received a single infusion of infliximab, randomized into three groups according to dosage. Patients were between the ages of 8 and 17 years with a history of CD for at least six months. They had moderate to severe disease that resisted conventional medications, including corticosteroids, currently the conventional treatment. The study was sponsored by Centocor, Inc., which manufactures infliximab.

On average, all patients experienced approximately 50 percent improvement by the second week as measured by a disease index that includes pain, growth rates and other measurements. During the study, every patient achieved a clinical response and 10 of the 21 achieved clinical remission, and experienced decreased pain and number of daily liquid bowel movements. There were no reactions at the infusion sites on the patients' arms.

"In addition to providing significant short-term medical benefits for children affected with CD, it also has the potential to significantly reduce the need for steroids - a treatment associated with significant side effects," said Dr. Baldassano. Side effects of current treatments -- corticosteroids and drugs affecting immune responses -- include acne, weight gain, impaired growth, osteoporosis, the risk of hepatitis, and bone marrow suppression.

Infliximab, marketed as Remicade by Centocor, Inc., is a genetically engineered monoclonal antibody that acts against TNF-alpha. Tumor necrosis factor alpha (TNF-alpha), a protein produced by the immune system, is among the causes of gastrointestinal tract inflammation. Monoclonal antibodies are naturally occurring human antibodies that are genetically altered in a laboratory, cloned in large numbers and introduced into the patient to target disease sites.

Crohn's disease is a chronic bowel disorder characterized by inflammation of the gastrointestinal tract. Symptoms may include pain, severe abdominal discomfort and more than 30 bowel movements each day. Most children with CD experience ongoing disease activity over the course of their lives, which may be complicated by the need for prolonged medication and numerous surgeries.

The average age for diagnosis of Crohn's disease is 10 to 11 years, though onset may also occur during adolescence and adulthood. Crohn's disease affects more than 100,000 children in the U.S. - causing emotional and social difficulties in addition to its painful physical symptoms.

Coauthors of the study were Christian P. Braegger, M.D., University Children's Hospital Zurich, Switzerland; Johanna C. Escher, M.D., The Children's Hospital, Boston; Kimberly DeWoody, Ph.D., Centocor, Inc.; David F. Hendricks, Centocor, Inc.; Gregory F. Keenan, M.D., Centocor, Inc.; and Harland S. Winter, M.D., Massachusetts General Hospital for Children, Boston.

Founded in 1855 as the nation's first pediatric hospital, The Children's Hospital of Philadelphia is ranked today as the best pediatric hospital in the nation by a comprehensive Child magazine survey. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding. Children's Hospital operates the largest pediatric healthcare system in the U.S. with more than 40 locations in Pennsylvania, New Jersey and Delaware.

Contact: Joey McCool Phone: (215) 590-7092 McCool@email.chop.edu