Adalimumab (an anti-tumor necrosis factor [TNF] antibody) is effective in maintaining remission in certain pediatric patients with Crohn's disease, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association.
Steroids are commonly used in Crohn's disease, but can stunt growth and delay puberty. Incidence of this disease, which causes intestinal inflammation, is on the rise in children.
This study is the largest double-blind study of an anti-TNF agent in children with Crohn's disease. It found that more than 80 percent of children with moderate to severe Crohn's disease responded to adalimumab within a month (response was defined as a decrease in Pediatric Crohn's Disease Activity Index ≥ 15 points from baseline). By six months, approximately 34 percent of patients were in clinical remission, and after a year, 28.4 percent were in remission.
The promising results of treatment with adalimumab are extremely encouraging, especially in this clinically challenging population resistant to conventional therapy. The goal of treatment is not only to induce and maintain clinical remission, but also to restore and preserve normal growth and pubertal development in these children.
Researchers studied 192 patients, ages 6 to 17 years, across 45 sites in Canada, Europe and the U.S. between April 2007 and May 2010. Depending on their body weight, patients were assigned to either a high-dose group, which received 40 mg of adalimumab every other week or 20 mg of adalimumab every other week. Patients assigned to a low-dose group either received 20 mg of adalimumab every other week or 10 mg of adalimumab every other week, again depending on their body weight. More children that received high than low dose were in remission at week 26, but the difference between dose groups was not statistically significant.