Among adolescents with Crohn disease not responding to treatment, use of the drug thalidomide resulted in improved clinical remission after 8 weeks of treatment compared with placebo.
This is according to a study appearing in the November 27 issue of JAMA.
As many as 1.2 million people in Europe and more than half a million in the United States are estimated to have Crohn disease, a chronic inflammatory disease involving the digestive system. Its incidence is increasing globally. "About 25 percent of people with Crohn disease develop symptoms as children, and these cases are generally more severe than adult-onset cases. Resistance or intolerance to therapy is common in children with Crohn disease, with up to approximately 18 percent of cases requiring surgery within 5 years from disease onset," according to background information in the article. Thalidomide is a drug used to treat inflammatory diseases of the skin and mucous membranes. Observational studies on thalidomide in patients with Crohn disease have reported encouraging results.
The researchers found that clinical remission was achieved by more children treated with thalidomide (13/28 [46.4 percent] vs. 3/26 [11.5 percent]). Responses were not different at 4 weeks, but greater improvement was observed at 8 weeks in the thalidomide group. Of the nonresponders to placebo who began receiving thalidomide, 11 of 21 (52.4 percent) subsequently reached remission at week 8. Overall, 31 of 49 children treated with thalidomide (63.3 percent) achieved clinical remission, and 32 of 49 (65.3 percent) achieved 75 percent response.
Average duration of clinical remission in the thalidomide group was 181 weeks vs. 6.3 weeks in the placebo group.
"These findings require replication to definitively determine the utility of this treatment," the authors conclude.