Note from CCFA's National Scientific Advisory Commitee:
This study confirms what is seen in adults.

Adalimumab is an effective rescue therapy in young Crohn's patients

Last Updated: 2010-01-01 9:00:11 -0400 (Reuters Health)

By David Douglas

NEW YORK (Reuters Health) - Adalimumab is an effective rescue therapy for children and adolescents with Crohn's disease who must discontinue infliximab, researchers report.

As lead investigator Dr. Joel R. Rosh of Goryeb Children's Hospital, Morristown, New Jersey told Reuters Health by email, the retrospective study "showed a very high rate of response and remission through one year of therapy."

In the December issue of The American Journal of Gastroenterology, Dr. Rosh and his colleagues report on 115 pediatric Crohn's disease patients who were diagnosed at an average age of 11. In nearly all cases (95%), the first biologic agent was infliximab, which was replaced by adalimumab at an average of 4.7 years after diagnosis. Infliximab was stopped mainly because of a loss of response (47%) or infusion reaction or intolerance (45%).

Six of the children (5%) received adalimumab as their first biologic agent.

Before starting on adalimumab, 75% of the children been hospitalized at least once for Crohn's disease and 32% had needed at least one surgery, with more than two-thirds of the surgeries involving bowel resection.

At 3, 6 and 12 months, clinical response rates were 65%, 71%, and 70%, respectively, and clinical remission rates were 32%, 43%, and 49%, respectively.

When they started on adalimumab, 38% of the children were taking corticosteroids. "The overall steroid exposure rate was reduced from 38%...at baseline to...13% at 12 months," the authors said.

"It was gratifying to see that even though more than 95% of the patients had been on infliximab and could no longer tolerate or respond to it, clinical improvement could be recaptured with adalimumab therapy," Dr. Rosh said.

He points out that the current results provide "strong evidence that the favorable response to biologic therapy in pediatric patients with Crohn's disease is an effect of this class of medications rather than being limited to any one agent."

He added, "There is a prospective study now being performed which will also give us information on primary biologic therapy with adalimumab in this age group."

Am J Gastroenterol 2009;104:3042-3049.