New Drug for Kids With Crohn's

Crohn's treatment using adalimumab is safe and effective for children

(RxWiki News) Treatments that do exist for Crohn's disease (CD) don't always work for everyone, kids included. But a new remedy helping adults with their stomach issues may work for children. Is it safe for the little ones?

Humira treats Crohn's disease in adults and is safe and effective for children as well, a new study has found.

The study, led by Jeffrey Hyams, MD, director of the gastroenterology department at Connecticut Children's Medical Center, aimed to see how safe and effective Humira is on children with Crohn's.

"Talk to a doctor about the right Crohn's treatment."

Adalimumab, commonly known as Humira, is typically used to treat rheumatoid arthritis.

Recent studies have shown it works on treating adults with Crohn's, an inflammatory bowel disease that affects the lining of the digestive tract.

The researchers looked at 192 children who didn't respond to the typical Crohn's treatment.

Their study was performed at 45 sites across the country and in Canada and Europe between April 2007 and May 2010.

The children participating were between 6 and 17-years old and had moderate to severe Crohn's disease, as defined by the Pediatric Crohn’s Disease Activity Index, at least 12 weeks before the study.

At the start of the study and two weeks after, the children received either a high or low dose of the medication through their skin depending on their body weight.

In the second part of the study at week 4, 188 or 82.4 percent of the patients were divided into groups based on how they reacted to the medicine and whether they had previously used infliximab, a drug that's commonly used to treat Crohn's.

Based on their body weight, one group received a high dosage of adalimumab at 20-40 mg and the other was given a low dose at 10-20 mg every other week for 48 weeks.

Neither the authors nor the participants knew who was receiving what.

Researchers kept track of patients' vital signs and any troubling effects of the drugs on participants.

They found that at week 26, a third of patients had no more Crohn's symptoms, and after a year, results remained the same.

They also found that a greater number of children had little to no stomach problems after taking the higher dosage compared to those who received the low dose, but the difference wasn't significant.

"Both doses were well tolerated, and no new safety concerns were raised," the authors wrote in their report.

"In children with moderately to severely active CD despite conventional treatment, adalimumab therapy in infliximab-naïve patients resulted in rates of response and remission similar to those observed with infliximab treatment."

In total, a little more than 80 percent of patients had completed the study.

After the first part of the study, a little more than half of the patients reported some adverse event with their treatment.

Two patients had serious infections and one had a viral infection, but all were treated and these patients continued the study.

During the second part of the study, 10 patients had infections.

The authors note their study didn't look at the differences among participants who had used infliximab and those who did not.

They also did not compare these patients to others who did not receive the adalimumab.

The authors served as consultants, received research funding and received speaker fees from a number of companies that may be a conflict of interest to the study.

Funding for the study came from Abbott Laboratories.

The study was published in the August 2012 issue of Gastroenterology journal.

Review Date: 
October 23, 2012