THURSDAY, Aug. 9, 2012 (HealthDay News) -- The "biologic" drug Humira could be an effective therapy for children with tough-to-treat Crohn's disease, a new study finds.
Crohn's disease is an inflammation of the digestive tract that can lead to swelling, pain and ulcers. Although the disease can affect any part of the digestive tract, the most common spot is the small intestine.
The new study revealed that treatment with Humira (adalimumab), could help children with Crohn's stay in remission without stunting their growth or delaying puberty, as can happen with other drugs currently used to treat the disease.
One expert not connected to the study welcomed the findings.
"This drug helps expand the available treatments to control inflammation in Crohn's disease," said Dr. Joseph Levy, a pediatric gastroenterologist at NYU Langone Medical Center, in New York City.
"This is a welcome addition and it will improve the quality of life of many of our patients in whom less powerful anti-inflammatory and immunosuppressive drugs have been ineffective," added Levy, who is also a professor of pediatrics and director of the division of gastroenterology at the NYU School of Medicine.
Humira falls into the relatively new class of monoclonal antibody, "biologic" medicines known as TNF-alpha inhibitors. The study -- which was funded by Humira's maker, Abbott Laboratories -- involved 192 children aged 6 to 17 who were being treated for Crohn's disease at centers in North America and Europe. The children had not responded to conventional treatment.
Researchers led by Dr. Jeffrey Hyams of Connecticut Children's Medical Center, in Hartford, randomly assigned the children to either a low- or high-dose regimen. Children in the high-dose group received either 20 or 40 milligrams (mg) of Humira every other week, depending on their body weight. Children in the low-dose group received either 10 mg or 20 mg of Humira on the same schedule, again according to their body weight.
The researchers found that within one month, more than 80 percent of children with moderate to severe Crohn's disease responded to the drug, and six months after the treatment began, 34 percent of the children were in remission. At one year, over 28 percent of the kids were still in remission, the study found.
More children who received the high dose were in remission at week 26 compared to kids on the lower dose, the researchers noted. They added however, that the differences between the two dose groups were not significant.
The study's authors conclude that Humira is a promising new treatment for children with Crohn's disease, since many are resistant to existing therapies that are commonly used.
Another expert was heartened by the study results.
"Crohn's disease is an autoimmune disease involving the gastrointestinal tract that most commonly affects children and young adults and whose incidence has been increasing in recent decades," noted Dr. Jeremiah Levine, chief of the division of gastroenterology at Cohen Children's Medical Center of New York in New Hyde Park, N.Y. He said that, "the newest medication used to control the disease (the monoclonal antibody infliximab) is occasionally associated with allergic reactions or lack of response."
Humira isn't as likely induce an allergic reaction, Levine said, and the new study suggests that it may be, "a safe and effective medication in children with moderate to severe Crohn's disease with a rapid onset of action."
However, both Levine and Levy said that potential side effects remain a concern.
"As is the case with all medications used to control the immune system, it needs to be used judiciously and monitored closely," Levy said.
The study was published in the August issue of Gastroenterology.
The American Academy of Pediatrics provides more information on Crohn's disease and children.