ADALIMUMAB (HUMIRA) IN KIDS: IS IT SAFE AND EFFECTIVE?

In 2014, the US Food and Drug Administration approved Humira for use in children 6 years of age and older who have moderate to severe Crohn's disease. That occurred after a comprehensive study of the medicine in 198 patients throughout North America and Europe. The children in the study had to have Crohn's disease for at least 3 months and they had to have tried at least one other medicine and failed.

They then received either a low dose or higher dose using the usual start up (induction) shots . They then continued on shots every other week for 6 months. Almost 60% of those who got the higher dose improved, and nearly 40% went into clinical remission, meaning they had no or almost no symptoms. By a year, 42% of those who started the higher dose continued to do well and 33% (1/3) remained in remission. Since those taking the higher dose did much better than those at the lower dose, the higher dose was approved for use.

100 of these patients continued on Humira under the strict guidelines of the study. As reported in 2017, 48% were still responding to the medicine 5 years after starting and 41% were in remission. If they had come into the original study on steroids, 63% were off steroids and in remission. And 30% of those who were also on another immune suppressing drug were able to discontinue that medicine. Growth also returned to normal for many of the children.

The side effects reported most were headaches, upper respiratory infections, diarrhea and anemia. Other infections also occurred but none were serious. There were no tumors or deaths reported in the trial. If patients stopped Humira, it was usually because their Crohn's disease returned.

It is important to note that Humira has been used a lot Crohn's disease since these studies. Side effects are being tracked. And like all immune – acting medicines, there are important risks for severe side effects. These are discussed in other blogs on Nutrition4IBD.

It is also important to note that Humira is approved for ulcerative colitis in adults, but the studies needed for approval in children are not yet finished. So Humira is only released for Crohn's disease (and juvenile arthritis) in children.