What is the role of adalimumab (Humira) in the treatment of pediatric Crohn disease?

Updated: Oct 23, 2018
  • Author: Andrew B Grossman, MD; Chief Editor: Carmen Cuffari, MD  more...
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Answer

Adalimumab (Humira), a fully humanized anti–TNF-α antibody, was approved by the US Food and Drug Administration (FDA) in September 2014 for children aged 6 years or older with moderately to severely active Crohn disease who have had an inadequate response to corticosteroids or immunomodulators (eg, azathioprine, 6-mercaptopurine, methotrexate). It is also a safe and effective substitute for patients who are allergic to infliximab or who develop high titers of human antichimeric antibodies (HACA). [6] Its approval was based on a prospective multicenter study in children with a Pediatric Crohn's Disease Activity Index (PCDAI) score of more than 30 for whom conventional treatment was unsuccessful (n= 192). The study demonstrated that adalimumab is effective for induction and maintenance of remission for pediatric Crohn disease and is well tolerated by children. [27, 28]

Adalimumab drug is already approved for the treatment of moderately to severely active Crohn's disease in adults.


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