FDA Approves Humira for the Treatment of Crohn's Disease in Children

AbbVie announced today that the US Food and Drug Administration (FDA) has approved Humira (adalimumab) to treat pediatric patients age 6 years and older afflicted with moderately to severely active Crohn’s disease who have not responded adequately to prior treatment with corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

This approval makes Humira the first and only at-home biologic treatment approved for use in pediatric patients with Crohn’s disease, a type of inflammatory bowel disease (IBD) characterized by symptoms that include abdominal pain, weight-loss, and diarrhea.

Humira is a tumor necrosis factor-alpha (TNF-α) inhibitor that patients can self-administer at home after receiving proper injection training and with appropriate monitoring by physicians. Humira is also approved for the treatment of rheumatoid arthritis in adults, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adults, ulcerative colitis, and chronic plaque psoriasis.

Jeffrey S. Hyams, MD, head of the Division of Digestive Diseases, Hepatology and Nutrition at Connecticut Children’s Medical Center, said in a news release, “Moderate to severe Crohn’s disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives. The approval of Humira for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease.”

This FDA approval was supported by the Phase 3 IMAgINE-1 trial, the largest multi-center, randomized, double-blind anti-TNF trial in patients 6 to 17 years of age with moderately to severely active Crohn's disease conducted to date. The trial evaluated multiple methods of Humira dosing to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn’s disease for whom certain other treatments have not especially been successful.

Humira affects the immune system and can lower the ability to fight infections, including infections caused by viruses, fungi, or bacteria that have spread throughout the body, as well as tuberculosis. More common side effects of Humira include injection site reactions (bruising, itching, rash, redness, and swelling), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

Patients should be tested for tuberculosis before starting treatment with Humira and should be monitored for signs and symptoms of tuberculosis during therapy. Patients with an active infection should not be treated with Humira, and patients who develop a serious infection during treatment should cease treatment.

"Children living with moderate to severe Crohn's disease have limited treatment options and AbbVie is pleased that Humira will now be an available option for many of these patients," said Michael Severino, MD, the executive vice president, Research and Development and chief scientific officer of AbbVie. Severino continued, "This approval underscores our continued commitment to innovate with Humira, both in studying potential new indications to help meet unmet medical needs and in helping to improve the standard of care for patients living with immune-mediated inflammatory diseases like Crohn's disease."