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FDA Expands Adalimumab (Humira) Label to Include Pediatric Patients With Crohn’s Disease

Eighth indication for TNF-alpha inhibitor

The FDA has given the green light to adalimumab (Humira, AbbVie) for reducing signs and symptoms, and for achieving and maintaining clinical remission, in pediatric Crohn’s disease patients 6 years of age and older who have had an inadequate response to corticosteroids or to immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.

The FDA approval represents the eighth indication for adalimumab in the U.S. and makes it the first biologic treatment approved for use in this patient population that can be administered at home.

The FDA’s decision was supported by data from the phase III IMAgINE-1 trial, which evaluated multiple dosing strategies for adalimumab to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn’s disease for whom certain other treatments had not worked well enough. IMAgINE-1 was the largest randomized, double-blind anti-tumor necrosis factor (TNF) trial in patients 6 to 17 years of age with moderately to severely active Crohn’s disease conducted to date.

Crohn’s disease is a type of inflammatory bowel disease that commonly involves the end of the small intestine and the large intestine. The disorder can appear at any age, but it is most often diagnosed in adolescents and young adults between 15 and 35 years of age. In the U.S., an estimated 38,000 children and teens have Crohn’s disease.

The symptoms of pediatric Crohn’s disease are similar to those in adults and can include abdominal pain, weight loss, and diarrhea. In addition, when Crohn’s disease is diagnosed in childhood, it may be more extensive than when it is diagnosed in adulthood.

Since there is no known cure for Crohn’s disease, one of the treatment goals in pediatric patients is to induce and maintain clinical remission.

Adalimumab works by inhibiting TNF-alpha. It can be self-administered after the patient receives proper injection training and with appropriate physician monitoring.

Adalimumab is used to reduce the signs and symptoms of:

  • Moderate-to-severe rheumatoid arthritis in adults
  • Moderate-to-severe polyarticular juvenile idiopathic arthritis in children 4 years of age and older
  • Psoriatic arthritis in adults
  • Ankylosing spondylitis in adults
  • Moderate-to-severe Crohn’s disease in adults and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments
  • Moderate-to-severe Crohn’s disease and to achieve and maintain clinical remission in children 6 years of age and older when corticosteroids and immunomodulators have not worked well enough

Moreover, adalimumab is indicated to help get moderate-to-severe ulcerative colitis under control (induce remission) in adults and to keep it under control (sustain remission) when certain other medications have not worked well enough.

Adalimumab is also approved to treat moderate-to-severe chronic plaque psoriasis in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide whether other systemic therapies are less appropriate.

Source: AbbVie; September 25, 2014.

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