FDA approves biologic treatment for pediatric ulcerative colitis

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The FDA approved AbbVie's biologic therapy Humira to treat moderate to severe active ulcerative colitis in pediatric patients, the company announced Feb. 24.

In clinical trials, pediatric patients that achieved clinical remission at week eight maintained remission at week 52, according to the company's phase 3 Envision I study.

Researchers studied how Humira interacted with pediatric patients with either moderate to severe ulcerative colitis. Patients treated with 2.4 mg/kg at week zero, 2.4 mg/kg at week one, 1.2 mg/kg at week two and 0.6 mg/kg at weeks four and six were more likely to achieve remission. Physicians will determine what dose to give patients based on their weight.

Approximately 22.6 percent of patients experienced a serious adverse event when taking Humira. Those events included headaches and worsening of ulcerative colitis symptoms.

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