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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