The Food and Drug Administration (FDA) has approved Stelara (ustekinumab; Janssen) for the treatment of adult patients with moderately to severely active ulcerative colitis.
The approval was based on data from a phase 3 study that included an induction phase (UNIFI-I), where patients received a single dose of Stelara intravenous infusion or placebo, followed by a maintenance phase (UNIFI-M), where subcutaneous injections were administered every 8 weeks for 44 weeks. In the induction study, 19% of patients treated with Stelara achieved clinical remission compared with 7% of patients in the placebo group. At 1 year, 45% of patients receiving Stelara were in clinical remission vs 26% of the placebo group; 43% of Stelara-treated patients were in clinical remission without the use of corticosteroids. In addition, 44% of patients treated with Stelara had achieved histologic-endoscopic mucosal improvement at Week 44.
“The FDA approval of Stelara for UC represents an exciting milestone, offering patients a new option that has demonstrated improvement of the histology and endoscopic appearance of the intestinal lining, while also offering patients the potential for response and remission without the need for steroids,” said William J. Sandborn, MD, Chief, Division of Gastroenterology, and Professor of Medicine, UC San Diego School of Medicine, and study investigator.
With regard to safety, the overall profile was found to be consistent with that seen in previous studies of ustekinumab. The most common adverse reactions reported in the ulcerative colitis trials included nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
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