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Ustekinumab is an antibody to interleukin-12 and interleukin-23 that is available for treatment of psoriasis and psoriatic arthritis. Researchers now report results of industry-funded trials of ustekinumab in moderate to severe Crohn disease.
In two induction trials, patients were randomized to 130 mg or a weight-based dose (approximately 6 mg/kg) of intravenous ustekinumab or placebo for 8 weeks. The primary endpoint was a reduction in Crohn's disease activity index (CDAI) of ≥100 points or CDAI <150. Responders were then randomized to a maintenance regimen of 90 mg subcutaneous ustekinumab every 8 or 12 weeks or placebo for 44 weeks.
In one trial, 741 patients were nonresponders to tumor necrosis factor (TNF) blockers or had unacceptable ad…