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Ustekinumab Demonstrates Rapid Relief of UC Symptoms in Clinical Trial
The interleukin-12/23 (IL-12/23) inhibitor ustekinumab achieved fast relief of symptoms among patients with moderate to severe ulcerative colitis (UC) who participated in the UNIFI clinical trial, researchers reported.
“Rapid symptomatic relief is an important treatment goal for patients with ulcerative colitis (UC),” the authors wrote in Clinical Gastroenterology and Hepatology. “We aimed to characterize early response with ustekinumab in patients with moderate-to-severe UC during the initial 16 weeks of treatment.”
A total of 961 patients were randomized (1:1:1) to receive intravenous ustekinumab, dosed at 130 mg or approximately 6 mg/kg, or placebo at Week 0. The trial assessed measures including symptomatic remission, absolute stool number, Mayo stool frequency and rectal bleeding subscores, partial Mayo score, C-reactive protein (CRP), and fecal calprotectin for all patients and for two subgroups: patients who were biologic-naïve and those who had experienced the failure of a biologic therapy.
“A significantly greater percentage of patients in ustekinumab 130 mg (20.0%; p=0.015) or ∼6 mg/kg (20.2%; p=0.012) groups achieved symptomatic remission at W2 versus placebo (12.9%). Mean [SD] changes from baseline in daily stool number at Day 7 were greater in ustekinumab groups (−1.1 [2.6] in 130 mg [p=0.065] and −1.2 [2.5] in ∼6 mg/kg [p=0.017]) versus placebo (−0.7 [2.7]),” the authors wrote.
The percentage of patients with a Mayo stool frequency score of ≤1 and a rectal bleeding score of 0 increased from baseline through to week 16 for both ustekinumab groups. By week 2, in both ustekinumab groups had experienced “significant improvements in partial Mayo scores,” vs placebo (p≤0.001). Further, substantially more patients the groups treated with ustekinumab had normalized CRP levels from week 2 to week 8 vs placebo (p≤0.05) and had normalized fecal calprotectin levels between week 2 and week 4 (p≤0.05).
“Ustekinumab improved symptoms in patients with UC compared with placebo in as early as 7 days, indicating rapid onset of effect after induction,” the authors concluded.
—Rebecca Mashaw
Reference:
Danese S, Sands, BE, Abreu MT, et al. Early symptomatic improvement after ustekinumab therapy in patients with ulcerative colitis: 16-week data from the UNIFI trial. Clin Gastroenterol Hepatol. Published online March 08, 2022
