Rapid symptomatic relief is an important treatment goal for patients with ulcerative colitis (UC). We aimed to characterize early response with ustekinumab in patients with moderate-to-severe UC during the initial 16 weeks of treatment.
We performed a post hoc analysis of data from the UNIFI trial. Patients (N=961) were randomized (1:1:1) to receive intravenous ustekinumab 130 mg or ∼6 mg/kg, or placebo at Week (W)0. Symptomatic remission, absolute stool number, Mayo stool frequency (SF) and rectal bleeding (RB) subscores, partial Mayo score, C-reactive protein (CRP), and fecal calprotectin (FCal) were assessed in the overall population and for patients in the biologic-naïve or prior biologic failure subgroups.
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 percentage of patients with SF≤1 and RB=0 increased from baseline through to W16 for both ustekinumab groups. Significant improvements in partial Mayo scores were observed by W2 in both ustekinumab groups versus placebo (p≤0.001). Significantly more patients in ustekinumab groups had normalized CRP levels from W2 to W8 versus placebo (p≤0.05). Similar results were observed with normalized FCal levels between W2 and W4 (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.
ClinicalTrials.gov: NCT02407236; https://clinicaltrials.gov/ct2/show/NCT02407236.

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