Standard Dosing of Infliximab Effective for Steroid-Refractory ASUC

Infliximab at 10 mg/kg showed no meaningful clinical difference in response among patients with steroid-refractory acute severe ulcerative colitis (ASUC) compared to standard dosing at 5 mg/kg, according to Australian investigators.

The researchers aimed to compare the efficacy of an intensified induction strategy (IIS) with 10 mg/kg infliximab versus the standard 5 mg/kg infliximab dose and also to investigate outcomes of various induction regimens, including standard and accelerated dosing schedules.

In an open-label, multicenter, randomized controlled trial, 138 patients were recruited from 13 Australian hospitals and randomized to receive either 10 mg/kg or 5 mg/kg infliximab. The 5 mg/kg group was further rerandomized into a standard induction strategy (SIS) or an accelerated induction strategy (AIS). The primary outcome was clinical response by day 7, defined by a reduction in the Lichtiger score. Secondary outcomes included time to response, remission rates, and colectomy rates by month 3.

The results showed no significant difference in clinical response between the 10 mg/kg and 5 mg/kg infliximab groups by day 7 (65% vs. 61%, p=0.62). Similarly, no significant differences were observed in secondary endpoints, including clinical response by day 14, remission rates, and colectomy rates at month 3. Adverse events were comparable across groups, with no significant difference in infectious events.

Reference

Choy MC, Christopher, Con D, et al. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): An open-label, multicentre, randomised controlled trial. The Lancet Gastroenterology & hepatology. Published online September 1, 2024. doi:https://doi.org/10.1016/s2468-1253(24)00200-0