Guselkumab for IBD passes muster in real world

In the real-world treatment of patients with inflammatory bowel disease (IBD), the use of guselkumab yields high remission rates and has an overall safety profile that mirrors those in randomized controlled trials, according to a large prospective study.

Researchers followed 234 adult patients with IBD initiating guselkumab at a tertiary centre in Chicago, Illinois, US, for up to 52 weeks. They collected clinical and biochemical data and assessed activity indices and adverse events (AEs) at designated time points.

The main outcome of clinical remission was defined as a Harvey-Bradshaw Index (HBI) of <5 for Crohn’s disease (CD) or Simple Clinical Colitis Activity Index (SCCAI) of ≤2 for ulcerative colitis (UC).

Of the patients, 142 had CD and 92 had UC. At week 12, clinical remission was achieved in 76.8 percent of patients with CD and 80.7 percent of those with UC, including 58.5 percent and 72.9 percent of CD and UC patients with active disease at baseline, respectively.

Remission was maintained through 6 months in 88.4 percent of patients with CD in 85.4 percent of those with UC.

At week 12, 72.9 percent patients with CD and 90 percent of those with UC had normal C-reactive protein levels at week 12.

Response to guselkumab treatment did not differ by disease location, extent, or behaviour.

In terms of safety, AEs occurred in 15 patients overall (6.4 percent), and most of these events were mild. AEs led to discontinuation of guselkumab treatment in seven patients.