TOPLINE:

Ustekinumab, a humanised monoclonal antibody, was well tolerated and demonstrated acceptable remission rates and drug persistence at 1 year in patients with refractory ulcerative colitis (UC).

METHODOLOGY:

• Researchers conducted a retrospective study across 16 centres in Belgium from September 2020 to June 2023 to assess the real-world effectiveness and safety of ustekinumab in 120 patients with UC (50.8% women).
• Overall, 94.2% and 68% of patients did not respond previously to at least one and two or more biological therapies, respectively.
• The primary endpoint was steroid-free clinical remission assessed at week 16, which was defined as a partial Mayo score of 2 or less, a rectal bleeding subscore of 0, no subscore greater than 1, and no corticosteroid therapy.
• Secondary outcomes included clinical, endoscopic, histologic, and biochemical remission and/or response, all defined on the basis of the specific criteria, at weeks 8, 16, and 52 and the end of treatment.

TAKEAWAY:

• At week 16, 34.2% of patients with UC achieved the primary endpoint of steroid-free clinical remission. By week 52, among patients still receiving ustekinumab, the rate improved to 44.7%.
• Histologic and endoscopic remission rates were 8.1% and 19.2% at week 16, rising to 11.1% and 25%, respectively, by week 52.
• Drug persistence was observed in 70.8% of patients at 1 year, with drug discontinuation owing to adverse events in 1.7% of patients. A total of 11 patients were hospitalised because of a UC flare.
• Smoking was associated with the early termination of ustekinumab (adjusted odds ratio, 3.058; P = .020).

IN PRACTICE:

"This multicentric real-life effectiveness study in patients with refractory ulcerative colitis shows acceptable remission rates, a good safety profile and a relatively high drug persistence rate of UST [ustekinumab], validating its role as a possible treatment strategy in ulcerative colitis patients," the authors of the study concluded.

SOURCE:

This study was led by Tom Holvoet, Department of Gastroenterology, UZ Gent, Corneel Heymanslaan, Ghent, Belgium. It was published online on September 16, 2025, in the Journal of Clinical Medicine.

LIMITATIONS:

This study was retrospective in nature and lacked a control group. Variability in follow-up time may have affected the generalisability of the findings. Missing data might have introduced bias.

DISCLOSURES:

This study did not receive any specific funding. Several authors reported receiving research funding, grants, personal fees, presentation fees, speaker fees, lecture fees, consultation fees, and advisory board fees and serving on speakers bureaus for various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.