Final VEDOKIDS data: Remission with maintenance vedolizumab durable in UC, less so in CD

Maintenance treatment with vedolizumab proved safe and effective in paediatric inflammatory bowel disease (IBD), with long-term remission achieved more frequently in children with ulcerative colitis (UC) than in those with Crohn’s disease (CD), according to the final 3-year data from the VEDOKIDS study.

At the final visit at 3 years, 35 of 73 children with UC and 18 of 64 children with CD had remained on vedolizumab (48 percent vs 28 percent; odds ratio [OR], 2.4, 95 percent confidence interval [CI], 1.2–4.8). Additionally, 19 and nine children, respectively, were in complete remission (26 percent vs 14 percent; OR, 2.2, 95 percent CI, 0.9–5.2). [ESPGHAN 2025, abstract G-OP070]

“When you look at predictors of outcome of complete remission at 3 years for CD, there was a huge difference whether this is isolated Crohn’s colitis or there is ileal involvement (25 percent in L2 vs 13 percent in L1 or L3; OR, 2.6, 95 percent CI, 0.5–12.2). In fact, the likelihood for 3 years [of] complete remission was similar to UC in those with isolated Crohn’s colitis,” reported senior investigator Dr Dan Turner from the Hebrew University of Jerusalem in Jerusalem, Israel.

“In UC, the extent of disease was not associated with the outcome (25 percent in E1/E2 vs 30 percent in E3/E4; OR, 0.6, 95 percent CI, 0.2–2.0),” Turner added.

In multivariate logistic regression analysis, response at week 6 (measured by wPCDAI ≤12.5 in CD and PUCAI <10 in UC) was a strong predictor of complete remission at 3 years (hazard ratio [HR], 2.6, 95 percent CI, 1.1–7.2). The same was true for complete remission at week 14, with 55 percent of those reaching complete remission at 14 weeks sustaining remission through 3 years.

In subgroup analysis, complete remission in UC occurred in a greater percentage of children weighing <30 vs >30 kg (64 percent vs 31 percent; OR, 6.5, 95 percent CI, 1.6–25.5). In contrast, complete remission rate in CD was similar between the <30 and >30 kg weight groups (10 percent vs 15 percent; OR, 0.6, 95 percent CI, 0.1–5.8).

Turner noted that children with UC weighing <30 kg received higher body surface area-adjusted doses of vedolizumab, whereas children with CD received similar doses. He pointed out that the higher remission rate in UC occurring in parallel with the higher doses received by some patients highlights the importance of adequate dosing in younger patients, who require a higher per-kilogram dose regardless of biologic use.

In terms of safety, 31 adverse events (AEs) possibly related to vedolizumab were documented among 23 children (17 percent), with none being serious. The most common TEAEs were headache, myalgia, upper respiratory tract infection, dyspnoea, skin redness, and fever, among others. AEs, particularly dyspnoea and leukocytoclastic vasculitis, led to treatment discontinuation in two children.

The prospective multicentre VEDOKIDS study involved children with IBD initiated on vedolizumab at any disease duration and with any degree of disease activity. These children were enrolled at 17 paediatric centres across Europe, US, and the Middle East. The primary outcome of complete remission was defined as steroid-free clinical remission and normal ESR/CRP with sustained vedolizumab treatment and without a surgery.