VEDOKIDS: Long-term outcomes of vedolizumab in paediatric IBD

The 36-month data of the VEDOKIDS trial demonstrated that long-term vedolizumab treatment was well-tolerated and effective in paediatric patients with ulcerative colitis (UC). In paediatric patients with Crohn’s disease (CD), the effectiveness appeared to be dependent on disease location, with isolated Crohn’s colitis showing the best outcomes.

The VEDOKIDS trial tested vedolizumab in 137 paediatric participants with inflammatory bowel disease (IBD): 73 participants with UC and 64 participants with CD. Dr Ohad Atia (Shaare Zedek Medical Centre, Israel) reported the ‘intention-to-treat’ analysis after 3-years of follow-up [1].

After 3 years, almost half of the participants with UC (48%) were still on treatment, and 28% of the participants with CD were still receiving vedolizumab. Complete remission, defined as steroid-free clinical remission plus normal ESR/CRP values, was documented in 26% of the participants with UC and in 14% of those with CD. “The complete remission rate was 2.6 times higher in participants with isolated colonic CD compared with those with ileal involvement,” noted Dr Atia. “Also, the 6-week response was an important predictor of the response at 3 years.” The findings suggested that shortening the dosing interval to 4 weeks may be a solution to regain a clinical response or clinical remission. As for safety, only 2 patients discontinued the study drug due to adverse events (AEs), including 1 case of dyspnoea and 1 case of leukocytoclastic vasculitis. In total, 31 AEs were reported.

The long-term results of the VEDOKIDS trial provide insights into which paediatric patients with IBD may benefit from long-term treatment with vedolizumab, how long-term responses can be predicted, and how a response can be regained without switching to a different therapy.

1. Atia O, et al. Long-term maintenance treatment with vedolizumab in pediatric IBD: a three-year follow-up of the prospective multicenter VEDOKIDS study. DOP06, 20th Congress of ECCO, 19–22 February 2025, Berlin, Germany.

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Posted on 8 April 2025