VEDOKIDS: Vedolizumab maintains remission in patients with paediatric IBD

Prospective long-term data on vedolizumab in children with Crohn’s disease (CD) and ulcerative colitis (UC) are limited. The VEDOKIDS study showed its potential as an effective maintenance therapy in this population.

The prospective, multicentre cohort study (NCT02862132) included 137 children with CD and UC who started vedolizumab, an anti-α4β7 integrin monoclonal antibody. Participants were followed at baseline and weeks 2, 6, 14, 30, and 54. Serum drug levels and stool calprotectin were repeatedly measured. The primary endpoint was sustained steroid-free remission (SSFR), defined as clinical remission without steroids or exclusive enteral nutrition at both 30 and 54 weeks. The findings were presented by Dr Ronen Stein (Children's Hospital of Philadelphia, PA, USA) [1].

Of the 137 enrolled children (55% UC and 46% CD, with mild disease), 51% of those with UC and 34% of those with CD achieved remission by week 54. SSFR rates were 40% and 23% in participants with UC and CD, respectively. Predictors of SSFR in CD included a lower Paediatric Crohn's Disease Activity Index (PCDAI) at baseline and week 6. In UC, the best predictor was the Paediatric Ulcerative Colitis Activity Index (PUCAI) at weeks 6 and 14.

The study recorded 197 adverse events, with 8 (5.8%) related to vedolizumab, leading to discontinuation in 2 cases. One lymphoma case was deemed unrelated to vedolizumab.

“Vedolizumab effectively maintains steroid-free remission in children with CD and UC. Children with CD who do not achieve a response by week 6 have a very low likelihood of achieving remission later. Overall, the safety profile was good, except for 1 lymphoma case with a questionable relationship to vedolizumab. We are following these patients for longer-term outcomes,” concluded Dr Stein.

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   1. Stein R, et al. Maintenance vedolizumab treatment in pediatric IBD: 54-week follow-up of the prospective multicenter VEDOKIDS study. 623, DDW 2024, 18–21 May, Washington DC, USA.

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Posted on 11 July 202411 July 2024