VEDOKIDS: Vedolizumab seems effective in paediatric IBD

Vedolizumab induction therapy was effective in paediatric participants with inflammatory bowel disease (IBD). The prospective, multicentre VEDOKIDS study also showed that disease severity at baseline might predict the response to vedolizumab in this population. Since data on the use of vedolizumab in children with IBD are limited, this study helps to understand the applicability of this agent in paediatric patients with IBD.

The VEDOKIDS study (NCT02862132), a prospective cohort study, included 142 children (0–18 years) with Crohn’s disease (CD; n=65) or ulcerative colitis (UC; n=77), of whom approximately 68% had failed on previous anti-TNF treatment [1]. The participants were exposed to intravenous vedolizumab 177 mg/m² Body Surface Area (BSA) up to a maximum of 300 mg at weeks 0, 2, 6 and then every 8 weeks. Clinical remission, defined as steroid-free and exclusive enteral nutrition (EEN)-free remission, was the main clinical outcome of the study. The results at week 14 were presented by Dr Dan Turner (Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Israel).

At week 14, 40% of the participants with CD achieved clinical remission and 21% reached steroid-free remission with normal erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP). For participants with UC, the corresponding figures were 51% and 36%. Moreover, significant treatment effects were already observed at week 6 (see Figure). Clinical remission proportions in participants receiving vedolizumab as first-line or second-line therapy were not significantly different, suggesting a comparable efficacy of vedolizumab in biologic-naïve participants and participants who failed on a biologic therapy. Notably, disease activity at baseline, measured by the Pediatric Ulcerative Colitis Activity Index (PUCAI), was predictive of clinical remission at week 14 (AUC 0.66; 95% CI 0.54–0.79). Moreover, Mucosal Inflammation Non-invasive (MINI) index (AUC 0.79; 95% CI 0.64–0.94) and weighted Pediatric Crohn's Disease Activity Index (wPCDAI) scores (AUC 0.70; 95% CI 0.57–0.84) were predictive of clinical remission. Dr Turner added that children >30 kg could be dosed as adults (300 mg), whereas children <30 kg may be dosed with 200 mg or 10 mg/kg.

Figure: Rapid improvement in clinical activity [1]



 

 

 

 

 

 

In total, 114 adverse events were reported. Of these adverse events, 32 were possibly related to vedolizumab therapy. Fortunately, all of those events were mild or moderate. Only 2 adverse event-related treatment discontinuations were reported: 1 case of leukocytoclastic vasculitis and 1 case of dyspnoea.

1. Shavit Z, et al. Outcome of induction therapy with vedolizumab in children: Results from the prospective, multi-centre VEDOKIDS study. OP05, ECCO 2022, 16–19 February.

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Posted on 12 April 20228 April 2024