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Review
. 2025 Jul 23:18:17562848251356063.
doi: 10.1177/17562848251356063. eCollection 2025.

A systematic review of vedolizumab in treating pediatric ulcerative colitis: efficacy and safety insights

Khawla Abu Hammour  1 , Adnan Abu Hamour  2 , Faris El-Dahiyat  3 , Mohammed Zawiah  4   5 , Rana K Abu-Farha  6
Affiliations
Review

A systematic review of vedolizumab in treating pediatric ulcerative colitis: efficacy and safety insights

Khawla Abu Hammour et al. Therap Adv Gastroenterol. .

Abstract

Background: Ulcerative colitis (UC) in pediatric patients often results in corticosteroid (CS) dependency, with many individuals developing resistance to conventional treatments such as anti-TNF agents. Vedolizumab, a monoclonal antibody targeting α4β7 integrin, has shown promise in adult populations, but data on its efficacy and safety in children and adolescents are limited.

Objectives: This systematic review aims to assess the effectiveness and safety of vedolizumab in treating UC in pediatric patients.

Design data sources and methods: The PRISMA statement's guidelines were followed in conducting this systematic review. Up until December 2024, a thorough search was carried out using keywords associated with inflammatory bowel disease (IBD), vedolizumab, and pediatric populations in the Cochrane Library, EMBASE, and PubMed. Case series of children and adolescents (less than 18 years old) with UC or unclassified IBD who were treated with vedolizumab were included in the research. Data on clinical response, mucosal healing, corticosteroid-free remission, clinical remission, and adverse events were extracted. Descriptive statistics were used in the statistical analysis.

Results: A total of 14 papers were considered in the current evaluation of the effectiveness and safety of vedolizumab. Nearly one-third (36%) of patients with UC/IBD-U experienced clinical remission at 6 weeks, half of the patients at 14 weeks (50%), and 48% and 53% of patients at 22 weeks, respectively. Forty-five percent of patients maintained clinical remission after 1 year. Less than 8% of UC/IBD-U patients experienced serious side effects, while 15%-34% of patients experienced mucosal healing.

Conclusion: Vedolizumab exhibits promising efficacy and a favorable safety profile in treating pediatric UC, with a sizable portion of patients achieving both clinical and corticosteroid-free remission. However, due to the limited sample sizes and lack of investigations, more randomized controlled trials and long-term research are needed to confirm these findings and develop more reliable clinical guidelines for its use in children and adolescents with UC. This means that even if the initial findings are promising, additional and better testing is required to ensure that vedolizumab is both effective and safe for young patients with UC.

Trial registration: The PROSPERO registration number for this systematic review is CRD420250651513.

Keywords: inflammatory bowel diseases; pediatric; treatment; ulcerative colitis; vedolizumab.

Plain language summary

Vedolizumab for children and teenagers with ulcerative colitis: what the research shows Ulcerative colitis (UC) is a long-term condition that causes inflammation in the large intestine, leading to symptoms such as diarrhea, abdominal pain, and fatigue. It can be especially challenging to treat in children and teenagers. Many young patients become dependent on steroid medications or stop responding to standard treatments over time. Vedolizumab is a newer type of medication known as a biologic. It works by targeting the inflammation specifically in the gut, rather than affecting the entire immune system. This focused action may help reduce side effects and improve treatment outcomes. Researchers reviewed 14 studies involving children and teens with UC or IBD-unclassified who were treated with Vedolizumab. Their goal was to understand how well the medicine worked and how safe it was for younger patients. The findings showed that about 1 in 3 children improved within the first 6 weeks of treatment. By week 14, almost half of the patients were experiencing better disease control, and around 45% maintained these improvements after one year. Endoscopic healing—when the gut lining looks healthier on a scope—was seen in 15% to 34% of patients. Serious side effects were uncommon, occurring in fewer than 8% of cases. These results suggest that Vedolizumab may be a safe and effective option for treating children and teenagers with UC, especially when other treatments are not working well. However, more large and long-term studies are needed to confirm how best to use this medicine in young people.

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