Skip to main content
Top

17-01-2025 | Chronic Inflammatory Bowel Disease in Pediatrics | Editor's Choice | News

Vedolizumab 'viable' maintenance treatment for children with IBD

Author: Joel Levy

print
PRINT
insite
SEARCH

medwireNews: In the VEDOKIDS study, a quarter of children with Crohn's disease and nearly half of those with ulcerative colitis achieved complete remission at week 54 of treatment with the monoclonal antibody vedolizumab.

Noting that the drug was well tolerated by the patients, Dan Turner (Hebrew University of Jerusalem, Israel) and colleagues, write: “Our study suggests that vedolizumab is a viable option for induction and long-term maintenance therapy in children with [inflammatory bowel disease] IBD, particularly those with ulcerative colitis.”

The study, published in The Lancet Gastroenterology & Hepatology, enrolled 137 children (54% female) aged up to 18 years who had initiated intravenous vedolizumab for IBD at centers in Israel, the USA, Italy, Ireland, Denmark, and Slovenia. Of the children, 47% had Crohn's disease, 47% had ulcerative colitis, and 7% had unclassified IBD and were included in the ulcerative colitis group. Patients were followed-up for a median of 42.3 weeks.

The suggested treatment protocol was an initial intravenous vedolizumab dose of 177 mg/m2 up to a maximum of 300 mg, with infusions at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks as needed. However, the researchers note that children were managed at the discretion of the physician and so actual treatment doses and frequencies varied. Most of the patients were already taking concomitant medications, such as immunomodulators and corticosteroids, and these could be continued during the study.

At week 54, 25% of children with Crohn's disease achieved complete remission, as did 47% of those with ulcerative colitis. Remission was defined as a median weighted Pediatric Crohn's Disease Activity Index (wPCDAI) score below 12.5 points or a Pediatric Ulcerative Colitis Activity Index (PUCAI) score below 10.0 points, as well as a C-reactive protein concentration lower than 1.5 times the upper limit of normal, without the need for surgery, steroids, or exclusive enteral nutrition.

Specifically, the median wPCDAI score decreased from 35 points at baseline to 13 points at week 54 and the median PUCAI decreased from 25 points at baseline to 5 points.

Elizabeth Spencer (Icahn School of Medicine, New York, USA) notes in a related comment that “[a] key finding from this study is that a robust, early response is a strong predictor of long-term outcomes.”

Indeed, the rate of sustained steroid-free and exclusive enteral nutrition-free clinical remission at week 54 was a significant 3.5 times more likely in patients with Crohn's disease who achieved clinical remission or a therapeutic response (at least a 17.5-point decrease in wPCDAI score) at 6 weeks compared with those who did not, at 39% versus 15%. Among those with ulcerative colitis who did and did not achieve clinical remission or a therapeutic response, defined as a PUCAI score decrease of at least 20 points, at 6 weeks, the corresponding rates were 53% versus 30%, although the difference was not significant.

The authors say that the findings “call for assessment of treatment success as early as week 6, rather than waiting until the end of the induction period.”

They also found that children with moderate-to-severe disease at week 6 were unlikely to experience steroid- and exclusive enteral nutrition-free remission at week 54, with this achieved by none of the patients with moderate-to-severe Crohn's disease (wPCDAI 40.0 to ≥57.5 points) and just 20% of those with moderate-to-severe ulcerative colitis (35.0 to ≥ 60.0 points).

Adverse events at week 54 occurred in 57% of patients, 8% of which were serious, although none of these were considered related to treatment. Vedolizumab-related adverse events were reported in 21% of the children during treatment, primarily headache (5%), myalgia (3%), and fever (3%).

Only 1% of patients discontinued treatment due to adverse events – one moderately severe case each of infusion reaction and leukocytoclastic vasculitis in patients with Crohn's disease – and there were no deaths.  

Spencer says that the the study “represents a step forward in the treatment of paediatric IBD,” and Turner et al conclude that “[b]y identifying clinical, laboratory, and microbiome predictors of efficacy, our findings could contribute to treatment optimisation and personalised care for children with IBD.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2025 Springer Healthcare Ltd, part of the Springer Nature Group

Lancet Gastroenterol Hepatol 2025; doi:10.1016/S2468-1253(24)00319-4
Lancet Gastroenterol Hepatol 2025; doi:10.1016/S2468-1253(24)00381-9

print
PRINT

Related topics