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Vedolizumab Therapy in Severe Pediatric Inflammatory Bowel Disease
Máire A Conrad1, Ronen E Stein, Elizabeth C Maxwell
1*Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; †Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and ‡Department of Biomedical Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Insights
Vedolizumab shows promise for pediatric inflammatory bowel disease (IBD), with over half of patients achieving clinical response by 22 weeks. While adverse events were noted, many were not directly linked to vedolizumab treatment.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacology
Background:
- Limited data exists on vedolizumab's efficacy and safety in pediatric inflammatory bowel disease (IBD).
- Vedolizumab is an established treatment for adult IBD, targeting gut-specific inflammation.
Purpose of the Study:
- To evaluate adverse events and clinical response to vedolizumab in children with refractory IBD.
- To assess vedolizumab's effectiveness in pediatric patients who failed anti-tumor necrosis factor therapy.
Main Methods:
- An observational prospective cohort study followed 21 pediatric IBD patients for 22 weeks.
- Data collected included disease activity, clinical response, concomitant medications, and adverse events.
- Patients had refractory IBD and had previously failed anti-tumor necrosis factor therapy.
Main Results:
- Clinical response was observed in 57.9% of patients by week 22.
- Systemic corticosteroid use decreased significantly from 71.4% to 33.3%.
- Steroid-free remission was achieved by 20% of patients by week 22; serum albumin and hematocrit improved, but C-reactive protein increased.
Conclusions:
- Vedolizumab demonstrates a notable clinical response in pediatric IBD patients, increasing over 22 weeks.
- Adverse events were observed, but causality with vedolizumab requires further investigation.
- Larger prospective studies are needed due to the small sample size and limited experience.
Background:
Vedolizumab is effective for inducing and maintaining remission in adults with inflammatory bowel disease (IBD); however, there is limited pediatric data. This study aimed to describe the adverse events and clinical response to vedolizumab in refractory pediatric IBD.
Methods:
Disease activity indices, clinical response, concomitant medication use, and adverse events were measured over 22 weeks in an observational prospective cohort study of children with refractory IBD who had failed anti-tumor necrosis factor therapy and subsequently initiated vedolizumab therapy.
Results:
Twenty-one subjects, 16 with Crohn disease, received vedolizumab. Clinical response was observed in 6/19 (31.6%) of the evaluable subjects at week 6 and in 11/19 (57.9%) by week 22. Before induction, 15/21 (71.4%) participants were treated with systemic corticosteroids, as compared with 7/21 (33.3%) subjects at 22 weeks. Steroid-free remission was seen in 1/20 (5.0%) subjects at 6 weeks, 3/20 (15.0%) at 14 weeks, and 4/20 (20.0%) at 22 weeks. There was statistically significant improvement in serum albumin and hematocrit; however, C-reactive protein increased by week 22 (P < 0.05). There were no infusion reactions. Vedolizumab was discontinued in 2 patients because of severe colitis, requiring surgical intervention.
Conclusions:
There is limited experience with vedolizumab therapy in pediatric IBD. There seems to be a marked number of subjects with clinical response in the first 6 weeks that increases further by week 22 despite the severity of disease in this cohort. Adverse events may not be directly related to vedolizumab. This study is limited by small sample size, and larger prospective studies are warranted.
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