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Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease
Namita Singh1, Shervin Rabizadeh, Jacqueline Jossen
1*Department of Pediatrics, Pediatric Inflammatory Bowel Disease Program, Cedars Sinai Medical Center, Los Angeles, California; †Department of Pediatrics, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine, Mount Sinai Hospital, New York, New York; and ‡Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, Hartford, CT; University of Connecticut School of Medicine, Farmington, Connecticut.
Insights
Vedolizumab shows promise for pediatric inflammatory bowel disease (IBD), with higher remission rates in ulcerative colitis (UC) and anti-tumor necrosis factor (TNF)-naive patients. Further trials are needed to confirm these findings in children with IBD.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacology
Background:
- Vedolizumab is approved for adult Crohn's disease (CD) and ulcerative colitis (UC).
- Off-label use of vedolizumab in pediatric inflammatory bowel disease (IBD) is increasing.
- Limited data exists on vedolizumab's efficacy and safety in pediatric IBD patients.
Purpose of the Study:
- To evaluate vedolizumab's real-world effectiveness in pediatric IBD patients.
- To identify predictors of clinical remission in children treated with vedolizumab.
- To assess the safety profile of vedolizumab in this population.
Main Methods:
- Retrospective review of pediatric IBD patients (<18 years) treated with vedolizumab across three centers.
- Data collected included demographics, disease characteristics, and prior treatments.
- Disease activity assessed using validated pediatric indices; remission defined at week 14.
Main Results:
- Fifty-two pediatric IBD patients (58% CD, 42% UC) were included.
- Week 14 remission rates were 76% for UC and 42% for CD.
- Anti-tumor necrosis factor (TNF)-naive patients demonstrated significantly higher remission rates (80% at week 14, 100% at week 22) compared to TNF-exposed patients.
Conclusions:
- Vedolizumab appears efficacious and safe for pediatric IBD treatment.
- Ulcerative colitis patients and anti-TNF-naive patients showed better response rates.
- Controlled trials are warranted to validate these findings in pediatric IBD.
Background:
Though vedolizumab has received regulatory approval for the treatment of Crohn's disease (CD) and ulcerative colitis (UC) in adults, there is increasing off-label use in children.
Aims:
To describe the experience with vedolizumab in pediatric inflammatory bowel disease (IBD) patients at 3 tertiary IBD centers and examine predictors of remission.
Methods:
A retrospective review identified pediatric IBD patients (age < 18 yrs) receiving vedolizumab. Data on demographics, disease behavior, location, activity, and previous treatments/surgeries were collected. Disease activity was assessed using the weighted pediatric CD activity index or pediatric UC activity index. Primary outcome was week 14 remission, defined as pediatric UC activity index <10 or weighted pediatric CD activity index <12.5. Descriptive statistics and univariate analyses were performed to examine associations of clinical characteristics with efficacy.
Results:
Fifty-two patients, 58% CD and 42% UC, initiated vedolizumab between June 2014 and August 2015. Median age at vedolizumab initiation was 14.9 (range 7-17) years. Ninety percent had failed ≥1 anti-tumor necrosis factor (TNF) agent. Week 14 remission rates for UC and CD were 76% and 42%, respectively (P < 0.05). Eighty percent of anti-TNF-naive patients experienced week 14 remission. At week 22, anti-TNF-naive patients had higher remission rates than TNF-exposed patients (100% versus 45%, P = 0.04). There were no infusion reactions or serious adverse events/infections.
Conclusions:
Our results suggest that vedolizumab is efficacious and safe in pediatric IBD patients, with UC patients experiencing earlier and higher rates of remission than CD patients. Anti-TNF-naive patients experienced higher remission rates than those with anti-TNF exposure. Controlled clinical trial data are needed to confirm these observations.
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