Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease

Namita Singh, Shervin Rabizadeh, Jacqueline Jossen, Nanci Pittman, Morgan Check, Ghonche Hashemi, Becky L. Phan, Jeffrey S. Hyams, Marla C. Dubinsky

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2121-2126
Number of pages6
JournalInflammatory Bowel Diseases
Volume22
Issue number9
DOIs
StatePublished - Aug 10 2016
Externally publishedYes

Fingerprint

Inflammatory Bowel Diseases
Pediatrics
Tumor Necrosis Factor-alpha
Ulcerative Colitis
Crohn Disease
vedolizumab
Off-Label Use
Controlled Clinical Trials
Demography
Therapeutics
Infection

Keywords

  • Crohn's disease
  • inflammatory bowel disease
  • pediatrics
  • ulcerative colitis
  • vedolizumab

ASJC Scopus subject areas

  • Immunology and Allergy
  • Medicine(all)
  • Gastroenterology

Cite this

Singh, N., Rabizadeh, S., Jossen, J., Pittman, N., Check, M., Hashemi, G., ... Dubinsky, M. C. (2016). Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease. Inflammatory Bowel Diseases, 22(9), 2121-2126. https://doi.org/10.1097/MIB.0000000000000865

Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease. / Singh, Namita; Rabizadeh, Shervin; Jossen, Jacqueline; Pittman, Nanci; Check, Morgan; Hashemi, Ghonche; Phan, Becky L.; Hyams, Jeffrey S.; Dubinsky, Marla C.

In: Inflammatory Bowel Diseases, Vol. 22, No. 9, 10.08.2016, p. 2121-2126.

Research output: Contribution to journalArticle

Singh, N, Rabizadeh, S, Jossen, J, Pittman, N, Check, M, Hashemi, G, Phan, BL, Hyams, JS & Dubinsky, MC 2016, 'Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease', Inflammatory Bowel Diseases, vol. 22, no. 9, pp. 2121-2126. https://doi.org/10.1097/MIB.0000000000000865
Singh, Namita ; Rabizadeh, Shervin ; Jossen, Jacqueline ; Pittman, Nanci ; Check, Morgan ; Hashemi, Ghonche ; Phan, Becky L. ; Hyams, Jeffrey S. ; Dubinsky, Marla C. / Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease. In: Inflammatory Bowel Diseases. 2016 ; Vol. 22, No. 9. pp. 2121-2126.
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abstract = "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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AU - Rabizadeh, Shervin

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AU - Check, Morgan

AU - Hashemi, Ghonche

AU - Phan, Becky L.

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AB - 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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