ORIGINAL PAPER
Safety and efficacy of vedolizumab in pediatric inflammatory bowel disease with emphasis on the very-early-onset group
1
Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, Children’s Memorial Health Institute, Warsaw, Poland
Submission date: 2023-01-15
Final revision date: 2023-02-03
Acceptance date: 2023-02-04
Publication date: 2023-06-26
Corresponding author
Sylwia Fabiszewska
Sylwia Fabiszewska, MD, Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, Children’s Memorial Health Institute, Warsaw, Poland
Sylwia Fabiszewska, MD, Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, Children’s Memorial Health Institute, Warsaw, Poland
Pediatr Pol 2023;98(2):123-132
KEYWORDS
Crohn diseaseulcerative colitisvedolizumabpediatric inflammatory bowel diseasevery-early-onset inflammatory bowel disease
TOPICS
ABSTRACT
Introduction:
Vedolizumab (VDZ) is effective in the induction and maintenance of remission in adults with inflammatory bowel disease (IBD). Pediatric data are still limited. This retrospective cohort study aimed to assess the safety and efficacy of VDZ in pediatric IBD including very-early-onset IBD (VEO-IBD).
Material and methods:
A review of pediatric IBD patients receiving VDZ was conducted. Laboratory parameters, nutritional status, and disease activity scores were compared between each follow-up visit and between two groups divided by age of disease onset – VEO-IBD (age of onset < 6-years-old) and non-VEO-IBD (age of onset ≥ 6 years < 17 years). The primary outcome was clinical response after induction therapy (at 4th dose visit). The secondary outcome was clinical remission after induction (at 4th dose visit) and maintenance phase (at 10th dose visit). Statistical considerations were included.
Results:
Seventy-two patients with pediatric IBD were included: 12 with Crohn disease (CD), 60 with ulcerative colitis (UC). The definition of VEO-IBD was met by 21 patients. After the induction phase, a clinical response was observed in 60/72 (83.3%) patients (51/60 with UC and 9/12 with CD) and clinical remission in 44/72 (61.1%) patients (40/60 with UC and 4/12 with CD). Clinical remission after the maintenance phase was achieved by 22/72 (30.6%) patients (16/60 with UC and 6/12 with CD). Improvement in the patients’ laboratory parameters and nutritional status was observed. No significant differences were observed in VDZ response between VEO-IBD and non-VEO-IBD.
Conclusions:
Vedolizumab was safe and effective in the treatment of pediatric IBD irrespective of age of disease onset.
Vedolizumab (VDZ) is effective in the induction and maintenance of remission in adults with inflammatory bowel disease (IBD). Pediatric data are still limited. This retrospective cohort study aimed to assess the safety and efficacy of VDZ in pediatric IBD including very-early-onset IBD (VEO-IBD).
Material and methods:
A review of pediatric IBD patients receiving VDZ was conducted. Laboratory parameters, nutritional status, and disease activity scores were compared between each follow-up visit and between two groups divided by age of disease onset – VEO-IBD (age of onset < 6-years-old) and non-VEO-IBD (age of onset ≥ 6 years < 17 years). The primary outcome was clinical response after induction therapy (at 4th dose visit). The secondary outcome was clinical remission after induction (at 4th dose visit) and maintenance phase (at 10th dose visit). Statistical considerations were included.
Results:
Seventy-two patients with pediatric IBD were included: 12 with Crohn disease (CD), 60 with ulcerative colitis (UC). The definition of VEO-IBD was met by 21 patients. After the induction phase, a clinical response was observed in 60/72 (83.3%) patients (51/60 with UC and 9/12 with CD) and clinical remission in 44/72 (61.1%) patients (40/60 with UC and 4/12 with CD). Clinical remission after the maintenance phase was achieved by 22/72 (30.6%) patients (16/60 with UC and 6/12 with CD). Improvement in the patients’ laboratory parameters and nutritional status was observed. No significant differences were observed in VDZ response between VEO-IBD and non-VEO-IBD.
Conclusions:
Vedolizumab was safe and effective in the treatment of pediatric IBD irrespective of age of disease onset.
REFERENCES (17)
1.
Benchimol EI, Fortinsky KJ, Gozdyra P, Van den Heuvel M, Van Limbergen J, Griffiths AM. Epidemiology of pediatric inflammatory bowel disease: a systematic review of international trends. Inflamm Bowel Dis 2011; 17: 423-439.
2.
Gasparetto M, Guariso G. Highlights in IBD epidemiology and its natural history in the paediatric age. Gastroenterol Res Pract 2013; 2013: 829040.
3.
Roberts SE, Thorne K, Thapar N, et al. A systematic review and meta-analysis of paediatric inflammatory bowel disease incidence and prevalence across Europe. J Crohns Colitis 2020; 14: 1119-1148.
4.
Kelsen JR, Sullivan KE, Rabizadeh S, et al. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper on the evaluation and management for patients with very early-onset inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2020; 70: 389-403.
5.
Uhlig HH, Charbit-Henrion F, Kotlarz D, et al. Clinical genomics for the diagnosis of monogenic forms of inflammatory bowel disease: a position paper from the Paediatric IBD Porto Group of European Society of Paediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2021; 72: 456-473.
6.
Wyant T, Leach T, Sankoh S, et al. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut 2015; 64: 77-83.
7.
Feagan BG, Rubin DT, Danese S, et al. Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists. Clin Gastroenterol Hepatol 2017; 15: 229-239.e5.
8.
Schneider AM, Weghuber D, Hetzer B, et al. Vedolizumab use after failure of TNF-α antagonists in children and adolescents with inflammatory bowel disease. BMC Gastroenterol 2018; 18: 140.
9.
Ledder O, Assa A, Levine A, et al. Vedolizumab in paediatric inflammatory bowel disease: a retrospective multi-centre experience from the Paediatric IBD Porto Group of ESPGHAN. J Crohns Colitis; 2017; 11: 1230-1237.
10.
Singh N, Rabizadeh S, Jossen J, et al. Multi-center experience of vedolizumab effectiveness in pediatric inflammatory bowel disease. Inflamm Bowel Dis 2016; 22: 2121-2126.
11.
Conrad MA, Stein RE, Maxwell EC, et al. Vedolizumab therapy in severe pediatric inflammatory bowel disease. Inflamm Bowel Dis 2016; 22: 2425-2431.
12.
Shavit-Brunschwig Z, Ledder O, Focht G, et al. P538 Vedolizumab is effective in real life paediatric inflammatory bowel disease: report from the prospective, multi-centre VEDOKIDS cohort study. J Crohns Colitis 2019; 13: 383.
13.
Levine A, Griffiths A, Markowitz J, et al. Pediatric modification of the montreal classification for inflammatory bowel disease: the Paris Classification. Inflamm Bowel Dis 2011; 17: 1314-1321.
14.
Fabiszewska S, Derda E, Szymańska E, Kierkuś J. Safety and effectiveness of vedolizumab for the treatment of pediatric patients with very early onset inflammatory bowel diseases. J Clin Med 2021; 10: 2997.
15.
Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013; 369: 699-710.
16.
Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2013; 369: 711-721.
17.
Yzet C, Diouf M, Singh S, et al. No benefit of concomitant immunomodulator therapy on efficacy of biologics that are not tumor necrosis factor antagonists in patients with inflammatory bowel diseases: a meta-analysis. Clin Gastroenterol Hepatol 2021; 19: 668-679.
Share
RELATED ARTICLE
We process personal data collected when visiting the website. The function of obtaining information about users and their behavior is carried out by voluntarily entered information in forms and saving cookies in end devices. Data, including cookies, are used to provide services, improve the user experience and to analyze the traffic in accordance with the Privacy policy. Data are also collected and processed by Google Analytics tool (more).
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
