ABSTRACT
Purpose
Vedolizumab (VDZ) was reported to be effective as a first-line biological in adult
ulcerative colitis (UC). The aim of this study was to investigate the safety and effectiveness
of VDZ as the first-line biological in pediatric refractory UC.
Methods
We retrospectively extracted data from pediatric patients with UC who received first-line
VDZ. The following were recorded: baseline characteristics; clinical activity of intestinal
disease, levels of fecal calprotectin (FC), C-reactive protein, and serum amyloid
A; and erythrocyte sedimentation rate. Clinical effectiveness, biochemical remission,
and safety of VDZ were also investigated.
Findings
Eight patients were identified (median age, 12 years). FC levels were abnormal in
all cases and were remarkably elevated in 3 patients. C-reactive protein, serum amyloid
A, and erythrocyte sedimentation rate values were abnormal in 2, 4, and 5 patients,
respectively. According to the pediatric UC activity index score, 1, 5, and 2 patients
had mild, moderate, and severe disease. Fourteen weeks after VDZ administration, 5
patients achieved remission, and 3 remained in remission until week 52. Of the 3 patients
who did not reach remission in week 14, two achieved remission by week 52. In week
52, five of the eight patients continued receiving VDZ and maintained remission. All
patients achieved clinical remission without corticosteroid use. No adverse events
were observed in any patient.
Implications
VDZ may serve as a safe and effective first-line biological option for treating pediatric
patients with UC. FC levels before VDZ administration may be predictive of long-term
remission.
Key words
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REFERENCES
- The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases.J Pharmacol Exp Ther. 2009; 330: 864-875
- The safety of vedolizumab for ulcerative colitis and Crohn's disease.Gut. 2017; 66: 839-851
- 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
- Safety and effectiveness of vedolizumab in paediatric patients with inflammatory bowel disease: an observational multicentre Spanish study.Eur J Pediatr. 2021; 180: 3029-3038
- Management of paediatric ulcerative colitis, part 1: ambulatory care—an evidence-based guideline from European Crohn's and Colitis Organization and European Society of Paediatric Gastroenterology, Hepatology and Nutrition.J Pediatr Gastroenterol Nutrition. 2018; 67: 257-291
- Biological therapy in pediatric age.Pharmacol Res. 2020; 161105120
- Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn’s disease—a systematic review with meta-analysis.Dig Liver Dis. 2021;
- Vedolizumab and anti-tumour necrosis factor α real-world outcomes in biologic-naïve inflammatory bowel disease patients: results from the EVOLVE study.J Crohns Colitis. 2021; 15: 1694-1706
- Vedolizumab use after failure of TNF-α antagonists in children and adolescents with inflammatory bowel disease.BMC Gastroenterol. 2018; 18: 140
- A pediatric case of moderate active ulcerative colitis successfully treated with vedolizumab in Japan.Clin J Gastroenterol. 2021; 14: 146-151
- Severe pediatric ulcerative colitis: a prospective multicenter study of outcomes and predictors of response.Gastroenterology. 2010; 138: 2282-2291
- Vedolizumab in the treatment of ulcerative colitis: an evidence-based review of safety, efficacy, and place of therapy.Core Evid. 2020; 15: 7-20
- Systematic review with network meta-analysis: comparative efficacy of biologics in the treatment of moderately to severely active ulcerative colitis.PloS One. 2016; 11e0165435
- Failure of vedolizumab as first-line biologic does not decrease response rates of second-line therapy.Am J Gastroenterol. 2018; 113: S382-S383
- Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease.Inflamm Bowel Dis. 2012; 18: 2218-2224
- Faecal calprotectin as reliable non-invasive marker to assess the severity of mucosal inflammation in children with inflammatory bowel disease.Dig Liver Dis. 2008; 40: 547-553
- Consecutive monitoring of faecal calprotectin during mesalazine suppository therapy for active rectal inflammation in ulcerative colitis.Aliment Pharmacol Ther. 2015; 42: 549-558
- Surrogate markers of intestinal inflammation are predictive of relapse in patients with inflammatory bowel disease.Gastroenterology. 2000; 119: 15-22
- Week 6 calprotectin best predicts likelihood of long-term endoscopic healing in Crohn's disease: a post-hoc analysis of the UNITI/IM-UNITI trials.J Crohns Colitis. 2021; 15: 462-470
- Early change in fecal calprotectin predicts one-year outcome in children newly diagnosed with ulcerative colitis.J Pediatr Gastroenterol Nutr. 2022; 74: 72-78
Article info
Publication history
Published online: June 29, 2022
Accepted:
June 7,
2022
Identification
Copyright
© 2022 Elsevier Inc.