Vedolizumab use after failure of TNF-α antagonists in children and adolescents with inflammatory bowel disease

BMC Gastroenterol. 2018 Sep 15;18(1):140. doi: 10.1186/s12876-018-0868-x.

Abstract

Background: Vedolizumab is safe and effective in adult patients with Crohn's disease (CD) and ulcerative colitis (UC); however, data in children with inflammatory bowel disease (IBD) are scarce. Therefore, we evaluated vedolizumab use in a cohort of Austrian paediatric patients with IBD.

Methods: Twelve patients (7 female; 7 CD; 5 UC), aged 8-17 years (median, 15 years), with severe IBD who received vedolizumab after tumour necrosis factor α antagonist treatment were retrospectively analysed. Clinical activity scores, relevant laboratory parameters, and auxological measures were obtained at infusion visits.

Results: In the CD group, 1/7 patient discontinued therapy due to a severe systemic allergic reaction; 1/7 and 2/7 patients achieved complete and partial response, respectively, at week 14; and 3/7 patients discontinued therapy due to a primary non-response or loss of response. In the UC group, complete clinical remission was achieved at weeks 2, 6, and 14 in 2/5, 1/5 and 1/5 patients respectively; partial response was observed in one patient at week 2. CD activity scores did not significantly change from baseline to week 38 (median 47.5 vs. 40 points, p = 1,0), while median UC activity scores changed from 70 to 5 points (p < 0,001). Substantial weight gain and increased albumin and haemoglobin levels were observed in both groups.

Conclusion: These results demonstrate that vedolizumab can be an effective treatment for individual paediatric patients with IBD who are unresponsive, intolerant, or experience a loss of efficacy in other therapies. However, vedolizumab appears to be more effective in paediatric UC than in paediatric CD.

Keywords: Crohn’s disease; Integrin antagonist; Paediatrics; Ulcerative colitis.

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / therapeutic use
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Child
  • Colitis, Ulcerative / blood
  • Colitis, Ulcerative / drug therapy*
  • Crohn Disease / blood
  • Crohn Disease / drug therapy*
  • Drug Hypersensitivity / etiology
  • Drug Therapy, Combination
  • Female
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Hemoglobinometry
  • Humans
  • Male
  • Remission Induction
  • Retrospective Studies
  • Serum Albumin / metabolism
  • Treatment Failure
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Weight Gain

Substances

  • Adrenal Cortex Hormones
  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • Serum Albumin
  • Tumor Necrosis Factor-alpha
  • vedolizumab

Supplementary concepts

  • Pediatric Crohn's disease
  • Pediatric ulcerative colitis