J Crohns Colitis: Efficacy and safety of vedolizumab in pediatric patients with ulcerative colitis or Crohn's disease

Vedolizumab, an integrin receptor antagonist, is the first and currently only drug that specifically targets inflammatory signaling pathways in the gut
.

Approved for the treatment of moderate-to-severe active disease with inadequate response, non-response, or intolerance to conventional therapy or tumor necrosis factor alpha (TNFα) inhibitorsAdult patients with ulcerative colitis (UC) and Crohn's disease (CD)

ulcerative colitis

However, to date, there are no systemic pharmacokinetic (PK) data of vedolizumab in childhood
inflammatory bowel disease (IBD) .

This article reports results from a Phase 2 clinical trial called HUBBLE, which evaluated the pharmacokinetics, safety, and efficacy of intravenous vedolizumab in the treatment of pediatric inflammatory bowel disease

child

Research Process

Research Process

Children aged 2-17 years with moderate to severe ulcerative colitis or Crohn's disease weighing ≥10 kg were recruited and randomized to receive low-dose or high-dose vedolizumab (≥30 kg: 150 or 200 mg; <30 kg: 100 or 200 mg; Day 1, Weeks 2, 6, and 14)
.

Pharmacokinetics, clinical response, and exposure-response correlations were assessed at week 14

Ulcerative Colitis Immunity

Drug trough concentration at week 14 in each group

Drug trough concentration at week 14 in each group

A total of 49 patients weighing ≥30 kg (25 UC, 24 CD) and 40 children weighing <30 kg (19 UC, 21 CD) were recruited, with a mean age distribution at baseline of 13.
5 and 7.
6 years
.

In each indication and dose group, the area under the concentration curve and the mean concentration increased almost 2-fold from the low dose to the high dose ; compared with the low dose group, the trough concentration of the drug was significantly higher in the high dose group

In each indication and dose group, the area under the concentration curve and the mean concentration increased almost 2-fold from low dose to high dose.

Treatment-Related Adverse Events

Treatment-Related Adverse Events

Treatment-related adverse events occurred in 14% (12/88) of the patients, and 6.
8% (6/88) developed anti-drug antibodies
.

Overall, vedolizumab exposure increased in an approximately dose-proportional manner
.

No clear dose-response relationship was observed in this study cohort

Exposure to vedolizumab increased in an approximately dose-proportional manner

Original source:

Original source:

Hyams Jeffrey S,Turner Dan,Cohen Stanley A et al.

Pharmacokinetics, Safety, and Efficacy of Intravenous Vedolizumab in Paediatric Patients with Ulcerative Colitis or Crohn's Disease: Results from the Phase 2 HUBBLE StudyLeave a Comment