Peer-influenced content. Sources you trust. No registration required. This is HCN.

The New England Journal of MedicineDupilumab for Eosinophilic Esophagitis in Patients 1 to 11 Years of Age

Dupilumab shows significant efficacy in achieving histologic remission in pediatric patients with eosinophilic esophagitis, highlighting potential for broader applications in managing type 2 inflammatory diseases.

Dupilumab, a monoclonal antibody targeting interleukin-4 and interleukin-13 pathways, demonstrated significant efficacy in inducing histologic remission in children with eosinophilic esophagitis (EoE) unresponsive to proton-pump inhibitors, according to a phase 3 trial. The study provides key insights into dosing regimens and safety profiles, emphasizing its potential use in clinical practice for managing pediatric EoE.

Study Design:

  • Participants: Children aged 1 to 11 years with active eosinophilic esophagitis, unresponsive to proton-pump inhibitors.
  • Groups: Patients were randomly assigned to higher-exposure or lower-exposure subcutaneous dupilumab regimens or placebo in a 2:2:1:1 ratio for 16 weeks (Part A).
  • Continuation: After Part A, eligible patients continued their respective dupilumab regimens or were reassigned from placebo to dupilumab for an additional 36 weeks (Part B).
  • Dosing: Dupilumab doses were tiered according to baseline body weight.
  • Primary Endpoint: Histologic remission (peak esophageal intraepithelial eosinophil count, ≤6 per high-power field) at week 16.
  • Secondary Endpoints: Tested hierarchically and included improvements in histologic, endoscopic, and transcriptomic measures.

Key Findings:

  • Histologic Remission: Achieved in 68% of patients in the higher-exposure group, 58% in the lower-exposure group, and 3% in the placebo group.
    • Differences: Higher-exposure regimen vs. placebo: 65 percentage points (95% CI, 48 to 81; P<0.001); Lower-exposure regimen vs. placebo: 55 percentage points (95% CI, 37 to 73; P<0.001).
  • Improvements: Higher-exposure dupilumab led to significant improvements in histologic, endoscopic, and transcriptomic measures compared to placebo.
  • Safety: Incidences of COVID-19, nausea, injection-site pain, and headache were at least 10 percentage points higher in the dupilumab groups than in the placebo group.
    • Serious Adverse Events: Reported in 3 patients during Part A and 6 patients overall during Part B.

HCN Medical Memo
The phase 3 trial of dupilumab in pediatric eosinophilic esophagitis demonstrates significant histologic remission and clinical improvements. In the future, dupilumab may be viewed as a viable option for managing children with EoE, especially those unresponsive to standard treatments. Monitoring for adverse events is crucial to ensure patient safety.


More on Esophagitis

The Healthcare Communications Network is owned and operated by IQVIA Inc.

Click below to leave this site and continue to IQVIA’s Privacy Choices form