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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.

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