Pediatric peanut allergy: peanut-patch immunotherapy yields opaque results

  • Fleischer DM & al.
  • JAMA
  • 22.02.2019

  • von Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • Peanut-patch immunotherapy for pediatric peanut allergy resulted in statistically but not clinically significantly more responders vs placebo in the PEPITES trial . 

Why this matters

  • Editorial: results are not straightforward to interpret, and clinicians will have to determine if 35.3% response rate is efficacy worth pursuing.
  • Oral immunotherapies are also showing promise, as per results just presented at the American Academy of Allergy, Asthma & Immunology 2019 Annual Meeting.

Key results

  • Adherence to treatment: 98.5%.
  • Response rates:
    • Treatment: 35.3% vs placebo: 13.6%.
    • Difference: 21.7% (95% CI, 12.4%-29.8%; P<.001 class="">).
    • Statistically significant (P<.001 but lower ci value misses fda-recommended and prespecified cutoff of for clinical significance.>
  • Adverse events were mostly site reactions:
    • 95.4% treatment vs 89% placebo.
  • All-cause discontinuation rates:
    • 10.5% treatment vs 9.3% placebo.
    • 1.7% in patch vs 0% in placebo discontinued because of adverse events.

Study design

  • Phase 3, randomized, double-blind, placebo-controlled trial.
  • 31 sites, 5 countries.
  • Children ages 4-11 years, n=356, randomly allocated to patch (n=238; 250 μg peanut protein) or placebo (n=118).
  • Primary outcome: percentage difference in responders, patch vs placebo; secondary outcomes not reported because trial results were not positive.
  • Funding: DBV Technologies.

Limitations

  • Children with history of life-threatening anaphylaxis to peanut excluded.
  • Duration only 12 months.