- 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 presentedat the American Academy of Allergy, Asthma & Immunology 2019 Annual Meeting.
- 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.
- 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.
- Children with history of life-threatening anaphylaxis to peanut excluded.
- Duration only 12 months.