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JAMA. 2019 Mar 12;321(10):946-955. doi: 10.1001/jama.2019.1113.

Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial.

Author information

1
Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora.
2
Gordon Sussman Clinical Research, Toronto, Ontario, Canada.
3
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.
4
Icahn School of Medicine at Mount Sinai, New York, New York.
5
Northwest Allergy and Asthma Center, University of Washington Children's Hospital and Regional Medical Center, Seattle.
6
Charité Universitätsmedizin Berlin, Berlin, Germany.
7
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
8
Clinique Spécialisée en Allergie de la Capital, Quebec, Quebec, Canada.
9
Paediatrics and Child Health, INFANT Centre and HRB-Clinical Research Facility, University College Cork, Cork, Ireland.
10
Children's Hospital at Westmead, Sydney, Australia.
11
University of California, San Diego, Rady Children's Hospital, San Diego.
12
Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, California.
13
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.
14
University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock.
15
St Marien Hospital Bonn, Bonn, Germany.
16
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania.
17
DBV Technologies, Montrouge, France.
18
Johns Hopkins Hospital, Baltimore, Maryland.
19
Cheema Research Inc, Mississauga, Ontario, Canada.
20
Division of Paediatrics, University of Western Australia School of Medicine, Perth, Children's Hospital, Nedlands, Australia.
21
Allergy Medical Group, Southport, Australia.
22
Ottawa Allergy Research Corporation, Ottawa, Ontario, Canada.
23
British Columbia Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
24
Our Lady's Children's Hospital, Dublin, Ireland.
25
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
26
University of Texas Southwestern Medical Center, Dallas.
27
University of North Carolina, Chapel Hill.
28
Boston Children's Hospital, Boston, Massachusetts.
29
Baylor College of Medicine, Texas Children's Hospital, Houston.
30
National Jewish Health, Denver, Colorado.
31
Massachusetts General Hospital, Boston.

Abstract

Importance:

There are currently no approved treatments for peanut allergy.

Objective:

To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among peanut-allergic children.

Design, Setting, and Participants:

Phase 3, randomized, double-blind, placebo-controlled trial conducted at 31 sites in 5 countries between January 8, 2016, and August 18, 2017. Participants included peanut-allergic children (aged 4-11 years [n = 356] without a history of a severe anaphylactic reaction) developing objective symptoms during a double-blind, placebo-controlled food challenge at an eliciting dose of 300 mg or less of peanut protein.

Interventions:

Daily treatment with peanut patch containing either 250 μg of peanut protein (n = 238) or placebo (n = 118) for 12 months.

Main Outcomes and Measures:

The primary outcome was the percentage difference in responders between the peanut patch and placebo patch based on eliciting dose (highest dose at which objective signs/symptoms of an immediate hypersensitivity reaction developed) determined by food challenges at baseline and month 12. Participants with baseline eliciting dose of 10 mg or less were responders if the posttreatment eliciting dose was 300 mg or more; participants with baseline eliciting dose greater than 10 to 300 mg were responders if the posttreatment eliciting dose was 1000 mg or more. A threshold of 15% or more on the lower bound of a 95% CI around responder rate difference was prespecified to determine a positive trial result. Adverse event evaluation included collection of treatment-emergent adverse events (TEAEs).

Results:

Among 356 participants randomized (median age, 7 years; 61.2% male), 89.9% completed the trial; the mean treatment adherence was 98.5%. The responder rate was 35.3% with peanut-patch treatment vs 13.6% with placebo (difference, 21.7% [95% CI, 12.4%-29.8%; P < .001]). The prespecified lower bound of the CI threshold was not met. TEAEs, primarily patch application site reactions, occurred in 95.4% and 89% of active and placebo groups, respectively. The all-causes rate of discontinuation was 10.5% in the peanut-patch group vs 9.3% in the placebo group.

Conclusions and Relevance:

Among peanut-allergic children aged 4 to 11 years, the percentage difference in responders at 12 months with the 250-μg peanut-patch therapy vs placebo was 21.7% and was statistically significant, but did not meet the prespecified lower bound of the confidence interval criterion for a positive trial result. The clinical relevance of not meeting this lower bound of the confidence interval with respect to the treatment of peanut-allergic children with epicutaneous immunotherapy remains to be determined.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02636699.

PMID:
30794314
PMCID:
PMC6439674
DOI:
10.1001/jama.2019.1113
[Indexed for MEDLINE]
Free PMC Article

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