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evident
Original paper
2015NEJMPediatrics

LEAP

Randomized trial of peanut consumption in infants at risk for peanut allergy

RCTFood allergy

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Overview

In high-risk infants, peanut consumption lowered peanut allergy at 60 months in both skin-prick-negative and skin-prick-positive cohorts.

Clinical takeaway

Among infants with severe eczema, egg allergy, or both, eating peanut rather than avoiding it lowered peanut allergy at 60 months. The primary result was analyzed separately in the skin-prick-negative and skin-prick-positive cohorts; both favored consumption.

Key result

In the skin-prick-negative ITT cohort, peanut allergy at 60 months was 13.7% with avoidance vs 1.9% with consumption (P<0.001); in the skin-prick-positive ITT cohort, 35.3% vs 10.6% (P=0.004).

Practice impact

For high-risk infants, introduce peanut rather than avoid it; interpret the two skin-prick cohorts separately.

Evidence

Study design

Randomized trial assigning infants to consume or avoid peanuts until 60 months of age, with the primary outcome assessed independently in skin-prick-negative and skin-prick-positive cohorts.

Enrollment

640

Follow-up

Until 60 months of age.

Geography

Not listed

Clinical question

Does peanut consumption or peanut avoidance better prevent peanut allergy in infants at high risk for the allergy?

Population

  • 640 infants at least 4 months but younger than 11 months of age with severe eczema, egg allergy, or both.
  • Skin-prick-negative cohort: no measurable wheal to peanut extract.
  • Skin-prick-positive cohort: wheal measuring 1 to 4 mm in diameter.

Intervention

Peanut consumption until 60 months of age.

Comparator

Peanut avoidance until 60 months of age.

Primary outcome

Proportion of participants with peanut allergy at 60 months of age, assessed independently in each skin-prick cohort.

In the skin-prick-negative ITT cohort (n=530), peanut allergy at 60 months was 13.7% with avoidance vs 1.9% with consumption (P<0.001). In the skin-prick-positive ITT cohort (n=98), it was 35.3% vs 10.6% (P=0.004).

Key results

  • Skin-prick-negative intention-to-treat cohort (n=530): peanut allergy at 60 months was 13.7% in the avoidance group and 1.9% in the consumption group (P<0.001).
  • Skin-prick-positive intention-to-treat cohort (n=98): peanut allergy at 60 months was 35.3% in the avoidance group and 10.6% in the consumption group (P=0.004).
  • There was no significant between-group difference in the incidence of serious adverse events.
  • As secondary immunologic findings, peanut-specific IgG4 increased predominantly in the consumption group, and a greater percentage of the avoidance group had elevated peanut-specific IgE. A larger skin-prick wheal and a lower peanut-specific IgG4:IgE ratio were associated with peanut allergy.

Harms

  • There was no significant between-group difference in the incidence of serious adverse events.

Clinical Use

Practice impact

  • For infants with severe eczema, egg allergy, or both, introduce peanut rather than counsel prolonged avoidance.
  • Counsel families using the matching skin-prick cohort: both groups benefited, but baseline allergy risk was higher if the wheal was 1 to 4 mm.

Applicability

  • Most applicable to infants at least 4 months but younger than 11 months with severe eczema, egg allergy, or both, including those with a peanut skin-prick wheal of 0 mm or 1 to 4 mm, followed to 60 months.

Limitations

  • Randomized N was 640; the ITT analyses used 530 skin-prick-negative and 98 skin-prick-positive infants (628 total).
  • The abstract reports no confidence intervals or effect estimates (RR or RD) for peanut allergy.
  • This is a high-risk sample, not unselected infants.

Common misinterpretations

  • Do not pool the two cohorts into one headline rate; the primary outcome was assessed independently in skin-prick-negative and skin-prick-positive infants.
  • LEAP randomized consumption versus avoidance in high-risk infants, not early introduction versus delayed introduction in the general infant population.

Citation

Du Toit G, Roberts G, Sayre PH, et al. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015;372(9):803-813. doi:10.1056/NEJMoa1414850

The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts.