Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial

J Allergy Clin Immunol. 2015 May;135(5):1240-8.e1-3. doi: 10.1016/j.jaci.2014.12.1917. Epub 2015 Feb 3.


Background: We previously reported the initial results of the first multicenter, randomized, double-blind, placebo-controlled clinical trial of peanut sublingual immunotherapy (SLIT), observing a favorable safety profile associated with modest clinical and immunologic effects in the first year.

Objective: We sought to provide long-term (3-year) clinical and immunologic outcomes for our peanut SLIT trial. Key end points were (1) percentage of responders at 2 years (ie, could consume 5 g of peanut powder or a 10-fold increase from baseline), (2) percentage reaching desensitization at 3 years, (3) percentage attaining sustained unresponsiveness after 3 years, (4) immunologic end points, and (5) assessment of safety parameters.

Methods: Response to treatment was evaluated in 40 subjects aged 12 to 40 years by performing a 10-g peanut powder oral food challenge after 2 and 3 years of daily peanut SLIT therapy. At 3 years, SLIT was discontinued for 8 weeks, followed by another 10-g oral food challenge and an open feeding of peanut butter to assess sustained unresponsiveness.

Results: Approximately 98% of the 18,165 doses were tolerated without adverse reactions beyond the oropharynx, with no severe symptoms or uses of epinephrine. A high rate (>50%) discontinued therapy. By study's end, 4 (10.8%) of 37 SLIT-treated participants were fully desensitized to 10 g of peanut powder, and all 4 achieved sustained unresponsiveness. Responders at 2 years showed a significant decrease in peanut-specific basophil activation and skin prick test titration compared with nonresponders.

Conclusions: Peanut SLIT induced a modest level of desensitization, decreased immunologic activity over 3 years in responders, and had an excellent long-term safety profile. However, most patients discontinued therapy by the end of year 3, and only 10.8% of subjects achieved sustained unresponsiveness.

Trial registration: NCT00580606.

Keywords: Peanut allergy; desensitization; follow-up; food allergy; sublingual immunotherapy.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Allergens / administration & dosage
  • Allergens / immunology
  • Arachis / adverse effects
  • Basophils / immunology
  • Basophils / metabolism
  • Comorbidity
  • Female
  • Follow-Up Studies
  • Humans
  • Immunoglobulin E / blood
  • Immunoglobulin E / immunology
  • Male
  • Peanut Hypersensitivity / immunology
  • Peanut Hypersensitivity / therapy*
  • Plant Proteins, Dietary / administration & dosage
  • Plant Proteins, Dietary / immunology
  • Sublingual Immunotherapy*
  • Treatment Outcome


  • Allergens
  • Plant Proteins, Dietary
  • Immunoglobulin E

Associated data