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

2015 May

Journal Article

Burks, W.; Wood, R.A.; Jones, S.M.; Sicherer, S.H.; Fleischer, D.M.; Scurlock, A.M.; Vickery, B.P.; Liu, A.H.; Henning, A.K.; Lindblad, R.; Dawson, P.; Plaut, M.; Sampson, H.A.

J Allergy Clin Immunol






Adolescent; allergens; Arachis; Basophils; Comorbidity; Female; Follow-Up Studies; Humans; Immunoglobulin E; Male; Peanut Hypersensitivity; Plant Proteins, Dietary; sublingual immunotherapy; Treatment Outcome

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.

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