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

• Published in: Journal of allergy and clinical immunology Vol. 135; no. 5; pp. 1240 - 1248.e3
• Main Authors: Burks, A. Wesley, Wood, Robert A., Jones, Stacie M., Sicherer, Scott H., Fleischer, David M., Scurlock, Amy M., Vickery, Brian P., Liu, Andrew H., Henning, Alice K., Lindblad, Robert, Dawson, Peter, Plaut, Marshall, Sampson, Hugh A.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2015; Elsevier Limited
• Subjects: Adolescent; Allergens - administration & dosage; Allergens - immunology; Allergies; Allergy and Immunology; Arachis - adverse effects; Arachis hypogaea; Basophils - immunology; Basophils - metabolism; Comorbidity; desensitization; Female; follow-up; Follow-Up Studies; Food allergies; food allergy; Humans; Immunoglobulin E - blood; Immunoglobulin E - immunology; Immunotherapy; Male; Peanut allergy; Peanut Hypersensitivity - immunology; Peanut Hypersensitivity - therapy; Peanuts; Plant Proteins, Dietary - administration & dosage; Plant Proteins, Dietary - immunology; Proteins; Sublingual Immunotherapy; Treatment Outcome; follow-up; SLIT; Peanut allergy; SPT; sublingual immunotherapy; OIT; food allergy; OFC; SCIT; desensitization; Oral food challenge; Subcutaneous immunotherapy; Skin prick test; Oral immunotherapy
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2014.12.1917

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. 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. 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. 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. 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.