Sublingual Immunotherapy for Peanut Allergy: Long-Term Follow-up of a Randomized Multicenter Trial
03/2015
Journal Article
Authors:
Burks, A.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.;
CoFAR), T.Consortium
Secondary:
J Allergy Clin Immunol
URL:
http://www.ncbi.nlm.nih.gov/pubmed/25656999
Keywords:
desensitization; follow-up; food allergy; Peanut allergy; sublingual immunotherapy
Abstract:
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.