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Sublingual immunotherapy for hazelnut food allergy: A randomized, double-blind, placebo-controlled study with a standardized hazelnut extract

2005; Elsevier BV; Volume: 116; Issue: 5 Linguagem: Inglês

10.1016/j.jaci.2005.08.027

1097-6825

Ernesto Enrique, Fernando Pineda, Tamim Malek, Joan Bartra, María Basagaña, R. Tella, José Vicente Castelló, Rosario Alonso, José Antonio de Mateo, Teresa Cerdá-Trias, María del Mar San Miguel-Moncín, Susana Monzón, Carmen García‐Rodríguez, Ricardo Palácios, Anna Cisteró‐Bahíma,

Respiratory and Cough-Related Research

BackgroundFood allergy may be life-threatening, and patients affected need to receive accurate diagnoses and treatment. Hazelnut has often been implicated as responsible for allergic reactions, and trace quantities can induce systemic reactions.ObjectiveThe aim of this study was to evaluate the efficacy and tolerance of sublingual immunotherapy with a standardized hazelnut extract in patients allergic to hazelnut.MethodsThis was a randomized, double-blind, placebo-controlled study. Inclusion criteria were a history of hazelnut allergy and positive skin prick test and double-blind placebo-controlled food challenge results. Patients were then randomly assigned into 2 treatment groups (hazelnut immunotherapy or placebo). Efficacy was assessed by double-blind, placebo-controlled food challenge after 8 to 12 weeks of treatment. Blood samples were drawn for measurement of specific IgE, IgG4, and serum cytokines before and after treatment.ResultsTwenty-three patients were enrolled and divided into 2 treatment groups. Twenty-two patients reached the planned maximum dose at 4 days. Systemic reactions were observed in only 0.2% of the total doses administered. Mean hazelnut quantity provoking objective symptoms increased from 2.29 g to 11.56 g (P = .02; active group) versus 3.49 g to 4.14 g (placebo; NS). Moreover, almost 50% of patients who underwent active treatment reached the highest dose (20 g), but only 9% in the placebo. Laboratory data showed an increase in IgG4 and IL-10 levels after immunotherapy in only the active group.ConclusionOur data confirm significant increases in tolerance to hazelnut after sublingual immunotherapy as assessed by double-blind, placebo-controlled food challenge, and good tolerance to this treatment.