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Multicenter, randomized, double-blind, placebo-controlled clinical trial of vital wheat gluten oral immunotherapy. The Journal of allergy and clinical immunology Nowak-Wegrzyn, A., Wood, R. A., Nadeau, K. C., Pongracic, J. A., Henning, A. K., Lindblad, R. W., Beyer, K., Sampson, H. A. 2018

Abstract

BACKGROUND: Wheat is a common food allergen that can cause anaphylaxis.OBJECTIVE: We sought to determine the efficacy and safety of vital wheat gluten (VWG) oral immunotherapy (OIT).METHODS: After baseline double-blind, placebo-controlled food challenge (DBPCFC), 46 patients with wheat allergy (median age, 8.7years; range, 4.2-22.3years) were randomized 1:1 to low-dose VWG OIT or placebo, with biweekly escalation to 1445mg of wheat protein (WP). After a year 1 DBPCFC, active subjects continued low-dose VWG OIT for another year and underwent a year 2 DBPCFC and, if passed, a subsequent off-therapy DBPCFC. Placebo-treated subjects crossed over to high-dose VWG OIT (maximum, 2748mg of WP).RESULTS: The median baseline successfully consumed dose (SCD) was 43mg of WP in both groups. At year 1, 12 (52.2%) of 23 low-dose VWG OIT-treated and 0 (0%) of 23 placebo-treated subjects achieved the primary end point of an SCD of 4443mg of WP or greater (P<.0001); median SCDs were 4443 and 143mg, respectively. At year 2, 7 (30.4%) of 23 low-dose VWG OIT-treated subjects were desensitized to an SCD of 7443mg of WP; 3 (13%) achieved sustained unresponsiveness 8 to 10weeks off therapy. Among placebo-treated subjects who crossed over to high-dose VWG OIT, 12 (57.1%) of 21 were desensitized after 1year (median SCD, 7443mg of WP; nonsignificant vs low-dose VWG OIT). At year 1, skin prick test responses and wheat- and omega-5 gliadin-specific IgE levels did not differ between groups; the low-dose VWG OIT median specific IgG4 level was greater than placebo (wheat, P=.0005; omega-5 gliadin, P=.0001). Year 1 SCDs correlated with wheat-specific (rho=0.55, P=.0003) and omega-5 gliadin-specific (rho=0.51, P=.001) IgG4 levels in all subjects. Among 7822 low-dose VWG OIT doses in year 1, 15.4% were associated with adverse reactions: 0.04% were severe, and 0.08% subjects received epinephrine. Among 7921 placebo doses, 5.8% were associated with adverse reactions; none were severe.CONCLUSIONS: Low- and high-dose VWG OIT induced desensitization in about one half of the subjects after 1year of treatment. Two years of low-dose VWG OIT resulted in 30% desensitization, and 13% had sustained unresponsiveness.

View details for DOI 10.1016/j.jaci.2018.08.041

View details for PubMedID 30389226