Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo- controlled multicenter trial David M. Fleischer, MD, A. Wesley Burks,

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Presentation transcript:

Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo- controlled multicenter trial David M. Fleischer, MD, A. Wesley Burks, MD, Brian P. Vickery, MD, Amy M. Scurlock, MD, Robert A. Wood, MD, Stacie M. Jones, MD, Scott H. Sicherer, MD, Andrew H. Liu, MD, Donald Stablein, PhD, Alice K. Henning, MS, Lloyd Mayer, MD, Robert Lindblad, MD, Marshall Plaut, MD, Hugh A. Sampson, MD Journal of Allergy and Clinical Immunology Volume 131, Issue 1, Pages 119-127.e7 (January 2013) DOI: 10.1016/j.jaci.2012.11.011 Copyright © 2012 Terms and Conditions

Fig 1 Enrollment and disposition of subjects. The 40 subjects who passed screening were randomized to placebo or peanut SLIT. After the Week 44 OFC, the study was unblinded. Subjects in the original Peanut SLIT group continued on maintenance peanut SLIT therapy and received a Week 68 OFC. Original placebo recipients were offered a higher dose peanut SLIT from Week 44 to Week 88 and then an OFC. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions

Fig 2 OFC SCD by treatment group. OFC doses successfully consumed were compared with initial 2-g baseline (BL) SCDs after 44 weeks of therapy from study entry for the randomized initially treated group and after 44 weeks of therapy from crossover initiation for the Crossover High Dose group. The median OFC SCD at Week 44 was significantly higher than at baseline OFC for Peanut SLIT subjects (21 vs 371 mg, P = .01) but not for Placebo subjects (71 vs 146 mg, P = .14). Stars identify the median. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions

Fig 3 OFC SCD for Peanut SLIT subjects who have Week 68 OFCs. The OFC SCDs of subjects are shown by the OFC doses successfully consumed at baseline (BL), Week 44, and Week 68 for Peanut SLIT subjects. At Week 68, the median dose successfully consumed increased to 996 mg, and this was significantly higher than at Week 44 (P = .05) and baseline (P = .009). Stars identify the median. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions

Fig 4 Change in PN-IgG4 levels during SLIT. Levels were compared after 44 weeks of therapy from study entry for the randomized initially treated group and after 44 weeks of therapy from crossover initiation for the Crossover High Dose group. The median increase in PN-IgG4 levels from baseline to Week 44 was statistically significantly higher in subjects in the Crossover High Dose group (P < .001) and in Peanut SLIT subjects compared with Placebo (0.3 vs 0.0 mgA/L, P < .001). Stars identify the median. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions

Fig E1 Study schematic. The study was divided into 2 phases: (1) a randomized, double-blind, placebo-controlled peanut SLIT trial through 44 weeks and (2) an unblinded additional 120 weeks of lower dose peanut SLIT treatment for the initial active therapy–treated subjects and 164 weeks of higher dose peanut SLIT for the initial placebo-treated subjects after crossover to active therapy. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions

Fig E2 Change in PN-IgE levels during SLIT. Levels were compared after 44 weeks of therapy from study entry for the randomized initially treated group and after 44 weeks of therapy from crossover initiation for the Crossover High Dose group. Median change from baseline (BL) was not statistically significantly higher in Peanut SLIT subjects compared with Placebo subjects (1.6 vs 0.5 kUA/L, P = .24). Stars identify the median. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions

Fig E3 In vitro basophil activation in Peanut SLIT and Placebo subjects. The %CD63+ basophil value is shown for 4 levels of peanut stimulant at baseline (BL), Week 29, and Week 44 by treatment group. A repeated-measures analysis with study visit and baseline %CD63+ values as covariates found the %CD63+ value was significantly lower for Peanut SLIT subjects compared with that for Placebo subjects for the 10−2 μg/mL crude peanut stimulant (Δ = −19.8, **P = .008) and the 10−3 μg/mL crude peanut stimulant (Δ = −11.9, *P = .049). CPE, Crude peanut extract. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions

Fig E4 End point titration area under the curve for Peanut SLIT subjects by Week 44 OFC response status. Values at Week 68 were compared with baseline (BL) values for Peanut SLIT Week 44 OFC responders and nonresponders. The median change for Week 44 OFC responders (n = 13) versus nonresponders (n = 4) was statistically significant (−17.0 vs 1.0, P = .03). Stars identify the median. Journal of Allergy and Clinical Immunology 2013 131, 119-127.e7DOI: (10.1016/j.jaci.2012.11.011) Copyright © 2012 Terms and Conditions