Brian P. Vickery, MD, Jelena P. Berglund, PhD, Caitlin M

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Presentation transcript:

Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective Brian P. Vickery, MD, Jelena P. Berglund, PhD, Caitlin M. Burk, BA, Jason P. Fine, PhD, Edwin H. Kim, MD, MHS, Jung In Kim, MS, Corinne A. Keet, MD, PhD, Michael Kulis, PhD, Kelly G. Orgel, BS, Rishu Guo, MD, PhD, Pamela H. Steele, CPNP, Yamini V. Virkud, MD, MPH, Ping Ye, PhD, Benjamin L. Wright, MD, Robert A. Wood, MD, A. Wesley Burks, MD Journal of Allergy and Clinical Immunology Volume 139, Issue 1, Pages 173-181.e8 (January 2017) DOI: 10.1016/j.jaci.2016.05.027 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Progression of subjects through the study. EoE, Eosinophilic esophagitis; IV, intravenous. Journal of Allergy and Clinical Immunology 2017 139, 173-181.e8DOI: (10.1016/j.jaci.2016.05.027) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Outcomes of E-OIT and standard-care treatment. A, Clinical outcomes of E-OIT. The proportion of overall subjects, and those in each treatment arm, achieving SU are shown for both intent-to-treat and per-protocol analyses. B, The distributions of psIgE among E-OIT participants and matched controls practicing allergen avoidance at baseline and end-of-study periods (median 29 and 43 months, respectively). Note that all psIgE levels of more than 100 were transformed to 101 for these analyses because dilutional analysis was not available for all high-titer samples. C, The proportions of E-OIT and control participants able to reintroduce peanut-containing foods in the diet at the end of the study period. D, The imputed proportions able to reintroduce peanut-containing foods in the diet with evidence-based worst-case assumptions. Journal of Allergy and Clinical Immunology 2017 139, 173-181.e8DOI: (10.1016/j.jaci.2016.05.027) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Association of baseline psIgE characteristics and outcomes. A, Both the baseline psIgE and the ratio of peanut-specific to total IgE are significantly lower among successes than among failures in the ITT population. B, Length of treatment broken down by tertiles of baseline psIgE. Significance testing by 1-way ANOVA. Journal of Allergy and Clinical Immunology 2017 139, 173-181.e8DOI: (10.1016/j.jaci.2016.05.027) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Immunoregulation during E-OIT at both doses tested. Log-transformed psIgE (A) and IgG4 (B), and raw data for mean wheal diameter of peanut skin tests (C) are plotted separately by group, with data from individuals connected by colored lines and the fitted time trajectory curve displayed with the raw data for these models. P values comparing the parameter estimates for the 2 groups for each outcome are also provided. Journal of Allergy and Clinical Immunology 2017 139, 173-181.e8DOI: (10.1016/j.jaci.2016.05.027) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Cumulative dose ingested during entry open OFCs in the E-OIT ITT population. Journal of Allergy and Clinical Immunology 2017 139, 173-181.e8DOI: (10.1016/j.jaci.2016.05.027) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Distribution of all allergic AEs during buildup and maintenance phases. Multiple symptoms included any single reaction that involved multiple systems (skin/gastrointestinal/upper respiratory/lower respiratory). This group does not overlap with the other groups that involved isolated symptoms in each specified category. The “Other” category included isolated symptoms that occurred with less than 5% frequency (isolated cough at 2%, isolated angioedema at 1%, and isolated eye-tearing at 0.5%). Journal of Allergy and Clinical Immunology 2017 139, 173-181.e8DOI: (10.1016/j.jaci.2016.05.027) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions