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Corinne A. Keet, MD, MS, Pamela A

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1 The safety and efficacy of sublingual and oral immunotherapy for milk allergy 
Corinne A. Keet, MD, MS, Pamela A. Frischmeyer-Guerrerio, MD, PhD, Ananth Thyagarajan, MD, John T. Schroeder, PhD, Robert G. Hamilton, PhD, Stephen Boden, MD, Pamela Steele, MSN, CPNP, AE-C, Sarah Driggers, RN, MPH, CCRP, A. Wesley Burks, MD, Robert A. Wood, MD  Journal of Allergy and Clinical Immunology  Volume 129, Issue 2, Pages e5 (February 2012) DOI: /j.jaci Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

2 Fig 1 Study timeline with key features highlighted. Subjects were randomized at T2 to either SLIT (goal dose, 7 mg), OITB (goal dose, 1000 mg), or OITA (goal dose, 2000 mg). CM-specific IgE, CM-specific IgG4, and CM-titrated skin prick test (SPT) results were obtained in all subjects at T1, T3 to T5, and T7. Basophil studies were done at T1, T2 to T5, and T7. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

3 Fig 2 Food challenge outcome. The CM protein threshold is shown for baseline (T1), after 12 weeks of maintenance (T4), after 60 weeks of maintenance (T5), and 1 week (T6) and 6 weeks (T7) off therapy. A, SLIT/SLIT group. B, SLIT/OITB group. C, SLIT/OITC groups. Bars represent medians. ∗P < .05 and ∗∗P < .01 compared with T1. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

4 Fig 3 Mechanistic changes. Individual line plots showing changes with treatment for the 3 randomization groups (A, SLIT/SLIT group; B, SLIT/OITB group; and C, SLIT/OITA group) in CM-specific IgE level (1), CM-specific IgG4 levels (2), and end point titration skin prick test responses. Shown is the average wheal size over 5 CM dilution. Bars represent medians. The shaded blue area represents the period of withdrawal of therapy. ∗P < .05 and ∗∗P < .01 compared with T1. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

5 Fig 4 Basophil activity. A, HR in media alone (SHR) or after stimulation with CM extract, goat anti-human IgE antibody (IgE), peanut extract (PN), or N-formylmethionine (f-met) at T1 to T5 and T7. B, Constitutive surface expression of CD63 and CD203c and intracellular Syk by basophils at T1 to T5 and T7. A box-and-whisker plot is shown; outliers are not shown. ∗P < .05 and ∗∗P < .01 compared with T1. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

6 Fig E1 Predictors of development of tolerance among subjects undergoing OIT. CM-specific IgE levels, CM-specific IgG4 levels, CM end point titration skin prick test responses, spontaneous basophil CD63 and CD203c expression, SHR, and HR to CM, T1 to T7 in subjects receiving SLIT/OIT who passed the final food challenge (Tolerant) and those who failed or did not qualify for the food challenge (Non-Tolerant) are shown. At T1, CM-specific IgE levels were lower in the tolerant group (P = .03). Both constitutive CD63 and C203c expression increased at T2 in only those who did not have tolerance (P < .001 and P = .001, respectively, for the difference in the change from T1 between groups). There were no other statistically significant differences at baseline, over time, or at T5 between the groups. Journal of Allergy and Clinical Immunology  , e5DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

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