Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy Stacie M. Jones, MD, A.

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Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy Stacie M. Jones, MD, A. Wesley Burks, MD, Corinne Keet, MD, Brian P. Vickery, MD, Amy M. Scurlock, MD, Robert A. Wood, MD, Andrew H. Liu, MD, Scott H. Sicherer, MD, Alice K. Henning, MS, Robert W. Lindblad, MD, Peter Dawson, PhD, Cecilia Berin, PhD, David M. Fleischer, MD, Donald Y.M. Leung, MD, Marshall Plaut, MD, Hugh A. Sampson, MD Journal of Allergy and Clinical Immunology Volume 137, Issue 4, Pages 1117-1127.e10 (April 2016) DOI: 10.1016/j.jaci.2015.12.1316 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Study enrollment, randomization, and treatment outcomes through year 4. Shaded boxes represent participants achieving SU. Journal of Allergy and Clinical Immunology 2016 137, 1117-1127.e10DOI: (10.1016/j.jaci.2015.12.1316) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 LFQ-2: Frequency and amount of egg consumption by treatment outcome status. A, Frequency of eating unbaked egg. The percentage of subjects who were eating unbaked egg several days per week or more was as follows: eOIT-SU group, 61%; eOIT-desensitized (eOIT-D) group, 25%; eOIT-not desensitized (eOIT-Not-D) group, 0%; and placebo group, 17%.* The percentage of subjects who were not eating unbaked egg was as follows: eOIT-SU group, 0%; eOIT-D group, 75%; eOIT-Not-D group, 86%; and placebo group, 67%. B, Amount of unbaked egg eaten at one time. The percentage of subjects who were eating a full serving or more of unbaked egg was as follows: eOIT-SU group, 83%; eOIT-D group, 13%; eOIT-Not-D group, 0%; and placebo group, 8%. C, Frequency of eating baked egg. The percentage of subjects who were eating baked egg several days per week or more was as follows: eOIT-SU group, 89%; eOIT-D group, 88%; eOIT-Not-D group, 29%; and placebo group, 33%.** The percentage of subjects who were not eating baked egg was as follows: eOIT-SU group, 0%; eOIT-D group, 13%; eOIT-Not-D group, 57%; and placebo group, 42%.* D, Amount of baked egg eaten at one time. The percentage of subjects who were eating 1 or more of baked egg goods was as follows: eOIT-SU group, 94%; eOIT-D group, 88%; eOIT-Not-D group, 29%; and placebo group, 50%.† *One placebo-treated subject enrolled in an eOIT study after completing LFQ-1 and consumes egg white powder daily but does not consume baked egg. †One placebo-treated subject crossed over to eOIT treatment per their site's institutional review board requirement after 2 years on study and consumes half a serving of concentrated egg less than monthly and 1 baked egg product daily. Journal of Allergy and Clinical Immunology 2016 137, 1117-1127.e10DOI: (10.1016/j.jaci.2015.12.1316) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Immune mechanistic assessments by year 4 treatment outcome status for eOIT-treated subjects. A, Change in egg-specific IgE levels over time. B, Change in egg-specific IgG4 levels over time. C, Change in egg IgG4/IgE ratio over time. D, Change in egg skin prick test response over time. E, Change in egg end point titration AUC over time. The egg IgG4/IgE ratio was calculated by converting IgG4 levels from milligrams of antibody per liter to nanograms per milliliter and converting IgE levels from kilounits of antibody per liter to nanograms per milliliter with the formula (IgG4 × 1000/IgE × 2.4). Egg end point titration AUC was calculated by adding together the scores from all 5 dilutions. Graphs designate Success as those subjects treated with eOIT who achieved SU versus Failure as those subjects treated with eOIT who did not achieve SU. Stars represent median values. BL, Baseline; M, month. Journal of Allergy and Clinical Immunology 2016 137, 1117-1127.e10DOI: (10.1016/j.jaci.2015.12.1316) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Effect of eOIT on basophil activation (percentage of CD63+ basophils) by year 4 treatment outcome status for eOIT-treated subjects. Top row, eOIT treatment failure. Bottom row, eOIT treatment success. Graphs designate Success because those subjects treated with eOIT who achieved SU versus Failure as those subjects treated with eOIT who did not achieve SU. Cells were stimulated with 0.001 μg/mL egg white extract (column 1), 0.01 μg mL egg white extract (column 2), 0.1 μg/mL egg white extract (column 3), or 1 μg/mL egg white extract (column 4). Diamonds represent mean values. BL, Baseline; M, month. Journal of Allergy and Clinical Immunology 2016 137, 1117-1127.e10DOI: (10.1016/j.jaci.2015.12.1316) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions