Stacie M. Jones, MD, Scott H. Sicherer, MD, A

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Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults Stacie M. Jones, MD, Scott H. Sicherer, MD, A. Wesley Burks, MD, Donald Y.M. Leung, MD, Robert W. Lindblad, MD, Peter Dawson, PhD, Alice K. Henning, MS, M. Cecilia Berin, PhD, David Chiang, MSc, Brian P. Vickery, MD, Robbie D. Pesek, MD, Christine B. Cho, MD, Wendy F. Davidson, PhD, Marshall Plaut, MD, Hugh A. Sampson, MD, Robert A. Wood, MD Journal of Allergy and Clinical Immunology Volume 139, Issue 4, Pages 1242-1252.e9 (April 2017) DOI: 10.1016/j.jaci.2016.08.017 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 CONSORT diagram. Enrollment and randomization of younger participants aged 4 to less than 6 years was conducted as in the full study population, as indicated. Enrollment was paused after the first 10 participants were enrolled for a predetermined interim DSMB safety review after 35 days (21 days of escalation and 14 days of maintenance) of dosing to ensure tolerability of the study product. Because of completed study enrollment, no further participants in the 4- to less than 6-year-old age range were enrolled after the DSMB review. Journal of Allergy and Clinical Immunology 2017 139, 1242-1252.e9DOI: (10.1016/j.jaci.2016.08.017) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 SCD from baseline to the week 52 OFC. A, Analysis by treatment group. B, Analysis by age and treatment group. Top panels represent the 4- to 11-year-old age group. Bottom panels represent the greater than 11-year-old age group. Solid lines represent median values, and hatched lines represent the upper and lower IQR. Journal of Allergy and Clinical Immunology 2017 139, 1242-1252.e9DOI: (10.1016/j.jaci.2016.08.017) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Immune mechanistic assessments over time by treatment group. A, Change in peanut-specific IgE levels over time. No significant differences over time were seen between treatment groups (P = .37). B, Change in peanut-specific IgG4 levels over time. A significant difference over time was seen between treatment groups (P < .0001), with a larger increase noted among the active Viaskin Peanut groups compared with the placebo group. C, Change in the peanut IgG4/IgE ratio over time. A significant difference over time was seen between treatment groups (P < .0001), with a larger increase noted among the active Viaskin Peanut groups compared with the placebo group. Solid lines represent median values, and hatched lines represent the upper and lower IQR. Journal of Allergy and Clinical Immunology 2017 139, 1242-1252.e9DOI: (10.1016/j.jaci.2016.08.017) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 SPT results over time by treatment group. No significant difference was noted among treatment groups over time; however, when examined within a treatment group, a decrease in SPT size was noted in the VP250 group (P = .02). Solid lines represent median values, and hatched lines represent the upper and lower IQR. Journal of Allergy and Clinical Immunology 2017 139, 1242-1252.e9DOI: (10.1016/j.jaci.2016.08.017) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Effect of peanut EPIT on basophil activation (percentage of CD63+ basophils) over time by treatment group. Top row, Placebo group; middle row, VP100 group; bottom row, VP250 group. Cells were stimulated with 0.001 μg/mL peanut extract (column 1), 0.01 μg/mL peanut extract (column 2), 0.1 μg/mL peanut extract (column 3), or 1 μg/mL peanut extract (column 4). Significant differences over time were observed only at a stimulation dose of 0.01 μg of peanut extract (P < .0001) when evaluating for a global treatment effect. Diamonds represent mean values. Journal of Allergy and Clinical Immunology 2017 139, 1242-1252.e9DOI: (10.1016/j.jaci.2016.08.017) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions