Allergen specificity of early peanut consumption and effect on development of allergic disease in the Learning Early About Peanut Allergy study cohort

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Allergen specificity of early peanut consumption and effect on development of allergic disease in the Learning Early About Peanut Allergy study cohort George du Toit, MB, BCh, FRCPCH, Peter H. Sayre, MD, PhD, Graham Roberts, FRCPCH, DM, Kaitie Lawson, MS, Michelle L. Sever, MSPH, PhD, Henry T. Bahnson, MPH, Helen R. Fisher, MSc, PhD, Mary Feeney, MSc, RD, Suzana Radulovic, MD, Monica Basting, MA, Marshall Plaut, MD, Gideon Lack, MB, BCh, FRCPCH Susan Chan, Adam Fox, Mable Abraham, Muhsinah Adam, Louise Coverdale, Claire Duncan, Amy Nixon, Una O’Dwyer-Leeson, Victoria Offord, Aine Sheridan, Fiona Watson, Natalie Witham, Kathryn Cockerell, Gail Harland, Tiffany Miller, Charlotte Stedman, Catherine Clarke, Richard Cleaver, Gemma Deutsch, Alicia Parr, Natalia Becares, Matthew Crossley, Natalia do Couto Francisco, Kerry Richards, Ewa Pietraszewicz, Alick Stephens, Asha Sudra, Rianne Wester, Alastair Wilson, Celine Wu, Jenna Heath, Kathryn Hersee, Devi Patkunam, Adam Asare, Eduard Chani, Judith Evind, Noha Lim, Audrey Plough, Judith Evind, Margarita Gomez Lorenzo, Joy Laurienzo Panza, Jackie Johnson, Jack Hu, Travis Mason George du Toit, MB, BCh, FRCPCH, Peter H. Sayre, MD, PhD, Graham Roberts, FRCPCH, DM, Kaitie Lawson, MS, Michelle L. Sever, MSPH, PhD, Henry T. Bahnson, MPH, Helen R. Fisher, MSc, PhD, Mary Feeney, MSc, RD, Suzana Radulovic, MD, Monica Basting, MA, Marshall Plaut, MD, Gideon Lack, MB, BCh, FRCPCH Susan Chan, Adam Fox, Mable Abraham, Muhsinah Adam, Louise Coverdale, Claire Duncan, Amy Nixon, Una O’Dwyer-Leeson, Victoria Offord, Aine Sheridan, Fiona Watson, Natalie Witham, Kathryn Cockerell, Gail Harland, Tiffany Miller, Charlotte Stedman, Catherine Clarke, Richard Cleaver, Gemma Deutsch, Alicia Parr, Natalia Becares, Matthew Crossley, Natalia do Couto Francisco, Kerry Richards, Ewa Pietraszewicz, Alick Stephens, Asha Sudra, Rianne Wester, Alastair Wilson, Celine Wu, Jenna Heath, Kathryn Hersee, Devi Patkunam, Adam Asare, Eduard Chani, Judith Evind, Noha Lim, Audrey Plough, Judith Evind, Margarita Gomez Lorenzo, Joy Laurienzo Panza, Jackie Johnson, Jack Hu, Travis Mason Journal of Allergy and Clinical Immunology Volume 141, Issue 4, Pages 1343-1353 (April 2018) DOI: 10.1016/j.jaci.2017.09.034 Copyright © 2017 The Authors Terms and Conditions

Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10 Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 1 Asthma and rhinoconjunctivitis burden over time. Rates of protocol-defined asthma, seasonal rhinoconjunctivitis, and perennial rhinoconjunctivitis in the consumption (green bars) and avoidance (gray bars) groups in the ITT population at 30, 60, and 72 months of age are shown. There are no significant differences between the 2 groups at any time point, as assessed by using χ2 tests. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 2 Eczema severity bands over time (SCORAD). Percentage of subjects with SCORAD assessments for eczema of 0, greater than 0 to 15, 15 or greater to 40, and greater than 40 are shown at baseline and at 12, 30, 60, and 72 months in the avoidance (left bar of each pair) and consumption (right bar of each pair) groups in the ITT population. There are no significant differences between the 2 groups at any time point, as assessed by using χ2 tests. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 3 Peanut SPT responses, peanut-specific IgE levels, and Ara h 2–specific IgE levels. Peanut SPT responses (top panel), peanut-specific IgE levels (middle panel), and Ara h 2 IgE levels (bottom panel) in the consumption and avoidance groups in the ITT (left column) and LEAP PP (right column) populations at 4 to 11, 12, 30, 60, and 72 months are shown. Boxes represent 25th and 75th percentiles, and error bars represent 2.5th and 97.5th percentiles. Lines connect the means over time for each randomized group. Solid gray lines represent the LEAP avoiders. Solid green lines represent LEAP consumers. Gray circles represent LEAP avoiders. Green circles represent LEAP consumers. *P value of .05 or less resulting from a comparison between the LEAP avoidance and LEAP consumption groups by using a 2-sample t test. **P value of .01 or less resulting from a comparison between the LEAP avoidance and LEAP consumption groups by using a 2-sample t test. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 4 Tree nut and sesame SPT responses. Sesame, Brazil nut, walnut, cashew, almond, and hazelnut SPT responses (in millimeters) in the consumption and avoidance groups in the ITT (top row) and LEAP PP (bottom row) populations at 4 to 11, 12, 30, 60, and 72 months of age are shown for sesame and at 60 and 72 months of age for the other tree nut outcomes. Boxes represent 25th and 75th percentiles, and error bars represent 2.5th and 97.5th percentiles. Lines connect the means over time for each randomized group. Solid gray lines represent the LEAP avoiders. Solid green lines represent LEAP consumers. Gray circles represent LEAP avoiders. Green circles represent LEAP consumers. *P value of .05 or less resulting from a comparison between the LEAP avoidance and LEAP consumption groups by using a 2-sample t test. **P value of .01 or less resulting from a comparison between the LEAP avoidance and LEAP consumption groups by using a 2-sample t test. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 5 Tree nut– and sesame-specific IgE levels. Sesame-, Brazil nut–, walnut-, cashew-, almond-, and hazelnut-specific IgE levels (in kilounits per liter) in the consumption and avoidance groups in the ITT (top row) and LEAP PP (bottom row) populations at 4 to 11, 12, 30, 60, and 72 months are shown. Boxes represent 25th and 75th percentiles, and error bars represent 2.5th and 97.5th percentiles. Lines connect the means over time for each randomized group. Solid gray lines represent the LEAP avoiders. Solid green lines represent LEAP consumers. Gray circles represent LEAP avoiders. Green circles represent LEAP consumers. *P value of .05 or less resulting from a comparison between the LEAP avoidance and LEAP consumption groups by using a 2-sample t test. **P value of .01 or less resulting from a comparison between the LEAP avoidance and LEAP consumption groups by using a 2-sample t test. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 6 Aeroallergen sensitization. Prevalence of an IgE level of 0.35 kU/L or greater for several aeroallergens in the consumption (green bars) and avoidance (gray bars) groups at 30, 60, and 72 months of age are shown. There are no significant differences between the 2 groups at any time point, as assessed by using χ2 tests. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 7 Cumulative burden Venn diagram at 60 months of age. Numbers of participants in the ITT population with protocol-defined eczema, rhinoconjunctivitis, asthma, or any likely food allergy are shown for the avoidance group (top left), consumption group (top right), and total study group (bottom). This illustrates the very high rate of single and multiple allergic diseases in the study population. Figures are numbers (percentage) of participants. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions

Fig 8 Peanut and egg allergy associations with development of allergic diseases. Rates of protocol-defined asthma (left), seasonal rhinoconjunctivitis (middle), and perennial rhinoconjunctivitis (right) at 60 (top) and 72 (bottom) months are shown in those with neither egg nor peanut allergy, egg allergy only, peanut allergy only, or both egg and peanut allergy. The number of subjects contributing to each group is presented in the denominator, and the number of subjects with each allergic disease within each group is presented in the numerator of the values annotated within each bar. Presence of egg allergy was defined per inclusion criteria at baseline, whereas peanut allergy was defined at 60 and 72 months. P values resulting from a multivariate logistic regression model (outcome of interest being each allergic disease) adjusted for peanut allergy, baseline egg allergy, and baseline SCORAD score are annotated within each panel. Journal of Allergy and Clinical Immunology 2018 141, 1343-1353DOI: (10.1016/j.jaci.2017.09.034) Copyright © 2017 The Authors Terms and Conditions