Reslizumab in children and adolescents with eosinophilic esophagitis: Results of a double-blind, randomized, placebo-controlled trial Jonathan M. Spergel,

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Presentation transcript:

Reslizumab in children and adolescents with eosinophilic esophagitis: Results of a double-blind, randomized, placebo-controlled trial Jonathan M. Spergel, MD, PhD, Marc E. Rothenberg, MD, PhD, Margaret H. Collins, MD, Glenn T. Furuta, MD, Jonathan E. Markowitz, MD, George Fuchs, MD, Molly A. O’Gorman, MD, Juan Pablo Abonia, MD, James Young, MS, Timothy Henkel, MD, PhD, H. Jeffrey Wilkins, MD, Chris A. Liacouras, MD Journal of Allergy and Clinical Immunology Volume 129, Issue 2, Pages 456-463.e3 (February 2012) DOI: 10.1016/j.jaci.2011.11.044 Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Randomization scheme and disposition of patients. Journal of Allergy and Clinical Immunology 2012 129, 456-463.e3DOI: (10.1016/j.jaci.2011.11.044) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Box-and-whisker plot showing peak esophageal eosinophil counts at baseline and end of therapy (EOT; A) and changes from baseline to end of therapy (B). Means are indicated by solid horizontal lines, medians are indicated by dashed lines, interquartile ranges are indicated by shaded boxes, 5th and 95th percentiles are indicated by bars, and points below or above the 5th and 95th percentiles are shown as outliers. P < .0001 for all comparisons of reslizumab versus placebo by using a ranked ANCOVA (see the Methods section for details). Journal of Allergy and Clinical Immunology 2012 129, 456-463.e3DOI: (10.1016/j.jaci.2011.11.044) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Categorical changes in physician’s eosinophilic esophagitis global assessment scores between baseline and end of therapy. P values from a logistic regression adjusted for the baseline value. Journal of Allergy and Clinical Immunology 2012 129, 456-463.e3DOI: (10.1016/j.jaci.2011.11.044) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Baseline peak esophageal eosinophil counts (in cells per hpf) versus end-of-therapy counts. Axes are on log scales. Graphs are divided by horizontal and vertical dashed lines that indicate various thresholds: 5 (little or no eosinophil infiltration), 15 (consensus recommendation for diagnosis of eosinophilic esophagitis2,3), 24 (entry criterion for this study), 50, 100, and 150 cells/hpf. The intersections of dashed lines indicating thresholds at baseline and end of therapy create boxes that indicate categorical change. Shading indicates categorical worsening (dark shading), no change (medium shading), or categorical improvement (light shading). Journal of Allergy and Clinical Immunology 2012 129, 456-463.e3DOI: (10.1016/j.jaci.2011.11.044) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Frequency of categorical improvement, worsening, or no change in peak esophageal eosinophil counts between baseline and end of therapy, as displayed in Fig E1. P values are from a logistic regression analysis of categorical data adjusted for the baseline value. Journal of Allergy and Clinical Immunology 2012 129, 456-463.e3DOI: (10.1016/j.jaci.2011.11.044) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions