Individualized therapy for persistent asthma in young children

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Presentation transcript:

Individualized therapy for persistent asthma in young children Anne M. Fitzpatrick, PhD, Daniel J. Jackson, MD, David T. Mauger, PhD, Susan J. Boehmer, MA, Wanda Phipatanakul, MD, MS, William J. Sheehan, MD, James N. Moy, MD, Ian M. Paul, MD, MSc, Leonard B. Bacharier, MD, Michael D. Cabana, MD, Ronina Covar, MD, Fernando Holguin, MD, Robert F. Lemanske, MD, Fernando D. Martinez, MD, Jacqueline A. Pongracic, MD, Avraham Beigelman, MD, Sachin N. Baxi, MD, Mindy Benson, MSN, PNP, Kathryn Blake, PharmD, James F. Chmiel, MD, Cori L. Daines, MD, Michael O. Daines, MD, Jonathan M. Gaffin, MD, Deborah Ann Gentile, MD, W. Adam Gower, MD, Elliot Israel, MD, Harsha Vardhan Kumar, MD, Jason E. Lang, MD, MPH, Stephen C. Lazarus, MD, John J. Lima, PharmD, Ngoc Ly, MD, Jyothi Marbin, MD, Wayne Morgan, MD, Ross E. Myers, MD, J. Tod Olin, MD, Stephen P. Peters, MD, PhD, Hengameh H. Raissy, PharmD, Rachel G. Robison, MD, Kristie Ross, MD, Christine A. Sorkness, PharmD, Shannon M. Thyne, MD, Stanley J. Szefler, MD Journal of Allergy and Clinical Immunology Volume 138, Issue 6, Pages 1608-1618.e12 (December 2016) DOI: 10.1016/j.jaci.2016.09.028 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Journal of Allergy and Clinical Immunology 2016 138, 1608-1618 Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Study diagram and procedures. Blood, Blood collection; Diary, electronic diary distribution and data review; Height, height measurement; Urine, urine collection. +, Procedure was performed. Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Flow chart depicting the number of participants who enrolled in the study, underwent randomization, completed the study, and provided analyzable data for analysis. Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 A, Probability of each asthma treatment being the best of the 3. Gray shading depicts participants who did not have a differential response. B and C, Percentage of ACDs (Fig 2, B) and probability of an exacerbation (Fig 2, C). Box plots represent the median value, 25th to 75th percentiles (shading), and 5th to 95th percentiles (whiskers). Outliers are shown as triangles. Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Probability of best response based on aeroallergen sensitization (A), previous exacerbation (B), sex (C), eosinophil count of 300/μL or greater (D), and combination of sensitization and eosinophil counts (E). P values correspond to the test of interaction between the predictor and treatment and indicate whether the pattern of treatment response differs according to subgroup. Sample sizes correspond to participants with evaluable data (n = 230). Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 5 Cumulative probability of an exacerbation requiring systemic corticosteroids for all participants with evaluable data (n = 230) stratified by aeroallergen sensitization (A), blood eosinophil counts of 300/μL or greater (B), and combinations of aeroallergen sensitization and blood eosinophil counts (C). Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 A, Patterns of treatment differences according to daily ICS versus LTRA or placebo during the run-in period. B, Patterns of treatment differences according to daily ICS versus LTRA or as-needed ICS receipt during the first treatment period. C, Patterns of treatment differences during each of the 3 treatment periods. Models included allergic sensitization, history of exacerbations, and sex as covariates. Best response probabilities and P values for each analysis were obtained from rank-ordered logistic regression with bootstrap CIs. P values correspond to the test of interaction between predictor and treatment in the logistic regression model and indicate whether the pattern of treatment response differs according to subgroup. P values are post hoc and not adjusted for multiple testing. Sample sizes correspond to all participants with evaluable data (n = 230). Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Patterns of treatment differences are shown according to serum ECP concentration (A), sensitization to pet aeroallergens (dog, cat, or both; B), mAPI status (C), serum IgE level (D), and urinary LTE4 concentration (E). Greater superiority of daily ICS was associated with an ECP concentration of 10 μg/L or greater and sensitization to a pet aeroallergen. mAPI status, serum IgE level, and urinary LTE4 concentration were not significant predictors. Probabilities and P values for each analysis were obtained from rank-ordered logistic regression with bootstrap CIs. P values correspond to the test of interaction between predictor and treatment in the logistic regression model and indicate whether the pattern of treatment response differs according to subgroup. Models included allergic sensitization, history of exacerbations, and sex as covariates, with the exception of the pet sensitization model, which was only adjusted for exacerbations and sex. P values for exploratory predictors are post hoc and not adjusted for multiple testing. Sample sizes correspond to all participants with evaluable data (n = 230, except where otherwise noted because of missing samples). Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E3 A and B, Percentage of ACDs during the course of the trial for all participants with evaluable data (n = 230), with nondifferential responders on the far left followed by differential responders on the right stratified by sensitization to at least 1 aeroallergen (A), blood eosinophil counts of 300/mL or greater (B), and combinations of sensitization and eosinophil counts (C). Box plot horizontal lines represent the median value, shaded boxes represent the 25th to 75th percentile, and whiskers represent the 5th to 95th percentile. Outliers are shown as triangles and represent data values from individual participants. Journal of Allergy and Clinical Immunology 2016 138, 1608-1618.e12DOI: (10.1016/j.jaci.2016.09.028) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions