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Racial/ethnic differences in eligibility for asthma biologics among pediatric populations - 04/11/21

Doi : 10.1016/j.jaci.2021.09.005 
Eric M. Wohlford, MD, PhD a, b, , Peter F. Huang, BA b, , Jennifer R. Elhawary, MS b, , Lauren A. Millette, PhD c, Maria G. Contreras, BS b, Jonathan Witonsky, MD a, b, Cécile T.J. Holweg, PhD c, Sam S. Oh, PhD, MPH b, Christine Lee, PharmD, PhD d, Christine Merenda, MPH, RN d, Ronald L. Rabin, MD e, Richardae Araojo, PharmD, MS d, Angel C.Y. Mak, PhD b, Celeste S. Eng, BS b, Donglei Hu, PhD b, Scott Huntsman, MS b, Michael A. LeNoir, MD f, Jose R. Rodríguez-Santana, MD, FAAP, FCCP g, Luisa N. Borrell, DDS, PhD h, , Esteban G. Burchard, MD, MPH b, i,
a Division of Pediatric Allergy and Immunology, University of California San Francisco, San Francisco, Calif 
b Department of Medicine, University of California San Francisco, San Francisco, Calif 
c Genentech Inc, South San Francisco, Calif 
d Office of Minority Health and Health Equity, US Food and Drug Administration, Silver Spring, Md 
e Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Md 
f Bay Area Pediatrics, Oakland, Calif 
g Centro de Neumologia Pediátrica, Caguas, Puerto Rico 
h Department of Epidemiology & Biostatistics, Graduate School of Public Health & Health Policy, City University of New York, New York, NY 
i Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, Calif 

Corresponding author: Jennifer Elhawary, MS, Rock Hall, 1550 4th St, Rm 582, Box 2911, San Francisco, CA 94158.Rock Hall1550 4th StRm 582Box 2911San FranciscoCA94158

Abstract

Background

Asthma is a heterogeneous disease. Clinical blood parameters differ by race/ethnicity and are used to distinguish asthma subtypes and inform therapies. Differences in subtypes may explain population-specific trends in asthma outcomes. However, these differences in racial/ethnic minority pediatric populations are unclear.

Objective

We investigated the association of blood parameters and asthma subtypes with asthma outcomes and examined population-specific eligibility for biologic therapies in minority pediatric populations.

Methods

Using data from 2 asthma case-control studies of pediatric minority populations, we performed case-control (N = 3738) and case-only (N = 2743) logistic regressions to quantify the association of blood parameters and asthma subtypes with asthma outcomes. Heterogeneity of these associations was tested using an interaction term between race/ethnicity and each exposure. Differences in therapeutic eligibility were investigated using chi-square tests.

Results

Race/ethnicity modified the association between total IgE and asthma exacerbations. Elevated IgE level was associated with worse asthma outcomes in Puerto Ricans. Allergic asthma was associated with worse outcomes in Mexican Americans, whereas eosinophilic asthma was associated with worse outcomes in Puerto Ricans. A lower proportion of Puerto Ricans met dosing criteria for allergic asthma–directed biologic therapy than other groups. A higher proportion of Puerto Ricans qualified for eosinophilic asthma–directed biologic therapy than African Americans.

Conclusions

We found population-specific associations between blood parameters and asthma subtypes with asthma outcomes. Our findings suggest that eligibility for asthma biologic therapies differs across pediatric racial/ethnic populations. These findings call for more studies in diverse populations for equitable treatment of minority patients with asthma.

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Key words : Asthma, pediatric asthma, biomarker-driven asthma therapeutics, asthma subtypes, peripheral blood parameters, white blood cell count, total IgE, minority pediatric populations

Abbreviations used : AEC, GALA II, ICS, OR, SAGE, SES, WBC


Plan


 This work was supported in part by the Sandler Family Foundation, the American Asthma Foundation, the RWJF Amos Medical Faculty Development Program, Harry Wm. and Diana V. Hind Distinguished Professor in Pharmaceutical Sciences II, the National Institute of General Medical Sciences (grant no. T32GM007546), the National Institute of Environmental Health Sciences (grant no. R01ES015794), the National Heart, Lung, and Blood Institute (grant nos. 2R01HL117004-05 and R01HL155024), the National Heart, Lung, and Blood Institute TOPMed grant (grant no. 1X01HL134589), and the Tobacco-Related Disease Research Program (grant no. 27IR-0030). This publication was supported by the Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) as part of a financial assistance award (grant no. U01FD005978) totaling $50,000, with 16% funded by the FDA/HHS, and $245,000 amount, with 80% funded by nongovernment source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by the FDA/HHS, or the US government. These comments do not bind or obligate the FDA. Funding for the work was also provided by Genentech Inc, a member of the Roche Group.
 Disclosure of potential conflict of interest: The authors whose names are listed above certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or nonfinancial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this article.


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