TY - JOUR
T1 - Aeroallergen Sensitization, Serum IgE, and Eosinophilia as Predictors of Response to Omalizumab Therapy During the Fall Season Among Children with Persistent Asthma
AU - NIAID-sponsored Inner-City Asthma Consortium
AU - Sheehan, William J.
AU - Krouse, Rebecca Z.
AU - Calatroni, Agustin
AU - Gergen, Peter J.
AU - Gern, James E.
AU - Gill, Michelle A.
AU - Gruchalla, Rebecca S.
AU - Khurana Hershey, Gurjit K.
AU - Kattan, Meyer
AU - Kercsmar, Carolyn M.
AU - Lamm, Carin I.
AU - Little, Frederic F.
AU - Makhija, Melanie M.
AU - Searing, Daniel A.
AU - Zoratti, Edward
AU - Busse, William W.
AU - Teach, Stephen J.
N1 - Funding Information:
This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract numbers HHSN272200900052C and HHSN272201000052I. Additional support was provided by the National Center for Research Resources and National Center for Advancing Translational Sciences, National Institutes of Health, under grants NCATS/NIH UL1TR000154, NCATS/NIH UL1TR000040, NCATS/NIH UL1TR000150, NCRR/NIH UL1TR000451, NCRR/NIH UL1TR001105, NIH NIAID 5R01AI098077, NCRR/NIH 1UL1RR025780, NCATS/NIH UL1TR001082, N01-AI-90052, NCATS/NIH UL1TR000075, NCRR/NCAT/NIH UL1TR000077-04, and K23-AI-104780. This project was also supported by TrialShare under the grant number UM1AI109565. The following were donated: omalizumab and a matching placebo by Novartis Pharmaceuticals; fluticasone and a matching placebo by GlaxoSmithKline under a clinical trial agreement with the University of Wisconsin-Madison; EpiPens by Mylan Inc.; and Ayr nasal rinse by BF Ascher & Co Inc. None of these companies had a role in the development or approval of the protocol, conduct of the trial, data analysis, manuscript preparation, or the decision to submit for publication.
Funding Information:
This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases , National Institutes of Health , Department of Health and Human Services , under contract numbers HHSN272200900052C and HHSN272201000052I . Additional support was provided by the National Center for Research Resources and National Center for Advancing Translational Sciences , National Institutes of Health, under grants NCATS/NIH UL1TR000154 , NCATS/NIH UL1TR000040 , NCATS/NIH UL1TR000150 , NCRR/NIH UL1TR000451 , NCRR/NIH UL1TR001105 , NIH NIAID 5R01AI098077 , NCRR/NIH 1UL1RR025780 , NCATS/NIH UL1TR001082 , N01-AI-90052 , NCATS/NIH UL1TR000075 , NCRR/NCAT/NIH UL1TR000077-04 , and K23-AI-104780 . This project was also supported by TrialShare under the grant number UM1AI109565 . The following were donated: omalizumab and a matching placebo by Novartis Pharmaceuticals; fluticasone and a matching placebo by GlaxoSmithKline under a clinical trial agreement with the University of Wisconsin-Madison; EpiPens by Mylan Inc.; and Ayr nasal rinse by BF Ascher & Co Inc. None of these companies had a role in the development or approval of the protocol, conduct of the trial, data analysis, manuscript preparation, or the decision to submit for publication.
Publisher Copyright:
© 2020 American Academy of Allergy, Asthma & Immunology
PY - 2020/10
Y1 - 2020/10
N2 - Background: Perennial aeroallergen sensitization is associated with greater asthma morbidity and is required for treatment with omalizumab. Objective: To investigate the predictive relationship between the number of aeroallergen sensitizations, total serum IgE, and serum eosinophil count, and response to omalizumab in children and adolescents with asthma treated during the fall season. Methods: This analysis includes inner-city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the placebo- and omalizumab-treated groups in 2 completed randomized clinical trials, the Inner-City Anti-IgE Therapy for Asthma study and the Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations study. Logistic regression modeled the relationship between greater degrees of markers of allergic inflammation and the primary outcome of fall season asthma exacerbations. Results: The analysis included 761 participants who were 62% male and 59% African American with a median age of 10 years. Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.11-1.60; P <.01), but not in the omalizumab-treated children (OR, 1.08; 95% CI, 0.91-1.28; P =.37), indicating a significant differential effect (P <.01). Likewise, there was a differential effect of omalizumab treatment in children with greater baseline total serum IgE levels (P <.01) or greater baseline serum eosinophil counts (P <.01). Multiple aeroallergen sensitization was the best predictor of response to omalizumab; treated participants sensitized to ≥4 different groups of aeroallergens had a 51% reduction in the odds of a fall exacerbation (OR, 0.49; 95% CI, 0.30-0.81; P <.01). Conclusions: In preventing fall season asthma exacerbations, treatment with omalizumab was most beneficial in children with a greater degree of allergic inflammation.
AB - Background: Perennial aeroallergen sensitization is associated with greater asthma morbidity and is required for treatment with omalizumab. Objective: To investigate the predictive relationship between the number of aeroallergen sensitizations, total serum IgE, and serum eosinophil count, and response to omalizumab in children and adolescents with asthma treated during the fall season. Methods: This analysis includes inner-city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the placebo- and omalizumab-treated groups in 2 completed randomized clinical trials, the Inner-City Anti-IgE Therapy for Asthma study and the Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations study. Logistic regression modeled the relationship between greater degrees of markers of allergic inflammation and the primary outcome of fall season asthma exacerbations. Results: The analysis included 761 participants who were 62% male and 59% African American with a median age of 10 years. Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.11-1.60; P <.01), but not in the omalizumab-treated children (OR, 1.08; 95% CI, 0.91-1.28; P =.37), indicating a significant differential effect (P <.01). Likewise, there was a differential effect of omalizumab treatment in children with greater baseline total serum IgE levels (P <.01) or greater baseline serum eosinophil counts (P <.01). Multiple aeroallergen sensitization was the best predictor of response to omalizumab; treated participants sensitized to ≥4 different groups of aeroallergens had a 51% reduction in the odds of a fall exacerbation (OR, 0.49; 95% CI, 0.30-0.81; P <.01). Conclusions: In preventing fall season asthma exacerbations, treatment with omalizumab was most beneficial in children with a greater degree of allergic inflammation.
KW - Aeroallergen sensitization
KW - Allergic inflammation
KW - Asthma
KW - IgE
KW - Omalizumab
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U2 - 10.1016/j.jaip.2020.03.051
DO - 10.1016/j.jaip.2020.03.051
M3 - Article
C2 - 32376491
AN - SCOPUS:85087395966
SN - 2213-2198
VL - 8
SP - 3021-3028.e2
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 9
ER -