TY - JOUR
T1 - Response to Omalizumab in Black and White Patients with Allergic Asthma
AU - Szefler, Stanley J.
AU - Jerschow, Elina
AU - Yoo, Bongin
AU - Janampally, Pranathi
AU - Pazwash, Hooman
AU - Holweg, Cecile T.J.
AU - Hudes, Golda
N1 - Funding Information:
Conflicts of interest: S.J. Szefler is an advisory panel member for AstraZeneca, Boehringer Ingelheim, Genentech, Inc., GlaxoSmithKline, Moderna, Novartis, Propeller Health, Regeneron, and Sanofi, and has received a research grant from Propeller Health. E. Jerschow has received a research grant from AstraZeneca and Cumberland Pharmaceuticals; is an advisory panel member for Genentech, Inc., GlaxoSmithKline, Novartis, Regeneron, and Sanofi; is a consultant for GlaxoSmithKline; and is a US Medical Licensing Examination committee member for the National Board of Medical Examiners. B. Yoo, P. Janampally, H. Pazwash, and C.T.J. Holweg are employees of Genentech, Inc., and stockholders in Roche. G. Hudes has received research grant support from AstraZeneca , Genentech , Inc., and Merck , and is an advisory board member for AstraZeneca and GlaxoSmithKline.
Funding Information:
This study was funded by Genentech , Inc., a member of the Roche Group, and Novartis Pharma AG. Third-party writing assistance was provided by Trishan Gajanand, PhD, Nicole Tom, PhD, and Jack Pike, PhD, of Envision Pharma Inc., and funded by Genentech , Inc., a member of the Roche Group, and Novartis Pharmaceuticals Corporation .
Publisher Copyright:
© 2021 The Authors
PY - 2021/11
Y1 - 2021/11
N2 - Background: Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed. Objective: To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma. Methods: Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV1 and Asthma Quality of Life Questionnaire (AQLQ) by racial group. Results: This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [−18.0% to 48.4%]) and FEV1 improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV1 improvement was observed in White versus Black patients throughout the study. Conclusions: This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV1, and AQLQ with omalizumab.
AB - Background: Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed. Objective: To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma. Methods: Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV1 and Asthma Quality of Life Questionnaire (AQLQ) by racial group. Results: This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [−18.0% to 48.4%]) and FEV1 improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV1 improvement was observed in White versus Black patients throughout the study. Conclusions: This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV1, and AQLQ with omalizumab.
KW - Asthma
KW - Omalizumab
KW - Race
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U2 - 10.1016/j.jaip.2021.07.013
DO - 10.1016/j.jaip.2021.07.013
M3 - Article
C2 - 34303017
AN - SCOPUS:85112603769
SN - 2213-2198
VL - 9
SP - 4021
EP - 4028
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 11
ER -