Possible Protective Effect of Omalizumab on Lung Function Decline in Patients Experiencing Asthma Exacerbations.

Background: Frequent exacerbations are associated with greater FEV ₁ decline in patients with asthma. The effect of omalizumab versus placebo on lung function in patients experiencing asthma exacerbations has not been previously examined.
Objective: To evaluate the relationship between postbaseline (treatment phase) exacerbation status and lung function decline in children, adolescents, and adults treated with omalizumab versus placebo using data from 3 pediatric and adolescent/adult studies.
Methods: Changes in percent predicted FEV ₁ (ppFEV ₁ ) and FEV ₁ by treatment (omalizumab/placebo) and postbaseline exacerbation status (exacerbators/nonexacerbators) were assessed in patients aged 6 to 11 years (IA05, n = 576) and 12 to 75 years (EXTRA/INNOVATE pooled, n = 1202). Pediatric patients were examined at treatment weeks 12, 24, 28, 40, and 52, and adolescent/adult data at weeks 4, 12, 20, and 28.
Results: Omalizumab-treated patients experienced larger increases in ppFEV ₁ and FEV ₁ compared with placebo-treated patients in the pediatric and pooled adolescent/adult populations. The response was observed in pediatric exacerbators, with significantly larger increases in ppFEV ₁ and FEV ₁ at week 12 (mean difference [95% CI], 4.11% [0.93%-7.30%], P = .011 for ppFEV ₁ ; 80 [10-140] mL, P = .017 for FEV ₁ ) and week 28 (mean difference [95% CI], 3.65% [0.11%-7.19%], P = .043 for ppFEV ₁ ; 100 [30-170] mL, P = .007 for FEV ₁ ). In the adolescent/adult population, both exacerbators and nonexacerbators derived similar benefit with omalizumab compared with placebo.
Conclusions: Findings from this post hoc analysis suggest that omalizumab may confer some protection against lung function decline among patients who experienced exacerbations during treatment.
(Copyright © 2020. Published by Elsevier Inc.)