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

Abstract

Frequent exacerbations are associated with greater FEV₁ decline in patients with asthma. The effect of omalizumab versus placebo on lung function in patients experiencing asthma exacerbations has not been previously examined. 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. Changes in percent predicted FEV₁ (ppFEV₁) and FEV₁ 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. Omalizumab-treated patients experienced larger increases in ppFEV₁ and FEV₁ 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 ppFEV₁ and FEV₁ at week 12 (mean difference [95% CI], 4.11% [0.93%-7.30%], P = .011 for ppFEV₁; 80 [10-140] mL, P = .017 for FEV₁) and week 28 (mean difference [95% CI], 3.65% [0.11%-7.19%], P = .043 for ppFEV₁; 100 [30-170] mL, P = .007 for FEV₁). In the adolescent/adult population, both exacerbators and nonexacerbators derived similar benefit with omalizumab compared with placebo. Findings from this post hoc analysis suggest that omalizumab may confer some protection against lung function decline among patients who experienced exacerbations during treatment.