Omalizumab Improves Lung Function and Reduces Eosinophils in Adolescents with Allergic Asthma

25 Aug, 20

Introduction

Pulmonary function gains peak in puberty and adolescents demonstrate better improvement in the lung function as compared to adults after asthma treatment. Failure to control asthma in adolescence has negative impact on clinical outcomes and quality of life. Omalizumab, a humanized monoclonal antibody against immunoglobulin E (IgE) improves the lung function, reduces the frequency of exacerbations, and reduces the healthcare utilization. However, the effect off omalizumab on lung function in adolescents in placebo-controlled studies has not been explored.

Aim

This post hoc analysis evaluated the effect of omalizumab therapy in adolescents with uncontrolled moderate-to-severe allergic asthma on lung function and eosinophil counts based on pooled spirometry measurements from 8 clinical trials.

Methods

Study Design

Pooled data analysis from 8 multicenter, randomized, placebo-controlled studies

Treatment Strategy

Cohort included adolescents aged between 12 to 17 years with moderate-to-severe allergic asthma from 8 randomized clinical studies.

Endpoints

Changes from baseline to end of study in
- Forced expiratory volume in 1 second (FEV₁)
- Percent predicted FEV₁ (ppFEV₁)
- Forced vital capacity (FVC)
- Blood eosinophil counts

Results

Out of the 340 adolescents, 59.7% received omalizumab (n = 203) and 40.3% received placebo (n=137)
Baseline demographic and clinical characteristics were similar between omalizumab and placebo treated groups
Omalizumab demonstrated greater improvements in all baseline lung function variables than placebo by end of study
The LSM treatment differences between the groups are shown in table 1.

Table 1. Comparison of clinical outcomes

Outcomes	Omalizumab group	Placebo group	LSM difference	P value
Mean (SD) increase in ppFEV₁	13.1% (14%)	9.2% (12.9%)	3%	0.035
Mean (SD) improvement in absolute FEV₁	215.8 (429.4)	114.8 (385.9)	120.9 ml	0.009
Mean (SD) improvement in FVC	224.7 (439)	133.8 (338.8)	101.5 ml	0.033
Mean (SD) reduction in blood eosinophil counts	-125 (234.2)	-17.2 (228.6)	-85.9 cells/µl	0.001

Conclusion

Omalizumab therapy significantly improved the lung function and decreased the blood eosinophil counts in adolescents with moderate-to-severe uncontrolled asthma.
The results of this post hoc analysis highlight the potential effect of omalizumab therapy in adolescents whose asthma is not controlled with the current therapies and the need to optimize treatment early in the disease course.

Ann Allergy Asthma Immunol.2020 Feb;124(2):190-96.