Omalizumab: A Review of Efficacy in a Real-Life Pediatric Asthma Clinic Population

Abstract

RationaleOmalizumab is FDA approved for treatment of moderate to severe persistent allergic asthma in patients ≥12 years of age who are not controlled by inhaled corticosteroids. There is limited data on its use in patients <12 years of age. This is a review of efficacy and safety of omalizumab in a real-life pediatric patient population, including patients <12 years of age.MethodsWe carried out a retrospective chart review of subjects 6-17 years of age who received omalizumab at an academic children’s hospital from January 2008 to June 2014. ACT (Asthma Control Test) scores and number of asthma exacerbations were evaluated at 52 weeks post-initiation of omalizumab.ResultsThe mean age of subjects was 11.3 (± 3.1) years. Sixty-five percent (18/32) of subjects were <12 years old and 50% (16/32) were male subjects. The mean baseline IgE level was 956.5 (± 917, range 26-4320) IU/mL. ACT scores improved by 8 (± 3.9) points at 52 weeks (p<0.0001). All subjects experienced a decrease in emergency room visits by 71%, number of hospitalizations by 76%, and number of oral steroids courses by 58% at week 52 of therapy (p<0.0001). Subjects <12 years of age had a decrease in emergency room visits by 72%, number of hospitalizations by 80% and number of oral steroid courses by 66% (p<0.0001). There was an adverse event rate of 0.68% (3/444) among administered injections.ConclusionsOmalizumab dramatically improved asthma control and is well tolerated in a pediatric patient population where the majority of children were <12 years of age. RationaleOmalizumab is FDA approved for treatment of moderate to severe persistent allergic asthma in patients ≥12 years of age who are not controlled by inhaled corticosteroids. There is limited data on its use in patients <12 years of age. This is a review of efficacy and safety of omalizumab in a real-life pediatric patient population, including patients <12 years of age. Omalizumab is FDA approved for treatment of moderate to severe persistent allergic asthma in patients ≥12 years of age who are not controlled by inhaled corticosteroids. There is limited data on its use in patients <12 years of age. This is a review of efficacy and safety of omalizumab in a real-life pediatric patient population, including patients <12 years of age. MethodsWe carried out a retrospective chart review of subjects 6-17 years of age who received omalizumab at an academic children’s hospital from January 2008 to June 2014. ACT (Asthma Control Test) scores and number of asthma exacerbations were evaluated at 52 weeks post-initiation of omalizumab. We carried out a retrospective chart review of subjects 6-17 years of age who received omalizumab at an academic children’s hospital from January 2008 to June 2014. ACT (Asthma Control Test) scores and number of asthma exacerbations were evaluated at 52 weeks post-initiation of omalizumab. ResultsThe mean age of subjects was 11.3 (± 3.1) years. Sixty-five percent (18/32) of subjects were <12 years old and 50% (16/32) were male subjects. The mean baseline IgE level was 956.5 (± 917, range 26-4320) IU/mL. ACT scores improved by 8 (± 3.9) points at 52 weeks (p<0.0001). All subjects experienced a decrease in emergency room visits by 71%, number of hospitalizations by 76%, and number of oral steroids courses by 58% at week 52 of therapy (p<0.0001). Subjects <12 years of age had a decrease in emergency room visits by 72%, number of hospitalizations by 80% and number of oral steroid courses by 66% (p<0.0001). There was an adverse event rate of 0.68% (3/444) among administered injections. The mean age of subjects was 11.3 (± 3.1) years. Sixty-five percent (18/32) of subjects were <12 years old and 50% (16/32) were male subjects. The mean baseline IgE level was 956.5 (± 917, range 26-4320) IU/mL. ACT scores improved by 8 (± 3.9) points at 52 weeks (p<0.0001). All subjects experienced a decrease in emergency room visits by 71%, number of hospitalizations by 76%, and number of oral steroids courses by 58% at week 52 of therapy (p<0.0001). Subjects <12 years of age had a decrease in emergency room visits by 72%, number of hospitalizations by 80% and number of oral steroid courses by 66% (p<0.0001). There was an adverse event rate of 0.68% (3/444) among administered injections. ConclusionsOmalizumab dramatically improved asthma control and is well tolerated in a pediatric patient population where the majority of children were <12 years of age. Omalizumab dramatically improved asthma control and is well tolerated in a pediatric patient population where the majority of children were <12 years of age.