PURPOSE: Omalizumab (Xolair) is a humanized monoclonal antibody used in the treatment of adults and adolescents with difficult to control allergic asthma. There are many adult studies on efficacy of Omalizumab revealing improvement in asthma exacerbations but there are very few pediatric studies. Omalizumab is not commonly used in pediatric asthma. Objective of this review was to review efficacy and safety of Omalizumabin in our pediatric patients.
METHODS: A retrospective chart review of pediatric patients who received Omalizumab in the past 10 years for difficult to control moderate to severe asthma at Nationwide Children's Hospital, Columbus, Ohio.
RESULTS: Total number of patients was 13, M:F 7:6, median age 13 years (range 9-17), median duration of therapy 36 months (range 1 to 59 months), 9 African American and 4 Caucasian, duration of asthma 15 years (8 to 16). Eight are still on therapy. All patients had severe persistent asthma. Twelve patients were receiving combination therapy (ICS and LABA). Only 4 patients claimed compliance with their asthma controller therapy. Five had family history of asthma, 6 had smoking exposure. Median IgE before starting Omalizumab was 249 (range 78 to 2600). Mean BMI was 25.7 and 46% of the patients were above the 100 percentile for BMI. Comparing between one year before and during omalizumab therapy, mean hospital admission/patient/year decreased from 1.7 ± 2.4 to 0.58 ± 1.4 (p<0.05). There was also a trend towards improvement in ED visits from 2.3 ± 3.2 to 1.7 ± 3. Mean FEV1 during one year before omalizumab therapy, at initiation of therapy and during therapy was 91 ±18, 94 ±17, and 93 ±11 and was not statistically different. Two of 13 patients were taken off omalizumab because of serious side effects, one with anaphylaxis and second with dilated cardiomyopathy. Anaphylaxis was noted on first dose and cardiomyopathy was diagnosed in 5th year on therapy.
CONCLUSIONS: Omalizumab is add-on therapy for some patients with allergic asthma. Most of patients on Omalizumab therapy in our cohort were non adherent to their daily controller therapy and 46% of them were obese. Adverse reactions in children are limiting factor.
CLINICAL IMPLICATIONS: Omalizumab can be a add-on therapy for some patients with allergic asthma but such patients should be closely monitored for complications.
DISCLOSURE: The following authors have nothing to disclose: Judy Pitts, Shahid Sheikh, Karen McCoy
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