A Randomized Trial of Subcutaneous Allergy Immunotherapy in Inner-city Children With Asthma Less Than 4 Years of Age

Abstract

To evaluate the effect of subcutaneous immunotherapy (SCIT) on asthma in inner-city children <4 years of age.Children between the ages of 18 to 47 months were recruited when seen in the asthma or allergy clinic at Jacobi Medical Center in Bronx, New York, which cares for a mostly low-income, inner-city population. Participants were required to have physician-diagnosed asthma or at least 2 lifetime episodes of wheezing and be at high risk of persistent asthma on the basis of an Asthma Predictive Index. Patients with any other chronic medical condition, history of severe prematurity, or a sustained oxygen requirement at birth were excluded. Although all patients had at least 1 common environmental allergen positive on skin-prick testing, most had multiple and mainly indoor allergen sensitizations. The majority of patients were male and used an asthma controller medication, with an average asthma symptom score indicating mild persistent asthma.Participants were randomly assigned to the SCIT (n = 27) or control group (n = 23). SCIT was administered per published guidelines, with biweekly maintenance injections. Asthma, nasal-ocular, and skin symptom scores and medication use were monitored by a phone call every 2 weeks. In interim power analysis, it was indicated there was an insufficient sample size to reach the planned power of 80%, so the study was terminated early before some participants had completed SCIT for 3 years.On the basis of intention-to-treat analysis, there was no statically significant difference in asthma, nasal-ocular, or skin symptom scores in the SCIT and control groups. Quality of life, as assessed by the parent, showed significant improvement in the SCIT group (β coefficient: 0.32; SE: 0.09; P ≤ .01), particularly related to interference of child’s asthma on family or work plans and nighttime symptoms. Allergen specific serum immunoglobulin G4 levels increased in the SCIT group only (P ≤ .04). New allergen sensitization or loss of sensitization rates at the end of the study were not significantly different between the SCIT and control groups. Systemic reactions occurred in in 22% of children and 1.8% of injections, all of which were mild and resolved with antihistamine administration. Children in the SCIT group missed 28% of injection visits.Apart from improved quality of life, allergen immunotherapy in inner-city children with asthma <4 years of age did not show significant improvement in asthma, allergy, or eczema clinical outcomes.Although perhaps limited by small sample size and a high rate of missed appointments, with the results, the authors support the common practice of waiting until near 5 years of age to start SCIT. Factors unique to an inner-city, younger pediatric population may warrant larger studies to determine the efficacy of early immunotherapy in improving asthma.