Omalizumab improves asthma outcomes among children with high serum IgE
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Children and adolescents with allergic asthma and serum IgE levels that exceed approved dosing ranges still benefitted from omalizumab, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.
These benefits included improved lung function, reduced health care utilization and reduced use of oral corticosteroids (OCS), Claire E. Atkinson, MD, an allergy and immunology fellow in the division of allergy and immunology, department of pediatrics, at the University of North Carolina School of Medicine in Chapel Hill, North Carolina, and colleagues wrote in the study.
Omalizumab (Xolair; Genentech, Novartis) has been approved to treat severe allergic asthma among children aged 6 years and older. According to the researchers, it improves asthma control while reducing asthma exacerbations and health care utilization.
However, it is only approved for children aged 12 years and older with pretreatment IgE serum levels between 30 IU/mL and 700 IU/mL and for children aged 6 to 11 years with IgE serum levels between 30 IU/mL and 1,300 IU/mL.
The retrospective study involved 17 patients (median age, 9 years; interquartile range [IQR], 6) with IgE serum levels above these ranges treated with omalizumab for moderate or severe allergic asthma for at least 6 months at the University of North Carolina between 2011 and 2020.
The researchers found decreases in visits to the ED and urgent care after treatment (median visits per year, 1 vs. 0; effect size [ES], –1 visits per year; 95% CI, –2 to –1) and in OCS use (median courses per year, 2 vs. 1; ES, –2 courses per year; 95% CI, –2 to –1).
However, the researchers did not find any significant change in the median rate of hospitalizations related to asthma, which were zero per year both before (IQR, 2)and after (IQR, 0) treatment (ES, 0 courses per year; 95% CI, –1 to 0).
Treatment appeared to improve lung function measurements, as demonstrated by increases from before vs. after treatment in median percentage of predicted FEV1 (86% vs. 97%; ES, 9 percentage points; 95% CI, –1 to 21), median percentage of predicted FEV1/forced vital capacity (73% vs. 79%; ES, 6 percentage points; 95% CI, 1-11) and median forced expiratory flow at 25% to 75% (54% vs. 78%; ES, 19.5 percentage points; 95% CI, 1-31).
The researchers did not find any significant differences in OCS use, health care visits or spirometry measurements between patients who had lower vs. higher IgE levels before treatment.
Although omalizumab appeared efficacious in children who had highly elevated IgE levels by improving lung function and reducing health care utilization and OCS use, the researchers cautioned that there are difficulties in getting insurance to cover omalizumab treatment.
The researchers also warned that their statistically significant results are exploratory in nature, so confirmatory studies are necessary. Larger studies assessing the efficacy of omalizumab in a substantial number of similar patients, the researchers continued, are needed as well.
Perspective
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These findings are not surprising because there are trials that have shown benefit from anti-IgE therapy among adults with severe asthma and total serum IgE higher than the approved thresholds. It is not surprising that this would be the case in children. It also is significant in that it adds to the available evidence on efficacy and safety among children with asthma.
Most of the data on children with high levels of IgE treated with omalizumab have been in case reports of children with cystic fibrosis and allergic bronchopulmonary aspergillosis who have demonstrated improved pulmonary function and reduced need for corticosteroids. The authors of this paper also cite another retrospective study of 11 children with moderate to severe asthma and above threshold IgE who showed similar benefit (Wang KY and colleagues).
My own experience mirrors the results of this study and the Wang study, but I have not treated many children with above-threshold IgE due to an inability to convince insurers to cover the cost of the therapy.
This study adds to the available evidence for efficacy and safety of omalizumab among children and teens with high levels of IgE (above the FDA authorized limits), which can be used to try to convince insurance companies to cover this therapy for these children. This would enlarge the pool of eligible patients who would benefit from this safe and effective therapy.
As the authors note, the limitations in the studies that are published include their retrospective nature, small number of patients and lack of comparator groups. The Cochrane Library has published at least three reviews on this very issue but has not been able to identify studies that fulfill its criteria, so the conclusions state that there is no evidence for safety or efficacy. This is a big hurdle when dealing with the insurers. We need large, randomized and controlled trials to truly determine if this approach is effective.
Reference:
Wang KY, et al. Allergy Asthma Proc. 2018;doi:10.2500/aap.2018.39.4146.
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