Omalizumab Improves Outcomes for Patients with Asthma, Comorbid Food Allergy

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Omalizumab (Xolair) treatment will lead to consistent improvements among those with asthma and comorbid food allergy, new findings suggest, though food allergy-specific outcomes are unclear.¹

These findings—drawn from new research by such authors as Alessandro Fiocchi, MD, director of allergy at the Pediatric Hospital Bambino Gesù in Rome—resulted from a post-hoc analysis of placebo-controlled, randomized clinical studies as well as real-world observational research.

Fiocchi et al. noted that prior findings had shown some success with omalizumab, including a small study which suggested that 2 years of omalizumab therapy among children with high total IgE levels, severe asthma, and food allergies led to diminished asthma exacerbations and desensitization to food allergens.² Nevertheless, they noted that such studies had been smaller and relatively sparse.

“The objective of this analysis was two-fold: 1) to assess the effect of comorbid food allergy on the baseline characteristics of patients with asthma, and 2) to assess whether omalizumab could improve healthcare resource use, quality of life, and productivity for patients with food allergy and asthma,” Fiocchi and colleagues wrote.¹

Background and Trial Design

The research team conducted their post hoc analysis on several studies evaluating omalizumab therapy in patients with allergic asthma. They included studies such as the IA05 randomized clinical trial for children (NCT00079937) in the age range of 6 - 11 and the 008/009 trials for patients aged 12 - 76 conducted prior to registration requirements (lacking an NCT number).

Additionally, the team looked at 2 real-world observational trials. Specifically, they highlighted the PROSPERO (NCT01922037) study on those aged 12 and older and the EXCELS (NCT00252135) study on the same age bracket.

The investigators noted that certain pivotal omalizumab studies regarding subjects with allergic asthma were excluded from their analysis given the notably limited number of individuals with comorbid food allergies participating. These had each had fewer than 50, thereby restricting the significance of any data.

In their assessment of each study, the research team placed participants into categories based on the presence or lack of a clinician-reported food allergy, according to baseline characteristics. Food allergy diagnostics, the team noted, were not available in the observational studies or trials. These included such as specific IgE levels, skin prick tests, oral food challenges, or details of specific allergens and history of reactions.

There were a variety of endpoints and timepoints implemented in each study. Wherever feasible, similar endpoints were presented across the included trials. Utilization of healthcare resources was assessed via an evaluation of hospitalizations, emergency room visits, and unscheduled physician visits.

Outcomes of patients’ asthma were identified using clinically significant or protocol-defined exacerbations observed within the clinical data as well as through the Asthma Control Test (ACT) in the observational analyses. The Asthma Quality of Life Questionnaire (AQLQ) was implemented by the investigators to look at life quality, with productivity being evaluated by marking down any missed work or school days and using the Work Productivity and Activity Impairment (WPAI): Asthma measure.

Baseline characteristics also included comorbidities, all of which were noted from the screenings. Food allergy-specific outcomes were not assessed in these data.

Notable Findings

Overall, the investigators reported that among patients known to have comorbid food allergy, evidence for increased atopy at the point of baseline was identified. Specifically, this was numerically higher levels of total IgE as well as atopic comorbidities.

Omalizumab therapy was shown by the research team to have consistently led to general and asthma-specific improvements in patient-centered outcomes. The medication improved use of healthcare resources for those with asthma, as evidenced by 1 study’s conclusion that all-cause emergency room visits at 1 year improved with treatment versus placebo. Specifically, there was a .43 rate of visits for those given omalizumab compared to .53 placebo (P = .179).

Such findings were also seen among individuals both with and without allergies to certain foods. Utilization of asthma-related resources saw comparable improvements in different studies. For example, the overall population at the 1-year mark saw a hospitalization rate of .07 for omalizumab versus .13 for placebo (P = .085), a rate of unscheduled visits to clinicians of .25 for omalizumab versus .29 for placebo (P = .382), and an emergency room visit rate of .11 for omalizumab versus .14 for placebo (P = .665).

Notably, the research team did find that implementation of healthcare resources at the 1-year mark for subjects given a placebo were shown to be numerically greater for those with food allergies compared to those without food allergy. The investigators also highlighted the post-hoc analysis’s overall strengths and weaknesses, highlighting any notable limitations.

“Our study is limited by the post hoc exploratory nature of the analysis,” they noted. “In addition, most outcomes assessed were asthma-specific, which limits extrapolation to all-cause or food allergy-specific outcomes Finally, food allergy in these studies was physician-reported and characteristics such as food allergens, food-specific IgE levels, skin prick test, and food challenge results were unavailable.”

References

1. ^{Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, Mustafa SS, Raut P, Cameron B, Gupta S, Fleischer DM. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma?. J Asthma Allergy. 2024;17:889-900. https://doi.org/10.2147/JAA.S475517.}
2. ^{Dinardo G, Cafarotti A, Galletta F, Fiocchi A, Arasi S. Omalizumab in severe asthma and food allergies with IgE levels >1500 kU/L: two-year evaluation. Pediatr Allergy Immunol. 2023;34(12):e14057. doi:10.1111/pai.14057.}