Omalizumab Improves Respiratory Symptoms With or Without Aspirin, Study Finds

Omalizumab treatment was able to significantly decrease extra-respiratory symptoms in patients with aspirin-exacerbated respiratory disease (AERD), with or without use of aspirin, a study has found.

Although daily corticosteroid therapy and/or frequent steroid bursts are often required to treat patients with AERD, the adverse effects of these medications push researchers to identify alternative medication suggestions.

“Omalizumab efficacy against extra-respiratory symptoms in AERD patients has not been reported,” wrote the researchers of this study. “We investigated the clinical efficacy of omalizumab against AERD-related extra-respiratory symptoms at baseline (without aspirin exposure; Study 1) and during aspirin challenge (Study 2).”

The results of this retrospective observational study were published in Journal of Allergy and Clinical Immunology.

The researchers evaluated the efficacy of omalizumab against AERD-related symptoms. Forty-three patients were recruited for omalizumab treatment between July 2009 and March 2019. After exclusion, 27 patients with AERD and 21 patients from the researchers' previous study were included in Study 1. Among these patients, 21 (77.8%) received systemic corticosteroid therapy at the time of omalizumab treatment. These patients received a median monthly dose of 300 mg of omalizumab.

Additionally, the researchers obtained background information on a patient’s AERD symptoms, baseline demographics, and clinical data.

In Study 2, the researchers selected 3 AERD symptoms: frequency of chest pain exacerbations, gastrointestinal symptoms (abdominal pain, nausea, and/or diarrhea), and cutaneous symptoms (pruritic, macular eruption, flushing, and/or rash), and observed these symptoms during a 1-year period before and after omalizumab treatment.

Study 1 found associations between omalizumab and decreased frequency of exacerbation of chest pain (22% vs 0%; P < .001), gastrointestinal symptoms (33.3% vs 7.4%; P = .016), and cutaneous symptoms (59.3% vs 7.4%; P < .001). These decreases remained significant even with reduced corticosteroid use.

"Omalizumab also attenuated all the extra-respiratory symptoms during the aspirin challenge in Study 2," the authors wrote.

The researchers acknowledged that this study had some limitations, including its small sample size, patients from a single center, and lack of patient data. However, they believe this study suggests that omalizumab is effective in reducing AERD symptoms in patients with or without the use of corticosteroids.

“Omalizumab treatment demonstrated clinical effectiveness against AERD-related extra-respiratory symptoms at baseline conditions (without aspirin exposure) and during aspirin challenge,” wrote the researchers. “Corticosteroid tapering or stopping is a major clinical benefit of omalizumab treatment. However, this preliminary evidence of omalizumab efficacy in AERD patients with extra-respiratory symptoms requires confirmation in randomized studies.”

Reference

Hayashi H, Fukutomi Y, Mitsui C, et al. Omalizumab ameliorates extra-respiratory symptoms in patients with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. Published online March 24, 2023. doi:10.1016/j.jaci.2023.03.014