Omalizumab

Current guidelines recommend adding long-acting muscarinic antagonists (LAMAs) in patients with uncontrolled asthma, despite the use of moderate to high doses of inhaled steroid-long-acting beta agonists (ICS/LABA). This study aims to analyze the factors related to the prescription of add-on LAMA in clinical practice for asthma patients, shedding light on physicians' preferences. This study included adult asthma patients on add-on LAMA and ICS/LABA monitored for at least one year in a national registry comprising 2053 asthmatics. Patients' characteristics and disease profiles were analyzed to identify factors associated with the prescription of add-on LAMA across the entire cohort. A comparative analysis was performed among three groups: MART (ICS/formoterol as a maintenance and reliever therapy) plus LAMA, Conventional (ICS/LABA as a maintenance and short-acting beta agonist as reliever) plus LAMA and Triple (ICS/LABA/LAMA single inhaler). LAMAs were added to ICS/LABA in 11.7 % of patients in the national registry. Logistic regression analysis revealed that older age, low FEV1 (%), Asthma Control Test (ACT) scores less than 20, and severe exacerbation were the main factors influencing the initiation of LAMA in our registry. However, demographic characteristics of asthma, control status, pulmonary function test results were similar among the three groups of LAMA users (p > 0.05). Physicians used LAMAs without phenotyping based on allergic status or eosinophil levels (p > 0.05). Mepolizumab was added after LAMA in all patients, while omalizumab was initiated before LAMA in 16.9 % of the patients receiving LAMA along with biologics. Add-on LAMAs were predominantly prescribed for older, uncontrolled, and exacerbated asthma patients with low FEV1.

Temporary eosinophilia is a potential adverse reaction of monoclonal antibody therapies in the treatment of a variety of type 2 inflammatory conditions, including asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). The pathophysiology, epidemiology, and clinical significance of eosinophilia and eosinophilic adverse reactions following the initiation of biologic therapy are unclear.

To describe the postmarketing, eosinophilic adverse reactions with clinical significance in patients treated with the 3 biologic therapies approved by the U.S. Food and Drug Administration (FDA) for CRSwNP: dupilumab, omalizumab, and mepolizumab.

The FDA Adverse Event Reporting System (FAERS) Public Dashboard was searched for eosinophilic adverse reactions related to dupilumab, omalizumab, and mepolizumab treatments from November 2004 to December 2022. Data regarding each of the eosinophilic adverse reactions were extracted and analyzed.

A total of 218, 270, and 134 reports of eosinophilic adverse reactions were reported among patients who were treated with dupilumab, omalizumab, and mepolizumab, respectively. The most common eosinophilic adverse reaction was eosinophilic granulomatosis with polyangiitis (338 patients), followed by eosinophilic respiratory tract reactions (158 patients). The most common indication for biological treatment among the reaction groups was asthma.

Eosinophilic adverse reactions are rare but consequential complications of biological treatment. They are more common among patients treated for asthma and chronic rhinosinusitis with nasal polyposis. Measuring and monitoring blood eosinophil levels may be appropriate in specific clinical instances when patients are started on different biologic therapies for type 2 inflammatory conditions.