Improved Clinical Outcomes in Patients With Severe Asthma Treated With Biologic Therapies

Patients with severe asthma treated with either omalizumab, benralizumab, or mepolizumab achieved improved clinical outcomes after 12 months, with the rate of complete responders increasing at the end of long-term follow-up.

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The single-center retrospective cohort study is published in Annals of Medicine.

“These present results show an improvement in all asthma control parameters after 12 months of treatment in the overall study population,” the researchers wrote. “These data are similar to those reported for key clinical parameters in real-world clinical studies and systematic reviews, in which mepolizumab, benralizumab, and omalizumab were effective therapies for asthma.”

The introduction of new biological therapies and advancements in biomarkers have paved the way for more targeted and personalized treatment options for the treatment of severe asthma. Currently, there are 5 biologics that have been approved for severe eosinophilic asthma: benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab.

In this study, the researchers aimed to evaluate the clinical features of complete responders vs noncomplete responders to long-term treatment with omalizumab, benralizumab, and mepolizumab in a real-world setting.

The study included patients from an acute tertiary care hospital in Barcelona, Spain, who started treatment with biologics for at least 6 months and had a follow-up of at least 12 months after initiation. Patients were followed up to March 2022.

Clinical characteristics used to measure the efficacy of treatments included exacerbation (measured using Asthma Control Test [ACT] score), lung function, use of maintenance oral corticosteroids (mOCS), fractional exhaled nitric oxide, and blood eosinophils at baseline, at 12 months, and at the end of follow-up.

Complete response to treatment was defined as no exacerbations or no use of mOCS, an ACT score greater than 20, and forced exhaled volume per 1 second (FEV₁) greater than 80% predicted.

A total of 97 patients met inclusion criteria and were treated with biologics. Of these patients, 7 were excluded. Therefore, the study population included 44 patients who received omalizumab, 24 with benralizumab, and 22 with mepolizumab.

Most patients were women (73%), and the mean (SD) age was 55.3 (15) years. After 12 months of treatment, 27.2% of patients had a complete response, which increased to 35.5% at the end of the mean follow-up of 55 months.

The rates of complete response identified were 30.2% in patients treated with omalizumab, 30.4% in patients with benralizumab, and 52.6% in patients with mepolizumab.

Additionally, long-term complete response was associated with better lung function in patients treated with mepolizumab and omalizumab, whereas long-term complete response was associated with fewer previous exacerbations in patients treated with benralizumab.

Furthermore, airflow obstructive pattern identified in 32.5% of cases at 12 months and 34.5% of cases at the end of follow-up was the main cause of not achieving a complete response to treatment.

However, the researchers acknowledged some limitations to the study, including being retrospective in design, a small sample size, and that pulmonary function improvement and lung remodeling seemed to remain an unmet need to reach clinical remission in patients treated with biologics.

Additionally, the researchers believe further research needs to be done to investigate the clinical benefits of switching biologics or the impact of discontinuation of biologics.

“Although previous studies have not targeted treatment-induced remission, in our opinion long-term clinical remission could be included as a therapeutic goal in studies of asthma treatments,” wrote the researchers. “Information on patients with complete response and its maintenance in the long-term is important to improve personalized care.”

Despite these limitations, the researchers believe the study provides evidence that biologics significantly improved clinical outcomes in patients with severe asthma.

Reference

Basagaña M, Martínez-Rivera C, Padró C, et al. Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis. Ann Med. 2024;56(1):2317356. doi:10.1080/07853890.2024.2317356