Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis

Abstract

Background

Some patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients’ characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice.

Methods

Data of a cohort of 90 patients with severe asthma who were treated with biologics (omalizumab, benralizumab, and mepolizumab) for at least 12 months and were followed up to March 2022. Data recorded included clinical characteristics and effectiveness of treatment (exacerbation, Asthma Control Test [ACT] score, lung function, use of maintenance oral corticosteroids [mOCS]), FeNO, and blood eosinophils at baseline, at 12 months, and at the end of follow-up. Complete response is considered if, in addition to not presenting exacerbations or the use of mOCS, the ACT score was >20 and, the FEV₁ >80% predicted.

Results

An improvement in all asthma control parameters was observed after 12 months of treatment and a mean follow-up of 55 months. After 12 months of treatment 27.2% of patients met the criteria of complete response and this percentage even increased to 35.3% at the end of follow-up. Long-term complete response was associated to better lung function with mepolizumab and omalizumab treatment and to less previous exacerbations in the benralizumab group. The main cause of not achieving a complete response was the persistence of an airflow obstructive pattern.

Conclusions

This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.

Key Messages

• Treatment with anti-IgE and anti-IL-5 biologics significantly improved clinical outcomes in severe asthma patients.

• The rate of complete responders of 27.2% at 12 months even increased to 35.3% at the end of a mean follow-up of 55 months.

• The persistence of an airflow obstructive pattern was the main cause of the failure to achieve complete response.

Keywords:

• Severe asthma
• biologics
• omalizumab
• benralizumab
• mepolizumab
• retrospective analysis

Acknowledgments

The authors thank Marta Pulido, MD, for editing the manuscript and editorial assistance.

Authors contributions

M.B. and C.M. designed the study, reviewed the literature, analyzed the results and drafted the manuscript. I.G.-O., M. M.-C., J.N., C.P., L.P., P.C., G.C.P., L.C., A.R., J.A. and A.R. participated in data collection. All authors reviewed and approved the final draft. The authors decline the use of artificial intelligence, language models, machine learning or similar technologies to create content or assist with writing or editing the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Study data are available from the authors (M.B. and C.M.) upon request.

Additional information

Funding

This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.