# Mepolizumab in patients with severe asthma and blood eosinophil counts between 150 and 300 cells per µL: benefits at two years

## TL;DR

Mepolizumab treatment over two years significantly reduced asthma exacerbations and improved lung function in patients with severe asthma and moderate blood eosinophil counts.

## Contribution

This study provides real-world evidence of mepolizumab's sustained benefits in patients with severe asthma and blood eosinophil counts between 150 and 300 cells/µL.

## Key findings

- The proportion of patients with clinically significant exacerbations decreased from 95% to 63% after two years of mepolizumab treatment.
- Maintenance oral corticosteroid use dropped by 85%, with 44% of patients discontinuing completely.
- Asthma control improved, with 82% of patients achieving a clinically meaningful improvement in asthma control scores.

## Abstract

Overview of the study. This study was funded by GSK (204710); please refer to the text for additional disclosures. #: analyses of annual exacerbation rates were performed using a generalised estimating equation model assuming a negative binomial distribution, with the covariate of treatment period pre- and post-exposure; ¶: assessed at Weeks 101–104; +: assessed at Months 21–24. ACQ: Asthma Control Questionnaire; BEC: blood eosinophil count; CSE: clinically significant exacerbation; FEV1: forced expiratory volume in 1 s; mOCS: maintenance oral corticosteroid; SC: subcutaneous.

Overview of the study. This study was funded by GSK (204710); please refer to the text for additional disclosures. #: analyses of annual exacerbation rates were performed using a generalised estimating equation model assuming a negative binomial distribution, with the covariate of treatment period pre- and post-exposure; ¶: assessed at Weeks 101–104; +: assessed at Months 21–24. ACQ: Asthma Control Questionnaire; BEC: blood eosinophil count; CSE: clinically significant exacerbation; FEV1: forced expiratory volume in 1 s; mOCS: maintenance oral corticosteroid; SC: subcutaneous.

Although clinical trial evidence exists, there is limited awareness of the real-world effectiveness of mepolizumab in patients with severe asthma and blood eosinophil counts (BEC) ≥150–<300 cells·μL−1.

REALITI-A, an international, prospective, single-arm, observational cohort study enrolled patients with severe asthma initiating mepolizumab. Outcomes assessed over 2 years pre- versus post-mepolizumab exposure included clinically significant exacerbations (CSEs), maintenance oral corticosteroid (mOCS) use, Asthma Control Questionnaire (ACQ)-5 scores and forced expiratory volume in 1 s (FEV1).

After 2 years of mepolizumab treatment, compared with pre-exposure, the proportion of patients with BEC ≥150–<300 cells·μL−1 (n=84) experiencing CSEs decreased from 95% to 63%, and the proportion experiencing exacerbations requiring hospitalisation or emergency department visits decreased from 43% to 19%. The rate of CSEs reduced from 4.53 to 1.47 per year (rate ratio 0.32, 95% CI 0.25, 0.41). After 2 years of mepolizumab exposure, the mean (95% CI) clinic pre-bronchodilator % predicted FEV1 was 80.1 (69.4, 90.7) compared with 62.6 (54.1, 71.1) at baseline (28% relative increase). The median average daily dose of mOCS decreased from 10.0 to 1.5 mg·day−1 (85% relative reduction from baseline); 44% of patients discontinued completely. The minimum clinically important difference in ACQ-5 (improvement ≥0.5) was achieved by 82% of patients, with a mean (95% CI) reduction of 1.76 (2.34, 1.19).

These real-world findings provide evidence for the 2-year sustained benefit following initiation of mepolizumab in patients with severe asthma who have poor disease control and BEC ≥150–<300 cells·μL−1.

Patients with severe asthma and blood eosinophil counts ≥150–<300 cells·μL−1 showed reduced severe disease exacerbations and maintenance oral corticosteroid use with mepolizumab, whilst improving asthma control and lung function in routine clinical practice
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