The role of ACT score in mepolizumab discontinuation

Abstract

Background

Mepolizumab is a therapy for severe asthma. We have little knowledge of the characteristics of people in the US that discontinue mepolizumab in clinical care.

Objective

To investigate the real-world efficacy and time to clinical discontinuation of mepolizumab, we evaluated individuals with asthma started on mepolizumab at the Cleveland Clinic. We hypothesized that individuals that discontinue mepolizumab have more severe and uncontrolled asthma at baseline.

Methods

Between 2016 and 2022, patients who started on mepolizumab consented to be assessed over 18 months. At baseline, a questionnaire including demographic and medical history was collected. Laboratory findings such as ACT score, F_ENO (Fractional Excretion of Nitric Oxide), and spirometry were recorded. At the conclusion of the observation period, the participants were divided into two categories: Group A and Group B.

Results

Group B [N = 28] discontinued mepolizumab (p < 0.05) at an average of 5.8 months (SD 4.2 months). Group A [N = 129] stayed on the therapy for at least 1 year. A participant with an ACT score less than 13 has an odds ratio of 6.64 (95% CI, 2.1 − 26.0) of discontinuing mepolizumab therapy. For a male, the odds of discontinuing mepolizumab therapy is 3.39 (95% CI, 1.1–11.2).

Conclusion

In this real-world study, we find that high eosinophil count may not be adequate in screening which individuals will benefit from mepolizumab. Up to 17% of patients fail therapy within 6 months, with male sex and low ACT score increasing risk of mepolizumab discontinuation at Cleveland Clinic.

Keywords:

• Asthma
• asthma control
• mepolizumab

Author contribution

Dr. Khatri contributed to the article as an employee of the Cleveland Clinic. The views expressed are her own and not necessarily represent the views of the National Institutes of Health or the United States Government.

Disclosure statement

All authors declare that they have received no support from any organization for the submitted work; MA does consultancy for Sanofi, EP did consultancy for AstraZeneca over two years ago; no other relationships or activities that could appear to have influenced the submitted work.

Additional information

Funding

The study was supported by the National Heart, Lung, and Blood Institute (HL103453 and HL081064). NS was supported by the Cleveland Clinic Catalyst Grant.