Real-World Effectiveness of Mepolizumab in Patients with Allergic and Non-Allergic Asthma

Abstract

Purpose

Real-world data on mepolizumab in patients with severe asthma and allergic and non-allergic phenotypes are limited. This study investigated the effectiveness of mepolizumab treatment in patients with severe asthma with allergic and non-allergic phenotypes.

Patients and Methods

This retrospective cohort study (GSK ID: 214148) used administrative claims data from the Optum Research Database. Eligible patients were ≥6 years of age with asthma and had ≥2 mepolizumab claims post-index. Index date was the first mepolizumab claim/administration (January 2016–December 2018). Patients were divided into two cohorts: allergic and non-allergic asthma, based on diagnosis codes, medication use and lab test results. Outcomes included the rate of asthma-related exacerbations and oral corticosteroid (OCS) use during the 12 months before (baseline period) and 12 months after (follow-up period) mepolizumab initiation. Study ended in December 2019.

Results

Overall, 240 (44.6%) and 298 (55.4%) patients were included in the allergic and non-allergic asthma cohorts, respectively. Mean (standard deviation [SD]) counts of asthma-related exacerbations were significantly reduced from baseline to follow-up in both the allergic and non-allergic asthma cohorts (3.2 [2.5] to 2.1 [2.1], p < 0.001 and 2.5 [2.2] to 1.7 [1.9], p < 0.001, respectively). The mean number of OCS pharmacy claims was significantly decreased by 33.3% and 41.4% from baseline to follow-up in the allergic and non-allergic cohorts, respectively (p < 0.001); mean daily OCS dose significantly decreased by 30.6% and 45.4%, respectively (p < 0.001) as well as the mean number of OCS bursts, which decreased by 44.9% and 41.8%, respectively (p < 0.001). No significant differences were observed between cohorts in reductions in asthma exacerbations, counts of OCS pharmacy claims or OCS bursts (baseline to follow-up).

Conclusion

Mepolizumab significantly reduced asthma exacerbations and OCS use in patients with allergic and non-allergic asthma, suggesting that mepolizumab provides real-world benefit in severe asthma irrespective of whether a patient has an allergic phenotype.

Keywords:

• severe asthma
• phenotype
• exacerbation
• oral corticosteroid

Data Sharing Statement

To access data for GSK sponsored research, please submit an enquiry via www.gsk-studyregister.com/en/. Data used to generate these results cannot be disclosed publicly. Proprietary data obtained from Optum may be accessed only with strictest data security and privacy protocols, and oversight with a restrictive license agreement.

Ethics Approval and Informed Consent

This study complied with all applicable laws regarding subject privacy. There was no direct subject contact or primary collection of individual human subject data. Study results omit subject identification; therefore, informed consent, ethics committee or institutional review board approval was not required.

Consent for Publication

Since informed consent was not required for this study, a consent for publication statement is not applicable.

Acknowledgments

Editorial support (in the form of writing assistance, including preparation of the draft manuscript under the direction and guidance of the authors, collating and incorporating authors’ comments for each draft, assembling tables and figures, grammatical editing and referencing) was provided by Robert Bloxham, PhD, Fishawack Indicia Ltd, UK, part of Avalere Health, and was funded by GSK. Parts of this research were presented at the American College of Allergy, Asthma & Immunology congress, 2022 as a poster presentation. The poster’s abstract was published in “Research Abstracts” in Annals of Allergy Asthma and Immunology: https://doi.org/10.1016/j.anai.2022.08.624.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

JS and AD are employees of GSK and hold GSK stocks/shares. JS also reports editorial support for manuscript preparation from Fishawack Indica Ltd, part of Avalere Health. AS and BC are employees of Optum, which received funding from GSK to conduct this study.

Additional information

Funding

This study was funded by GSK (GSK Study ID: 214148). GSK was involved in the study design, data acquisition, data analysis and interpretation of the data, and manuscript preparation.