Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study)

Stephanie Korn; Katrin Milger; Dirk Skowasch; Christian Schulz; Cordula Mohrlang; Martin Wernitz; Thomas Paulsson; Michael Hennig; Roland Buhl

doi:10.2147/JAA.S403286

Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study)

J Asthma Allergy. 2023 May 11:16:541-552. doi: 10.2147/JAA.S403286. eCollection 2023.

Authors

Stephanie Korn¹, Katrin Milger², Dirk Skowasch³, Christian Schulz⁴, Cordula Mohrlang⁵, Martin Wernitz⁵, Thomas Paulsson⁶, Michael Hennig⁵, Roland Buhl⁷

Affiliations

¹ IKF Pneumologie Mainz, Mainz and Thoraxklinik Heidelberg, Heidelberg, Germany.
² Department of Medicine V, University Hospital, LMU Munich, Munich and Comprehensive Pneumology Center Munich (CPC-M), Member of the German Center for Lung Research (DZL), Munich, Germany.
³ University Hospital Bonn, Pneumology, Bonn, Germany.
⁴ University Hospital Regensburg, Internal Medicine II, Pneumology, Regensburg, Germany.
⁵ GlaxoSmithKline GmbH & Co. KG, Munich, Germany.
⁶ GlaxoSmithKline Plc, Brentford, UK.
⁷ Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany.

Abstract

Purpose: The German Asthma Net (GAN) operates a Severe Asthma Registry that provides an overview of the clinical presentation and management of patients with severe asthma. Based upon data from the GAN registry, the MepoGAN study aimed to describe clinical profiles and treatment outcomes of patients who were treated with the anti-IL-5 monoclonal antibody mepolizumab (Nucala^TM) in routine practice in Germany.

Patients and methods: The MepoGAN study is a descriptive retrospective non-interventional cohort study. Mepolizumab patients enrolled in the GAN registry were evaluated with results being described in two different data sets: Cohort 1 (n=131) started on mepolizumab when the patients entered the registry. Results were reported after 4 months of therapy. Patients in Cohort 2 (n=220) were on treatment with mepolizumab at the time of enrollment and follow-up data were collected after a further year of treatment. Outcome measures included asthma control, lung function, disease symptoms, OCS use, and exacerbations.

Results: Patients enrolled in the registry who started on mepolizumab in Cohort 1 had a mean age of 55 years, were former smokers in 51% of the cases, had a mean blood eosinophil count of 500 cells/μL, and frequently had maintenance OCS use (55%). In this real-world setting, mepolizumab therapy was associated with a clinically relevant reduction in blood eosinophils (-445.7 cells/μL), OCS use (-30%), and improvement in asthma control. Fifty-five percent (vs 10% at baseline) of the patients reported controlled or partially controlled asthma 4 months after starting therapy. In patients who were already treated with mepolizumab at registry enrollment (Cohort 2), asthma control and lung function remained stable after a further year of observation.

Conclusion: The GAN registry data confirm the effectiveness of mepolizumab in a real-world setting. Treatment benefits are maintained over time. While the asthma of patients treated in routine practice was more severe, the results observed with mepolizumab are broadly consistent with RCTs.

Keywords: asthma control; mepolizumab; patient profile; real-world; registry; severe asthma.

Grants and funding

This study was funded by GSK (GSK ID: 213579). Editorial support for the manuscript (in the form of writing assistance under the direction and guidance of the authors) was provided by Dr. Anja Luetke (medinform, Ratekau, Germany), and was funded by GlaxoSmithKline GmbH & Co. KG, Munich, Germany. Statistical support was provided by Annette Holtdirk (Kottmann GmbH & Co KG, Hamm, Germany), and was funded by GlaxoSmithKline GmbH & Co. KG, Munich, Germany.