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

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:

• severe asthma
• registry
• real-world
• mepolizumab
• patient profile
• asthma control

Acknowledgment

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

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

Stephanie Korn received consulting fees from Astra Zeneca, Boehringer Ingelheim, GSK, Novartis, Sanofi and Teva.

Kathrin Milger received consulting fees from AstraZeneca, GSK, Novartis and Sanofi, honoraria for lectures from AstraZeneca, GSK, Novartis and Sanofi and travelling grants from AstraZeneca.

Dirk Skowasch reports personal fees and/or grants from AstraZeneca, Bayer, Boehringer-Ingelheim, Chiesi, GSK, Janssen-Cilag, Sanofi, Novartis and Pfizer; grants from DFG and BMBF, outside the submitted work.

Roland Buhl received grants to Mainz University from Boehringer Ingelheim, GSK, Novartis and Roche, honoraria for lectures from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, Cipla, GSK, Novartis, Roche, Sanofi and Teva and consulting fees for advisory boards from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, GSK, Novartis, Roche and Sanofi. He is a member of the GINA science committee, and co-author of the German asthma guidelines.

Christian Schulz reports personal fees from AstraZeneca, personal fees from Novartis, personal fees from Boehringer Ingelheim, outside the submitted work.

Cordula Mohrlang, Michael Hennig and Thomas Paulsson are employees and shareholders of GSK.

Martin Wernitz received consulting fees from GSK for designing, writing and managing the study. Martin Wernitz is an independent consultant for GlaxoSmithKline GmbH & Co. KG, Munich, Germany. The authors report no other conflicts of interest in this work.

Additional information

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.