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.

Efficacy and safety of mepolizumab in a Chinese population with severe asthma: a phase III, randomised, double-blind, placebo-controlled trial

“…Although these study requirements were designed to ensure accurate interpretation of the study results, they do not necessarily reflect real-world clinical practice; however, such restrictions on eligibility criteria would be expected in phase III trials of patients with severe asthma. Evidence from global and European observational/registry studies demonstrates that clinical benefit with mepolizumab in patients with severe asthma in real-world settings is consistent with randomised controlled trials [ 31 – 33 ]. In addition, like many clinical trial programmes conducted during the COVID-19 pandemic, this study experienced challenges in recruiting patients and conducting site visits.…”

Efficacy and Safety of Mepolizumab in the Management of Severe Eosinophilic Asthma: A Systematic Review

“…Retrospective analyses also found consistent 50%-90% reductions in exacerbations and OCS requirements in less controlled settings [ 26 , 32 , 39 ]. The benefits have been confirmed across the spectrum of asthma severity and prior medication use [ 21 , 23 , 29 ]. The longer term real-world studies also found no loss of efficacy over one to three years [ 12 , 21 , 41 ].…”

“…The benefits have been confirmed across the spectrum of asthma severity and prior medication use [ 21 , 23 , 29 ]. The longer term real-world studies also found no loss of efficacy over one to three years [ 12 , 21 , 41 ].…”

“…These studies demonstrated strengths in their selection methods, measurement techniques, reporting, and control of confounders. Fifteen studies that were rated as having an overall high risk of bias were those by Korn et al [ 21 ], Ribas et al [ 22 ], Harrison et al [ 23 ], Numata et al [ 24 ], Casale et al [ 25 ], Yılmaz et al [ 26 ], Taillé et al [ 27 ], Crimi et al [ 28 ], Llanos et al [ 29 ], Maglio et al [ 30 ], Atayık et al [ 31 ], Silver et al [ 32 ], Koistinen et al [ 33 ], Farah et al [ 34 ] and González-Pérez et al [ 35 ]. The studies that had a high risk of selection bias, performance bias, and other biases included those by Ribas et al [ 22 ], Maglio et al [ 30 ], and González-Pérez et al [ 35 ].…”

“…This indicates that benefits of mepolizumab persist only with continued usage. Registry studies, such as the one by Korn et al [ 21 ], provide further real-world evidence that mepolizumab maintains stable asthma control and lung function after at least a year of treatment. Similarly, a 37-month study by Loli-Ausejo et al showed ongoing reductions in exacerbations in clinical practice [ 41 ].…”