In Germany, up to 15% of patients treated according to Nationale VersorgungsLeitlinien/Global Initiative for Asthma level 4 or 5 guidelines (NLV/GINA 4/5) have poor asthma control, and only a small portion of these patients use biologics, according to study findings published in Journal of Asthma and Allergy.
Patients with severe or difficult-to-treat asthma are categorized as having GINA 4/5 asthma. Suspecting that such patients in Germany did not make optimal use of existing therapies for severe disease — especially novel biologic therapies — researchers sought to characterize and estimate the number of patients in Germany with NVL/GINA 4/5 asthma, both controlled and uncontrolled.
The researchers conducted a retrospective analysis of data collected from January to December 2019 (prior to the COVID-19 pandemic) that included anonymized longitudinal data covering about 80% of all statutory health insurance prescriptions in Germany. This dataset included information on prescriptions, basic patient demographics, and the prescriber’s location.
Researchers determined that 625,301 patients with GINA 4/5 asthma (both controlled and uncontrolled) were included in the dataset. Within this GINA 4/5 asthma cohort, researchers defined patients with severe, uncontrolled asthma as those whose prescriptions indicated evidence of frequent/excessive use of short-acting β2-agonists (SABA) or frequent/excessive use of oral corticosteroids [OCS]. Frequent/excessive SABA use was defined as the use of at least 3 prescriptions on days in which a patient had no prescription for inhaled corticosteroids (ICS); frequent/excessive OCS use was determined by an elaborate scoring system created by researchers that took into account both number of prescriptions and whether the prescription was given by a specialist or primary care doctor.
Further data analysis showed that 54,026 patients had uncontrolled GINA 4/5 asthma, and that the percentage of patients in this category varied widely by region (from 7% to 15%). Notably, the GINA 4/5 cohort with uncontrolled asthma included just 2000 patients receiving treatment with biologic therapy; another 10,000 patients with GINA 4/5 asthma who used biologic therapy were deemed to have controlled asthma.
With respect to the characteristics of patients on asthma maintenance therapy, researchers found that patients were 50.7% female, with a mean age of 50.0 years and a median age of 52.0 years; 34.5% male, with a mean age of 42.3 years and a median age of 45.0 years; and 14.8% unknown, with mean age of 41.2 years and a median age of 45.0 years. Asthma medications used included ICS, long-acting β2-agonists (LABA), long-acting muscarinic antagonists (LAMA), ICS/LABA combinations, theophylline, montelukast, or biologic agents.
A major limitation of this study was the lack of diagnoses in the database analyzed, which meant that diagnoses were inferred based on medications prescribed. Researchers were also unable to determine the actual dose of OCS administered in the patients studied.
In light of the study’s finding that biologic therapy was used by only 12,000 patients overall, and by only 2000 of the more than 54,000 patients with GINA 4/5 uncontrolled asthma, researchers concluded that their analysis might indicate the existence of a possible “treatment gap.” They added that the significant number of German patients with uncontrolled GINA 4/5 asthma who are not currently using biologics might benefit from such therapy, and that this treatment gap warrants additional exploration.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Bergmann KC, Skowasch D, Timmermann H, et al. Prevalence of patients with uncontrolled asthma despite NVL/GINA step 4/5 treatment in Germany. J Asthma Allergy. Published online July 4, 2022. doi:10.2147/JAA.S365967