Real-World Study Confirms Safety of Biologic Therapies in Asthma, Shows Reduced Pneumonia Risk
Key Insights
A large retrospective study using real-world data found that biologic therapies for asthma were not associated with increased respiratory infection risk over three years.
The analysis revealed that biologic treatment was actually linked to a modest reduction in pneumonia risk compared to non-biologic treatment.
Specific biologics including dupilumab and anti-IL-5 (search) therapies showed protective effects against pneumonia and other lower respiratory infections.
Data presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology has revealed that biologic therapies for asthma do not increase respiratory infection risk and may actually provide protective benefits against pneumonia. The findings from a large real-world study address longstanding safety concerns about these immune-modulating treatments.
Study Design and Population
Researchers led by Taha Al-Shaikhly from Penn State College of Medicine (search) conducted a retrospective population-based study using the TriNetX US Collaborative Network, a comprehensive real-world healthcare database. The study included patients aged 12 years or older with moderate or severe persistent asthma receiving medium-to-high doses of inhaled corticosteroids along with long-acting beta agonists.
Biologic exposure was defined as treatment with dupilumab, omalizumab, anti-IL-5 (search) agents, or tezepelumab within three months of asthma diagnosis, while patients not receiving biologics served as controls. Researchers applied 1:1 propensity score matching to balance the two groups for demographics and comorbidities.
Key Safety Findings
The three-year analysis assessed respiratory infection risk, including upper respiratory tract infections, sinusitis, pneumonia, and other lower respiratory infections. After propensity score matching, biologic therapy use was not associated with an increased risk of respiratory tract infections.
Notably, the analysis showed a modest reduction in pneumonia risk among patients receiving biologic treatment. Overall, biologic therapy was associated with a lower likelihood of pneumonia compared with non-biologic treatment.
Drug-Specific Results
Individual biologic agents demonstrated varying safety profiles. Dupilumab use was linked to a lower probability of pneumonia and was also associated with a reduced risk of other lower respiratory infections. Anti-IL-5 (search) therapies were similarly associated with a decreased risk of pneumonia.
Omalizumab showed no increased risk of respiratory infections, while tezepelumab use was also not associated with a higher infection risk.
Clinical Implications
These findings provide reassuring evidence regarding the safety profile of biologic therapies in asthma management. The researchers concluded that in real-world clinical practice, biologic treatments for asthma do not appear to increase the risk of respiratory infections. Moreover, some biologic agents—particularly dupilumab and anti-IL-5 (search) therapies—may even be associated with a reduced incidence of pneumonia.
Biologic therapies are increasingly used for patients with moderate to severe asthma, especially those with type 2 inflammation who remain symptomatic despite standard treatment. These targeted drugs improve asthma control and reduce exacerbations, but concerns have been raised about possible increased infection risk since they act on immune pathways.
The authors note that these results support the continued use of biologic therapies as an effective and safe option for patients with moderate to severe asthma who require advanced treatment strategies.