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Biologics for asthma and risk of pneumonia
Maria Gabriella Matera1, Josuel Ora2, Luigino Calzetta3
1Unit of Pharmacology, Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
Objective:
Modification of the immune system with biologics raises theoretical concerns about the risk of infections but it is still unclear whether currently routinely used biologics in severe asthma may facilitate the development of pneumonia. Therefore, we aimed to determine whether omalizumab, mepolizumab, benralizumab, and dupilumab are associated with pneumonia in a real-world setting.
Methods:
A retrospective disproportionality analysis was performed using adverse event (AE) reports submitted to FAERS from January 2020 to September 30, 2023. MedDRA was used to identify infections and infestations and then pneumonia cases. ROR and PRR were used to measure disproportionality.
Results:
The percentage of reported cases of pneumonia compared to infections and infestations was highest for mepolizumab (36.8%), followed by omalizumab (32.6%), benralizumab (19.2%) and dupilumab (5.7%). We found a moderate or strong signal for increased risk of pneumonia with mepolizumab (ROR = 3.74, 95%CI 3.50-4.00), omalizumab (ROR = 3.26, 95%CI 3.06-3.49) and benralizumab (ROR = 2.65, 95%CI 2.49-2.83).
Conclusions:
Mepolizumab, omalizumab and benralizumab, but not dupilumab, were associated with high odds of reporting pneumonia. Our results represent only potential associations between these biologics and pneumonia but not causality. The nature of the FAERS database is such that the cause of the reported events is uncertain. Therefore, we can only roughly estimate the incidence of AEs by the signal strength (ROR value). Nevertheless, although causality could not be assessed, the signal from our study is interesting. We believe it deserves to be further substantiated by real-world studies with robust designs.
Insights
Biologics like mepolizumab, omalizumab, and benralizumab may increase pneumonia risk in severe asthma patients. Dupilumab showed no such association. Further real-world studies are needed to confirm these findings.
Area of Science:
- Immunology
- Pulmonology
- Pharmacovigilance
Background:
- Biologic therapies for severe asthma modulate the immune system, raising theoretical infection risks.
- The association between specific biologics and pneumonia development in severe asthma remains unclear.
Purpose of the Study:
- To investigate the real-world association between omalizumab, mepolizumab, benralizumab, and dupilumab and the risk of pneumonia.
Main Methods:
- Retrospective analysis of adverse event reports from FAERS (January 2020-September 2023).
- Used MedDRA to identify pneumonia cases among infections and infestations.
- Calculated Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) to assess disproportionality.
Main Results:
- Mepolizumab (36.8%), omalizumab (32.6%), and benralizumab (19.2%) showed higher percentages of pneumonia cases compared to dupilumab (5.7%).
- A moderate to strong signal for increased pneumonia risk was observed for mepolizumab (ROR=3.74), omalizumab (ROR=3.26), and benralizumab (ROR=2.65).
- Dupilumab was not associated with an increased reporting of pneumonia.
Conclusions:
- Mepolizumab, omalizumab, and benralizumab are associated with a higher reporting of pneumonia, unlike dupilumab.
- These findings suggest potential associations, not causality, requiring further investigation through robust real-world study designs.
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