| アブストラクト | 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. |
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| ジャーナル名 | The Journal of asthma : official journal of the Association for the Care of Asthma |
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| Pubmed追加日 | 2024/1/31 |
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| 投稿者 | Matera, Maria Gabriella; Ora, Josuel; Calzetta, Luigino; Rogliani, Paola; Cazzola, Mario |
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| 組織名 | Unit of Pharmacology, Department of Experimental Medicine, University of Campania;"Luigi Vanvitelli", Naples, Italy.;Division of Respiratory Medicine, University Hospital "Fondazione Policlinico Tor;Vergata", Rome, Italy.;Respiratory Disease and Lung Function Unit, Department of Medicine and Surgery,;University of Parma, Parma, Italy.;Unit of Respiratory Medicine, Department of Experimental Medicine, University of;Rome "Tor Vergata", Rome, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38294705/ |
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