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Denosumab and risk of community-acquired pneumonia: A population-based cohort study.

CONTEXT
Recent meta-analyses of randomized controlled trials raised concerns that denosumab might increase the risk of infection. However, data of denosumab on the risk of community-acquired pneumonia is sparse.


OBJECTIVE
To examine the risk of community-acquired pneumonia in subjects receiving denosumab compared to those receiving alendronate.


DESIGN
We conducted a propensity score-matched cohort study with a UK primary care database (IQVIA Medical Research Database). We examined the relation of denosumab to community-acquired pneumonia using a Cox proportional hazard model.


PARTICIPANTS
The study subjects were osteoporotic patients >45 years who were initiators of denosumab or alendronate from August 1, 2010, to September 17, 2020.


OUTCOME MEASURES
Community-acquired pneumonia.


RESULTS
Patients treated with denosumab (n=933) were compared with those treated with alendronate (n=4,652). In the matched population, the mean (SD) age was 77 (11) years, 89% were women, and about half of the study population had a history of major osteoporotic fracture. Over five years of follow-up, the incidence of community-acquired pneumonia per 1000 person-years was 72.0 (95% confidence interval [CI] 60.1, 85.7) in the denosumab group and 75.1 (95%CI 69.4, 81.2) in the alendronate group. The hazard of community-acquired pneumonia was similar between denosumab and alendronate users (hazard ratio [HR] 0.96; 95% 0.79, 1.16). The results remain consistent in a series of sensitivity analyses, with HR ranging from 0.82 (95% CI 0.65, 1.04) to 0.99 (95% CI 0.81, 1.21).


CONCLUSION
Denosumab does not significantly increase the susceptibility of community-acquired pneumonia and could possibly be safely used for the management of osteoporosis.