Denosumab and Risk of Community-acquired Pneumonia: A Population-based Cohort Study.

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

OBJECTIVE

This work aimed to examine the risk of community-acquired pneumonia in individuals receiving denosumab compared to those receiving alendronate.

METHODS

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. The study participants were osteoporotic patients older than 45 years who were initiators of denosumab or alendronate from August 1, 2010, to September 17, 2020. The outcome measure was community-acquired pneumonia.

RESULTS

Patients treated with denosumab (n = 933) were compared with those treated with alendronate (n = 4652). 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 5 years of follow-up, the incidence of community-acquired pneumonia per 1000 person-years was 72.0 (95% 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% CI, 0.79-1.16). The results remained 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.