Infections in de novo kidney transplant recipients treated with the RANKL inhibitor denosumab.
Bonani M, Frey D, et al.Transplantation 2016 [record in progress]
Aims
To conduct a posthoc analysis assessing the impact of denosumab on the incidence and severity of infections in the first year after kidney transplantation.
Interventions
Participants were randomized to receive either subcutaneous injections of 60 mg denosumab at baseline and after 6 months on top of standard treatment (calcium and vitamin D), versus standard treatment alone.
Participants
90 de novo kidney transplant recipients
Outcomes
The primary outcomes measured were the incidence and severity of all infections including urinary tract infections, CMV viremia, flu-like syndromes, polyoma viremia, herpes simplex type 1 and herpes zoster infections and other relevant infections, and adverse events.
Follow-up
1 year
CET Conclusions
This paper reports a post-hoc analysis of infective episodes from a randomised trial of the RANKL inhibitor Denosumab for the prevention of osteoporosis in renal transplant recipients. The analysis demonstrates a significant increase in urinary tract infections with Denosumab, although not in more severe episodes of pyelonephritis. Other infections (CMV, BK, HSV) were unaffected. It is interesting that no increase in infection is seen in post-menopausal women taking the drug, meaning that the observation is limited to the immunosuppressed transplant population. Whilst the infections experienced are of limited clinical severity, clearly caution is required when using the drug in this population.
Data analysis
Strict intention-to-treat analysis
Quality notes
Previously assessed as Bonani M, et al. Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial. Am J Transplant. 2016;16(6):1882-1891.
Trial registration
Clinicaltrials.gov - NCT01377467