BACKGROUND: While early steroid withdrawal (ESW) is hypothesized to lower the risk of infection, previous studies failed to demonstrate this benefit. These were limited by small sample sizes; as such our goal was to compare the risk of infection in kidney transplant (KT) recipients who got ESW versus steroid maintenance (SM) regimens using a national registry.

METHODS: We studied 55893 first-time KT recipients in 2003-2010 who used Medicare as their primary insurance, and were prescribed (1) cyclosporine or tacrolimus and (2) mycophenolates, azathioprine, sirolimus or everolimus for maintenance immunosuppression. Infections during the year post-KT were ascertained by ICD-9 codes. We built shared gamma frailty Cox models to compare the hazards of infections between the ESW and SM groups, adjusting for donor and recipient variables and center level variations.

RESULTS: The ESW group had more preemptive transplants (13.8% vs 10.8%) and fewer deceased donors (68.3% vs 74.8%); other characteristics including HLA mismatch were similar. There was no statistically significant difference in the hazard of infections overall between the two groups (aHR=_0.971.00_1.04; Table). When stratified by infection type, the ESW group had a slightly higher hazard of UTI, but lower hazards of sepsis, pneumonia, intestinal infections, herpes/adenovirus, candidiasis and fungal infections. Hazard of CMV, C.difficile, respiratory viral, endemic fungal and mycobacterial infections were similar.

CONCLUSIONS: KT recipients who received ESW regimens showed lower hazards of many infections even after adjusting for recipient, donor, and center level confounders.

Table. Hazards of infections comparing the early steroid withdrawal group to the steroid maintenance group

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