Efficacy and safety of basiliximab as initial immunosuppression in liver transplantation: A single center study.

Annals of Hepatology 2020; 19(5): 541-545.

Aims
The aim of this study was to investigate the safety and efficacy of basiliximab induction in liver transplant recipients.

Interventions
Participants were randomised into two groups: the first group, in which patients received standard triple immunosuppression (IS) regimen including steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF); or the second group, where patients received induction IS regimen including basiliximab, low dose steroids and MMF with delayed introduction of calcineurin inhibitors (CNI).

Participants
89 living donor liver transplant recipients.

Outcomes
The primary outcome was patient mortality. The secondary outcomes were acute rejection rate, and development of renal impairment and other adverse events.

Follow-up
6 months

CET Conclusions
In this study, liver transplant recipients were randomised to one of two immune suppression regimens. The first consisted of steroids, MMF and tacrolimus, the second consisted of basiliximab, low dose steroids, MMF and late introduction tacrolimus. There are some concerns in terms of trial methodology that may put the study at risk of bias; there is no description of the randomisation method so we cannot be sure that it was truly random, or if allocation concealment was maintained. Also, there does not seem to have been any attempt to blind patients or investigators. There is no flow chart presented to allow readers to understand if any patients were excluded, at what stage, and for what reasons. The primary outcome is described as patient mortality in the first 6 months, but the intention of the study was to look at renal impairment with tacrolimus reduction, so this should have been the primary outcome. The outcome “early renal dysfunction” is not defined in the paper and the “post-operative” creatinine presented is not at a defined time-point. Statistical methods used in the analysis were appropriate, but there is no power calculation presented. The results of the study show that outcomes including patient and graft survival, infection, acute cellular rejection were similar between groups. There was a significant reduction in early renal dysfunction, neurological complications and new-onset diabetes in the basiliximab group. This conclusion should be viewed in the context of the concerns raised above.

Jadad score
1

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
N/A

Funding source
No funding received