Immunosuppression Modifications Based on an Immune Response Assay: Results of a Randomized, Controlled Trial
Ravaioli M, Flavia N, et alTransplantation 2015 Aug;99(8):1625-32
Aims
To assess the clinical benefit of adjusting immunosuppressive therapy based on immune function assay results compared to a group managed with the standard clinical practice.
Interventions
Standard practice or serial immune function testing performed with a commercially available in vitro diagnostic before transplantation (ImmuKnow)
Participants
202 Adult liver recipients, 102 assigned to standard practice and 100 to serial immune function testing
Outcomes
Acute rejection, infection, systemic inflammatory response syndrome, cytomegalovirus viral syndrome.
Follow-up
12 months
CET Conclusions
In this study the authors have attempted to establish the value of a nonspecific study of immune responsiveness in modifying immunosuppression in liver transplant recipients. It was a randomised parallel blinded interventional trial comparing management of immunosuppression with tacrolimus and steroid taper as per their standard protocol or in fact manipulating the tacrolimus level based on the assay of cellular immunity (IMMUKNOW). In this assay CD4+ cells from the recipient are stimulated with PHA and the levels of ATP are measured. The trial was adequately powered and 202 liver transplant recipients were randomised. They were able to reduce tacrolimus doses significantly based on the cellular immune assay in the intervention arm and also found that infection was less frequent in the intervention arm. The authors feel that this testing of the immune function did provide additional data which helped to optimise their use of tacrolimus. Although this is a nonspecific measurement of cellular immunity there was better patient survival in the intervention arm. The authors felt that this optimisation of immunosuppression did improve patient outcomes, primarily by decreasing bacterial and fungal infections by avoiding over immunosuppression.
Data analysis
Available case analysis
Trial registration
Clinicaltrials.gov - NCT01764581