Induction therapy: clinical and quality of life outcomes in aged renal transplant recipients

Palanisamy AP, Al Manasra AR, et al

Aims
To address the effectiveness of induction agents in renal transplant recipients ≥50 years of age.

Interventions
All patients received either rabbit antithymocyte globulin (rATG) or interleukin 2 receptor antagonists (IL-2RA) in addition to tacrolimus (FK), mycophenolate mofetil (MMF), and corticosteroids.

Participants
111 renal transplant recipients ≥50 years of age; 48 received IL-2RA and 63 received rATG.

Outcomes
Efficacy outcomes were the incidence of biopsy proven acute rejection, steroid resistant rejection and renal function at 1 year post-transplant. Safety endpoints included the incidence of post-transplant infections, including cytomegalovirus (CMV), BK infection, and nephropathy, and other significant bacterial infections. The incidence of post-transplant malignancies, including post-transplant lymphoproliferative disease (PTLD) and skin cancers and quality of life were evaluated.

Follow-up
1 year

CET Conclusions
This manuscript reports a substudy of a randomised trial comparing IL2 receptor antibody induction (basiliximab or daclizumab) with rATG in elderly recipients (aged 50 or over). The authors find trends towards lower acute rejection rates and hospital readmissions in the ATG group, with significant improvements in certain domains of the SF-36 quality of life tool. This is an interesting study as the measurement of success of transplantation in elderly patients is biased more towards improved quality of life due to the higher rate of death with a functioning graft. Despite this, elderly recipients are often analysed together with younger patients, or excluded from trials altogether. There are some major limitations here though. This is an unplanned substudy, and the lack of blinding makes the risk of bias in subjective outcomes such as quality of life measures questionable. Given that the original study required significantly larger numbers of patients, it is also very likely underpowered for the efficacy outcomes reported. The findings would need to be confirmed in a prospective study in this group of recipients.

Jadad score
1

Data analysis
Available case analysis

Allocation concealment
No

Quality notes
Previously assessed as Pilch, N. A., D. J. Taber, et al. (2014). "Prospective Randomized Controlled Trial of Rabbit Antithymocyte Globulin Compared With IL-2 Receptor Antagonist Induction Therapy in Kidney Transplantation." Annals of Surgery 259(5): 888-893.

Trial registration
Clinicaltrials.gov – NCT00859131

Funding source
No funding received