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Belatacept Improves Long-term Outcomes after Kidney Transplantation

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Belatacept and Long-Term Outcomes in Kidney Transplantation

Introduction

Advancement in post transplantation immunosuppressive management has reduced rates of acute rejection and improved one-year outcome in patients who underwent kidney transplantation. But there is no improvement in long-term renal allograft survival due to cardiovascular disease and chronic allograft neuropathy. The reason may be due to chronic toxicities associated with calcineuriun inhibitors, which is a current immunosuppression standard of care. They are also associated with worsening hypertension, diabetes, and dyslipidemia. There is a need for selective immunosuppressants that may improve long-term patient and allograft survival by avoiding chronic toxicities of nonselective suppressive therapies.

Belatacept is a selective co stimulation blocker designed to provide effective immunosuppression and avoid renal and nonrenal toxicities associated with calcineurin inhibitors. This phase III study is assessed (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial) by a more intensive (MI) or less intensive (LI) regimen of belatacept versus cyclosporine in patients undergoing a kidney transplant. In phase II study, it was proved that belatacept demonstrated acute rejection and better renal function compared to the cyclosporine-based regimen.

Objective

The main objective of the study was to determine long-term outcomes of belatacept in patients who had kidney transplantation and to assess the patient and graft survival, renal function, and incidence of acute rejection in each belatacept group compared to cyclosporine group. Renal function was assessed on the basis of estimated glomerular filtration rate (eGFR) which was calculated with the use of six-variable Modification of Diet in Renal Disease equation.

Study Design

The study design was three years, international, randomized, single blind, parallel group study with an active control.

Statistical analysis

Kaplan-Meier-method and Cox regression were used for the statistical analysis.

Sample Size

Total 738 patients were enrolled in which 666 patients underwent randomization. At the end, 153 patients were evaluated for more intensity belatacept, 163 evaluated for less intensity belatacept, and 131 evaluated for cyclosporine after 84 months.

Inclusion criteria

The inclusion criteria for the study were 18 year and older patients who received a living donor or standard criteria deceased donor kidney transplant.

Exclusion criteria

Donors of more than 60 years age, or more than 50 years who had at least two risk factors like a Cerebrovascular accident, hypertension, anticipated cold ischemia of more than 24 h, patients who received a kidney after the cardiac death of the donor. Patients with concurrent non-renal solid organ transplant were also excluded from the study.

Procedure

The participants were randomized into three groups and underwent kidney transplantation. Different groups of patients were treated with the drugs belatacept (MI and LI) and cyclosporine in different doses. Different parameters were evaluated in 12, 36, 60 and 84 months.

Results

Efficacy on the basis of Kaplan−Meier

Rates of death (%)

Rate of graft loss (%)

Estimated glomerular filtration in percentage (%)

Safety

The cumulative incidence rates of serious infections were 10.6, 10.7, and 13.3 events per 100 person years of treatment exposure up to month 84 for patients randomly assigned to the more-intensive belatacept regimen, those assigned to the less-intensive regimen, and those assigned to cyclosporine, respectively.

Donor-specific antibodies in percentage (%)

This proved that the development of donor-specific antibodies were significantly lower with each belatacept regimen than with cyclosporine.

Conclusion

From the above results, it was proved that seven years after kidney transplantation graft survival and the mean eGFR were significantly higher with belatacept (both the more-intensive regimen and the less-intensive regimen) than with cyclosporine.

Reference

Vincenti F et.al. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28; 374(4):333-43.

Available at: http://www.ncbi.nlm.nih.gov/pubmed/26816011/

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