Transplant Trial Watch

Ten-Year Outcomes in a Randomized Phase II Study of Kidney Transplant Recipients Administered Belatacept 4-Weekly or 8-Weekly.

Vincenti F, Blancho G, et al.

American Journal of Transplantation 2017; 31: 31.


Aims
To compare outcomes at 10 years posttransplant in belatacept-treated and cyclosporine (CsA) treated patients participating in the previous phase II IM103-100 study*.

Interventions
Participants were first randomized to receive more-intensive (MI)-based belatacept, less-intensive (LI)-based belatacept, or CsA-based immunosuppression. Participants randomized to belatacept MI or belatacept LI were re-randomized at 6 months or 3 months posttransplant to receive belatacept 5 mg/kg either every 4 weeks or every 8 weeks.

Participants
218 kidney transplant recipients of a primary or repeat transplant from a living or deceased donor, aged ≥18 years.

Outcomes
Renal function and efficacy and safety outcomes were measured including death or graft loss, serious adverse events, serious infections, any-grade viral infections, any-grade fungal infections, and malignancies.

Follow-up
10 years

CET Conclusions
This manuscript reports the 10-year outcomes from the original phase II study of Belatacept. Kidney transplant recipients were randomised to one of three arms – low-dose (LI) belatacept, high-dose (MI) belatacept or cyclosporine. At 3-6 months post-transplant, belatacept treated patients were re-randomised to 4-weekly or 8-weekly belatacept infusions. 10-year outcomes demonstrate numerically higher cumulative acute rejection rates in the LI belatacept arm (HR 1.6 compared to cyclosporine) and in the 8-weekly infusion group (HR 2.0 vs cyclosporine), although numbers are small so significance is not reached. GFR was excellent in both belatacept groups at 10 years, and significantly better than the cyclosporine group. These data support the findings from the subsequent BENEFIT trials, demonstrating superior function but an increased risk of early acute rejection with belatacept treatment. The numbers of patients analysed beyond 5 years is small (<50% of those randomised), meaning that most analyses are underpowered.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Quality notes
Previously assessed as *Vincenti F, et al. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005;353:770‐781.

Trial registration
Clinicaltrials.gov - NCT00035555

Funding source
Industry funded