Session Time: 3:15pm-4:45pm
Presentation Time: 3:39pm-3:51pm
*Purpose: Renal function and adverse event profiles in kidney transplant (KTx) patients under belatacept (BELA) based immunosuppression are significantly improved over calcineurin inhibitors, however BELA is also associated with increased rejection risk. Whether gender-based differences exist for BELA-based benefits and risks are not known. The purpose of this study was to analyze results from the BEST trial with a focus on effects of gender and induction therapy.
*Methods: The BEST trial was a prospective, randomized, multi-center trial designed to compare two BELA-based, calcineurin inhibitor-free (CNI), early corticosteroid withdrawal (ECSW) regimens with a tacrolimus (TAC)-based ECSW regimen in combination with depleting induction. Subgroup analyses were performed by recipient gender. The primary endpoint was patient death, renal allograft loss, or eGFR< 45ml/min/1.73m2.
*Results: Twice as many males as females were enrolled in this trial. Results for female and male subgroups are shown in Tables 1 and 2, respectively. Significantly fewer females met the primary endpoint in both BELA groups compared to rATG/TAC group, while no difference between groups was observed in males (Tables 1 and 2). Females showed a numerically lower rate of BPAR and infections in the ALEM/BELA and rATG/TAC groups compared to rATG/BELA group. Males had significantly higher rejection rates with either BELA regimen compared to rATG/TAC. Females also experienced renal function benefits with BELA with fewer patients with eGFR <45 mL/min/1.72m2 at two years, whereas males did not appear to experience renal function benefits with BELA. Males experienced significantly more neurotoxicity and gastrointestinal toxicity from TAC compared to BELA-based regimens.
*Conclusions: Females appeared to have more benefit in eGFR from BELA-based regimens, and less rejection when treated with ALEM/BELA. Males, but not females, had less neurotoxicity and GI toxicity in BELA-based regimens compared to TAC. In summary, these data indicate that BELA-based, CNI-free, ESW regimens demonstrate significant gender-based differences in outcomes between BELA-based and CNI-based ESW regimens.
To cite this abstract in AMA style:Wilson N, Shields AR, Wiseman A, Christianson AL, Tremblay S, Kaufman D, Leone JP, Matas AJ, West-Thielke P, Alloway RR, Woodle ES. Belatacept-Based Regimens: Induction and Recipient Gender Influence Outcomes [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/belatacept-based-regimens-induction-and-recipient-gender-influence-outcomes/. Accessed March 6, 2021.
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