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Efficacy and safety of bleselumab in kidney transplant recipients: A phase 2, randomized, open-label, noninferiority study

Robert C Harland, Goran Klintmalm, Stephen Jensik, Harold Yang, Jonathan Bromberg, John Holman, Mysore S Anil Kumar, Vicki Santos, Tami Jo Larson, Xuegong Wang
American Journal of Transplantation 2019 September 11
This study assessed the efficacy and safety of the anti-CD40 monoclonal antibody bleselumab (ASKP1240) in de novo kidney transplant recipients over 36 months post-transplant. Transplant recipients were randomized (1:1:1) to standard of care (SoC: 0.1 mg/kg/day immediate-release tacrolimus [IR-TAC]; target minimum blood concentration (Ctrough ) 4-11 ng/mL] plus 1 g mycophenolate mofetil [MMF] twice daily), or bleselumab (200 mg on days 0/7/14/28/42/56/70/90, and monthly thereafter) plus either MMF or IR-TAC (0.1 mg/kg/day; target Ctrough  4-11 ng/mL days 0-30, then 2-5 ng/mL). All received basiliximab induction (20 mg pre-transplant and on Day 3-5 post-transplant) and corticosteroids. 138 transplant recipients received ≥1 dose of study drug (SoC [n=48]; bleselumab + MMF [n=46]; bleselumab + IR-TAC [n=44]). For the primary endpoint (incidence of biopsy-proven acute rejection [BPAR] at 6 months), bleselumab + IR-TAC was non-inferior to SoC (difference 2.8%; 95% confidence interval [CI] -8.1-13.8%), and bleselumab + MMF did not demonstrate noninferiority to SoC (difference 30.7%; 95% CI 15.2-46.2%). BPAR incidence slightly increased through Month 36 in all groups, with bleselumab + IR-TAC continuing to demonstrate noninferiority to SoC. Bleselumab had a favorable benefit-risk ratio. Most treatment-emergent adverse events were as expected for kidney transplant recipients. This article is protected by copyright. All rights reserved.


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