Originally aired on Tuesday, December 3rd, 2019 • Hosted by the Transplant Pharmacy Community of Practice (TxPharm COP)
"Efficacy and safety of bleselumab in kidney transplant recipients: A phase 2, randomized, open-label, noninferiority study."
(Am J Transplant. 2019 Sep 11. doi: 10.1111/ajt.15591. [Epub ahead of print])
In this article:
This study assessed the efficacy and safety of the anti-CD40 monoclonal antibody bleselumab (ASKP1240) in de novo kidney transplant recipients over 36 months posttransplant.... For the primary endpoint (incidence of biopsy-proven acute rejection [BPAR] at 6 months), bleselumab + IR-TAC was noninferior to SoC, and bleselumab + MMF did not demonstrate noninferiority to SoC. 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 (see also ClinicalTrials.gov NCT01780844).
Bharath Ravichandran, PharmD • University of Maryland Medical Center, Baltimore, MD
Stephen Jensik, MD • Rush University Medical Center, Chicago, IL