A Pilot Randomized Controlled Trial of de novo Belatacept-Based Immunosuppression in Lung Transplantation
A Pilot Randomized Controlled Trial of de novo Belatacept-Based Immunosuppression in Lung Transplantation
ABSTRACT The development of donor-specific antibodies (DSA) after lung transplantation is common and results in adverse outcomes. In kidney transplantation, Belatacept has been associated with a lower incidence of DSA, but experience with Belatacept in lung transplantation is limited. We conducted a 2-center pilot randomized controlled trial of de novo immunosuppression with Belatacept after lung transplantation to assess the feasibility of conducting a pivotal trial. Twenty-seven participants were randomized to Control (Tacrolimus, Mycophenolate Mofetil, and prednisone, n = 14) or Belatacept-based immunosuppression (Tacrolimus, Belatacept, and prednisone until day 89 followed by Belatacept, Mycophenolate Mofetil, and prednisone, n = 13). All participants were treated with rabbit anti-thymocyte globulin for induction immunosuppression. We permanently stopped randomization and treatment with Belatacept after 3 participants in the Belatacept arm died compared to none in the Control arm. Subsequently, 2 additional participants in the Belatacept arm died for a total of 5 deaths compared to none in the Control arm (log rank p = 0.016). We did not detect a significant difference in DSA development, acute cellular rejection, or infection between the 2 groups. We conclude that this investigational regimen using Belatacept after lung transplantation is associated with significantly increased mortality.
Schechtman Kenneth、Mittler Brigitte、Dore Peter、Witt Chad、Vazquez-Guillamet Rodrigo、Nava Ruben、Puri Varun、Gelman Andrew、Kreisel Daniel、Hachem Ramsey R.、Byers Derek、Halverson Laura、Bernadt Cory、Askar Medhat、Huang Howard J.
Division of Biostatistics, Washington University in St. LouisDivision of Pulmonary and Critical Care, Washington University in St. LouisDivision of Biostatistics, Washington University in St. LouisDivision of Pulmonary and Critical Care, Washington University in St. LouisDivision of Pulmonary and Critical Care, Washington University in St. LouisDivision of Cardiothoracic Surgery, Washington University in St. LouisDivision of Cardiothoracic Surgery, Washington University in St. LouisDivision of Cardiothoracic Surgery, Washington University in St. LouisDivision of Cardiothoracic Surgery, Washington University in St. LouisDivision of Pulmonary and Critical Care, Washington University in St. LouisDivision of Pulmonary and Critical Care, Washington University in St. LouisDivision of Pulmonary and Critical Care, Washington University in St. LouisDepartment of Pathology and Immunology, Washington University in St. LouisDepartment of Pathology and Laboratory Medicine, Texas A & M College of MedicineHouston Methodist Hospital
医学研究方法临床医学内科学
Schechtman Kenneth,Mittler Brigitte,Dore Peter,Witt Chad,Vazquez-Guillamet Rodrigo,Nava Ruben,Puri Varun,Gelman Andrew,Kreisel Daniel,Hachem Ramsey R.,Byers Derek,Halverson Laura,Bernadt Cory,Askar Medhat,Huang Howard J..A Pilot Randomized Controlled Trial of de novo Belatacept-Based Immunosuppression in Lung Transplantation[EB/OL].(2025-03-28)[2025-05-21].https://www.medrxiv.org/content/10.1101/2021.11.12.21265985.点此复制
评论