A pilot randomized controlled trial of de novo belatacept-based immunosuppression following anti-thymocyte globulin induction in lung transplantation

Howard J. Huang, Kenneth Schechtman, Medhat Askar, Cory Bernadt, Brigitte Mittler, Peter Dore, Chad Witt, Derek Byers, Rodrigo Vazquez-Guillamet, Laura Halverson, Ruben Nava, Varun Puri, Andrew Gelman, Daniel Kreisel, Ramsey R. Hachem

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

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 two-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 three participants in the Belatacept arm died compared to none in the Control arm. Subsequently, two additional participants in the Belatacept arm died for a total of five deaths compared to none in the Control arm (log rank p =.016). We did not detect a significant difference in DSA development, acute cellular rejection, or infection between the two groups. We conclude that the investigational regimen used in this study is associated with increased mortality after lung transplantation. (Figure presented.).

Original languageEnglish (US)
Pages (from-to)1884-1892
Number of pages9
JournalAmerican Journal of Transplantation
Volume22
Issue number7
DOIs
StatePublished - Jul 2022

Keywords

  • alloantibody
  • clinical research/practice
  • clinical trial
  • immunosuppressant - fusion proteins and monoclonal antibodies: belatacept
  • immunosuppression/immune modulation
  • lung transplantation/pulmonology

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

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