Low-dose thymoglobulin as second-line treatment for steroid-resistant acute GvHD: an analysis of the JSHCT

Bone Marrow Transplant. 2017 Feb;52(2):252-257. doi: 10.1038/bmt.2016.247. Epub 2016 Nov 21.

Abstract

A nationwide retrospective study for the clinical outcomes of 99 patients who had received thymoglobulin at a median total dose of 2.5 mg/kg (range, 0.5-18.5 mg/kg) as a second-line treatment for steroid-resistant acute GvHD was conducted. Of the 92 evaluable patients, improvement (complete or partial response) was observed in 55 patients (60%). Multivariate analysis demonstrated that male sex and grade III and IV acute GvHD were associated with a lower improvement rate, whereas thymoglobulin dose (<2.0, 2.0-3.9 and ⩾4.0 mg/kg) was NS. Factors associated with significantly higher nonrelapse mortality included higher patient age (⩾50 years), grade IV acute GvHD, no improvement of GvHD and higher dose of thymoglobulin (hazard ratio, 2.55; 95% confidence interval, 1.34-4.85; P=0.004 for 2.0-3.9 mg/kg group and 1.79; 0.91-3.55; P=0.093 for ⩾4.0 mg/kg group). Higher dose of thymoglobulin was associated with a higher incidence of bacterial infections, CMV antigenemia and any additional infection. Taken together, low-dose thymoglobulin at a median total dose of 2.5 mg/kg provides a comparable response rate to standard-dose thymoglobulin reported previously, and <2.0 mg/kg thymoglobulin is recommended in terms of the balance between efficacy and adverse effects.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Allografts
  • Antilymphocyte Serum / administration & dosage*
  • Child
  • Child, Preschool
  • Disease-Free Survival
  • Drug Resistance / drug effects*
  • Female
  • Graft vs Host Disease / drug therapy*
  • Graft vs Host Disease / mortality
  • Hematopoietic Stem Cell Transplantation*
  • Humans
  • Japan / epidemiology
  • Male
  • Middle Aged
  • Recurrence
  • Registries*
  • Sex Factors
  • Survival Rate

Substances

  • Antilymphocyte Serum
  • thymoglobulin