Haematologica (Dec 2017)

Steroid treatment of acute graft-versus-host disease grade I: a randomized trial

  • Andrea Bacigalupo,
  • Giuseppe Milone,
  • Alessandra Cupri,
  • Antonio Severino,
  • Franca Fagioli,
  • Massimo Berger,
  • Stella Santarone,
  • Patrizia Chiusolo,
  • Simona Sica,
  • Sonia Mammoliti,
  • Roberto Sorasio,
  • Daniela Massi,
  • Maria Teresa Van Lint,
  • Anna Maria Raiola,
  • Francesca Gualandi,
  • Carmine Selleri,
  • Maria Pia Sormani,
  • Alessio Signori,
  • Antonio Risitano,
  • Francesca Bonifazi

DOI
https://doi.org/10.3324/haematol.2017.171157
Journal volume & issue
Vol. 102, no. 12

Abstract

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Patients with acute graft-versus-host disease (GvHD) grade I were randomized to an observation arm (n=85) or to a treatment arm (n=86) consisting of 6-methylprednisolone 1 mg/kg/day, after stratification for age and donor type. The primary end point was development of grade II–IV GvHD. The cumulative incidence of grade II–IV GvHD was 50% in the observation arm and 33% in the treatment arm (P=0.005). However, grade III–IV GvHD was comparable (13% vs. 10%, respectively; P=0.6), and this was true for sibling and alternative donor transplants. Moderate/severe chronic GvHD was also comparable (17% vs. 9%). In multivariate analysis, an early interval between transplant and randomization (