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Blood, 15 May 2006, Vol. 107, No. 10, pp. 4177-4181.
Prepublished online as a Blood First Edition Paper on January 31, 2006; DOI 10.1182/blood-2005-12-4851.
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Submitted December 7, 2005
Accepted December 31, 2005
Treatment of acute graft versus host disease with prednisolone: significant survival advantage for day +5 responders and no advantage for non responders receiving anti-thymocyte globulin
Maria Teresa Van Lint, Giuseppe Milone, Salvatore Leotta, Cornelio Uderzo, Rosanna Scime, Sandro Dallorso, Anna Locasciulli, Stefano Guidi, Nicola Mordini, Simona Sica, Laura Cudillo, Franca Fagioli, Carmine Selleri, Barbara Bruno, G Arcese, and Andrea Bacigalupo*
Divisione Ematologia 2 Genova, San Martino, Italy
Cattedra di Ematologia, Catania, Italy
Clinica Pediatrica, Monza, Italy
Divisione Ematologia Ospedale Cervello, Palermo, Italy
Medicina IV Ospedale Gaslini, Genova, Italy
Divisione Ematologia , San Camillo, Roma, Italy
Cattedra Ematologia, Careggi Firenze, Italy
Divisione Ematologia, Cuneo, Italy
Cattedra Ematologia , Universita Cattolica, Roma, Italy
Cattedra Ematologia , Universita Tor Vergata, Roma, Italy
Clinica Pediatrica, Torino, Italy
Cattedra Ematologica, Napoli, Italy
* Corresponding author; email: andrea.bacigalupo{at}hsanmartino.it.
Newly diagnosed patients with acute graft versus host disease (GvHD) (grade I-IV), (n=211) were given 6-methylprednisolone (MPred) 2 mg/kg/day for five consecutive days: 150 patients (71%) tapered MPred on day+5 and were considered responders; 61 patients (29%) could not taper their steroid dose and were considered non responders. The cumulative incidence of transplant related mortality (TRM) for responders and non responders is respectively 27% vs 49% (p=0.0005), the 5 year survival 53% and 35% (p=0.007) .
Non responders on day+5 (n=61) were randomized to receive MPred 5 mg/kg/day for 10 days alone (n=34) or in combination with rabbit anti-thymocyte globulin (ATG) (thymoglobuline 6.25 mg/kg in 10 days) (n=27) . The two groups were balanced for clinical and GvHD characteristic. One month after randomization 26% had a complete response, 25% a partial response, 33% stable GvHD , 10% worsened and 8% had died: there was no significant difference in response, TRM and survival between the non-ATG and ATG group.
Five days of prednisolone as first line therapy of acute GvHD identifies patients with different risk of TRM, and second line therapy with a combination of MPred + ATG does not improve patient outcome, as compared to MPred alone.
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