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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.
TRANSPLANTATION Treatment of acute graft-versus-host disease with prednisolone: significant survival advantage for day +5 responders and no advantage for nonresponders receiving antithymocyte globulinFrom the Divisione Ematologia 2 Genova San Martino, Genoa; Cattedra di Ematologia Catania, Catania; Clinica Pediatrica Monza, Monza; Divisione Ematologia Ospedale Cervello, Palermo; Medicina IV Ospedale Gaslini Genova, Genoa; Divisione Ematologia, San Camillo Roma, Rome; Cattedra Ematologia, Careggi Firenze, Florence; Divisione Ematologia Cuneo, Cuneo; Cattedra Ematologia, Università Cattolica, Rome; Cattedra Ematologia, Università Tor Vergata Roma, Rome; Clinica Pediatrica Torino, Turin; and Cattedra Ematologica Napoli, Naples, Italy.
Newly diagnosed patients with acute graft-versus-host disease (GvHD, grades I-IV; n = 211) were given 6-methylprednisolone (6MPred) 2 mg/kg per day for 5 consecutive days; 150 patients (71%) tapered 6MPred on day +5 and were considered responders; 61 patients (29%) could not taper their steroid dose and were considered nonresponders. The cumulative incidence of transplant-related mortality (TRM) for responders and nonresponders is, respectively, 27% and 49% (P = .009), and the 5-year survival is 53% and 35% (P = .007). Nonresponders on day +5 (n = 61) were randomized to receive 6MPred 5 mg/kg per day for 10 days alone (n = 34) or in combination with rabbit antithymocyte globulin (ATG, 6.25 mg/kg in 10 days; n = 27). The 2 groups were balanced for clinical and GvHD characteristics. One month after randomization, 26% had a complete response; 23%, a partial response; 33%, stable GvHD; 10%, worsened; and 8%, died. There was no significant difference in response, TRM, and survival between the non-ATG and ATG group. In conclusion, 5 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 6MPred + ATG does not improve patient outcome, compared with 6MPred alone.
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