TY - JOUR
T1 - A Phase III Study of Infliximab and Corticosteroids for the Initial Treatment of Acute Graft-versus-Host Disease
AU - Couriel, Daniel R.
AU - Saliba, Rima
AU - de Lima, Marcos
AU - Giralt, Sergio
AU - Andersson, Borje
AU - Khouri, Issa
AU - Hosing, Chitra
AU - Ippoliti, Cindy
AU - Shpall, Elizabeth J.
AU - Champlin, Richard
AU - Alousi, Amin
N1 - Funding Information:
Financial disclosure: This article was supported by Centocor, Inc. Preliminary results of this study were presented in the American Society of Blood and Marrow Transplantation Annual Meeting in February 2004.
PY - 2009/12
Y1 - 2009/12
N2 - Anti-Tumor Necrosis Factor Alpha (TNF-α) therapy with infliximab has shown to be effective for patients with steroid-refractory acute graft-versus-host disease (aGVHD). An open-labeled, phase III trial was conducted to determine if the addition of infliximab to steroids could improve results for patients with newly diagnosed grade II-IV aGVHD. A total of 63 patients were randomized either to 2 mg/kg/day methylprednisolone (MP) or infliximab + MP. Average age was 47 years (range: 20-70 years); 64% were male. Fifty-three percent and 51% of patients received a matched-sibling and/or bone marrow (BM) graft. Sixty-seven percent had grade II, 33% grade III-IV aGVHD; 62% had skin, 53% gastrointestinal (GI), and 7% had liver involvement. At days 7 and 28, the response rate for infliximab + MP versus MP was 52% versus 78%, P=.03 and 62% versus 58%, P=.7, respectively. Cumulative incidences of GVHD-related mortality, nonrelapse mortality (NRM), and overall survival (OS) were not significantly different between the 2 groups (GVHD-related mortality: 38% versus 32%, P=.6; NRM: 52% versus 36%, P=.3; OS: 17% and 28%, P=.4 for infliximab + MP versus MP, respectively). Patients with newly diagnosed aGVHD derive no benefit from the addition of anti-TNF-α therapy with infliximab when compared to corticosteroids alone.
AB - Anti-Tumor Necrosis Factor Alpha (TNF-α) therapy with infliximab has shown to be effective for patients with steroid-refractory acute graft-versus-host disease (aGVHD). An open-labeled, phase III trial was conducted to determine if the addition of infliximab to steroids could improve results for patients with newly diagnosed grade II-IV aGVHD. A total of 63 patients were randomized either to 2 mg/kg/day methylprednisolone (MP) or infliximab + MP. Average age was 47 years (range: 20-70 years); 64% were male. Fifty-three percent and 51% of patients received a matched-sibling and/or bone marrow (BM) graft. Sixty-seven percent had grade II, 33% grade III-IV aGVHD; 62% had skin, 53% gastrointestinal (GI), and 7% had liver involvement. At days 7 and 28, the response rate for infliximab + MP versus MP was 52% versus 78%, P=.03 and 62% versus 58%, P=.7, respectively. Cumulative incidences of GVHD-related mortality, nonrelapse mortality (NRM), and overall survival (OS) were not significantly different between the 2 groups (GVHD-related mortality: 38% versus 32%, P=.6; NRM: 52% versus 36%, P=.3; OS: 17% and 28%, P=.4 for infliximab + MP versus MP, respectively). Patients with newly diagnosed aGVHD derive no benefit from the addition of anti-TNF-α therapy with infliximab when compared to corticosteroids alone.
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U2 - 10.1016/j.bbmt.2009.08.003
DO - 10.1016/j.bbmt.2009.08.003
M3 - Article
C2 - 19896079
AN - SCOPUS:70350567157
SN - 1083-8791
VL - 15
SP - 1555
EP - 1562
JO - Biology of Blood and Marrow Transplantation
JF - Biology of Blood and Marrow Transplantation
IS - 12
ER -