Treatment of severe steroid refractory acute graft-versus-host disease with infliximab, a chimeric human/mouse antiTNF alpha antibody

Acute graft-versus-host disease (aGVHD) is a serious complication of alloge neic peripheral blood stem cell transplantation (PBSCT). Patients with seve re aGVHD not responding to treatment with steroids have a poor prognosis. W e treated four patients with severe aGVHD refractory to steroids with infli ximab, a chimeric human/mouse antiTNF alpha antibody. Patients (CML 2, MM 1 , AML 1) developed grade III-IV GVHD at a median of 34 days (range 15-76) a fter myeloablative PBSCT (two), donor lymphocyte infusion for relapsed CML (one) or non-myeloablative PBSCT (one), respectively. All patients had seve re intestinal involvement in addition to skin and/or liver disease and had received treatment with high-dose steroids (four) for a median of 11 days ( range 5-17) in addition to CsA (four) and MMF (three). Infliximab (10 mg/kg ) was given once a week until clinical improvement. In three of four patien ts a complete resolution of diarrhea and significant improvement of skin an d liver disease were observed. Two patients received one, one patient two a nd one patient three infliximab infusions. At present two patients are aliv e >200 days after therapy, one with limited cGVHD. Two patients died, one o f progressive malignant disease without GVHD and one of refractory GVHD. In fliximab is apparently an active drug for the treatment of aGVHD.