Use of infliximab/daclizumab combination for the treatment of acute and chronic graft versus host disease of the liver and gut

Abstract

We report the use of Infliximab/Daclizumab combination for the treatment of acute and chronic graft versus host disease (GVHD) of the liver and gut in two children who failed standard GVHD therapy. Infliximab was given at a dose of 10 mg/kg weekly × 4 and Daclizumab 1 mg/kg days 1, 4, 8, 15, 22. Patient #1 (Pt) developed grade 2 chronic GVHD of the liver a year after his third allogeneic HLA-matched sibling bone marrow transplant (BMT) for relapsed juvenile myelomonocytic leukemia. Despite immunosuppressive therapy with FK506, mycophenolate mofetil and prednisone 2 mg/kg/dose, liver enzymes failed to normalize. Within 1 week of initiation of therapy with Infliximab/Daclizumab, liver enzymes and bilirubin normalized. Pt #2 developed acute GVHD of the liver and gut grade 3 day +37 after allogeneic-HLA matched sibling BMT for Philadelphia positive acute lymphoblastic leukemia. Pt did not show clinical response despite the addition of prednisone 2 mg/kg/dose to his immunosuppressive regimen. Resolution of acute GVHD was observed within two weeks of initiation of Infliximab/Daclizumab. Both patients tolerated the regimen well with no toxicities and were off immunosuppression 8 and 11 months respectively from the initiation of therapy for GVHD. We conclude that the combination of Infliximab/Daclizumab seems to be effective in the treatment of acute and chronic GVHD of the liver and gut. Future prospective studies in a larger cohort of patients are needed to confirm this observation.