Basiliximab is well tolerated and effective in the treatment of steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation

Basifiximab, a chimeric interleukin-2 receptor (IL-2-R) antagonist, was evaluated in 17 patients with steroid-refractory acute graft-versus-host disease (GVHD) after allogeneic stem cell transplantation (SCT). Patients were transplanted from a related (n=6) or unrelated (n=11) HLA-identical donor because of acute lymphoblastic leukemia (n=4), acute myeloid leukemia (n=3), chronic myeloid leukemia (n=7), myelodysplastic syndrome (n=1), non-Hodgkin's lymphoma (n=1), and multiple myeloma (n=1). Basiliximab was given at a dose of 2x20 mg on 2 consecutive day's after steroid-refractory acute GVHD had developed. Basiliximab was repeated on day 8 in cases of persistent GVHD. A median of four basiliximab infusions (range 1-12) were given to these patients. None had infusion-associated or cytokine-related side-effects after basiliximab. Twelve of 17 patients (71%) responded to basiliximab, 9/17 (53%) had a complete response (CR) of acute GVHD and 3/17 (18%) had a partial response (PR). Five of 17 patients (29%) did not respond. Chronic GVHD developed in 8/13 evaluable patients and only, 2/8 had responded to basiliximab before. Five of 13 evaluable patients have no signs of chronic GVHD and all five had a CR or PR after basiliximab. This is the first report on the safety of basiliximab in patients with steroid-refractory, acute GVHD. Our data suggest that basiliximab is effective in a substantial proportion of these patients.