title: Basiliximab is well tolerated and effective in the treatment of steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation.
abstract: Basiliximab, 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 2 x 20 mg on 2 consecutive days 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.
authors.affiliation: Dept. of Internal Medicine, Division of Hematology and Oncology, University Hospital Charité, Campus Virchow-Klinikum, Humboldt-University, Berlin, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Massenkeil
authors.forename: S
authors.initials: S
authors.lastname: Rackwitz
authors.forename: I
authors.initials: I
authors.lastname: Genvresse
authors.forename: O
authors.initials: O
authors.lastname: Rosen
authors.forename: B
authors.initials: B
authors.lastname: Dörken
authors.forename: R
authors.initials: R
authors.lastname: Arnold
mesh_terms: D000305:Adrenal Cortex Hormones / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000077552:Basiliximab; D002908:Chronic Disease; D004351:Drug Resistance; D005260:Female; D006086:Graft vs Host Disease / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D019337:Hematologic Neoplasms / Q000628:therapy; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects*; D011993:Recombinant Fusion Proteins; D012074:Remission Induction; D012449:Safety; D019172:Transplantation Conditioning; D014184:Transplantation, Homologous / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab