Efficacy of the interleukin-2 receptor antagonist basiliximab in steroid-refractory acute graft-versus-host disease

Br J Haematol. 2005 Aug;130(4):568-74. doi: 10.1111/j.1365-2141.2005.05631.x.


Acute graft-versus-host disease (aGVHD) occurs in up to 80% of patients who undergo allogeneic stem cell transplantation (SCT) and contributes significantly to transplant-related mortality (TRM). We conducted a prospective phase II trial to assess the efficacy and feasibility of treating steroid-refractory aGVHD with basiliximab, a chimaeric monoclonal antibody directed against the alpha chain of the interleukin-2 (IL-2) receptor. Basiliximab was administered intravenously at a dose of 20 mg on days 1 and 4. Twenty-three patients were enrolled between October 1999 and July 2004. We found a primary overall response rate of 82.5% with four patients (17.5%) showing a complete response and 15 patients (65%) a partial response. Six patients were again treated successfully with an IL-2 receptor antagonist because of recurrence of aGVHD. The rates of infections, chronic GVHD, malignancy recurrence and 1-year TRM following immunosuppression with basiliximab were comparable with those found with other treatment modalities for aGVHD. We conclude that basiliximab is efficient and feasible for steroid-refractory aGVHD and merits further evaluation.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Acute Disease
  • Adult
  • Antibodies, Monoclonal / therapeutic use*
  • Basiliximab
  • Drug Tolerance
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Graft vs Host Disease / drug therapy*
  • Hematologic Neoplasms / surgery
  • Hematopoietic Stem Cell Transplantation* / mortality
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Prospective Studies
  • Receptors, Interleukin-2 / antagonists & inhibitors*
  • Recombinant Fusion Proteins / therapeutic use*
  • Steroids / therapeutic use
  • Transplantation Conditioning
  • Transplantation, Homologous
  • Treatment Outcome


  • Antibodies, Monoclonal
  • Immunosuppressive Agents
  • Receptors, Interleukin-2
  • Recombinant Fusion Proteins
  • Steroids
  • Basiliximab