Basiliximab for the treatment of steroid refractory acute graft-versus-host-disease following allogeneic stem cell transplantation

Management of steroid-refractory acute graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation continues to be a major challenge; however, no standard second-line therapy exists. IL2 plays a crucial role in the pathogenesis of acute GVHD. Basiliximab is a chimeric monoclonal antibody that blocks the alpha-chain of the interleukin-2 (IL-2) receptor complex. We report our clinical experience with basiliximab in the second line management of steroid refractory acute GVHD. Thirty-eight patients were retrospectively studied from June 2012 to March 2015. Basiliximab 20 mg was given intravenously on days 1 and 4 to patients unresponsive after 5 to 7 days or progressing within 3 days on high dose corticosteroids. A second course of basiliximab was given to patients with continued symptoms after 7-10 days. Response was assessed at day 28 following initiation of basiliximab. Table 1 describes patient characteristics. Acute GVHD was diagnosed at a median of 110 days (range 11-474) and basiliximab was given at a median of 102 days (18- 290) after transplant. Acute GVHD organ involvement included: 45% gastrointestinal (GI), 13% skin, and 3% liver with 40% of patients having multi-organ involvement. On average, patients were on high dose steroid therapy (2mg/kg) for 11 days (4-28) before being declared steroid refractory and initiated on basiliximab. At day 28 after basiliximab overall response rate was 42% with 21% of patients achieving a complete response, 13% with a partial response, 8% with a mixed response and 58% with no response or disease progression. Fortytwo percent of patients required utilization of a third agent for steroid refractory GVHD. Overall survival at day 28 post basiliximab was 63%, average time to death after dose of basiliximab was 59 days (6-188). Nine of 38 patients (23%) remain alive at a median follow up of 16.5 months. Primary causes of death include progressive GVHD (55%), infection (27%) and other treatedrelated mortality (17%). Basiliximab is a reasonable option for patients with steroid refractory GVHD, however better therapeutic options for SR GVHD are needed. Prospective and preferably randomized studies are needed in this setting.