Daclizumab, an efficient treatment for steroid-refractory acute graft-versus-host disease.

In a phase II study, daclizumab was given as single second-line agent to 62 patients with steroid-refractory acute graft-versus-host disease (aGVHD). Complete resolution of aGVHD was achieved in 68.8% of patients. This response rate was significantly associated with a lower number of involved organs and smaller extent of skin involvement. The 4-year event-free survival (EFS) was 54.6%. Grade > or =III aGVHD, > or =2 involved organs at baseline and patient age >18 years were independently associated with lower EFS. Daclizumab could be a suitable alternative treatment for aGVHD, particularly when limited to the skin or gastrointestinal tract.