1. ¹Allogeneic Bone Marrow Transplantation Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
2. ²Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
3. ³Department of Biostatistics and Epidemiology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
4. ⁴Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

Correspondence: Dr M-A Perales, Allogeneic Bone Marrow Transplantation Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA. E-mail: peralesm@mskcc.org

Received 22 August 2006; Revised 6 June 2007; Accepted 7 June 2007; Published online 9 July 2007.

Abstract

Daclizumab has been shown to have activity in acute GVHD, but appears to be associated with an increased risk of infection. To investigate further the long-term effects of daclizumab, we performed a retrospective review of 57 patients who underwent an allogeneic hematopoietic stem cell transplant from January 1993 through June 2000 and were treated with daclizumab for steroid-refractory acute GVHD. The median number of daclizumab doses given was 5 (range 1–22). GVHD was assessed at baseline, days 15, 29 and 43. By day 43, 54% patients had an improvement in their overall GVHD score, including 76% patients aged 18. Opportunistic infections developed in 95% patients. Forty-three patients (75%) died following treatment with daclizumab. The causes of death included active GVHD and infection (79%), active GVHD (5%), chronic GVHD (2%) and relapse (14%). Patients with grade 3–4 GVHD had a significantly shorter median survival than patients with grade 1–2 GVHD (2.0 vs 5.1 months, P=0.001). Daclizumab has no infusion-related toxicity, is active in steroid-refractory GVHD, especially among pediatric patients, but is associated with significant morbidity and mortality due to infectious complications. Careful patient selection and aggressive prophylaxis against viral and fungal infections are recommended.