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Blood, Vol. 95 No. 1 (January 1), 2000:
pp. 83-89
Daclizumab, a humanized anti-interleukin-2 receptor alpha chain
antibody, for treatment of acute graft-versus-host disease
D. Przepiorka,
N. A. Kernan,
C. Ippoliti,
E. B. Papadopoulos,
S. Giralt,
I. Khouri,
J.-G. Lu,
J. Gajewski,
A. Durett,
K. Cleary,
R. Champlin,
B. S. Andersson, and
S. Light
From Baylor College of Medicine Center for Cell and Gene Therapy,
Houston, TX; The Memorial Sloan-Kettering Cancer Center, New York, NY;
University of Texas M. D. Anderson Cancer Center, Houston, TX; and
Hoffmann-La Roche, Inc., Nutley, NJ.
Daclizumab, a humanized monoclonal IgG1 directed against the 
chain of the interleukin-2 receptor (IL-2R), is a competitive inhibitor
of IL-2 on activated lymphocytes. To test the hypothesis that specific
inhibition of activated lymphocytes in patients with ongoing acute
graft-versus-host disease (GVHD) might ameliorate the process, we
treated 43 patients with advanced or steroid-refractory GVHD with
daclizumab. The first cohort of 24 patients was treated with daclizumab
1 mg/kg on days 1, 8, 15, 22, and 29. On day 43, the complete response
(CR) rate was 29% (95% confidence interval [CI],
13%-51%). Survival on day 120 was 29% (95% CI, 13%-51%). A second
cohort of 19 patients was treated with daclizumab 1 mg/kg on days 1, 4, 8, 15, and 22. For these patients, the CR rate on day 43 was 47% (95%
CI, 24%-71%), and survival on day 120 was 53% (95%
CI, 29%-76%). There were no infusion-related reactions and no serious
side effects related to daclizumab. Following treatment, there was a
reduction in serum concentrations of soluble IL-2R and peripheral blood
CD3 + 25+ lymphocytes, but these changes
were not predictive of response. Daclizumab has substantial activity
for the treatment of acute GVHD, and the second regimen evaluated is
recommended for a controlled study. (Blood, 2000; 95:83-89)
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