Anti-human-T-lymphocyte immunoglobulin (ATLG) significantly lowers chronic graft-versus-host disease (GVHD) rates and reduces risks associated with long-term immune suppression, according to a long-term randomized study of 201 patients undergoing hematopoietic cell transplantation (HCT).
All patients received standard cyclosporine and methotrexate as GVHD prophylaxis, and randomly received ALTG (n=103) or did not (n=98). Only patients without a second transplant at 100 days were included in the analyses of chronic GVHD (ATLG group=90 patients; non-ATLG group=80 patients). Median follow-up was 8.6 years.
The 8-year incidence of extensive chronic GVHD was 14% in the ATLG group vs. 52% in the non-ATLG group (p<0.0001).
Severe GVHD-free and relapse-free survival was 34% vs. 13% in the ALTG and non-ALTG groups, respectively (p=0.0003). The probability of surviving and being free of immunosuppressive therapy at 8 years was 47% in the ATLG group and 11% in the non-ATLG group.
There were no significant differences in the two arms on non-relapse mortality, incidence of relapse, mortality due to relapse, disease-free survival and overall survival.
The use of ATLG in HCT significantly improved severe GVHD-free and relapse-free survival in this study and “substantially increases the probability of surviving free of immunosuppressive therapy, and thus reduces the risk associated with long-term immunosuppression.”