For patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation, sitagliptin combined with tacrolimus and sirolimus results in a low incidence of grade II to IV acute graft-versus-host disease (GVHD) by day 100, according to a study published in the Jan. 7 issue of the New England Journal of Medicine.
Sherif S. Farag, M.D., Ph.D., from the Indiana University School of Medicine in Indianapolis, and colleagues conducted a phase 2 clinical trial to examine the reduction in incidence of grade II to IV acute GVHD from 30 percent to no more than 15 percent by day 100 with sitagliptin plus tacrolimus and sirolimus. Thirty-six patients received myeloablative conditioning followed by mobilized peripheral-blood stem cell transplants from matched related or unrelated donors.
The researchers found that by day 100, acute GVHD occurred in two of 36 patients. The incidence of grade II to IV GVHD and of grade III or IV GVHD was 5 and 3 percent, respectively. At one year, nonrelapse mortality was zero. The one-year cumulative incidence of relapse was 26 percent, and for chronic GVHD, it was 37 percent. At one year, GVHD-free, relapse-free survival was 46 percent. Toxic effects were similar to those seen in patients undergoing allogeneic stem cell transplantation.
“Inhibition of dipeptidyl peptidase 4 should be further investigated in randomized trials that compare sitagliptin with current standard GVHD prophylaxis regimens,” the authors write.
Two authors disclosed financial ties to the biopharmaceutical industry.