A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease.

Author(s): Hockenbery DM, Cruickshank S, Rodell TC, Gooley T, Schuening FG, Rowley SD, David D, Brunvand M, Berryman B, Abhyankar S, Bouvier ME, McDonald GB

Affiliation(s): Fred Hutchinson Cancer Research Center & University of Washington School of Medicine, Seattle, WA, United States.

Publication date & source: 2007-01-23, Blood., [Epub ahead of print]

Publication type:

We tested the hypothesis that oral beclomethasone dipropionate (BDP) would control gastrointestinal graft-vs-host-disease (anorexia, vomiting, and diarrhea). Patients were randomized to prednisone for ten days and either oral BDP 8 mg/day (N=62) or placebo (N=67) tablets for fifty days. At Study Day-10, prednisone was rapidly tapered while continuing study drug. On an intent-to-treat basis, the risk of GVHD-treatment failure was reduced for the BDP group at Study Day-50 (hazard ratio 0.63, 95% CI 0.35-1.13) and at 30 days follow-up (HR 0.55, 95% CI 0.32, 0.93). Among patients eligible for prednisone taper at Study Day-10, the risk of GVHD-treatment failure was significantly reduced at both Study Days-50 and -80 (HR 0.39 and 0.38, respectively). By day-200 post-transplant, 5 patients randomized to BDP had died, compared to 16 deaths on placebo, a 67% reduction in the hazard of mortality (HR 0.33, p=0.03). In 47 recipients of unrelated and HLA-mismatched stem cells, mortality at transplant day-200 was reduced by 91% in the BDP group, compared to placebo (HR 0.09, p=0.02). The survival benefit was durable to one-year post-randomization. Oral BDP prevents relapses of gastrointestinal GVHD following tapering of prednisone; survival is statistically significantly better among patients receiving BDP.