ORAL BECLOMETHASONE DIPROPIONATE FOR TREATMENT OF INTESTINAL GRAFT-VERSUS-HOST DISEASE - A RANDOMIZED, CONTROLLED TRIAL

Background & Aims: Beclomethasone dipropionate (BDP), a topically acti ve steroid, seemed to be an effective treatment for intestinal graft-v ersus-host disease (GVHD) in a phase I study. The aim of this study wa s to compare the effectiveness of oral BDP to that of placebo capsules in treatment of intestinal GVHD. Methods: Sixty patients with anorexi a and poor oral intake because of intestinal GVHD were randomized to r eceive prednisone (1 mg . kg(-1) . day(-1)) plus either oral BDP (8 mg /day) or placebo capsules. Initial responders who were eating at least 70% of caloric needs at evaluation on day 10 continued to take study capsules for an additional 20 days while the prednisone dose was rapid ly tapered. The primary end point was the frequency of a durable treat ment response at day 30 of treatment. Results: The initial treatment r esponse at day 10 was 22 of 31 (71%) in the BDP/prednisone group vs. 1 6 of 29 (55%) for the placebo/prednisone group. The durable treatment response at day 30 was 22 of 31 (71%) vs. 12 of 29 (41%), respectively (P = 0.02). Conclusions: The combination of oral BDP capsules and pre dnisone was more effective than prednisone alone in treating intestina l GVHD. Oral BDP allowed prednisone doses to be rapidly tapered withou t recurrent intestinal symptoms.