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Title: Oral Beclomethasone Dipropionate Controls Gastrointestinal Graft Versus Host Disease, Allows Corticosteroid Withdrawal and Improves Survival: Presented at ASBMT

"Oral Beclomethasone Dipropionate Controls Gastrointestinal Graft Versus Host Disease, Allows Corticosteroid Withdrawal and Improves Survival: Presented at ASBMT"

By Alan McClelland HONOLULU, HI -- February 21, 2006 -- Oral beclomethasone dipropionate (BDP) appears to be effective in controlling gastrointestinal graft versus host disease (GvHD), according to a presentation made here at the 2006 Blood and Marrow Transplantation Tandem Meetings (ASBMT). In addition, the presented data suggest that the reduced mortality achieved with BDP could be attributed to avoidance of immune suppression (reduced corticosteroid exposure), fewer fatal infections and preservation of the mucosal barrier. GvHD is a significant and often life-threatening complication of allogeneic stem cell transplantation. The use of prednisone for control of GvHD is known to increase the patient's risk of infection. In a presentation here on February 18[^th, George McDonald, MD, Head, Gastroenterology/Hepatology Section, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States, presented the results of a 4-year, multicenter, randomized clinical trial of the oral topical steroid BDP for control of gastrointestinal GvHD.

BDP has been used for more than 40 years in the treatment of asthma and other inflammatory diseases of the lung, but its use for control of GvHD has only recently been investigated.

In their clinical trial, Dr. McDonald and colleagues randomized 129 patients who had endoscopic biopsy confirmed intestinal GvHD to treatment with either BDP or placebo. At day 10, responding patients had their prednisone tapered rapidly. The researchers continued treatment with BDP or placebo to study day 50, and compared patient survival in the two groups at study day 200.

At day 200, overall survival was 76% in the placebo arm, whereas in the BDP group had a survival rate of 92%.

The risk of death in the BDP group was 66% lower than in the placebo group and 51% lower at 1 year. These differences were highly statistically significant, Dr. McDonald.

Infections were more common in the placebo group, contributing to the deaths of 9 patients (13.4%) compared with 3 patients (4.8%) in the BDP treated group. The relapse rate was also higher in the placebo group compared with the BDP group (13.4% vs. 4.8%).

Dr. McDonald concluded that oral BDP is effective in control of gastrointestinal GvHD after prednisone taper, and suggested that reduced mortality in patients receiving BDP therapy could be attributed to avoidance of immune suppression (reduced corticosteroid exposure), fewer fatal infections and preservation of the mucosal barrier.

"This is a highly effective way of avoiding prednisone" said Dr. McDonald. Responding to a question concerning the timing of Food and Drug Administration (FDA) approval for this treatment, he indicated that the drug is on a "fast track" and the drug's developers hope that it will be approved in the US and Europe within a year.

[Presentation title: Oral Beclomethasone Dipropionate for Gastrointestinal GvHD; a Corticosteroid-Sparing Treatment with Improved Survival at Day +200. Abstract 2]

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