Feasibility and response to budesonide as topical corticosteroid therapy for acute intestinal GVHD

Therapy of acute intestinal GVHD is still one of the main challenges after allogeneic transplantation. Increasing systemic immunosuppression (IS) is t he first choice and includes corticosteroids and lymphocyte antibodies, oft en associated with severe side-effects. In inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, topical steroid therapy is used very successfully. Because of the similarity between these and acute intes tinal GVHD we conducted a trial with oral budesonide (Budenofalk), a new to pically active glucocorticoid, to treat patients with acute GVHD greater th an or equal to grade II. After a diagnosis of aGVHD greater than or equal t o grade II, 22 patients received increased IS, mainly systemic corticostero ids, and additionally budesonide 9 mg/day divided into three doses. Improve ment in aGVHD, infectious side-effects, reduction of systemic IS and outcom e were documented. Results were compared with the results of 19 control pat ients, who were treated only by increasing IS dose. In 17/22 patients (70%) , treated with budesonide, the acute intestinal GVHD resolved and no relaps e occurred after decreasing the systemic IS, while continuing budesonide. I n only 8/19 patients in the control group did the acute intestinal GVHD res olve and 2/8 patients had a relapse of intestinal GVHD after decreasing IS, with an overall response of 33%. No severe intestinal infections occurred. We conclude that budesonide may be effective in acute intestinal GVHD as a topical corticosteroid and prospective, randomized studies should demonstr ate its efficacy in allowing reduction of systemic immunosuppressive therap y, and its side-effects.