Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: A randomized, controlled trial

McDonald, George B.; Bouvier, M; Hockenbery, David M.; Stern, Jean M.; Gooley, Ted; Farrand, Allen L.; Murakami, Carol S.; Levine, Douglas S.

doi:10.1016/s0016-5085(98)70361-0

Cited by 80 publications

(66 citation statements)

References 29 publications

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“…These data are similar to the recently published results showing a 71% response to beclomethasone treatment compared to 55% in the control group. 3 In our survey, despite the fast reduction of MP, no relapse occurred while BUD was continued. This was also observed for Crohn's disease in placebo controlled studies, showing that low-dose BUD prolongs time to relapse.…”

Section: Discussionmentioning

confidence: 50%

“…With beclomethasone dipropionate, a topical corticosteroid administered orally, promising results have been reported in the treatment of acute intestinal GVHD. 2,3 Budesonide (BUD) is a new topical active glucocorticoid with a high affinity for the glucocorticoid receptor 4 and high anti-inflammatory activity. Budenofalk capsules (Dr Falk Pharma GmbH, Freiburg, Germany) are a preparation releasing budesonide at pH у 6.4 which is mainly resorbed in the terminal ileum and ascending colon.…”

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confidence: 99%

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

Bertz

Afting

Kreisel

et al. 1999

Bone Marrow Transplant

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Summary:Therapy of acute intestinal GVHD is still one of the main challenges after allogeneic transplantation. Increasing systemic immunosuppression (IS) is the first choice and includes corticosteroids and lymphocyte antibodies, often 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 intestinal GVHD we conducted a trial with oral budesonide (Budenofalk), a new topically active glucocorticoid, to treat patients with acute GVHD у grade II. After a diagnosis of aGVHD у grade II, 22 patients received increased IS, mainly systemic corticosteroids, and additionally budesonide 9 mg/day divided into three doses. Improvement in aGVHD, infectious side-effects, reduction of systemic IS and outcome were documented. Results were compared with the results of 19 control patients, who were treated only by increasing IS dose. In 17/22 patients (70%), treated with budesonide, the acute intestinal GVHD resolved and no relapse occurred after decreasing the systemic IS, while continuing budesonide. In only 8/19 patients in the control group did the acute intestinal GVHD resolve 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 demonstrate its efficacy in allowing reduction of systemic immunosuppressive therapy, and its sideeffects.

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Section: Discussionmentioning

confidence: 50%

mentioning

confidence: 99%

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

Bertz

Afting

Kreisel

et al. 1999

Bone Marrow Transplant

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“…Therefore, major efforts have been directed at new regimens that would reduce systemic steroid use. 3,6,16 Mielcarek et al 4 reported that initial treatment with low-dose glucocorticoids (1 mg/ kg/day) for patients with grades I-II GVHD did not compromise disease control or mortality, and was associated with a decreased risk of invasive fungal infections and a shorter duration of hospitalization.…”

Section: Discussionmentioning

confidence: 99%

“…The current first-line therapy for aGVHD is methylprednisolone (MP, 1-2 mg/kg/day). 3,4 McDonald et al 5,6 reported on patients who received prednisone (1 mg/kg/ day) for the treatment of intestinal GVHD. The initial treatment response at day 10 was 16 of 29 (55%) and the durable treatment response at day 30 was 12 of 29 (41%).…”

Section: Introductionmentioning

confidence: 99%

Low-dose MTX combined with low-dose methylprednisolone as a first-line therapy for the treatment of acute GVHD: safety and feasibility

Wang

Liu

et al. 2010

Bone Marrow Transplant

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To study the efficacy and safety of a low dose of MTX combined with a low dose of methylprednisolone (MP) as a first-line therapy in the treatment of acute GVHD (aGVHD) after allogeneic hematopoietic SCT, 32 patients received i.v. MTX at a dose of 10 mg or oral MTX at a dose of 15 mg every 3-7 days (repeated at day 3 after the first dose and then at a weekly interval) combined with a low dose of MP (0.5 mg/kg/day) until a complete or partial response was achieved, or until treatment failure or intolerable side effects occurred. The overall treatment response rate was 81% (26/32 patients) and the response rate at day 28 was 75% (24/32 patients). The response rate for GVHD involving various organs was 88% (23/26) in the skin, 75% (3/4) in the liver and 81% (9/11) in the gut. Grade 3 toxicities occurred in only three patients presenting cytopenias. The estimated survival at 2 years was 77%. From this analysis, MTX in combination with a low dose of MP appears to be a well-tolerated, effective and inexpensive regime when used as a first-line treatment for aGVHD.

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“…10,11 Moreover, topical beclomethasone dipropionate has been demonstrated to be active in the treatment of the gastrointestinal manifestations of acute GVHD. 12,13 Here, we present the results of a retrospective evaluation of the efficacy of BUD in 13 patients who received BUD for the treatment of mild or moderate predominantly gastrointestinal manifestations of cGVHD.…”

Section: Introductionmentioning

confidence: 99%

Enteral budesonide in treatment for mild and moderate gastrointestinal chronic GVHD

Andree

Hilgendorf

Leithaeuser

et al. 2008

Bone Marrow Transplant

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Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: A randomized, controlled trial

Cited by 80 publications

References 29 publications

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

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

Low-dose MTX combined with low-dose methylprednisolone as a first-line therapy for the treatment of acute GVHD: safety and feasibility

Enteral budesonide in treatment for mild and moderate gastrointestinal chronic GVHD

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