Oral graft vs. host disease in children - Treatment with topical tacrolimus ointment

:  Oral chronic graft vs. host disease (GVHD) frequently presents in patients with sclerotic features of skin GVHD and is often associated with considerable limitations of oral food intake and decreased quality of life. Systemic tacrolimus is efficacious for prophylaxis and treatment of acute and ch...

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Bibliographic Details
Published in:Pediatric transplantation 2007-05, Vol.11 (3), p.306-309
Main Authors: Albert, Michael H., Becker, B., Schuster, F. R., Klein, B., Binder, V., Adam, K., Nienhoff, C., Führer, M., Borkhardt, A.
Format: Article
Language:English
Subjects:
Administration, Topical
Adolescent
Antibacterial agents
Antibiotics. Antiinfectious agents. Antiparasitic agents
Biological and medical sciences
Child
Female
General aspects
Graft vs Host Disease - drug therapy
Graft vs Host Disease - etiology
Hematopoietic Stem Cell Transplantation - adverse effects
Humans
Immunosuppressive Agents - therapeutic use
Male
Medical sciences
Mouth Diseases - drug therapy
Mouth Diseases - etiology
Ointments
oral graft vs. host disease
pediatric
Pharmacology. Drug treatments
Pilot Projects
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
tacrolimus
Tacrolimus - therapeutic use
Treatment Outcome
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Summary::  Oral chronic graft vs. host disease (GVHD) frequently presents in patients with sclerotic features of skin GVHD and is often associated with considerable limitations of oral food intake and decreased quality of life. Systemic tacrolimus is efficacious for prophylaxis and treatment of acute and chronic GVHD and topical tacrolimus has shown activity in chronic GVHD skin lesions. We therefore initiated a pilot study to investigate the safety and efficacy of topical tacrolimus ointment in children with oral GVHD. Six patients suffering from oral GVHD (five chronic and one acute) were included in the study. Tacrolimus ointment 0.1% was applied twice daily using sterile gauze. The only side‐effects observed were a slight burning discomfort after the first application in one patient and after food intake in another patient. Tacrolimus was absorbed systemically in four of six patients. Of six patients, we observed a complete response in two, a very good partial response (VGPR) in two, and a PR in two patients, respectively. We conclude that topical application of tacrolimus ointment holds promise as a safe and efficacious treatment for oral GVHD in children. The Food and Drug Administration has recently issued a health advisory about a potential cancer risk associated with topical tacrolimus treatment of the skin; therefore, its benefits should be weighed against its potential risks and diligent long‐term follow‐up should be carried out especially in children.
ISSN:1397-3142
1399-3046
DOI:10.1111/j.1399-3046.2006.00666.x