A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children

Journal of Allergy and Clinical Immunology

Volumn 102, Issue 4 II, 1998, Pages 637-644

  Boguniewicz, Mark ^a,b   Fiedler, Virginia C ^c   Raimer, Sharon ^d   Lawrence, Ira D ^e   Leung, Donald Y M ^a,b   Hanifin, Jon M ^f  

^a NATIONAL JEWISH MEDICAL AND RESEARCH CENTER   (United States)

^b Children's Hospital Colorado   (United States)

^c UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^d UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^e ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^f OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

Atopic dermatitis; Children pediatric; Eczema; Ointment; Tacrolimus

Indexed keywords

TACROLIMUS;

ADOLESCENT; ARTICLE; ATOPIC DERMATITIS; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ECZEMA; FEMALE; HUMAN; MALE; MULTICENTER STUDY; OINTMENT; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; TOPICAL DRUG ADMINISTRATION;

ADMINISTRATION, TOPICAL; ADOLESCENT; CHILD; DERMATITIS, ATOPIC; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; TACROLIMUS; TREATMENT OUTCOME;

EID: 0031792219     PISSN: 00916749     EISSN: None     Source Type: Journal    
DOI: 10.1016/s0091-6749(98)70281-7     Document Type: Article

References (27)

1. Schultz-Larsen F, Holm NV, Henningsen K. Atopic dermatitis. A genetic-epidemiologic study in a population-based twin sample. J Am Acad Dermatol 1986;15:487-94.
2. Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol 1980;92:44-7.
3. Rasmussen JE. Management of atopic dermatitis. Allergy 1989;44(suppl)9:108-13.
4. Leung DYM. Atopic dermatitis: the skin as a window into the pathogenesis of chronic allergic diseases. J Allergy Clin Immunol 1995;96:302-18.
5. Ohmen JD, Hanifin JM, Nickoloff BJ, Rea TH, Wyzykowski R, Kim J, et al. Overexpression of IL-10 in atopic dermatitis: contrasting cytokine patterns with delayed-type hypersensitivity reactions. J Immunol 1995;154:1956-63.
6. Hamid Q, Boguniewicz M, Leung DYM. Differential in situ cytokine gene expression in acute vs. chronic atopic dermatitis. J Clin Invest 1994;94:870-6.
7. Hanifin J. Atopic dermatitis in infants and pediatric patients. Pediatr Clin North Am 1991;38:763-89.
8. Sowden JM, Berth-Jones J, Ross JS, Motley RJ, Marks R, Finlay AY, et al. Double-blind, controlled, crossover study of cyclosporin in adults with severe refractory atopic dermatitis. Lancet 1991;338:137-40.
9. De Rie MA, Meinardi MHM, Dos J. Lack of efficacy of topical cyclosporin A in atopic dermatitis and allergic contact dermatitis. Acta Derm Venereol 1991;71:452-4.
10. Kino T, Hatanaka H, Hashimoto M, Nishiyama M, Goto T, Okuhara M, et al. FK-506, a novel immunosuppressant isolated from a Streptomyces I. Fermentation, isolation, physico-chemical and biological characteristics. J Antibiot 1987;40:1249-55.
11. Mon A, Suko M, Nishizaki Y, Kamoinuma O, Matsuzaki G, Ito K, et al. Regulation of interleukin-5 production by peripheral blood mononuclear cells from atopic patients with FK506, cyclosporin A and glucocorticoid. Int Arch Allergy Immunol 1994;104:32-5.
12. Nakagawa H, Etoh T, Ishibashi Y, Higaki Y, Kawashima M, Torii H,etal. Tacrolimus ointment for atopic dermatitis [letter]. Lancet 1994;344:883.
13. Ruzicka T, Bieber T, Schöff E, Rubins A, Dobozy A, Bos JD, et al. A short-term trial of tacrolimus ointment for atopic dermatitis. N Engl J Med 1997;337:816-21.
14. Kawashima M, Nakagawa H, Ohtsuki M, Tamaki K, Ishibashi Y Tacrolimus concentration in blood during topical treatment of atopic dermatitis [letter]. Lancet 1996;348:1240-1.
15. Alak AM, Cook M, Bekersky I. A highly sensitive enzyme-linked immunosorbent assay for the determination of tacrolimus in atopic dermatitis patients. Ther Drug Monit 1997;19:88-91.
16. Kershner RP, Fitzsimmons WE. Relationship of FK506 whole blood concentrations and efficacy and toxicity after liver and kidney transplantation. Transplantation 1996;62:920-6.
17. O'Keefe SJ, Tamura J, Kincaid RL, Tocci JM, O'Neill EA. FK-506- and CsA-sensitive activation of the interleukin-2 promoter by calcineurin. Nature 1992;357:692-4.
18. Chan SC, Brown MA, Wilcox TM, Li S-H, Stevens SR, Tara D, et al. Abnormal IL-4 gene expression by atopic dermatitis T lymphocytes is reflected in altered nuclear protein interactions with IL-4 transcriptional regulatory element. J Invest Dermatol 1996;106:1131-6.
19. Yoshimura N, Matsui S, Hamashima T, Oka T. Effect of a new immunosuppressive agent, FK506, on human lymphocyte responses in vitro. II. Inhibition of the production of IL-2 and gamma-IFN, but not B cell-stimulating factor 2. Transplantation 1989;47:356-9.
20. Schreiber SL, Crabtree GR. The mechanism of action of cyclosporin A and FK506. Immunol Today 1992;13:136-42.
21. de Paulis A, Stellato C, Cirillo R, Ciccarelli A, Oriente A, Marone G. Anti-inflammatory effect of FK-506 on human skin mast cells. J Invest Dermatol 1992;99:723-8.
22. Kaplan A, Matsue H, Shibaki A, Kawashima T, Kobayashi H, Ohkawara A. The effects of cyclosporin A and FK506 on human skin mast cells. J Dermatol Sci 1995;10:130-8.
23. Thomson AW, Nalesnik M, Abu-Elmagd K, Starzl T. Influence of FK 506 on T lymphocytes, Langerhans' cells and the expression of cytokine receptors and adhesion molecules in psoriatic skin lesions: a preliminary study. Transplant Proc 1991;23:3330-1.
24. Van der Heijden F, Wierenga EA, Bos JD, Kapsenberg JL. High frequency of IL-4 producing CD4+ allergen-specific T lymphocytes in atopic dermatitis lesional skin. J Invest Dermatol 1991;97:389-94.
25. Hamid Q, Naseer T, Minshall EM, Song YL, Boguniewicz M, Leung DYM. In vivo expression of IL-12 and IL-13 in atopic dermatitis. J Allergy Clin Immunol 1996;98:225-31.
26. Grewe M, Gyufko K, Schopf E, Krutmann J. Lesional expression of interferon-γ in atopic eczema. Lancet 1994;343:25-6.
27. Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh) 1989;144:13-4.