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Titolo:
Nonclinical and early clinical development of tacrolimus ointment for the treatment of atopic dermatitis
Autore:
Bekersky, I; Fitzsimmons, W; Tanase, A; Maher, RM; Hodosh, E; Lawrence, I;
Indirizzi:
Fujisawa Healthcare Inc, Deerfield, IL 60015 USA Fujisawa Healthcare Inc Deerfield IL USA 60015 c, Deerfield, IL 60015 USA Fujisawa Pharmaceut Co Ltd, Osaka, Japan Fujisawa Pharmaceut Co Ltd Osaka Japan Pharmaceut Co Ltd, Osaka, Japan
Titolo Testata:
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
fascicolo: 1, volume: 44, anno: 2001,
pagine: S17 - S27
SICI:
0190-9622(200101)44:1<S17:NAECDO>2.0.ZU;2-K
Fonte:
ISI
Lingua:
ENG
Soggetto:
PEPTIDYL-PROLYL ISOMERASE; T-CELL ACTIVATION; HUMAN MAST-CELLS; IMMUNOSUPPRESSANT FK506; HISTAMINE-RELEASE; CYCLOSPORINE-A; FK-506; TRIAL; DEPHOSPHORYLATION; TRANSCRIPTION;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
56
Recensione:
Indirizzi per estratti:
Indirizzo: Bekersky, I Fujisawa Healthcare Inc, 3 Pkwy N, Deerfield, IL 60015 USA Fujisawa Healthcare Inc 3 Pkwy N Deerfield IL USA 60015 15 USA
Citazione:
I. Bekersky et al., "Nonclinical and early clinical development of tacrolimus ointment for the treatment of atopic dermatitis", J AM ACAD D, 44(1), 2001, pp. S17-S27

Abstract

Tacrolimus ointment, formulated for the treatment of atopic dermatitis, isthe first in a dass of topical immunomodulators. Its mechanism of action is based on calcineurin inhibition, which results in suppression of antigen-specific T-cell activation and inhibition of inflammatory cytokine release. Animal and human studies have shown chat topically applied tacrolimus is minimally absorbed into the systemic circulation, the fraction that is absorbed is extensively distributed, and tacrolimus does not accumulate in tissues following repeated topical application. In addition, tacrolimus ointmentis not inherently irritating, sensitizing, phototoxic, or photoallergenic when applied to intact skin. Unlike some topical corticosteroids, tacrolimus ointment does not cause a decrease in collagen synthesis or skin thickness, nor does it produce skin abnormalities or depigmentation. In animal studies, repeated daily application of tacrolimus ointment up to 1 year is associated with dermal findings similar to those following vehicle application (mild to moderate dermal irritation and microscopic findings of acanthosis,hyperkeratosis, and superficial inflammation). In a 52-week study with Yucatan micropigs, no noteworthy macroscopic or microscopic changes (either dermal or systemic) related to the application of tacrolimus ointment (0.03% to 0.3% concentrations) were observed. Tacrolimus ointment was shown to be safe and effective in phase 2 and early phase 3 studies. Significant improvements in atopic dermatitis were observed in the majority of patients treated with tacrolimus ointment. The most common adverse events associated withits use were a transient burning sensation and pruritus at the site of application. Blood tacrolimus concentrations were below the limit of quantitation in most patients.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 06/04/20 alle ore 08:22:59