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Tacrolimus ointment. A review of its therapeutic potential as a topical therapy in atopic dermatitis.
Am J Clin Dermatol. 2001; 2(6):389-406.AJ

Abstract

Tacrolimus, a macrolide immunomodulator, is believed to control atopic dermatitis by inhibiting T lymphocyte activation, altering cell surface expression on antigen-presenting dendritic cells and modulating the release of inflammatory mediators from skin mast cells and basophils. Tacrolimus ointment penetrates human skin with no systemic accumulation after repeated applications; systemic absorption is generally low, with most patients in clinical trials having blood concentrations of the drug below the limit of quantification. Moderate to severe atopic dermatitis significantly improved (measured using multiple end-points, including > or = 90% improvement in Physician's Global Evaluation of Clinical Response) with tacrolimus 0.03 and 0.1% ointment compared with vehicle in both adult (n = 304 and 328) and pediatric (n = 351) patients in three 12-week, double-blind, randomized, phase III trials. In adults, tacrolimus ointment was effective therapy for the treatment of atopic dermatitis on all skin regions, including the head and neck. The 0.1% concentration was more effective than the 0.03% concentration. Clinical improvement in moderate to severe atopic dermatitis in adult (n = 316) or pediatric (n = 255) patients was seen as early as week 1, and improvement continued and/or was maintained for up to 6 and/or 12 months in long-term studies. The 0.1% formulation was also effective and well tolerated for up to 2 years. Tacrolimus 0.03 and 0.1% ointment was associated with significant quality-of-life benefit in adults, children (aged 5 to 15 years) and toddlers (aged 2 to 4 years) with atopic dermatitis in 12-week phase III trials (n = 985). Skin burning and pruritus were the most common application site adverse events in adult and pediatric patients in short-term and long-term trials. These events were generally of short duration and mild or moderate severity. Cutaneous infections occurred with a similar incidence after treatment with tacrolimus ointment to that seen after vehicle in short-term trials.

CONCLUSION

Both short- and long-term monotherapy with tacrolimus 0.03 and 0.1% ointment improves moderate to severe atopic dermatitis in adult and pediatric patients. Topical tacrolimus ointment is well tolerated, with the majority of adverse events being localized, transient in nature and of mild or moderate severity. Tacrolimus ointment provides a promising addition to the currently available treatments for atopic dermatitis; it can be used as a short- or long-term intermittent therapy for moderate to severe disease, including disease on the head or neck, in adult (0.1 and 0.03% formulations) and pediatric (0.03% formulation) patients who are not adequately responsive to or are intolerant of conventional treatments.

Authors+Show Affiliations

Adis International Limited, Auckland, New Zealand. demail@adis.co.nzNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

11770393

Citation

Cheer, S M., and G L. Plosker. "Tacrolimus Ointment. a Review of Its Therapeutic Potential as a Topical Therapy in Atopic Dermatitis." American Journal of Clinical Dermatology, vol. 2, no. 6, 2001, pp. 389-406.
Cheer SM, Plosker GL. Tacrolimus ointment. A review of its therapeutic potential as a topical therapy in atopic dermatitis. Am J Clin Dermatol. 2001;2(6):389-406.
Cheer, S. M., & Plosker, G. L. (2001). Tacrolimus ointment. A review of its therapeutic potential as a topical therapy in atopic dermatitis. American Journal of Clinical Dermatology, 2(6), 389-406.
Cheer SM, Plosker GL. Tacrolimus Ointment. a Review of Its Therapeutic Potential as a Topical Therapy in Atopic Dermatitis. Am J Clin Dermatol. 2001;2(6):389-406. PubMed PMID: 11770393.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tacrolimus ointment. A review of its therapeutic potential as a topical therapy in atopic dermatitis. AU - Cheer,S M, AU - Plosker,G L, PY - 2002/1/5/pubmed PY - 2002/6/11/medline PY - 2002/1/5/entrez SP - 389 EP - 406 JF - American journal of clinical dermatology JO - Am J Clin Dermatol VL - 2 IS - 6 N2 - UNLABELLED: Tacrolimus, a macrolide immunomodulator, is believed to control atopic dermatitis by inhibiting T lymphocyte activation, altering cell surface expression on antigen-presenting dendritic cells and modulating the release of inflammatory mediators from skin mast cells and basophils. Tacrolimus ointment penetrates human skin with no systemic accumulation after repeated applications; systemic absorption is generally low, with most patients in clinical trials having blood concentrations of the drug below the limit of quantification. Moderate to severe atopic dermatitis significantly improved (measured using multiple end-points, including > or = 90% improvement in Physician's Global Evaluation of Clinical Response) with tacrolimus 0.03 and 0.1% ointment compared with vehicle in both adult (n = 304 and 328) and pediatric (n = 351) patients in three 12-week, double-blind, randomized, phase III trials. In adults, tacrolimus ointment was effective therapy for the treatment of atopic dermatitis on all skin regions, including the head and neck. The 0.1% concentration was more effective than the 0.03% concentration. Clinical improvement in moderate to severe atopic dermatitis in adult (n = 316) or pediatric (n = 255) patients was seen as early as week 1, and improvement continued and/or was maintained for up to 6 and/or 12 months in long-term studies. The 0.1% formulation was also effective and well tolerated for up to 2 years. Tacrolimus 0.03 and 0.1% ointment was associated with significant quality-of-life benefit in adults, children (aged 5 to 15 years) and toddlers (aged 2 to 4 years) with atopic dermatitis in 12-week phase III trials (n = 985). Skin burning and pruritus were the most common application site adverse events in adult and pediatric patients in short-term and long-term trials. These events were generally of short duration and mild or moderate severity. Cutaneous infections occurred with a similar incidence after treatment with tacrolimus ointment to that seen after vehicle in short-term trials. CONCLUSION: Both short- and long-term monotherapy with tacrolimus 0.03 and 0.1% ointment improves moderate to severe atopic dermatitis in adult and pediatric patients. Topical tacrolimus ointment is well tolerated, with the majority of adverse events being localized, transient in nature and of mild or moderate severity. Tacrolimus ointment provides a promising addition to the currently available treatments for atopic dermatitis; it can be used as a short- or long-term intermittent therapy for moderate to severe disease, including disease on the head or neck, in adult (0.1 and 0.03% formulations) and pediatric (0.03% formulation) patients who are not adequately responsive to or are intolerant of conventional treatments. SN - 1175-0561 UR - https://www.unboundmedicine.com/medline/citation/11770393/Tacrolimus_ointment__A_review_of_its_therapeutic_potential_as_a_topical_therapy_in_atopic_dermatitis_ L2 - https://dx.doi.org/10.2165/00128071-200102060-00005 DB - PRIME DP - Unbound Medicine ER -