Farmacoriflessioni
Tacrolimus unguento
TACROLIMUS OINTMENT
MARZIA LAZZERINI, FEDERICO MARCHETTI, GIORGIO LONGO
Clinica Pediatrica, IRCCS “Burlo Garofolo”, Università di Trieste
Febbraio 2004 - pagg. 102 -107
Abstract
The safety and efficacy of tacrolimus - a macrolide with immunosuppressive properties -
were proven in atopic dermatitis in several trials versus placebo and in two trials versus topical
steroids. The drug, as a 0.03% ointment, has been now approved for use in children
older than two years affected by eczema, while the use of the 0.1% preparation, which has
an activity comparable to medium strenght steroids, has been restricted to adults. The target
of tacrolimus are T lymphocites and the receptors with high affinity for IgE on the Langerhans
cells. Its cost is more than ten times higher than topical steroids and its use should
therefore be limited to moderate to severe eczema resistant to conventional treatment with
steroids.
Parole chiave
Classificazione MeSH
Bibliografia
1. Leung DYM, Bieber T. Atopic Dermatitis.
Lancet 2003;361:151-60.
2. Hoare C, Li Wan Po A, Williams H. Systematic review of treatments for atopic eczema. Health Technol Assess 2000;4:1-191.
3. Williams H. New Treatments for atopic dermatitis. Good news, but when and how to use tacrolimus and pimecrolimus is a muddle. BMJ 2002;324:1533-4.
4. Reitamo S. Tacrolimus: a new topical immunomodulatory therapy for atopic dermatitis. J Allergy Clin Immunol 2001;107:445-8.
5. Nghiem P, Pearson G, Langley RG.Tacrolimus and pimecrolimus: from clever prokaryotes to inhibiting calcineurin and treating atopic dermatitis. J Am Acad Dermatol 2002;46:228- 41.
6. Wollenberg A, Sharma S, von Bubnoff D, Geiger E, Haberstok J, Bieber T. Topical tacrolimus (FK506) leads to profound phenotypic and functional alterations of epidermal antigen- presenting dendritic cells in atopic dermatitis. J Allergy Clin Immunol 2001;107:519- 25.
7. Remitz A, Kyllonen H, Granlud H, Reitamo S. Tacrolimus ointment reduces stafilococcal colonization of atopic dermatitis lesions (letter). J Allergy Clin Immunol 2001;107:196.
8. Haunk PJ, Leung DYM. Tacrolimus (FK506): new treatments approach in superantigen- associated disease like atopic dermatitis. J Allergy Clin Immunol 2001;107:391- 2.
9. Panhans-Grob A, Novak N, Kraft S, Bieber T. Human epidermal Langerhans cells are targets for the immunosuppressive macrolide tacrolimus (FK506). J Allergy Clin Immunol 2001;107:345-2.
10. Lawrence ID. Tacrolimus (FK506): experience in dermatology. Dermatol Ther 1998; 5:74-84.
11. Protopic 0.03%. Riassunto delle caratteristiche del prodotto. Italia, Fujisawa 2003.
12. Bogoniewicz M, et al. A randomized vehicle- controlled trial of tacrolimus ointment for the treatment of atopic dermatitis in children. J Allergy Clin Immunol 1998;102:637-44.
13. Ruzicka T, et al. A short-term trial of tacrolimus ointment for atopic dermatitis. N Engl J Med 1997;337:816-21.
14. Paller A, et al. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. J Am Acad Dermatol 2001;44:S47-57.
15. Hanifin JM, et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part I, Efficacy. J Am Acad Dermatol 2001;44:S28-38.
16. Reitamo S, et al. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis. J Allergy Clin Immunol 2002;109:539-46.
17. Reitamo S, et al. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol 2002;109:547-55.
18. Kawakami T, et al. Safe and effective treatment of refractory facial lesion in atopic dermatitis using topical tacrolimus following corticosteroid discontinuation. Dermatology 2001;203:32-7.
19. Drake L, et al. The impact of tacrolimus ointment on health-related quality of life of adult and pediatrics patients with atopic dermatitis. J Am Acad Dermatol 2001:44:S65-72.
20. Kang S, et al. Long term safety and efficacy ot tacrolimus ointment for the treatment of atopic dermatitis in children . J Am Acad Dermatol 2001:44:S58-64.
21. Reitamo S, et al. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adult with atopic dermatitis. Arch Dermatol 2000;136:999-1006.
22. Reitamo S, et al. Tacrolimus ointment does not effect collagen synthesis: result of a single- center randomized trial. J Invest Dermatol 1998;111:396-8.
23. Soter NA, et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part II, Safety. J Am Acad Dermatol 2001;44:S28-38.
24. Topical tacrolimus - a role in atopic dermatitis? Drug and Therapeutics Bulletin 2002;40 (10):73-5.
25. Thomas KS, Armstrong S, Avery A, et al. Randomized controlled trial of a short burst of a potent topical corticosteroid versus prolunged use of a mild preparation for children with mild to moderate atopic eczema. BMJ 2002; 324:768-71.
26. Patel RR, Vander Straten MR, Korman NJ. The safety and efficacy of tacrolimus therapy in patients younger than 2 years with atopic dermatitis. Arch Dermatol 2003p;139 (9):1184-6.
2. Hoare C, Li Wan Po A, Williams H. Systematic review of treatments for atopic eczema. Health Technol Assess 2000;4:1-191.
3. Williams H. New Treatments for atopic dermatitis. Good news, but when and how to use tacrolimus and pimecrolimus is a muddle. BMJ 2002;324:1533-4.
4. Reitamo S. Tacrolimus: a new topical immunomodulatory therapy for atopic dermatitis. J Allergy Clin Immunol 2001;107:445-8.
5. Nghiem P, Pearson G, Langley RG.Tacrolimus and pimecrolimus: from clever prokaryotes to inhibiting calcineurin and treating atopic dermatitis. J Am Acad Dermatol 2002;46:228- 41.
6. Wollenberg A, Sharma S, von Bubnoff D, Geiger E, Haberstok J, Bieber T. Topical tacrolimus (FK506) leads to profound phenotypic and functional alterations of epidermal antigen- presenting dendritic cells in atopic dermatitis. J Allergy Clin Immunol 2001;107:519- 25.
7. Remitz A, Kyllonen H, Granlud H, Reitamo S. Tacrolimus ointment reduces stafilococcal colonization of atopic dermatitis lesions (letter). J Allergy Clin Immunol 2001;107:196.
8. Haunk PJ, Leung DYM. Tacrolimus (FK506): new treatments approach in superantigen- associated disease like atopic dermatitis. J Allergy Clin Immunol 2001;107:391- 2.
9. Panhans-Grob A, Novak N, Kraft S, Bieber T. Human epidermal Langerhans cells are targets for the immunosuppressive macrolide tacrolimus (FK506). J Allergy Clin Immunol 2001;107:345-2.
10. Lawrence ID. Tacrolimus (FK506): experience in dermatology. Dermatol Ther 1998; 5:74-84.
11. Protopic 0.03%. Riassunto delle caratteristiche del prodotto. Italia, Fujisawa 2003.
12. Bogoniewicz M, et al. A randomized vehicle- controlled trial of tacrolimus ointment for the treatment of atopic dermatitis in children. J Allergy Clin Immunol 1998;102:637-44.
13. Ruzicka T, et al. A short-term trial of tacrolimus ointment for atopic dermatitis. N Engl J Med 1997;337:816-21.
14. Paller A, et al. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. J Am Acad Dermatol 2001;44:S47-57.
15. Hanifin JM, et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part I, Efficacy. J Am Acad Dermatol 2001;44:S28-38.
16. Reitamo S, et al. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis. J Allergy Clin Immunol 2002;109:539-46.
17. Reitamo S, et al. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol 2002;109:547-55.
18. Kawakami T, et al. Safe and effective treatment of refractory facial lesion in atopic dermatitis using topical tacrolimus following corticosteroid discontinuation. Dermatology 2001;203:32-7.
19. Drake L, et al. The impact of tacrolimus ointment on health-related quality of life of adult and pediatrics patients with atopic dermatitis. J Am Acad Dermatol 2001:44:S65-72.
20. Kang S, et al. Long term safety and efficacy ot tacrolimus ointment for the treatment of atopic dermatitis in children . J Am Acad Dermatol 2001:44:S58-64.
21. Reitamo S, et al. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adult with atopic dermatitis. Arch Dermatol 2000;136:999-1006.
22. Reitamo S, et al. Tacrolimus ointment does not effect collagen synthesis: result of a single- center randomized trial. J Invest Dermatol 1998;111:396-8.
23. Soter NA, et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part II, Safety. J Am Acad Dermatol 2001;44:S28-38.
24. Topical tacrolimus - a role in atopic dermatitis? Drug and Therapeutics Bulletin 2002;40 (10):73-5.
25. Thomas KS, Armstrong S, Avery A, et al. Randomized controlled trial of a short burst of a potent topical corticosteroid versus prolunged use of a mild preparation for children with mild to moderate atopic eczema. BMJ 2002; 324:768-71.
26. Patel RR, Vander Straten MR, Korman NJ. The safety and efficacy of tacrolimus therapy in patients younger than 2 years with atopic dermatitis. Arch Dermatol 2003p;139 (9):1184-6.