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One-year Treatment with 0.1% Tacrolimus Ointment versus a Corticosteroid Regimen in Adults with Moderate to Severe Atopic Dermatitis: A Randomized, Double-blind, Comparative Trial
A one-year, randomized, double-blind study was conducted in 80 patients with atopic dermatitis treated with tacrolimus ointment or a corticosteroid regimen (hydrocortisone acetate 1% ointment for head and neck, hydrocortisone butyrate 0.1% ointment for trunk and limbs) to compare efficacy and safety, and effects on Th2-reactivity.
The study was completed by 36/40 patients in the tacrolimus group, and 31/40 patients in the corticosteroid group. In both groups affected body surface area, eczema area and severity index, and transepidermal water loss decreased at months 6 and 12. Tacrolimus was superior for all efficacy scores at month 6, and in the head and neck area at month 12. Recall antigen reactivity increased at month 12 in both groups. Adverse events were reported by 40/40 patients in the tacrolimus, and by 34/40 patients in the corticosteroid group. Long-term treatment with topical tacrolimus or a corticosteroid regimen improves atopic dermatitis and recall antigen reactivity, suggesting an improvement in the Th1/Th2-balance.
Johanna Mandelin, Anita Remitz, Hannele Virtanen, Sakari Reitamo
Boguniewicz M, Leung DYM. Atopic dermatitis. J Allergy Clin Immunol 2006; 117: S475–480.
Stenger D, Delbruck H, Krumrey K, Zaun H. Standardisierte Recall-antigentestung bei Patienten mit malignem Melanom, endogenen Ekzematikern und Gesunden. Z Hautkr 1983; 58: 293–304.
Ellis C, Fradin M, Messana J, Brown M, Siegel M, Hartley H, et al. Cyclosporine for plaque-type psoriasis. Results of a multidose, double-blind trial. N Engl J Med 1991; 324: 277–284.
Ulrich C, Hackethal M, Meyer T, Geusau A, Nindl I, Ulrich M, et al. Skin infections in organ transplant recipients. J Dtsch Dermatol Ges 2008; 6: 98–105.
Bouwes Bavinck JN, Hardie DR, Green A, Cutmore S, MacNaught A, O’Sullivan B, et al. The risk of skin cancer in renal transplant recipients in Queensland, Australia. A follow-up study. Transplantation 1996; 61: 715–721.
Mandelin J, Remitz A, Virtanen H, Reitamo S. Recall antigen reactions in patients with atopic dermatitis treated with tacrolimus ointment for 1 year. J Allergy Clin Immunol 2008; 121: 777–779.
Simpson D, Noble S. Tacrolimus ointment: a review of its use in atopic dermatitis and its clinical potential in other inflammatory skin conditions. Drugs 2005; 65: 827–858.
Yan J, Chen SL, Wang XL, Zhou W, Wang FS. Meta-analysis of tacrolimus ointment for atopic dermatitis in pediatric patients. Pediatr Dermatol 2008; 25: 117–120.
Hanifin JM, Paller AS, Eichenfield L, Clark RA, Korman N, Weinstein G, et al. Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis. J Am Acad Dermatol 2005; 53 Suppl 2: S186–S194.
Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, et al. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol 2008; 159: 942–951.
Remitz A, Harper J, Rustin M, Goldschmidt W, Palatsi R, van der Valk P, et al. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. Acta Derm Venereol 2007; 87: 54–61.
Reitamo S, Ortonne JP, Sand C, Bos J, Cambazard F, Bieber T, et al. Long-term treatment with 0.1% tacrolimus ointment in adults with atopic dermatitis: results of a two-year, multicentre, noncomparative study. Acta Derm Venereol 2007; 87: 406–412.
Margolis D, Hoffstad O, Bilker W. Lack of association between exposure to topical calcineurin inhibitors and skin cancer in adults. Dermatology 2007; 214: 289–295.
Arellano FM, Wentworth CE, Arana A, Fernandez C, Paul CF. Risk of lymphoma following exposure to calcineurin inhibitors and topical steroids in patients with atopic dermatitis. J Invest Dermatol 2007; 127: 808–816.
Luger TA, Lahfa M, Fölster-Holst R, Gulliver WP, Allen R, Molloy S, et al. Long-term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids in adults with moderate to severe atopic dermatitis. J Dermatolog Treat 2004; 15: 169–178.
Neumann E, Amtage D, Bruckner-Tuderman L, Mockenhaupt M. A single-center open-label long-term comparison of tacrolimus ointment and topical corticosteroids for treatment of atopic dermatitis. J Dtsch Dermatol Ges 2008; 6: 548–553.
Reitamo S, Ortonne JP, Sand C, Cambazard F, Bieber T, Fölster-Holst R, et al. A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol 2005; 152: 1282–1289.
Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol 1989; 144 Suppl: 13–14.
Pinnagoda J, Tupker RA, Agner T, Serup J. Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis 1990; 22: 164–178.
Howell MD, Kim BE, Gao P, Grant AV, Boguniewicz M, De Benedetto A, et al. Cytokine modulation of atopic dermatitis filaggrin skin expression. J Allergy Clin Immunol 2007; 120: 150–155.
Cork MJ, Danby S, Vasilopoulos Y, Moustafa M, MacGowan A, Varghese J, et al. Epidermal barrier dysfunction in atopic dermatitis. In: Reitamo S, Luger TA, Steinhoff M, editors. Textbook of atopic dermatitis. London: Informa Healthcare, 2008: p. 35–57.
Leung DY. Atopic dermatitis: new insights and opportunities for therapeutic intervention. J Allergy Clin Immunol 2000; 105: 860–876.
Reitamo S, Rissanen J, Remitz A, Granlund H, Erkko P, Elg P, et al. Tacrolimus ointment does not affect collagen synthesis: results of a single-center randomized trial. J Invest Dermatol 1998; 111: 396–398.
Kyllönen H, Remitz A, Mandelin JM, Elg P, Reitamo S. Effect of one-year intermittent treatment with topical tacrolimus monotherapy on skin collagen synthesis in patients with atopic dermatitis. Br J Dermatol 2004; 150: 1174–1181.
Reitamo S, Wollenberg A, Schöpf E, Perrot JL, Marks R, Ruzicka T, et al. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Arch Dermatol 2000; 136: 999–1006.
Laske N, Niggemann B. Does the severity of atopic dermatitis correlate with serum IgE levels? Pediatr Allergy Immunol 2004; 15: 86–88.
Williams H, Flohr C. How epidemiology has challenged 3 prevailing concepts about atopic dermatitis. J Allergy Clin Immunol 2006; 118: 209–213.
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Volume 90, Issue 2
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