- List articles in this issue
Safety and Efficacy of Tacrolimus Ointment Versus Pimecrolimus Cream in the Treatment of Patients with Atopic Dermatitis Previously Treated with Corticosteroids
Adult and pediatric patients (n = 347) with atopic dermatitis enrolled in three multicenter, randomized, 6-week studies who had previously used steroids were analyzed to examine the null hypothesis that improvement in atopic dermatitis initiated after prior treatment with steroids eliminates any subsequent treatment differences between tacrolimus ointment and pimecrolimus cream. Of these patients, 171 were randomized to tacrolimus ointment and 176 to pimecrolimus cream. Based on improvement in the Eczema Area and Severity Index at the end of study, tacrolimus ointment was significantly more effective than pimecrolimus cream (p = 0.0002). Tacrolimus ointment was also significantly more effective than pimecrolimus cream at the end of study in all secondary end-points. Overall, the frequency of adverse events was comparable between treatment groups (24.0% for tacrolimus ointment vs. 25.6% for pimecrolimus cream). Tacrolimus ointment is more effective, with a similar safety profile, compared with pimecrolimus cream in patients with atopic dermatitis previously treated with topical corticosteroids.
Robert S. Kirsner, Michael P. Heffernan and Richard Antaya
Akdis CA, Akdis M, Bieber T, Bindslev-Jensen C, Boguniewicz M, Eigenmann P, et al. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/ American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Report. Allergy 2006; 61: 969–987.
Lewis-Jones S, Mugglestone MA. Management of atopic eczema in children aged up to 12 years: summary of NICE guidance. Br Med J 2007; 335: 1263–1264.
Maloney JM, Morman MR, Stewart DM, Tharp MD, Brown JJ, Rajagopalan R. Clobetasol propionate emollient 0.05% in the treatment of atopic dermatitis. Int J Dermatol 1998; 37: 142–144.
Lubach D, Bensmann A, Bornemann U. Steroid-induced dermal atrophy. Investigations on discontinuous application. Dermatologica 1989; 179: 67–72.
Garrott HM, Walland MJ. Glaucoma from topical corticosteroids to the eyelids. Clin Experiment Ophthalmol 2004; 32: 224–226.
Ellison JA, Patel L, Ray DW, David TJ, Clayton PE. Hypothalamic-pituitary-adrenal function and glucocorticoid sensitivity in atopic dermatitis. Pediatrics 2000; 105: 794–799.
Protopic Prescribing Information: Astellas Pharma US, Inc.; Revised: January 2006.
Elidel Prescribing Information: Novartis Pharmaceuticals Corp.; Revised: August 2007.
Hanifin JM, Ling MR, Langley R, Breneman D, Rafal E. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part I, efficacy. J Am Acad Dermatol 2001; 44: S28–S38.
Paller A, Eichenfield LF, Leung DY, Stewart D, Appell M. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. J Am Acad Dermatol 2001; 44: S47–S57.
Soter NA, Fleischer AB, Jr., Webster GF, Monroe E, Lawrence I. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. J Am Acad Dermatol 2001; 44: S39–S46.
Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Cherill R, Marshall K, et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol 2002; 46: 495–504.
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.
Kang S, Lucky AW, Pariser D, Lawrence I, Hanifin JM. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. J Am Acad Dermatol 2001; 44: S58–S64.
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: S186–S194.
Koo JY, Fleischer AB, Jr., Abramovits W, Pariser DM, McCall CO, Horn TD, et al. Tacrolimus ointment is safe and effective in the treatment of atopic dermatitis: results in 8000 patients. J Am Acad Dermatol 2005; 53: S195–S205.
Remitz A, Harper J, Rustin M, Goldschmidt WF, Palatsi R, van der Valk PG, 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 JD, 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, non-comparative study. Acta Derm Venereol 2007; 87: 406–412.
Meurer M, Fölster-Holst R, Wozel G, Weidinger G, Jünger M, Bräutigam M. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology 2002; 205: 271–277.
Meurer M, Fartasch M, Albrecht G, Vogt T, Worm M, Ruzicka T, et al. Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis. Dermatology 2004; 208: 365–372.
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.
Papp K, Staab D, Harper J, Potter P, Puig L, Ortonne JP, et al. Effect of pimecrolimus cream 1% on the long-term course of pediatric atopic dermatitis. Int J Dermatol 2004; 43: 978–983.
Paller AS, Lebwohl M, Fleischer AB Jr., Antaya R, Langley RG, Kirsner RS, et al. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol 2005; 52: 810–822.
Hanifin J, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol 1980; 92: 44–47.
Barbier N, Paul C, Luger T, Allen R, De Prost Y, Papp K, et al. Validation of the Eczema Area and Severity Index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. Br J Dermatol 2004; 150: 96–102.
Zuberbier T, Orlow SJ, Paller AS, Taïeb A, Allen R, Hernanz-Hermosa JM, et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol 2006; 118: 226–232.
Fleischer AB Jr., Abramovits W, Breneman D, Jaracz E. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat 2007; 18: 151–157.
Kempers S, Boguniewicz M, Carter E, Jarratt M, Pariser D, Stewart D, et al. A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis. J Am Acad Dermatol 2004; 51: 515–525.
There are no related articles.
Share with your friends
There is no supplementary for this article.
Volume 90, Issue 1
View at PubMed