Background: Cyclosporin A (CsA) has been shown to be highly effective in the therapy of atopic dermatitis (AD). However, little information exists on the treatment of AD patients with Sandimmun Neoral® (Neoral), a microemulsion of CsA with improved pharmacokinetic properties in comparison to Sandimmun®. Objective: We have compared the efficacy and tolerability of Sandimmun and Neoral. Methods: In a randomised, monocentric, double-blind, cross-over pilot study (n = 14), each formulation was administered for 8 weeks, followed by switching to the other treatment group for another 8 weeks. Results: After 2 weeks of therapy, the improvement under Neoral therapy was significantly higher than with Sandimmun (disease activity p = 0.047; extent of disease p = 0.016). In contrast, after 8 weeks of therapy, both formulations yielded similar improvement in the patients’ condition. Conclusion: While both formulations are effective and well tolerated in the treatment of severe AD, Neoral may have a faster onset of action and higher initial efficacy, which makes it an adequate replacement for Sandimmun.

Keywords:
Atopic dermatitis, Sandimmun, Sandimmun Neoral, Efficacy, Tolerability
1.
Kägi MK, Wüthrich B, Montano E, Barandun J, Blaser K, Walker Ch: Differential cytokine profiles in peripheral blood lymphocyte supernatants and skin biopsies from patients with different forms of atopic dermatitis, psoriasis and normal individuals. Int Arch Allergy Immunol 1994;103:332–340.
2.
Kägi MK, Joller-Jemelka H, Wüthrich B: Correlation of eosinophils, eosinophil cationic protein and soluble interleukin-2 receptor with the clinical activity of atopic dermatitis. Dermatology 1992;185:88–92.
3.
Kapp A, Piskorski A, Schöpf E: Elevated levels of interleukin-2 receptor in sera of patients with atopic dermatitis. Br J Dermatol 1988;119: 707–710.
4.
Wüthrich B, Joller-Jemelka H, Kägi MK: Levels of soluble ICAM-l in atopic dermatitis. Allergy 1995;50:88–89.
5.
Leung DYM: Atopic dermatitis: Immunobiology and treatment with immune modulators. Clin Exp Immunol 1997;107(suppl 1):25–30.
6.
Sowden JM, Berth-Jones J, Ross JS, Motley RJ, Marks R, Finlay AY, Salek MS, Graham-Brown RAC, Allen BR, Camp RDR: Double-blind, controlled, crossover study of cyclosporin in adults with severe refractory atopic dermatitis. Lancet 1991;338:137–140.
7.
Munro CS, Levell NJ, Shuster S, Friedmann PS: Maintenance treatment with cyclosporin in atopic eczema. Br J Dermatol 1994;130:376– 380.
8.
Sepp N, Fritsch PO: Can cyclosporin A induce permanent remission of atopic dermatitis? Br J Dermatol 1993;128:213–216.
9.
Chawla M, Ali M, Marks R: Comparison of the steady state pharmacokinetics of two formulations of cyclosporin in patients with atopic dermatitis. Br J Dermatol 1996;135(suppl 48): 9–14.
10.
Elder CA, Moore M, Chang CT, Jin J, Charnick S, Nedelman J, Cohen A, Guzzo C, Lowe N, Simpson K, Karara AH, Meligeni J: Efficacy and pharmacokinetics of two formulations of cyclosporine A in patients with psoriasis. J Clin Pharmacol 1995;35:865–875.
11.
Feutren G, Abeywickrama K, Friend D, von Graffenried B: Renal function and blood pressure in psoriatic patients treated with cyclosporin A. Br J Dermatol 1990;122(suppl 36): 57–69.
12.
Vonderscher J, Meinzer A: Rationale for the development of Sandimmun Neoral. Transplant Proc 1994;26:2925–2927.
13.
Bourke JF, Berth-Jones J, Holder J, Graham-Brown RAC: A new microemulsion formulation of cyclosporin (Neoral) is effective in treatment of cyclosporin-resistant dermatoses. Br J Dermatol 1996;134:777–779.
14.
Hanifin TM, Rajka G: Diagnostic features of atopic dermatitis. Acta Derm Venereol (Stockh) 1980;S2:44–47.
15.
Diepgen TL, Fartasch M, Hornstein OP: Evaluation and relevance of atopic basic and minor features in patients with atopic dermatitis and the general population. Acta Derm Venereol (Stockh) 1989 suppl;144:50–54.
16.
Erkko P, Grandlund IL, Nuutinen M, Reitamo S: Comparison of cyclosporin A pharmacokinetics of a new microemulsion formulation and standard oral preparation in patients with psoriasis. Br J Dermatol 1997;136:82–88.
1999
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