Comparison of Two Formulations of Cyclosporin A in the Treatment of Severe Atopic Dermatitis

Abstract

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.

Cyclosporin in the treatment of patients with atopic eczema – a systematic review and meta‐analysis

“…The study comparing two different formulations of cyclosporin observed a more rapid response (after 2 weeks) in the group treated with the microemulsion (Neoral®) compared patients receiving the older formulation Sandimmun®. After 8 weeks of treatment, the mean decrease was similar in both groups 29 …”

“…All 15 studies were performed in Europe. Sample size ranged from 10 to 106 patients with the majority (80%) of studies including less than 50 patients 23,25,27,29–37 . Three studies included only children, four studies both children and adults, and eight studies exclusively adults (Table 1).…”

Guidelines of care for the management of atopic dermatitis

“…While all formulations of CSA are effective in AD, the microemulsion formulation demonstrated more rapid onset of action and greater initial efficacy relative to the conventional formulation in one double-blind, cross-over study. 40 Modified microemulsion formulation of CSA is not bioequivalent to the non-modified formulation (both are available in oral capsules and solution), and the medications should not be used interchangeably.…”

Effect of Low-Dose Cyclosporin A Microemulsion on Disease Severity, Interleukin-6, Interleukin-8 and Tumor Necrosis Factor Alpha Production in Severe Pediatric Atopic Dermatitis

“…Several studies have shown that oral cyclosporin A (CyA) is beneficial in the treatment of children with severe AD [22, 23, 24, 25]. CyA inhibits T cell activation and cytokine production [21, 22], thus potentially downregulating crucial steps in the immunopathogenesis of AD.…”