First experience with enteric-coated mycophenolate sodium (Myfortic) in severe recalcitrant adult atopic dermatitis: an open label study.

BACKGROUND

Severe atopic dermatitis (AD) is often treated successfully with oral immunosuppressive drugs such as cyclosporin (CsA) or oral corticosteroids. However, some patients develop adverse effects or are unresponsive to these first-choice oral immunosuppressive drugs.

OBJECTIVES

To evaluate whether enteric-coated mycophenolate sodium (EC-MPS) is an effective treatment in patients with severe, recalcitrant AD.

METHODS

Ten patients with severe, recalcitrant AD were treated with EC-MPS 720 mg twice daily for 6 months. All patients had to discontinue other oral immunosuppressive drugs due to adverse effects (n = 8) or nonresponsiveness (n = 2). Disease activity was monitored using the Severity Scoring of Atopic Dermatitis (modified SCORAD) index and the Leicester Sign Score (LSS). Additionally, the level of serum thymus and activation-regulated cytokine (TARC) was measured. During treatment, safety laboratory examination was performed. Total serum immunoglobulin E (IgE) was followed during treatment. Use of topical corticosteroids was recorded before and during treatment.

RESULTS

Compared with baseline, the mean scores for disease activity significantly decreased during treatment with EC-MPS [modified SCORAD (P = 0.04), LSS severity (P = 0.01), LSS extent (P = 0.01)]. In addition, serum TARC levels and total serum IgE levels significantly decreased after treatment compared with before (P = 0.03; P = 0.05). Disease activity decreased after approximately 2 months of treatment and stabilized during the 6-month treatment period. No differences in the amount of topical corticosteroids used in the 6 months prior to treatment compared with the 6-month treatment period were found (P = 0.4). None of the patients discontinued use of EC-MPS and only mild adverse effects were seen.

CONCLUSIONS

In this study EC-MPS at a dose of 720 mg twice daily for 6 months has proven to be an effective and well-tolerated treatment for patients with severe, recalcitrant AD.