Original article
Enteric-coated mycophenolate sodium versus cyclosporin A as long-term treatment in adult patients with severe atopic dermatitis: A randomized controlled trial

https://doi.org/10.1016/j.jaad.2010.04.027Get rights and content

Background

Cyclosporin A (CsA) is frequently used in the treatment of severe atopic dermatitis (AD). Enteric-coated mycophenolate sodium (EC-MPS) may be an alternative with equal efficacy and fewer side effects.

Objective

The aim of this observer-blinded randomized controlled trial was to compare EC-MPS with CsA as long-term treatment in adult patients with severe AD.

Methods

Fifty five patients with AD were treated with CsA (5 mg/kg) in a 6-week run-in period. Thereafter, patients either received CsA (3 mg/kg; n = 26) or EC-MPS (1440 mg; n = 24) during a maintenance phase of 30 weeks and there was a 12-week follow-up period. Disease activity was measured using the objective SCORAD and serum thymus and activation-regulated chemokine (TARC) levels and side effects were registered.

Results

During the first 10 weeks the objective SCORAD and serum TARC levels in the EC-MPS study arm were higher in comparison with the CsA study arm. In addition, 7 of the 24 patients treated with EC-MPS required short oral corticosteroid courses. During maintenance phase disease activity was comparable in both study arms. Side effects in both study arms were mild and transient. After study medication withdrawal, disease activity of the patients in the CsA study arm significantly increased compared with the EC-MPS study arm.

Limitation

The nonblinding of patients and prescriber of rescue medication are limitations.

Conclusions

This study shows that EC-MPS is as effective as CsA as maintenance therapy in patients with AD. However, clinical improvement with EC-MPS is delayed in comparison with CsA. Clinical remission after stopping EC-MPS lasts longer compared with CsA.

Section snippets

Patients

Patients were recruited from the Department of Dermatology of the University Medical Center Utrecht between November 2005 and November 2007. Eligible patients were 18 years or older and had the diagnosis AD according to the criteria of Hanifin and Rajka.21 Patients included showed an insufficient response to treatment with potent topical corticosteroids at time of inclusion. The exclusion criteria were: oral immunosuppressive treatment in the last 6 weeks; concomitant ultraviolet therapy;

Patients

The flow chart of the study (Fig 1) depicts the patients included in the study and the reasons for dropout during the run-in period, maintenance phase, and follow-up period. A total of 55 patients were included and started the treatment with CsA (5 mg/kg), 26 patients received CsA (3 mg/kg), and 24 patients EC-MPS (1440 mg). Baseline characteristics (Table I) were similar in both study arms with exception for objective SCORAD and serum TARC levels, this was higher in the patients starting with

Discussion

To our knowledge, this randomized controlled trial is the first study comparing two oral immunosuppressive drugs head-on in the maintenance treatment of AD. The results of this study show that after a run-in period (treatment with CsA 5 mg/kg) objective SCORAD and serum TARC levels in the EC-MPS (1440 mg) study arm did not differ from those in the CsA (3 mg/kg) study arm after a maintenance phase of 30 weeks. However, patients in the EC-MPS study arm used more rescue medication during the

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    Supported by Novartis Pharma BV.

    Conflicts of interest: None declared.

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