Original articleEnteric-coated mycophenolate sodium versus cyclosporin A as long-term treatment in adult patients with severe atopic dermatitis: A randomized controlled trial
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
References (34)
- et al.
Double-blind, controlled, crossover study of cyclosporin in adults with severe refractory atopic dermatitis
Lancet
(1991) - et al.
The efficacy, tolerability and safety of a new oral formulation of Sandimmun–Sandimmun Neoral in severe refractory atopic dermatitis
J Eur Acad Dermatol Venereol
(1998) - et al.
Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients
Am J Transplant
(2004) - et al.
Serum thymus and activation-regulated chemokine (TARC) and cutaneous T cell-attracting chemokine (CTACK) levels in allergic diseases: TARC and CTACK are disease-specific markers for atopic dermatitis
J Allergy Clin Immunol
(2004) - et al.
Translating the science of quality of life into practice: what do dermatology life quality index scores mean?
J Invest Dermatol
(2005) - et al.
Inhibition of CD4+CD25+ regulatory T-cell function by calcineurin-dependent interleukin-2 production
Blood
(2006) - et al.
Effects of guanine nucleotide depletion on cell cycle progression in human T lymphocytes
Blood
(1998) - et al.
Efficacy and safety of enteric-coated mycophenolate sodium in de novo renal transplant recipients: pooled data from three 12-month multicenter, open-label, prospective studies
Transplant Proc
(2007) - et al.
Systematic review of treatments for atopic eczema
Health Technol Assess
(2000) - et al.
Maintenance treatment with cyclosporin in atopic eczema
Br J Dermatol
(1994)
Cyclosporin in atopic dermatitis: a multicenter placebo-controlled study
Br J Dermatol
Systemic therapeutic options for severe atopic dermatitis
J Dtsch Dermatol Ges
Identification of calcineurin as a key signaling enzyme in T-lymphocyte activation
Nature
Efficacy and safety of long-term treatment with cyclosporin A for atopic dermatitis
J Eur Acad Dermatol Venereol
Cyclosporin in atopic dermatitis: time to relapse and effect of intermittent therapy
Br J Dermatol
Cyclosporin in the treatment of patients with atopic eczema–a systematic review and meta-analysis
J Eur Acad Dermatol Venereol
Mechanism of action of mycophenolate mofetil
Ther Drug Monit
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Supported by Novartis Pharma BV.
Conflicts of interest: None declared.