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

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...

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Published in:	Journal of the American Academy of Dermatology 2011-06, Vol.64 (6), p.1074-1084
Main Authors:	Haeck, Inge M., MD, Knol, Mirjam J., PhD, ten Berge, Onno, MD, van Velsen, Sara G.A., MD, de Bruin-Weller, Marjolein S., MD, PhD, Bruijnzeel-Koomen, Carla A.F.M., MD, PhD
Format:	Article
Language:	eng
Subjects:	Adult adults Allergic diseases atopic dermatitis Biological and medical sciences Chemokine CCL17 - blood cyclosporin A Cyclosporine - therapeutic use Dermatitis, Atopic - drug therapy Dermatology enteric-coated mycophenolate sodium Enzyme Inhibitors Female Humans Immunoglobulin E - blood Immunopathology Immunosuppressive Agents - therapeutic use Male Medical sciences Middle Aged Mycophenolic Acid - administration & dosage Mycophenolic Acid - analogs & derivatives randomized controlled trial Skin allergic diseases. Stinging insect allergies Tablets, Enteric-Coated
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Summary:	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.
ISSN:	0190-9622 1097-6787