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Journal of the American Academy of Dermatology
Volume 44, n° 4
pages 643-651 (avril 2001)
Doi : 10.1067/mjd.2001.112400
Intermittent short courses of cyclosporine microemulsion for the long-term management of psoriasis: A 2-year cohort study
 

Vincent C.Y. Ho, MD, FRCPC a, Christopher E.M. Griffiths, MD, FRCP b, John Berth-Jones, FRCP c, Kim A. Papp, MD, PhD, FRCPC d, Francisco Vanaclocha, MD e, Esteban Dauden, MD, PhD f, Anna Beard, BSc g, Lohita Puvanarajan, MSc h, Carle Paul, MD i
Vancouver, British Columbia and Waterloo, Ontario, Canada; Manchester, Coventry, and London, United Kingdom; Madrid, Spain; and Basel, Switzerland 
From the Division of Dermatology, University of British Columbia, The Skin Care Center, Vancouver General Hospitala; the Dermatology Centre, Hope Hospital, University of Manchesterb; the Department of Dermatology, Walsgrave Hospital, Coventryc; Grand River Hospital/St Mary's General Hospital, Waterlood; Hospital 12 de Octubre, Jefe de Servicio de Dermatologia,e and the Hospital La Princesa, Servicio de Dermatologia,f Madrid; Novartis Pharmaceuticals UK Ltd, Camberleyg; Hartington Statistics and Data Management Ltd, Londonh; and Clinical Research and Development, Novartis Pharma AG, Basel.i 

Abstract

Background: Cyclosporine is effective in psoriasis, but long-term continuous therapy may be limited by renal impairment and hypertension. Intermittent short courses of treatment should minimize side effects and improve the risk-benefit ratio. Objective: Our purpose was to assess the long-term efficacy and safety of intermittent short courses of the microemulsion formulation of cyclosporine (Neoral) in the management of chronic plaque psoriasis unresponsive to topical therapies. Methods: In a multicenter open cohort study, 76 subjects were treated intermittently over a 2-year period. Patients with chronic plaque psoriasis were treated with cyclosporine until clearance of psoriasis or for a maximum of 12 weeks. Patients were then randomized into two groups. Group A stopped cyclosporine abruptly, whereas group B had the dose reduced by 1 mg/kg per day each week until cessation, which was within 4 weeks. On relapsing, patients received further courses of cyclosporine. Intermittent treatment was continued in this way for 42 years. Results: There was no statistically significant difference in the percentage of time in remission during the 2-year period between patients randomized to stop cyclosporine abruptly (56.2%) and patients randomized to taper cyclosporine within 4 weeks (61.8%). The mean percentage of time that patients received treatment during the study was 40.5% for randomization group A, 46.2% for randomization group B, and 42.8% overall. The median time to relapse was 115.5 days after the first treatment course but became progressively shorter after multiple treatment courses. Mean blood pressure and serum creatinine levels did not show any clinically significant changes over time. Conclusions: This study indicates that intermittent short courses of cyclosporine are effective in patients with moderate to severe psoriasis for up to 2 years while improving the safety profile relative to continuous cyclosporine monotherapy.

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 The members of the Psoriasis Intermittent Short Courses of Efficacy of Sandimmun Neoral (PISCES) study group are as follows: Canada: W. Gulliver, V. C. Ho, S. Murray, K. Papp, G. Sibbald, P. Draga; Spain: A. Boliche, J. Escudero, E. Dauden, F. Vanaclocha, I. Andres; UK: I. Ahmed, G. Barclay, J. Berth-Jones, N. Craven, S. George, M. Goodfield, C. E. M. Griffiths, P. Harrison, G. Holmes, D. Kemmett, H. Lewis, K. McElhone, D. Seukeran, S. Sidhu, D. Stewart, J. Waterhouse, L. Puvanarajan, C. Haliburn, R. Keefe, A. Beard; Novartis Pharma AG, Switzerland: C. Paul, J. Ericson.
 Reprint requests: V. C. Ho, MD, Division of Dermatology, University of British Columbia, The Skin Care Center, Vancouver General Hospital, 835 W 10th Ave, Vancouver, BC, Canada V5Z 4E8. E-mail: vho@interchange.ubc.ca.
 J Am Acad Dermatol 2001;44:643-51



© 2001  American Academy of Dermatology, Inc. Published by Elsevier Masson SAS@@#104157@@
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