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Rheumatology Advance Access originally published online on October 21, 2009
Rheumatology 2009 48(12):1595-1599; doi:10.1093/rheumatology/kep295
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

A prospective open-label study of mycophenolate mofetil for the treatment of diffuse systemic sclerosis

Chris T. Derk1, Elizabeth Grace1, Max Shenin1, Manisha Naik1, Steffan Schulz1 and Wen Xiong1

1Division of Rheumatology, Thomas Jefferson University, Philadelphia, PA, USA.

Correspondence to: Chris T. Derk, Division of Rheumatology, Thomas Jefferson University, 613 Curtis Building, 1015 Walnut Street, Philadelphia, PA 19107, USA. E-mail: chris.derk{at}jefferson.edu


  Abstract

Objective. To evaluate the efficacy and safety of mycophenolate mofetil for the treatment of SSc.

Methods. We recruited 15 patients with dcSSc to take part in an open-label study using mycophenolate mofetil to treat their disease over a 12-month period. The primary outcome measure was the modified Rodnan skin score (mRSS), whereas secondary outcomes included the Medsger severity score, pulmonary function studies, 2D echocardiograms and the Short Form Health Survey (SF)-36 questionnaire.

Results. The mRSS significantly improved in those patients who tolerated the medication for >3 months (P < 0.0001), and there was a statistically significant improvement in the Medsger severity scores of the general (P = 0.05), peripheral vascular involvement (P = 0.05) and skin (P = 0.0003) scores. The SF-36 scores improved (P = 0.05) and the pulmonary function studies showed a trend towards improvement, though not of statistical significance. The mean pulmonary artery pressure by 2D echocardiography did not change.

Conclusions. In this prospective open-label study of mycophenolate mofetil for the treatment of dcSSc, we observed significant improvements in skin scores, peripheral vascular involvement and patient-perceived health status. Pulmonary function studies did not worsen as expected, but instead showed a trend towards improvement. Controlled trials are needed to further investigate this trend for improved pulmonary function studies.

KEY WORDS: Mycophenolate mofetil, Mycophenolic acid, Fibrosis, Systemic sclerosis, Scleroderma, Treatment

Submitted 7 April 2009; revised version accepted 12 August 2009.
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