Open Access Open Badges Research article

Mycophenolate sodium treatment in patients with primary Sjögren syndrome: a pilot trial

Peter Willeke1*, Bernhard Schlüter2, Heidemarie Becker1, Heiko Schotte1, Wolfram Domschke1 and Markus Gaubitz1

Author Affiliations

1 Department of Medicine B, Muenster University Hospital, Albert Schweitzer Street 33, D-48129 Muenster, Germany

2 Institute of Clinical Chemistry and Laboratory Medicine, Muenster University Hospital, Albert Schweitzer Street 33, D-48129 Muenster, Germany

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Arthritis Research & Therapy 2007, 9:R115  doi:10.1186/ar2322

Published: 6 November 2007


The aim of this study was to evaluate the efficacy and safety of mycophenolate sodium (MPS) in patients with primary Sjögren syndrome (pSS) refractory to other immunosuppressive agents. Eleven patients with pSS were treated with MPS up to 1,440 mg daily for an observation period of 6 months in this single-center, open-label pilot trial. At baseline, after 3 months, and after 6 months, we examined the clinical status, including glandular function tests, as well as different laboratory parameters associated with pSS. In addition, subjective parameters were determined on the basis of different questionnaires. Treatment with MPS was well tolerated in 8 of 11 patients. Due to vertigo or gastrointestinal discomfort, two patients did not complete the trial. One patient developed pneumonia 2 weeks after treatment and was withdrawn. In the remaining patients, MPS treatment resulted in subjective improvement of ocular dryness on a visual analogue scale and a reduced demand for artificial tear supplementations. However, no significant alterations of objective parameters for dryness of eyes and mouth were observed, although a substantial improvement of glandular functions occurred in two patients with short disease duration. In addition, treatment with MPS resulted in significant reduction of hypergammaglobulinemia and rheumatoid factors as well as an increase of complement levels and white blood cells. MPS promises to be an additional therapeutic option for patients with pSS, at least in those with shorter disease duration. Further investigations about the efficacy and safety of MPS in pSS have to be performed in larger numbers of patients.