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

Arthritis Res Ther. 2007;9(6):R115. doi: 10.1186/ar2322.

Abstract

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 One patient developed pneumonia 2 weeks after treatment and was withdrawn.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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Drug Tolerance
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Lacrimal Apparatus / drug effects
  • Lacrimal Apparatus / physiopathology
  • Middle Aged
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / adverse effects
  • Mycophenolic Acid / therapeutic use*
  • Prospective Studies
  • Safety
  • Saliva / metabolism
  • Sjogren's Syndrome / drug therapy*
  • Sjogren's Syndrome / immunology
  • Sjogren's Syndrome / pathology
  • Sjogren's Syndrome / physiopathology
  • Surveys and Questionnaires
  • Xerophthalmia / drug therapy
  • Xerophthalmia / physiopathology
  • gamma-Globulins / metabolism

Substances

  • Immunosuppressive Agents
  • gamma-Globulins
  • Mycophenolic Acid