A double blind placebo controlled trial of azathioprine in the treatment of primary Sjögren's syndrome

J Rheumatol. 1998 May;25(5):896-9.


Objective: To establish whether there is a place for low dose azathioprine (AZA) as a disease modifying agent in patients with uncomplicated primary Sjögren's syndrome (SS).

Methods: Twenty-five patients with primary SS were entered into a double blind, placebo controlled trial of AZA (1 mg/kg/day) for a period of 6 months.

Results: Six patients, all receiving active drug, withdrew because of side effects. There was no significant change in disease activity variables when measured clinically, serologically, or histologically.

Conclusion: This trial suggests that low dose AZA does not have a role as a disease modifying agent in SS.

Publication types

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

MeSH terms

  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / adverse effects
  • Antirheumatic Agents / therapeutic use*
  • Azathioprine / administration & dosage
  • Azathioprine / adverse effects
  • Azathioprine / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Sjogren's Syndrome / drug therapy*
  • Treatment Outcome


  • Antirheumatic Agents
  • Azathioprine