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.