A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF AZATHIOPRINE IN THE TREATMENT OF PRIMARY SJOGRENS-SYNDROME

Objective. To establish whether there is a place for low dose azathiop rine (AZA) as a disease modifying agent in patients with uncomplicated primary Sjogren's syndrome (SS). Methods. Twenty-five patients with p rimary SS were entered into a double blind, placebo controlled trial o f AZA (1 mg/kg/day) for a period of 6 months. Results. Six patients, a ll receiving active drug, withdrew because of side effects. There was no significant change in disease activity variables when measured clin ically, serologically, or histologically. Conclusion. This trial sugge sts that low dose AZA does not have a role as a disease modifying agen t in SS.