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Objective. There is no effective treatment for patients with primary Sjögren’s syndrome (SS). Since tumor necrosis factor (TNF) could be a key element in the pathogenesis of primary SS, we conducted a multicenter, randomized, double-blind, placebocontrolled trial to evaluate the effect of infliximab in primary SS.

Methods. A total of 103 patients with primary SS were randomly assigned to receive infliximab infusions (5 mg/kg) or placebo at weeks 0, 2, and 6 and were followed up for 22 weeks. All patients fulfilled the new American-European Consensus Group criteria for SS and had active disease as assessed by values> 50 mm on 2 of 3 visual analog scales (VAS)(0–100 mm) that evaluated joint pain, fatigue, and buccal, ocular, skin, vaginal, or bronchial dryness. A favorable overall response was defined as the patient having> 30% improvement between weeks 0 and 10 in the values on 2 of the 3 VAS. Secondary …