Iguratimod treatment reduces disease activity in early primary Sjögren's syndrome: An open-label pilot study.

Objectives: To evaluate the efficacy and safety of iguratimod in patients with early primary Sjögren's syndrome (pSS).
Methods: Twenty-seven disease-modifying antirheumatic drug-naive female patients met the revised American-European Consensus Group criteria for pSS were enrolled in this open-label pilot study. Patients were treated with iguratimod 25 mg twice a day for 24 weeks. The disease activity was assessed with European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 12 and 24 weeks. Salivary and lacrimal gland function, laboratory, and subjective variables were also assessed. Generalized estimating equations were used to analyze parameters over time.
Results: ESSDAI (median, 5 versus 2 versus 2, p  < .01), IgG (median, 26.6 versus 22.4 versus 21.4 g/L, p  < .01) and rheumatoid factor (median, 119.9 versus 94.1 versus 83.8 lU/mL, p  < .01) levels decreased significantly during iguratimod treatment. ESSPRI, salivary and lacrimal gland function, fatigue and health-related quality of life did not change during treatment. One patient experienced thrombocytopenia, and no other serious adverse effects were observed.
Conclusion: In this study, iguratimod treatment is safe and effective for improving disease activity and laboratory parameters in early pSS patients.