Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.
Mod Rheumatol. 2021 Mar;31(2):394-398. doi: 10.1080/14397595.2020.1789335. Epub 2020 Aug 3.
To evaluate the efficacy and safety of iguratimod in patients with early primary Sjögren's syndrome (pSS).
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.
ESSDAI (median, 5 versus 2 versus 2, < .01), IgG (median, 26.6 versus 22.4 versus 21.4 g/L, < .01) and rheumatoid factor (median, 119.9 versus 94.1 versus 83.8 lU/mL, < .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.
In this study, iguratimod treatment is safe and effective for improving disease activity and laboratory parameters in early pSS patients.
评估昔布类药物依那西普在原发性干燥综合征（pSS）早期患者中的疗效和安全性。
本开放标签初步研究共纳入 27 例符合修订后的美国-欧洲抗风湿病联盟（EULAR）pSS 分类标准的初治女性患者。患者接受依那西普 25mg，每日 2 次，治疗 24 周。分别于第 12 周和第 24 周采用 EULAR 干燥综合征疾病活动指数（ESSDAI）和 EULAR 干燥综合征患者报告指数（ESSPRI）评估疾病活动度。同时评估唾液腺和泪腺功能、实验室和主观变量。采用广义估计方程分析各参数随时间的变化。
ESSDAI（中位数，5 分比 2 分比 2 分， < .01）、IgG（中位数，26.6 克/升比 22.4 克/升比 21.4 克/升， < .01）和类风湿因子（中位数，119.9 国际单位/毫升比 94.1 国际单位/毫升比 83.8 国际单位/毫升， < .01）水平在依那西普治疗期间显著下降。ESSPRI、唾液腺和泪腺功能、疲劳和健康相关生活质量在治疗期间均无变化。1 例患者出现血小板减少症，但未观察到其他严重不良反应。
本研究表明，依那西普治疗可安全有效地改善早期 pSS 患者的疾病活动度和实验室参数。
