Leverenz David L, St Clair E William
Department of Medicine, Division of Rheumatology and Immunology, School of Medicine, Duke University, 40 Duke Medicine Circle, Durham, NC, 27110, USA.
F1000Res. 2019 Aug 29;8. doi: 10.12688/f1000research.19842.1. eCollection 2019.
Primary Sjögren's syndrome is a chronic autoimmune disease characterized by salivary and lacrimal gland dysfunction, leading to substantial morbidity and reduced quality of life. Many patients with primary Sjögren's syndrome also have extraglandular systemic complications, some of which can be organ- or life-threatening. Over the last decade, numerous targeted immunomodulatory therapies for primary Sjögren's syndrome have failed to show a benefit in clinical trials, and as yet no disease-modifying therapy has been approved for this disease. Herein, we provide an updated review of the clinical trial landscape for primary Sjögren's syndrome and the numerous efforts to move the field forward, including the development of new classification criteria and outcome measures, the results of recent clinical trials in this field, the challenges faced in the search for effective therapies, and the expanding pipeline of novel therapies under development.
原发性干燥综合征是一种慢性自身免疫性疾病，其特征为唾液腺和泪腺功能障碍，可导致严重发病并降低生活质量。许多原发性干燥综合征患者还存在腺外系统性并发症，其中一些可能危及器官或生命。在过去十年中，针对原发性干燥综合征的众多靶向免疫调节疗法在临床试验中均未显示出益处，且目前尚无针对该疾病的疾病修正疗法获批。在此，我们对原发性干燥综合征的临床试验情况以及推动该领域进展的诸多努力进行了更新综述，包括新分类标准和结局指标的制定、该领域近期临床试验的结果、寻找有效疗法所面临的挑战以及正在研发的新型疗法的不断扩充。
