Bertsias George, Fanouriakis Antonis, Bartsakoulia Marina, Galanakis Petros, Boumpas Dimitrios T
Rheumatology and Clinical Immunology, University of Crete Medical School, Heraklion, Greece.
Division of Immunity, Institute of Molecular Biology and Biotechnology-Foundation for Research and Technology - Hellas (FORTH), Heraklion, Greece.
Mediterr J Rheumatol. 2024 Jun 30;35(Suppl 2):392-401. doi: 10.31138/mjr.160524.tns. eCollection 2024 Jun.
Systemic lupus erythematosus (SLE) has a spectrum of phenotypes. Its management should target remission or low disease activity, prevention of relapses and organ damage, minimisation of drug-related harms, and optimisation of health-related quality of life. Advances in our understanding of the disease pathophysiology have expanded the treatment armamentarium with targeted biologics that demonstrate superiority over conventional drugs in controlling activity, reducing flares and glucocorticoid exposure, and improving patient-related outcomes. In view of this, there is a critical need for real-world evidence providing insight into the spectrum of activity, the treatment landscape, and unmet needs among SLE patients. Such information can support regulatory and reimbursement decision-making. The primary objective of the NYMERIA multicentre study is to generate real-world evidence on the activity state of SLE patients treated in routine care settings in Greece. The overarching aim is to capture the disease burden based on both clinical aspects and the patient perspective.
系统性红斑狼疮(SLE)具有一系列表型。其治疗应旨在实现缓解或低疾病活动度,预防复发和器官损害,将药物相关危害降至最低,并优化健康相关生活质量。我们对该疾病病理生理学认识的进展扩大了治疗手段,出现了靶向生物制剂,这些生物制剂在控制疾病活动、减少病情复发和糖皮质激素暴露以及改善患者相关结局方面显示出优于传统药物的优势。鉴于此,迫切需要来自真实世界的证据,以深入了解SLE患者的疾病活动谱、治疗现状和未满足的需求。此类信息可为监管和报销决策提供支持。NYMERIA多中心研究的主要目标是生成关于在希腊常规护理环境中接受治疗的SLE患者活动状态的真实世界证据。总体目标是从临床方面和患者角度全面了解疾病负担。