Non-interventional observational retrospective-prospective study of health-related quality of life (EuroQoL) in patients with vasculitis associated with antineutrophil cytoplasmic antibodies undergoing treatment with rituximab

Working with patients with Anti-neutrophil cytoplasmic antibody (ANCA)- associated vasculitis (AAV) requires a clear understanding of their current health status. In the scientific literature, there is not enough data on their quality of life with the different therapeutic regimens. No generic tools have been developed to assess functional indicators and health status. The aim of the study is to measure the health-related quality of life (physical, psychological and social functioning) in a Bulgarian population of patients with systemic vasculitis associated with ANCA undergoing treatment with rituximab using a common tool. Design – retrospective-prospective, observational, non- interventional, controlled study in two periods, in two rheumatology centers in Bulgaria. Treatment with rituximab leads to qualitative and quantitative improvement in all components of physical health, mental and social components. All measured parameters are within the normal range for the general population. Rituximab treatment of AAV is the best therapeutic alternative in current rheumatology practice.针对抗中性粒细胞胞浆抗体（Anti-neutrophil cytoplasmic antibody, ANCA）相关血管炎（Anti-neutrophil cytoplasmic antibody-associated vasculitis, AAV）患者开展临床诊疗工作时，需清晰掌握其当前健康状态。现有科学文献中，关于该类患者在不同治疗方案下的生活质量相关数据仍较为匮乏，且尚未开发出用于评估其功能指标与健康状态的通用工具。本研究旨在借助通用评估工具，对保加利亚患者群体中接受利妥昔单抗（rituximab）治疗的抗中性粒细胞胞浆抗体相关性系统性血管炎患者的健康相关生活质量（涵盖躯体、心理及社会功能维度）进行量化测评。本研究采用两阶段回顾性前瞻性设计，在保加利亚两家风湿病学中心开展观察性非干预对照研究。研究结果显示，利妥昔单抗治疗可使患者躯体健康、心理健康及社会功能各维度均实现质与量的双重改善，所有实测参数均处于普通人群的正常参考范围内。综上，利妥昔单抗用于抗中性粒细胞胞浆抗体相关血管炎的治疗，是当前风湿病临床实践中的最优治疗选择。