Galindo-Izquierdo María, Bahamontes-Rosa Noemí, Sarto-Ferres Berta, Galvez-Fernandez Marta, Cortés-Hernández Josefina
Rheumatology Department, Instituto de Investigación Hospital 12 de Octubre, Madrid, Spain.
Biopharmaceuticals Medical, AstraZeneca, Madrid, Spain.
Lupus Sci Med. 2025 Feb 12;12(1):e001486. doi: 10.1136/lupus-2024-001486.
Anifrolumab (Saphnelo) is approved for adult patients with moderate-severe systemic lupus erythematosus (SLE). Considering its commercialisation in Spain in 2023, observational studies describing the use of anifrolumab in routine clinical practice are limited. The aim of the AZAHAR study is to describe the characteristics and clinical outcomes of patients with SLE who initiated anifrolumab during its first year of marketing in Spain.
This is an observational retrospective study including ~120 patients with moderate-severe SLE who received anifrolumab in Spain in 20 centres from 1 June 2023 to 31 May 2024. Patients will be followed up every 6 months after the first infusion of anifrolumab for a period between 6 and 18 months until the end of the study (31 December 2024). Data will be obtained through the review of medical records, considering as primary outcomes disease activity measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000, clinical SLEDAI, Physician Global Assessment and Lupus Low Disease Activity State and remission, defined by Definitions of Remission in SLE-21, and as secondary outcomes, SLE treatment, flare incidence, anifrolumab adherence and persistence (time on treatment) and healthcare resources utilisation.
The final protocol of the study will be approved by ethics committees/institutional review boards (IRB)/independent ethics committees at each site.
NCT06626945.
阿尼鲁单抗（Saphnelo）已被批准用于治疗中度至重度系统性红斑狼疮（SLE）的成年患者。鉴于其于2023年在西班牙上市，描述阿尼鲁单抗在常规临床实践中使用情况的观察性研究有限。AZAHAR研究的目的是描述在西班牙上市第一年开始使用阿尼鲁单抗的SLE患者的特征和临床结局。
这是一项观察性回顾性研究，纳入了2023年6月1日至2024年5月31日期间在西班牙20个中心接受阿尼鲁单抗治疗的约120例中度至重度SLE患者。在首次输注阿尼鲁单抗后，每6个月对患者进行一次随访，为期6至18个月，直至研究结束（2024年12月31日）。数据将通过查阅病历获得，主要结局指标包括用2000年系统性红斑狼疮疾病活动指数（SLEDAI）、临床SLEDAI、医生整体评估和狼疮低疾病活动状态及缓解来衡量的疾病活动，缓解定义依据SLE-21缓解定义；次要结局指标包括SLE治疗、疾病复发率、阿尼鲁单抗的依从性和持续性（治疗时间）以及医疗资源利用情况。
该研究的最终方案将由各研究点的伦理委员会/机构审查委员会（IRB）/独立伦理委员会批准。
NCT06626945。
