AZAHAR Study. Observational Retrospective Study To Describe Characteristics And Clinical Outcomes of Patients With Systemic Lupus Erythematosus Initiating Saphnelo (Anifrolumab) in a Real-World Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 152
- 试验地点
- 13
- 主要终点
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
研究概览
简要总结
AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1, 2023 to May 31, 2024.
The overall objective is to describe the characteristics and clinical outcomes of patients with SLE that initiated anifrolumab during its first year of commercialization in Spain.
详细描述
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by altered immune response with excessive cytokines and antibodies production. Immune response activation and maintained inflammatory status promote a multisystemic dysfunction affecting numerous organs.
Anifrolumab, a monoclonal antibody that binds to type 1 IFN, which it is involved in pathways altered in SLE , blocks its effects. In clinical trials showed beneficial effects controlling the disease activity in patients with moderate and severe SLE, compared to standard of care. This biologic treatment was marketed in Spain on June 1, 2023. This study aims to describe real world evidence of anifrolumab in Spain since its commercialization.
The primary objective is to describe disease activity (including low disease activity state, (LLDAS)) and clinical remission at the initiation with anifrolumab and every 6 months, up to 18 months, after anifrolumab initiation.
The secondary objectives are:
- To estimate the flare incidence rate, overall, and considering severe flares only, during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation.
- To describe SLE treatment, especially the use of corticosteroids (CS), during the previous 12 months before anifrolumab initiation, and every 6 months, up to 18 months after anifrolumab initiation.
- To describe anifrolumab persistence and adherence rate over time during treatment with anifrolumab.
- To describe healthcare resources utilization (HRU) for SLE during the previous 12 months before anifrolumab initiation and every 6 months, up to 18 months after anifrolumab initiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled the 2019 EULAR/ACR criteria for SLE at the date of anifrolumab initiation.
- •Aged 18 years or older at the date of anifrolumab initiation.
- •Have initiated anifrolumab between June 1st, 2023, and May 31st, 2024
- •Have at least 12 months of medical history prior to anifrolumab initiation.
排除标准
- •Current or previous exposure to anifrolumab as part of a clinical trial or Early Access Program (EAP).
结局指标
主要结局
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
时间窗: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
The total score ranges between 0 and 105, with higher scores representing increased disease activity.
Physician Global Assessment (PGA) score
时间窗: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
PGA ranges from 0 to 3, with 0 representing the total inactivity of the disease and 3 an important activity. An increase of ≥1 score since the last visit is indicative of a flare.
Changes in SLEDAI-2K score
时间窗: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Change from baseline in SLEDAI-2K score for consecutive timepoints.
Changes in PGA score
时间窗: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Change from baseline in PGA score for consecutive timepoints.
Proportion of patients achieving low disease activity state
时间窗: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
LLDAS requires all the following criteria to be met: * SLEDAI-2K score ≤ 4, with no activity in the major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever). * No new SLEDAI-2K assessed disease activity compared to the previous visit. * PGA score ≤ 1 * Prednisone or equivalent dosage ≤ 7.5 mg/day * No non-standard immunosuppressant dosing, with antimalarials allowed.
Proportion of patients achieving clinical remission
时间窗: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Clinical remission will be measured as DORIS-21, a composite endpoint including: * Clinical SLEDAI score of 0 (no disease activity) * PGA \<0.5 * Prednisolone dose of 5 mg/day or less. * Stable use of antimalarials, immunosuppressives, and biologics.
次要结局
- Flares incidence rate(12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.)
- Anifrolumab adherence(Up to 18 months since anifrolumab initiation.)
- Anifrolumab persistence(Up to 18 months since anifrolumab initiation.)
- Proportion of patients receiving any of dose of corticosteroids (CS)(Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.)
- Annual cumulative dose of CS(Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months)
- Proportion of patients treated with any biologic treatment(Previous 12 months before anifrolumab initiation.)
- Proportion of patients treated with any antimalarial medication(Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.)
- Proportion of patients treated with any immunosuppressive medication(Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.)
- Hospitalization rate attributable to SLE(Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.)
- Intensive care unit (ICU) admission rate attributable to SLE(Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.)
- Emergency room (ER) admission rate attributable to SLE(Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.)
- Primary care (PC) visits rate attributable to SLE(Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.)
- Specialist visits rate attributable to SLE(Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.)