A Non-Interventional Descriptive Multi-Country Study of Saphnelo™ (Anifrolumab-fnia) Utilization in Females of Reproductive Potential
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 26,000,000
- 主要终点
- Incidence of anifrolumab use
研究概览
简要总结
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. SAPHNELO™ (anifrolumab-fnia), a fully human IgG1 κ monoclonal antibody, is a novel therapeutic option approved for add-on treatment of moderate-to-severe SLE in the United States (US) on 30 July 2021 and in the European Union on 14 February 2022. To fulfill US Food and Drug Administration (FDA) post-marketing requirements for the evaluation of anifrolumab safety in pregnancy, additional evidence is needed to better understand the real-world drug utilization of anifrolumab in female patients of reproductive potential.
详细描述
Research Questions:
- What is the incidence and prevalence of anifrolumab use among females of reproductive potential in selected countries where anifrolumab is marketed?
- What are the baseline characteristics and drug utilization patterns in females of reproductive potential who initiate treatment with anifrolumab in selected countries where anifrolumab is marketed?
Primary Objectives:
1a. To describe trends in the annual incidence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status.
1b. To describe trends in the annual prevalence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the primary objective cohort for a given calendar year interval, if they satisfy the following inclusion and
排除标准
- •within that year:
- •Inclusion Criteria:
- •Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives)
- •Female sex at index date
- •Age ≥15 and ≤50 years at index date
- •Exclusion Criteria:
- •(Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date
- •Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria:
- •Inclusion criteria
- •Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives).
- •Female sex at index date.
- •Age ≥15 and ≤50 years at index date.
- •≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date.
- •(For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date.
- •Exclusion criteria
- •Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date.
研究组 & 干预措施
Study population for primary objectives
Patients will be included in the primary objective cohort for a given calendar year interval, if they satisfy the following inclusion and exclusion criteria within that year:
Inclusion criteria
- Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives)
- Female sex at index date
- Age ≥15 and ≤50 years at index date
Exclusion criteria
1. (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date
Note: Cohort selection criteria for the primary objectives will be assessed repeatedly within calendar year intervals during the patient identification period to enable evaluation of annual anifrolumab use incidence and prevalence outcomes.
干预措施: Anifrolumab (Drug)
Study population for secondary objectives
Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria:
Inclusion criteria
- Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives)
- Female sex at index date
- Age ≥15 and ≤50 years at index date
- ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date.
- (For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date
Exclusion criteria
1. Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date
干预措施: Anifrolumab (Drug)
结局指标
主要结局
Incidence of anifrolumab use
时间窗: 1 year
Within each country, the incidence of anifrolumab will be assessed within each calendar year interval of the overall patient identification period. The follow-up period within each calendar year interval starts on the calendar year-specific index date and ends on the earliest of the following dates within that same year: (1) last date of observability (enrollment/activity), (2) death date, (3) 51st birthday, (4) end of the study period, (5) December 31st (end of calendar year), or (6) date of anifrolumab initiation (for objective 1a only). Incidence will be reported as the number of female patients of reproductive potential with incident anifrolumab use per (1) 1,000,000 females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI and (2) per 1,000,000 person-years of follow-up among females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI.
Prevalence of anifrolumab use
时间窗: 1 year
Within each country, the prevalence of anifrolumab use will be assessed within each calendar year interval of the follow-up period by calculating the number and percentage with prevalent anifrolumab use among all female patients of reproductive potential in a given calendar year (with 95% CI), as well as number of female patients of reproductive potential with prevalent anifrolumab use per 1,000,000 female patients of reproductive potential in a given calendar year (with 95% CI).
次要结局
- Baseline patient characteristics(At anifrolumab treatment initiation (index date))
- Baseline SLE treatment characteristics(At anifrolumab treatment initiation (index date))
- Anifrolumab treatment utilization patterns(From anifrolumab treatment initiation (index date) up to 84 days post-initiation)
- Anifrolumab-exposed pregnancies(From anifrolumab treatment initiation (index date) up to 93 days after date of last dose)