Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus (LASER) An External Comparator Arm Study for the TULIP Trials Using the University of Toronto Lupus Clinic Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 561
- 试验地点
- 2
- 主要终点
- SLICC/ACR damage index (SDI) at week 208
研究概览
简要总结
This is an External control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active Systemic lupus erythematosus (SLE). Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death, loss to follow-up, trial dis-enrollment, or week 208 assessment (in LTE study).
详细描述
This is an External Control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active (Systemic lupus erythematosus) SLE. Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death, loss to follow-up, trial dis-enrollment, or week 208 assessment (in LTE study). Patients in the University of Toronto Lupus Clinic will be indexed at the first date of clinical assessment within the patient enrollment period for which they satisfy all eligibility criteria and are receiving at least one eligible SOC treatment (i.e., their 'index assessment') and will be followed up until the earliest occurrence of death, loss to follow-up, UTLC disenrollment, or end of study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 through 70 years at index date.
- •Weight ≥40.0 kg at index date.
- •Diagnosis of paediatric or adult SLE ≥24 weeks prior to index date using ≥4 of the 11 modified ACR classification criteria at least one of which must be positive antinuclear antibody test, anti-dsDNA antibodies, or anti-Smith antibody elevated to above normal level.
- •SLEDAI-2K score ≥6 points (Table 8 in Appendix) at index date.
- •No record of current pregnancy at index date.
- •Valid measurement of SDI (Table 9 in Appendix) at index date.
排除标准
- •Selected key exclusion criteria from the TULIP trials have been adapted to the RW setting and will be applied to patients in the UTLC. Patients who meet any of the following criteria will be excluded from the study:
- •Corticosteroid dose >40 mg/day (oral prednisone equivalent) at index date.
- •Any record of receiving any biologic agent (e.g., anifrolumab, belimumab, rituximab, abatacept) at index date or within 4 weeks prior to index date.
- •Any record of malignancy at any point prior to index date, except skin malignancy ≥1 year prior to index date.
- •Record of persistent, new or recurrent nephrotic syndrome, chronic dialysis, or renal transplant at index date.
- •Serum creatinine >2.0 mg/dL (or >181 μmol/L) at index date.
- •The following additional exclusion criteria may be applied to the study cohort at the time of analysis, if it is judged that their application will not significantly reduce the sample size available:
- •Record of alcohol consumption ≥14 units/week at index date or ≤1 year prior to index date
研究组 & 干预措施
Tulip Trial Group
Patients who initiated 300 mg of anifrolumab in TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway)-1 or -2.
Toronto Lupus Cohort Group
Participants who received RW Standard Of Care for SLE from the University of Toronto Lupus Clinic (UTLC) registry.
结局指标
主要结局
SLICC/ACR damage index (SDI) at week 208
时间窗: 208 weeks
Organ Damage measured using the SDI . The SDI is designed to assess irreversible damage across 12 organ systems in SLE patients, independently of cause or attribution.
次要结局
- Time to first organ damage progression as measured by SDI.(208 weeks)
- SDI at week 208 by organ damage at baseline(208 weeks)
- Cumulative steroid intake(208 weeks)
- Average daily steroid dose(208 weeks)