Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,016
- 主要终点
- Responder Rate
研究概览
简要总结
This pooled analysis will assess data from the Phase 3 belimumab registration studies BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and agreed prior to the unblinding of either study. The primary objective is to evaluate the impact of belimumab treatment on a more severe subpopulation of systemic lupus erythematosus (SLE) subjects from BLISS-52 and BLISS-76 to aid physicians and payers in decision making. Subjects are from the modified Intent-to-Treat (ITT) population defined as randomized subjects who received at least 1 dose of study agent. This more severe subpopulation will have renal, neurological, haematological, or cardiovascular/respiratory organ domain involvement (as defined by a British Isles Lupus Assessment Group (BILAG) domain score of A, B or C in at least one of the domains) at baseline AND anti-double-stranded deoxyribonucleic acid (anti-dsDNA) positive (≥ 30 IU/mL) at baseline OR low C3 and/or C4 complement relative to the normal range at baseline.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Key exclusion criteria for BLISS-52 and BLISS-76 included:
- •severe active lupus nephritis or Central Nervous System (CNS) lupus
- •pregnancy
- •receipt of any B cell target therapy at any time
- •receipt of an investigational agent within 60 days prior to Day 0 for non-biologics and within 1 year for biologics
- •receipt of abatacept (within 1 year), intravenous (IV) cyclophosphamide (within 6 months), anti-tumor necrosis factor (anti-TNF) therapy, anakinra, IV immunoglobulin (IVIG), prednisone > 100 mg/day, or plasmapheresis within 3 months, or live vaccine within 1 month.
研究组 & 干预措施
Adults with systemic lupus erythematosus (SLE)
Subjects with SLE receiving ongoing stable SLE treatment
干预措施: Belimumab 1 mg/kg (Drug)
Adults with systemic lupus erythematosus (SLE)
Subjects with SLE receiving ongoing stable SLE treatment
干预措施: Belimumab 10 mg/kg (Drug)
Adults with systemic lupus erythematosus (SLE)
Subjects with SLE receiving ongoing stable SLE treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Responder Rate
时间窗: Week 52
Response is defined as: ≥4 point reduction from baseline in SELENA SLEDAI score, no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores.
次要结局
- SELENA SLEDAI(Week 52)
- SF-36(Week 24)
- Time to first flare by SLE Flare Index(Up to Week 52)