Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Belimumab 1 mg/kg; Drug: Belimumab 10 mg/kg; Drug: Placebo

• Registration Number: NCT01914770
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1016

Inclusion Criteria

Not provided

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with systemic lupus erythematosus (SLE)	Belimumab 1 mg/kg	Subjects with SLE receiving ongoing stable SLE treatment
Adults with systemic lupus erythematosus (SLE)	Belimumab 10 mg/kg	Subjects with SLE receiving ongoing stable SLE treatment
Adults with systemic lupus erythematosus (SLE)	Placebo	Subjects with SLE receiving ongoing stable SLE treatment

Primary Outcome Measures

Name	Time	Method
Responder Rate	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.

Secondary Outcome Measures

Name	Time	Method
SELENA SLEDAI	Week 52	Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score at Week 52
SF-36	Week 24	Mean change in SF-36 Health Survey physical component summary score (PCS) at Week 24
Time to first flare by SLE Flare Index	Up to Week 52	Time to 1st SLE flare after 24 weeks by modified SLE Flare Index