N/A
N=1,514
BENLYSTA® Special Drug Use Investigation
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT03370263 ↗Enrolled (actual)
1,514
Serious AEs
15.5%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Adverse Drug Reactions (ADRs) — 107; 110; 47; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Benlysta (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions (ADRs) |
107; 110; 47; 0 | — |
| PRIMARY Number of Participants With Serious ADR of Events Defined as a Priority Study Matter |
3; 0; 0; 0; 27; 24 | — |
| PRIMARY Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24 |
-2.5; -2.8; -2.8; -4.0 | — |
| PRIMARY Change From Baseline in SELENA SLEDAI Score at Week 52 |
-3.1; -3.6; -3.2 | — |
| PRIMARY Change From Baseline in Lupus Impact Tracker Score at Week 24 |
— | — |
| PRIMARY Change From Baseline in Lupus Impact Tracker Score at Week 52 |
— | — |
| PRIMARY Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 |
-0.44; -0.51; -0.44 | — |
| PRIMARY Change From Baseline in PGA Score at Week 52 |
-0.64; -0.62; -0.53 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 4 |
-1.57; -1.61; -0.70; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 8 |
-3.46; -2.26; -1.15; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 12 |
-2.97; -2.81; -1.59; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 16 |
-4.59; -3.48; -0.70; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 20 |
-5.15; -3.90; -2.50; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 24 |
-4.36; -4.07; -2.61; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 28 |
-6.15; -4.24; -2.61; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 32 |
-6.59; -4.73; -2.67; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 36 |
-6.85; -5.01; -3.04; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 40 |
-5.61; -5.15; -3.17; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 44 |
-7.20; -5.40; -3.44; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 48 |
-7.43; -5.03; -3.63; 0.00 | — |
| PRIMARY Percent Change From Baseline in Mean Daily Steroid Dose at Week 52 |
-8.27; -3.98; -3.89; 0.00 | — |
| PRIMARY Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24 |
48; 68; 34 | — |
| PRIMARY Number of Participants Who Achieved LLDAS Response Criteria at Week 52 |
36; 57; 37 | — |
| PRIMARY Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24 |
36.590; 27.721; 31.765; 5.000 | — |
| PRIMARY Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52 |
30.984; 26.890; 28.346; 5.000 | — |
| PRIMARY Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24 |
82.57; 82.08; 83.79; 96.00; 18.26; 16.88 | — |
| PRIMARY Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52 |
85.45; 85.05; 85.16; 97.00; 18.71; 17.34 | — |
| PRIMARY Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24 |
39.03; 38.14; 39.85 | — |
| PRIMARY Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52 |
39.60; 38.55; 39.73 | — |
| PRIMARY Change From Baseline in Urine Protein/Creatinine Ratio at Week 24 |
0.25200; 0.17000; 0.12000 | — |
| PRIMARY Change From Baseline in Urine Protein/Creatinine Ratio at Week 52 |
0.15000; 0.15000; 0.10000; 0.00000 | — |
Summary
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta") in daily clinical practice. The aim of conducting this drug use investigation (DUI) in all subjects until data are accumulated from a certain number of subjects after Benlysta being marketed, data will be collected on safety and effectiveness of Benlysta in an early stage and thereby to take the necessary measures for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The observation period per subject will be 52 weeks from the start of Benlysta administration. BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Eligibility Criteria
Inclusion Criteria
- The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT03370263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.