Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Lupus, Systemic Lupus Erythematosus, Antibodies, Autoimmune Diseases, Belimumab
Brief summary
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
Detailed description
This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.
Interventions
DRUGBelimumab 100 mg SC
Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
Sponsors
GlaxoSmithKline
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria * Active SLE disease * On stable SLE treatment regimen
Exclusion criteria
* Pregnant or nursing * Have received treatment with an B cell targeted therapy * Have received treatment with a biologic investigational agent in the past year * Have received intravenous (IV) cyclophosphamide within 180 days of Day 0 * Have severe lupus kidney disease * Have active central nervous system (CNS) lupus * Have required management of acute or chronic infections with the past 60 days * Have current drug or alcohol abuse or dependence or within the past year * Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | Up to 24 weeks | SEE ALSO ADVERSE EVENTS RESULTS SECTION |
| Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 | Baseline, 24 weeks | — |
| Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. | Baseline, 24 Weeks | — |
| Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 | Baseline, 24 weeks | — |
| Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 | Baseline, 24 weeks | — |
| Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | Baseline, 24 Weeks | — |
| Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | Baseline, 24 Weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24 | Baseline, 24 Weeks | SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. |
| Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24 | Baseline, 24 weeks | — |
| Absolute Change From Baseline in Complement C3 at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in Compliment C3 at Week 24 | Baseline, 24 Weeks | — |
| Absolute Change From Baseline in Complement C4 at Week 24 | Baseline, 24 weeks | — |
| Median Percent Change From Baseline in Complement C4 at Week 24 | Baseline, 24 Weeks | — |
| Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 | Baseline, 24 Weeks | — |
| Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. | Baseline, 24 weeks | — |
| Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in HDL at Week 24 | Baseline, 24 week | — |
| Absolute Change From Baseline in Total Cholesterol at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in Total Cholesterol at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in Triglycerides at Week 24 | Baseline, 24 weeks | — |
| Absolute Change From Baseline in Triglycerides at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in Anti-dsDNA at Week 24 | Baseline, 24 weeks | — |
| Absolute Change From Baseline in IgA at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in IgA at Week 24 | Baseline, 24 weeks | — |
| Absolute Change From Baseline in IgG at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in IgG at Week 24 | Baseline, 24 Weeks | — |
| Absolute Change From Baseline in IgM at Week 24 | Baseline, 24 Weeks | — |
| Median Percent Change From Baseline in IgM at Week 24 | Baseline, 24 weeks | — |
| Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 | Baseline, 24 Weeks | PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity. |
| Mean Percent Change From Baseline in PGA Score at Week 24. | Baseline, 24 weeks | The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity. |
Countries
Mexico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Belimumab SC Q2WKS | 28 |
| Belimumab SC 3X/WK | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Belimumab SC Q2WKS | Belimumab SC 3X/WK | Total |
|---|---|---|---|
| Age Continuous | 39.2 years STANDARD_DEVIATION 11.5 | 40.9 years STANDARD_DEVIATION 13.1 | 40.1 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment Mexico | 4 participants | 3 participants | 7 participants |
| Region of Enrollment United States | 24 participants | 25 participants | 49 participants |
| Sex: Female, Male Female | 26 Participants | 27 Participants | 53 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 28 | 18 / 28 |
| serious Total, serious adverse events | 2 / 28 | 4 / 28 |
Outcome results
Primary
Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | 27.7 cells/mm^3 | Standard Error 6 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | 19.6 cells/mm^3 | Standard Error 6.2 |
Primary
Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 | -81.9 cells/mm^3 | Standard Error 18.5 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 | -95.0 cells/mm^3 | Standard Error 20.8 |
Primary
Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | 1100.3 cells/mL | Standard Error 389.8 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | -77.2 cells/mL | Standard Error 456.9 |
Primary
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 | -53.5 cells/mm^3 | Standard Error 20.4 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 | -75.3 cells/mm^3 | Standard Error 23.6 |
Primary
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.
SEE ALSO ADVERSE EVENTS RESULTS SECTION
Time frame: Up to 24 weeks
Population: Please see Adverse Events Section
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab SC Q2WKS | Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | Percent of patients with at least 1 AE | 89.3 Percentage of participants |
| Belimumab SC Q2WKS | Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | Percent of patients with at least 1 Serious AE | 7.1 Percentage of participants |
| Belimumab SC Q2WKS | Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | Percent of patients with an AE resulting in death | 0 Percentage of participants |
| Belimumab SC 3X/WK | Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | Percent of patients with at least 1 AE | 85.7 Percentage of participants |
| Belimumab SC 3X/WK | Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | Percent of patients with at least 1 Serious AE | 14.3 Percentage of participants |
| Belimumab SC 3X/WK | Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | Percent of patients with an AE resulting in death | 0 Percentage of participants |
Primary
Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | 84.2 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | 100.0 Percentage |
Primary
Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 | -60.9 Percentage | Full Range 6.47 |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 | -66.7 Percentage | Full Range 8 |
Primary
Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | 45.2 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | 10.2 Percentage |
Primary
Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. | -33.5 Percentage | Full Range 8.88 |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. | -38.2 Percentage | Full Range 13.26 |
Secondary
Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 | -33.1 IU/mL | Standard Error 11.1 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 | -6.0 IU/mL | Standard Error 12.2 |
Secondary
Absolute Change From Baseline in Complement C3 at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes only patients with low C3 (\<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in Complement C3 at Week 24 | 188.0 mg/L | Standard Error 51.5 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in Complement C3 at Week 24 | 4.0 mg/L | Standard Error 44.3 |
Secondary
Absolute Change From Baseline in Complement C4 at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes only patients with low C4 (\<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in Complement C4 at Week 24 | 7.2 mg/dL | Standard Error 1.7 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in Complement C4 at Week 24 | 2.3 mg/dL | Standard Error 1.4 |
Secondary
Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 | 0.1 mmol/L | Standard Error 0.04 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 | 0.0 mmol/L | Standard Error 0.08 |
Secondary
Absolute Change From Baseline in IgA at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in IgA at Week 24 | -0.3 g/L | Standard Error 0.08 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in IgA at Week 24 | -0.3 g/L | Standard Error 0.1 |
Secondary
Absolute Change From Baseline in IgG at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in IgG at Week 24 | -2.2 g/L | Standard Error 0.7 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in IgG at Week 24 | -1.4 g/L | Standard Error 0.7 |
Secondary
Absolute Change From Baseline in IgM at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in IgM at Week 24 | -0.3 g/L | Standard Error 0.04 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in IgM at Week 24 | -0.4 g/L | Standard Error 0.07 |
Secondary
Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Time frame: Baseline, 24 Weeks
Population: Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 | -0.4 Scores on a 3-point scale | Standard Error 0.09 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 | -0.4 Scores on a 3-point scale | Standard Error 0.09 |
Secondary
Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.
Time frame: Baseline, 24 Weeks
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24 | -2.9 Points on a scale | Standard Error 0.8 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24 | -3.1 Points on a scale | Standard Error 0.5 |
Secondary
Absolute Change From Baseline in Total Cholesterol at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in Total Cholesterol at Week 24 | 0.1 mmol/L | Standard Error 0.09 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in Total Cholesterol at Week 24 | 0.0 mmol/L | Standard Error 0.2 |
Secondary
Absolute Change From Baseline in Triglycerides at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Absolute Change From Baseline in Triglycerides at Week 24 | -0.1 mmol/L | Standard Error 0.14 |
| Belimumab SC 3X/WK | Absolute Change From Baseline in Triglycerides at Week 24 | -0.0 mmol/L | Standard Error 0.15 |
Secondary
Mean Percent Change From Baseline in PGA Score at Week 24.
The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Time frame: Baseline, 24 weeks
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Mean Percent Change From Baseline in PGA Score at Week 24. | -26.1 Percentage | Standard Error 6.6 |
| Belimumab SC 3X/WK | Mean Percent Change From Baseline in PGA Score at Week 24. | -24.8 Percentage | Standard Error 13.1 |
Secondary
Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24
Time frame: Baseline, 24 weeks
Population: LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24 | -35.8 Percentage | Standard Error 9.1 |
| Belimumab SC 3X/WK | Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24 | -40.5 Percentage | Standard Error 8.6 |
Secondary
Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.
Time frame: Baseline, 24 weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab SC Q2WKS | Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. | 20.5 µg/mL | Standard Deviation 11.6 |
| Belimumab SC 3X/WK | Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. | 120.8 µg/mL | Standard Deviation 53.7 |
Secondary
Median Percent Change From Baseline in Anti-dsDNA at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in Anti-dsDNA at Week 24 | -24.0 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in Anti-dsDNA at Week 24 | 0.0 Percentage |
Secondary
Median Percent Change From Baseline in Complement C4 at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes only patients with low C4 (\<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in Complement C4 at Week 24 | 76.9 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in Complement C4 at Week 24 | 40.0 Percentage |
Secondary
Median Percent Change From Baseline in Compliment C3 at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes only patients with low C3 (\<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in Compliment C3 at Week 24 | 25.8 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in Compliment C3 at Week 24 | 3.6 Percentage |
Secondary
Median Percent Change From Baseline in HDL at Week 24
Time frame: Baseline, 24 week
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in HDL at Week 24 | 4.8 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in HDL at Week 24 | 2.2 Percentage |
Secondary
Median Percent Change From Baseline in IgA at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in IgA at Week 24 | -8.1 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in IgA at Week 24 | -10.7 Percentage |
Secondary
Median Percent Change From Baseline in IgG at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in IgG at Week 24 | -11.1 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in IgG at Week 24 | -9.5 Percentage |
Secondary
Median Percent Change From Baseline in IgM at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in IgM at Week 24 | -25.6 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in IgM at Week 24 | -26.9 Percentage |
Secondary
Median Percent Change From Baseline in Total Cholesterol at Week 24
Time frame: Baseline, 24 Weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in Total Cholesterol at Week 24 | 1.0 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in Total Cholesterol at Week 24 | 1.6 Percentage |
Secondary
Median Percent Change From Baseline in Triglycerides at Week 24
Time frame: Baseline, 24 weeks
Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab SC Q2WKS | Median Percent Change From Baseline in Triglycerides at Week 24 | -4.9 Percentage |
| Belimumab SC 3X/WK | Median Percent Change From Baseline in Triglycerides at Week 24 | 4.5 Percentage |