Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632241
Recruitment Status : Completed
First Posted : July 2, 2012
Results First Posted : July 5, 2019
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Biological: Placebo plus standard therapy
Biological: Belimumab 10 mg/kg plus standard therapy
Drug: Standard therapy
Enrollment 503
Recruitment Details This study evaluated the efficacy and safety of belimumab compared with placebo in adult participants with Systemic Lupus Erythematosus (SLE). This was a multicenter study conducted at United States (88 centers), United Kingdom (6), South Africa (5), France (4), Columbia (6) and Brazil (18).
Pre-assignment Details A total of 503 participants were randomized of which 496 received at-least one dose of study medication during double-blinded phase (7 participants were randomized but not treated as they were randomized in error). A total of 359 out of 373 participants who completed double-blinded phase opted to continue optional open-label (OL) extension phase.
Arm/Group Title Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 mg/kg
Hide Arm/Group Description In double-blinded phase, participants received matching placebo to belimumab administered as intravenous (IV) infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 milligram per kilogram (mg/kg) administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76. In double-blinded phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Period Title: Double-blinded (Up to Week 52)
Started 165 331
Completed 121 252
Not Completed 44 79
Reason Not Completed
Site Closed             3             5
Protocol Violation             2             6
Lost to Follow-up             1             8
Physician Decision             9             12
Lack of Efficacy             9             15
Withdrawal by Subject             10             14
Adverse Event             10             19
Period Title: Open-label (Week 52 to Week 76)
Started 117 [1] 242 [1]
Completed 107 220
Not Completed 10 22
Reason Not Completed
Withdrawal by Subject             5             2
Physician Decision             1             4
Lost to Follow-up             1             4
Site Closed             2             8
Protocol Violation             0             2
Lack of Efficacy             0             2
Adverse Event             1             0
[1]
As the OL phase was optional, participants did not choose to enter the OL Phase.
Arm/Group Title Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 mg/kg Total
Hide Arm/Group Description In double-blinded phase, participants received matching placebo to belimumab administered as intravenous (IV) infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 milligram per kilogram (mg/kg) administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76. In double-blinded phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76. Total of all reporting groups
Overall Number of Baseline Participants 165 331 496
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 331 participants 496 participants
39.5  (12.06) 38.7  (11.00) 38.9  (11.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 331 participants 496 participants
Female
158
  95.8%
322
  97.3%
480
  96.8%
Male
7
   4.2%
9
   2.7%
16
   3.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 165 participants 331 participants 496 participants
Black or African American
165
 100.0%
331
 100.0%
496
 100.0%
1.Primary Outcome
Title Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase]
Hide Description SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in Lupus National Assessment(SELENA)SLEDAI[SS] score (with modified SLEDAI-2K scoring for proteinuria [PU]), no worsening (increase of <0.30 points from Baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics(BILAG)A organ domain score [ODS] or 2 new BILAG B ODS compared with Baseline. Drop-outs and treatment failures were set to non-responders. Analysis performed using a logistic regression model for comparison between belimumab and placebo with covariates treatment group, Baseline SS score (with modified SLEDAI-2K scoring for PU) (<=9 versus [vs.] >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (United States [US]/Canada vs. Rest of World). The Modified Intention-To-Treat (mITT) population comprised of safety population excluding participants who had any assessment at 3 sites (202196, 202513 or 107286).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. One participant in the mITT population Belimumab 10 mg/kg arm did not have a screening or Baseline PGA assessment; therefore, this participant did not contribute to the SRI/component analysis.
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 149 298
Measure Type: Number
Unit of Measure: Percentage of participants
41.6 48.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (DB Phase), Belimumab 10 mg/kg (DB Phase)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1068
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
0.93 to 2.11
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase
Hide Description SRI response is defined as >=4 point reduction, from OL Baseline in SS score (with the modified SLEDAI-2K scoring for PU), no worsening (increase of <0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the OL phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the OL phase, Baseline was defined as Day 1 of the double-blind phase.
Time Frame Week 24 of OL phase (Week 76)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT OL population comprised of Intent-to-Treat (ITT) OL population (all randomized participants who received at least one dose of OL treatment) excluding participants who had any assessment at 3 sites (202196, 202513 or 107286). Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
Overall Number of Participants Analyzed 69 208
Measure Type: Number
Unit of Measure: Percentage of participants
18.8 73.6
3.Primary Outcome
Title Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase]
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had common nSAEs (>=5%) and any SAEs are presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Time Frame Week 52 to Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) OL Population comprised of all randomized participants who received atleast one dose of open label treatment.
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 117 242
Measure Type: Count of Participants
Unit of Measure: Participants
nSAEs
23
  19.7%
49
  20.2%
SAEs
6
   5.1%
13
   5.4%
4.Primary Outcome
Title Number of Participants With Severe AEs [OL Phase]
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Time Frame Week 52 to Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OL Population
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 117 242
Measure Type: Count of Participants
Unit of Measure: Participants
10
   8.5%
9
   3.7%
5.Primary Outcome
Title Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase]
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to treatment discontinuation have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Time Frame Week 52 to Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OL Population
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 117 242
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.9%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase]
Hide Description Blood samples were collected for the assessment of hematology parameters. The parameters assessed were activated partial thromboplastin time (APTT), hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to Division of Microbiology and Infectious Diseases (DMID [Modified from DMID Adult Toxicity Tables, 2001]) AE Severity Grading. Number of participants with worst toxicity Grade 3 or 4 for hematology parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Time Frame Week 52 to Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 115 235
Measure Type: Count of Participants
Unit of Measure: Participants
APTT, Grade 3, n=93,203 Number Analyzed 93 participants 203 participants
0
   0.0%
1
   0.5%
APTT, Grade 4, n=93,203 Number Analyzed 93 participants 203 participants
0
   0.0%
0
   0.0%
Hemoglobin, Grade 3, n=115,235 Number Analyzed 115 participants 235 participants
4
   3.5%
6
   2.6%
Hemoglobin, Grade 4, n=115,235 Number Analyzed 115 participants 235 participants
0
   0.0%
0
   0.0%
Leukocytes, Grade 3, n=114,235 Number Analyzed 114 participants 235 participants
0
   0.0%
6
   2.6%
Leukocytes, Grade 4, n=114,235 Number Analyzed 114 participants 235 participants
0
   0.0%
0
   0.0%
Neutrophils, Grade 3, n=114,234 Number Analyzed 114 participants 234 participants
2
   1.8%
6
   2.6%
Neutrophils, Grade 4, n=114,234 Number Analyzed 114 participants 234 participants
0
   0.0%
1
   0.4%
Platelets, Grade 3, n=115,235 Number Analyzed 115 participants 235 participants
0
   0.0%
0
   0.0%
Platelets, Grade 4, n=115,235 Number Analyzed 115 participants 235 participants
0
   0.0%
0
   0.0%
Prothrombin time, Grade 3, n=93, 204 Number Analyzed 93 participants 204 participants
3
   3.2%
2
   1.0%
Prothrombin time, Grade 4, n=93, 204 Number Analyzed 93 participants 204 participants
1
   1.1%
3
   1.5%
7.Primary Outcome
Title Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase]
Hide Description Blood samples were collected for the assessment of liver function and other chemistry parameters. The parameters assessed were alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), bilirubin, albumin, creatinine, hyperglycemia, hypoglycemia and urate. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for liver function and other chemistry parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Time Frame Week 52 to Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OL Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 115 236
Measure Type: Count of Participants
Unit of Measure: Participants
ALP, Grade 3
0
   0.0%
0
   0.0%
ALP, Grade 4
0
   0.0%
0
   0.0%
ALT, Grade 3
0
   0.0%
0
   0.0%
ALT, Grade 4
0
   0.0%
0
   0.0%
AST, Grade 3
0
   0.0%
0
   0.0%
AST, Grade 4
0
   0.0%
0
   0.0%
Bilirubin, Grade 3
0
   0.0%
0
   0.0%
Bilirubin, Grade 4
0
   0.0%
0
   0.0%
GGT, Grade 3
0
   0.0%
1
   0.4%
GGT, Grade 4
0
   0.0%
0
   0.0%
Albumin, Grade 3
0
   0.0%
2
   0.8%
Albumin, Grade 4
1
   0.9%
0
   0.0%
Creatinine, Grade 3
0
   0.0%
0
   0.0%
Creatinine, Grade 4
0
   0.0%
0
   0.0%
Hypoglycemia, Grade 3
0
   0.0%
0
   0.0%
Hypoglycemia, Grade 4
0
   0.0%
0
   0.0%
Hyperglycemia, Grade 3
1
   0.9%
4
   1.7%
Hyperglycemia, Grade 4
0
   0.0%
0
   0.0%
Urate, Grade 3
0
   0.0%
0
   0.0%
Urate, Grade 4
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase]
Hide Description Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Time Frame Week 52 to Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 115 234
Measure Type: Count of Participants
Unit of Measure: Participants
Protein, Grade 3, n=115, 234 Number Analyzed 115 participants 234 participants
0
   0.0%
0
   0.0%
Protein, Grade 4, n=115,234 Number Analyzed 115 participants 234 participants
0
   0.0%
0
   0.0%
Protein/Creatinine, Grade 3,n=112,227 Number Analyzed 112 participants 227 participants
5
   4.5%
5
   2.2%
Protein/Creatinine, Grade 4, n=112,227 Number Analyzed 112 participants 227 participants
3
   2.7%
0
   0.0%
9.Primary Outcome
Title Number of Participants With Worst Toxicity Grade of 3 or 4 of Immunoglobulins [OL Phase]
Hide Description Serum samples were obtained for the measurement of immunoglobulin G. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 of immunoglobulin G have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Time Frame Week 52 to Week 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OL Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 117 239
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3
0
   0.0%
1
   0.4%
Grade 4
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Percentage of Participants Achieving SRI-SS Response Rate at Week 52 [DB Phase]
Hide Description SRI is defined as >=4 point reduction, from Baseline in SS 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 compared with Baseline. Drop-outs and Treatment failures were set to non-responders. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SS score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. One participant in the mITT population Belimumab 10 mg/kg arm did not have a screening or Baseline PGA assessment; therefore, this participant did not contribute to the SRI/component analysis.
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 149 298
Measure Type: Number
Unit of Measure: Percentage of participants
41.6 49.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (DB Phase), Belimumab 10 mg/kg (DB Phase)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0937
Comments Nominal p-value due to step-down sequential testing procedure.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
0.94 to 2.15
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Achieving SRI-SS Response Rate With the SELENA SLEDAI for Scoring of Proteinuria at Week 24 of OL Phase
Hide Description SRI response is defined as >=4 point reduction, from OL Baseline in SS scoring for PU, no worsening (increase of <0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the open-label phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the open-label phase, Baseline was defined as Day 1 of the double-blind phase.
Time Frame Week 24 of OL phase (Week 76)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT OL Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 67 208
Measure Type: Number
Unit of Measure: Percentage of participants
19.4 73.1
12.Secondary Outcome
Title Time to First Severe Flare (as Measured by the Modified SLE Flare Index) up to 52 Weeks [DB Phase]
Hide Description Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SS SLE flare index that excludes severe flares (SF) that were triggered only by an increase in SS score to >12 (this may only represent a modest increase in disease activity). Treatment failures were imputed as SF. For participants who died, data were censored at date of death if no SF occurred before death. Only post-Baseline SF were considered. Analysis was performed using Cox proportional hazards model for the comparison between belimumab and placebo adjusting for Baseline SS-S2K score (<=9 vs. >=10), baseline complement levels (at least 1 C3/C4 low vs. no C3/C4 low), and region (US/Canada vs. Rest of World). Median and inter-Quartile range (1st and 3rd Quartiles) have been presented.
Time Frame Up to 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 149 299
Median (Inter-Quartile Range)
Unit of Measure: Days
NA [1] 
(346 to NA)
NA [1] 
(NA to NA)
[1]
NA indicated data was not available because the number of events was too low to estimate the value.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (DB Phase), Belimumab 10 mg/kg (DB Phase)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2264
Comments Nominal p-value due to step-down sequential testing procedure.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.51 to 1.17
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to First Severe Flare (as Measured by the Modified SLE Flare Index) [OL Phase]
Hide Description Time to first severe SLE flare is defined as the number of days from OL treatment start date until the participant met an event (event date - OL treatment start date +1). Analyses of severe SLE flare was performed on modified SS SLE flare index that excludes SF that were triggered only by an increase in SS score to >12. For participants who died, data were censored at date of death if no SF occurred before death. Only post first OL treatment SF were considered. Median and inter-Quartile range (25th and 75th percentile) have been presented.
Time Frame Up to Week 24 of OL Phase (Week 76)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT OL Population
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 109 225
Median (Inter-Quartile Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
232 [1] 
(232 to NA)
[1]
NA indicated data was not available because the number of events was too low to estimate the value.
14.Secondary Outcome
Title Percent of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Week 40 Through 52, in Participants Receiving Greater Than 7.5 mg/Day at Baseline [DB Phase]
Hide Description Average (avg.) daily prednisone (PRED.) dose was calculated taking into account all steroids taken intravenously, intramuscularly, subcutaneously, intradermally and orally for both Systemic Lupus Erythema (SLE) and non-SLE reasons. A responder was defined as having a PRED. reduction [REDN.] by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. Drop-outs and Treatment failures were imputed as having no REDN. in PRED. (if Baseline PRED. >7.5 mg/day). At Baseline, the avg. daily prednisone dose [PD] was the sum of all PDs over 7 consecutive days [excluding Day 0], divided (DIV.) by 7. For analysis, the avg. PD was the total PD during Weeks 40 through 52 DIV. by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline PD, Baseline SS-S2K score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World).
Time Frame Baseline and Week 40 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only participants with Baseline prednisone dose >7.5 mg/day were included.
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 95 184
Measure Type: Number
Unit of Measure: Percentage of participants
12.6 14.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (DB Phase), Belimumab 10 mg/kg (DB Phase)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4996
Comments Nominal p-value due to step-down sequential testing procedure.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.61 to 2.80
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percent of Participants Whose Average Prednisone Dose Had Been Reduced to <=7.5 mg/Day in Participants Receiving Greater Than 7.5 mg/Day at Pre-belimumab Baseline (at Week 28 of OL Phase)
Hide Description Average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, subcutaneously, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as a participant who decreased their daily prednisone dose to <=7.5 mg/day from an OL Baseline dose >7.5 mg/day. The OL Baseline was defined as the last available value prior to the initiation of treatment with belimumab. The average daily prednisone dose was the sum of all PDs over 7 consecutive days including OL Week 28 divided by 7. Only those participants with data available at the specified data points were analyzed.
Time Frame OL Baseline and Week 28 of OL Phase (Week 80)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT OL Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description:
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Overall Number of Participants Analyzed 54 138
Measure Type: Number
Unit of Measure: Percentage of participants
14.8 31.9
16.Secondary Outcome
Title Number of Participants With nSAEs and SAEs [DB Phase]
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Safety population was defined as all participants who were randomized and treated with at least one dose of study treatment. Number of participants who had common nSAEs (>=5%) and any SAEs are presented.
Time Frame Up to 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 165 331
Measure Type: Count of Participants
Unit of Measure: Participants
nSAE
77
  46.7%
196
  59.2%
SAE
31
  18.8%
36
  10.9%
17.Secondary Outcome
Title Number of Participants With Severe AEs [DB Phase]
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented.
Time Frame Up to 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 165 331
Measure Type: Count of Participants
Unit of Measure: Participants
37
  22.4%
46
  13.9%
18.Secondary Outcome
Title Number of Participants With AEs Leading to Treatment Discontinuation [DB Phase]
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to treatment discontinuation have been presented.
Time Frame Up to 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 165 331
Measure Type: Count of Participants
Unit of Measure: Participants
12
   7.3%
22
   6.6%
19.Secondary Outcome
Title Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase]
Hide Description Blood samples were collected for the assessment of hematology parameters up to 52 Weeks. The parameters assessed were APTT, hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for hematology parameters have been presented.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 161 327
Measure Type: Count of Participants
Unit of Measure: Participants
APTT, Grade 3, n=159,318 Number Analyzed 159 participants 318 participants
0
   0.0%
3
   0.9%
APTT, Grade 4, n=159,318 Number Analyzed 159 participants 318 participants
0
   0.0%
2
   0.6%
Hemoglobin, Grade 3, n=161,327 Number Analyzed 161 participants 327 participants
5
   3.1%
15
   4.6%
Hemoglobin, Grade 4, n=161,327 Number Analyzed 161 participants 327 participants
1
   0.6%
0
   0.0%
Leukocytes, Grade 3, n=161,327 Number Analyzed 161 participants 327 participants
3
   1.9%
17
   5.2%
Leukocytes, Grade 4, n=161,327 Number Analyzed 161 participants 327 participants
1
   0.6%
0
   0.0%
Neutrophils, Grade 3, n=161,327 Number Analyzed 161 participants 327 participants
9
   5.6%
28
   8.6%
Neutrophils, Grade 4, n=161,327 Number Analyzed 161 participants 327 participants
1
   0.6%
5
   1.5%
Platelets, Grade 3, n=161,327 Number Analyzed 161 participants 327 participants
1
   0.6%
1
   0.3%
Platelets, Grade 4, n=161,327 Number Analyzed 161 participants 327 participants
0
   0.0%
1
   0.3%
Prothrombin time, Grade 3, n=159, 318 Number Analyzed 159 participants 318 participants
8
   5.0%
10
   3.1%
Prothrombin time, Grade 4, n=159,318 Number Analyzed 159 participants 318 participants
2
   1.3%
6
   1.9%
20.Secondary Outcome
Title Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase]
Hide Description Blood samples were collected for the assessment of liver function and other chemistry parameters up to 52 Weeks. The parameters assessed were ALT, AST, GGT, albumin, hyperglycemia and hypoglycemia. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Only those participants with worst toxicity Grade of 3 or 4 for other chemistry parameters have been presented.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 161 327
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grade 3
0
   0.0%
2
   0.6%
AST, Grade 3
0
   0.0%
2
   0.6%
GGT, Grade 3
6
   3.7%
6
   1.8%
GGT, Grade 4
0
   0.0%
1
   0.3%
Albumin, Grade 3
5
   3.1%
3
   0.9%
Albumin, Grade 4
1
   0.6%
1
   0.3%
Hyperglycemia, Grade 3
4
   2.5%
7
   2.1%
Hyperglycemia, Grade 4
1
   0.6%
1
   0.3%
Hypoglycemia, Grade 3
0
   0.0%
4
   1.2%
Hypoglycemia, Grade 4
3
   1.9%
1
   0.3%
21.Secondary Outcome
Title Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [DB Phase]
Hide Description Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 52 Weeks. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Only those participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase)
Hide Arm/Group Description:
In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.
In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Overall Number of Participants Analyzed 161 324
Measure Type: Count of Participants
Unit of Measure: Participants
Protein, Grade 3, n=161, 324 Number Analyzed 161 participants 324 participants
0
   0.0%
1
   0.3%
Protein/creatinine, Grade 3,n=161,322 Number Analyzed 161 participants 322 participants
8
   5.0%
25
   7.8%
Protein/creatinine, Grade 4, n=161,322 Number Analyzed 161 participants 322 participants
12
   7.5%
11
   3.4%
Time Frame nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
Adverse Event Reporting Description nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
 
Arm/Group Title Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase) Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Hide Arm/Group Description In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks. In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76 In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
All-Cause Mortality
Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase) Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/165 (0.00%)      2/331 (0.60%)      0/117 (0.00%)      0/242 (0.00%)    
Hide Serious Adverse Events
Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase) Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/165 (18.79%)      36/331 (10.88%)      6/117 (5.13%)      13/242 (5.37%)    
Blood and lymphatic system disorders         
Anaemia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 1/117 (0.85%)  1 0/242 (0.00%)  0
Leukopenia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Cardiac disorders         
Pericarditis  1  3/165 (1.82%)  3 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Acute myocardial infarction  1  0/165 (0.00%)  0 1/331 (0.30%)  1 1/117 (0.85%)  1 0/242 (0.00%)  0
Atrial fibrillation  1  1/165 (0.61%)  1 0/331 (0.00%)  0 1/117 (0.85%)  1 0/242 (0.00%)  0
Cardiomyopathy  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Myocardial infarction  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Tachycardia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Ventricular tachycardia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Eye disorders         
Idiopathic orbital inflammation  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Colitis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Diarrhoea  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Enteritis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Intestinal obstruction  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Pancreatitis acute  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Small intestinal perforation  1  0/165 (0.00%)  0 1/331 (0.30%)  2 0/117 (0.00%)  0 0/242 (0.00%)  0
General disorders         
Non-cardiac chest pain  1  0/165 (0.00%)  0 2/331 (0.60%)  2 0/117 (0.00%)  0 0/242 (0.00%)  0
Pyrexia  1  1/165 (0.61%)  1 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Chest pain  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Fatigue  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Serositis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Soft tissue inflammation  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Oedema  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Hepatobiliary disorders         
Cholecystitis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Cholecystitis acute  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Infections and infestations         
Pneumonia  1  6/165 (3.64%)  6 2/331 (0.60%)  2 0/117 (0.00%)  0 2/242 (0.83%)  2
Cellulitis  1  1/165 (0.61%)  1 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Urinary tract infection  1  2/165 (1.21%)  3 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Amoebic colitis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Appendicitis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Arthritis gonococcal  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Atypical pneumonia  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Clostridium difficile infection  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Dengue fever  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Diverticulitis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Lung infection  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Meningitis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Paronychia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Sepsis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Staphylococcal sepsis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Upper respiratory tract infection  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Viral tonsillitis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Bacteraemia  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Oesophageal candidiasis  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Soft tissue infection  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Injury, poisoning and procedural complications         
Accidental overdose  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Joint injury  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Pelvic fracture  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Pulmonary contusion  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Wrist fracture  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Metabolism and nutrition disorders         
Dehydration  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Hyperkalaemia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Hypoalbuminaemia  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Hypoglycaemia  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Systemic lupus erythematosus  1  1/165 (0.61%)  1 3/331 (0.91%)  4 0/117 (0.00%)  0 1/242 (0.41%)  1
SLE arthritis  1  1/165 (0.61%)  2 2/331 (0.60%)  2 0/117 (0.00%)  0 0/242 (0.00%)  0
Costochondritis  1  0/165 (0.00%)  0 2/331 (0.60%)  2 0/117 (0.00%)  0 0/242 (0.00%)  0
Muscular weakness  1  0/165 (0.00%)  0 2/331 (0.60%)  2 0/117 (0.00%)  0 0/242 (0.00%)  0
Arthritis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Fibromyalgia  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Musculoskeletal chest pain  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Musculoskeletal pain  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Myositis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Osteoarthritis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 1/242 (0.41%)  1
Rhabdomyolysis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Tendonitis  1  0/165 (0.00%)  0 0/331 (0.00%)  0 1/117 (0.85%)  1 0/242 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Squamous cell carcinoma of the cervix  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident  1  0/165 (0.00%)  0 1/331 (0.30%)  1 1/117 (0.85%)  1 0/242 (0.00%)  0
Coma  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Dystonia  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Idiopathic intracranial hypertension  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Radiculopathy  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Transient ischaemic attack  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Syncope  1  0/165 (0.00%)  0 0/331 (0.00%)  0 1/117 (0.85%)  1 1/242 (0.41%)  1
Chorea  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Hemiparesis  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  1/165 (0.61%)  1 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Ectopic pregnancy  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Psychiatric disorders         
Depression suicidal  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Insomnia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Suicidal ideation  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Renal and urinary disorders         
Lupus nephritis  1  2/165 (1.21%)  2 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Acute kidney injury  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Azotaemia  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Glomerulonephritis  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Nephrotic syndrome  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Proteinuria  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Renal failure  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Urinary retention  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/165 (0.61%)  1 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Dyspnoea  1  0/165 (0.00%)  0 2/331 (0.60%)  3 0/117 (0.00%)  0 1/242 (0.41%)  1
Lupus pneumonitis  1  1/165 (0.61%)  1 1/331 (0.30%)  2 0/117 (0.00%)  0 0/242 (0.00%)  0
Pleurisy  1  0/165 (0.00%)  0 2/331 (0.60%)  2 0/117 (0.00%)  0 0/242 (0.00%)  0
Lung consolidation  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Lupus pleurisy  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Pulmonary embolism  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
Skin and subcutaneous tissue disorders         
Butterfly rash  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Systemic lupus erythematosus rash  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Vascular disorders         
Haematoma  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Lupus vasculitis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Malignant hypertension  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Orthostatic hypotension  1  0/165 (0.00%)  0 1/331 (0.30%)  1 0/117 (0.00%)  0 0/242 (0.00%)  0
Raynaud's phenomenon  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Vasculitis  1  1/165 (0.61%)  1 0/331 (0.00%)  0 0/117 (0.00%)  0 0/242 (0.00%)  0
Hypertension  1  0/165 (0.00%)  0 0/331 (0.00%)  0 0/117 (0.00%)  0 1/242 (0.41%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (DB Phase) Belimumab 10 mg/kg (DB Phase) Placebo to Belimumab 10 mg/kg (OL Phase) Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/165 (46.67%)      196/331 (59.21%)      23/117 (19.66%)      49/242 (20.25%)    
Gastrointestinal disorders         
Diarrhoea  1  9/165 (5.45%)  12 31/331 (9.37%)  34 0/117 (0.00%)  0 0/242 (0.00%)  0
Nausea  1  15/165 (9.09%)  21 18/331 (5.44%)  29 0/117 (0.00%)  0 0/242 (0.00%)  0
Vomiting  1  7/165 (4.24%)  8 19/331 (5.74%)  21 0/117 (0.00%)  0 0/242 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  14/165 (8.48%)  20 48/331 (14.50%)  58 4/117 (3.42%)  6 20/242 (8.26%)  21
Urinary tract infection  1  19/165 (11.52%)  24 43/331 (12.99%)  57 7/117 (5.98%)  7 13/242 (5.37%)  15
Influenza  1  17/165 (10.30%)  23 28/331 (8.46%)  35 7/117 (5.98%)  8 16/242 (6.61%)  18
Sinusitis  1  9/165 (5.45%)  9 26/331 (7.85%)  33 0/117 (0.00%)  0 0/242 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  10/165 (6.06%)  12 16/331 (4.83%)  17 7/117 (5.98%)  7 3/242 (1.24%)  3
Nervous system disorders         
Headache  1  18/165 (10.91%)  25 39/331 (11.78%)  47 0/117 (0.00%)  0 0/242 (0.00%)  0
Psychiatric disorders         
Insomnia  1  10/165 (6.06%)  10 18/331 (5.44%)  18 0/117 (0.00%)  0 0/242 (0.00%)  0
Depression  1  9/165 (5.45%)  9 15/331 (4.53%)  15 0/117 (0.00%)  0 0/242 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  7/165 (4.24%)  7 18/331 (5.44%)  23 0/117 (0.00%)  0 0/242 (0.00%)  0
Vascular disorders         
Hypertension  1  4/165 (2.42%)  5 18/331 (5.44%)  21 0/117 (0.00%)  0 0/242 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01632241    
Other Study ID Numbers: 115471
HGS1006-C1112 ( Other Identifier: Human Genome Sciences Inc. )
2011-005672-42 ( EudraCT Number )
U1111-1139-9723 ( Other Identifier: Universal Trial Number )
First Submitted: June 28, 2012
First Posted: July 2, 2012
Results First Submitted: June 12, 2019
Results First Posted: July 5, 2019
Last Update Posted: February 6, 2020