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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-52)

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: NCT00424476
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : May 5, 2011
Last Update Posted : December 12, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: Placebo
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg
Enrollment 865
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks. Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks. Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Period Title: Overall Study
Started 287 288 290
Completed 226 240 241
Not Completed 61 48 49
Reason Not Completed
Withdrawal by Subject             7             6             3
Adverse Event             19             16             15
Lack of Efficacy             16             12             12
Lack of Compliance             1             1             1
Lost to Follow-up             4             6             3
Protocol Violation             7             2             3
Physician Decision             3             2             3
Other             4             3             9
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg Total
Hide Arm/Group Description Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks. Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks. Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 287 288 290 865
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 287 participants 288 participants 290 participants 865 participants
36.2  (11.8) 35.0  (10.6) 35.4  (10.8) 35.5  (11.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants 288 participants 290 participants 865 participants
≤ 45 years 225 236 236 697
Between 45 and 65 years 57 48 52 157
≥ 65 years 5 4 2 11
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 288 participants 290 participants 865 participants
Female
270
  94.1%
271
  94.1%
280
  96.6%
821
  94.9%
Male
17
   5.9%
17
   5.9%
10
   3.4%
44
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants 288 participants 290 participants 865 participants
Europe 33 34 31 98
South America 145 143 140 428
Southeast Asia 103 106 115 324
Australia 6 5 4 15
1.Primary Outcome
Title SLE Responder Index (SRI) Response Rate at Week 52
Hide Description

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and 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.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Number of Participants Analyzed 287 288 290
Measure Type: Number
Unit of Measure: Percentage of participants
43.6 51.4 57.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.
Method Regression, Logistic
Comments Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: <2g vs ≥2g per 24hr; Race: African/indig-American vs Other)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.83
Confidence Interval 95%
1.30 to 2.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0129
Comments After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05).
Method Regression, Logistic
Comments Adjusted for baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.10 to 2.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.
Hide Description [Not Specified]
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Number of Participants Analyzed 287 288 290
Measure Type: Number
Unit of Measure: Percentage of participants
46.0 53.1 58.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
1.21 to 2.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0189
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.07 to 2.14
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change in Physician's Global Assessment (PGA) at Wk 24.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Number of Participants Analyzed 287 288 290
Mean (Standard Error)
Unit of Measure: Scores on a 3-point scale
-0.39  (0.03) -0.44  (0.03) -0.54  (0.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for baseline PGA score and baseline stratification factors.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2712
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for baseline PGA score and baseline stratification factors.
4.Secondary Outcome
Title Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.
Hide Description The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Number of Participants Analyzed 287 288 290
Mean (Standard Error)
Unit of Measure: Scores on a scale
3.64  (0.42) 3.65  (0.43) 3.58  (0.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8870
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for the baseline PCS score and baseline stratification factors.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8127
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for the baseline PCS score and baseline stratification factors.
5.Secondary Outcome
Title Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52
Hide Description [Not Specified]
Time Frame Baseline, Weeks 40 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Number of Participants Analyzed 192 204 204
Measure Type: Number
Unit of Measure: Percentage of participants
12.0 20.6 18.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0526
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline prednisone dose level and baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.75
Confidence Interval (2-Sided) 95%
0.99 to 3.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0252
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline prednisone dose level and baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
1.08 to 3.31
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Adverse Events (AE) Overview
Hide Description SEE ALSO ADVERSE EVENTS RESULTS SECTION
Time Frame Up to 56 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Number of Participants Analyzed 287 288 290
Measure Type: Number
Unit of Measure: Percentage of participants
Percent of patients with at least 1 AE 91.6 91.7 91.7
Percent of patients with at least 1 Serious AE 12.5 16.3 14.1
Percent of patients with an AE resulting in death 1.0 0.7 1.4
Time Frame Up to 56 weeks.
Adverse Event Reporting Description Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
 
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks. Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks. Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
All-Cause Mortality
Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/287 (12.54%)   47/288 (16.32%)   41/290 (14.14%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/287 (0.00%)  0/288 (0.00%)  2/290 (0.69%) 
Anaemia haemolytic autoimmune * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Haemolytic anaemia * 1  1/287 (0.35%)  0/288 (0.00%)  2/290 (0.69%) 
Hypochromic anaemia * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Lymphopenia * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Thrombocytopenia * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Cardiac disorders       
Cardiac arrest * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Cardiac failure congestive * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Myocardial infarction * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Myocardial ischaemia * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Pericardial effusion * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Pericarditis * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Pericarditis lupus * 1  1/287 (0.35%)  0/288 (0.00%)  1/290 (0.34%) 
Ear and labyrinth disorders       
Vertigo positional * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Endocrine disorders       
Hypothyroidism * 1  0/287 (0.00%)  2/288 (0.69%)  0/290 (0.00%) 
Eye disorders       
Blindness unilateral * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Glaucoma * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Ocular vasculitis * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Retinal detachment * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  1/287 (0.35%)  1/288 (0.35%)  0/290 (0.00%) 
Diarrhoea * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Gastritis * 1  0/287 (0.00%)  2/288 (0.69%)  0/290 (0.00%) 
Haematemesis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Ileus paralytic * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Lupus enteritis * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Melaena * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Mesenteric vein thrombosis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Mouth ulceration * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Oesophagitis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Pancreatitis acute * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Peptic ulcer * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Peritonitis * 1  1/287 (0.35%)  0/288 (0.00%)  1/290 (0.34%) 
Vasculitis gastrointestinal * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
General disorders       
Death * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Infusion related reaction * 1  1/287 (0.35%)  1/288 (0.35%)  1/290 (0.34%) 
Non-cardiac chest pain * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Pyrexia * 1  1/287 (0.35%)  4/288 (1.39%)  4/290 (1.38%) 
Hepatobiliary disorders       
Biliary dilatation * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Cholangitis acute * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Cholecystitis chronic * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Cholelithiasis * 1  1/287 (0.35%)  2/288 (0.69%)  1/290 (0.34%) 
Portal vein thrombosis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Immune system disorders       
Anaphylactic reaction * 1  0/287 (0.00%)  2/288 (0.69%)  1/290 (0.34%) 
Drug hypersensitivity * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Food allergy * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Infections and infestations       
Acinetobacter bacteraemia * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Acute sinusitis * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Appendiceal abscess * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Appendicitis * 1  0/287 (0.00%)  0/288 (0.00%)  2/290 (0.69%) 
Appendicitis perforated * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Bacterial sepsis * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Bronchitis * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Cellulitis * 1  1/287 (0.35%)  4/288 (1.39%)  1/290 (0.34%) 
Conjunctivitis bacterial * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Cystitis * 1  0/287 (0.00%)  1/288 (0.35%)  1/290 (0.34%) 
Dengue fever * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Diarrhoea infectious * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Ecthyma * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Escherichia sepsis * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Gastroenteritis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Gastroenteritis bacterial * 1  2/287 (0.70%)  0/288 (0.00%)  0/290 (0.00%) 
Haematoma infection * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Hepatitis A * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Herpes zoster * 1  2/287 (0.70%)  2/288 (0.69%)  1/290 (0.34%) 
Herpes zoster multi-dermatomal * 1  0/287 (0.00%)  2/288 (0.69%)  0/290 (0.00%) 
Joint abscess * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Kidney infection * 1  0/287 (0.00%)  0/288 (0.00%)  2/290 (0.69%) 
Otitis media chronic * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Phlebitis infective * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Pneumonia * 1  5/287 (1.74%)  1/288 (0.35%)  1/290 (0.34%) 
Pneumonia bacterial * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Pyelonephritis * 1  2/287 (0.70%)  1/288 (0.35%)  0/290 (0.00%) 
Sepsis * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Septic shock * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Subcutaneous abscess * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Upper respiratory tract infection * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Urinary tract infection * 1  2/287 (0.70%)  4/288 (1.39%)  2/290 (0.69%) 
Viral upper respiratory tract infection * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/287 (0.00%)  1/288 (0.35%)  1/290 (0.34%) 
Femoral neck fracture * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Fibula fracture * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Incisional hernia * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Investigations       
Weight decreased * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/287 (0.35%)  0/288 (0.00%)  1/290 (0.34%) 
Intervertebral disc protrusion * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Myalgia * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Myositis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Osteochondrosis * 1  1/287 (0.35%)  1/288 (0.35%)  0/290 (0.00%) 
Osteonecrosis * 1  0/287 (0.00%)  3/288 (1.04%)  1/290 (0.34%) 
SLE arthritis * 1  1/287 (0.35%)  0/288 (0.00%)  3/290 (1.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Benign breast neoplasm * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Nervous system disorders       
Cerebral haemorrhage * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Cerebral infarction * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Headache * 1  1/287 (0.35%)  1/288 (0.35%)  1/290 (0.34%) 
Ischaemic stroke * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Syncope * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Tension headache * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1  1/287 (0.35%)  1/288 (0.35%)  3/290 (1.03%) 
Abortion spontaneous incomplete * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Psychiatric disorders       
Adjustment disorder * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Completed suicide * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Delirium * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Depression * 1  1/287 (0.35%)  0/288 (0.00%)  1/290 (0.34%) 
Intentional self-injury * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Mania * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Panic attack * 1  1/287 (0.35%)  0/288 (0.00%)  1/290 (0.34%) 
Personality disorder * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Renal and urinary disorders       
Cystitis haemorrhagic * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Haematuria * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Lupus nephritis * 1  0/287 (0.00%)  3/288 (1.04%)  3/290 (1.03%) 
Nephrotic syndrome * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Renal failure acute * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Renal vein thrombosis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Reproductive system and breast disorders       
Menorrhagia * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Uterine haemorrhage * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Uterine polyp * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Respiratory, thoracic and mediastinal disorders       
Bronchospasm * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Dyspnoea * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Pleural effusion * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Respiratory failure * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Skin and subcutaneous tissue disorders       
Angioedema * 1  0/287 (0.00%)  1/288 (0.35%)  1/290 (0.34%) 
Cutaneous vasculitis * 1  1/287 (0.35%)  0/288 (0.00%)  1/290 (0.34%) 
Mucocutaneous rash * 1  0/287 (0.00%)  0/288 (0.00%)  1/290 (0.34%) 
Rash erythematous * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Rash maculo-papular * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Systemic lupus erythematosus rash * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Urticaria * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Vascular disorders       
Aortic dissection * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Deep vein thrombosis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
Hypertension * 1  0/287 (0.00%)  1/288 (0.35%)  1/290 (0.34%) 
Hypertensive crisis * 1  0/287 (0.00%)  0/288 (0.00%)  2/290 (0.69%) 
Hypotension * 1  1/287 (0.35%)  1/288 (0.35%)  1/290 (0.34%) 
Thrombophlebitis superficial * 1  2/287 (0.70%)  0/288 (0.00%)  0/290 (0.00%) 
Vasculitis * 1  0/287 (0.00%)  1/288 (0.35%)  0/290 (0.00%) 
Vena cava thrombosis * 1  1/287 (0.35%)  0/288 (0.00%)  0/290 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   222/287 (77.35%)   219/288 (76.04%)   223/290 (76.90%) 
Blood and lymphatic system disorders       
Anaemia * 1  13/287 (4.53%)  13/288 (4.51%)  15/290 (5.17%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  18/287 (6.27%)  8/288 (2.78%)  13/290 (4.48%) 
Diarrhoea * 1  19/287 (6.62%)  28/288 (9.72%)  30/290 (10.34%) 
Dyspepsia * 1  15/287 (5.23%)  11/288 (3.82%)  11/290 (3.79%) 
Gastritis * 1  7/287 (2.44%)  10/288 (3.47%)  15/290 (5.17%) 
Mouth ulceration * 1  18/287 (6.27%)  5/288 (1.74%)  12/290 (4.14%) 
Nausea * 1  31/287 (10.80%)  16/288 (5.56%)  23/290 (7.93%) 
Vomiting * 1  13/287 (4.53%)  16/288 (5.56%)  14/290 (4.83%) 
General disorders       
Fatigue * 1  12/287 (4.18%)  17/288 (5.90%)  18/290 (6.21%) 
Oedema peripheral * 1  21/287 (7.32%)  20/288 (6.94%)  17/290 (5.86%) 
Pyrexia * 1  17/287 (5.92%)  15/288 (5.21%)  16/290 (5.52%) 
Infections and infestations       
Bronchitis * 1  7/287 (2.44%)  21/288 (7.29%)  16/290 (5.52%) 
Cystitis * 1  9/287 (3.14%)  12/288 (4.17%)  22/290 (7.59%) 
Gastroenteritis * 1  16/287 (5.57%)  20/288 (6.94%)  12/290 (4.14%) 
Influenza * 1  25/287 (8.71%)  22/288 (7.64%)  33/290 (11.38%) 
Nasopharyngitis * 1  23/287 (8.01%)  30/288 (10.42%)  20/290 (6.90%) 
Pharyngitis * 1  7/287 (2.44%)  16/288 (5.56%)  15/290 (5.17%) 
Upper respiratory tract infection * 1  47/287 (16.38%)  41/288 (14.24%)  36/290 (12.41%) 
Urinary tract infection * 1  24/287 (8.36%)  27/288 (9.38%)  26/290 (8.97%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  33/287 (11.50%)  21/288 (7.29%)  32/290 (11.03%) 
Arthritis * 1  18/287 (6.27%)  13/288 (4.51%)  15/290 (5.17%) 
Back pain * 1  25/287 (8.71%)  25/288 (8.68%)  19/290 (6.55%) 
Nervous system disorders       
Dizziness * 1  23/287 (8.01%)  16/288 (5.56%)  15/290 (5.17%) 
Headache * 1  75/287 (26.13%)  58/288 (20.14%)  66/290 (22.76%) 
Psychiatric disorders       
Insomnia * 1  14/287 (4.88%)  9/288 (3.13%)  21/290 (7.24%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  25/287 (8.71%)  23/288 (7.99%)  16/290 (5.52%) 
Dyspnoea * 1  15/287 (5.23%)  6/288 (2.08%)  3/290 (1.03%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  17/287 (5.92%)  10/288 (3.47%)  17/290 (5.86%) 
Vascular disorders       
Hypertension * 1  30/287 (10.45%)  24/288 (8.33%)  17/290 (5.86%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
For multi-center trials, no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review at least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00424476    
Other Study ID Numbers: HGS1006-C1057
BLISS-52 ( Other Identifier: Human Genome Sciences Inc. )
110752 ( Other Identifier: GSK )
First Submitted: January 17, 2007
First Posted: January 19, 2007
Results First Submitted: April 7, 2011
Results First Posted: May 5, 2011
Last Update Posted: December 12, 2016