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A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

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ClinicalTrials.gov Identifier: NCT01484496
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : July 25, 2017
Last Update Posted : June 5, 2018
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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Biological: Placebo
Biological: Belimumab 200 mg SC
Drug: Standard therapy
Enrollment 839

Recruitment Details Participants (Par.) with active systemic lupus erythematosus (SLE) and who were on appropriate stable standard SLE therapy for a period of at least 30 days prior to Day 0 before entering the study were eligible for participation in the study.
Pre-assignment Details A total of 1427 par. were screened, out of these 588 par. were screen failures and 839 par. were randomized, of which 836 par. received at least one dose of study treatment. Par. who successfully completed the initial 52-week Double-blind Phase had a choice to enter into a 6-month Open-label Extension Phase of this study.
Arm/Group Title Placebo SC Belimumab 200 mg SC Open-Label - Placebo SC to Belimumab 200 mg SC Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
Hide Arm/Group Description Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly. Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly
Period Title: Period 1
Started 280 556 0 0
Completed 214 463 0 0
Not Completed 66 93 0 0
Reason Not Completed
Protocol Violation             3             4             0             0
Physician Decision             5             1             0             0
Lack of Efficacy             10             15             0             0
Adverse Event             25             40             0             0
Withdrawal by Subject             15             12             0             0
Lost to Follow-up             2             6             0             0
Positive Pregnancy             1             6             0             0
Treatment Failure             3             6             0             0
Lack of Compliance             2             1             0             0
Unable to Visit Site             0             2             0             0
Period Title: Period 2
Started 0 0 206 456
Completed 0 0 191 434
Not Completed 0 0 15 22
Reason Not Completed
Lack of Efficacy             0             0             1             3
Adverse Event             0             0             5             13
Other             0             0             9             6
Arm/Group Title Placebo SC Belimumab 200 mg SC Total
Hide Arm/Group Description Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Total of all reporting groups
Overall Number of Baseline Participants 280 556 836
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 280 participants 556 participants 836 participants
39.6  (12.61) 38.1  (12.10) 38.6  (12.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 556 participants 836 participants
Female
268
  95.7%
521
  93.7%
789
  94.4%
Male
12
   4.3%
35
   6.3%
47
   5.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 556 participants 836 participants
White/Caucasian/European Heritage 160 326 486
Middle East/North African Heritage 6 10 16
Central Asian Heritage 0 2 2
East Asian Heritage 15 29 44
Japanese Heritage 16 13 29
South Asian Heritage 0 2 2
Southeast Asian Heritage 32 73 105
African American/African Heritage 30 56 86
American Indian or Alaska Native 21 43 64
Native Hawaiian or Other Pacific Islander 0 2 2
1.Primary Outcome
Title Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Hide Description SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, 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 or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included.
Arm/Group Title Placebo SC Belimumab 200 mg SC
Hide Arm/Group Description:
Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Overall Number of Participants Analyzed 279 554
Measure Type: Number
Unit of Measure: Percentage of par.
48.4 61.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo SC, Belimumab 200 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
1.25 to 2.25
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
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 SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.
Time Frame Baseline (Day 0, prior to dosing) to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at that particular timepoints were analyzed.
Arm/Group Title Placebo SC Belimumab 200 mg SC
Hide Arm/Group Description:
Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Overall Number of Participants Analyzed 51 59
Median (Full Range)
Unit of Measure: Days
118
(2 to 364)
171
(5 to 358)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo SC, Belimumab 200 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.35 to 0.74
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline
Hide Description For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Time Frame Baseline (Day 0, prior to dosing), Weeks 40 through Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only par. with Baseline prednisone dose >7.5 mg/day were included.
Arm/Group Title Placebo SC Belimumab 200 mg SC
Hide Arm/Group Description:
Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Overall Number of Participants Analyzed 168 335
Measure Type: Number
Unit of Measure: Percentage of par.
11.9 18.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo SC, Belimumab 200 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0732
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
0.95 to 2.84
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period.
Adverse Event Reporting Description SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
 
Arm/Group Title Placebo SC Belimumab 200 mg SC Open-Label - Placebo SC to Belimumab 200 mg SC Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
Hide Arm/Group Description Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly. Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
All-Cause Mortality
Placebo SC Belimumab 200 mg SC Open-Label - Placebo SC to Belimumab 200 mg SC Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/280 (0.71%)   3/556 (0.54%)   0/206 (0.00%)   0/456 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo SC Belimumab 200 mg SC Open-Label - Placebo SC to Belimumab 200 mg SC Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/280 (15.71%)   60/556 (10.79%)   14/206 (6.80%)   25/456 (5.48%) 
Blood and lymphatic system disorders         
Thrombocytopenia  1  3/280 (1.07%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Anaemia  1  1/280 (0.36%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Disseminated intravascular coagulation  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Febrile neutropenia  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Hypochromic anaemia  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Antiphospholipid syndrome  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Iron deficiency anaemia  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Cardiac disorders         
Myocardial infarction  1  0/280 (0.00%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Cardiac arrest  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Cardiac failure congestive  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Coronary artery disease  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Mitral valve incompetence  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Pericarditis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Eye disorders         
Cataract  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Exfoliation syndrome  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Eyelid oedema  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Gastrointestinal disorders         
Abdominal pain  1  1/280 (0.36%)  1/556 (0.18%)  0/206 (0.00%)  1/456 (0.22%) 
Dysphagia  1  2/280 (0.71%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Small intestinal obstruction  1  0/280 (0.00%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Abdominal hernia  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Abdominal pain upper  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Diarrhoea  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Haemorrhoids thrombosed  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Mouth ulceration  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Pancreatitis chronic  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  1/456 (0.22%) 
Vomiting  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Large intestine perforation  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Gastric ulcer  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Lip swelling  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
General disorders         
Non-cardiac chest pain  1  1/280 (0.36%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Pyrexia  1  0/280 (0.00%)  3/556 (0.54%)  0/206 (0.00%)  0/456 (0.00%) 
Peripheral swelling  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Systemic inflammatory response syndrome  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Cholecystitis chronic  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Immune system disorders         
Drug hypersensitivity  1  0/280 (0.00%)  1/556 (0.18%)  1/206 (0.49%)  0/456 (0.00%) 
Infections and infestations         
Cellulitis  1  2/280 (0.71%)  3/556 (0.54%)  0/206 (0.00%)  1/456 (0.22%) 
Pneumonia  1  1/280 (0.36%)  4/556 (0.72%)  1/206 (0.49%)  1/456 (0.22%) 
Pneumonia bacterial  1  2/280 (0.71%)  3/556 (0.54%)  0/206 (0.00%)  0/456 (0.00%) 
Urosepsis  1  0/280 (0.00%)  3/556 (0.54%)  0/206 (0.00%)  0/456 (0.00%) 
Bacterial sepsis  1  0/280 (0.00%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Urinary tract infection bacterial  1  0/280 (0.00%)  2/556 (0.36%)  0/206 (0.00%)  1/456 (0.22%) 
Amoebic dysentery  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Bronchitis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Corynebacterium sepsis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Dengue fever  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Diarrhoea infectious  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Escherichia urinary tract infection  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
External ear cellulitis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Gastroenteritis viral  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Herpes virus infection  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Herpes zoster  1  0/280 (0.00%)  1/556 (0.18%)  2/206 (0.97%)  0/456 (0.00%) 
Meningitis bacterial  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Oral candidiasis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Osteomyelitis bacterial  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Perirectal abscess  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Pulmonary tuberculosis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Pyelonephritis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Pyelonephritis acute  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  1/456 (0.22%) 
Respiratory syncytial virus bronchitis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Salmonellosis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Septic shock  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Subcutaneous abscess  1  1/280 (0.36%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Tuberculosis of central nervous system  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Urinary tract infection  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Viral upper respiratory tract infection  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Abdominal abscess  1  0/280 (0.00%)  0/556 (0.00%)  2/206 (0.97%)  0/456 (0.00%) 
Appendicitis  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Bronchitis viral  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Mycobacterial infection  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Paraspinal abscess  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Arthritis infective  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Cystitis bacterial  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Gastroenteritis  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Staphylococcal sepsis  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Tuberculosis  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Urinary tract infection staphylococcal  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Injury, poisoning and procedural complications         
Procedural vomiting  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Ankle fracture  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Humerus fracture  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Rib fracture  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Investigations         
Hepatic enzyme increased  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
International normalised ratio increased  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Liver function test abnormal  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Troponin increased  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Metabolism and nutrition disorders         
Electrolyte imbalance  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Hypernatraemia  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Metabolic acidosis  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Dehydration  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Musculoskeletal and connective tissue disorders         
SLE arthritis  1  1/280 (0.36%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Arthralgia  1  0/280 (0.00%)  1/556 (0.18%)  1/206 (0.49%)  0/456 (0.00%) 
Back pain  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Costochondritis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Musculoskeletal chest pain  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Neck pain  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Osteoarthritis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Pain in extremity  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Polyarthritis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Synovitis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Endometrial cancer  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Intraductal proliferative breast lesion  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Lipoma of breast  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Thyroid neoplasm  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  1/280 (0.36%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Headache  1  2/280 (0.71%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Neuropsychiatric lupus  1  0/280 (0.00%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Syncope  1  1/280 (0.36%)  1/556 (0.18%)  0/206 (0.00%)  1/456 (0.22%) 
Generalised tonic-clonic seizure  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Haemorrhage intracranial  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Intracranial venous sinus thrombosis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Lupus encephalitis  1  1/280 (0.36%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Transient ischaemic attack  1  0/280 (0.00%)  1/556 (0.18%)  1/206 (0.49%)  0/456 (0.00%) 
Vocal cord paralysis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Central nervous system lupus  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  0/280 (0.00%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Psychiatric disorders         
Suicidal ideation  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Depression  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Suicide attempt  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Renal and urinary disorders         
Renal failure acute  1  0/280 (0.00%)  4/556 (0.72%)  0/206 (0.00%)  0/456 (0.00%) 
Lupus nephritis  1  1/280 (0.36%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Nephritis  1  1/280 (0.36%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Nephrotic syndrome  1  2/280 (0.71%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Nephritic syndrome  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Nephrolithiasis  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Proteinuria  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Renal tubular necrosis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Acute kidney injury  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  2/456 (0.44%) 
Haematuria  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Reproductive system and breast disorders         
Cervical dysplasia  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Cystocele  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Ovarian cyst  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Uterine polyp  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Uterine prolapse  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Vaginal haemorrhage  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Polycystic ovaries  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Respiratory, thoracic and mediastinal disorders         
Pleurisy  1  1/280 (0.36%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Acute respiratory failure  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  1/456 (0.22%) 
Alveolitis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Dyspnoea  1  1/280 (0.36%)  0/556 (0.00%)  1/206 (0.49%)  1/456 (0.22%) 
Pulmonary arterial hypertension  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Pulmonary haemorrhage  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Lupus pleurisy  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Pleuritic pain  1  0/280 (0.00%)  0/556 (0.00%)  1/206 (0.49%)  0/456 (0.00%) 
Skin and subcutaneous tissue disorders         
Systemic lupus erythematosus rash  1  1/280 (0.36%)  2/556 (0.36%)  0/206 (0.00%)  0/456 (0.00%) 
Angioedema  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Drug eruption  1  1/280 (0.36%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Skin ulcer  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Urticaria  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  1/456 (0.22%) 
Rash pruritic  1  0/280 (0.00%)  0/556 (0.00%)  0/206 (0.00%)  1/456 (0.22%) 
Vascular disorders         
Deep vein thrombosis  1  1/280 (0.36%)  1/556 (0.18%)  1/206 (0.49%)  2/456 (0.44%) 
Lupus vasculitis  1  2/280 (0.71%)  0/556 (0.00%)  0/206 (0.00%)  0/456 (0.00%) 
Hypertension  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Orthostatic hypotension  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
Thrombosis  1  0/280 (0.00%)  1/556 (0.18%)  0/206 (0.00%)  0/456 (0.00%) 
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo SC Belimumab 200 mg SC Open-Label - Placebo SC to Belimumab 200 mg SC Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   218/280 (77.86%)   403/556 (72.48%)   42/206 (20.39%)   78/456 (17.11%) 
Gastrointestinal disorders         
Nausea  1  22/280 (7.86%)  38/556 (6.83%)  1/206 (0.49%)  5/456 (1.10%) 
Diarrhoea  1  14/280 (5.00%)  27/556 (4.86%)  3/206 (1.46%)  8/456 (1.75%) 
Infections and infestations         
Viral upper respiratory tract infection  1  24/280 (8.57%)  48/556 (8.63%)  9/206 (4.37%)  17/456 (3.73%) 
Nasopharyngitis  1  22/280 (7.86%)  38/556 (6.83%)  9/206 (4.37%)  7/456 (1.54%) 
Urinary tract infection bacterial  1  18/280 (6.43%)  41/556 (7.37%)  2/206 (0.97%)  14/456 (3.07%) 
Upper respiratory tract infection bacterial  1  14/280 (5.00%)  30/556 (5.40%)  3/206 (1.46%)  9/456 (1.97%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  15/280 (5.36%)  28/556 (5.04%)  4/206 (1.94%)  5/456 (1.10%) 
Arthralgia  1  11/280 (3.93%)  31/556 (5.58%)  6/206 (2.91%)  11/456 (2.41%) 
Nervous system disorders         
Headache  1  25/280 (8.93%)  57/556 (10.25%)  4/206 (1.94%)  10/456 (2.19%) 
Psychiatric disorders         
Insomnia  1  20/280 (7.14%)  18/556 (3.24%)  0/206 (0.00%)  1/456 (0.22%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  19/280 (6.79%)  22/556 (3.96%)  1/206 (0.49%)  8/456 (1.75%) 
Vascular disorders         
Hypertension  1  14/280 (5.00%)  25/556 (4.50%)  4/206 (1.94%)  2/456 (0.44%) 
1
Term from vocabulary, MedDRA 17.0
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01484496     History of Changes
Other Study ID Numbers: 112341
2011-003814-18
HGS1006-C1115
First Submitted: November 28, 2011
First Posted: December 2, 2011
Results First Submitted: January 30, 2017
Results First Posted: July 25, 2017
Last Update Posted: June 5, 2018