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Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (BLISS-LN)

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: NCT01639339
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : July 7, 2020
Last Update Posted : July 7, 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 Lupus Nephritis
Interventions Biological: Placebo plus standard therapy
Biological: Belimumab 10 mg/kg plus standard therapy
Drug: Standard therapy
Enrollment 448
Recruitment Details This was a Phase 3, multi-center, multi-national, randomized, double-blind, placebo-controlled study that evaluated safety and efficacy of intravenous (IV) belimumab 10 milligrams per kilogram (mg/kg) plus standard of care (SoC) compared to placebo plus SoC in adult participants with active lupus nephritis. The study was conducted in 21 countries.
Pre-assignment Details A total of 797 participants were screened for the study of which 448 participants were enrolled. The results presented are for the primary analysis (double blind treatment period).
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Period Title: Overall Study
Started 224 224
Completed 170 186
Not Completed 54 38
Reason Not Completed
Withdrawal by Subject             26             19
Physician Decision             11             5
Lost to Follow-up             5             4
Protocol Violation             0             2
Lack of Efficacy             2             1
Adverse Event             10             7
Arm/Group Title Placebo Belimumab 10 mg/kg Total
Hide Arm/Group Description Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. Total of all reporting groups
Overall Number of Baseline Participants 224 224 448
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 224 participants 224 participants 448 participants
33.0  (10.64) 33.7  (10.73) 33.4  (10.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants 224 participants 448 participants
Female
196
  87.5%
198
  88.4%
394
  87.9%
Male
28
  12.5%
26
  11.6%
54
  12.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 224 participants 448 participants
American Indian (AI) or Alaska Native (AN) 6 4 10
Asian-Central/South Asian Heritage (H) 2 3 5
Asian-Japanese/East Asian/Southeast Asian H 107 112 219
Mixed Asian 1 0 1
Black or African American (AA) 31 30 61
White/Caucasian/European H 71 72 143
White/Caucasian/Arabic/North African H 4 1 5
Multiple-AA/African H and AI or AN and White 1 1 2
Multiple-Asian and White 1 1 2
1.Primary Outcome
Title Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104
Hide Description PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGFR) was not more than 20 percent (%) below the pre-flare value or >=60 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not in one of 2 sites excluded due to GCP compliance. Percentage of participants with PERR at Week 104 has been presented.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Overall Number of Participants Analyzed 223 223
Measure Type: Number
Unit of Measure: Percentage of participants
32.3 43.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0311
Comments P-value was calculated using logistic regression model. Test 1 of 5 in a step-down sequential testing procedure.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.04 to 2.32
Estimation Comments Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.
2.Secondary Outcome
Title Percentage of Participants With Complete Renal Response (CRR) at Week 104
Hide Description CRR is defined as urinary protein creatinine ratio <0.5, eGRF was not more than 10% below the pre-flare value or >=90 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Overall Number of Participants Analyzed 223 223
Measure Type: Number
Unit of Measure: Percentage of participants
19.7 30.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0167
Comments P-value was calculated using logistic regression model. Test 2 of 5 in a step-down sequential testing procedure.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
1.11 to 2.74
Estimation Comments Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.
3.Secondary Outcome
Title Percentage of Participants With PERR at Week 52
Hide Description PERR is defined as urinary protein creatinine ratio <=0.7, eGRF was not more than 20% below the pre-flare value or >=60 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Overall Number of Participants Analyzed 223 223
Measure Type: Number
Unit of Measure: Percentage of participants
35.4 46.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0245
Comments P-value was calculated using logistic regression model. Test 3 of 5 in a step-down sequential testing procedure.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
1.06 to 2.38
Estimation Comments Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.
4.Secondary Outcome
Title Number of Participants With Time to Death or Renal Related Event
Hide Description Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrawn from the study, or are lost to follow-up were censored on the date of the event. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.
Time Frame Up to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Overall Number of Participants Analyzed 223 223
Measure Type: Count of Participants
Unit of Measure: Participants
63
  28.3%
35
  15.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments P-value was calculated using Cox proportional hazards model. Test 4 of 5 in a step-down sequential testing procedure.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.34 to 0.77
Estimation Comments Treatment comparison between Belimumab 10 mg/kg and placebo using Cox proportional hazards ratio and its corresponding 95% confidence interval has been presented.
5.Secondary Outcome
Title Percentage of Participants With Ordinal Renal Response (ORR) at Week 104
Hide Description ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was <0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is >=50% decrease from Baseline in uPCR and one of the following: value <1 if Baseline <=3, or value <3 if the Baseline was >3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Overall Number of Participants Analyzed 223 223
Measure Type: Number
Unit of Measure: Percentage of participants
CRR 19.7 30.0
PRR 17.0 17.5
Non responder 63.2 52.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments P-value is rank analysis of covariance model comparing Belimumab and Placebo with covariates for treatment group, induction regimen(CYC vs MMF),race(Black vs Non-black), Baseline uPCR, and eGFR. Test 5 of 5 in step-down sequential testing procedure
Method Rank ANCOVA
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Number of Participants Reporting On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AE/ SAE has been reported.
Time Frame Up to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprises of all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Overall Number of Participants Analyzed 224 224
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
211
  94.2%
214
  95.5%
Any SAE
67
  29.9%
58
  25.9%
7.Other Pre-specified Outcome
Title Number of Participants Reporting On-treatment Adverse Events of Special Interest (AESI)
Hide Description An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths (On-treatment AE with death occurring anytime). Number of participants reporting on-treatment AESI has been presented.
Time Frame Up to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
Overall Number of Participants Analyzed 224 224
Measure Type: Count of Participants
Unit of Measure: Participants
Malignancies excluding NMSC
0
   0.0%
2
   0.9%
Malignancies including NMSC
0
   0.0%
3
   1.3%
PISR
29
  12.9%
26
  11.6%
All infections of special interest
34
  15.2%
30
  13.4%
Depression/suicide/self-injury
16
   7.1%
11
   4.9%
Deaths
3
   1.3%
4
   1.8%
Time Frame AEs and SAEs were reported from start of treatment until Week 104. All AEs are included regardless of time since last investigational product (IP) treatment.
Adverse Event Reporting Description AEs and SAEs were collected for Safety Population.
 
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.
All-Cause Mortality
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   5/224 (2.23%)      6/224 (2.68%)    
Hide Serious Adverse Events
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/224 (34.82%)      65/224 (29.02%)    
Blood and lymphatic system disorders     
Anaemia  1  6/224 (2.68%)  6 1/224 (0.45%)  1
Febrile neutropenia  1  0/224 (0.00%)  0 3/224 (1.34%)  3
Leukopenia  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Pancytopenia  1  0/224 (0.00%)  0 2/224 (0.89%)  2
Bone marrow toxicity  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Hypoglobulinaemia  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Lymphadenopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Cardiac disorders     
Pericardial effusion  1  3/224 (1.34%)  4 0/224 (0.00%)  0
Aortic valve incompetence  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Cardiac failure acute  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Cardiac failure congestive  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pericarditis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pericarditis uraemic  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Supraventricular tachycardia  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Endocrine disorders     
Hyperparathyroidism  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Gastrointestinal disorders     
Vomiting  1  2/224 (0.89%)  2 2/224 (0.89%)  2
Diarrhoea  1  0/224 (0.00%)  0 3/224 (1.34%)  3
Gastritis  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Nausea  1  0/224 (0.00%)  0 2/224 (0.89%)  2
Pancreatitis  1  2/224 (0.89%)  2 0/224 (0.00%)  0
Abdominal pain  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Chronic gastritis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Enteritis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Epiploic appendagitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Gastrointestinal inflammation  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Haemorrhoids  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Impaired gastric emptying  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Large intestine perforation  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Vasculitis gastrointestinal  1  1/224 (0.45%)  1 0/224 (0.00%)  0
General disorders     
Pyrexia  1  3/224 (1.34%)  3 2/224 (0.89%)  2
Non-cardiac chest pain  1  2/224 (0.89%)  2 2/224 (0.89%)  2
Asthenia  1  2/224 (0.89%)  2 0/224 (0.00%)  0
Fatigue  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Generalised oedema  1  0/224 (0.00%)  0 1/224 (0.45%)  2
Mucosal inflammation  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pain  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Serositis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Systemic inflammatory response syndrome  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Hepatobiliary disorders     
Cholecystitis acute  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Immune system disorders     
Hypersensitivity  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Immunosuppression  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Infections and infestations     
Pneumonia  1  10/224 (4.46%)  11 10/224 (4.46%)  11
Herpes zoster  1  2/224 (0.89%)  2 4/224 (1.79%)  4
Lung infection  1  4/224 (1.79%)  4 2/224 (0.89%)  2
Urinary tract infection  1  2/224 (0.89%)  2 4/224 (1.79%)  4
Gastroenteritis  1  5/224 (2.23%)  5 0/224 (0.00%)  0
Cellulitis  1  3/224 (1.34%)  3 0/224 (0.00%)  0
Sepsis  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Subcutaneous abscess  1  1/224 (0.45%)  1 2/224 (0.89%)  3
Bronchitis  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Cytomegalovirus colitis  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Endocarditis  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Influenza  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Pulmonary tuberculosis  1  0/224 (0.00%)  0 2/224 (0.89%)  2
Pyelonephritis  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Upper respiratory tract infection  1  2/224 (0.89%)  2 0/224 (0.00%)  0
Abscess limb  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Acute sinusitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Appendicitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Arthritis bacterial  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Bacteraemia  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Bone abscess  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Bronchopulmonary aspergillosis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Clostridium difficile colitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Cytomegalovirus infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Diverticulitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Enteritis infectious  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Enterocolitis bacterial  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Enterocolitis viral  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Escherichia urinary tract infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Furuncle  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Herpes oesophagitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Large intestine infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Periorbital cellulitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Peritonitis bacterial  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pneumonia bacterial  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Pneumonia cytomegaloviral  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pneumonia streptococcal  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Proteus infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Pulmonary nocardiosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Respiratory syncytial virus bronchitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Rhodococcus infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Septic shock  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Sinusitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Staphylococcal abscess  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Staphylococcal infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Tuberculosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Urosepsis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Varicella  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Varicella zoster viral infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Viral infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Wound infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Injury, poisoning and procedural complications     
Skin laceration  1  0/224 (0.00%)  0 2/224 (0.89%)  2
Brain herniation  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Contusion  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Head injury  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Joint injury  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Ligament injury  1  0/224 (0.00%)  0 1/224 (0.45%)  2
Post procedural haematoma  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Spinal compression fracture  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Tibia fracture  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Wrist fracture  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Investigations     
Blood creatinine increased  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Blood immunoglobulin G decreased  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Foetal biophysical profile score equivocal  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Hepatic enzyme increased  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Weight decreased  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Metabolism and nutrition disorders     
Hyperkalaemia  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Hypophagia  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Metabolic acidosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Systemic lupus erythematosus  1  4/224 (1.79%)  4 1/224 (0.45%)  1
Arthralgia  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Back pain  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Flank pain  1  2/224 (0.89%)  2 0/224 (0.00%)  0
Intervertebral disc protrusion  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Musculoskeletal chest pain  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Oligoarthritis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Osteonecrosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Rhabdomyolysis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Spinal osteoarthritis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Tendonitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Papillary thyroid cancer  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Thymoma  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Nervous system disorders     
Cerebral infarction  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Cerebrovascular accident  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Central nervous system lupus  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Encephalopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Epilepsy  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Generalized tonic-clonic seizure  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Haemorrhage intracranial  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Headache  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Hypertensive encephalopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Metabolic encephalopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Polyneuropathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Posterior reversible encephalopathy syndrome  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Seizure  1  1/224 (0.45%)  2 0/224 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion missed  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Foetal death  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Prolonged labour  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Psychiatric disorders     
Mental status changes  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Suicide attempt  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Renal and urinary disorders     
Lupus nephritis  1  8/224 (3.57%)  10 2/224 (0.89%)  2
Acute kidney injury  1  5/224 (2.23%)  5 2/224 (0.89%)  2
End stage renal disease  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Nephrotic syndrome  1  0/224 (0.00%)  0 2/224 (0.89%)  4
Renal impairment  1  0/224 (0.00%)  0 2/224 (0.89%)  2
Azotaemia  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Nephrolithiasis  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Renal failure  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Pleural effusion  1  2/224 (0.89%)  2 1/224 (0.45%)  1
Acute pulmonary oedema  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Aspiration  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Dyspnoea  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Organizing pneumonia  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pneumomediastinum  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pneumothorax  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Pulmonary alveolar haemorrhage  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Pulmonary arterial hypertension  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Pulmonary embolism  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Respiratory failure  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Skin and subcutaneous tissue disorders     
Angioedema  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Erythema annulare  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Systemic lupus erythematosus rash  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Vascular disorders     
Hypertension  1  1/224 (0.45%)  1 2/224 (0.89%)  2
Hypotension  1  1/224 (0.45%)  1 1/224 (0.45%)  1
Deep vein thrombosis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
Hypertensive emergency  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Shock haemorrhagic  1  1/224 (0.45%)  1 0/224 (0.00%)  0
Thrombosis  1  0/224 (0.00%)  0 1/224 (0.45%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   191/224 (85.27%)      186/224 (83.04%)    
Blood and lymphatic system disorders     
Anaemia  1  23/224 (10.27%)  26 13/224 (5.80%)  16
Leukopenia  1  19/224 (8.48%)  29 15/224 (6.70%)  28
Gastrointestinal disorders     
Diarrhoea  1  48/224 (21.43%)  56 45/224 (20.09%)  59
Nausea  1  24/224 (10.71%)  33 21/224 (9.38%)  28
Vomiting  1  16/224 (7.14%)  21 16/224 (7.14%)  25
Abdominal pain  1  13/224 (5.80%)  13 12/224 (5.36%)  15
Dyspepsia  1  15/224 (6.70%)  18 9/224 (4.02%)  10
Abdominal pain upper  1  6/224 (2.68%)  7 16/224 (7.14%)  16
General disorders     
Oedema peripheral  1  13/224 (5.80%)  17 16/224 (7.14%)  23
Pyrexia  1  17/224 (7.59%)  20 11/224 (4.91%)  14
Fatigue  1  14/224 (6.25%)  15 12/224 (5.36%)  12
Oedema  1  12/224 (5.36%)  15 9/224 (4.02%)  9
Infections and infestations     
Upper respiratory tract infection  1  74/224 (33.04%)  134 81/224 (36.16%)  159
Urinary tract infection  1  37/224 (16.52%)  72 43/224 (19.20%)  73
Nasopharyngitis  1  31/224 (13.84%)  50 35/224 (15.63%)  60
Gastroenteritis  1  23/224 (10.27%)  28 21/224 (9.38%)  24
Bronchitis  1  19/224 (8.48%)  26 18/224 (8.04%)  24
Herpes zoster  1  19/224 (8.48%)  20 17/224 (7.59%)  17
Conjunctivitis  1  5/224 (2.23%)  5 13/224 (5.80%)  13
Metabolism and nutrition disorders     
Hypokalaemia  1  20/224 (8.93%)  23 24/224 (10.71%)  36
Musculoskeletal and connective tissue disorders     
Arthralgia  1  32/224 (14.29%)  52 26/224 (11.61%)  44
Back pain  1  17/224 (7.59%)  17 17/224 (7.59%)  24
Muscle spasms  1  15/224 (6.70%)  18 18/224 (8.04%)  25
Pain in extremity  1  8/224 (3.57%)  9 12/224 (5.36%)  14
Nervous system disorders     
Headache  1  35/224 (15.63%)  57 34/224 (15.18%)  51
Dizziness  1  19/224 (8.48%)  21 13/224 (5.80%)  18
Psychiatric disorders     
Insomnia  1  18/224 (8.04%)  19 10/224 (4.46%)  10
Respiratory, thoracic and mediastinal disorders     
Cough  1  21/224 (9.38%)  23 30/224 (13.39%)  38
Skin and subcutaneous tissue disorders     
Rash  1  17/224 (7.59%)  18 23/224 (10.27%)  31
Acne  1  9/224 (4.02%)  11 12/224 (5.36%)  13
Vascular disorders     
Hypertension  1  20/224 (8.93%)  23 12/224 (5.36%)  14
1
Term from vocabulary, MedDRA 22.0
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
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: NCT01639339    
Other Study ID Numbers: 114054
2011-004570-28 ( EudraCT Number )
First Submitted: July 10, 2012
First Posted: July 12, 2012
Results First Submitted: June 17, 2020
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020