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

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ClinicalTrials.gov Identifier: NCT01639339
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : July 7, 2020
Last Update Posted : March 19, 2021
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 study evaluated safety and efficacy of intravenous (IV) belimumab 10 mg/kg plus standard of care (SoC) compared to placebo plus SoC in adult participants with active lupus nephritis. This was a Phase 3, multi-center, multi-national study consisting of a randomized, double-blind, placebo-controlled period and an open-label extension period. The study was conducted in 21 countries.
Pre-assignment Details A total of 797 participants were screened of which 349 participants failed screening and 448 participants were randomized in double-blind period. In open-label period, a total of 257 participants were enrolled of which 2 participants did not receive open-label study treatment and 255 participants received open-label belimumab.
Arm/Group Title Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10
Hide Arm/Group Description Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (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. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. 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. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
Period Title: Double-blind Period (Up to Week 104)
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
Period Title: Open-label Period (Up to Week 28)
Started 123 [1] 132
Completed 122 124
Not Completed 1 8
Reason Not Completed
Withdrawal by Subject             0             2
Lost to Follow-up             0             1
Protocol Violation             0             1
Adverse Event             1             4
[1]
Of the 356 participants who completed the double-blind period, 279 were eligible for open-label treatment. As enrolling into the open-label period was optional, only 257 participants enrolled, of whom 255 started open-label treatment.
Arm/Group Title Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 Total
Hide Arm/Group Description Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (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. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. 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. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. 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: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants 224 participants 448 participants
American Indian (AI) or Alaska Native (AN)
6
   2.7%
4
   1.8%
10
   2.2%
Asian-Central/South Asian Heritage (H)
2
   0.9%
3
   1.3%
5
   1.1%
Asian-Japanese/East Asian/Southeast Asian H
107
  47.8%
112
  50.0%
219
  48.9%
Mixed Asian
1
   0.4%
0
   0.0%
1
   0.2%
Black or African American (AA)
31
  13.8%
30
  13.4%
61
  13.6%
White/Caucasian/European H
71
  31.7%
72
  32.1%
143
  31.9%
White/Caucasian/Arabic/North African H
4
   1.8%
1
   0.4%
5
   1.1%
Multiple-AA/African H and AI or AN and White
1
   0.4%
1
   0.4%
2
   0.4%
Multiple-Asian and White
1
   0.4%
1
   0.4%
2
   0.4%
1.Primary Outcome
Title Double-blind Period: 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 (eGRF) 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 treatment group, 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 excluded due to Good Clinical Practice (GCP) non-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 milligrams per kilogram (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.Primary Outcome
Title Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (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, is 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 AEs and SAEs have been reported.
Time Frame From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Open-Label Population comprised of all participants who received at least one dose of open-label treatment.
Arm/Group Title Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (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. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
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. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
Overall Number of Participants Analyzed 123 132
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
76
  61.8%
92
  69.7%
Any SAE
5
   4.1%
10
   7.6%
3.Primary Outcome
Title Open-label Period: Number of Participants Reporting 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.
Time Frame From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Open-Label Population.
Arm/Group Title Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (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. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
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. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
Overall Number of Participants Analyzed 123 132
Measure Type: Count of Participants
Unit of Measure: Participants
Malignancies excluding NMSC
0
   0.0%
0
   0.0%
Malignancies including NMSC
0
   0.0%
0
   0.0%
PISR
4
   3.3%
5
   3.8%
All infections of special interest
2
   1.6%
6
   4.5%
Depression/suicide/self-injury
2
   1.6%
4
   3.0%
Deaths
1
   0.8%
0
   0.0%
4.Secondary Outcome
Title Double-blind Period: 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 milligrams per kilogram (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.
5.Secondary Outcome
Title Double-blind Period: 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 milligrams per kilogram (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.
6.Secondary Outcome
Title Double-blind Period: 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, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. 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 milligrams per kilogram (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.
7.Secondary Outcome
Title Double-blind Period: 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 milligrams per kilogram (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]
8.Secondary Outcome
Title Double-blind Period: Number of Participants Reporting On-treatment AEs and 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, is 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 AEs and SAEs has been reported.
Time Frame Up to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised 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 milligrams per kilogram (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%
9.Secondary Outcome
Title Double-blind Period: Number of Participants Reporting 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 data is displayed.
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 milligrams per kilogram (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 All-cause mortality, non-SAEs and SAEs were summarised from the start of the first treatment up to Week 104 in double-blind period and from the first open-label dose up to Week 32 (8 weeks after last dose) in open-label extension period.
Adverse Event Reporting Description All-cause mortality, non-SAEs and SAEs were reported for safety population (double-blind period) and safety open-label population (open-label period). Non-serious adverse events not meeting 5% in the open label period were reported as 0% incidence but could have incidences between 0 and 5%.
 
Arm/Group Title Placebo Belimumab 10 mg/kg Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to 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 milligrams per kilogram (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. Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (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. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. 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. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
All-Cause Mortality
Placebo Belimumab 10 mg/kg Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/224 (2.23%)      6/224 (2.68%)      1/123 (0.81%)      0/132 (0.00%)    
Hide Serious Adverse Events
Placebo Belimumab 10 mg/kg Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/224 (34.82%)      65/224 (29.02%)      5/123 (4.07%)      10/132 (7.58%)    
Blood and lymphatic system disorders         
Anaemia  1  6/224 (2.68%)  6 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Febrile neutropenia  1  0/224 (0.00%)  0 3/224 (1.34%)  3 0/123 (0.00%)  0 0/132 (0.00%)  0
Leukopenia  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pancytopenia  1  0/224 (0.00%)  0 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Bone marrow toxicity  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Hypoglobulinaemia  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Lymphadenopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Cardiac disorders         
Pericardial effusion  1  3/224 (1.34%)  4 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Aortic valve incompetence  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Cardiac failure acute  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Cardiac failure congestive  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pericarditis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pericarditis uraemic  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Supraventricular tachycardia  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Acute myocardial infarction  1  0/224 (0.00%)  0 0/224 (0.00%)  0 0/123 (0.00%)  0 1/132 (0.76%)  1
Endocrine disorders         
Hyperparathyroidism  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Gastrointestinal disorders         
Vomiting  1  2/224 (0.89%)  2 2/224 (0.89%)  2 1/123 (0.81%)  2 0/132 (0.00%)  0
Diarrhoea  1  0/224 (0.00%)  0 3/224 (1.34%)  3 0/123 (0.00%)  0 0/132 (0.00%)  0
Gastritis  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Nausea  1  0/224 (0.00%)  0 2/224 (0.89%)  2 1/123 (0.81%)  1 0/132 (0.00%)  0
Pancreatitis  1  2/224 (0.89%)  2 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Abdominal pain  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Chronic gastritis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Enteritis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Epiploic appendagitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Gastrointestinal inflammation  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Haemorrhoids  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Impaired gastric emptying  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Large intestine perforation  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Vasculitis gastrointestinal  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Cyclic vomiting syndrome  1  0/224 (0.00%)  0 0/224 (0.00%)  0 1/123 (0.81%)  1 0/132 (0.00%)  0
Abdominal pain lower  1  0/224 (0.00%)  0 0/224 (0.00%)  0 1/123 (0.81%)  1 0/132 (0.00%)  0
General disorders         
Pyrexia  1  3/224 (1.34%)  3 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Non-cardiac chest pain  1  2/224 (0.89%)  2 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Asthenia  1  2/224 (0.89%)  2 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Fatigue  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Generalised oedema  1  0/224 (0.00%)  0 1/224 (0.45%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Mucosal inflammation  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pain  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Serositis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Systemic inflammatory response syndrome  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Multiple organ dysfunction syndrome  1  0/224 (0.00%)  0 0/224 (0.00%)  0 1/123 (0.81%)  1 0/132 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis acute  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Immune system disorders         
Hypersensitivity  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Immunosuppression  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Infections and infestations         
Pneumonia  1  10/224 (4.46%)  11 10/224 (4.46%)  11 2/123 (1.63%)  2 1/132 (0.76%)  1
Herpes zoster  1  2/224 (0.89%)  2 4/224 (1.79%)  4 0/123 (0.00%)  0 1/132 (0.76%)  1
Lung infection  1  4/224 (1.79%)  4 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Urinary tract infection  1  2/224 (0.89%)  2 4/224 (1.79%)  4 0/123 (0.00%)  0 0/132 (0.00%)  0
Gastroenteritis  1  5/224 (2.23%)  5 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Cellulitis  1  3/224 (1.34%)  3 0/224 (0.00%)  0 0/123 (0.00%)  0 1/132 (0.76%)  1
Sepsis  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Subcutaneous abscess  1  1/224 (0.45%)  1 2/224 (0.89%)  3 0/123 (0.00%)  0 0/132 (0.00%)  0
Bronchitis  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Cytomegalovirus colitis  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Endocarditis  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Influenza  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pulmonary tuberculosis  1  0/224 (0.00%)  0 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Pyelonephritis  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 1/132 (0.76%)  1
Upper respiratory tract infection  1  2/224 (0.89%)  2 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Abscess limb  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Acute sinusitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 1/132 (0.76%)  1
Appendicitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Arthritis bacterial  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Bacteraemia  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Bone abscess  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Bronchopulmonary aspergillosis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Clostridium difficile colitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 1/132 (0.76%)  1
Cytomegalovirus infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Diverticulitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Enteritis infectious  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Enterocolitis bacterial  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Enterocolitis viral  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Escherichia urinary tract infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Furuncle  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Herpes oesophagitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Large intestine infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Periorbital cellulitis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Peritonitis bacterial  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pneumonia bacterial  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Pneumonia cytomegaloviral  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pneumonia streptococcal  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Proteus infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Pulmonary nocardiosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Respiratory syncytial virus bronchitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Rhodococcus infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Septic shock  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Sinusitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Staphylococcal abscess  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Staphylococcal infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Tuberculosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Urosepsis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Varicella  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Varicella zoster viral infection  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Viral infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Wound infection  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Complicated appendicitis  1  0/224 (0.00%)  0 0/224 (0.00%)  0 1/123 (0.81%)  1 0/132 (0.00%)  0
Disseminated tuberculosis  1  0/224 (0.00%)  0 0/224 (0.00%)  0 0/123 (0.00%)  0 1/132 (0.76%)  1
Genital infection  1  0/224 (0.00%)  0 0/224 (0.00%)  0 1/123 (0.81%)  1 0/132 (0.00%)  0
Otitis media  1  0/224 (0.00%)  0 0/224 (0.00%)  0 0/123 (0.00%)  0 1/132 (0.76%)  1
Pyelonephritis acute  1  0/224 (0.00%)  0 0/224 (0.00%)  0 1/123 (0.81%)  1 0/132 (0.00%)  0
Injury, poisoning and procedural complications         
Skin laceration  1  0/224 (0.00%)  0 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Brain herniation  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Contusion  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Head injury  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Joint injury  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Ligament injury  1  0/224 (0.00%)  0 1/224 (0.45%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Post procedural haematoma  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Spinal compression fracture  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Tibia fracture  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Wrist fracture  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Investigations         
Blood creatinine increased  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Blood immunoglobulin G decreased  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Foetal biophysical profile score equivocal  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Hepatic enzyme increased  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Weight decreased  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Metabolism and nutrition disorders         
Hyperkalaemia  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Hypophagia  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Metabolic acidosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Systemic lupus erythematosus  1  4/224 (1.79%)  4 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Arthralgia  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Back pain  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Flank pain  1  2/224 (0.89%)  2 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Intervertebral disc protrusion  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Musculoskeletal chest pain  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Oligoarthritis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Osteonecrosis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Rhabdomyolysis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Spinal osteoarthritis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Tendonitis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Muscular weakness  1  0/224 (0.00%)  0 0/224 (0.00%)  0 1/123 (0.81%)  2 0/132 (0.00%)  0
Pain in extremity  1  0/224 (0.00%)  0 0/224 (0.00%)  0 0/123 (0.00%)  0 1/132 (0.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Papillary thyroid cancer  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Thymoma  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Nervous system disorders         
Cerebral infarction  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Cerebrovascular accident  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Central nervous system lupus  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Encephalopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Epilepsy  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Generalized tonic-clonic seizure  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Haemorrhage intracranial  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Headache  1  0/224 (0.00%)  0 1/224 (0.45%)  1 1/123 (0.81%)  1 0/132 (0.00%)  0
Hypertensive encephalopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Metabolic encephalopathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Polyneuropathy  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Posterior reversible encephalopathy syndrome  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Seizure  1  1/224 (0.45%)  2 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion missed  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Foetal death  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Prolonged labour  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Unintended pregnancy  1  0/224 (0.00%)  0 0/224 (0.00%)  0 0/123 (0.00%)  0 1/132 (0.76%)  1
Psychiatric disorders         
Mental status changes  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Suicide attempt  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 1/132 (0.76%)  1
Renal and urinary disorders         
Lupus nephritis  1  8/224 (3.57%)  10 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Acute kidney injury  1  5/224 (2.23%)  5 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
End stage renal disease  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Nephrotic syndrome  1  0/224 (0.00%)  0 2/224 (0.89%)  4 0/123 (0.00%)  0 0/132 (0.00%)  0
Renal impairment  1  0/224 (0.00%)  0 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Azotaemia  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Nephrolithiasis  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Renal failure  1  0/224 (0.00%)  0 1/224 (0.45%)  1 1/123 (0.81%)  1 0/132 (0.00%)  0
Reproductive system and breast disorders         
Cervical dysplasia  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Endometriosis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pleural effusion  1  2/224 (0.89%)  2 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Acute pulmonary oedema  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Aspiration  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Dyspnoea  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Organizing pneumonia  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pneumomediastinum  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pneumothorax  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Pulmonary alveolar haemorrhage  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Pulmonary arterial hypertension  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Pulmonary embolism  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Respiratory failure  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Skin and subcutaneous tissue disorders         
Angioedema  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Erythema annulare  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Systemic lupus erythematosus rash  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Vascular disorders         
Hypertension  1  1/224 (0.45%)  1 2/224 (0.89%)  2 0/123 (0.00%)  0 0/132 (0.00%)  0
Hypotension  1  1/224 (0.45%)  1 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Deep vein thrombosis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
Hypertensive emergency  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Shock haemorrhagic  1  1/224 (0.45%)  1 0/224 (0.00%)  0 0/123 (0.00%)  0 0/132 (0.00%)  0
Thrombosis  1  0/224 (0.00%)  0 1/224 (0.45%)  1 0/123 (0.00%)  0 0/132 (0.00%)  0
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 Placebo to Belimumab 10 mg/kg Belimumab 10 mg/kg to Belimumab 10 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   191/224 (85.27%)      186/224 (83.04%)      34/123 (27.64%)      39/132 (29.55%)    
Blood and lymphatic system disorders         
Anaemia  1  23/224 (10.27%)  26 13/224 (5.80%)  16 0/123 (0.00%)  0 0/132 (0.00%)  0
Leukopenia  1  19/224 (8.48%)  29 15/224 (6.70%)  28 0/123 (0.00%)  0 0/132 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  48/224 (21.43%)  56 45/224 (20.09%)  59 0/123 (0.00%)  0 0/132 (0.00%)  0
Nausea  1  24/224 (10.71%)  33 21/224 (9.38%)  28 0/123 (0.00%)  0 0/132 (0.00%)  0
Vomiting  1  16/224 (7.14%)  21 16/224 (7.14%)  25 0/123 (0.00%)  0 0/132 (0.00%)  0
Abdominal pain  1  13/224 (5.80%)  13 12/224 (5.36%)  15 0/123 (0.00%)  0 0/132 (0.00%)  0
Dyspepsia  1  15/224 (6.70%)  18 9/224 (4.02%)  10 0/123 (0.00%)  0 0/132 (0.00%)  0
Abdominal pain upper  1  6/224 (2.68%)  7 16/224 (7.14%)  16 0/123 (0.00%)  0 0/132 (0.00%)  0
General disorders         
Oedema peripheral  1  13/224 (5.80%)  17 16/224 (7.14%)  23 0/123 (0.00%)  0 0/132 (0.00%)  0
Pyrexia  1  17/224 (7.59%)  20 11/224 (4.91%)  14 0/123 (0.00%)  0 0/132 (0.00%)  0
Fatigue  1  14/224 (6.25%)  15 12/224 (5.36%)  12 0/123 (0.00%)  0 0/132 (0.00%)  0
Oedema  1  12/224 (5.36%)  15 9/224 (4.02%)  9 0/123 (0.00%)  0 0/132 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  74/224 (33.04%)  134 81/224 (36.16%)  159 14/123 (11.38%)  18 23/132 (17.42%)  24
Urinary tract infection  1  37/224 (16.52%)  72 43/224 (19.20%)  73 10/123 (8.13%)  12 12/132 (9.09%)  14
Nasopharyngitis  1  31/224 (13.84%)  50 35/224 (15.63%)  60 8/123 (6.50%)  9 3/132 (2.27%)  3
Gastroenteritis  1  23/224 (10.27%)  28 21/224 (9.38%)  24 0/123 (0.00%)  0 0/132 (0.00%)  0
Bronchitis  1  19/224 (8.48%)  26 18/224 (8.04%)  24 0/123 (0.00%)  0 0/132 (0.00%)  0
Herpes zoster  1  19/224 (8.48%)  20 17/224 (7.59%)  17 0/123 (0.00%)  0 0/132 (0.00%)  0
Conjunctivitis  1  5/224 (2.23%)  5 13/224 (5.80%)  13 0/123 (0.00%)  0 0/132 (0.00%)  0
Metabolism and nutrition disorders         
Hypokalaemia  1  20/224 (8.93%)  23 24/224 (10.71%)  36 0/123 (0.00%)  0 0/132 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  32/224 (14.29%)  52 26/224 (11.61%)  44 5/123 (4.07%)  5 7/132 (5.30%)  8
Back pain  1  17/224 (7.59%)  17 17/224 (7.59%)  24 0/123 (0.00%)  0 0/132 (0.00%)  0
Muscle spasms  1  15/224 (6.70%)  18 18/224 (8.04%)  25 0/123 (0.00%)  0 0/132 (0.00%)  0
Pain in extremity  1  8/224 (3.57%)  9 12/224 (5.36%)  14 0/123 (0.00%)  0 0/132 (0.00%)  0
Nervous system disorders         
Headache  1  35/224 (15.63%)  57 34/224 (15.18%)  51 0/123 (0.00%)  0 0/132 (0.00%)  0
Dizziness  1  19/224 (8.48%)  21 13/224 (5.80%)  18 0/123 (0.00%)  0 0/132 (0.00%)  0
Psychiatric disorders         
Insomnia  1  18/224 (8.04%)  19 10/224 (4.46%)  10 0/123 (0.00%)  0 0/132 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  21/224 (9.38%)  23 30/224 (13.39%)  38 0/123 (0.00%)  0 0/132 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash  1  17/224 (7.59%)  18 23/224 (10.27%)  31 0/123 (0.00%)  0 0/132 (0.00%)  0
Acne  1  9/224 (4.02%)  11 12/224 (5.36%)  13 0/123 (0.00%)  0 0/132 (0.00%)  0
Vascular disorders         
Hypertension  1  20/224 (8.93%)  23 12/224 (5.36%)  14 0/123 (0.00%)  0 0/132 (0.00%)  0
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: March 19, 2021