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GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

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ClinicalTrials.gov Identifier: NCT01345253
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : December 2, 2016
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: Belimumab
Drug: Placebo
Enrollment 709
Recruitment Details This study consisted of a 52 week blinded treatment period in Northeast Asia (China, Japan, Korea) which was followed by an optional open-label (OL) extension period in China for evaluation of belimumab in participants (par.) with active systemic lupus erythematosus (SLE).
Pre-assignment Details A total of 707 par. were randomized, 705 received at least 1 dose of investigational product (Safety Population), 677 par. were included in the primary efficacy population (MITT Population) of which 663 were evaluable for the primary endpoint. The participant flow and baseline characteristics are presented for MITT Population (Pop).
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28. Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Period Title: Double-blind (DB) Phase (52 Weeks)
Started 226 451
Completed 170 372
Not Completed 56 79
Reason Not Completed
Adverse Event             22             27
Lack of Efficacy             11             7
Protocol Violation             1             5
Met Protocol Defined Stopping Criteria             6             1
Lost to Follow-up             3             8
Physician Decision             4             12
Withdrawal by Subject             9             19
Period Title: Open-label Phase (Up to Year 5 Week 44)
Started 134 [1] 290 [2]
Completed 69 146
Not Completed 65 144
Reason Not Completed
Adverse Event             7             18
Death             0             1
Lack of Efficacy             3             7
Protocol Violation             2             5
Lost to Follow-up             4             6
Physician Decision             11             24
Withdrawal by Subject             37             82
Not Recorded             1             1
[1]
Only eligible China par. enrolled in OL phase from MITT + additional 9 China par. from Safety Pop
[2]
Only eligible China par. enrolled in OL phase from MITT + additional 16 China par. from Safety Pop
Arm/Group Title Placebo Belimumab 10 mg/kg Total
Hide Arm/Group Description Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28. Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28. Total of all reporting groups
Overall Number of Baseline Participants 226 451 677
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 226 participants 451 participants 677 participants
31.7  (9.18) 32.3  (9.65) 32.1  (9.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 451 participants 677 participants
Female
210
  92.9%
419
  92.9%
629
  92.9%
Male
16
   7.1%
32
   7.1%
48
   7.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 451 participants 677 participants
Asian - Central/South Asian Heritage
2
   0.9%
4
   0.9%
6
   0.9%
Asian - East Asian Heritage
195
  86.3%
403
  89.4%
598
  88.3%
Asian - Japanese Heritage
24
  10.6%
40
   8.9%
64
   9.5%
Asian - South East Asian Heritage
4
   1.8%
3
   0.7%
7
   1.0%
Asian - Mixed Race
1
   0.4%
1
   0.2%
2
   0.3%
1.Primary Outcome
Title Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
Hide Description SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed 217 446
Measure Type: Number
Unit of Measure: Percentage of participants
40.1 53.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
1.40 to 2.82
Estimation Comments Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).
2.Secondary Outcome
Title Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
Hide Description The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed 218 447
Measure Type: Number
Unit of Measure: Percentage of participants
42.2 55.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
1.41 to 2.83
Estimation Comments Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
3.Secondary Outcome
Title Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.
Hide Description SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time point were analyzed.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed 183 367
Measure Type: Number
Unit of Measure: Percentage of participants
23.5 32.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0116
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.13 to 2.74
Estimation Comments Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
4.Secondary Outcome
Title Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.
Hide Description Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.
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 received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed 184 352
Median (Inter-Quartile Range)
Unit of Measure: Days
0.0
(0.0 to 172.0)
0.0
(0.0 to 213.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0288
Comments [Not Specified]
Method Rank ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.
Hide Description Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed 226 451
Median (Inter-Quartile Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Due to low event rates of participants in both treatment groups having severe SFI flares, the median time and interquartile range could not be estimated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.34 to 0.73
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase
Hide Description SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at time of assessment. Excludes participants with a SELENA SLEDAI score <4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.
Time Frame Weeks 24 and 48 for Years 2, 3, 4, 5 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population: all participants in China who received at least 1 dose of belimumab during open-label phase, exclusive of site 086485. Only those participants available at the specified time points were analyzed (represented by n=x).
Arm/Group Title Belimumab 10mg/kg (Open-label Phase)
Hide Arm/Group Description:
All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24, Year 2, n=326 Number Analyzed 326 participants
66.0
Week 48, Year 2, n=299 Number Analyzed 299 participants
69.6
Week 24, Year 3, n=271 Number Analyzed 271 participants
72.3
Week 48, Year 3, n=247 Number Analyzed 247 participants
70.9
Week 24, Year 4, n=233 Number Analyzed 233 participants
71.7
Week 48, Year 4, n=194 Number Analyzed 194 participants
76.8
Week 24, Year 5, n= 156 Number Analyzed 156 participants
81.4
Week 48, Year 5, n= 82 Number Analyzed 82 participants
80.5
Week 24, Year 6, n= 36 Number Analyzed 36 participants
86.1
Week 48, Year 6, n= 5 Number Analyzed 5 participants
60.0
Time Frame Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44.
Adverse Event Reporting Description SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
 
Arm/Group Title Placebo (Double-blind Phase) Belimumab 10 mg/kg (Double-blind Phase) Belimumab 10 mg/kg (Open-label Phase)
Hide Arm/Group Description Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period. Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period. All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.
All-Cause Mortality
Placebo (Double-blind Phase) Belimumab 10 mg/kg (Double-blind Phase) Belimumab 10 mg/kg (Open-label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/235 (0.43%)   0/470 (0.00%)   1/424 (0.24%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Double-blind Phase) Belimumab 10 mg/kg (Double-blind Phase) Belimumab 10 mg/kg (Open-label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/235 (18.30%)   58/470 (12.34%)   96/424 (22.64%) 
Blood and lymphatic system disorders       
Pancytopenia  1  1/235 (0.43%)  1/470 (0.21%)  0/424 (0.00%) 
Histiocytosis haematophagic  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Leukopenia  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Anaemia  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Granulocytopenia  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Thrombocytopenia  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Haemolytic anaemia  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Cardiac disorders       
Cardiomyopathy  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Cardiac failure  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Myocardial ischaemia  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Wolff-Parkinson-White syndrome  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Congenital, familial and genetic disorders       
Dermoid cyst  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Ear and labyrinth disorders       
Vertigo  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Vertigo positional  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Eye disorders       
Cataract  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Glaucoma  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Retinal detachment  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/235 (0.00%)  2/470 (0.43%)  1/424 (0.24%) 
Allergic colitis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Haemorrhoidal haemorrhage  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Lupus pancreatitis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Oesophageal varices haemorrhage  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Pancreatitis chronic  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Ascites  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Chronic gastritis  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Gastric varices haemorrhage  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Haemorrhoids  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Intestinal obstruction  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Intestinal perforation  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Intestinal pseudo-obstruction  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Upper gastrointestinal haemorrhage  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
General disorders       
Pyrexia  1  4/235 (1.70%)  2/470 (0.43%)  1/424 (0.24%) 
Generalised oedema  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Polyserositis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Chest discomfort  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Granuloma  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Peripheral swelling  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  0/235 (0.00%)  2/470 (0.43%)  2/424 (0.47%) 
Cholelithiasis  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Infections and infestations       
Herpes zoster  1  2/235 (0.85%)  6/470 (1.28%)  6/424 (1.42%) 
Pneumonia  1  1/235 (0.43%)  2/470 (0.43%)  4/424 (0.94%) 
Appendicitis  1  0/235 (0.00%)  2/470 (0.43%)  2/424 (0.47%) 
Lung infection  1  2/235 (0.85%)  0/470 (0.00%)  2/424 (0.47%) 
Pyelonephritis acute  1  0/235 (0.00%)  2/470 (0.43%)  0/424 (0.00%) 
Salmonella sepsis  1  2/235 (0.85%)  0/470 (0.00%)  0/424 (0.00%) 
Skin infection  1  1/235 (0.43%)  1/470 (0.21%)  0/424 (0.00%) 
Arthritis salmonella  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Bacterial pyelonephritis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Cellulitis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Cellulitis streptococcal  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Cystitis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Cytomegalovirus infection  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Disseminated tuberculosis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Enteritis infectious  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Escherichia urinary tract infection  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Gastroenteritis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Gastrointestinal fungal infection  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Infectious colitis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Lymph node tuberculosis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Meningitis tuberculous  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Otitis media acute  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Pneumonia bacterial  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Pneumonia mycoplasmal  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Pneumonia streptococcal  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Sepsis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Spleen tuberculosis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Tuberculosis liver  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Tuberculous pleurisy  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Upper respiratory tract infection bacterial  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Urinary tract infection enterococcal  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Viral upper respiratory tract infection  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Upper respiratory tract infection  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Soft tissue infection  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Pulmonary tuberculosis  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Pneumonia viral  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Periorbital infection  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Periodontitis  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Ludwig angina  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Gingivitis  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Cutaneous tuberculosis  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Breast abscess  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Bartholin's abscess  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Injury, poisoning and procedural complications       
Contusion  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Femoral neck fracture  1  1/235 (0.43%)  0/470 (0.00%)  1/424 (0.24%) 
Fractured sacrum  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Humerus fracture  1  0/235 (0.00%)  1/470 (0.21%)  1/424 (0.24%) 
Jaw fracture  1  0/235 (0.00%)  1/470 (0.21%)  1/424 (0.24%) 
Ligament rupture  1  0/235 (0.00%)  1/470 (0.21%)  1/424 (0.24%) 
Patella fracture  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Road traffic accident  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Scapula fracture  1  0/235 (0.00%)  1/470 (0.21%)  1/424 (0.24%) 
Fall  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Spinal compression fracture  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Concussion  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Lip injury  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Meniscus injury  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Multiple fractures  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Post procedural haemorrhage  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Thermal burn  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Thoracic vertebral fracture  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Investigations       
Blood creatinine increased  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Platelet count decreased  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Protein urine present  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Metabolism and nutrition disorders       
Hyperkalaemia  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Hypoproteinaemia  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Musculoskeletal and connective tissue disorders       
SLE arthritis  1  2/235 (0.85%)  0/470 (0.00%)  0/424 (0.00%) 
Intervertebral disc protrusion  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Synovial cyst  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Tenosynovitis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Loose body in joint  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Osteonecrosis  2  0/235 (0.00%)  0/470 (0.00%)  6/424 (1.42%) 
Arthralgia  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Systemic lupus erythematosus  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Uterine leiomyoma  1  0/235 (0.00%)  2/470 (0.43%)  2/424 (0.47%) 
Anogenital warts  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Benign breast neoplasm  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Cervix carcinoma  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Ovarian adenoma  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Thyroid adenoma  1  0/235 (0.00%)  1/470 (0.21%)  1/424 (0.24%) 
Fibroadenoma of breast  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Benign ear neoplasm  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Benign renal neoplasm  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Haemangioma  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Haemangioma of liver  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Vaginal cancer  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Papillary thyroid cancer  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Nervous system disorders       
Lupus encephalitis  1  1/235 (0.43%)  1/470 (0.21%)  1/424 (0.24%) 
Brain stem infarction  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Cerebral infarction  1  0/235 (0.00%)  1/470 (0.21%)  1/424 (0.24%) 
Dysarthria  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Epilepsy  1  1/235 (0.43%)  0/470 (0.00%)  1/424 (0.24%) 
Syncope  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Cerebrovascular insufficiency  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Hypoaesthesia  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Neuropsychiatric lupus  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Noninfectious myelitis  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Pregnancy, puerperium and perinatal conditions       
Ectopic pregnancy  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Abortion spontaneous  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Foetal growth restriction  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Psychiatric disorders       
Acute psychosis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Suicidal ideation  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Suicide attempt  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Post-traumatic stress disorder  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Renal and urinary disorders       
Lupus nephritis  1  5/235 (2.13%)  5/470 (1.06%)  12/424 (2.83%) 
Proteinuria  1  2/235 (0.85%)  0/470 (0.00%)  0/424 (0.00%) 
Renal failure  1  0/235 (0.00%)  2/470 (0.43%)  0/424 (0.00%) 
Haematuria  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Hydronephrosis  1  1/235 (0.43%)  0/470 (0.00%)  1/424 (0.24%) 
Lupus cystitis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Ureteric stenosis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Nephrolithiasis  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Ureterolithiasis  2  0/235 (0.00%)  0/470 (0.00%)  2/424 (0.47%) 
Reproductive system and breast disorders       
Metrorrhagia  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Bartholin's cyst  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Dysfunctional uterine bleeding  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Endometrial thickening  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Menstruation irregular  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Lupus pleurisy  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Lupus pneumonitis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Pulmonary hypertension  1  0/235 (0.00%)  1/470 (0.21%)  1/424 (0.24%) 
Respiratory failure  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis allergic  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Erythema multiforme  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Systemic lupus erythematosus rash  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Drug eruption  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Erythema  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
Vascular disorders       
Arterial rupture  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Deep vein thrombosis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Lupus vasculitis  1  0/235 (0.00%)  1/470 (0.21%)  0/424 (0.00%) 
Necrosis ischaemic  1  0/235 (0.00%)  1/470 (0.21%)  2/424 (0.47%) 
Phlebitis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Varicose vein  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Vasculitis  1  1/235 (0.43%)  0/470 (0.00%)  0/424 (0.00%) 
Thrombophlebitis superficial  2  0/235 (0.00%)  0/470 (0.00%)  1/424 (0.24%) 
1
Term from vocabulary, MedDRA 18.1
2
Term from vocabulary, MedDRA 21.1
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 (Double-blind Phase) Belimumab 10 mg/kg (Double-blind Phase) Belimumab 10 mg/kg (Open-label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   108/235 (45.96%)   207/470 (44.04%)   263/424 (62.03%) 
Gastrointestinal disorders       
Diarrhoea  1  14/235 (5.96%)  28/470 (5.96%)  28/424 (6.60%) 
General disorders       
Pyrexia  1  17/235 (7.23%)  28/470 (5.96%)  36/424 (8.49%) 
Infections and infestations       
Upper respiratory tract infection  1  39/235 (16.60%)  65/470 (13.83%)  149/424 (35.14%) 
Nasopharyngitis  1  26/235 (11.06%)  56/470 (11.91%)  24/424 (5.66%) 
Viral upper respiratory tract infection  1  15/235 (6.38%)  33/470 (7.02%)  59/424 (13.92%) 
Upper respiratory tract infection bacterial  1  12/235 (5.11%)  16/470 (3.40%)  37/424 (8.73%) 
Urinary tract infection  2  11/235 (4.68%)  21/470 (4.47%)  41/424 (9.67%) 
Herpes zoster  2  10/235 (4.26%)  23/470 (4.89%)  34/424 (8.02%) 
Urinary tract infection bacterial  2  2/235 (0.85%)  20/470 (4.26%)  23/424 (5.42%) 
Metabolism and nutrition disorders       
Hypokalaemia  2  8/235 (3.40%)  11/470 (2.34%)  24/424 (5.66%) 
Nervous system disorders       
Headache  1  16/235 (6.81%)  23/470 (4.89%)  20/424 (4.72%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  16/235 (6.81%)  30/470 (6.38%)  30/424 (7.08%) 
1
Term from vocabulary, MedDRA 18.1
2
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
The primary objective for DB was efficacy and the participant flow is aligned with the MITT population. The primary objective for OL is safety and includes only China par. from DB + additional 25 China par. from the Safety Pop who were not in MITT.
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
ClinicalTrials.gov Identifier: NCT01345253     History of Changes
Other Study ID Numbers: 113750
First Submitted: April 28, 2011
First Posted: May 2, 2011
Results First Submitted: June 9, 2016
Results First Posted: December 2, 2016
Last Update Posted: October 4, 2019