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Trial record 4 of 108 for:    selena

Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT00071487
Recruitment Status : Completed
First Posted : October 28, 2003
Results First Posted : August 28, 2012
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: Placebo
Drug: Belimumab 1 mg/kg
Drug: Belimumab 4 mg/kg
Drug: Belimumab 10 mg/kg
Enrollment 449
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study. Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study. Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 52-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
Period Title: 52-Week Double-Blind Period
Started 113 114 111 111
Completed 93 87 94 90
Not Completed 20 27 17 21
Reason Not Completed
Adverse Event             5             8             4             8
Lack of Efficacy             1             2             0             1
Withdrawal by Subject             7             11             7             7
Physician Decision             1             0             0             0
Lost to Follow-up             0             0             2             2
Pregnancy             0             1             0             0
Protocol Violation             0             1             1             0
Death             0             1             0             0
Lack of Compliance             6             3             3             3
Period Title: 24-Week Open-Label Extension Period
Started 0 [1] 19 [2] 24 [3] 302 [4]
Completed 0 19 23 279
Not Completed 0 0 1 23
Reason Not Completed
Adverse Event             0             0             1             6
Lack of Efficacy             0             0             0             3
Withdrawal by Subject             0             0             0             9
Pregnancy             0             0             0             1
Lost to Follow-up             0             0             0             2
Lack of Compliance             0             0             0             2
[1]
Of 93: 88 switched to 10 mg/kg; 5 elected not to continue in the open-label extension period.
[2]
Of 87: 65 switched to 10 mg/kg; 3 elected not to continue in the open-label extension period.
[3]
Of 94: 64 switched to 10 mg/kg; 6 elected not to continue in the open-label extension period.
[4]
Of 90: 85 continued with 10 mg/kg; 5 elected not to continue in the open-label extension period.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC Total
Hide Arm/Group Description Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. Total of all reporting groups
Overall Number of Baseline Participants 113 114 111 111 449
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 114 participants 111 participants 111 participants 449 participants
42.2  (10.9) 42.0  (11.7) 42.6  (10.7) 41.8  (11.7) 42.2  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 114 participants 111 participants 111 participants 449 participants
Female
102
  90.3%
107
  93.9%
105
  94.6%
105
  94.6%
419
  93.3%
Male
11
   9.7%
7
   6.1%
6
   5.4%
6
   5.4%
30
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 114 participants 111 participants 111 participants 449 participants
United States 113 113 111 109 446
Canada 0 1 0 2 3
1.Primary Outcome
Title Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
Hide Description SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 113 114 111 111
Mean (Standard Error)
Unit of Measure: percent change
-17.2  (5.1) -23.3  (4.4) -11.3  (5.4) -23.7  (4.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3677
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.1
Confidence Interval (2-Sided) 95%
-19.4 to 7.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4244
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.9
Confidence Interval (2-Sided) 95%
-8.7 to 20.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3296
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.5
Confidence Interval (2-Sided) 95%
-19.6 to 6.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)
Hide Description The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
Time Frame 0 to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 113 114 111 111
Median (Inter-Quartile Range)
Unit of Measure: days
83
(42 to 140)
68
(39 to 146)
61
(29 to 147)
70
(29 to 154)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6423
Comments P-value was not adjusted for multiple testing.
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8536
Comments P-value was not adjusted for multiple testing.
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9705
Comments P-value was not adjusted for multiple testing.
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change From Baseline in SELENA SLEDAI Score at Week 52
Hide Description SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 113 114 111 111
Mean (Standard Error)
Unit of Measure: percent change
-20.6  (5.2) -29.7  (4.3) -23.9  (7.3) -27.9  (5.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1763
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.1
Confidence Interval (2-Sided) 95%
-22.4 to 4.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7112
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-20.9 to 14.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3320
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.4
Confidence Interval (2-Sided) 95%
-22.2 to 7.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52
Hide Description SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.
Time Frame Baseline and every 4 to 8 weeks through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 113 114 111 111
Mean (Standard Error)
Unit of Measure: ratio score*days
317.3  (14.0) 288.7  (12.5) 320.3  (14.0) 286.9  (13.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1287
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -28.6
Confidence Interval (2-Sided) 95%
-65.6 to 8.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8807
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.98
Confidence Interval (2-Sided) 95%
-36.2 to 42.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Missing data was handled by using LOCF imputation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1131
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -30.41
Confidence Interval (2-Sided) 95%
-68.1 to 7.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52
Hide Description The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 113 114 111 111
Mean (Standard Error)
Unit of Measure: percent change
-19.1  (4.3) -20.8  (4.3) -26.5  (3.4) -22.0  (4.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7823
Comments P-value was not adjusted for multiple testing
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-13.8 to 10.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1774
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.4
Confidence Interval (2-Sided) 95%
-18.2 to 3.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6406
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value was not adjusted for multiple testing.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-14.8 to 9.1
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Area Under the Curve (AUC) of BILAG Score at Week 52
Hide Description The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.
Time Frame Baseline and every 4 to 8 weeks through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 113 114 111 111
Mean (Standard Error)
Unit of Measure: ratio score*days
315.4  (12.3) 310.6  (12.0) 300.4  (9.3) 302.7  (12.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7822
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-38.6 to 29.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3332
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.9
Confidence Interval (2-Sided) 95%
-45.3 to 15.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4660
Comments P-value was not adjusted for multiple testing.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.7
Confidence Interval (2-Sided) 95%
-46.9 to 21.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks
Hide Description SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.
Time Frame 0 to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 113 114 111 111
Median (Inter-Quartile Range)
Unit of Measure: days
78
(34 to 138)
63
(54 to 110)
84
(51 to 139)
62
(33 to 108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5615
Comments P-value was not adjusted for multiple comparisons.
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7593
Comments P-value was not adjusted for multiple testing.
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2273
Comments P-value was not adjusted for multiple testing.
Method Log Rank
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Patients With a Reduction in Prednisone Dose
Hide Description Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.
Time Frame Baseline, weeks 40 to 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subgroup of the MITT population, which included only patients with baseline prednisone dose > 7.5 mg/day.
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Overall Number of Participants Analyzed 48 40 35 38
Measure Type: Number
Unit of Measure: percentatge of particpants
27.1 20.0 31.4 44.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 1 mg/kg Plus SOC
Comments Patients who dropped out or had missing data were considered failures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4355
Comments P-value was not adjusted for multiple testing.
Method Likelihood ratio chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference from placebo
Estimated Value -7.1
Confidence Interval (2-Sided) 95%
-24.7 to 10.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 4 mg/kg Plus SOC
Comments Patients who dropped out or had missing data were considered failures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6669
Comments P-value was not adjusted for multiple testing.
Method Likelihood ratio chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference from placebo
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
-15.5 to 24.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC, Belimumab 10 mg/kg Plus SOC
Comments Patients who dropped out or had missing data were considered failures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0882
Comments P-value was not adjusted for multiple testing.
Method Likelihood ratio chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference from placebo
Estimated Value 17.7
Confidence Interval (2-Sided) 95%
-2.5 to 37.9
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Adverse Events (AE) Overview
Hide Description Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).
Time Frame Up to 84 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC Open-Label Extension Period: All Active
Hide Arm/Group Description:
Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to belimumab 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
Overall Number of Participants Analyzed 113 114 111 111 345
Measure Type: Number
Unit of Measure: percentage of participants
Percent of patients with at least 1 AE 97.3 97.4 96.4 97.3 96.2
Percent of patients with at least 1 SAE 19.5 18.4 13.5 16.2 9.6
Percent of patients with an AE resulting in death 0 0.9 0 0.9 0
Time Frame Up to 84 weeks
Adverse Event Reporting Description Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).
 
Arm/Group Title Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC Open-label Extension Period: All Active
Hide Arm/Group Description Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
All-Cause Mortality
Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC Open-label Extension Period: All Active
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC Open-label Extension Period: All Active
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/113 (19.47%)   21/114 (18.42%)   15/111 (13.51%)   18/111 (16.22%)   33/345 (9.57%) 
Blood and lymphatic system disorders           
Aplastic anaemia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Febrile neutropenia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Haemolysis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Thrombocytopenia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Cardiac disorders           
Acute coronary syndrome * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Angina pectoris * 1  1/113 (0.88%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Atrial fibrillation * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Coronary artery disease * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Myocardial infarction * 1  1/113 (0.88%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Pericarditis lupus * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Pleuropericarditis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Endocrine disorders           
Adrenal insufficiency * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Appendicitis noninfective * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Gastroduodenitis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Gastroenteritis noninfectious * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Pancreatitis * 1  0/113 (0.00%)  0/114 (0.00%)  2/111 (1.80%)  0/111 (0.00%)  0/345 (0.00%) 
Rectal haemorrhage * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Rectocele * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Small intestinal obstruction * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
General disorders           
Adhesion * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Non-cardiac chest pain * 1  2/113 (1.77%)  1/114 (0.88%)  0/111 (0.00%)  1/111 (0.90%)  3/345 (0.87%) 
Pyrexia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Hepatobiliary disorders           
Cholecystitis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Cholelithiasis * 1  0/113 (0.00%)  1/114 (0.88%)  2/111 (1.80%)  0/111 (0.00%)  0/345 (0.00%) 
Hepatotoxicity * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Infections and infestations           
Anal infection * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Bronchitis acute * 1  0/113 (0.00%)  1/114 (0.88%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Cellulitis * 1  0/113 (0.00%)  2/114 (1.75%)  1/111 (0.90%)  0/111 (0.00%)  1/345 (0.29%) 
Clostridium colitis * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Furuncle * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Gastroenteritis viral * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Herpes zoster * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Lobar pneumonia * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Pneumonia * 1  1/113 (0.88%)  2/114 (1.75%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Pneumonia bacterial * 1  0/113 (0.00%)  1/114 (0.88%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Pyelonephritis acute * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Sepsis * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Septic arthritis streptobacillus * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Streptococcal bacteraemia * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Urinary tract infection * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  1/345 (0.29%) 
Viral infection * 1  1/113 (0.88%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
West Nile viral infection * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Wound infection * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Injury, poisoning and procedural complications           
Ankle fracture * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  1/345 (0.29%) 
Patella fracture * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Post procedural haematoma * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Road traffic accident * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Seroma * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Therapeutic agent toxicity * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  1/345 (0.29%) 
Investigations           
Haematocrit decreased * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Haemoglobin decreased * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Pulmonary function test decreased * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Weight decreased * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Metabolism and nutrition disorders           
Dehydration * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Hyperglycaemia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Musculoskeletal and connective tissue disorders           
Arthritis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Bursitis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Costochondritis * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Intervertebral disc degeneration * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Intervertebral disc protrusion * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Lumbar spinal stenosis * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Musculoskeletal chest pain * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Osteoarthritis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Osteonecrosis * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Spondylosis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Tenosynovitis * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
B-cell lymphoma * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Lung neoplasm malignant * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Metastases to bone * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Metastases to bone marrow * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Squamous cell carcinoma of skin * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Uterine leiomyoma * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Nervous system disorders           
Cauda equina syndrome * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Convulsion * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Encephalopathy * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Grand mal convulsion * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Headache * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Neuralgia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Paraesthesia * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Simple partial seizures * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Transient ischaemic attack * 1  0/113 (0.00%)  2/114 (1.75%)  1/111 (0.90%)  1/111 (0.90%)  1/345 (0.29%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Pregnancy * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Psychiatric disorders           
Completed suicide * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Depression * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Renal and urinary disorders           
Calculus ureteric * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Cystocele * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Glomerulonephritis * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Lupus nephritis * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Proteinuria * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  2/111 (1.80%)  3/345 (0.87%) 
Renal failure * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Reproductive system and breast disorders           
Cervical dysplasia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Menometrorrhagia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Ovarian cyst * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Vulvar dysplasia * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory distress syndrome * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Asthma * 1  0/113 (0.00%)  1/114 (0.88%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Bronchospasm * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Chronic obstructive airways disease exacerbated * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Dyspnoea * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  2/345 (0.58%) 
Dyspnoea exacerbated * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  1/345 (0.29%) 
Epistaxis * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Pleural effusion * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Pleurisy * 1  2/113 (1.77%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Pneumonia aspiration * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Respiratory failure * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Skin and subcutaneous tissue disorders           
Angioneurotic oedema * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Dermatitis allergic * 1  0/113 (0.00%)  1/114 (0.88%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Systemic lupus erythematosus rash * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Surgical and medical procedures           
Post procedural drainage * 1  1/113 (0.88%)  0/114 (0.00%)  0/111 (0.00%)  0/111 (0.00%)  0/345 (0.00%) 
Vascular disorders           
Arteriosclerosis * 1  0/113 (0.00%)  1/114 (0.88%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
Deep vein thrombosis * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  1/345 (0.29%) 
Hypertensive crisis * 1  0/113 (0.00%)  0/114 (0.00%)  0/111 (0.00%)  1/111 (0.90%)  0/345 (0.00%) 
Vasculitis * 1  0/113 (0.00%)  0/114 (0.00%)  1/111 (0.90%)  0/111 (0.00%)  0/345 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Plus SOC Belimumab 1 mg/kg Plus SOC Belimumab 4 mg/kg Plus SOC Belimumab 10 mg/kg Plus SOC Open-label Extension Period: All Active
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   103/113 (91.15%)   107/114 (93.86%)   100/111 (90.09%)   105/111 (94.59%)   312/345 (90.43%) 
Blood and lymphatic system disorders           
Anaemia * 1  3/113 (2.65%)  5/114 (4.39%)  7/111 (6.31%)  2/111 (1.80%)  19/345 (5.51%) 
Leukopenia * 1  5/113 (4.42%)  4/114 (3.51%)  6/111 (5.41%)  9/111 (8.11%)  12/345 (3.48%) 
Lymphadenopathy * 1  5/113 (4.42%)  2/114 (1.75%)  5/111 (4.50%)  6/111 (5.41%)  5/345 (1.45%) 
Gastrointestinal disorders           
Abdominal pain * 1  9/113 (7.96%)  6/114 (5.26%)  4/111 (3.60%)  4/111 (3.60%)  8/345 (2.32%) 
Constipation * 1  6/113 (5.31%)  3/114 (2.63%)  4/111 (3.60%)  4/111 (3.60%)  9/345 (2.61%) 
Diarrhoea * 1  19/113 (16.81%)  19/114 (16.67%)  23/111 (20.72%)  17/111 (15.32%)  34/345 (9.86%) 
Dyspepsia * 1  8/113 (7.08%)  3/114 (2.63%)  5/111 (4.50%)  7/111 (6.31%)  7/345 (2.03%) 
Gastrooesophageal reflux disease * 1  5/113 (4.42%)  11/114 (9.65%)  5/111 (4.50%)  7/111 (6.31%)  26/345 (7.54%) 
Mouth ulceration * 1  11/113 (9.73%)  9/114 (7.89%)  12/111 (10.81%)  17/111 (15.32%)  18/345 (5.22%) 
Nausea * 1  27/113 (23.89%)  31/114 (27.19%)  22/111 (19.82%)  33/111 (29.73%)  39/345 (11.30%) 
Vomiting * 1  13/113 (11.50%)  14/114 (12.28%)  15/111 (13.51%)  9/111 (8.11%)  15/345 (4.35%) 
General disorders           
Fatigue * 1  34/113 (30.09%)  27/114 (23.68%)  33/111 (29.73%)  27/111 (24.32%)  72/345 (20.87%) 
Infusion site reaction * 1  6/113 (5.31%)  3/114 (2.63%)  12/111 (10.81%)  2/111 (1.80%)  2/345 (0.58%) 
Non-cardiac chest pain * 1  9/113 (7.96%)  6/114 (5.26%)  6/111 (5.41%)  6/111 (5.41%)  9/345 (2.61%) 
Oedema peripheral * 1  13/113 (11.50%)  15/114 (13.16%)  18/111 (16.22%)  15/111 (13.51%)  41/345 (11.88%) 
Pain * 1  3/113 (2.65%)  1/114 (0.88%)  6/111 (5.41%)  5/111 (4.50%)  12/345 (3.48%) 
Pyrexia * 1  14/113 (12.39%)  13/114 (11.40%)  17/111 (15.32%)  15/111 (13.51%)  18/345 (5.22%) 
Infections and infestations           
Bronchitis * 1  7/113 (6.19%)  5/114 (4.39%)  11/111 (9.91%)  14/111 (12.61%)  23/345 (6.67%) 
Gastroenteritis viral * 1  4/113 (3.54%)  6/114 (5.26%)  5/111 (4.50%)  4/111 (3.60%)  6/345 (1.74%) 
Influenza * 1  8/113 (7.08%)  6/114 (5.26%)  11/111 (9.91%)  7/111 (6.31%)  7/345 (2.03%) 
Sinusitis * 1  21/113 (18.58%)  11/114 (9.65%)  15/111 (13.51%)  17/111 (15.32%)  34/345 (9.86%) 
Upper respiratory tract infection * 1  33/113 (29.20%)  36/114 (31.58%)  36/111 (32.43%)  29/111 (26.13%)  58/345 (16.81%) 
Urinary tract infection * 1  18/113 (15.93%)  16/114 (14.04%)  18/111 (16.22%)  20/111 (18.02%)  33/345 (9.57%) 
Vaginal mycosis * 1  8/113 (7.08%)  3/114 (2.63%)  8/111 (7.21%)  4/111 (3.60%)  10/345 (2.90%) 
Viral infection * 1  5/113 (4.42%)  3/114 (2.63%)  8/111 (7.21%)  0/111 (0.00%)  2/345 (0.58%) 
Viral upper respiratory tract infection * 1  5/113 (4.42%)  5/114 (4.39%)  6/111 (5.41%)  5/111 (4.50%)  10/345 (2.90%) 
Injury, poisoning and procedural complications           
Contusion * 1  7/113 (6.19%)  10/114 (8.77%)  7/111 (6.31%)  6/111 (5.41%)  12/345 (3.48%) 
Investigations           
Creatinine renal clearance decreased * 1  4/113 (3.54%)  5/114 (4.39%)  8/111 (7.21%)  5/111 (4.50%)  8/345 (2.32%) 
Weight decreased * 1  6/113 (5.31%)  6/114 (5.26%)  5/111 (4.50%)  5/111 (4.50%)  17/345 (4.93%) 
Weight increased * 1  8/113 (7.08%)  6/114 (5.26%)  8/111 (7.21%)  7/111 (6.31%)  28/345 (8.12%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  2/113 (1.77%)  6/114 (5.26%)  0/111 (0.00%)  0/111 (0.00%)  3/345 (0.87%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  42/113 (37.17%)  41/114 (35.96%)  37/111 (33.33%)  41/111 (36.94%)  102/345 (29.57%) 
Arthritis * 1  18/113 (15.93%)  16/114 (14.04%)  21/111 (18.92%)  18/111 (16.22%)  47/345 (13.62%) 
Back pain * 1  16/113 (14.16%)  15/114 (13.16%)  15/111 (13.51%)  16/111 (14.41%)  42/345 (12.17%) 
Bursitis * 1  2/113 (1.77%)  6/114 (5.26%)  6/111 (5.41%)  4/111 (3.60%)  7/345 (2.03%) 
Fibromyalgia * 1  4/113 (3.54%)  2/114 (1.75%)  5/111 (4.50%)  6/111 (5.41%)  12/345 (3.48%) 
Joint swelling * 1  10/113 (8.85%)  9/114 (7.89%)  11/111 (9.91%)  7/111 (6.31%)  14/345 (4.06%) 
Myalgia * 1  14/113 (12.39%)  15/114 (13.16%)  10/111 (9.01%)  15/111 (13.51%)  28/345 (8.12%) 
Pain in extremity * 1  8/113 (7.08%)  14/114 (12.28%)  13/111 (11.71%)  10/111 (9.01%)  34/345 (9.86%) 
SLE arthritis * 1  6/113 (5.31%)  5/114 (4.39%)  2/111 (1.80%)  9/111 (8.11%)  4/345 (1.16%) 
Synovitis * 1  4/113 (3.54%)  4/114 (3.51%)  6/111 (5.41%)  6/111 (5.41%)  8/345 (2.32%) 
Tendonitis * 1  3/113 (2.65%)  2/114 (1.75%)  4/111 (3.60%)  8/111 (7.21%)  8/345 (2.32%) 
Nervous system disorders           
Dizziness * 1  8/113 (7.08%)  8/114 (7.02%)  12/111 (10.81%)  6/111 (5.41%)  10/345 (2.90%) 
Headache * 1  27/113 (23.89%)  29/114 (25.44%)  31/111 (27.93%)  35/111 (31.53%)  50/345 (14.49%) 
Hypoaesthesia * 1  3/113 (2.65%)  4/114 (3.51%)  5/111 (4.50%)  6/111 (5.41%)  13/345 (3.77%) 
Migraine * 1  11/113 (9.73%)  11/114 (9.65%)  6/111 (5.41%)  15/111 (13.51%)  19/345 (5.51%) 
Paraesthesia * 1  1/113 (0.88%)  7/114 (6.14%)  3/111 (2.70%)  1/111 (0.90%)  4/345 (1.16%) 
Sinus headache * 1  6/113 (5.31%)  1/114 (0.88%)  0/111 (0.00%)  2/111 (1.80%)  3/345 (0.87%) 
Psychiatric disorders           
Anxiety * 1  6/113 (5.31%)  6/114 (5.26%)  8/111 (7.21%)  3/111 (2.70%)  19/345 (5.51%) 
Depression * 1  9/113 (7.96%)  16/114 (14.04%)  12/111 (10.81%)  10/111 (9.01%)  31/345 (8.99%) 
Insomnia * 1  10/113 (8.85%)  5/114 (4.39%)  5/111 (4.50%)  9/111 (8.11%)  35/345 (10.14%) 
Renal and urinary disorders           
Haematuria * 1  3/113 (2.65%)  3/114 (2.63%)  4/111 (3.60%)  7/111 (6.31%)  5/345 (1.45%) 
Proteinuria * 1  6/113 (5.31%)  6/114 (5.26%)  7/111 (6.31%)  4/111 (3.60%)  17/345 (4.93%) 
Pyuria * 1  1/113 (0.88%)  6/114 (5.26%)  4/111 (3.60%)  3/111 (2.70%)  4/345 (1.16%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  12/113 (10.62%)  13/114 (11.40%)  8/111 (7.21%)  13/111 (11.71%)  25/345 (7.25%) 
Dyspnoea * 1  7/113 (6.19%)  3/114 (2.63%)  8/111 (7.21%)  9/111 (8.11%)  17/345 (4.93%) 
Epistaxis * 1  3/113 (2.65%)  3/114 (2.63%)  0/111 (0.00%)  7/111 (6.31%)  4/345 (1.16%) 
Nasal congestion * 1  9/113 (7.96%)  6/114 (5.26%)  3/111 (2.70%)  2/111 (1.80%)  7/345 (2.03%) 
Nasal ulcer * 1  2/113 (1.77%)  6/114 (5.26%)  2/111 (1.80%)  6/111 (5.41%)  5/345 (1.45%) 
Pharyngolaryngeal pain * 1  2/113 (1.77%)  7/114 (6.14%)  5/111 (4.50%)  2/111 (1.80%)  5/345 (1.45%) 
Pleurisy * 1  9/113 (7.96%)  5/114 (4.39%)  4/111 (3.60%)  2/111 (1.80%)  7/345 (2.03%) 
Pleuritic pain * 1  7/113 (6.19%)  6/114 (5.26%)  6/111 (5.41%)  5/111 (4.50%)  7/345 (2.03%) 
Throat irritation * 1  8/113 (7.08%)  4/114 (3.51%)  1/111 (0.90%)  3/111 (2.70%)  6/345 (1.74%) 
Skin and subcutaneous tissue disorders           
Alopecia * 1  13/113 (11.50%)  10/114 (8.77%)  9/111 (8.11%)  11/111 (9.91%)  24/345 (6.96%) 
Erythema * 1  4/113 (3.54%)  6/114 (5.26%)  10/111 (9.01%)  3/111 (2.70%)  12/345 (3.48%) 
Pruritus * 1  8/113 (7.08%)  5/114 (4.39%)  5/111 (4.50%)  8/111 (7.21%)  13/345 (3.77%) 
Rash * 1  12/113 (10.62%)  16/114 (14.04%)  17/111 (15.32%)  8/111 (7.21%)  25/345 (7.25%) 
Rash maculo-papular * 1  9/113 (7.96%)  3/114 (2.63%)  7/111 (6.31%)  6/111 (5.41%)  13/345 (3.77%) 
Systemic lupus erythematosus rash * 1  5/113 (4.42%)  2/114 (1.75%)  4/111 (3.60%)  6/111 (5.41%)  12/345 (3.48%) 
Urticaria * 1  0/113 (0.00%)  5/114 (4.39%)  6/111 (5.41%)  3/111 (2.70%)  6/345 (1.74%) 
Vascular disorders           
Hypertension * 1  5/113 (4.42%)  6/114 (5.26%)  5/111 (4.50%)  13/111 (11.71%)  25/345 (7.25%) 
Raynaud's phenomenon * 1  4/113 (3.54%)  6/114 (5.26%)  4/111 (3.60%)  4/111 (3.60%)  6/345 (1.74%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00071487    
Other Study ID Numbers: LBSL02
First Submitted: October 24, 2003
First Posted: October 28, 2003
Results First Submitted: February 27, 2012
Results First Posted: August 28, 2012
Last Update Posted: August 7, 2013