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A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

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ClinicalTrials.gov Identifier: NCT00712933
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Intervention Drug: belimumab
Enrollment 738
Recruitment Details This was a multi-center, continuation trial of belimumab and was conducted at 115 centers in 28 countries. Participants with Systemic Lupus Erythematosus (SLE), who had completed the Phase 3 HGS1006-C1056 or HGS1006-C1057 trial or participants who had previously received subcutaneous belimumab in Protocol HGS1006-C1070 were included in this trial.
Pre-assignment Details 738 participants were enrolled in the study and 735 received at least one dose of belimumab.Out of 735 participants, 368 completed the study and 370 withdrew from the study.
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Period Title: Overall Study
Started 735
Completed 368
Not Completed 367
Reason Not Completed
Adverse Event             69
Lack of Efficacy             6
Lost to Follow-up             22
Non-compliance with study drug             13
Other Pregnancy             37
Sponsor decision             14
Withdrew consent             4
Hip replacement surgery             1
Involved in Clinical research             3
Participant hospitalized             1
Participant travelled overseas             2
Death of patient             1
Other Physician decision             1
Not committed to contraception             1
Participant received medication             1
Physician Decision             36
Protocol Violation             4
Withdrawal by Subject             151
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Baseline Participants 735
Hide Baseline Analysis Population Description
Modified Intention to Treat (MITT) includes all participants who were enrolled in BEL112234 and were treated with at least one dose of belimumab in the continuation study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 735 participants
37.2  (11.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 735 participants
Female
695
  94.6%
Male
40
   5.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 735 participants
Black or African American/African Heritage
18
   2.4%
American Indian or Alaska Native
225
  30.6%
East Asian Heritage
118
  16.1%
South Asian Heritage
38
   5.2%
Southeast Asian Heritage
58
   7.9%
Middle East/North African Heritage
22
   3.0%
White/Caucasian/European Heritage
256
  34.8%
1.Primary Outcome
Title Number of Participants With Adverse Events (AE)
Hide Description An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.
Time Frame Up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Measure Type: Number
Unit of Measure: Participants
Any-time post Baseline,n=735 Number Analyzed 735 participants
706
Year 0-1,n=735 Number Analyzed 735 participants
617
Year 1-2 ,n =701 Number Analyzed 701 participants
502
Year 2-3, n= 620 Number Analyzed 620 participants
441
Year 3-4,n= 514 Number Analyzed 514 participants
344
Year 4-5,n= 442 Number Analyzed 442 participants
261
Year 5-6, n =345 Number Analyzed 345 participants
181
Year 6-7, n= 219 Number Analyzed 219 participants
92
Year 7-8, n = 65 Number Analyzed 65 participants
26
Year 8 plus,n = 6 Number Analyzed 6 participants
3
2.Primary Outcome
Title AE Rates by System Organ Class (SOC) During the Study
Hide Description AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Time Frame Up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Overall Number of Units Analyzed
Type of Units Analyzed: Subject years
3352
Measure Type: Number
Unit of Measure: Adverse events per 100 participant years
Infections and infestations 101.8
Gastrointestinal disorders 32.8
Musculoskeletal and connective tissuedisorder 32.8
Nervous system disorders 22.6
Skin and subcutaneous and tissue disorders 22.5
Respiratory,thoracic and mediastinal disorder 14.9
Vascular disorders 13.3
General disorders and administration sitecondition 11.8
Injury, poisoning andprocedural complications 11.5
Blood and lymphatic system disorders 7.5
Eye disorders 6.6
Reproductive system and breast disorders 6.4
Investigations 5.8
Psychiatric disorders 5.6
Renal and urinary and disorder 5.3
Metabolism and nutrition disorder 3.6
Cardiac disorders 3.0
Ear and labyrinth disorder 2.4
Neoplasms benign,malignant andunspecified 2.2
Hepatobiliary disorders 1.8
Immune system disorder 1.2
Endocrine disorders 1.0
Social circumstances 0.7
Congenital, familial and genetic disorders 0.1
Pregnancy, puerperium and perinatal conditions 0.1
Product Issues 0.1
3.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAE)
Hide Description An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.
Time Frame Up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Measure Type: Number
Unit of Measure: Participants
Any post-Baseline,n=735 Number Analyzed 735 participants
231
Year 0-1,n=735 Number Analyzed 735 participants
78
Year 1-2,n = 701 Number Analyzed 701 participants
58
Year 2-3,n = 620 Number Analyzed 620 participants
66
Year 3-4,n= 514 Number Analyzed 514 participants
44
Year 4-5 ,n= 442 Number Analyzed 442 participants
27
Year 5-6,n=345 Number Analyzed 345 participants
16
Year 6-7,n= 219 Number Analyzed 219 participants
11
Year 7-8,n= 65 Number Analyzed 65 participants
1
Year 8 plus,n= 6 Number Analyzed 6 participants
0
4.Primary Outcome
Title SAE Rates by SOC During the Study
Hide Description SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Time Frame Up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Overall Number of Units Analyzed
Type of Units Analyzed: Subject years
3352
Measure Type: Number
Unit of Measure: Adverse events per 100 participant years
Infections and infestations 5.1
Blood and lymphatic system disorders 1.0
Musculoskeletal and connective tissue disorder 1.0
Gastrointestinal disorders 1.0
Renal and urinary disorders 0.8
Vascular disorders 0.8
Injury, poisoning andprocedural complications 0.8
General disorders and administration sitecondition 0.6
Nervous system disorders 0.6
Respiratory, thoracic and mediastinal disorder 0.5
Cardiac disorders 0.5
Skin and subcutaneous tissue disorders 0.5
Neoplasms benign, malignant and unspecified 0.4
Reproductive system and breast disorder 0.4
Psychiatric disorders 0.4
Hepatobiliary disorders 0.3
Metabolism and nutrition disorders 0.1
Pregnancy, puerperium and perinatal condition 0.1
Endocrine disorders 0.1
Immune system disorders 0.1
Ear and labyrinth disorders 0.1
Eye disorders 0.1
5.Primary Outcome
Title Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Seconds
Year1,Week4,APTT,n=208 Number Analyzed 208 participants
0.7  (5.27)
Year1,Week12,APTT,n=208 Number Analyzed 208 participants
2.1  (12.31)
Year1,Week24,APTT,n=686 Number Analyzed 686 participants
0.1  (9.10)
Year1,Week36,APTT,n=193 Number Analyzed 193 participants
2.5  (5.75)
Year1,Week48,APTT,n=666 Number Analyzed 666 participants
0.8  (9.48)
Year2,Week24,APTT,n=625 Number Analyzed 625 participants
2.7  (9.74)
Year2,Week48,APTT,n=572 Number Analyzed 572 participants
2.7  (9.66)
Year3,Week24,APTT,n=521 Number Analyzed 521 participants
3.4  (10.01)
Year3,Week48,APTT,n=470 Number Analyzed 470 participants
3.9  (11.41)
Year4,Week24,APTT,n=422 Number Analyzed 422 participants
3.5  (10.70)
Year4,Week48,APTT,n=412 Number Analyzed 412 participants
4.2  (6.63)
Year5,Week24,APTT,n=383 Number Analyzed 383 participants
4.1  (10.71)
Year5,Week48,APTT,n=349 Number Analyzed 349 participants
3.5  (6.35)
Year6,Week24,APTT,n=292 Number Analyzed 292 participants
3.8  (6.58)
Year6,Week48,APTT,n=277 Number Analyzed 277 participants
4.3  (7.91)
Year7,Week24,APTT,n=177 Number Analyzed 177 participants
6.4  (14.52)
Year7,Week48,APTT,n=131 Number Analyzed 131 participants
4.1  (6.23)
Year8,Week24,APTT,n=52 Number Analyzed 52 participants
5.6  (7.54)
Year8,Week48,APTT,n=13 Number Analyzed 13 participants
4.2  (3.98)
Year9,Week24,APTT,n=6 Number Analyzed 6 participants
5.0  (6.39)
Year9,Week48,APTT,n=1 Number Analyzed 1 participants
9.0 [1]   (NA)
Exit, APTT,n=586 Number Analyzed 586 participants
3.2  (10.71)
8 Week,Follow up,n=524 Number Analyzed 524 participants
3.4  (8.14)
Year1,Week4,PT,n=205 Number Analyzed 205 participants
-0.22  (5.139)
Year1,Week12,PT,n=206 Number Analyzed 206 participants
1.71  (19.533)
Year1,Week24,PT,n=686 Number Analyzed 686 participants
-0.43  (8.267)
Year1,Week36,PT,n=193 Number Analyzed 193 participants
0.13  (3.357)
Year1,Week48,PT,n=666 Number Analyzed 666 participants
-0.45  (8.174)
Year2,Week24,PT,n=626 Number Analyzed 626 participants
0.15  (11.528)
Year2,Week48,PT,n=572 Number Analyzed 572 participants
-0.26  (8.925)
Year3,Week24,PT,n=521 Number Analyzed 521 participants
0.12  (9.609)
Year3,Week48,PT,n=469 Number Analyzed 469 participants
0.63  (14.334)
Year4,Week24,PT,n=422 Number Analyzed 422 participants
0.06  (10.458)
Year4,Week48,PT,n=412 Number Analyzed 412 participants
0.40  (4.228)
Year5,Week24,PT,n=384 Number Analyzed 384 participants
-0.14  (10.810)
Year5,Week48,PT,n=349 Number Analyzed 349 participants
0.61  (11.276)
Year6,Week24,PT,n=292 Number Analyzed 292 participants
0.64  (8.023)
Year6,Week48,PT,n=278 Number Analyzed 278 participants
0.85  (12.414)
Year7,Week24,PT,n=177 Number Analyzed 177 participants
1.76  (14.272)
Year7,Week48,PT,n=131 Number Analyzed 131 participants
0.36  (2.290)
Year8,Week24,PT,n=52 Number Analyzed 52 participants
1.21  (6.716)
Year8,Week48,PT,n=13 Number Analyzed 13 participants
0.52  (0.600)
Year9,Week24,PT,n=6 Number Analyzed 6 participants
0.50  (0.657)
Year9,Week48,PT,n=1 Number Analyzed 1 participants
1.00 [1]   (NA)
Exit,PT, n=587 Number Analyzed 587 participants
0.25  (9.973)
8 Week, Follow up,n=524 Number Analyzed 524 participants
0.50  (4.965)
[1]
NA indicates standard deviation was not calculable for a single data point
6.Primary Outcome
Title Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Billion cells per liter
Baso,Year1,Week4,n=693 Number Analyzed 693 participants
0.002  (0.0172)
Baso,Year1,Week12,n=694 Number Analyzed 694 participants
0.002  (0.0187)
Baso,Year1,Week24,n=696 Number Analyzed 696 participants
0.002  (0.0176)
Baso,Year1,Week36,n=682 Number Analyzed 682 participants
0.002  (0.0179)
Baso,Year1,Week48,n=684 Number Analyzed 684 participants
0.003  (0.0183)
Baso,Year2,Week24,n=629 Number Analyzed 629 participants
0.004  (0.0190)
Baso,Year2,Week48,n=589 Number Analyzed 589 participants
0.004  (0.0200)
Baso,Year3,Week24,n=533 Number Analyzed 533 participants
0.005  (0.0165)
Baso,Year3,Week48,n=476 Number Analyzed 476 participants
0.008  (0.0194)
Baso,Year4,Week24,n=446 Number Analyzed 446 participants
0.007  (0.0192)
Baso,Year4,Week48,n=423 Number Analyzed 423 participants
0.008  (0.0202)
Baso,Year5,Week24,n=389 Number Analyzed 389 participants
0.007  (0.0191)
Baso,Year5,Week48,n=360 Number Analyzed 360 participants
0.005  (0.0191)
Baso,Year6,Week24,n=306 Number Analyzed 306 participants
0.006  (0.0184)
Baso,Year6,Week48,n=282 Number Analyzed 282 participants
0.007  (0.0198)
Baso,Year7,Week24,n=181 Number Analyzed 181 participants
0.007  (0.0211)
Baso,Year7,Week48,n=130 Number Analyzed 130 participants
0.012  (0.0259)
Baso,Year8,Week24,n=52 Number Analyzed 52 participants
0.014  (0.0187)
Baso,Year8,Week48,n=13 Number Analyzed 13 participants
0.001  (0.0166)
Baso,Year9,Week24,n=6 Number Analyzed 6 participants
0.003  (0.0082)
Baso,Year9,Week48,n=1 Number Analyzed 1 participants
0.010 [1]   (NA)
Baso,Exit,n=614 Number Analyzed 614 participants
0.005  (0.0204)
Baso,8 Week,Follow up,n=532 Number Analyzed 532 participants
0.009  (0.0253)
Eos,Year1,Week4,n=693 Number Analyzed 693 participants
0.007  (0.1597)
Eos,Year1,Week12,n=694 Number Analyzed 694 participants
0.003  (0.1595)
Eos,Year1,Week24,n=696 Number Analyzed 696 participants
0.000  (0.1614)
Eos,Year1,Week36,n=682 Number Analyzed 682 participants
0.020  (0.1866)
Eos,Year1,Week48,n=684 Number Analyzed 684 participants
0.001  (0.1763)
Eos,Year2,Week24,n=629 Number Analyzed 629 participants
0.004  (0.1605)
Eos,Year2,Week48,n=589 Number Analyzed 589 participants
-0.004  (0.1858)
Eos,Year3,Week24,n=533 Number Analyzed 533 participants
-0.011  (0.2074)
Eos,Year3,Week48,n=476 Number Analyzed 476 participants
-0.026  (0.2053)
Eos,Year4,Week24,n=446 Number Analyzed 446 participants
-0.041  (0.1792)
Eos,Year4,Week48,n=423 Number Analyzed 423 participants
-0.047  (0.1676)
Eos,Year5,Week24,n=389 Number Analyzed 389 participants
-0.035  (0.1949)
Eos,Year5,Week48,n=360 Number Analyzed 360 participants
-0.045  (0.1807)
Eos,Year6,Week24,n=306 Number Analyzed 306 participants
-0.046  (0.1801)
Eos,Year6,Week48,n=282 Number Analyzed 282 participants
-0.037  (0.1976)
Eos,Year7,Week24,n=181 Number Analyzed 181 participants
-0.046  (0.1710)
Eos,Year7,Week48,n=130 Number Analyzed 130 participants
-0.020  (0.2276)
Eos,Year8,Week24,n=52 Number Analyzed 52 participants
-0.017  (0.1753)
Eos,Year8,Week48,n=13 Number Analyzed 13 participants
-0.041  (0.1130)
Eos,Year9,Week24,n=6 Number Analyzed 6 participants
-0.088  (0.1078)
Eos,Year9,Week48,n=1 Number Analyzed 1 participants
-0.040 [1]   (NA)
Eos, Exit, n=614 Number Analyzed 614 participants
-0.026  (0.1754)
Eso, 8 Week Follow up, n=532 Number Analyzed 532 participants
-0.030  (0.1920)
Leu,Year1,Week4,n=696 Number Analyzed 696 participants
0.16  (1.928)
Leu,Year1,Week12,n=697 Number Analyzed 697 participants
0.19  (2.106)
Leu,Year1,Week24,n=697 Number Analyzed 697 participants
0.04  (2.142)
Leu,Year1,Week36,n=682 Number Analyzed 682 participants
0.05  (2.190)
Leu,Year1,Week48,n=684 Number Analyzed 684 participants
0.02  (2.274)
Leu,Year2,Week24,n=630 Number Analyzed 630 participants
-0.19  (2.287)
Leu,Year2,Week48,n=589 Number Analyzed 589 participants
-0.11  (2.449)
Leu,Year3,Week24,n=533 Number Analyzed 533 participants
-0.03  (2.544)
Leu,Year3,Week24,n=476 Number Analyzed 476 participants
0.06  (2.393)
Leu,Year4,Week24,n=446 Number Analyzed 446 participants
-0.01  (2.520)
Leu,Year4,Week48,n=423 Number Analyzed 423 participants
-0.06  (2.661)
Leu,Year5,Week24,n=389 Number Analyzed 389 participants
0.05  (2.430)
Leu,Year5,Week48,n=360 Number Analyzed 360 participants
-0.06  (2.463)
Leu,Year6,Week24,n=306 Number Analyzed 306 participants
0.04  (2.449)
Leu,Year6,Week48,n=282 Number Analyzed 282 participants
0.17  (2.579)
Leu,Year7,Week24,n=181 Number Analyzed 181 participants
0.12  (2.395)
Leu,Year7,Week48,n=130 Number Analyzed 130 participants
0.48  (2.354)
Leu,Year8,Week24,n=52 Number Analyzed 52 participants
0.38  (2.761)
Leu,Year8,Week48,n=13 Number Analyzed 13 participants
-0.65  (3.136)
Leu,Year9,Week24,n=6 Number Analyzed 6 participants
-0.35  (3.422)
Leu,Year9,Week48,n=1 Number Analyzed 1 participants
-3.90 [1]   (NA)
Leu, Exit, n=614 Number Analyzed 614 participants
0.18  (2.650)
Leu, 8 Week Follow up,n=532 Number Analyzed 532 participants
0.21  (2.496)
Lymp,Year1,Week4,n=693 Number Analyzed 693 participants
0.093  (0.5986)
Lymp,Year1,Week12,n=694 Number Analyzed 694 participants
0.107  (0.6607)
Lymp,Year1,Week24,n=696 Number Analyzed 696 participants
0.066  (0.6544)
Lymp,Year1,Week36,n=682 Number Analyzed 682 participants
0.119  (0.6583)
Lymp,Year1,Week48,n=684 Number Analyzed 684 participants
0.048  (0.6361)
Lymp,Year2,Week24,n=629 Number Analyzed 629 participants
0.051  (0.6898)
Lymp,Year2,Week48,n=589 Number Analyzed 589 participants
0.067  (0.6971)
Lymp,Year3,Week24,n=533 Number Analyzed 533 participants
0.057  (0.6717)
Lymp,Year3,Week48,n=476 Number Analyzed 476 participants
0.038  (0.6676)
Lymp,Year4,Week24,n=446 Number Analyzed 446 participants
0.054  (0.6858)
Lymp,Year4,Week48,n=423 Number Analyzed 423 participants
0.067  (0.7186)
Lymp,Year5,Week24,n=389 Number Analyzed 389 participants
0.023  (0.6810)
Lymp,Year5,Week48,n=360 Number Analyzed 360 participants
0.078  (0.7485)
Lymp,Year6,Week24,n=306 Number Analyzed 306 participants
0.147  (0.7251)
Lymp,Year6,Week48,n=282 Number Analyzed 282 participants
0.168  (0.7523)
Lymp,Year7,Week24,n=181 Number Analyzed 181 participants
0.175  (0.7670)
Lymp,Year7,Week48,n=130 Number Analyzed 130 participants
0.169  (0.6639)
Lymp,Year8,Week24,n=52 Number Analyzed 52 participants
0.300  (0.7553)
Lymp,Year8,Week48,n=13 Number Analyzed 13 participants
0.052  (0.5252)
Lymp,Year9,Week24,n=6 Number Analyzed 6 participants
-0.032  (0.6156)
Lymp,Year9,Week48,n=1 Number Analyzed 1 participants
-0.460 [2]   (NA)
Lymp,Exit,n=614 Number Analyzed 614 participants
0.128  (0.7808)
Lymp,8 Week Follow up,n=532 Number Analyzed 532 participants
0.140  (0.7453)
Mono,Year1,Week4,n=693 Number Analyzed 693 participants
0.025  (0.2108)
Mono,Year1,Week12,n=694 Number Analyzed 694 participants
0.036  (0.2043)
Mono,Year1,Week24,n=696 Number Analyzed 696 participants
0.028  (0.2127)
Mono,Year1,Week36,n=682 Number Analyzed 682 participants
0.053  (0.2053)
Mono,Year1,Week48,n=684 Number Analyzed 684 participants
0.050  (0.2069)
Mono,Year2,Week24,n=629 Number Analyzed 629 participants
0.034  (0.1992)
Mono,Year2,Week48,n=589 Number Analyzed 589 participants
0.050  (0.2172)
Mono,Year3,Week24,n=533 Number Analyzed 533 participants
0.053  (0.2314)
Mono,Year3,Week48,n=476 Number Analyzed 476 participants
0.084  (0.1994)
Mono,Year4,Week24,n=446 Number Analyzed 446 participants
0.071  (0.2085)
Mono,Year4,Week48,n=423 Number Analyzed 423 participants
0.076  (0.2040)
Mono,Year5,Week24,n=389 Number Analyzed 389 participants
0.089  (0.2015)
Mono,Year5,Week48,n=360 Number Analyzed 360 participants
0.088  (0.2044)
Mono,Year6,Week24,n=306 Number Analyzed 306 participants
0.087  (0.2043)
Mono,Year6,Week48,n=282 Number Analyzed 282 participants
0.086  (0.2063)
Mono,Year7,Week24,n=181 Number Analyzed 181 participants
0.113  (0.2155)
Mono,Year7,Week48,n=130 Number Analyzed 130 participants
0.134  (0.2090)
Mono,Year8,Week24,n=52 Number Analyzed 52 participants
0.173  (0.2014)
Mono,Year8,Week48,n=13 Number Analyzed 13 participants
0.021  (0.1503)
Mono,Year9,Week24,n=6 Number Analyzed 6 participants
0.022  (0.1931)
Mono,Year9,Week48,n=1 Number Analyzed 1 participants
-0.120 [2]   (NA)
Mono, Exit,n=614 Number Analyzed 614 participants
0.083  (0.2157)
Mono, 8 Week Follow up, n=532 Number Analyzed 532 participants
0.084  (0.2189)
Neu,Yaer1,Week4,n=688 Number Analyzed 688 participants
0.024  (2.0482)
Neru,Year1,Week12,n=690 Number Analyzed 690 participants
0.047  (2.1575)
Neu,Year1,Week24,n=691 Number Analyzed 691 participants
-0.059  (2.1845)
Neu,Year1,Week36,n=677 Number Analyzed 677 participants
-0.141  (2.1907)
Neu,Year1,Week48,n=679 Number Analyzed 679 participants
-0.078  (2.3164)
Neu,Year2,Week24,n=624 Number Analyzed 624 participants
-0.286  (2.2746)
Neu,Year2,Week48,n=584 Number Analyzed 584 participants
-0.230  (2.3963)
Neu,Year3,Week24,n=528 Number Analyzed 528 participants
-0.135  (2.4914)
Neu,Year3,Week48,n=471 Number Analyzed 471 participants
-0.049  (2.3683)
Neu,Year4,Week24,n=446 Number Analyzed 446 participants
-0.104  (2.3846)
Neu,Year4,Week48,n=423 Number Analyzed 423 participants
-0.160  (2.5563)
Neu,Year5,Week24,n=384 Number Analyzed 384 participants
-0.031  (2.3060)
Neu,Year5,Week48,n=356 Number Analyzed 356 participants
-0.198  (2.3952)
Neu,Year6,Week24,n=306 Number Analyzed 306 participants
-0.151  (2.3083)
Neu,Year6,Week48,n=282 Number Analyzed 282 participants
-0.060  (2.4314)
Neu,Year7,Week24,n=181 Number Analyzed 181 participants
-0.129  (2.3908)
Neu,Year7,Week48,n=130 Number Analyzed 130 participants
-0.687  (3.0412)
Neu,Year8,Week24,n=52 Number Analyzed 52 participants
-0.092  (2.3908)
Neu,Year8,Week48,n=13 Number Analyzed 13 participants
-0.687  (3.0412)
Neu,Year9,Week24,n=6 Number Analyzed 6 participants
-0.257  (2.9192)
Neu,Year9,Week48,n=1 Number Analyzed 735 participants
-3.300 [2]   (NA)
Neu, Exit, n=609 Number Analyzed 609 participants
-0.006  (2.5612)
Neu,8 Week Follow up,n=528 Number Analyzed 528 participants
0.001  (2.3935)
NeuBF,Year1,Week4,n=4 Number Analyzed 4 participants
0.013  (0.1473)
NeuBF,Year1,Week12,n=4 Number Analyzed 4 participants
0.073  (0.1106)
NeuBF,Year1,Week24,n=5 Number Analyzed 5 participants
-0.000  (0.2699)
NeuBF,Year1,Week36,n=4 Number Analyzed 4 participants
0.045  (0.0465)
NeuBF,Year1,Week48,n=2 Number Analyzed 2 participants
0.105  (0.1909)
NeuBF,Year2,Week24,n=1 Number Analyzed 1 participants
0.120 [1]   (NA)
NeuBF,Year2,Week48,n=0 Number Analyzed 0 participants
NeuBF,Year3,Week24,n=1 Number Analyzed 1 participants
0.070 [1]   (NA)
NeuBF,Year3,Week48,n=0 Number Analyzed 0 participants
NeuBF,Year7,Week24,n=0 Number Analyzed 0 participants
NeuBF,Exit,n=2 Number Analyzed 2 participants
0.465  (0.6435)
NeuS,Year1,Week4,n=693 Number Analyzed 693 participants
0.021  (2.0450)
NeuS,Year1,Week12,n=694 Number Analyzed 694 participants
0.051  (2.1519)
NeuS,Year1,Week24,n=696 Number Analyzed 696 participants
-0.055  (2.1757)
NeuS,Year1,Week36,n=682 Number Analyzed 682 participants
-0.139  (2.1819)
NeuS,Year1,Week48,n=684 Number Analyzed 684 participants
-0.079  (2.3128)
NeuS,Year2,Week24,n=629 Number Analyzed 629 participants
-0.289  (2.2609)
NeuS,Year2,Week48,n=589 Number Analyzed 589 participants
-0.226  (2.3846)
NeuS,Year3,Week24,n=533 Number Analyzed 533 participants
-0.130  (2.4736)
NeuS,Year3,Week48,n=476 Number Analyzed 476 participants
-0.041  (2.3547)
NeuS,Year4,Week24,n=446 Number Analyzed 446 participants
-0.097  (2.3804)
NeuS,Year4,Week48,n=423 Number Analyzed 423 participants
-0.158  (2.5542)
NeuS,Year5,Week24,n=389 Number Analyzed 389 participants
-0.024  (2.2893)
NeuS,Year5,Week48,n=360 Number Analyzed 360 participants
-0.184  (2.3831)
NeuS,Year6,Week24,n=306 Number Analyzed 306 participants
-0.147  (2.3029)
NeuS,Year6,Week48,n=282 Number Analyzed 282 participants
-0.058  (2.4310)
NeuS,Year7,Week24,n=181 Number Analyzed 181 participants
-0.151  (2.2248)
NeuS,Year7,Week48,n=130 Number Analyzed 130 participants
0.191  (2.2514)
NeuS,Year8,Week24,n=52 Number Analyzed 52 participants
-0.092  (2.3908)
NeuS,Year8,Week48,n=13 Number Analyzed 13 participants
-0.687  (3.0412)
NeuS,Year9,Week24,n=6 Number Analyzed 6 participants
-0.257  (2.9192)
NeuS,Year9,Week48,n=1 Number Analyzed 1 participants
-3.300 [2]   (NA)
NeuS,Exit,n=614 Number Analyzed 614 participants
-0.008  (2.5501)
NeuS,8 Week Followup,n=532 Number Analyzed 532 participants
0.007  (2.3824)
Plt,Year1,Week4,n=683 Number Analyzed 683 participants
8.1  (38.82)
Plt,Year1,Week12,n=690 Number Analyzed 690 participants
4.6  (43.63)
Plt,Year1,Week24,n=687 Number Analyzed 687 participants
-0.5  (47.73)
Plt,Year1,Week36,n=680 Number Analyzed 680 participants
-2.9  (50.25)
Plt,Year1,Week48,n=677 Number Analyzed 677 participants
-9.3  (50.81)
Plt,Year2,Week24,n=631 Number Analyzed 631 participants
-15.4  (53.80)
Plt,Year2,Week48,n=583 Number Analyzed 583 participants
-20.3  (56.39)
Plt,Year3,Week24,n=526 Number Analyzed 526 participants
-19.9  (57.88)
Plt,Year3,Week48,n=476 Number Analyzed 476 participants
-13.4  (65.16)
Plt,Year4,Week24,n=441 Number Analyzed 441 participants
-14.0  (59.05)
Plt,Year4,Week48,n=420 Number Analyzed 420 participants
-18.2  (63.80)
Plt,Year5,Week24,n=388 Number Analyzed 388 participants
-19.3  (61.49)
Plt,Year5,Week48,n=360 Number Analyzed 360 participants
-17.9  (63.36)
Plt,Year6,Week24,n=305 Number Analyzed 305 participants
-13.3  (61.54)
Plt,Year6,Week48,n=282 Number Analyzed 282 participants
-13.4  (60.89)
Plt,Year7,Week24,n=181 Number Analyzed 181 participants
-15.3  (63.95)
Plt,Year7,Week48,n=130 Number Analyzed 130 participants
-16.3  (70.75)
Plt,Year8,Week24,n=52 Number Analyzed 52 participants
-2.3  (80.69)
Plt,Year8,Week48,n=13 Number Analyzed 13 participants
-29.9  (88.66)
Plt,Year9,Week24,n=6 Number Analyzed 6 participants
-5.0  (82.67)
Plt,Year9,Week48,n=1 Number Analyzed 1 participants
57.0 [2]   (NA)
Plt,Exit,n=613 Number Analyzed 613 participants
-11.0  (64.36)
Plt,8Week Followup,n=530 Number Analyzed 530 participants
-11.2  (60.57)
[1]
NA indicates standard deviation was not calculable for a single data point.
[2]
NA indicates standard deviation was not calculable for a single data point
7.Primary Outcome
Title Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Gram per liter (g/L)
Hg,Year1, Week 4,n=697 Number Analyzed 697 participants
-0.3  (7.05)
Hg,Year1,Week12,n=698 Number Analyzed 698 participants
0.1  (8.75)
Hg,Year1,Week24,n=699 Number Analyzed 699 participants
0.1  (9.48)
Hg,Year1,Week36,n=688 Number Analyzed 688 participants
0.3  (9.90)
Hg,Year1,Week48,n=686 Number Analyzed 686 participants
1.0  (11.03)
Hg,Year2,Week24,n=635 Number Analyzed 635 participants
1.0  (11.31)
Hg,Year2,Week48,n=591 Number Analyzed 591 participants
1.3  (12.12)
Hg,Year3,Week24,n=534 Number Analyzed 534 participants
2.2  (12.79)
Hg,Year3,Week48,n=478 Number Analyzed 478 participants
2.9  (12.67)
Hg,Year4,Week24,n=446 Number Analyzed 446 participants
2.6  (12.93)
Hg,Year,Week48,n=424 Number Analyzed 424 participants
2.4  (13.59)
Hg,Year5,Week24,n=390 Number Analyzed 390 participants
2.9  (12.76)
Hg,Year5,Week48,n=362 Number Analyzed 362 participants
3.2  (13.26)
Hg,Year6,Week24,n=306 Number Analyzed 306 participants
2.7  (13.19)
Hg,Year6,Week48,n=282 Number Analyzed 282 participants
2.3  (13.83)
Hg,Year7,Week24,n=181 Number Analyzed 181 participants
2.9  (14.54)
Hg,Year7,Week48,n=130 Number Analyzed 130 participants
4.0  (14.66)
Hg,Year8,Week24,n=52 Number Analyzed 52 participants
1.5  (14.84)
Hg,Year8,Week48,n=13 Number Analyzed 13 participants
-0.2  (13.95)
Hg,Year9,Week24,n=6 Number Analyzed 6 participants
-0.7  (20.67)
Hg,Year9,Week48,n=1 Number Analyzed 1 participants
-29.0 [1]   (NA)
Hg,Exit,n=619 Number Analyzed 619 participants
3.2  (13.90)
Hg,8 Week Follow up,n=534 Number Analyzed 534 participants
2.8  (13.71)
[1]
NA indicates standard deviation was not calculable for a single data point.
8.Primary Outcome
Title Change From Baseline in Hematocrit at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Percentage of blood by volume
Hematocrit,Year1,Week4,n=697 Number Analyzed 697 participants
0.01  (2.250)
Hematocrit,Year1,Week12,n=698 Number Analyzed 698 participants
0.38  (2.729)
Hematocrit,Year1,Week24,n=699 Number Analyzed 699 participants
0.75  (2.928)
Hematocrit,Year1,Week36,n=688 Number Analyzed 688 participants
0.53  (2.954)
Hematocrit,Year1,Week48,n=686 Number Analyzed 686 participants
0.35  (3.286)
Hematocrit,Year2,Week24,n=635 Number Analyzed 635 participants
0.94  (3.427)
Hematocrit,Year2,Week48,n=591 Number Analyzed 591 participants
0.78  (3.584)
Hematocrit,Year3,Week24,n=534 Number Analyzed 534 participants
1.29  (3.828)
Hematocrit,Year3,Week48,n=478 Number Analyzed 478 participants
1.39  (3.800)
Hematocrit,Year4,Week24,n=446 Number Analyzed 446 participants
1.67  (3.834)
Hematocrit,Year4,Week48,n=424 Number Analyzed 424 participants
1.15  (3.998)
Hematocrit,Year5,Week24,n=390 Number Analyzed 390 participants
1.69  (3.776)
Hematocrit,Year5,Week48,n=362 Number Analyzed 362 participants
1.98  (3.842)
Hematocrit,Year6,Week24,n=306 Number Analyzed 306 participants
1.93  (3.939)
Hematocrit,Year6,Week48,n=282 Number Analyzed 282 participants
2.07  (4.023)
Hematocrit,Year7,Week24,n=181 Number Analyzed 181 participants
1.81  (4.251)
Hematocrit,Year7,Week48,n=130 Number Analyzed 130 participants
2.11  (4.238)
Hematocrit,Year8,Week24,n=52 Number Analyzed 52 participants
1.42  (4.390)
Hematocrit,Year8,Week48,n=13 Number Analyzed 13 participants
1.48  (4.234)
Hematocrit,Year9,Week24,n=6 Number Analyzed 6 participants
2.03  (6.001)
Hematocrit,Year9,Week48,n=1 Number Analyzed 1 participants
-6.00 [1]   (NA)
Hematocrit,Exit,n=619 Number Analyzed 619 participants
1.91  (4.202)
Hematocrit,8 Week Follow up,n=534 Number Analyzed 534 participants
1.85  (4.077)
[1]
NA indicates standard deviation was not calculable for a single data point
9.Primary Outcome
Title Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Trillions cells per liter
Eryth,Year1,Week4,n=697 Number Analyzed 697 participants
-0.00  (0.231)
Eryth,Year1,Week12,n=698 Number Analyzed 698 participants
0.04  (0.280)
Eryth,Year1,Week24,n=699 Number Analyzed 699 participants
0.06  (0.293)
Eryth,Year1,Week36,n=688 Number Analyzed 688 participants
0.06  (0.299)
Eryth,Year1,Week48,n=686 Number Analyzed 686 participants
0.06  (0.328)
Eryth,Year2,Week24,n=635 Number Analyzed 635 participants
0.07  (0.335)
Eryth,Year2,Week48,n=591 Number Analyzed 591 participants
0.04  (0.362)
Eryth,Year3,Week24,n=534 Number Analyzed 534 participants
0.04  (0.364)
Eryth,Year3,Week48,n=478 Number Analyzed 478 participants
0.05  (0.381)
Eryth,Year4,Week24,n=446 Number Analyzed 446 participants
0.06  (0.372)
Eryth,Year,Week48,n=424 Number Analyzed 424 participants
0.05  (0.379)
Eryth,Year5,Week24,n=390 Number Analyzed 390 participants
0.09  (0.375)
Eryth,Year5,Week48,n=362 Number Analyzed 362 participants
0.11  (0.383)
Eryth,Year6,Week24,n=306 Number Analyzed 306 participants
0.12  (0.396)
Eryth,Year6,Week48,n=282 Number Analyzed 282 participants
0.17  (0.408)
Eryth,Year7,Week24,n=181 Number Analyzed 181 participants
0.17  (0.415)
Eryth,Year7,Week48,n=130 Number Analyzed 130 participants
0.22  (0.387)
Eryth,Year8,Week24,n=52 Number Analyzed 52 participants
0.21  (0.375)
Eryth,Year8,Week48,n=13 Number Analyzed 13 participants
0.15  (0.207)
Eryth,Year9,Week24,n=6 Number Analyzed 6 participants
0.30  (0.374)
Eryth,Year9,Week48,n=1 Number Analyzed 1 participants
0.20 [1]   (NA)
Eryth,Exit,n=619 Number Analyzed 619 participants
0.14  (0.431)
Eryth,8 Week Follow up,n=534 Number Analyzed 534 participants
0.13  (0.411)
[1]
NA indicates standard deviation was not calculable for a single data point.
10.Primary Outcome
Title Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Hide Description Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Ca,Year1,Week4,n=697 Number Analyzed 697 participants
0.0030  (0.0763)
Ca,Year1,Week12,n=696 Number Analyzed 696 participants
0.0020  (0.0749)
Ca,Year1,Week24,n=696 Number Analyzed 696 participants
-0.0035  (0.0750)
Ca,Year1,Week36,n=677 Number Analyzed 677 participants
0.0024  (0.0836)
Ca,Year1,Week48,n=687 Number Analyzed 687 participants
-0.0065  (0.0778)
Ca,Year2,Week24,n=636 Number Analyzed 636 participants
-0.0075  (0.0764)
Ca,Year2,Week48,n=587 Number Analyzed 587 participants
-0.0091  (0.0837)
Ca,Year3,Week24,n=526 Number Analyzed 526 participants
-0.0047  (0.0810)
Ca,Year3,Week48,n=481 Number Analyzed 481 participants
-0.0123  (0.0800)
Ca,Year4,Week24,n=438 Number Analyzed 438 participants
-0.0056  (0.0771)
Ca,Year,Week48,n=418 Number Analyzed 418 participants
-0.0193  (0.0805)
Ca,Year5,Week24,n=387 Number Analyzed 387 participants
-0.0129  (0.0885)
Ca,Year5,Week48,n=358 Number Analyzed 358 participants
-0.0140  (0.0919)
Ca,Year6,Week24,n=303 Number Analyzed 303 participants
-0.0053  (0.0903)
Ca,Year6,Week48,n=283 Number Analyzed 283 participants
-0.0146  (0.0870)
Ca,Year7,Week24,n=182 Number Analyzed 182 participants
-0.0076  (0.0839)
Ca,Year7,Week48,n=130 Number Analyzed 130 participants
-0.0079  (0.1172)
Ca,Year8,Week24,n=51 Number Analyzed 51 participants
0.0003  (0.0806)
Ca,Year8,Week48,n=13 Number Analyzed 13 participants
-0.0395  (0.0611)
Ca,Year9,Week24,n=6 Number Analyzed 6 participants
-0.0402  (0.0336)
Ca,Year9,Week48,n=1 Number Analyzed 1 participants
-0.0642 [1]   (NA)
Ca,Exit,n=619 Number Analyzed 619 participants
0.0006  (0.0864)
Ca,8 Week Follow up,n=534 Number Analyzed 534 participants
-0.0014  (0.0909)
CO2,Year1,Week4,n=701 Number Analyzed 701 participants
-0.0  (2.77)
CO2,Year1,Week12,n=700 Number Analyzed 700 participants
-0.1  (2.76)
CO2,Year1,Week24,n=701 Number Analyzed 701 participants
-0.1  (2.73)
CO2,Year1,Week36,n=682 Number Analyzed 682 participants
0.1  (2.73)
CO2,Year1,Week48,n=692 Number Analyzed 692 participants
-0.1  (2.78)
CO2,Year2,Week24,n=641 Number Analyzed 641 participants
-0.3  (2.94)
CO2,Year2,Week48,n=692 Number Analyzed 692 participants
-0.3  (2.87)
CO2,Year3,Week24,n=531 Number Analyzed 531 participants
-0.2  (2.90)
CO2,Year3,Week48,n=486 Number Analyzed 486 participants
-0.4  (2.75)
CO2,Year4,Week24,n=438 Number Analyzed 438 participants
-0.0  (2.76)
CO2,Year4,Week48,n=418 Number Analyzed 418 participants
-0.5  (3.04)
CO2,Year5,Week24,n=393 Number Analyzed 393 participants
-0.2  (2.90)
CO2,Year5,Week48,n=361 Number Analyzed 361 participants
-0.8  (2.82)
CO2,Year6,Week24,n=303 Number Analyzed 303 participants
-0.0  (2.86)
CO2,Year6,Week48,n=284 Number Analyzed 284 participants
-0.5  (2.76)
CO2,Year7,Week24,n=182 Number Analyzed 182 participants
0.2  (2.78)
CO2,Year7,Week48,n=130 Number Analyzed 130 participants
0.2  (2.67)
CO2,Year8,Week24,n=52 Number Analyzed 52 participants
1.0  (2.78)
CO2,Year8,Week48,n=13 Number Analyzed 13 participants
0.4  (3.38)
CO2,Year9,Week24,n=6 Number Analyzed 6 participants
-0.3  (0.82)
CO2,Year9,Week48,n=1 Number Analyzed 1 participants
-3.0 [1]   (NA)
CO2,Exit,n=625 Number Analyzed 625 participants
-0.3  (3.00)
CO2,8 week Follow up,n=538 Number Analyzed 538 participants
-0.2  (3.00)
Chloride,Year1,Week4,n=707 Number Analyzed 707 participants
0.3  (2.33)
Chloride,Year1,Week12,n=704 Number Analyzed 704 participants
0.6  (2.56)
Chloride,Year1,Week24,n=703 Number Analyzed 703 participants
0.6  (2.42)
Chloride,Year1,Week36,n=684 Number Analyzed 684 participants
0.6  (2.47)
Chloride,Year1,Week48,n=693 Number Analyzed 693 participants
0.4  (2.44)
Chloride,Year2,Week24,n=643 Number Analyzed 643 participants
0.5  (2.62)
Chloride,Year2,Week48,n=598 Number Analyzed 598 participants
0.5  (2.81)
Chloride,Year3,Week24,n=535 Number Analyzed 535 participants
0.7  (3.04)
Chloride,Year3,Week48,n=488 Number Analyzed 488 participants
0.6  (2.73)
Chloride,Year4,Week24,n=439 Number Analyzed 439 participants
0.5  (2.74)
Chloride,Year4,Week48,n=421 Number Analyzed 421 participants
0.7  (2.84)
Chloride,Year5,Week24,n=392 Number Analyzed 392 participants
0.6  (2.95)
Chloride,Year5,Week48,n=362 Number Analyzed 362 participants
0.6  (2.77)
Chloride,Year6,Week24,n=304 Number Analyzed 304 participants
1.0  (2.74)
Chloride,Year6,Week48,n=286 Number Analyzed 286 participants
0.8  (2.67)
Chloride,Year7,Week24,n=183 Number Analyzed 183 participants
0.7  (2.57)
Chloride,Year7,Week48,n=130 Number Analyzed 130 participants
1.1  (2.73)
Chloride,Year8,Week24,n=52 Number Analyzed 52 participants
1.3  (2.86)
Chloride,Year8,Week48,n=13 Number Analyzed 13 participants
1.2  (3.54)
Chloride,Year9,Week24,n=6 Number Analyzed 6 participants
3.2  (1.47)
Chloride,Year9,Week48,n=1 Number Analyzed 1 participants
1.0 [1]   (NA)
Chloride,Exit,n=624 Number Analyzed 624 participants
0.4  (3.06)
Chloride,8 Week Follow up,n=538 Number Analyzed 538 participants
0.4  (2.82)
Mg,Year1,Week4,n=707 Number Analyzed 707 participants
-0.003  (0.0583)
Mg,Year1,Week 12,n=705 Number Analyzed 705 participants
-0.006  (0.0647)
Mg,Year1,Week 24,n=703 Number Analyzed 703 participants
-0.003  (0.0604)
Mg,Year1,Week 36,n=684 Number Analyzed 684 participants
-0.004  (0.0616)
Mg,Year1,Week 48,n=693 Number Analyzed 693 participants
0.002  (0.0597)
Mg,Year2,Week 24,n=643 Number Analyzed 643 participants
0.002  (0.0694)
Mg,Year2,Week 48,n=598 Number Analyzed 598 participants
0.001  (0.0711)
Mg,Year3,Week 24,n=535 Number Analyzed 535 participants
0.010  (0.0668)
Mg,Year3,Week 48,n=488 Number Analyzed 488 participants
0.010  (0.0669)
Mg,Year4,Week 24,n=439 Number Analyzed 439 participants
0.016  (0.0700)
Mg,Year4,Week 48,n=421 Number Analyzed 421 participants
0.017  (0.0709)
Mg,Year 5,Week 24,n=393 Number Analyzed 393 participants
0.016  (0.0673)
Mg,Year 5,Week 48,n=362 Number Analyzed 362 participants
0.021  (0.0688)
Mg,Year 6,Week 24,n=304 Number Analyzed 304 participants
0.013  (0.0718)
Mg,Year 6,Week 48,n=286 Number Analyzed 286 participants
0.011  (0.0639)
Mg,Year 7,Week 24,n=183 Number Analyzed 183 participants
0.010  (0.0692)
Mg,Year 7,Week 48,n=130 Number Analyzed 130 participants
0.013  (0.0635)
Mg,Year 8,Week 24,n=52 Number Analyzed 52 participants
0.025  (0.0702)
Mg,Year 8,Week 48,n=13 Number Analyzed 13 participants
0.042  (0.0685)
Mg,Year 9,Week 24,n=6 Number Analyzed 6 participants
0.030  (0.0613)
Mg,Year 9,Week 48,n=1 Number Analyzed 1 participants
0.040 [1]   (NA)
Mg, Exit,n=625 Number Analyzed 625 participants
0.022  (0.0738)
Mg,8 Week Follow up,n=539 Number Analyzed 539 participants
0.021  (0.0729)
Phos, Year1, Week4,n=707 Number Analyzed 707 participants
0.0102  (0.1908)
Phos, Year1, Week12,n=705 Number Analyzed 705 participants
0.0004  (0.1999)
Phos, Year1, Week24,n=703 Number Analyzed 703 participants
-0.0126  (0.1964)
Phos, Year1, Week 36,n=684 Number Analyzed 684 participants
0.0101  (0.1976)
Phos, Year1, Week48,n=693 Number Analyzed 693 participants
-0.0110  (0.2086)
Phos, Year2, Week24,n=643 Number Analyzed 643 participants
-0.0026  (0.2138)
Phos, Year2, Week48,n=598 Number Analyzed 598 participants
-0.0044  (0.2062)
Phos, Year3, Week24,n=535 Number Analyzed 535 participants
-0.0109  (0.2028)
Phos, Year3, Week48,n=488 Number Analyzed 488 participants
-0.0185  (0.2138)
Phos, Year4, Week24,n=439 Number Analyzed 439 participants
-0.0072  (0.2067)
Phos, Year4, Week48,n=421 Number Analyzed 421 participants
-0.0143  (0.2118)
Phos, Year5, Week24,n=393 Number Analyzed 393 participants
-0.0199  (0.2751)
Phos, Year5, Week48,n=362 Number Analyzed 362 participants
-0.0320  (0.2145)
Phos, Year6, Week24,n=304 Number Analyzed 304 participants
-0.0238  (0.2214)
Phos, Year6, Week48,n=286 Number Analyzed 286 participants
-0.0123  (0.2113)
Phos, Year 7, Week 24,n=183 Number Analyzed 183 participants
-0.0196  (0.1970)
Phos, Year 7, Week 48,n=130 Number Analyzed 130 participants
-0.0101  (0.1912)
Phos, Year 8, Week 24,n=52 Number Analyzed 52 participants
-0.0041  (0.2038)
Phos, Year 8, Week48,n=13 Number Analyzed 13 participants
-0.0340  (0.1337)
Phos, Year9, Week 24,n=6 Number Analyzed 6 participants
-0.0803  (0.0823)
Phos, Year 9, Week 48,n=1 Number Analyzed 1 participants
0.0447 [1]   (NA)
Phos, Exit, n=625 Number Analyzed 625 participants
-0.0111  (0.2243)
Phos, 8 Week Follow up,n=539 Number Analyzed 539 participants
-0.0034  (0.2233)
K, Year 1, Week 4, n=701 Number Analyzed 701 participants
0.07  (0.411)
K, Year 1, Week 12, n=700 Number Analyzed 700 participants
0.03  (0.380)
K, Year 1, Week 24, n=701 Number Analyzed 701 participants
0.01  (0.377)
K, Year 1, Week 36, n=682 Number Analyzed 682 participants
0.04  (0.387)
K, Year 1, Week 48, n=692 Number Analyzed 692 participants
0.01  (0.377)
K, Year 2, Week 24, n=641 Number Analyzed 641 participants
0.01  (0.393)
K, Year 2, Week 48, n=592 Number Analyzed 592 participants
0.02  (0.372)
K, Year 3, Week 24, n=531 Number Analyzed 531 participants
0.05  (0.401)
K, Year 3, Week 48, n=486 Number Analyzed 486 participants
0.06  (0.421)
K, Year 4, Week 24, n=438 Number Analyzed 438 participants
0.06  (0.408)
K, Year 4, Week 48, n=418 Number Analyzed 418 participants
0.03  (0.397)
K, Year 5, Week 24, n=393 Number Analyzed 393 participants
0.08  (0.427)
K, Year 5, Week 48, n=362 Number Analyzed 362 participants
0.02  (0.404)
K, Year 6, Week 24, n=303 Number Analyzed 303 participants
0.06  (0.429)
K, Year 6, Week 48, n=284 Number Analyzed 284 participants
0.05  (0.437)
K, Year 7, Week 24, n=182 Number Analyzed 182 participants
0.05  (0.445)
K, Year 7, Week 48, n=130 Number Analyzed 130 participants
0.05  (0.413)
K, Year 8, Week 24, n=52 Number Analyzed 52 participants
-0.02  (0.418)
K, Year 8, Week 48, n=13 Number Analyzed 13 participants
-0.12  (0.300)
K, Year 9, Week 24, n=6 Number Analyzed 6 participants
0.05  (0.259)
K, Year 9, Week 48, n=1 Number Analyzed 1 participants
0.00 [1]   (NA)
K, Exit, n=624 Number Analyzed 624 participants
0.06  (0.435)
K, 8 Week Follow up, n=537 Number Analyzed 537 participants
0.07  (0.452)
Na, Year 1, Week 4, n=707 Number Analyzed 707 participants
0.1  (2.07)
Na, Year 1, Week 12, n=705 Number Analyzed 705 participants
0.3  (2.25)
Na, Year 1, Week 24, n=703 Number Analyzed 703 participants
0.4  (2.16)
Na, Year 1, Week 36, n=684 Number Analyzed 684 participants
0.4  (2.10)
Na, Year 1, Week 48, n=693 Number Analyzed 693 participants
0.1  (2.09)
Na, Year 2, Week 24, n=643 Number Analyzed 643 participants
-0.0  (2.30)
Na, Year 2, Week 48, n=598 Number Analyzed 598 participants
0.1  (2.63)
Na, Year 3, Week 24, n=535 Number Analyzed 535 participants
0.2  (2.54)
Na, Year 3, Week 48, n=488 Number Analyzed 488 participants
0.3  (2.36)
Na, Year 4, Week 24, n=439 Number Analyzed 439 participants
0.1  (2.31)
Na, Year 4, Week 48, n=421 Number Analyzed 421 participants
0.3  (2.36)
Na, Year 5, Week 24, n=393 Number Analyzed 393 participants
0.3  (2.61)
Na, Year 5, Week 48, n=362 Number Analyzed 362 participants
0.3  (2.18)
Na, Year 6, Week 24, n=304 Number Analyzed 304 participants
0.3  (2.22)
Na, Year 6, Week 48, n=286 Number Analyzed 286 participants
0.4  (2.44)
Na, Year 7, Week 24, n=183 Number Analyzed 183 participants
0.1  (2.22)
Na, Year 7, Week 48, n=130 Number Analyzed 130 participants
0.1  (2.38)
Na, Year 8, Week 24, n=52 Number Analyzed 52 participants
0.2  (2.67)
Na, Year 8, Week 48, n=13 Number Analyzed 13 participants
0.1  (2.14)
Na, Year 9, Week 24, n=6 Number Analyzed 6 participants
1.0  (1.79)
Na, Year 9, Week 48, n=1 Number Analyzed 1 participants
-3.0 [1]   (NA)
Na, Exist, n=624 Number Analyzed 624 participants
0.1  (2.55)
Na, 8 Week Follow up, n=538 Number Analyzed 538 participants
0.3  (2.36)
[1]
NA indicates standard deviation was not calculable for a single data point.
11.Primary Outcome
Title Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
Hide Description Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Ratio
BUN/Cr,Year1,Week4,n=707 Number Analyzed 707 participants
-0.2  (4.66)
BUN/Cr,Year1,Week12,n=705 Number Analyzed 705 participants
-0.3  (4.88)
BUN/CrYear1,Week24,n=703 Number Analyzed 703 participants
-0.7  (5.02)
BUN/Cr,Year1,Week36,n=683 Number Analyzed 683 participants
-0.5  (5.61)
BUN/Cr,Year1,Week48,n=693 Number Analyzed 693 participants
-0.2  (5.26)
BUN/Cr,Year2,Week24,n=643 Number Analyzed 643 participants
-0.1  (5.68)
BUN/Cr,Year2,Week48,n=598 Number Analyzed 598 participants
0.5  (5.55)
BUN/Cr,Year3,Week24,n=535 Number Analyzed 535 participants
1.4  (5.48)
BUN/Cr,Year3,Week48,n=488 Number Analyzed 488 participants
1.2  (5.92)
BUN/Cr,Year4,Week24,n=439 Number Analyzed 439 participants
1.4  (5.65)
BUN/Cr,Year 4,Week48,n=421 Number Analyzed 421 participants
1.0  (5.85)
BUN/Cr,Year5,Week24,n=393 Number Analyzed 393 participants
0.7  (5.51)
BUN/Cr,Year5,Week48,n=362 Number Analyzed 362 participants
1.0  (5.62)
BUN/Cr,Year6,Week24,n=304 Number Analyzed 304 participants
1.0  (5.35)
BUN/Cr,Year6,Week48,n=286 Number Analyzed 286 participants
1.3  (5.74)
BUN/Cr,Year7,Week24,n=183 Number Analyzed 183 participants
0.8  (5.68)
BUN/Cr,Year7,Week48,n=130 Number Analyzed 130 participants
1.2  (5.47)
BUN/Cr,Year8,Week24,n=52 Number Analyzed 52 participants
3.3  (4.64)
BUN/Cr,Year8,Week48,n=13 Number Analyzed 13 participants
3.5  (6.04)
BUN/Cr,Year9,Week24,n=6 Number Analyzed 6 participants
3.5  (3.08)
BUN/Cr,Year9,Week48,n=1 Number Analyzed 1 participants
1  (2.0)
BUN/Cr,Exit,n=625 Number Analyzed 625 participants
0.9  (6.05)
BUN/Cr,8 Week Follow up,n=539 Number Analyzed 539 participants
0.9  (5.91)
12.Primary Outcome
Title Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Hide Description Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Alb,Year1,Week4,n=707 Number Analyzed 707 participants
-0.1  (2.36)
Alb,Year1,Week12,n=705 Number Analyzed 705 participants
0.2  (2.67)
Alb,Year1,Week24,n=703 Number Analyzed 703 participants
0.6  (3.03)
Alb,Year1,Week36,n=684 Number Analyzed 684 participants
0.7  (3.23)
Alb,Year1,Week48,n=693 Number Analyzed 693 participants
1.2  (3.52)
Alb,Year2,Week24,n=643 Number Analyzed 643 participants
1.2  (3.49)
Alb,Year2,Week48,n=598 Number Analyzed 598 participants
1.2  (3.67)
Alb,Year3,Week24,n=535 Number Analyzed 535 participants
1.2  (3.78)
Alb,Year3,Week48,n=488 Number Analyzed 488 participants
1.4  (4.02)
Alb,Year4,Week24,n=439 Number Analyzed 439 participants
1.7  (4.02)
Alb,Year 4,Week48,n=421 Number Analyzed 421 participants
1.9  (4.04)
Alb,Year5,Week24,n=393 Number Analyzed 393 participants
1.9  (3.85)
Alb,Year5,Week48,n=362 Number Analyzed 362 participants
2.3  (3.89)
Alb,Year6,Week24,n=304 Number Analyzed 304 participants
2.2  (3.78)
Alb,Year6,Week48,n=286 Number Analyzed 286 participants
2.1  (4.07)
Alb,Year7,Week24,n=183 Number Analyzed 183 participants
2.0  (3.60)
Alb,Year7,Week48,n=130 Number Analyzed 130 participants
2.3  (3.92)
Alb,Year8,Week24,n=52 Number Analyzed 52 participants
1.9  (4.16)
Alb,Year8,Week48,n=13 Number Analyzed 13 participants
1.1  (4.11)
Alb,Year9,Week24,n=6 Number Analyzed 6 participants
0.7  (3.01)
Alb,Year9,Week48,n=1 Number Analyzed 1 participants
1.0 [1]   (NA)
Alb,Exit,n=625 Number Analyzed 625 participants
1.8  (4.74)
Alb,8 Week Follow up,n=539 Number Analyzed 539 participants
1.7  (4.66)
Pro,Year1,Week4,n=707 Number Analyzed 707 participants
-1.4  (3.81)
Pro,Year1,Week12,n=705 Number Analyzed 705 participants
-2.0  (4.30)
Pro,Year1,Week24,n=703 Number Analyzed 703 participants
-1.9  (4.68)
Pro,Year1,Week36,n=684 Number Analyzed 684 participants
-2.3  (4.75)
Pro,Year1,Week48,n=693 Number Analyzed 693 participants
-1.8  (4.94)
Pro,Year2,Week24,n=643 Number Analyzed 643 participants
-2.3  (5.05)
Pro,Year2,Week48,n=598 Number Analyzed 598 participants
-2.7  (5.53)
Pro,Year3,Week24,n=535 Number Analyzed 535 participants
-3.1  (5.62)
Pro,Year3,Week48,n=488 Number Analyzed 488 participants
-3.5  (5.91)
Pro,Year4,Week24,n=439 Number Analyzed 439 participants
-3.2  (5.87)
Pro,Year 4,Week48,n=421 Number Analyzed 421 participants
-3.2  (6.07)
Pro,Year5,Week24,n=393 Number Analyzed 393 participants
-3.5  (5.75)
Pro,Year5,Week48,n=362 Number Analyzed 362 participants
-3.6  (5.78)
Pro,Year6,Week24,n=304 Number Analyzed 304 participants
-3.9  (5.57)
Pro,Year6,Week48,n=286 Number Analyzed 286 participants
-4.0  (5.79)
Pro,Year7,Week24,n=183 Number Analyzed 183 participants
-4.3  (5.36)
Pro,Year7,Week48,n=130 Number Analyzed 130 participants
-3.9  (5.32)
Pro,Year8,Week24,n=52 Number Analyzed 52 participants
-5.1  (6.38)
Pro,Year8,Week48,n=13 Number Analyzed 13 participants
-4.8  (5.02)
Pro,Year9,Week24,n=6 Number Analyzed 6 participants
-7.7  (7.03)
Pro,Year9,Week48,n=1 Number Analyzed 1 participants
0.0 [1]   (NA)
Pro,Exit,n=625 Number Analyzed 625 participants
-3.4  (6.45)
Pro,8 Week Follow up,n=539 Number Analyzed 539 participants
-3.7  (6.42)
[1]
NA indicates standard deviation was not calculable for a single data point.
13.Primary Outcome
Title Change From Baseline in BUN and Glucose at the Indicated Time Points
Hide Description Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: mmol/L
BUN,Year1,Week4,n=707 Number Analyzed 707 participants
0.0299  (1.6783)
BUN,Year1,Week12,n=705 Number Analyzed 705 participants
0.0402  (1.9768)
BUN,Year1,Week24,n=703 Number Analyzed 703 participants
-0.1443  (1.3723)
BUN,Year1,Week36,n=683 Number Analyzed 683 participants
-0.0592  (1.6916)
BUN,Year1,Week48,n=693 Number Analyzed 693 participants
-0.0406  (1.5541)
BUN,Year2,Week24,n=643 Number Analyzed 643 participants
-0.0760  (1.6652)
BUN,Year2,Week48,n=598 Number Analyzed 598 participants
0.0631  (1.6429)
BUN,Year3,Week24,n=535 Number Analyzed 535 participants
0.0524  (1.6850)
BUN,Year3,Week48,n=488 Number Analyzed 488 participants
-0.1013  (1.6910)
BUN,Year4,Week24,n=439 Number Analyzed 439 participants
0.0967  (1.9398)
BUN,Year 4,Week48,n=421 Number Analyzed 421 participants
0.0672  (2.1393)
BUN,Year5,Week24,n=393 Number Analyzed 393 participants
-0.0291  (2.0169)
BUN,Year5,Week48,n=362 Number Analyzed 362 participants
0.0899  (2.0903)
BUN,Year6,Week24,n=304 Number Analyzed 304 participants
0.0959  (1.9852)
BUN,Year6,Week48,n=286 Number Analyzed 286 participants
0.2325  (2.2724)
BUN,Year7,Week24,n=183 Number Analyzed 183 participants
-0.0026  (1.6623)
BUN,Year7,Week48,n=130 Number Analyzed 130 participants
0.1455  (1.7145)
BUN,Year8,Week24,n=52 Number Analyzed 52 participants
0.5458  (1.7299)
BUN,Year8,Week48,n=13 Number Analyzed 13 participants
0.3883  (1.4603)
BUN,Year9,Week24,n=6 Number Analyzed 6 participants
0.1648  (1.0466)
BUN,Year9,Week48,n=1 Number Analyzed 1 participants
0.5700 [1]   (NA)
BUN,Exit,n=625 Number Analyzed 625 participants
0.2448  (2.4618)
BUN,8 Week Follow up,n=539 Number Analyzed 539 participants
0.0822  (2.5567)
Glucose,Year1,Week4,n=707 Number Analyzed 707 participants
-0.0031  (1.0221)
Glucose,Year1,Week12,n=705 Number Analyzed 705 participants
0.0333  (1.0627)
Glucose,Year1,Week24,n=702 Number Analyzed 702 participants
-0.0396  (1.2656)
Glucose,Year1,Week36,n=684 Number Analyzed 684 participants
0.0099  (1.0269)
Glucose,Year1,Week48,n=693 Number Analyzed 693 participants
0.0010  (1.1726)
Glucose,Year2,Week24,n=643 Number Analyzed 643 participants
0.0143  (1.3227)
Glucose,Year2,Week48,n=598 Number Analyzed 598 participants
-0.0082  (1.1352)
Glucose,Year3,Week24,n=535 Number Analyzed 535 participants
-0.0159  (1.3222)
Glucose,Year3,Week48,n=488 Number Analyzed 488 participants
0.0309  (1.1841)
Glucose,Year4,Week24,n=439 Number Analyzed 439 participants
-0.0160  (1.2213)
Glucose,Year 4,Week48,n=421 Number Analyzed 421 participants
-0.0259  (1.1936)
Glucose,Year5,Week24,n=393 Number Analyzed 393 participants
0.0554  (1.1255)
Glucose,Year5,Week48,n=362 Number Analyzed 362 participants
0.0655  (1.2946)
Glucose,Year6,Week24,n=303 Number Analyzed 303 participants
0.1290  (1.1163)
Glucose,Year6,Week48,n=286 Number Analyzed 286 participants
0.2001  (1.2411)
Glucose,Year7,Week24,n=183 Number Analyzed 183 participants
0.2303  (1.0514)
Glucose,Year7,Week48,n=130 Number Analyzed 130 participants
0.2335  (0.8346)
Glucose,Year8,Week24,n=52 Number Analyzed 52 participants
0.3301  (0.9052)
Glucose,Year8,Week48,n=13 Number Analyzed 13 participants
0.1431  (0.8115)
Glucose,Year9,Week24,n=6 Number Analyzed 6 participants
0.2128  (0.4914)
Glucose,Year9,Week48,n=1 Number Analyzed 1 participants
0.4739 [2]   (NA)
Glucose,Exit,n=624 Number Analyzed 624 participants
0.1842  (1.8723)
Glucose,8 Week Follow up,n=539 Number Analyzed 539 participants
0.0338  (1.4139)
[1]
NA indicates standard deviation was not calculable for a single data point.
[2]
NA indicates standard deviation was not calculable for a single data point
14.Primary Outcome
Title Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Hide Description Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
Urate,Year1,Week4,n=707 Number Analyzed 707 participants
1.0332  (45.8504)
Urate,Year1,Week12,n=704 Number Analyzed 704 participants
0.4089  (54.3182)
Urate,Year1,Week24,n=703 Number Analyzed 703 participants
-0.0510  (49.2328)
Urate,Year1,Week36,n=684 Number Analyzed 684 participants
0.6713  (50.7341)
Urate,Year1,Week48,n=693 Number Analyzed 693 participants
-1.5147  (50.5928)
Urate,Year2,Week24,n=643 Number Analyzed 643 participants
2.7246  (55.7467)
Urate,Year2,Week48,n=598 Number Analyzed 598 participants
4.1255  (60.0251)
Urate,Year3,Week24,n=535 Number Analyzed 535 participants
6.7497  (60.4118)
Urate,Year3,Week48,n=488 Number Analyzed 488 participants
6.9744  (63.6876)
Urate,Year4,Week24,n=439 Number Analyzed 439 participants
5.9658  (66.6167)
Urate,Year 4,Week48,n=421 Number Analyzed 421 participants
4.0772  (67.9587)
Urate,Year5,Week24,n=393 Number Analyzed 393 participants
-0.5634  (66.9130)
Urate,Year5,Week48,n=362 Number Analyzed 362 participants
-0.8979  (67.3843)
Urate,Year6,Week24,n=304 Number Analyzed 304 participants
2.9530  (62.3168)
Urate,Year6,Week48,n=286 Number Analyzed 286 participants
1.1244  (67.3175)
Urate,Year7,Week24,n=183 Number Analyzed 183 participants
2.1521  (53.0854)
Urate,Year7,Week48,n=130 Number Analyzed 130 participants
4.0062  (58.3577)
Urate,Year8,Week24,n=52 Number Analyzed 52 participants
-1.1003  (51.8840)
Urate,Year8,Week48,n=13 Number Analyzed 13 participants
29.2043  (80.1811)
Urate,Year9,Week24,n=6 Number Analyzed 6 participants
0.2187  (45.1947)
Urate,Year9,Week48,n=1 Number Analyzed 1 participants
-69.6640 [1]   (NA)
Urate,Exit,n=625 Number Analyzed 625 participants
1.6479  (74.4078)
Urate,8 Week Follow up,n=539 Number Analyzed 539 participants
-2.7404  (75.5887)
Cr,Year1,Week4,n=707 Number Analyzed 707 participants
0.913  (14.2222)
Cr,Year1,Week12,n=705 Number Analyzed 705 participants
0.751  (14.0933)
Cr,Year1,Week24,n=703 Number Analyzed 703 participants
0.823  (9.5372)
Cr,Year1,Week36,n=684 Number Analyzed 684 participants
1.313  (13.1107)
Cr,Year1,Week48,n=693 Number Analyzed 693 participants
0.439  (11.1364)
Cr,Year2,Week24,n=643 Number Analyzed 643 participants
-0.217  (13.9502)
Cr,Year2,Week48,n=598 Number Analyzed 598 participants
-0.922  (13.6541)
Cr,Year3,Week24,n=535 Number Analyzed 535 participants
-3.870  (17.8146)
Cr,Year3,Week48,n=488 Number Analyzed 488 participants
-4.844  (17.7059)
Crea,Year4,Week24,n=439 Number Analyzed 439 participants
-3.196  (22.2874)
Crea,Year 4,Week48,n=421 Number Analyzed 421 participants
-2.145  (30.9370)
Cr,Year5,Week24,n=393 Number Analyzed 393 participants
-1.999  (32.6689)
Cr,Year5,Week48,n=362 Number Analyzed 362 participants
-1.918  (28.8788)
Cr,Year6,Week24,n=304 Number Analyzed 304 participants
-2.125  (24.2374)
Cr,Year6,Week48,n=286 Number Analyzed 286 participants
-1.534  (28.8012)
Cr,Year7,Week24,n=183 Number Analyzed 183 participants
-2.511  (15.6881)
Cr,Year7,Week48,n=130 Number Analyzed 130 participants
-2.586  (14.0864)
Cr,Year8,Week24,n=52 Number Analyzed 52 participants
-4.659  (16.3056)
Cr,Year8,Week48,n=13 Number Analyzed 13 participants
-6.175  (6.6311)
Cr,Year9,Week24,n=6 Number Analyzed 6 participants
-8.933  (5.6925)
Cr,Year9,Week48,n=1 Number Analyzed 1 participants
0.040 [1]   (NA)
Cr,Exit,n=624 Number Analyzed 624 participants
0.606  (35.9813)
Cr,8 Week Follow up,n=539 Number Analyzed 539 participants
-1.108  (39.0635)
[1]
NA indicates standard deviation was not calculable for a single data point.
15.Primary Outcome
Title Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
Hide Description Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: International Units/liter (IU/L)
ALT, Year 1 Week 4, n=707 Number Analyzed 707 participants
-0.4  (10.18)
ALT, Year 1 Week 12, n=705 Number Analyzed 705 participants
-0.9  (12.31)
ALT, Year 1 Week 24, n=703 Number Analyzed 703 participants
-0.9  (19.46)
ALT, Year 1 Week 36, n=684 Number Analyzed 684 participants
-1.0  (15.61)
ALT, Year 1 Week 48, n=693 Number Analyzed 693 participants
-0.7  (15.04)
ALT, Year 2 Week 24, n=643 Number Analyzed 643 participants
0.2  (23.56)
ALT, Year 2 Week 48, n=598 Number Analyzed 598 participants
2.7  (57.67)
ALT, Year 3 Week 24, n=535 Number Analyzed 535 participants
-1.3  (14.40)
ALT, Year 3 Week 48, n=488 Number Analyzed 488 participants
0.1  (21.21)
ALT, Year 4 Week 24, n=439 Number Analyzed 439 participants
-0.1  (18.72)
ALT, Year 4 Week 48, n=421 Number Analyzed 421 participants
-0.6  (17.59)
ALT, Year 5 Week 24, n=393 Number Analyzed 393 participants
-1.3  (18.74)
ALT, Year 5 Week 48, n=362 Number Analyzed 362 participants
-0.4  (22.72)
ALT, Year 6 Week 24, n=304 Number Analyzed 304 participants
-0.2  (20.54)
ALT, Year 6 Week 48, n=286 Number Analyzed 286 participants
0.9  (20.94)
ALT, Year 7 Week 24, n=183 Number Analyzed 183 participants
1.3  (19.46)
ALT, Year 7 Week 48, n=130 Number Analyzed 130 participants
-0.1  (16.79)
ALT, Year 8 Week 24, n=52 Number Analyzed 52 participants
2.7  (31.15)
ALT, Year 8 Week 48, n=13 Number Analyzed 13 participants
5.8  (33.54)
ALT, Year 9 Week 24, n=6 Number Analyzed 6 participants
9.3  (27.77)
ALT, Year 9 Week 48, n=1 Number Analyzed 1 participants
-6.0 [1]   (NA)
ALT, Exit, n=624 Number Analyzed 624 participants
-0.6  (17.03)
ALT, 8 Week follow-up, n=539 Number Analyzed 539 participants
-0.8  (17.06)
ALP, Year 1 Week 4, n=707 Number Analyzed 707 participants
0.0  (11.85)
ALP, Year 1 Week 12, n=705 Number Analyzed 705 participants
0.5  (13.31)
ALP, Year 1 Week 24, n=703 Number Analyzed 703 participants
2.1  (17.76)
ALP, Year 1 Week 36, n=684 Number Analyzed 684 participants
1.7  (22.81)
ALP, Year 1 Week 48, n=693 Number Analyzed 693 participants
4.6  (21.18)
ALP, Year 2 Week 24, n=643 Number Analyzed 643 participants
5.1  (21.58)
ALP, Year 2 Week 48, n=598 Number Analyzed 598 participants
6.1  (23.23)
ALP, Year 3 Week 24, n=535 Number Analyzed 535 participants
5.9  (18.95)
ALP, Year 3 Week 48, n=488 Number Analyzed 488 participants
7.3  (22.22)
ALP, Year 4 Week 24, n=439 Number Analyzed 439 participants
7.2  (21.56)
ALP, Year 4 Week 48, n=421 Number Analyzed 421 participants
8.1  (27.35)
ALP, Year 5 Week 24, n=393 Number Analyzed 393 participants
7.2  (21.01)
ALP, Year 5 Week 48, n=362 Number Analyzed 362 participants
8.5  (20.61)
ALP, Year 6 Week 24, n=304 Number Analyzed 304 participants
9.4  (23.28)
ALP, Year 6 Week 48, n=286 Number Analyzed 286 participants
11.5  (27.39)
ALP, Year 7 Week 24, n=183 Number Analyzed 183 participants
10.9  (28.08)
ALP, Year 7 Week 48, n=130 Number Analyzed 130 participants
7.5  (22.50)
ALP, Year 8 Week 24, n=52 Number Analyzed 52 participants
12.9  (26.64)
ALP, Year 8 Week 48, n=13 Number Analyzed 13 participants
6.1  (30.04)
ALP, Year 9 Week 24, n=6 Number Analyzed 6 participants
4.2  (35.43)
ALP, Year 9 Week 48, n=1 Number Analyzed 1 participants
12.0 [1]   (NA)
ALP, Exit, n=625 Number Analyzed 625 participants
7.5  (25.35)
ALP, 8 Week follow-up, n=539 Number Analyzed 539 participants
6.1  (23.00)
AST, Year 1 Week 4, n=701 Number Analyzed 701 participants
-0.6  (10.56)
AST, Year 1 Week 12, n=700 Number Analyzed 700 participants
-1.3  (14.12)
AST, Year 1 Week 24, n=701 Number Analyzed 701 participants
-1.0  (20.79)
AST, Year 1 Week 36, n=682 Number Analyzed 682 participants
-1.0  (17.88)
AST, Year 1 Week 48, n=692 Number Analyzed 692 participants
-0.9  (14.38)
AST, Year 2 Week 24, n=641 Number Analyzed 641 participants
-0.4  (22.22)
AST, Year 2 Week 48, n=592 Number Analyzed 592 participants
2.9  (57.25)
AST, Year 3 Week 24, n=531 Number Analyzed 531 participants
-1.4  (13.26)
AST, Year 3 Week 48, n=486 Number Analyzed 486 participants
-0.5  (17.23)
AST, Year 4 Week 24, n=438 Number Analyzed 438 participants
-0.9  (14.60)
AST, Year 4 Week 48, n=418 Number Analyzed 418 participants
-0.7  (15.32)
AST, Year 5 Week 24, n=393 Number Analyzed 393 participants
-1.3  (16.07)
AST, Year 5 Week 48, n=362 Number Analyzed 362 participants
-0.8  (18.57)
AST, Year 6 Week 24, n=303 Number Analyzed 303 participants
-0.5  (16.95)
AST, Year 6 Week 48, n=284 Number Analyzed 284 participants
-0.2  (19.00)
AST, Year 7 Week 24, n=182 Number Analyzed 182 participants
0.6  (13.43)
AST, Year 7 Week 48, n=130 Number Analyzed 130 participants
-0.3  (10.78)
AST, Year 8 Week 24, n=52 Number Analyzed 52 participants
3.0  (33.93)
AST, Year 8 Week 48, n=13 Number Analyzed 13 participants
5.8  (24.01)
AST, Year 9 Week 24, n=6 Number Analyzed 6 participants
7.7  (19.63)
AST, Year 9 Week 48, n=1 Number Analyzed 1 participants
0.0 [1]   (NA)
AST, Exit, n=625 Number Analyzed 625 participants
-0.6  (18.88)
AST, 8 Week follow-up, n=539 Number Analyzed 539 participants
-1.1  (16.58)
GGT, Year 1 Week 4, n=707 Number Analyzed 707 participants
-0.4  (23.39)
GGT, Year 1 Week 12, n=705 Number Analyzed 705 participants
-1.4  (23.12)
GGT, Year 1 Week 24, n=703 Number Analyzed 703 participants
-0.2  (39.50)
GGT, Year 1 Week 36, n=684 Number Analyzed 684 participants
1.0  (64.60)
GGT, Year 1 Week 48, n=693 Number Analyzed 693 participants
0.9  (35.99)
GGT, Year 2 Week 24, n=643 Number Analyzed 643 participants
-0.7  (34.81)
GGT, Year 2 Week 48, n=598 Number Analyzed 598 participants
0.1  (34.63)
GGT, Year 3 Week 24, n=535 Number Analyzed 535 participants
-1.6  (33.88)
GGT, Year 3 Week 48, n=488 Number Analyzed 488 participants
1.7  (45.42)
GGT, Year 4 Week 24, n=439 Number Analyzed 439 participants
0.1  (39.13)
GGT, Year 4 Week 48, n=421 Number Analyzed 421 participants
1.1  (54.41)
GGT, Year 5 Week 24, n=393 Number Analyzed 393 participants
-2.0  (37.17)
GGT, Year 5 Week 48, n=362 Number Analyzed 362 participants
-0.7  (43.39)
GGT, Year 6 Week 24, n=304 Number Analyzed 304 participants
-1.0  (42.04)
GGT, Year 6 Week 48, n=286 Number Analyzed 286 participants
1.3  (41.84)
GGT, Year 7 Week 24, n=183 Number Analyzed 183 participants
1.8  (37.06)
GGT, Year 7 Week 48, n=130 Number Analyzed 130 participants
-1.0  (27.86)
GGT, Year 8 Week 24, n=52 Number Analyzed 52 participants
2.7  (39.90)
GGT, Year 8 Week 48, n=13 Number Analyzed 13 participants
-0.3  (27.97)
GGT, Year 9 Week 24, n=6 Number Analyzed 6 participants
13.3  (26.96)
GGT, Year 9 Week 48, n=1 Number Analyzed 1 participants
-7.0 [1]   (NA)
GGT, Exit, n=625 Number Analyzed 625 participants
0.7  (41.40)
GGT, 8 Week follow-up, n=539 Number Analyzed 539 participants
0.2  (39.22)
LDH, Year 1 Week 4, n=701 Number Analyzed 701 participants
-4.1  (77.93)
LDH, Year 1 Week 12, n=700 Number Analyzed 700 participants
-6.0  (80.55)
LDH, Year 1 Week 24, n=701 Number Analyzed 701 participants
-6.6  (80.09)
LDH, Year 1 Week 36, n=682 Number Analyzed 682 participants
-8.8  (80.05)
LDH, Year 1 Week 48, n=692 Number Analyzed 692 participants
-7.3  (81.32)
LDH, Year 2 Week 24, n=641 Number Analyzed 641 participants
-9.4  (85.83)
LDH, Year 2 Week 48, n=592 Number Analyzed 592 participants
-9.6  (95.52)
LDH, Year 3 Week 24, n=532 Number Analyzed 532 participants
-11.8  (93.90)
LDH, Year 3 Week 48, n=486 Number Analyzed 486 participants
-15.1  (94.65)
LDH, Year 4 Week 24, n=438 Number Analyzed 438 participants
-16.5  (99.93)
LDH, Year 4 Week 48, n=418 Number Analyzed 418 participants
-16.9  (102.11)
LDH, Year 5 Week 24, n=393 Number Analyzed 393 participants
-17.5  (106.45)
LDH, Year 5 Week 48, n=362 Number Analyzed 362 participants
-19.8  (108.33)
LDH, Year 6 Week 24, n=303 Number Analyzed 303 participants
-21.7  (115.77)
LDH, Year 6 Week 48, n=284 Number Analyzed 284 participants
-21.3  (122.62)
LDH, Year 7 Week 24, n=182 Number Analyzed 182 participants
-15.2  (44.05)
LDH, Year 7 Week 48, n=130 Number Analyzed 130 participants
-16.3  (42.51)
LDH, Year 8 Week 24, n=52 Number Analyzed 52 participants
-14.3  (40.14)
LDH, Year 8 Week 48, n=13 Number Analyzed 13 participants
-31.5  (53.04)
LDH, Year 9 Week 24, n=6 Number Analyzed 6 participants
-27.2  (32.64)
LDH, Year 9 Week 48, n=1 Number Analyzed 1 participants
-65.0 [1]   (NA)
LDH, Exit, n=624 Number Analyzed 624 participants
-13.1  (90.39)
LDH, 8 Week follow-up, n=538 Number Analyzed 538 participants
-12.7  (95.65)
[1]
NA indicates standard deviation was not calculable for a single data point.
16.Primary Outcome
Title Change From Baseline in Bilirubin (Bili) Levels
Hide Description Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: µmol/L
Year 1 Week 4, n=707 Number Analyzed 707 participants
0.142  (2.8398)
Year 1 Week 12, n=705 Number Analyzed 705 participants
0.008  (2.6383)
Year 1 Week 24, n=703 Number Analyzed 703 participants
0.217  (3.1280)
Year 1 Week 36, n=684 Number Analyzed 684 participants
0.173  (2.7566)
Year 1 Week 48, n=693 Number Analyzed 693 participants
0.367  (2.8441)
Year 2 Week 24, n=643 Number Analyzed 643 participants
0.488  (2.9346)
Year 2 Week 48, n=598 Number Analyzed 598 participants
0.540  (3.2181)
Year 3 Week 24, n=535 Number Analyzed 535 participants
0.606  (3.1612)
Year 3 Week 48, n=488 Number Analyzed 488 participants
0.637  (3.2474)
Year 4 Week 24, n=439 Number Analyzed 439 participants
0.548  (2.9773)
Year 4 Week 48, n=421 Number Analyzed 421 participants
0.629  (3.4680)
Year 5 Week 24, n=393 Number Analyzed 393 participants
0.410  (2.6931)
Year 5 Week 48, n=362 Number Analyzed 362 participants
0.788  (3.1324)
Year 6 Week 24, n=304 Number Analyzed 304 participants
0.801  (2.9946)
Year 6 Week 48, n=285 Number Analyzed 285 participants
0.638  (3.0669)
Year 7 Week 24, n=183 Number Analyzed 183 participants
0.938  (2.8158)
Year 7 Week 48, n=130 Number Analyzed 130 participants
1.129  (3.0314)
Year 8 Week 24, n=52 Number Analyzed 52 participants
1.280  (3.0707)
Year 8 Week 48, n=13 Number Analyzed 13 participants
0.768  (3.0434)
Year 9 Week 24, n=6 Number Analyzed 6 participants
0.028  (2.0182)
Year 9 Week 48, n=1 Number Analyzed 1 participants
-2.870 [1]   (NA)
Exit, n=624 Number Analyzed 624 participants
0.573  (3.3274)
8 Week follow-up, n=539 Number Analyzed 539 participants
0.572  (3.1052)
[1]
NA indicates standard deviation was not calculable for a single data point.
17.Primary Outcome
Title Change From Baseline in Immunoglobulin G (IgG) Levels
Hide Description Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 9 years
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MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Mean (Standard Deviation)
Unit of Measure: g/L
Year 1 Week 12, n=213 Number Analyzed 213 participants
-1.571  (2.2970)
Year 1 Week 24, n=709 Number Analyzed 709 participants
-1.963  (2.7334)
Year 1 Week 48, n=695 Number Analyzed 695 participants
-2.507  (3.1054)
Year 2 Week 24, n=482 Number Analyzed 482 participants
-3.058  (3.6147)
Year 2 Week 48, n=605 Number Analyzed 605 participants
-3.232  (3.7414)
Year 3 Week 24, n=143 Number Analyzed 143 participants
-3.453  (3.7073)
Year 3 Week 48, n=405 Number Analyzed 405 participants
-3.791  (4.0450)
Year 4 Week 24, n=146 Number Analyzed 146 participants
-3.839  (4.1411)
Year 4 Week 48, n=362 Number Analyzed 362 participants
-3.794  (3.8780)
Year 5 Week 24, n=111 Number Analyzed 111 participants
-4.356  (3.6399)
Year 5 Week 48, n=322 Number Analyzed 322 participants
-4.323  (4.0169)
Year 6 Week 24, n=71 Number Analyzed 71 participants
-5.111  (3.8846)
Year 6 Week 48, n=268 Number Analyzed 268 participants
-4.697  (3.9599)
Year 7 Week 24, n=50 Number Analyzed 50 participants
-4.803  (3.5908)
Year 7 Week 48, n=115 Number Analyzed 115 participants
-4.982  (4.0769)
Year 8 Week 24, n=18 Number Analyzed 18 participants
-6.016  (3.8450)
Year 8 Week 48, n=12 Number Analyzed 12 participants
-5.520  (5.1564)
Year 9 Week 48, n=1 Number Analyzed 1 participants
0.710 [1]   (NA)
Exit, n=627 Number Analyzed 627 participants
-4.138  (4.0025)
8 Week Follow up, n=543 Number Analyzed 543 participants
-4.325  (4.0246)
[1]
NA indicates standard deviation was not calculable for a single data point.
18.Primary Outcome
Title Number of Participants With Immunogenic Response by Year
Hide Description Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame Up to 9 years
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MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Measure Type: Number
Unit of Measure: Participants
Year 0-1 Negative, n=717 Number Analyzed 717 participants
707
Year 1-2 Negative, n=684 Number Analyzed 684 participants
656
Year 2-3 Negative, n=590 Number Analyzed 590 participants
577
Year 3-4, Negative, n=502 Number Analyzed 502 participants
498
Year 4-5 Negative, n=432 Number Analyzed 432 participants
432
Year 5-6 Negative, n=336 Number Analyzed 336 participants
336
Year 6-7 Negative, n=212 Number Analyzed 212 participants
212
Year 7-8 Negative, n=64 Number Analyzed 64 participants
64
Year 8 plus Negative, n=6 Number Analyzed 6 participants
6
Year 0-1 Transient +, n=717 Number Analyzed 717 participants
10
Year 1-2 Transient + n=684 Number Analyzed 684 participants
18
Year 2-3 Transient +, n=590 Number Analyzed 590 participants
9
Year 3-4 Transient +, n=502 Number Analyzed 502 participants
4
Year 4-5 Transient +, n=432 Number Analyzed 432 participants
0
Year 5-6 Transient +, n=336 Number Analyzed 336 participants
0
Year 6-7 Transient +, n=212 Number Analyzed 212 participants
0
Year 7-8 Transient +, n=64 Number Analyzed 64 participants
0
Year 8 plus Transient +, n=6 Number Analyzed 6 participants
0
Year 0-1 Persistent+,n=717 Number Analyzed 717 participants
0
Year 1-2 Persistent+,n=684 Number Analyzed 684 participants
10
Year 2-3 Persistent+,n=590 Number Analyzed 590 participants
3
Year 3-4 Persistent+,n=502 Number Analyzed 502 participants
0
Year 4-5 Persistent+,n=432 Number Analyzed 432 participants
0
Year 5-6 Persistent+,n=336 Number Analyzed 336 participants
0
Year 6-7 Persistent+,n=212 Number Analyzed 212 participants
0
Year 7-8 Persistent+,n=64 Number Analyzed 64 participants
0
Year 8 plus Persistent+,n=6 Number Analyzed 6 participants
0
Year 0-1 Unknown, n=717 Number Analyzed 717 participants
0
Year 1-2 Unknown, n=684 Number Analyzed 684 participants
0
Year 2-3 Unknown, n=590 Number Analyzed 590 participants
1
Year 3-4 Unknown, n=502 Number Analyzed 502 participants
0
Year 4-5 Unknown, n=432 Number Analyzed 432 participants
0
Year 5-6 Unknown, n=336 Number Analyzed 336 participants
0
Year 6-7 Unknown, n=212 Number Analyzed 212 participants
0
Year 7-8 Unknown, n=64 Number Analyzed 64 participants
0
Year 8 plus Unknown, n=6 Number Analyzed 6 participants
0
19.Primary Outcome
Title Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Hide Description Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame Up to 9 years
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MITT Population
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description:
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Measure Type: Number
Unit of Measure: Participants
Baseline, n=735 Number Analyzed 735 participants
6
Any Time Post Baseline, n=735 Number Analyzed 735 participants
64
Year 0-1, n=735 Number Analyzed 735 participants
22
Year 1-2, n=701 Number Analyzed 701 participants
24
Year 2-3, n=620 Number Analyzed 620 participants
22
Year 3-4, n=514 Number Analyzed 514 participants
19
Year 4-5, n=442 Number Analyzed 442 participants
15
Year 5-6, n=345 Number Analyzed 345 participants
10
Year 6-7, n=219 Number Analyzed 219 participants
8
Year 7-8, n=65 Number Analyzed 65 participants
2
More than 8 Years, n=6 Number Analyzed 6 participants
0
20.Primary Outcome
Title Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Hide Description Participants who had improving SLE disease activity for at least 8 weeks, at the investigator’s discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.
Time Frame Up to 9 years
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MITT Population
Arm/Group Title Participants With no Prednisone and Other Steroids at Baseline Participants With Baseline Daily Dose of >0 to <=7.5 mg Participants With Baseline Daily Dose of >7.5 to <=40 mg Participants With Baseline Daily Dose of >40 mg
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Participants were not receiving prednisone and other steroids at Baseline.
Participants were receiving a daily dose of >0 to <=7.5 mg of prednisone and other steroids at Baseline.
Participants were receiving a daily dose of >7.5 to <=40 mg of prednisone and other steroids at Baseline.
Participants were receiving a daily dose of >40 mg of prednisone and other steroids at Baseline.
Overall Number of Participants Analyzed 43 227 462 1
Measure Type: Number
Unit of Measure: Participants
Total daily dose=0, Year 1, Week 24 40 5 1 0
Total daily dose >0 to <=7.5, Year 1, Week 24 1 194 71 0
Total daily dose >7.5 to <=40, Year 1, Week 24 2 18 376 1
Total daily dose >40, Year 1, Week 24 0 0 1 0
Total daily dose=0, Year 1, Week 48 40 13 13 0
Total daily dose >0 to <=7.5, Year 1, Week 48 2 180 123 0
Total daily dose >7.5 to <=40, Year 1, Week 48 0 19 301 1
Total daily dose >40, Year 1, Week 48 1 0 4 0
Total daily dose=0, Year 2, Week 24 39 19 20 0
Total daily dose >0 to <=7.5, Year 2, Week 24 3 157 145 0
Total daily dose >7.5 to <=40, Year 2, Week 24 0 25 237 1
Total daily dose >40, Year 2, Week 24 0 0 5 0
Total daily dose=0, Year 2, Week 48 36 24 21 0
Total daily dose >0 to <=7.5, Year 2, Week 48 1 143 163 0
Total daily dose >7.5 to <=40, Year 2, Week 48 1 26 195 1
Total daily dose >40, Year 2, Week 48 0 0 1 0
Total daily dose=0, Year 3, Week 24 33 19 25 0
Total daily dose >0 to <=7.5, Year 3, Week 24 3 130 159 0
Total daily dose >7.5 to <=40, Year 3, Week 24 1 27 157 1
Total daily dose >40, Year 3, Week 24 0 0 0 0
Total daily dose=0, Year 3, Week 48 31 20 30 0
Total daily dose >0 to <=7.5, Year 3, Week 48 3 122 127 0
Total daily dose >7.5 to <=40, Year 3, Week 48 0 23 145 1
Total daily dose >40, Year 3, Week 48 0 0 2 0
Total daily dose=0, Year 4, Week 24 28 17 34 0
Total daily dose >0 to <=7.5, Year 4, Week 24 3 110 134 0
Total daily dose >7.5 to <=40, Year 4, Week 24 2 23 120 1
Total daily dose >40, Year 4, Week 24 0 0 2 0
Total daily dose=0, Year 4, Week 48 22 18 40 0
Total daily dose >0 to <=7.5, Year 4, Week 48 3 100 129 1
Total daily dose >7.5 to <=40, Year 4, Week 48 1 16 108 0
Total daily dose >40, Year 4, Week 48 0 1 0 0
Total daily dose=0, Year 5, Week 24 19 28 33 0
Total daily dose >0 to <=7.5, Year 5, Week 24 3 84 124 1
Total daily dose >7.5 to <=40, Year 5, Week 24 1 16 99 0
Total daily dose >40, Year 5, Week 24 0 0 2 0
Total daily dose=0, Year 5, Week 48 17 26 34 0
Total daily dose >0 to <=7.5, Year 5, Week 48 1 75 119 1
Total daily dose >7.5 to <=40, Year 5, Week 48 1 13 85 0
Total daily dose >40, Year 5, Week 48 0 0 0 0
Total daily dose=0, Year 6, Week 24 10 25 33 0
Total daily dose >0 to <=7.5, Year 6, Week 24 2 62 99 1
Total daily dose >7.5 to <=40, Year 6, Week 24 0 10 76 0
Total daily dose >40, Year 6, Week 24 0 0 2 0
Total daily dose=0, Year 6, Week 48 10 24 35 0
Total daily dose >0 to <=7.5, Year 6, Week 48 1 54 90 1
Total daily dose >7.5 to <=40, Year 6, Week 48 0 11 68 0
Total daily dose >40, Year 6, Week 48 0 0 0 0
Total daily dose=0, Year 7, Week 24 4 10 29 0
Total daily dose >0 to <=7.5, Year 7, Week 24 0 41 64 1
Total daily dose >7.5 to <=40, Year 7, Week 24 1 3 40 0
Total daily dose >40, Year 7, Week 24 0 0 0 0
Total daily dose=0, Year 7, Week 48 4 3 24 0
Total daily dose >0 to <=7.5, Year 7, Week 48 0 32 34 1
Total daily dose >7.5 to <=40, Year 7, Week 48 0 6 29 0
Total daily dose >40, Year 7, Week 48 0 0 0 0
Total daily dose=0, Year 8, Week 24 2 1 8 0
Total daily dose >0 to <=7.5, Year 8, Week 24 0 13 15 1
Total daily dose >7.5 to <=40, Year 8, Week 24 0 2 11 0
Total daily dose >40, Year 8, Week 24 0 0 0 0
Total daily dose=0, Year 8, Week 48 1 0 5 0
Total daily dose >0 to <=7.5, Year 8, Week 48 0 3 6 0
Total daily dose >7.5 to <=40, Year 8, Week 48 0 2 1 0
Total daily dose >40, Year 8, Week 48 0 0 0 0
Total daily dose=0, Year 9, Week 24 0 0 1 0
Total daily dose >0 to <=7.5, Year 9, Week 24 0 1 3 0
Total daily dose >7.5 to <=40, Year 9, Week 24 0 1 0 0
Total daily dose >40, Year 9, Week 24 0 0 0 0
Total daily dose=0, Year 9, Week 48 0 0 0 0
Total daily dose >0 to <=7.5, Year 9, Week 48 0 1 4 0
Total daily dose >7.5 to <=40, Year 9, Week 48 0 1 0 0
Total daily dose >40, Year 9, Week 48 0 0 0 0
21.Primary Outcome
Title Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Hide Description The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score – Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame Up to 9 years
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MITT Population
Arm/Group Title Belimumab 10mg/kg IV
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Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
Overall Number of Participants Analyzed 735
Measure Type: Number
Unit of Measure: Participants
Year 1,Week 48, n=716 Number Analyzed 716 participants
39
Year 2,Week 48, n=667 Number Analyzed 667 participants
50
Year 3,Week 48, n=580 Number Analyzed 580 participants
56
Year 4,Week 48, n=488 Number Analyzed 488 participants
57
Year 5,Week 48, n=423 Number Analyzed 423 participants
51
Year 6,Week 48, n=330 Number Analyzed 330 participants
41
Year 7,Week 48, n=213 Number Analyzed 213 participants
28
Year 8,Week 48, n=65 Number Analyzed 65 participants
8
Year 9,Week 48, n=6 Number Analyzed 6 participants
0
Time Frame On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
Adverse Event Reporting Description The MITT consisted of all randomized participants who received at least one dose of trial medication.
 
Arm/Group Title Belimumab 10mg/kg IV
Hide Arm/Group Description Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
All-Cause Mortality
Belimumab 10mg/kg IV
Affected / at Risk (%)
Total   11/735 (1.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
Belimumab 10mg/kg IV
Affected / at Risk (%) # Events
Total   231/735 (31.43%)    
Blood and lymphatic system disorders   
Leukopenia  1  8/735 (1.09%)  9
Anaemia  1  7/735 (0.95%)  7
Thrombocytopenia  1  6/735 (0.82%)  7
Haemolytic anaemia  1  2/735 (0.27%)  2
Lymphadenopathy  1  2/735 (0.27%)  2
Neutropenia  1  2/735 (0.27%)  2
Agranulocytosis  1  1/735 (0.14%)  1
Disseminated intravascular coagulation  1  1/735 (0.14%)  1
Febrile neutropenia  1  1/735 (0.14%)  1
Haemorrhagic disorder  1  1/735 (0.14%)  1
Thrombotic thrombocytopenic purpura  1  1/735 (0.14%)  1
Cardiac disorders   
Myocardial ischaemia  1  2/735 (0.27%)  2
Angina pectoris  1  1/735 (0.14%)  1
Angina unstable  1  1/735 (0.14%)  1
Aortic valve sclerosis  1  1/735 (0.14%)  1
Atrioventricular block second degree  1  1/735 (0.14%)  1
Cardiac arrest  1  1/735 (0.14%)  1
Cardiac tamponade  1  1/735 (0.14%)  1
Cardiogenic shock  1  1/735 (0.14%)  1
Coronary artery occlusion  1  1/735 (0.14%)  1
Lupus myocarditis  1  1/735 (0.14%)  1
Myocardial infarction  1  1/735 (0.14%)  1
Pericardial effusion  1  1/735 (0.14%)  1
Pericarditis  1  1/735 (0.14%)  1
Pericarditis lupus  1  1/735 (0.14%)  1
Sinus tachycardia  1  1/735 (0.14%)  1
Ear and labyrinth disorders   
Vertigo positional  1  1/735 (0.14%)  1
Endocrine disorders   
Hyperthyroidism  1  1/735 (0.14%)  1
Hypothyroidism  1  1/735 (0.14%)  1
Eye disorders   
Maculopathy  1  1/735 (0.14%)  1
Gastrointestinal disorders   
Gastritis  1  5/735 (0.68%)  5
Abdominal pain  1  3/735 (0.41%)  3
Pancreatitis acute  1  3/735 (0.41%)  3
Haemorrhoids  1  2/735 (0.27%)  2
Oesophagitis  1  2/735 (0.27%)  2
Vomiting  1  2/735 (0.27%)  2
Abdominal adhesions  1  1/735 (0.14%)  1
Abdominal hernia  1  1/735 (0.14%)  1
Abdominal pain upper  1  1/735 (0.14%)  1
Duodenitis  1  1/735 (0.14%)  1
Food poisoning  1  1/735 (0.14%)  1
Gastrooesophageal reflux disease  1  1/735 (0.14%)  1
Haematemesis  1  1/735 (0.14%)  1
Haemorrhoidal haemorrhage  1  1/735 (0.14%)  1
Ileus  1  1/735 (0.14%)  1
Lupus enteritis  1  1/735 (0.14%)  2
Mouth ulceration  1  1/735 (0.14%)  1
Nausea  1  1/735 (0.14%)  1
Proctitis  1  1/735 (0.14%)  1
Rectal ulcer  1  1/735 (0.14%)  1
General disorders   
Pyrexia  1  9/735 (1.22%)  10
Non-cardiac chest pain  1  4/735 (0.54%)  4
Complication associated with device  1  1/735 (0.14%)  1
Cyst  1  1/735 (0.14%)  1
Face oedema  1  1/735 (0.14%)  1
Fatigue  1  1/735 (0.14%)  1
Oedema peripheral  1  1/735 (0.14%)  1
Pain  1  1/735 (0.14%)  1
Peripheral swelling  1  1/735 (0.14%)  1
Hepatobiliary disorders   
Cholelithiasis  1  5/735 (0.68%)  5
Biliary dilatation  1  1/735 (0.14%)  1
Cholangitis acute  1  1/735 (0.14%)  1
Cholecystitis acute  1  1/735 (0.14%)  1
Gallbladder non-functioning  1  1/735 (0.14%)  1
Lupus hepatitis  1  1/735 (0.14%)  1
Portal vein thrombosis  1  1/735 (0.14%)  1
Immune system disorders   
Drug hypersensitivity  1  2/735 (0.27%)  2
Infections and infestations   
Pneumonia bacterial  1  14/735 (1.90%)  16
Cellulitis  1  12/735 (1.63%)  14
Urinary tract infection  1  9/735 (1.22%)  9
Urinary tract infection bacterial  1  9/735 (1.22%)  11
Pneumonia  1  8/735 (1.09%)  8
Appendicitis  1  6/735 (0.82%)  6
Gastroenteritis  1  5/735 (0.68%)  5
Herpes zoster  1  5/735 (0.68%)  5
Bacterial pyelonephritis  1  3/735 (0.41%)  3
Bacterial sepsis  1  3/735 (0.41%)  3
Septic shock  1  3/735 (0.41%)  4
Viral upper respiratory tract infection  1  3/735 (0.41%)  3
Abscess soft tissue  1  2/735 (0.27%)  2
Acute sinusitis  1  2/735 (0.27%)  2
Bronchitis  1  2/735 (0.27%)  2
Bronchitis bacterial  1  2/735 (0.27%)  2
Cytomegalovirus infection  1  2/735 (0.27%)  2
Diarrhoea infectious  1  2/735 (0.27%)  2
Escherichia infection  1  2/735 (0.27%)  2
Gastroenteritis viral  1  2/735 (0.27%)  2
Influenza  1  2/735 (0.27%)  2
Pyelonephritis acute  1  2/735 (0.27%)  2
Respiratory tract infection viral  1  2/735 (0.27%)  2
Soft tissue infection  1  2/735 (0.27%)  2
Subcutaneous abscess  1  2/735 (0.27%)  2
Wound infection bacterial  1  2/735 (0.27%)  2
Abdominal infection  1  1/735 (0.14%)  1
Abscess of salivary gland  1  1/735 (0.14%)  1
Acinetobacter bacteraemia  1  1/735 (0.14%)  1
Acinetobacter infection  1  1/735 (0.14%)  1
Amoebic dysentery  1  1/735 (0.14%)  1
Anal abscess  1  1/735 (0.14%)  2
Bronchitis viral  1  1/735 (0.14%)  1
Bursitis infective  1  1/735 (0.14%)  1
Bursitis infective staphylococcal  1  1/735 (0.14%)  1
Cellulitis staphylococcal  1  1/735 (0.14%)  1
Cutaneous tuberculosis  1  1/735 (0.14%)  1
Enterococcal bacteraemia  1  1/735 (0.14%)  1
Enterocolitis infectious  1  1/735 (0.14%)  1
Erysipelas  1  1/735 (0.14%)  1
Escherichia bacteraemia  1  1/735 (0.14%)  1
Escherichia sepsis  1  1/735 (0.14%)  1
Fungaemia  1  1/735 (0.14%)  1
Gastroenteritis bacterial  1  1/735 (0.14%)  1
Gastrointestinal fungal infection  1  1/735 (0.14%)  1
Gastrointestinal infection  1  1/735 (0.14%)  1
Gastrointestinal viral infection  1  1/735 (0.14%)  1
Hepatitis A  1  1/735 (0.14%)  1
Herpes zoster cutaneous disseminated  1  1/735 (0.14%)  1
Infectious colitis  1  1/735 (0.14%)  1
Infectious pleural effusion  1  1/735 (0.14%)  2
Joint abscess  1  1/735 (0.14%)  1
Joint tuberculosis  1  1/735 (0.14%)  1
Kidney infection  1  1/735 (0.14%)  3
Latent tuberculosis  1  1/735 (0.14%)  1
Meningitis aseptic  1  1/735 (0.14%)  2
Osteomyelitis chronic  1  1/735 (0.14%)  1
Parasitic gastroenteritis  1  1/735 (0.14%)  1
Pelvic inflammatory disease  1  1/735 (0.14%)  1
Peritonitis  1  1/735 (0.14%)  1
Peritonitis bacterial  1  1/735 (0.14%)  1