Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Belimumab, SLE, Antibodies, Lupus, Autoimmune Diseases
Brief summary
This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.
Detailed description
This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.
Interventions
BIOLOGICALBelimumab 1 mg/kg
Belimumab 1 mg/kg IV over one hour every 28 days
BIOLOGICALBelimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days
Sponsors
GlaxoSmithKline
Human Genome Sciences Inc., a GSK Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit. * Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.
Exclusion criteria
* Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Up to Week 440 | Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| SAE Rates by System Organ Class (SOC) During the Study | Up to Week 440 | 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 Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / participants Years. participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study. |
| Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Up to Week 440 | Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Up to Week 440 | Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Erythrocytes at the Indicated Time Points | Up to Week 440 | Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Hematocrit at the Indicated Time Points | Up to Week 440 | Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Hemoglobin at the Indicated Time Points | Up to Week 440 | Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Albumin and Protein at the Indicated Time Points | Up to Week 440 | Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Up to Week 440 | Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Up to Week 440 | Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Creatinine Clearance at the Indicated Time Points | Up to Week 440 | Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in BUN/Creatinine at the Indicated Time Points | Up to Week 440 | Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Up to Week 432 | Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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. |
| Number of Participants With the Indicated Immunogenic Response | Up to Week 440 | Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | Up to Week 432 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Up to Week 440 | Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | Up to Week 440 | An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed. |
| AE Rates by System Organ Class (SOC) During the Study | Up Week 440 | 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 adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / Participant Years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving SRI Response at Indicated Time Points | Up to Week 440 | The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:\>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of \<0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Up to Week 432 | Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA \>=30 International Units/milliliter \[IU/mL\]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Up to Week 432 | Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Observed Complement C3 and C4 Levels at Indicated Time Points | Up to Week 440 | Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 \<90 milligram per deciliter (mg/dL) and C4 \<16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | Up to Week 432 | Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 \<90 milligrams per decilitre (mg/dL) and C4 \<16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Up to Week 432 | Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to \<=7.5 mg/day from \>7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Up to Week 432 | Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with \>= 50% reduction in proteinuria among participants with Baseline proteinuria \>0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Observed B-cell Levels at Indicated Time Points. | Up to Week 432 | B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Up to Week 432 | B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Up to Week 384 | Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change \>0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X). |
| Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | Up to Week 384 | The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X). |
| Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Up to Week 384 | The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X). |
| Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Up to Week 384 | The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X). |
| Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Up to Week 384 | The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (\>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X). |
| Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Up to Week 392 | Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (\<0.5 nanograms per milliliter \[ng/mL\]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
Countries
United States
Participant flow
Pre-assignment details
Participants with systemic lupus erythematosus who completed the Phase 3 HGS1006-C1056 were enrolled to receive belimumab
Participants by arm
| Arm | Count |
|---|---|
| Belimumab 10 mg/kg IV Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation. | 268 |
| Total | 268 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 25 |
| Overall Study | Developed withdrawal criteria- pregnancy | 4 |
| Overall Study | Elected to exit due to site closure | 2 |
| Overall Study | Lack of Efficacy | 14 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Non-compliance with study drug | 6 |
| Overall Study | Physician Decision | 17 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Sponsor decision to end study | 14 |
| Overall Study | Subject incarcerated | 1 |
| Overall Study | Subject moved out of state | 1 |
| Overall Study | Withdrawal by Subject | 31 |
Baseline characteristics
| Characteristic | Belimumab 10 mg/kg IV |
|---|---|
| Age, Continuous | 42.8 Years STANDARD_DEVIATION 11.33 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 8 Participants |
| Race/Ethnicity, Customized Asian: Central Asian Heritage | 0 Participants |
| Race/Ethnicity, Customized Asian: East Asian Heritage | 2 Participants |
| Race/Ethnicity, Customized Asian: Japanese Heritage | 3 Participants |
| Race/Ethnicity, Customized Asian: South Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Asian: Southeast Asian Heritage | 7 Participants |
| Race/Ethnicity, Customized Black or African American/African Heritage | 57 Participants |
| Race/Ethnicity, Customized Mixed Race | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White: Middle East/North African Heritage | 3 Participants |
| Race/Ethnicity, Customized White: White/Caucasian/European Heritage | 183 Participants |
| Sex: Female, Male Female | 250 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 266 / 268 |
| serious Total, serious adverse events | 112 / 268 |
Outcome results
Primary
AE Rates by System Organ Class (SOC) During the Study
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 adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / Participant Years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Time frame: Up Week 440
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Infections and infestations | 134.4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Musculoskeletal and connective tissue disorders | 75.5 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Gastrointestinal disorders | 53.6 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Injury, poisoning and procedural complications | 32.3 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Skin and subcutaneous tissue disorders | 30 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Nervous system disorders | 29.7 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Respiratory, thoracic and mediastinal disorders | 28.5 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | General disorders and administration sitecondition | 27.9 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Psychiatric disorders | 12.4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Metabolism and nutrition disorders | 10.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Vascular disorders | 9.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Investigations | 9.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Eye disorders | 8.2 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Reproductive system and breast disorders | 6.7 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Cardiac disorders | 6.4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Immune system disorders | 6 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Renal and urinary disorders | 5.3 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Neoplasms benign, malignant and unspecified | 5 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Blood and lymphatic system disorders | 4.4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Ear and labyrinth disorders | 3.8 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Hepatobiliary disorders | 2.3 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Endocrine disorders | 1.8 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Social circumstances | 0.8 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Congenital, familial and genetic disorders | 0.5 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Pregnancy, puerperium and perinatal conditions | 0.1 Adverse events/100 participant-years |
Primary
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 3, Week 48, n= 202 | 4 Seconds | Standard Deviation 5.34 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 4, Week 24, n= 201 | 4.2 Seconds | Standard Deviation 6.51 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 1, Week 36, n= 71 | -0.42 Seconds | Standard Deviation 3.943 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 3, Week 24, n= 206 | 0.26 Seconds | Standard Deviation 2.983 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 5, Week 24, n= 174 | 0.6 Seconds | Standard Deviation 3.56 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, 8 Week, Follow-Up, n= 103 | 0.33 Seconds | Standard Deviation 2.202 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 1, Week 4, n= 82 | 1.3 Seconds | Standard Deviation 4.46 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 1, Week 12, n= 79 | 1 Seconds | Standard Deviation 4.56 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 1, Week 24, n= 243 | 0.7 Seconds | Standard Deviation 4.81 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 1, Week 36, n= 71 | 1.4 Seconds | Standard Deviation 4.83 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 1, Week 48, n= 246 | 1.7 Seconds | Standard Deviation 5.37 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 2, Week 24, n= 231 | 2.7 Seconds | Standard Deviation 5.88 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 2, Week 48, n= 220 | 3.9 Seconds | Standard Deviation 5.39 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 3, Week 24, n= 206 | 4.5 Seconds | Standard Deviation 4.92 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 4, Week 48, n= 185 | 4.7 Seconds | Standard Deviation 8.19 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 5, Week 24, n= 174 | 4.7 Seconds | Standard Deviation 7.03 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 5, Week 48, n= 171 | 3.6 Seconds | Standard Deviation 5.46 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 6, Week 24, n= 160 | 4.3 Seconds | Standard Deviation 6.37 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 6, Week 48, n= 126 | 4.8 Seconds | Standard Deviation 7.71 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 7, Week 24, n= 118 | 4.4 Seconds | Standard Deviation 4.77 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 7, Week 48, n= 92 | 5 Seconds | Standard Deviation 9.55 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 8, Week 24, n= 59 | 4.7 Seconds | Standard Deviation 5.02 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 8, Week 48, n= 28 | 4.7 Seconds | Standard Deviation 5.51 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Year 9, Week 24, n= 2 | 8.5 Seconds | Standard Deviation 13.44 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, Exit, n= 230 | 3.1 Seconds | Standard Deviation 6.72 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | APTT, 8 Week, Follow-Up, n= 104 | 3.3 Seconds | Standard Deviation 8.58 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 1, Week 4, n= 82 | -0.05 Seconds | Standard Deviation 1.463 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 1, Week 12, n= 79 | -0.66 Seconds | Standard Deviation 3.502 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 1, Week 24, n= 244 | -0.04 Seconds | Standard Deviation 3.239 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 1, Week 48, n= 246 | 0.2 Seconds | Standard Deviation 4.493 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 2, Week 24, n= 233 | 0.52 Seconds | Standard Deviation 5.059 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 2, Week 48, n= 221 | 0.24 Seconds | Standard Deviation 2.693 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 3, Week 48, n= 202 | 0.34 Seconds | Standard Deviation 3.77 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 4, Week 24, n= 201 | 0.39 Seconds | Standard Deviation 3.047 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 4, Week 48, n= 186 | 1.96 Seconds | Standard Deviation 14.36 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 5, Week 48, n= 172 | 0.5 Seconds | Standard Deviation 5.488 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 6, Week 24, n= 160 | 0.39 Seconds | Standard Deviation 3.333 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 6, Week 48, n= 126 | 0.55 Seconds | Standard Deviation 3.473 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 7, Week 24, n= 118 | 0.72 Seconds | Standard Deviation 3.23 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 7, Week 48, n= 92 | 0.68 Seconds | Standard Deviation 5.149 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 8, Week 24, n= 58 | 0.5 Seconds | Standard Deviation 2.401 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 8, Week 48, n= 28 | 1.85 Seconds | Standard Deviation 4.759 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Year 9, Week 24, n= 2 | 1.45 Seconds | Standard Deviation 2.758 |
| Belimumab 10 mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | PT, Exit, n= 229 | 0.57 Seconds | Standard Deviation 3.972 |
Primary
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 6, Week 24, n= 175 | 1 Units per liter | Standard Deviation 20.87 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase,Year 1,Week 36,n=234 | -0.3 Units per liter | Standard Deviation 11.29 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 1, Week 36, n=238 | -0.1 Units per liter | Standard Deviation 18.64 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 7, Week 48, n= 97 | -9.5 Units per liter | Standard Deviation 57.15 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 2, Week 24, n= 246 | -4.8 Units per liter | Standard Deviation 36.29 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 2, Week 48, n= 231 | -5.4 Units per liter | Standard Deviation 40.42 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 3, Week 24, n= 215 | -8.1 Units per liter | Standard Deviation 40.13 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 3, Week 48, n= 205 | -9.2 Units per liter | Standard Deviation 47.95 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 4, Week 24, n= 204 | -7.7 Units per liter | Standard Deviation 45.12 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 4, Week 48, n= 191 | -4.7 Units per liter | Standard Deviation 53.17 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 5, Week 24, n= 184 | -5.5 Units per liter | Standard Deviation 48.34 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 5, Week 48, n= 176 | -10.3 Units per liter | Standard Deviation 49.81 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 6, Week 24, n= 172 | -2.7 Units per liter | Standard Deviation 72.28 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 6, Week 48, n= 134 | -5.3 Units per liter | Standard Deviation 55.64 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 1, Week 4, n= 251 | 0.5 Units per liter | Standard Deviation 14.89 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 1, Week 12, n= 248 | -0.5 Units per liter | Standard Deviation 11.01 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 1, Week 24, n= 246 | -0.1 Units per liter | Standard Deviation 12.27 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 1, Week 36, n= 238 | 0.3 Units per liter | Standard Deviation 14.12 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 1, Week 48, n= 250 | 0.4 Units per liter | Standard Deviation 14.64 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 2, Week 24, n= 248 | 0.8 Units per liter | Standard Deviation 12.33 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 2, Week 48, n= 233 | 1.7 Units per liter | Standard Deviation 16.67 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 3, Week 24, n= 218 | 0.9 Units per liter | Standard Deviation 12.32 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 3, Week 48, n= 209 | 0.4 Units per liter | Standard Deviation 14.93 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 4, Week 24, n= 207 | 1.7 Units per liter | Standard Deviation 17.02 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 4, Week 48, n= 194 | 2.4 Units per liter | Standard Deviation 24.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 5, Week 24, n= 184 | 1.8 Units per liter | Standard Deviation 15.79 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 5, Week 48, n= 178 | 0.3 Units per liter | Standard Deviation 17.15 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 6, Week 48, n= 134 | -0.1 Units per liter | Standard Deviation 13.25 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 7, Week 24, n= 123 | -2.8 Units per liter | Standard Deviation 13.96 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 7, Week 48, n= 97 | -2.8 Units per liter | Standard Deviation 15.06 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 8, Week 24, n= 60 | -5.1 Units per liter | Standard Deviation 12.06 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 8, Week 48, n= 28 | -0.6 Units per liter | Standard Deviation 11.39 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Year 9, Week 24, n= 2 | 5 Units per liter | Standard Deviation 4.24 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, Exit, n= 235 | -1.2 Units per liter | Standard Deviation 13.77 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alanine aminotransferase, 8 Week, Follow-Up, n= 10 | 0.1 Units per liter | Standard Deviation 14.46 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 1, Week 4, n= 251 | -0.8 Units per liter | Standard Deviation 13.82 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 1, Week 12, n= 248 | 0.4 Units per liter | Standard Deviation 17.41 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 1, Week 24, n= 246 | 0.3 Units per liter | Standard Deviation 16.72 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 1, Week 36, n= 238 | 1.2 Units per liter | Standard Deviation 16.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 1, Week 48, n= 250 | 3.3 Units per liter | Standard Deviation 19.97 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 2, Week 24, n= 248 | 4.9 Units per liter | Standard Deviation 21.17 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 2, Week 48, n= 233 | 5.8 Units per liter | Standard Deviation 21.25 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 3, Week 24, n= 218 | 5.4 Units per liter | Standard Deviation 20.61 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 3, Week 48, n= 209 | 3.1 Units per liter | Standard Deviation 21.89 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 4, Week 24, n= 207 | 6.5 Units per liter | Standard Deviation 29.67 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 4, Week 48, n= 194 | 6.2 Units per liter | Standard Deviation 33.31 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 5, Week 24, n= 184 | 7.8 Units per liter | Standard Deviation 24.75 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 5, Week 48, n= 178 | 6.7 Units per liter | Standard Deviation 26.55 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 6, Week 24, n= 175 | 7.5 Units per liter | Standard Deviation 33.87 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 6, Week 48, n= 134 | 6.6 Units per liter | Standard Deviation 26.36 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 7, Week 24, n= 123 | 5.5 Units per liter | Standard Deviation 25 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 7, Week 48, n= 97 | 5.2 Units per liter | Standard Deviation 24.83 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 8, Week 24, n= 60 | 2.3 Units per liter | Standard Deviation 29.63 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 8, Week 48, n= 28 | 0.3 Units per liter | Standard Deviation 38.97 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Year 9, Week 24, n= 2 | 19.5 Units per liter | Standard Deviation 24.75 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, Exit, n= 235 | 4.6 Units per liter | Standard Deviation 23.59 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Alkaline phosphatase, 8 Week, Follow-Up, n= 107 | 2.8 Units per liter | Standard Deviation 26.98 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase ,Year 1, Week 4, n= 242 | 0.3 Units per liter | Standard Deviation 11.18 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase ,Year 1,Week 12, n= 245 | -0.6 Units per liter | Standard Deviation 9.37 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase ,Year 1,Week 24, n= 244 | -0.8 Units per liter | Standard Deviation 8.14 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase ,Year 1,Week 48, n= 250 | -0.2 Units per liter | Standard Deviation 10.67 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 2, Week 24,n=246 | 0.4 Units per liter | Standard Deviation 10.97 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 2, Week 48,n=231 | 1 Units per liter | Standard Deviation 12.24 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 3,Week 24,n=215 | 0.2 Units per liter | Standard Deviation 9.49 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase ,Year 3,Week 48, n= 205 | 0.1 Units per liter | Standard Deviation 14.63 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 4,Week 24, n=204 | 1.3 Units per liter | Standard Deviation 14.74 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 4, Week 48,n=191 | 3.7 Units per liter | Standard Deviation 32.99 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 5,Week 24, n=184 | 1.7 Units per liter | Standard Deviation 16.27 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 5,Week 48, n=176 | 0.6 Units per liter | Standard Deviation 15.15 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 6,Week 24,n= 172 | 2.4 Units per liter | Standard Deviation 22.03 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 6,Week 48, n=134 | 1 Units per liter | Standard Deviation 13.55 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 7,Week 24,n=121 | -0.6 Units per liter | Standard Deviation 13.14 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 7, Week 48, n=97 | -1.1 Units per liter | Standard Deviation 14.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 8, Week 24,n=60 | -2.7 Units per liter | Standard Deviation 9.66 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 8, Week 48, n=28 | 0.1 Units per liter | Standard Deviation 8.02 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Year 9, Week 24, n= 2 | 5 Units per liter | Standard Deviation 4.24 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase , Exit, n= 235 | -0.4 Units per liter | Standard Deviation 15.07 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Aspartate aminotransferase,8 Week,Follow-Up, n=107 | -0.7 Units per liter | Standard Deviation 12.45 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 1, Week 4, n= 251 | 0.5 Units per liter | Standard Deviation 22.54 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 1,Week 12, n= 248 | 0.5 Units per liter | Standard Deviation 21.44 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 1,Week 24, n= 246 | -1.3 Units per liter | Standard Deviation 20.21 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 1, Week 48, n=250 | 2.2 Units per liter | Standard Deviation 39.98 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 2,Week 24, n= 248 | 1.2 Units per liter | Standard Deviation 27.97 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 2, Week 48,n= 233 | 1.9 Units per liter | Standard Deviation 28.88 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 3, Week 24, n=218 | 1.8 Units per liter | Standard Deviation 20.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 3, Week 48, n=209 | -2.4 Units per liter | Standard Deviation 31.27 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 4, Week 24, n=207 | 2.5 Units per liter | Standard Deviation 45.58 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 4, Week 48, n=194 | 1.5 Units per liter | Standard Deviation 47.03 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 5,Week 24, n= 184 | -0.4 Units per liter | Standard Deviation 32.51 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 5, Week 48, n=178 | 0.6 Units per liter | Standard Deviation 40.11 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 6, Week 24, n=175 | -3.3 Units per liter | Standard Deviation 40.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 6, Week 48, n=134 | -4.4 Units per liter | Standard Deviation 37.08 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 7, Week 24, n=123 | -7.2 Units per liter | Standard Deviation 38.88 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 7, Week 48, n= 97 | -8.8 Units per liter | Standard Deviation 36.19 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 8, Week 24, n= 60 | -12.9 Units per liter | Standard Deviation 35.44 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 8, Week 48, n= 28 | -6.9 Units per liter | Standard Deviation 31.02 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Year 9, Week 24, n= 2 | 2.5 Units per liter | Standard Deviation 3.54 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, Exit, n= 235 | -2.2 Units per liter | Standard Deviation 35.29 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Gamma glutamyl transferase, 8 Week,Follow-Up,n=107 | 2.1 Units per liter | Standard Deviation 35.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 1, Week 4, n= 242 | 0.2 Units per liter | Standard Deviation 26.46 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 1, Week 12, n= 245 | -2.4 Units per liter | Standard Deviation 29.56 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 1, Week 24, n= 244 | -2.2 Units per liter | Standard Deviation 37.57 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 1, Week 36, n= 234 | -2.8 Units per liter | Standard Deviation 34.88 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 1, Week 48, n= 250 | -4.3 Units per liter | Standard Deviation 35.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 7, Week 24, n= 121 | -7.9 Units per liter | Standard Deviation 53.17 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 8, Week 24, n= 60 | -11.2 Units per liter | Standard Deviation 58.81 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 8, Week 48, n= 28 | -5.5 Units per liter | Standard Deviation 81.78 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Year 9, Week 24, n= 2 | -9.5 Units per liter | Standard Deviation 0.71 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , Exit, n= 235 | -6.5 Units per liter | Standard Deviation 56.73 |
| Belimumab 10 mg/kg IV | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points | Lactate dehydrogenase , 8 Week, Follow-Up, n= 107 | -3.4 Units per liter | Standard Deviation 52.66 |
Primary
Change From Baseline in Albumin and Protein at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 1, Week 48, n= 250 | 1.1 Grams per liter | Standard Deviation 2.88 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 3, Week 24, n= 218 | 1.3 Grams per liter | Standard Deviation 3.41 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 6, Week 24, n= 175 | 1.8 Grams per liter | Standard Deviation 4.05 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 7, Week 48, n= 97 | 1.6 Grams per liter | Standard Deviation 4.19 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 7, Week 48, n= 97 | -4.3 Grams per liter | Standard Deviation 5.87 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 1, Week 4, n= 251 | -0.3 Grams per liter | Standard Deviation 2.17 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 1, Week 12, n= 248 | 0.1 Grams per liter | Standard Deviation 2.53 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 1, Week 24, n= 246 | 0.3 Grams per liter | Standard Deviation 2.47 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 1, Week 36, n= 238 | 0.4 Grams per liter | Standard Deviation 2.69 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 2, Week 24, n= 248 | 1.1 Grams per liter | Standard Deviation 3.18 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 2, Week 48, n= 233 | 1.2 Grams per liter | Standard Deviation 3.25 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 3, Week 48, n= 209 | 1.4 Grams per liter | Standard Deviation 3.65 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 4, Week 24, n= 207 | 1.3 Grams per liter | Standard Deviation 3.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 4, Week 48, n= 194 | 1.5 Grams per liter | Standard Deviation 3.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 5, Week 24, n= 184 | 1.7 Grams per liter | Standard Deviation 3.76 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 5, Week 48, n= 178 | 2 Grams per liter | Standard Deviation 3.69 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 6, Week 48, n= 134 | 1.8 Grams per liter | Standard Deviation 4.09 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 7, Week 24, n= 123 | 1.4 Grams per liter | Standard Deviation 4.14 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 8, Week 24, n= 60 | 2 Grams per liter | Standard Deviation 4.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 8, Week 48, n= 28 | 2.9 Grams per liter | Standard Deviation 3.92 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Year 9, Week 24, n= 2 | 1 Grams per liter | Standard Deviation 0 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, Exit, n= 235 | 2.2 Grams per liter | Standard Deviation 3.59 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Albumin, 8 Week, Follow-Up, n= 107 | 1.8 Grams per liter | Standard Deviation 3.77 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 1, Week 4, n= 251 | -1.3 Grams per liter | Standard Deviation 3.73 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 1, Week 12, n= 248 | -1.9 Grams per liter | Standard Deviation 4.41 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 1, Week 24, n= 246 | -2.1 Grams per liter | Standard Deviation 4.31 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 1, Week 36, n= 238 | -2.6 Grams per liter | Standard Deviation 4.59 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 1, Week 48, n= 250 | -1.8 Grams per liter | Standard Deviation 4.91 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 2, Week 24, n= 248 | -2.2 Grams per liter | Standard Deviation 4.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 2, Week 48, n= 233 | -2.6 Grams per liter | Standard Deviation 5.08 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 3, Week 24, n= 218 | -2.6 Grams per liter | Standard Deviation 5 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 3, Week 48, n= 209 | -3 Grams per liter | Standard Deviation 5.36 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 4, Week 24, n= 207 | -3.4 Grams per liter | Standard Deviation 5.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 4, Week 48, n= 194 | -3.6 Grams per liter | Standard Deviation 5.22 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 5, Week 24, n= 184 | -3.4 Grams per liter | Standard Deviation 5.44 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 5, Week 48, n= 178 | -3.4 Grams per liter | Standard Deviation 5.16 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 6, Week 24, n= 175 | -4 Grams per liter | Standard Deviation 5.55 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 6, Week 48, n= 134 | -3.5 Grams per liter | Standard Deviation 5.81 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 7, Week 24, n= 123 | -4.3 Grams per liter | Standard Deviation 5.56 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 8, Week 24, n= 60 | -4.1 Grams per liter | Standard Deviation 5.78 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 8, Week 48, n= 28 | -3 Grams per liter | Standard Deviation 5.18 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Year 9, Week 24, n= 2 | -1.5 Grams per liter | Standard Deviation 2.12 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, Exit, n= 235 | -2.6 Grams per liter | Standard Deviation 5.53 |
| Belimumab 10 mg/kg IV | Change From Baseline in Albumin and Protein at the Indicated Time Points | Protein, 8 Week, Follow-Up, n= 107 | -3.1 Grams per liter | Standard Deviation 6.19 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 1, Week 4, n= 257 | 0.001 Billion cells per liter | Standard Deviation 0.0157 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 1, Week 12, n= 249 | 0.002 Billion cells per liter | Standard Deviation 0.0173 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 1, Week 24, n= 249 | 0.003 Billion cells per liter | Standard Deviation 0.0175 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 1, Week 36, n= 240 | 0.003 Billion cells per liter | Standard Deviation 0.0172 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 1, Week 48, n= 254 | 0.001 Billion cells per liter | Standard Deviation 0.016 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 2, Week 24, n= 250 | 0.002 Billion cells per liter | Standard Deviation 0.0159 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 2, Week 48, n= 233 | 0.001 Billion cells per liter | Standard Deviation 0.0157 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 3, Week 24, n= 219 | 0.004 Billion cells per liter | Standard Deviation 0.0156 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 3, Week 48, n= 211 | 0.004 Billion cells per liter | Standard Deviation 0.0179 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 4, Week 24, n= 210 | 0.004 Billion cells per liter | Standard Deviation 0.0157 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 4, Week 48, n= 194 | 0.002 Billion cells per liter | Standard Deviation 0.0159 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 5, Week 48, n= 184 | 0.005 Billion cells per liter | Standard Deviation 0.0226 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 6, Week 48, n= 132 | 0.003 Billion cells per liter | Standard Deviation 0.0178 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 7, Week 24, n= 122 | 0.005 Billion cells per liter | Standard Deviation 0.0189 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 7, Week 48, n= 96 | 0.009 Billion cells per liter | Standard Deviation 0.0188 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 8, Week 24, n= 60 | 0.002 Billion cells per liter | Standard Deviation 0.0155 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 8, Week 48, n= 29 | 0.002 Billion cells per liter | Standard Deviation 0.0147 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Exit, n= 233 | 0.005 Billion cells per liter | Standard Deviation 0.0183 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, 8 Week, Follow-Up, n= 106 | 0.004 Billion cells per liter | Standard Deviation 0.0186 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 1, Week 4, n= 257 | -0.001 Billion cells per liter | Standard Deviation 0.0893 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 1, Week 12, n= 249 | 0.005 Billion cells per liter | Standard Deviation 0.1089 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 1, Week 24, n= 249 | 0.008 Billion cells per liter | Standard Deviation 0.1281 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 1, Week 36, n= 240 | 0.004 Billion cells per liter | Standard Deviation 0.1279 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 4, Week 48, n= 194 | -0.032 Billion cells per liter | Standard Deviation 0.1407 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 4, Week 48, n= 194 | -0.35 Billion cells per liter | Standard Deviation 2.207 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 1, Week 4, n= 257 | 0.076 Billion cells per liter | Standard Deviation 0.4223 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 8, Week 48, n= 29 | 0.059 Billion cells per liter | Standard Deviation 0.8495 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 1, Week 4, n= 257 | 0.028 Billion cells per liter | Standard Deviation 0.1673 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 1, Week 12, n= 249 | 0.036 Billion cells per liter | Standard Deviation 0.1694 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 6, Week 48, n= 132 | 0.049 Billion cells per liter | Standard Deviation 0.1808 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 1, Week 48, n= 254 | -0.037 Billion cells per liter | Standard Deviation 1.7955 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 2, Week 48, n= 233 | -0.283 Billion cells per liter | Standard Deviation 2.1226 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 7, Week 24, n= 122 | -0.315 Billion cells per liter | Standard Deviation 2.1382 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 8, Week 48, n= 29 | -0.681 Billion cells per liter | Standard Deviation 2.4214 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 9, Week 24, n= 2 | -4.44 Billion cells per liter | Standard Deviation 0.5798 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 1, Week 12, n= 249 | 0.098 Billion cells per liter | Standard Deviation 1.7212 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 6, Week 48, n= 132 | -0.249 Billion cells per liter | Standard Deviation 2.1432 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 8, Week 24, n= 60 | -0.025 Billion cells per liter | Standard Deviation 2.2303 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 1, Week 4, n= 254 | 2.9 Billion cells per liter | Standard Deviation 35.71 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 2, Week 24, n= 249 | -17.5 Billion cells per liter | Standard Deviation 56.18 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 7, Week 48, n= 96 | -0.026 Billion cells per liter | Standard Deviation 0.1401 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 8, Week 24, n= 60 | -0.031 Billion cells per liter | Standard Deviation 0.1425 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 8, Week 48, n= 29 | -0.032 Billion cells per liter | Standard Deviation 0.1121 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 9, Week 24, n= 2 | -0.08 Billion cells per liter | Standard Deviation 0.0141 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Exit, n= 233 | -0.026 Billion cells per liter | Standard Deviation 0.1295 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, 8 Week, Follow-Up, n= 106 | -0.022 Billion cells per liter | Standard Deviation 0.1401 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 1, Week 4, n= 257 | 0.08 Billion cells per liter | Standard Deviation 1.642 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 1, Week 12, n= 249 | 0.18 Billion cells per liter | Standard Deviation 1.856 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 1, Week 24, n= 249 | -0.02 Billion cells per liter | Standard Deviation 1.884 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 1, Week 36, n= 240 | 0.04 Billion cells per liter | Standard Deviation 2.092 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 1, Week 48, n= 254 | -0.01 Billion cells per liter | Standard Deviation 1.863 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 2, Week 24, n= 250 | -0.19 Billion cells per liter | Standard Deviation 2.087 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 2, Week 48, n= 233 | -0.27 Billion cells per liter | Standard Deviation 2.19 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 3, Week 24, n= 219 | -0.33 Billion cells per liter | Standard Deviation 1.959 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 3, Week 48, n= 211 | -0.42 Billion cells per liter | Standard Deviation 1.876 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 4, Week 24, n= 210 | -0.29 Billion cells per liter | Standard Deviation 2.205 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 5, Week 24, n= 188 | -0.4 Billion cells per liter | Standard Deviation 2.112 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 5, Week 48, n= 184 | -0.18 Billion cells per liter | Standard Deviation 2.389 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 6, Week 24, n= 176 | -0.4 Billion cells per liter | Standard Deviation 2.161 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 6, Week 48, n= 132 | -0.24 Billion cells per liter | Standard Deviation 2.164 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 7, Week 24, n= 122 | -0.22 Billion cells per liter | Standard Deviation 2.149 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 7, Week 48, n= 96 | 0.05 Billion cells per liter | Standard Deviation 2.388 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 8, Week 24, n= 60 | 0.17 Billion cells per liter | Standard Deviation 2.297 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 8, Week 48, n= 29 | -0.63 Billion cells per liter | Standard Deviation 2.549 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Year 9, Week 24, n= 2 | -3.7 Billion cells per liter | Standard Deviation 1.273 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, Exit, n= 233 | 0.09 Billion cells per liter | Standard Deviation 2.969 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Leukocytes, 8 Week, Follow-Up, n= 106 | -0.11 Billion cells per liter | Standard Deviation 2.613 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 1, Week 12, n= 249 | 0.039 Billion cells per liter | Standard Deviation 0.558 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 1, Week 24, n= 249 | 0.002 Billion cells per liter | Standard Deviation 0.5023 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 1, Week 36, n= 240 | 0.059 Billion cells per liter | Standard Deviation 0.5002 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 1, Week 48, n= 254 | -0.02 Billion cells per liter | Standard Deviation 0.5129 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 2, Week 24, n= 250 | -0.073 Billion cells per liter | Standard Deviation 0.5033 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 2, Week 48, n= 233 | -0.036 Billion cells per liter | Standard Deviation 0.5299 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 3, Week 24, n= 219 | 0.002 Billion cells per liter | Standard Deviation 0.5621 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 3, Week 48, n= 211 | -0.028 Billion cells per liter | Standard Deviation 0.572 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 4, Week 24, n= 210 | -0.036 Billion cells per liter | Standard Deviation 0.5809 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 4, Week 48, n= 194 | -0.067 Billion cells per liter | Standard Deviation 0.5678 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 5, Week 24, n= 188 | -0.07 Billion cells per liter | Standard Deviation 0.5924 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 5, Week 48, n= 184 | -0.047 Billion cells per liter | Standard Deviation 0.629 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 6, Week 24, n= 176 | -0.021 Billion cells per liter | Standard Deviation 0.5876 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 6, Week 48, n= 132 | -0.008 Billion cells per liter | Standard Deviation 0.5564 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 7, Week 24, n= 122 | 0.011 Billion cells per liter | Standard Deviation 0.6439 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 7, Week 48, n= 96 | 0.143 Billion cells per liter | Standard Deviation 0.6619 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 8, Week 24, n= 60 | 0.126 Billion cells per liter | Standard Deviation 0.6291 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Year 9, Week 24, n= 2 | 0.765 Billion cells per liter | Standard Deviation 1.4354 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, Exit, n= 233 | -0.025 Billion cells per liter | Standard Deviation 0.6129 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Lymphocytes, 8 Week, Follow-Up, n= 106 | 0.029 Billion cells per liter | Standard Deviation 0.6256 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 1, Week 24, n= 249 | 0.024 Billion cells per liter | Standard Deviation 0.1678 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 1, Week 36, n= 240 | 0.054 Billion cells per liter | Standard Deviation 0.1806 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 1, Week 48, n= 254 | 0.044 Billion cells per liter | Standard Deviation 0.1754 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 2, Week 24, n= 250 | 0.053 Billion cells per liter | Standard Deviation 0.1809 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 2, Week 48, n= 233 | 0.052 Billion cells per liter | Standard Deviation 0.1805 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 3, Week 24, n= 219 | 0.059 Billion cells per liter | Standard Deviation 0.1809 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 3, Week 48, n= 211 | 0.071 Billion cells per liter | Standard Deviation 0.1903 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 4, Week 24, n= 210 | 0.065 Billion cells per liter | Standard Deviation 0.1875 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 4, Week 48, n= 194 | 0.084 Billion cells per liter | Standard Deviation 0.1782 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 5, Week 24, n= 188 | 0.095 Billion cells per liter | Standard Deviation 0.1878 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 5, Week 48, n= 184 | 0.086 Billion cells per liter | Standard Deviation 0.1983 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 6, Week 24, n= 176 | 0.072 Billion cells per liter | Standard Deviation 0.1826 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 7, Week 24, n= 122 | 0.098 Billion cells per liter | Standard Deviation 0.1996 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 7, Week 48, n= 96 | 0.097 Billion cells per liter | Standard Deviation 0.2032 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 8, Week 24, n= 60 | 0.101 Billion cells per liter | Standard Deviation 0.1909 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 8, Week 48, n= 29 | 0.024 Billion cells per liter | Standard Deviation 0.2074 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Year 9, Week 24, n= 2 | 0.03 Billion cells per liter | Standard Deviation 0.3818 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, Exit, n= 233 | 0.075 Billion cells per liter | Standard Deviation 0.1846 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Monocytes, 8 Week, Follow-Up, n= 106 | 0.093 Billion cells per liter | Standard Deviation 0.1958 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 1, Week 4, n= 257 | -0.027 Billion cells per liter | Standard Deviation 1.6734 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 1, Week 12, n= 249 | 0.1 Billion cells per liter | Standard Deviation 1.7293 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 1, Week 24, n= 249 | -0.059 Billion cells per liter | Standard Deviation 1.8685 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 1, Week 36, n= 240 | -0.086 Billion cells per liter | Standard Deviation 2.1086 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 2, Week 24, n= 250 | -0.176 Billion cells per liter | Standard Deviation 2.0209 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 3, Week 24, n= 219 | -0.397 Billion cells per liter | Standard Deviation 1.8521 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 3, Week 48, n= 211 | -0.443 Billion cells per liter | Standard Deviation 1.763 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 4, Week 24, n= 210 | -0.288 Billion cells per liter | Standard Deviation 2.1214 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 4, Week 48, n= 194 | -0.342 Billion cells per liter | Standard Deviation 2.1425 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 5, Week 24, n= 188 | -0.392 Billion cells per liter | Standard Deviation 1.9654 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 5, Week 48, n= 184 | -0.207 Billion cells per liter | Standard Deviation 2.2312 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 6, Week 24, n= 176 | -0.424 Billion cells per liter | Standard Deviation 2.0787 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 6, Week 48, n= 132 | -0.251 Billion cells per liter | Standard Deviation 2.1415 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 7, Week 48, n= 96 | -0.176 Billion cells per liter | Standard Deviation 2.3755 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Year 8, Week 24, n= 60 | -0.025 Billion cells per liter | Standard Deviation 2.2303 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, Exit, n= 233 | 0.058 Billion cells per liter | Standard Deviation 2.9836 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils, 8 Week, Follow-Up, n= 106 | -0.214 Billion cells per liter | Standard Deviation 2.5793 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 1, Week 4, n= 257 | -0.028 Billion cells per liter | Standard Deviation 1.6685 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 1, Week 24, n= 249 | -0.059 Billion cells per liter | Standard Deviation 1.8683 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 1, Week 36, n= 240 | -0.086 Billion cells per liter | Standard Deviation 2.1097 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 1, Week 48, n= 254 | -0.044 Billion cells per liter | Standard Deviation 1.8014 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 2, Week 24, n= 250 | -0.177 Billion cells per liter | Standard Deviation 2.0163 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 2, Week 48, n= 233 | -0.284 Billion cells per liter | Standard Deviation 2.1204 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 3, Week 24, n= 219 | -0.397 Billion cells per liter | Standard Deviation 1.8509 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 3, Week 48, n= 211 | -0.444 Billion cells per liter | Standard Deviation 1.7607 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 4, Week 24, n= 210 | -0.286 Billion cells per liter | Standard Deviation 2.1249 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 4, Week 48, n= 194 | -0.342 Billion cells per liter | Standard Deviation 2.1464 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 5, Week 24, n= 188 | -0.39 Billion cells per liter | Standard Deviation 1.9703 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 5, Week 48, n= 184 | -0.207 Billion cells per liter | Standard Deviation 2.2273 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 6, Week 24, n= 176 | -0.422 Billion cells per liter | Standard Deviation 2.0826 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 7, Week 24, n= 122 | -0.313 Billion cells per liter | Standard Deviation 2.1378 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 7, Week 48, n= 96 | -0.179 Billion cells per liter | Standard Deviation 2.3698 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 8, Week 48, n= 29 | -0.681 Billion cells per liter | Standard Deviation 2.4214 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Year 9, Week 24, n= 2 | -4.44 Billion cells per liter | Standard Deviation 0.5798 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, Exit, n= 233 | 0.046 Billion cells per liter | Standard Deviation 2.8796 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Neutrophils segmented, 8 Week, Follow-Up, n= 106 | -0.215 Billion cells per liter | Standard Deviation 2.5788 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 1, Week 12, n= 248 | -1.1 Billion cells per liter | Standard Deviation 42.04 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 1, Week 24, n= 247 | -2 Billion cells per liter | Standard Deviation 41.13 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 1, Week 36, n= 238 | -5.9 Billion cells per liter | Standard Deviation 46.11 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 1, Week 48, n= 252 | -8.4 Billion cells per liter | Standard Deviation 46.36 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 2, Week 48, n= 233 | -18.8 Billion cells per liter | Standard Deviation 56.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 3, Week 24, n= 218 | -17 Billion cells per liter | Standard Deviation 56.86 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 3, Week 48, n= 210 | -22.4 Billion cells per liter | Standard Deviation 57.11 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 4, Week 24, n= 210 | -14.6 Billion cells per liter | Standard Deviation 64.11 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 4, Week 48, n= 193 | -17 Billion cells per liter | Standard Deviation 60.26 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 5, Week 24, n= 188 | -19 Billion cells per liter | Standard Deviation 65.99 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 5, Week 48, n= 184 | -17.6 Billion cells per liter | Standard Deviation 65.69 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 6, Week 24, n= 175 | -18.9 Billion cells per liter | Standard Deviation 62.88 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 6, Week 48, n= 132 | -23.7 Billion cells per liter | Standard Deviation 67.73 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 7, Week 24, n= 121 | -14 Billion cells per liter | Standard Deviation 77.75 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 7, Week 48, n= 96 | -24.7 Billion cells per liter | Standard Deviation 64.56 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 8, Week 24, n= 60 | -30.5 Billion cells per liter | Standard Deviation 65.89 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 8, Week 48, n= 29 | -40.7 Billion cells per liter | Standard Deviation 62.84 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Year 9, Week 24, n= 2 | 37 Billion cells per liter | Standard Deviation 83.44 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, Exit, n= 233 | -9.4 Billion cells per liter | Standard Deviation 59.82 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Platelets, 8 Week, Follow-Up, n= 106 | -8 Billion cells per liter | Standard Deviation 70.29 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 5, Week 24, n= 188 | 0.003 Billion cells per liter | Standard Deviation 0.0168 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 6, Week 24, n= 176 | 0.003 Billion cells per liter | Standard Deviation 0.0149 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Basophils, Year 9, Week 24, n= 2 | 0.02 Billion cells per liter | Standard Deviation 0.0141 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 1, Week 48, n= 254 | 0.007 Billion cells per liter | Standard Deviation 0.1216 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 2, Week 24, n= 250 | 0.006 Billion cells per liter | Standard Deviation 0.1228 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 2, Week 48, n= 233 | -0.009 Billion cells per liter | Standard Deviation 0.1234 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 3, Week 24, n= 219 | -0.002 Billion cells per liter | Standard Deviation 0.1303 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 3, Week 48, n= 211 | -0.023 Billion cells per liter | Standard Deviation 0.1276 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 4, Week 24, n= 210 | -0.034 Billion cells per liter | Standard Deviation 0.125 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 5, Week 24, n= 188 | -0.038 Billion cells per liter | Standard Deviation 0.1281 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 5, Week 48, n= 184 | -0.019 Billion cells per liter | Standard Deviation 0.1547 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 6, Week 24, n= 176 | -0.027 Billion cells per liter | Standard Deviation 0.1169 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 6, Week 48, n= 132 | -0.038 Billion cells per liter | Standard Deviation 0.1227 |
| Belimumab 10 mg/kg IV | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points | Eosinophils, Year 7, Week 24, n= 122 | -0.017 Billion cells per liter | Standard Deviation 0.1269 |
Primary
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 8, Week 48, n= 28 | -0.1603 Millimoles per liter | Standard Deviation 1.5417 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 3, Week 48, n= 209 | 0.1719 Millimoles per liter | Standard Deviation 1.4829 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, 8 Week, Follow-Up, n= 107 | 0.0046 Millimoles per liter | Standard Deviation 0.1029 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 2, Week 48, n= 233 | 0.003 Millimoles per liter | Standard Deviation 0.0699 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 8, Week 24, n= 60 | -0.0223 Millimoles per liter | Standard Deviation 0.2186 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 9, Week 24, n= 2 | 0.1467 Millimoles per liter | Standard Deviation 0.1893 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, 8 Week, Follow-Up, n= 107 | 0.0438 Millimoles per liter | Standard Deviation 0.2131 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 1, Week 4, n= 242 | 0.07 Millimoles per liter | Standard Deviation 0.407 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 5, Week 24, n= 184 | 0 Millimoles per liter | Standard Deviation 0.406 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 1, Week 4, n= 251 | 0.026 Millimoles per liter | Standard Deviation 1.4283 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 1, Week 12, n= 248 | -0.1695 Millimoles per liter | Standard Deviation 1.4782 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 1, Week 24, n= 246 | -0.1612 Millimoles per liter | Standard Deviation 1.9011 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 1, Week 36, n= 238 | -0.1732 Millimoles per liter | Standard Deviation 1.5648 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 1, Week 48, n= 250 | -0.1013 Millimoles per liter | Standard Deviation 1.5557 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 2, Week 24, n= 248 | -0.1873 Millimoles per liter | Standard Deviation 1.6796 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 2, Week 48, n= 233 | -0.0134 Millimoles per liter | Standard Deviation 1.7024 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 3, Week 24, n= 218 | -0.0552 Millimoles per liter | Standard Deviation 1.7117 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 3, Week 48, n= 209 | -0.0472 Millimoles per liter | Standard Deviation 1.6693 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 4, Week 24, n= 207 | -0.09 Millimoles per liter | Standard Deviation 1.6775 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 4, Week 48, n= 194 | -0.1162 Millimoles per liter | Standard Deviation 1.721 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 5, Week 24, n= 184 | -0.0331 Millimoles per liter | Standard Deviation 1.6526 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 5, Week 48, n= 178 | 0.0176 Millimoles per liter | Standard Deviation 1.7712 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 6, Week 24, n= 175 | -0.0029 Millimoles per liter | Standard Deviation 1.6054 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 6, Week 48, n= 134 | -0.0858 Millimoles per liter | Standard Deviation 1.6972 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 7, Week 24, n= 123 | 0.0246 Millimoles per liter | Standard Deviation 1.6668 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 7, Week 48, n= 97 | -0.008 Millimoles per liter | Standard Deviation 1.6683 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 8, Week 24, n= 60 | -0.1152 Millimoles per liter | Standard Deviation 1.5362 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Year 9, Week 24, n= 2 | -0.1805 Millimoles per liter | Standard Deviation 1.06 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, Exit, n= 235 | 0.0501 Millimoles per liter | Standard Deviation 1.7369 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Blood urea nitrogen, 8 Week, Follow-Up, n= 107 | 0.3248 Millimoles per liter | Standard Deviation 2.2109 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 1, Week 4, n= 251 | 0.1088 Millimoles per liter | Standard Deviation 1.1734 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 1, Week 12, n= 248 | 0.2006 Millimoles per liter | Standard Deviation 1.1712 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 1, Week 24, n= 246 | 0.0881 Millimoles per liter | Standard Deviation 1.2279 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 1, Week 36, n= 238 | 0.2158 Millimoles per liter | Standard Deviation 1.2519 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 1, Week 48, n= 250 | 0.1482 Millimoles per liter | Standard Deviation 1.5029 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 2, Week 24, n= 248 | 0.1146 Millimoles per liter | Standard Deviation 1.3072 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 2, Week 48, n= 233 | 0.323 Millimoles per liter | Standard Deviation 1.5426 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 3, Week 24, n= 218 | 0.1927 Millimoles per liter | Standard Deviation 1.4319 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 4, Week 24, n= 207 | 0.2737 Millimoles per liter | Standard Deviation 1.6169 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 4, Week 48, n= 194 | 0.2523 Millimoles per liter | Standard Deviation 2.1698 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 5, Week 24, n= 184 | 0.2579 Millimoles per liter | Standard Deviation 1.4792 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 5, Week 48, n= 178 | 0.2964 Millimoles per liter | Standard Deviation 1.7205 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 6, Week 24, n= 175 | 0.2903 Millimoles per liter | Standard Deviation 1.7746 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 6, Week 48, n= 134 | 0.3897 Millimoles per liter | Standard Deviation 1.7503 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 7, Week 24, n= 123 | 0.297 Millimoles per liter | Standard Deviation 2.257 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 7, Week 48, n= 97 | 0.5098 Millimoles per liter | Standard Deviation 1.8839 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 8, Week 24, n= 60 | 0.449 Millimoles per liter | Standard Deviation 1.9609 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 8, Week 48, n= 28 | 0.7571 Millimoles per liter | Standard Deviation 2.2408 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Year 9, Week 24, n= 2 | 0.8845 Millimoles per liter | Standard Deviation 0.4094 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, Exit, n= 235 | 0.2986 Millimoles per liter | Standard Deviation 1.3871 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Glucose, 8 Week, Follow-Up, n= 107 | 0.3354 Millimoles per liter | Standard Deviation 1.4114 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 1, Week 4, n= 242 | 0.0071 Millimoles per liter | Standard Deviation 0.0888 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 1, Week 12, n= 247 | -0.0043 Millimoles per liter | Standard Deviation 0.0872 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 1, Week 24, n= 244 | -0.0023 Millimoles per liter | Standard Deviation 0.0889 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 1, Week 36, n= 235 | -0.0156 Millimoles per liter | Standard Deviation 0.0884 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 1, Week 48, n= 250 | 0.0007 Millimoles per liter | Standard Deviation 0.0896 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 2, Week 24, n= 246 | -0.0017 Millimoles per liter | Standard Deviation 0.0946 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 2, Week 48, n= 231 | -0.0019 Millimoles per liter | Standard Deviation 0.0922 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 3, Week 24, n= 214 | -0.0009 Millimoles per liter | Standard Deviation 0.09 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 3, Week 48, n= 205 | -0.0109 Millimoles per liter | Standard Deviation 0.1004 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 4, Week 24, n= 204 | -0.0115 Millimoles per liter | Standard Deviation 0.095 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 4, Week 48, n= 191 | -0.0072 Millimoles per liter | Standard Deviation 0.0889 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 5, Week 24, n= 184 | -0.0181 Millimoles per liter | Standard Deviation 0.0986 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 5, Week 48, n= 176 | -0.0011 Millimoles per liter | Standard Deviation 0.0912 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 6, Week 24, n= 172 | -0.0107 Millimoles per liter | Standard Deviation 0.0977 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 6, Week 48, n= 134 | 0.0007 Millimoles per liter | Standard Deviation 0.0925 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 7, Week 24, n= 121 | 0.0014 Millimoles per liter | Standard Deviation 0.0873 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 7, Week 48, n= 97 | 0.0063 Millimoles per liter | Standard Deviation 0.0964 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 8, Week 24, n= 60 | -0.0123 Millimoles per liter | Standard Deviation 0.0788 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 8, Week 48, n= 28 | 0.0021 Millimoles per liter | Standard Deviation 0.0935 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Year 9, Week 24, n= 2 | -0.005 Millimoles per liter | Standard Deviation 0.0354 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Calcium, Exit, n= 235 | 0.0151 Millimoles per liter | Standard Deviation 0.0923 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 1, Week 4, n= 243 | -0.2 Millimoles per liter | Standard Deviation 2.72 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 1, Week 12, n= 245 | -0.4 Millimoles per liter | Standard Deviation 2.62 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 1, Week 24, n= 244 | -0.2 Millimoles per liter | Standard Deviation 2.51 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 1, Week 36, n= 234 | -0.1 Millimoles per liter | Standard Deviation 2.67 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 1, Week 48, n= 250 | -0.2 Millimoles per liter | Standard Deviation 2.64 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 2, Week 24, n= 246 | 0 Millimoles per liter | Standard Deviation 2.58 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 2, Week 48, n= 231 | -0.5 Millimoles per liter | Standard Deviation 2.78 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 3, Week 24, n= 215 | -0.5 Millimoles per liter | Standard Deviation 2.75 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 3, Week 48, n= 205 | -0.9 Millimoles per liter | Standard Deviation 2.82 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 4, Week 24, n= 204 | -0.6 Millimoles per liter | Standard Deviation 2.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 4, Week 48, n= 191 | -0.6 Millimoles per liter | Standard Deviation 2.79 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 5, Week 24, n= 184 | -0.9 Millimoles per liter | Standard Deviation 2.68 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 5, Week 48, n= 176 | -0.7 Millimoles per liter | Standard Deviation 2.73 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 6, Week 24, n= 172 | -0.8 Millimoles per liter | Standard Deviation 2.62 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 6, Week 48, n= 134 | -0.7 Millimoles per liter | Standard Deviation 3.23 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 7, Week 24, n= 121 | -0.7 Millimoles per liter | Standard Deviation 2.84 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 7, Week 48, n= 97 | -0.3 Millimoles per liter | Standard Deviation 3.14 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 8, Week 24, n= 60 | -0.5 Millimoles per liter | Standard Deviation 3.17 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 8, Week 48, n= 28 | -0.7 Millimoles per liter | Standard Deviation 2.87 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Year 9, Week 24, n= 2 | -1 Millimoles per liter | Standard Deviation 1.41 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, Exit, n= 235 | 0.1 Millimoles per liter | Standard Deviation 2.74 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Carbon dioxide, 8 Week, Follow-Up, n= 107 | 0 Millimoles per liter | Standard Deviation 2.55 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 1, Week 4, n= 251 | 0.2 Millimoles per liter | Standard Deviation 2.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 1, Week 12, n= 248 | 0.1 Millimoles per liter | Standard Deviation 2.53 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 1, Week 24, n= 246 | 0.3 Millimoles per liter | Standard Deviation 2.31 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 1, Week 36, n= 238 | 0.5 Millimoles per liter | Standard Deviation 2.43 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 1, Week 48, n= 250 | 0 Millimoles per liter | Standard Deviation 2.53 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 2, Week 24, n= 248 | 0.1 Millimoles per liter | Standard Deviation 2.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 2, Week 48, n= 233 | 0.1 Millimoles per liter | Standard Deviation 3.03 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 3, Week 24, n= 218 | -0.1 Millimoles per liter | Standard Deviation 3.01 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 3, Week 48, n= 209 | 0.1 Millimoles per liter | Standard Deviation 3.06 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 4, Week 24, n= 207 | -0.4 Millimoles per liter | Standard Deviation 3.28 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 4, Week 48, n= 194 | -0.3 Millimoles per liter | Standard Deviation 2.83 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 5, Week 24, n= 184 | -0.3 Millimoles per liter | Standard Deviation 3.06 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 5, Week 48, n= 178 | -0.1 Millimoles per liter | Standard Deviation 3.02 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 6, Week 24, n= 175 | 0 Millimoles per liter | Standard Deviation 3.11 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 6, Week 48, n= 134 | 0.3 Millimoles per liter | Standard Deviation 2.89 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 7, Week 24, n= 123 | 0.4 Millimoles per liter | Standard Deviation 3.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 7, Week 48, n= 97 | 0.5 Millimoles per liter | Standard Deviation 3.28 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 8, Week 24, n= 60 | 0.5 Millimoles per liter | Standard Deviation 3.21 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 8, Week 48, n= 28 | 1.1 Millimoles per liter | Standard Deviation 2.49 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Year 9, Week 24, n= 2 | 1.5 Millimoles per liter | Standard Deviation 2.12 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, Exit, n= 235 | -0.5 Millimoles per liter | Standard Deviation 2.96 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Chloride, 8 Week, Follow-Up, n= 107 | 0.1 Millimoles per liter | Standard Deviation 2.65 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 1, Week 4, n= 251 | 0.002 Millimoles per liter | Standard Deviation 0.0673 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 1, Week 12, n= 248 | -0.005 Millimoles per liter | Standard Deviation 0.0625 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 1, Week 24, n= 246 | 0.004 Millimoles per liter | Standard Deviation 0.0599 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 1, Week 36, n= 238 | 0.001 Millimoles per liter | Standard Deviation 0.066 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 1, Week 48, n= 250 | 0.001 Millimoles per liter | Standard Deviation 0.0677 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 2, Week 24, n= 248 | 0.003 Millimoles per liter | Standard Deviation 0.0709 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 3, Week 24, n= 218 | 0.007 Millimoles per liter | Standard Deviation 0.0719 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 3, Week 48, n= 209 | 0.011 Millimoles per liter | Standard Deviation 0.0681 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 4, Week 24, n= 207 | 0.009 Millimoles per liter | Standard Deviation 0.0682 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 4, Week 48, n= 194 | 0.012 Millimoles per liter | Standard Deviation 0.0692 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 5, Week 24, n= 184 | 0.017 Millimoles per liter | Standard Deviation 0.062 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 5, Week 48, n= 178 | 0.014 Millimoles per liter | Standard Deviation 0.0622 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 6, Week 24, n= 175 | 0.017 Millimoles per liter | Standard Deviation 0.067 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 6, Week 48, n= 134 | 0.003 Millimoles per liter | Standard Deviation 0.0664 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 7, Week 24, n= 123 | 0.004 Millimoles per liter | Standard Deviation 0.0691 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 7, Week 48, n= 97 | 0.001 Millimoles per liter | Standard Deviation 0.0681 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 8, Week 24, n= 60 | -0.006 Millimoles per liter | Standard Deviation 0.0644 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 8, Week 48, n= 28 | 0.016 Millimoles per liter | Standard Deviation 0.0599 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Year 9, Week 24, n= 2 | 0.02 Millimoles per liter | Standard Deviation 0.0283 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, Exit, n= 235 | 0.03 Millimoles per liter | Standard Deviation 0.0676 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Magnesium, 8 Week, Follow-Up, n= 107 | 0.028 Millimoles per liter | Standard Deviation 0.0728 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 1, Week 4, n= 251 | 0.0165 Millimoles per liter | Standard Deviation 0.1857 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 1, Week 12, n= 248 | -0.0065 Millimoles per liter | Standard Deviation 0.1851 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 1, Week 24, n= 246 | 0.0106 Millimoles per liter | Standard Deviation 0.2027 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 1, Week 36, n= 238 | -0.0039 Millimoles per liter | Standard Deviation 0.1825 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 1, Week 48, n= 250 | 0.0019 Millimoles per liter | Standard Deviation 0.1926 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 2, Week 24, n= 248 | -0.0133 Millimoles per liter | Standard Deviation 0.2219 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 2, Week 48, n= 233 | 0.0099 Millimoles per liter | Standard Deviation 0.1968 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 3, Week 24, n= 218 | 0.0033 Millimoles per liter | Standard Deviation 0.2129 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 3, Week 48, n= 209 | 0.0017 Millimoles per liter | Standard Deviation 0.221 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 4, Week 24, n= 207 | -0.0022 Millimoles per liter | Standard Deviation 0.2145 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 4, Week 48, n= 194 | -0.0102 Millimoles per liter | Standard Deviation 0.1765 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 5, Week 24, n= 184 | -0.015 Millimoles per liter | Standard Deviation 0.1899 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 5, Week 48, n= 178 | -0.0035 Millimoles per liter | Standard Deviation 0.1892 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 6, Week 24, n= 175 | -0.004 Millimoles per liter | Standard Deviation 0.2153 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 6, Week 48, n= 134 | -0.0139 Millimoles per liter | Standard Deviation 0.2097 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 7, Week 24, n= 123 | 0.0296 Millimoles per liter | Standard Deviation 0.1962 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 7, Week 48, n= 97 | 0.031 Millimoles per liter | Standard Deviation 0.1875 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Year 8, Week 48, n= 28 | -0.0054 Millimoles per liter | Standard Deviation 0.2093 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Phosphate, Exit, n= 235 | 0.0161 Millimoles per liter | Standard Deviation 0.2151 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 1, Week 12, n= 245 | 0.02 Millimoles per liter | Standard Deviation 0.412 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 1, Week 24, n= 244 | 0.02 Millimoles per liter | Standard Deviation 0.409 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 1, Week 36, n= 234 | 0.03 Millimoles per liter | Standard Deviation 0.427 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 1, Week 48, n= 250 | -0.04 Millimoles per liter | Standard Deviation 0.413 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 2, Week 24, n= 246 | 0.01 Millimoles per liter | Standard Deviation 0.42 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 2, Week 48, n= 231 | 0.02 Millimoles per liter | Standard Deviation 0.426 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 3, Week 24, n= 215 | 0.01 Millimoles per liter | Standard Deviation 0.418 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 3, Week 48, n= 205 | 0.01 Millimoles per liter | Standard Deviation 0.466 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 4, Week 24, n= 204 | -0.02 Millimoles per liter | Standard Deviation 0.409 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 4, Week 48, n= 191 | 0.04 Millimoles per liter | Standard Deviation 0.417 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 5, Week 48, n= 176 | 0.06 Millimoles per liter | Standard Deviation 0.427 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 6, Week 24, n= 172 | -0.03 Millimoles per liter | Standard Deviation 0.431 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 6, Week 48, n= 134 | 0.06 Millimoles per liter | Standard Deviation 0.438 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 7, Week 24, n= 121 | 0.04 Millimoles per liter | Standard Deviation 0.379 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 7, Week 48, n= 97 | 0.06 Millimoles per liter | Standard Deviation 0.387 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 8, Week 24, n= 60 | 0 Millimoles per liter | Standard Deviation 0.354 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 8, Week 48, n= 28 | 0.1 Millimoles per liter | Standard Deviation 0.401 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Year 9, Week 24, n= 2 | 0.05 Millimoles per liter | Standard Deviation 0.212 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, Exit, n= 235 | 0.11 Millimoles per liter | Standard Deviation 0.431 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Potassium, 8 Week, Follow-Up, n= 107 | 0.07 Millimoles per liter | Standard Deviation 0.493 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 1, Week 4, n= 251 | 0.4 Millimoles per liter | Standard Deviation 2.67 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 1, Week 12, n= 248 | 0 Millimoles per liter | Standard Deviation 2.67 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 1, Week 24, n= 246 | 0.3 Millimoles per liter | Standard Deviation 2.02 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 1, Week 36, n= 238 | 0.3 Millimoles per liter | Standard Deviation 2.46 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 1, Week 48, n= 250 | -0.1 Millimoles per liter | Standard Deviation 2.06 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 2, Week 24, n= 248 | 0 Millimoles per liter | Standard Deviation 2.19 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 2, Week 48, n= 233 | 0 Millimoles per liter | Standard Deviation 2.58 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 3, Week 24, n= 218 | -0.1 Millimoles per liter | Standard Deviation 2.18 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 3, Week 48, n= 209 | 0.4 Millimoles per liter | Standard Deviation 2.44 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 4, Week 24, n= 207 | 0.2 Millimoles per liter | Standard Deviation 2.54 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 4, Week 48, n= 194 | 0.1 Millimoles per liter | Standard Deviation 2.36 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 5, Week 24, n= 184 | 0.1 Millimoles per liter | Standard Deviation 2.19 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 5, Week 48, n= 178 | 0 Millimoles per liter | Standard Deviation 2.37 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 6, Week 24, n= 175 | 0.1 Millimoles per liter | Standard Deviation 2.33 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 6, Week 48, n= 134 | 0.3 Millimoles per liter | Standard Deviation 2.72 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 7, Week 24, n= 123 | 0.3 Millimoles per liter | Standard Deviation 2.97 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 7, Week 48, n= 97 | 0.3 Millimoles per liter | Standard Deviation 2.49 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 8, Week 24, n= 60 | 0.2 Millimoles per liter | Standard Deviation 2.32 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 8, Week 48, n= 28 | 0.4 Millimoles per liter | Standard Deviation 1.95 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Year 9, Week 24, n= 2 | -1 Millimoles per liter | Standard Deviation 1.41 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, Exit, n= 235 | 0.1 Millimoles per liter | Standard Deviation 2.32 |
| Belimumab 10 mg/kg IV | Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Sodium, 8 Week, Follow-Up, n= 107 | 0.8 Millimoles per liter | Standard Deviation 2.33 |
Primary
Change From Baseline in BUN/Creatinine at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 1, Week 4, n= 251 | -0.2 Ratio | Standard Deviation 4.69 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 1, Week 36, n= 238 | -0.4 Ratio | Standard Deviation 5.07 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 1, Week 48, n= 250 | -0.2 Ratio | Standard Deviation 5.29 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 7, Week 48, n= 97 | 0.7 Ratio | Standard Deviation 5.42 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 1, Week 12, n= 248 | -0.5 Ratio | Standard Deviation 4.86 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 1, Week 24, n= 246 | -0.6 Ratio | Standard Deviation 5.31 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 2, Week 24, n= 248 | -0.2 Ratio | Standard Deviation 5.76 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 2, Week 48, n= 233 | 0.3 Ratio | Standard Deviation 4.78 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 3, Week 24, n= 218 | 0.8 Ratio | Standard Deviation 5.63 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 3, Week 48, n= 209 | 0.9 Ratio | Standard Deviation 5.61 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 4, Week 24, n= 207 | 1.2 Ratio | Standard Deviation 5.86 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 4, Week 48, n= 194 | 0.9 Ratio | Standard Deviation 6.05 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 5, Week 24, n= 184 | 1 Ratio | Standard Deviation 5.52 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 5, Week 48, n= 178 | 1.2 Ratio | Standard Deviation 6.49 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 6, Week 24, n= 175 | 1.2 Ratio | Standard Deviation 5.79 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 6, Week 48, n= 134 | 1 Ratio | Standard Deviation 6.38 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 7, Week 24, n= 123 | 1.1 Ratio | Standard Deviation 5.75 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 8, Week 24, n= 60 | 0.8 Ratio | Standard Deviation 5.09 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 8, Week 48, n= 28 | 0.4 Ratio | Standard Deviation 5.28 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Year 9, Week 24, n= 2 | -0.5 Ratio | Standard Deviation 0.71 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, Exit, n= 235 | 1.1 Ratio | Standard Deviation 5.57 |
| Belimumab 10 mg/kg IV | Change From Baseline in BUN/Creatinine at the Indicated Time Points | BUN/creatinine, 8 Week, Follow-Up, n= 107 | 1.3 Ratio | Standard Deviation 5.99 |
Primary
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 4, Week 24, n= 207 | 0.13 Milliliters per second | Standard Deviation 0.3981 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 1, Week 4, n= 251 | -0.022 Milliliters per second | Standard Deviation 0.2312 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 1, Week 12, n= 248 | 0.01 Milliliters per second | Standard Deviation 0.2455 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 1, Week 24, n= 246 | 0.028 Milliliters per second | Standard Deviation 0.2831 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 1, Week 36, n= 238 | 0.034 Milliliters per second | Standard Deviation 0.3083 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 1, Week 48, n= 250 | 0.017 Milliliters per second | Standard Deviation 0.306 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 2, Week 24, n= 248 | 0.047 Milliliters per second | Standard Deviation 0.3145 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 2, Week 48, n= 233 | 0.04 Milliliters per second | Standard Deviation 0.3498 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 3, Week 24, n= 218 | 0.093 Milliliters per second | Standard Deviation 0.38 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 3, Week 48, n= 209 | 0.093 Milliliters per second | Standard Deviation 0.3784 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 4, Week 48, n= 194 | 0.084 Milliliters per second | Standard Deviation 0.3628 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 5, Week 24, n= 184 | 0.087 Milliliters per second | Standard Deviation 0.3724 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 5, Week 48, n= 178 | 0.04 Milliliters per second | Standard Deviation 0.3652 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 6, Week 24, n= 175 | 0.035 Milliliters per second | Standard Deviation 0.3971 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 6, Week 48, n= 134 | 0.039 Milliliters per second | Standard Deviation 0.3985 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 7, Week 24, n= 123 | -0.007 Milliliters per second | Standard Deviation 0.4482 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 7, Week 48, n= 97 | 0.005 Milliliters per second | Standard Deviation 0.4424 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 8, Week 24, n= 60 | -0.018 Milliliters per second | Standard Deviation 0.4682 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 8, Week 48, n= 28 | -0.042 Milliliters per second | Standard Deviation 0.2808 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Year 9, Week 24, n= 2 | -0.083 Milliliters per second | Standard Deviation 0.165 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, Exit, n= 235 | 0.011 Milliliters per second | Standard Deviation 0.3986 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine Clearance at the Indicated Time Points | Creatinine clearance, 8 Week, Follow-Up, n= 106 | 0.036 Milliliters per second | Standard Deviation 0.3467 |
Primary
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 3, Week 48, n= 209 | 0.9 Micromoles per liter | Standard Deviation 5.61 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 1, Week 12, n= 248 | 0.165 Micromoles per liter | Standard Deviation 2.4872 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 1, Week 4, n= 250 | -0.2 Micromoles per liter | Standard Deviation 4.69 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 1, Week 12, n= 248 | -0.5 Micromoles per liter | Standard Deviation 4.86 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 1, Week 24, n= 246 | -0.6 Micromoles per liter | Standard Deviation 5.31 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 1, Week 36, n= 237 | -0.4 Micromoles per liter | Standard Deviation 5.07 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 1, Week 48, n= 250 | -0.2 Micromoles per liter | Standard Deviation 5.29 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 2, Week 24, n= 248 | -0.2 Micromoles per liter | Standard Deviation 5.76 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 2, Week 48, n= 233 | 0.3 Micromoles per liter | Standard Deviation 4.78 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 3, Week 24, n= 218 | 0.8 Micromoles per liter | Standard Deviation 5.63 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 4, Week 24, n= 207 | 1.2 Micromoles per liter | Standard Deviation 5.86 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 4, Week 48, n= 194 | 0.9 Micromoles per liter | Standard Deviation 6.05 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 5, Week 24, n= 184 | 1 Micromoles per liter | Standard Deviation 5.52 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 5, Week 48, n= 178 | 1.2 Micromoles per liter | Standard Deviation 6.49 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 6, Week 24, n= 175 | 1.2 Micromoles per liter | Standard Deviation 5.79 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 6, Week 48, n= 134 | 1 Micromoles per liter | Standard Deviation 6.38 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 7, Week 24, n= 123 | 1.1 Micromoles per liter | Standard Deviation 5.75 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 7, Week 48, n= 97 | 0.7 Micromoles per liter | Standard Deviation 5.42 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 8, Week 24, n= 60 | 0.8 Micromoles per liter | Standard Deviation 5.09 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 8, Week 48, n= 28 | 0.4 Micromoles per liter | Standard Deviation 5.28 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Year 9, Week 24, n= 2 | -0.5 Micromoles per liter | Standard Deviation 0.71 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, Exit, n= 235 | 1.1 Micromoles per liter | Standard Deviation 5.57 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Creatinine, 8 Week, Follow-Up, n= 107 | 1.3 Micromoles per liter | Standard Deviation 5.99 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 1, Week 4, n= 251 | -1.653 Micromoles per liter | Standard Deviation 46.0197 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 1, Week 12, n= 248 | -5.5803 Micromoles per liter | Standard Deviation 52.2256 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 1, Week 24, n= 246 | -11.6488 Micromoles per liter | Standard Deviation 55.2277 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 1, Week 36, n= 238 | -9.984 Micromoles per liter | Standard Deviation 57.2999 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 1, Week 48, n= 250 | -4.108 Micromoles per liter | Standard Deviation 58.0533 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 2, Week 24, n= 248 | -6.4785 Micromoles per liter | Standard Deviation 57.0915 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 2, Week 48, n= 233 | -4.6501 Micromoles per liter | Standard Deviation 60.3008 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 3, Week 24, n= 218 | 1.6919 Micromoles per liter | Standard Deviation 63.7367 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 3, Week 48, n= 209 | -4.5543 Micromoles per liter | Standard Deviation 66.183 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 4, Week 24, n= 207 | -4.8112 Micromoles per liter | Standard Deviation 60.2771 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 4, Week 48, n= 194 | -2.0736 Micromoles per liter | Standard Deviation 60.7226 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 5, Week 24, n= 184 | -5.296 Micromoles per liter | Standard Deviation 65.2308 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 5, Week 48, n= 178 | -5.7908 Micromoles per liter | Standard Deviation 65.6118 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 6, Week 24, n= 175 | -2.084 Micromoles per liter | Standard Deviation 73.3489 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 6, Week 48, n= 134 | -8.7672 Micromoles per liter | Standard Deviation 74.9078 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 7, Week 24, n= 123 | -2.0775 Micromoles per liter | Standard Deviation 72.282 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 7, Week 48, n= 97 | -0.1021 Micromoles per liter | Standard Deviation 60.8139 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 8, Week 24, n= 60 | 2.0387 Micromoles per liter | Standard Deviation 66.4246 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 8, Week 48, n= 28 | 1.1266 Micromoles per liter | Standard Deviation 62.7192 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Year 9, Week 24, n= 2 | -1.782 Micromoles per liter | Standard Deviation 16.402 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, Exit, n= 235 | -7.3728 Micromoles per liter | Standard Deviation 71.4811 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Urate, 8 Week, Follow-Up, n= 107 | -6.6934 Micromoles per liter | Standard Deviation 84.8414 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 1, Week 4, n= 251 | 0.008 Micromoles per liter | Standard Deviation 2.0889 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 1, Week 24, n= 246 | 0.075 Micromoles per liter | Standard Deviation 2.2546 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 1, Week 36, n= 238 | 0.124 Micromoles per liter | Standard Deviation 2.4316 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 1, Week 48, n= 250 | 0.231 Micromoles per liter | Standard Deviation 2.3675 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 2, Week 24, n= 248 | 0.359 Micromoles per liter | Standard Deviation 2.7306 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 2, Week 48, n= 233 | 0.307 Micromoles per liter | Standard Deviation 3.0385 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 3, Week 24, n= 218 | 0.249 Micromoles per liter | Standard Deviation 2.8298 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 3, Week 48, n= 209 | -0.115 Micromoles per liter | Standard Deviation 2.548 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 4, Week 24, n= 207 | -0.276 Micromoles per liter | Standard Deviation 2.6718 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 4, Week 48, n= 194 | -0.156 Micromoles per liter | Standard Deviation 2.823 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 5, Week 24, n= 184 | -0.147 Micromoles per liter | Standard Deviation 2.8668 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 5, Week 48, n= 178 | 0.13 Micromoles per liter | Standard Deviation 2.7449 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 6, Week 24, n= 175 | -0.067 Micromoles per liter | Standard Deviation 2.7954 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 6, Week 48, n= 134 | 0.268 Micromoles per liter | Standard Deviation 2.6834 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 7, Week 24, n= 123 | -0.071 Micromoles per liter | Standard Deviation 2.7018 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 7, Week 48, n= 97 | 0.285 Micromoles per liter | Standard Deviation 2.85 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 8, Week 24, n= 60 | 0.529 Micromoles per liter | Standard Deviation 2.8249 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 8, Week 48, n= 28 | 0.175 Micromoles per liter | Standard Deviation 2.4435 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Year 9, Week 24, n= 2 | -0.45 Micromoles per liter | Standard Deviation 1.4142 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, Exit, n= 235 | 0.403 Micromoles per liter | Standard Deviation 2.8268 |
| Belimumab 10 mg/kg IV | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Bilirubin, 8 Week, Follow-Up, n= 107 | -0.191 Micromoles per liter | Standard Deviation 3.2759 |
Primary
Change From Baseline in Erythrocytes at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 3, Week 24, n= 219 | 0.06 Trillions cells per liter | Standard Deviation 0.361 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 6, Week 24, n= 176 | 0.13 Trillions cells per liter | Standard Deviation 0.405 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 8, Week 48, n= 29 | 0.39 Trillions cells per liter | Standard Deviation 0.403 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 1, Week 4, n= 257 | 0 Trillions cells per liter | Standard Deviation 0.243 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 1, Week 12, n= 249 | 0.01 Trillions cells per liter | Standard Deviation 0.284 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 1, Week 24, n= 250 | 0.04 Trillions cells per liter | Standard Deviation 0.291 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 1, Week 36, n= 240 | 0.03 Trillions cells per liter | Standard Deviation 0.309 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 1, Week 48, n= 254 | 0.06 Trillions cells per liter | Standard Deviation 0.337 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 2, Week 24, n= 249 | 0.06 Trillions cells per liter | Standard Deviation 0.341 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 2, Week 48, n= 233 | 0.04 Trillions cells per liter | Standard Deviation 0.338 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 3, Week 48, n= 211 | 0.04 Trillions cells per liter | Standard Deviation 0.362 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 4, Week 24, n= 210 | 0.03 Trillions cells per liter | Standard Deviation 0.37 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 4, Week 48, n= 194 | 0.07 Trillions cells per liter | Standard Deviation 0.376 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 5, Week 24, n= 189 | 0.08 Trillions cells per liter | Standard Deviation 0.395 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 5, Week 48, n= 184 | 0.1 Trillions cells per liter | Standard Deviation 0.412 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 6, Week 48, n= 132 | 0.19 Trillions cells per liter | Standard Deviation 0.393 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 7, Week 24, n= 122 | 0.2 Trillions cells per liter | Standard Deviation 0.438 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 7, Week 48, n= 96 | 0.19 Trillions cells per liter | Standard Deviation 0.441 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 8, Week 24, n= 60 | 0.25 Trillions cells per liter | Standard Deviation 0.404 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Year 9, Week 24, n= 2 | 0.1 Trillions cells per liter | Standard Deviation 0 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, Exit, n= 233 | 0.26 Trillions cells per liter | Standard Deviation 0.398 |
| Belimumab 10 mg/kg IV | Change From Baseline in Erythrocytes at the Indicated Time Points | Erythrocytes, 8 Week, Follow-Up, n= 106 | 0.2 Trillions cells per liter | Standard Deviation 0.415 |
Primary
Change From Baseline in Hematocrit at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 1, Week 12, n= 249 | 0.11 Percentage | Standard Deviation 2.62 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 5, Week 48, n= 184 | 1.98 Percentage | Standard Deviation 3.943 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 6, Week 24, n= 176 | 2.16 Percentage | Standard Deviation 3.94 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 7, Week 24, n= 122 | 2.34 Percentage | Standard Deviation 4.166 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 8, Week 24, n= 60 | 2.68 Percentage | Standard Deviation 3.807 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 1, Week 4, n= 257 | 0.16 Percentage | Standard Deviation 2.247 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 1, Week 24, n= 250 | 0.31 Percentage | Standard Deviation 2.683 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 1, Week 36, n= 240 | 0.2 Percentage | Standard Deviation 2.836 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 1, Week 48, n= 254 | 0.73 Percentage | Standard Deviation 3.087 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 2, Week 24, n= 249 | 0.81 Percentage | Standard Deviation 3.321 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 2, Week 48, n= 233 | 1.09 Percentage | Standard Deviation 3.433 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 3, Week 24, n= 219 | 1.4 Percentage | Standard Deviation 3.604 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 3, Week 48, n= 211 | 1.53 Percentage | Standard Deviation 3.545 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 4, Week 24, n= 210 | 1.39 Percentage | Standard Deviation 3.448 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 4, Week 48, n= 194 | 1.67 Percentage | Standard Deviation 3.414 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 5, Week 24, n= 189 | 1.78 Percentage | Standard Deviation 3.596 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 6, Week 48, n= 132 | 2.49 Percentage | Standard Deviation 3.561 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 7, Week 48, n= 96 | 1.86 Percentage | Standard Deviation 4.108 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 8, Week 48, n= 29 | 3.49 Percentage | Standard Deviation 3.554 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Year 9, Week 24, n= 2 | 0.7 Percentage | Standard Deviation 0.99 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, Exit, n= 233 | 3.25 Percentage | Standard Deviation 3.613 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit, 8 Week, Follow-Up, n= 106 | 3.04 Percentage | Standard Deviation 3.478 |
Primary
Change From Baseline in Hemoglobin at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 1, Week 12, n= 249 | 0.3 Grams per liter | Standard Deviation 8.17 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 1, Week 4, n= 257 | 0 Grams per liter | Standard Deviation 7.03 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 1, Week 24, n= 250 | 0.5 Grams per liter | Standard Deviation 8.81 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 1, Week 36, n= 240 | 0.5 Grams per liter | Standard Deviation 9.51 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 1, Week 48, n= 254 | 2.1 Grams per liter | Standard Deviation 10.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 2, Week 24, n= 250 | 2.5 Grams per liter | Standard Deviation 11.07 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 2, Week 48, n= 233 | 2.4 Grams per liter | Standard Deviation 11.76 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 3, Week 24, n= 219 | 3.7 Grams per liter | Standard Deviation 11.93 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 3, Week 48, n= 211 | 3.9 Grams per liter | Standard Deviation 11.86 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 4, Week 24, n= 210 | 2.5 Grams per liter | Standard Deviation 11.91 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 4, Week 48, n= 194 | 3.2 Grams per liter | Standard Deviation 11.82 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 5, Week 24, n= 189 | 3.7 Grams per liter | Standard Deviation 12.44 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 5, Week 48, n= 184 | 3.7 Grams per liter | Standard Deviation 13.71 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 6, Week 24, n= 176 | 3.7 Grams per liter | Standard Deviation 13.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 6, Week 48, n= 132 | 4.2 Grams per liter | Standard Deviation 13.13 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 7, Week 24, n= 122 | 3.3 Grams per liter | Standard Deviation 14.73 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 7, Week 48, n= 96 | 2.6 Grams per liter | Standard Deviation 14.98 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 8, Week 24, n= 60 | 5.2 Grams per liter | Standard Deviation 12.78 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 8, Week 48, n= 29 | 8.4 Grams per liter | Standard Deviation 12.98 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Year 9, Week 24, n= 2 | -3 Grams per liter | Standard Deviation 2.83 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, Exit, n= 233 | 7.2 Grams per liter | Standard Deviation 12.46 |
| Belimumab 10 mg/kg IV | Change From Baseline in Hemoglobin at the Indicated Time Points | Hemoglobin, 8 Week, Follow-Up, n= 106 | 6.5 Grams per liter | Standard Deviation 11.93 |
Primary
Number of Participants With the Indicated Immunogenic Response
Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur 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 Week 440
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 2-3, n=240 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 3-4, n=214 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 4-5, n=195 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 7 plus, n=63 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 1-2, n=255 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 2-3, n=240 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 3-4, n=214 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 4-5, n=195 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 6-7, n=125 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 7 plus, n=63 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 6-7, n=125 | 125 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 0-1, n=267 | 262 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 1-2, n=255 | 251 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 2-3, n=240 | 239 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 5-6, n=185 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 3-4, n=214 | 213 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 4-5, n=195 | 195 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 5-6, n=185 | 185 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Negative, Year 7 plus, n=63 | 63 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 0-1, n=267 | 5 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 1-2, n=255 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 2-3, n=240 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 3-4, n=214 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 4-5, n=195 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 6-7, n=125 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Transient positive, Year 7 plus, n=63 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 0-1, n=267 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 1-2, n=255 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 5-6, n=185 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Persistent positive, Year 6-7, n=125 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 0-1, n=267 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Immunogenic Response | Unknown, Year 5-6, n=185 | 0 Participants |
Primary
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.
Time frame: Up to Week 440
Population: Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Any time post baseline, n=268 | 267 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 0-1, n=268 | 260 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 1-2, n=259 | 235 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 2-3, n=244 | 206 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 3-4, n=219 | 184 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 4-5, n=202 | 167 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 5-6, n=192 | 145 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 6-7, n=130 | 87 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | AE, Year 7 plus, n=65 | 31 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Any time post baseline, n=268 | 112 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 0-1, n=268 | 33 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 1-2, n=259 | 30 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 2-3, n=244 | 25 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 3-4, n=219 | 22 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 4-5, n=202 | 24 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 5-6, n=192 | 16 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 6-7, n=130 | 13 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | SAE, Year 7 plus, n=65 | 3 Participants |
Primary
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 5-6, n= 59, 132 | 5.1 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 3-4, n= 68, 150 | 4.4 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 7+, n= 0, 65 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 4-5, n= 61, 139 | 4.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 0-1, n= 91, 177 | 7.7 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 6-7, n= 12, 118 | 8.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 1-2, n= 79, 177 | 3.8 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 2-3, n= 75, 168 | 2.7 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 7+, n= 0, 65 | 10.8 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 1-2, n= 79, 177 | 20.3 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 5-6, n= 59, 132 | 9.1 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 2-3, n= 75, 168 | 8.3 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 3-4, n= 68, 150 | 6 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 4-5, n= 61, 139 | 9.4 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 6-7, n= 12, 118 | 11.9 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. | Year 0-1, n= 91, 177 | 23.2 Percentage of Participants |
Primary
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 440
Population: MITT Population. Only those subjects with abnormal (\>124 umol/L) creatinine at baseline by year interval.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 4-5, n= 2, 2 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 6-7, n= 1, 1 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 0-1, n= 6, 3 | 16.7 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 1-2, n= 5, 3 | 20 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 2-3, n= 3, 3 | 33.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 3-4, n= 2, 2 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 5-6, n= 2, 2 | 50 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 7+, n= 0, 0 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 7+, n= 0, 0 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 4-5, n= 2, 2 | 50 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 2-3, n= 3, 3 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 6-7, n= 1, 1 | 100 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 5-6, n= 2, 2 | 0 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 0-1, n= 6, 3 | 33.3 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 3-4, n= 2, 2 | 50 Percentage of Participants |
| Belimumab 10 mg/kg IV (Belimumab) | Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. | Year 1-2, n= 5, 3 | 0 Percentage of Participants |
Primary
SAE Rates by System Organ Class (SOC) During the Study
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 Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / participants Years. participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/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 Week 440
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Injury, poisoning and procedural complications | 1.4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Psychiatric disorders | 0.5 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Renal and urinary disorders | 0.5 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Hepatobiliary disorders | 0.4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Infections and infestations | 4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Gastrointestinal disorders | 2.2 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Musculoskeletal and connective tissue disorders | 2 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | General disorders and administration sitecondition | 1.7 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Nervous system disorders | 1.4 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Vascular disorders | 1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Neoplasms benign, malignant and unspecified | 1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Respiratory, thoracic and mediastinal disorders | 0.7 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Cardiac disorders | 0.6 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Metabolism and nutrition disorders | 0.6 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Blood and lymphatic system disorders | 0.3 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Reproductive system and breast disorders | 0.3 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Immune system disorders | 0.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Investigations | 0.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Skin and subcutaneous tissue disorders | 0.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Congenital, familial and genetic disorders | 0.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Endocrine disorders | 0.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Eye disorders | 0.1 Adverse events/100 participant-years |
| Belimumab 10 mg/kg IV | SAE Rates by System Organ Class (SOC) During the Study | Pregnancy, puerperium and perinatal conditions | 0.1 Adverse events/100 participant-years |
Primary
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 1 , Week 24, n= 255 | 74.5 Millimeters of mercury | Standard Deviation 9.96 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 2 , Week 24, n= 251 | 74.5 Millimeters of mercury | Standard Deviation 11.01 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 2 , Week 48, n= 236 | 73.5 Millimeters of mercury | Standard Deviation 10.17 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 3 , Week 24, n= 223 | 73.6 Millimeters of mercury | Standard Deviation 10.32 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 3 , Week 48, n= 214 | 73.4 Millimeters of mercury | Standard Deviation 10.12 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 4 , Week 24, n= 214 | 74.4 Millimeters of mercury | Standard Deviation 9.56 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 4 , Week 48, n= 199 | 75.2 Millimeters of mercury | Standard Deviation 10.52 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 5 , Week 24, n= 187 | 74.3 Millimeters of mercury | Standard Deviation 9.89 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 5 , Week 48, n= 185 | 73.4 Millimeters of mercury | Standard Deviation 10.15 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 1 , Week 24, n= 255 | 120 Millimeters of mercury | Standard Deviation 16.14 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 3 , Week 48, n= 214 | 120.2 Millimeters of mercury | Standard Deviation 14.44 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 4 , Week 48, n= 199 | 121.4 Millimeters of mercury | Standard Deviation 15.03 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 6 , Week 48, n= 138 | 121.7 Millimeters of mercury | Standard Deviation 15.86 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 7 , Week 24, n= 124 | 121.6 Millimeters of mercury | Standard Deviation 14.73 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 7 , Week 48, n= 98 | 120.6 Millimeters of mercury | Standard Deviation 14.19 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 8 , Week 24, n= 60 | 120.5 Millimeters of mercury | Standard Deviation 14.65 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 6 , Week 48, n= 138 | 73.9 Millimeters of mercury | Standard Deviation 10.78 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Baseline, n= 268 | 74.3 Millimeters of mercury | Standard Deviation 9.92 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 7 , Week 24, n= 124 | 75.2 Millimeters of mercury | Standard Deviation 9.5 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 7 , Week 48, n= 98 | 73.1 Millimeters of mercury | Standard Deviation 9.94 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 1 , Week 48, n= 255 | 73.5 Millimeters of mercury | Standard Deviation 9.92 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 8 , Week 24, n= 60 | 73.4 Millimeters of mercury | Standard Deviation 9.79 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 8 , Week 48, n= 29 | 73.6 Millimeters of mercury | Standard Deviation 8.27 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 9 , Week 24, n= 2 | 90 Millimeters of mercury | Standard Deviation 12.73 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Year 6 , Week 24, n= 178 | 74.1 Millimeters of mercury | Standard Deviation 10.25 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | DBP, Exit, n= 233 | 75.2 Millimeters of mercury | Standard Deviation 9.77 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Baseline, n= 268 | 119.7 Millimeters of mercury | Standard Deviation 15.75 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 1 , Week 48, n= 255 | 120.2 Millimeters of mercury | Standard Deviation 14.66 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 2 , Week 24, n= 251 | 120.1 Millimeters of mercury | Standard Deviation 16.49 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 4 , Week 24, n= 214 | 121.4 Millimeters of mercury | Standard Deviation 14.61 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 5 , Week 24, n= 187 | 120.7 Millimeters of mercury | Standard Deviation 14.92 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 5 , Week 48, n= 185 | 119.9 Millimeters of mercury | Standard Deviation 15.29 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 2 , Week 48, n= 236 | 119.1 Millimeters of mercury | Standard Deviation 15.22 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 6 , Week 24, n= 178 | 121.5 Millimeters of mercury | Standard Deviation 15.29 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 3 , Week 24, n= 223 | 120.7 Millimeters of mercury | Standard Deviation 16.23 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 8 , Week 48, n= 29 | 118.2 Millimeters of mercury | Standard Deviation 11.73 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Year 9 , Week 24, n= 2 | 115.5 Millimeters of mercury | Standard Deviation 6.36 |
| Belimumab 10 mg/kg IV | Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. | SBP, Exit, n= 233 | 123.3 Millimeters of mercury | Standard Deviation 15.53 |
Secondary
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).
Time frame: Up to Week 384
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 1, Week 48, n= 260 | 4.91 Score on a scale | Standard Deviation 10.785 |
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 2, Week 48, n= 252 | 4.82 Score on a scale | Standard Deviation 11.414 |
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 3, Week 48, n= 235 | 4.85 Score on a scale | Standard Deviation 11.614 |
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 4, Week 48, n= 210 | 4.14 Score on a scale | Standard Deviation 11.269 |
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 5, Week 48, n= 193 | 4.81 Score on a scale | Standard Deviation 11.962 |
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 6, Week 48, n= 184 | 3.7 Score on a scale | Standard Deviation 11.787 |
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 7, Week 48, n= 126 | 5.74 Score on a scale | Standard Deviation 11.644 |
| Belimumab 10 mg/kg IV | Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point | Year 8, Week 48, n= 65 | 4.28 Score on a scale | Standard Deviation 10.949 |
Secondary
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).
Time frame: Up to Week 384
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 5, Week 48, n= 193 | 2.22 Score on a scale | Standard Deviation 11.22 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 7, Week 48, n= 126 | 3.19 Score on a scale | Standard Deviation 11.269 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 4, Week 48, n= 212 | 5.01 Score on a scale | Standard Deviation 8.752 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 5, Week 48, n= 193 | 6.12 Score on a scale | Standard Deviation 9.314 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 6, Week 48, n= 185 | 4.79 Score on a scale | Standard Deviation 9.406 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 1, Week 48, n= 259 | 2.47 Score on a scale | Standard Deviation 10.113 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 2, Week 48, n= 255 | 2.99 Score on a scale | Standard Deviation 10.428 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 3, Week 48, n= 236 | 2.54 Score on a scale | Standard Deviation 10.399 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 4, Week 48, n= 212 | 2.52 Score on a scale | Standard Deviation 11.099 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 6, Week 48, n= 185 | 2.71 Score on a scale | Standard Deviation 11.274 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | MCS, Year 8, Week 48, n= 65 | 3.91 Score on a scale | Standard Deviation 11.066 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 1, Week 48, n= 259 | 3.41 Score on a scale | Standard Deviation 8.603 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 2, Week 48, n= 255 | 4.64 Score on a scale | Standard Deviation 8.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 3, Week 48, n= 236 | 5.93 Score on a scale | Standard Deviation 8.51 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 7, Week 48, n= 126 | 7.7 Score on a scale | Standard Deviation 9.887 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point | PCS, Year 8, Week 48, n= 65 | 6.73 Score on a scale | Standard Deviation 10.107 |
Secondary
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).
Time frame: Up to Week 384
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 1 , Week 48, n= 261 | 9.7 Score on a scale | Standard Deviation 23.36 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 5 , Week 48, n= 193 | 10.88 Score on a scale | Standard Deviation 24.549 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 1 , Week 48, n= 260 | 5.66 Score on a scale | Standard Deviation 14.693 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 3 , Week 48, n= 236 | 7.85 Score on a scale | Standard Deviation 21.994 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 3 , Week 48, n= 236 | 3.73 Score on a scale | Standard Deviation 28.258 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 8 , Week 48, n=65 | 7.18 Score on a scale | Standard Deviation 33.91 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 2 , Week 48, n= 255 | 9.2 Score on a scale | Standard Deviation 24.389 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 3 , Week 48, n= 236 | 10.97 Score on a scale | Standard Deviation 23.409 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 4 , Week 48, n= 212 | 8.33 Score on a scale | Standard Deviation 24.181 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 6 , Week 48, n= 185 | 8.82 Score on a scale | Standard Deviation 23.636 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 7 , Week 48, n= 126 | 14.48 Score on a scale | Standard Deviation 24.969 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Bodily pain, Year 8 , Week 48, n= 65 | 11.94 Score on a scale | Standard Deviation 22.93 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 2 , Week 48, n= 255 | 6.14 Score on a scale | Standard Deviation 15.156 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 3 , Week 48, n= 236 | 8.84 Score on a scale | Standard Deviation 15.929 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 4 , Week 48, n= 212 | 7.29 Score on a scale | Standard Deviation 16.069 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 5 , Week 48, n= 193 | 9.19 Score on a scale | Standard Deviation 17.742 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 6 , Week 48, n= 185 | 7.24 Score on a scale | Standard Deviation 18.187 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 7 , Week 48, n= 126 | 8.71 Score on a scale | Standard Deviation 18.693 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | General health, Year 8 , Week 48, n= 65 | 8.18 Score on a scale | Standard Deviation 19.994 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 1 , Week 48, n= 260 | 4 Score on a scale | Standard Deviation 17.71 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 2 , Week 48, n= 255 | 3.62 Score on a scale | Standard Deviation 17.46 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 3 , Week 48, n= 236 | 2.34 Score on a scale | Standard Deviation 17.817 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 4 , Week 48, n= 212 | 2.33 Score on a scale | Standard Deviation 20.172 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 5 , Week 48, n= 193 | 1.78 Score on a scale | Standard Deviation 20.662 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 6 , Week 48, n= 185 | 3.6 Score on a scale | Standard Deviation 19.968 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 7 , Week 48, n= 126 | 4.39 Score on a scale | Standard Deviation 19.811 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Mental health, Year 8 , Week 48, n= 65 | 6.08 Score on a scale | Standard Deviation 18.551 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 1 , Week 48, n= 260 | 6.34 Score on a scale | Standard Deviation 21.498 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 2 , Week 48, n= 255 | 6.25 Score on a scale | Standard Deviation 21.185 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 4 , Week 48, n= 212 | 6.38 Score on a scale | Standard Deviation 22.112 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 5 , Week 48, n= 193 | 7.62 Score on a scale | Standard Deviation 24.486 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 6 , Week 48, n= 185 | 6.72 Score on a scale | Standard Deviation 24.81 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 7 , Week 48, n= 126 | 11.25 Score on a scale | Standard Deviation 26.422 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Physical functioning, Year 8 , Week 48, n= 65 | 11.83 Score on a scale | Standard Deviation 27.065 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 1 , Week 48, n= 261 | 4.96 Score on a scale | Standard Deviation 25.714 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 2 , Week 48, n= 254 | 4.74 Score on a scale | Standard Deviation 27.92 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 4 , Week 48, n= 212 | 3.32 Score on a scale | Standard Deviation 28.237 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 5 , Week 48, n= 193 | 3.61 Score on a scale | Standard Deviation 28.774 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 6 , Week 48, n= 185 | 3.13 Score on a scale | Standard Deviation 31.614 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role emotional, Year 7 , Week 48, n= 126 | 3.27 Score on a scale | Standard Deviation 30.385 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 1 , Week 48, n= 260 | 8.91 Score on a scale | Standard Deviation 26.393 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 2 , Week 48, n= 253 | 8 Score on a scale | Standard Deviation 27.106 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 3 , Week 48, n= 236 | 10.05 Score on a scale | Standard Deviation 26.525 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 4 , Week 48, n= 212 | 8.27 Score on a scale | Standard Deviation 28.998 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 5 , Week 48, n= 193 | 10.86 Score on a scale | Standard Deviation 29.839 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 6 , Week 48, n= 185 | 6.91 Score on a scale | Standard Deviation 30.995 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 7 , Week 48, n= 126 | 13.53 Score on a scale | Standard Deviation 31.347 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Role physical, Year 8 , Week 48, n= 65 | 11.51 Score on a scale | Standard Deviation 34.385 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 1 , Week 48, n= 261 | 7.61 Score on a scale | Standard Deviation 26.901 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 2 , Week 48, n= 255 | 7.21 Score on a scale | Standard Deviation 27.218 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 3 , Week 48, n= 236 | 9.59 Score on a scale | Standard Deviation 27.989 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 4 , Week 48, n= 212 | 6.9 Score on a scale | Standard Deviation 28.598 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 5 , Week 48, n= 193 | 8.16 Score on a scale | Standard Deviation 30.079 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 6 , Week 48, n= 185 | 6.96 Score on a scale | Standard Deviation 28.695 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 7 , Week 48, n= 126 | 10.32 Score on a scale | Standard Deviation 31.784 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Social functioning, Year 8 , Week 48, n= 65 | 9.81 Score on a scale | Standard Deviation 32.135 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 1 , Week 48, n= 260 | 8.87 Score on a scale | Standard Deviation 21.449 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 2 , Week 48, n= 255 | 7.13 Score on a scale | Standard Deviation 22.287 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 3 , Week 48, n= 236 | 8.17 Score on a scale | Standard Deviation 20.742 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 4 , Week 48, n= 212 | 8.04 Score on a scale | Standard Deviation 21.742 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 5 , Week 48, n= 193 | 8.23 Score on a scale | Standard Deviation 24.937 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 6 , Week 48, n= 185 | 6.93 Score on a scale | Standard Deviation 23.023 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 7 , Week 48, n= 126 | 11.69 Score on a scale | Standard Deviation 22.709 |
| Belimumab 10 mg/kg IV | Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints | Vitality, Year 8 , Week 48, n= 65 | 6.47 Score on a scale | Standard Deviation 22.033 |
Secondary
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 1, Week 24, n= 128 | -9.77 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 1, Week 48, n= 130 | -15.58 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 2, Week 24, n= 126 | -27.5 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 2, Week 48, n= 128 | -30.12 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 3, Week 24, n= 120 | -34.22 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 3, Week 48, n= 116 | -34.92 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 4, Week 24, n= 112 | -38.58 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 4, Week 48, n= 100 | -54.46 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 5, Week 24, n= 98 | -54.39 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 5, Week 48, n= 96 | -64.43 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 6, Week 24, n= 87 | -64.04 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 6, Week 48, n= 66 | -64.91 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 7, Week 24, n= 63 | -74.74 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 7, Week 48, n= 48 | -78.15 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 8, Week 24, n= 35 | -79.1 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 8, Week 48, n= 16 | -72.38 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Year 9, Week 24, n= 1 | -77.6 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. | Exit, n= 120 | -66.67 Percentage change |
Secondary
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 1, Wk 24, n= 245 | -31.82 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 1, Wk 48, n= 237 | -51.61 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 2, Wk 24, n= 233 | -61.76 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 2, Wk 48, n= 218 | -66.21 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 3, Wk 24, n= 206 | -69.68 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 3, Wk 48, n= 196 | -72.77 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 4, Wk 24, n= 191 | -75.16 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 4, Wk 48, n= 175 | -78.33 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 6, Wk 48, n= 109 | -82.94 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 5, Wk 24, n= 166 | -80.26 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 5, Wk 48, n= 161 | -81.06 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 6, Wk 24, n= 154 | -81.87 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 7, Wk 24, n= 107 | -83.22 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 7, Wk 48, n= 82 | -80.96 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 8, Wk 24, n= 52 | -78.94 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 8, Wk 48, n= 27 | -85.29 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Yr 9, Wk 24, n= 2 | -63.65 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+, Exit, n= 203 | -80.6 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 24, n= 243 | -16.13 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 48, n= 240 | -38.74 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 24, n= 239 | -25 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 24, n= 210 | -33.97 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 24, n= 204 | -19.52 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 48, n= 187 | -16.67 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 48, n= 174 | -37.46 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 24, n= 167 | -44.44 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 48, n= 126 | -50 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 24, n= 57 | -71.43 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 48, n= 28 | -85 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 9, Wk 24, n= 2 | 210.98 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Exit, n= 226 | -50 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 1, Wk 24, n= 238 | -32.29 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 1, Wk 48, n= 235 | -40 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 2, Wk 48, n= 221 | -30 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 3, Wk 48, n= 199 | -40.54 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 4, Wk 24, n= 199 | -29.41 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 4, Wk 48, n= 184 | -29.29 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 5, Wk 24, n= 178 | -44.6 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 5, Wk 48, n= 171 | -45.65 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 6, Wk 24, n= 165 | -62.5 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 7, Wk 24, n= 114 | -47.5 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 7, Wk 48, n= 89 | -58.33 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 8, Wk 24, n= 55 | -62.07 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 8, Wk 48, n= 27 | -84.62 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 9, Wk 24, n= 1 | -79.4 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Exit, n= 224 | -51.42 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 1, Wk 24, n= 243 | -32.49 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 1, Wk 48, n= 240 | -61.11 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 2, Wk 24, n= 239 | -66 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 2, Wk 48, n= 225 | -70.64 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 3, Wk 48, n= 204 | -88.89 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 4, Wk 48, n= 186 | -94.17 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 5, Wk 24, n= 181 | -96.25 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 5, Wk 48, n= 174 | -96.75 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 6, Wk 24, n= 167 | -96.53 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 6, Wk 48, n= 126 | -97.96 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 8, Wk 24, n= 57 | -98.64 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 8, Wk 48, n= 28 | -98.68 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 9, Wk 24, n= 2 | -96.15 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Exit, n= 225 | -96.83 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 1, Wk 24, n= 244 | 87.65 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 2, Wk 24, n= 233 | 11.11 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 2, Wk 48, n= 217 | -7.69 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 3, Wk 24, n= 205 | -23.26 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 3, Wk 48, n= 196 | -35.29 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 4, Wk 24, n= 191 | -40 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 4, Wk 48, n= 175 | -50 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 5, Wk 24, n= 166 | -50 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 6, Wk 24, n= 153 | -57.89 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 6, Wk 48, n= 108 | -63.4 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 7, Wk 24, n= 106 | -67.18 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 7, Wk 48, n= 81 | -71.43 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 8, Wk 48, n= 27 | -64.71 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Exit, n= 202 | -61.41 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 1, Wk 24, n= 245 | -55.56 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 1, Wk 48, n= 237 | -69.7 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 2, Wk 24, n= 233 | -77.27 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 7, Wk 24, n= 107 | -87.39 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 7, Wk 48, n= 82 | -84.78 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 9, Wk 24, n= 2 | -61.93 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 1, Wk 24, n= 240 | -33.35 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 2, Wk 48, n= 223 | -72.31 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 4, Wk 24, n= 201 | -93.14 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 5, Wk 24, n= 180 | -96.99 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 6, Wk 24, n= 165 | -98.04 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 1, Wk 24, n= 244 | -37.2 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 3, Wk 24, n= 212 | -64.82 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 4, Wk 48, n= 187 | -81.58 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Exit, n= 226 | -88.58 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 3, Wk 48, n= 209 | -74.24 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 5, Wk 48, n= 179 | -81.14 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 7, Wk 24, n= 120 | -82.73 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 9, Wk 24, n= 2 | -66.04 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Exit, n= 232 | -80.81 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 6, Wk 48, n= 123 | -62.5 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 3, Wk 24, n= 211 | -78.57 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 4, Wk 24, n= 204 | -93.14 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 7, Wk 24, n= 117 | -98 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 7, Wk 48, n= 91 | -98.46 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 1, Wk 48, n= 237 | 42.86 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 5, Wk 48, n= 160 | -58.87 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 8, Wk 24, n= 52 | -67.03 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 9, Wk 24, n= 2 | -75.96 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 2, Wk 48, n= 218 | -79.5 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 3, Wk 24, n= 206 | -80.11 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 3, Wk 48, n= 196 | -84.41 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 4, Wk 24, n= 191 | -81.93 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 4, Wk 48, n= 175 | -84.21 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 5, Wk 24, n= 166 | -86.09 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 5, Wk 48, n= 161 | -87.5 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 6, Wk 24, n= 154 | -86.88 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 6, Wk 48, n= 109 | -86.93 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 8, Wk 24, n= 52 | -83.7 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 8, Wk 48, n= 27 | -88.15 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/27-naive, Exit, n= 203 | -86.42 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 1, Wk 48, n= 238 | -56.33 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 2, Wk 24, n= 236 | -65.21 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 3, Wk 24, n= 208 | -83.71 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 3, Wk 48, n= 202 | -89.28 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 4, Wk 48, n= 185 | -94.85 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 5, Wk 48, n= 172 | -98.04 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 6, Wk 48, n= 125 | -98.76 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 7, Wk 24, n= 116 | -98.85 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 7, Wk 48, n=89 | -99.22 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 8, Wk 24, n= 56 | -99.33 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 8, Wk 48, n= 28 | -99.71 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 9, Wk 24, n= 2 | -97.92 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20+/69+activated, Exit, n= 226 | -98.99 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 1, Wk 48, n= 241 | -50 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 2, Wk 24, n= 240 | -47.83 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 2, Wk 48, n= 226 | -53.92 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 3, Wk 48, n= 205 | -71.43 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 4, Wk 24, n= 205 | -73.76 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 5, Wk 24, n= 182 | -86.46 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 5, Wk 48, n= 175 | -88.89 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 6, Wk 24, n= 168 | -91.3 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 6, Wk 48, n= 127 | -90.91 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 7, Wk 24, n= 118 | -92.31 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 7, Wk 48, n= 92 | -93.83 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 8, Wk 24, n= 57 | -93.39 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 8, Wk 48, n= 28 | -97.56 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 9, Wk 24, n= 2 | -80.78 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 1, Wk 24, n= 250 | -32.56 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 1, Wk 48, n= 251 | -51.61 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 2, Wk 24, n= 244 | -61.71 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 2, Wk 48, n= 231 | -66.67 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 3, Wk 24, n= 217 | -70.21 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 4, Wk 24, n= 209 | -75.61 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 4, Wk 48, n= 192 | -78.54 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 5, Wk 24, n= 187 | -80.56 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 6, Wk 24, n= 172 | -81.85 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 6, Wk 48, n= 130 | -82.34 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 7, Wk 48, n= 95 | -80.95 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 8, Wk 24, n= 59 | -79.87 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 8, Wk 48, n= 28 | -84.79 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 48, n= 225 | -26.23 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 48, n= 204 | -37.98 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 24, n= 182 | -33.33 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 24, n= 117 | -50 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 48, n= 92 | -70.76 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 2, Wk 24, n= 234 | -27.05 Percentage change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 3, Wk 24, n= 207 | -37.5 Percentage change |
Secondary
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 \<90 milligrams per decilitre (mg/dL) and C4 \<16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 3, Week 48, n=83 | 46.15 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 4, Week 24, n=81 | 57.14 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 4, Week 48, n= 66 | 30.63 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 2, Week 48, n= 80 | 16.71 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 3, Week 24, n= 74 | 24.26 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 4, Week 24, n= 72 | 32.43 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 5, Week 24, n= 63 | 33.93 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 5, Week 48, n= 61 | 34.29 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 6, Week 24, n= 55 | 35.71 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 6, Week 48, n= 37 | 34.57 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 7, Week 24, n= 41 | 36.11 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 7, Week 48, n= 32 | 42.04 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 8, Week 24, n= 20 | 36.97 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 8, Week 48, n= 9 | 30.16 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Exit, n= 74 | 39.05 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 1, Week 24, n=95 | 30.77 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 1, Week 48, n=93 | 40 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 2, Week 24, n=93 | 42.86 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 2, Week 48, n=94 | 47.73 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 3, Week 24, n=84 | 50 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 4, Week 48, n=71 | 58.33 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 5, Week 24, n=70 | 70.33 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 5, Week 48, n=70 | 65.15 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 6, Week 24, n=62 | 71.36 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 6, Week 48, n=45 | 57.14 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 7, Week 24, n=49 | 63.64 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 7, Week 48, n=35 | 62.5 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 8, Week 24, n=24 | 78.97 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 9, Week 24, n=1 | 100 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Exit, n=85 | 75 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 1, Week 24, n= 83 | 10.91 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 1, Week 48, n= 83 | 17.86 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 2, Week 24, n= 81 | 18.64 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C3, Year 3, Week 48, n= 73 | 22.73 Percent Change |
| Belimumab 10 mg/kg IV | Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points | C4, Year 8, Week 48, n=12 | 69.74 Percent Change |
Secondary
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (\<0.5 nanograms per milliliter \[ng/mL\]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 392
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Baseline, n=268 | 8 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 1, Week 24, n= 252 | 14 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 1, Week 48, n= 255 | 16 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 2, Week 48, n= 237 | 19 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 3, Week 48, n= 224 | 17 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 4, Week 48, n= 208 | 26 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 5, Week 48, n= 190 | 19 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 6, Week 48, n= 150 | 21 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 7, Week 48, n= 112 | 21 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Year 8, Week 48, n= 59 | 5 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | Exit, n= 235 | 29 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. | 8 Week Follow-Up, n= 106 | 10 Participants |
Secondary
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA \>=30 International Units/milliliter \[IU/mL\]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 3, Week 48, n= 116 | 86.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 8, Week 24, n= 35 | 29 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Baseline, n= 135 | 193 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 1, Week 24, n= 128 | 127.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 1, Week 48, n= 130 | 123 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 2, Week 24, n= 126 | 93.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 2, Week 48, n= 128 | 95 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 3, Week 24, n= 120 | 82.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 4, Week 24, n= 112 | 87.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 4, Week 48, n= 100 | 76.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 5, Week 24, n= 98 | 60 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 5, Week 48, n= 96 | 47.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 6, Week 24, n= 87 | 47 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 6, Week 48, n= 66 | 50 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 7, Week 24, n= 63 | 35 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 7, Week 48, n= 48 | 32 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 8, Week 48, n= 16 | 50.5 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Year 9, Week 24, n= 1 | 45 International units per milliliter |
| Belimumab 10 mg/kg IV | Observed Anti-double Stranded DNA Levels at Indicated Time Points. | Exit, n= 120 | 37 International units per milliliter |
Secondary
Observed B-cell Levels at Indicated Time Points.
B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 48, n= 29 | 5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Baseline, n= 262 | 112.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 1, Wk 24, n= 251 | 68 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 1, Wk 48, n= 242 | 50 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 2, Wk 24, n= 238 | 37.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 2, Wk 48, n= 224 | 34 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 3, Wk 24, n= 212 | 31 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 4, Wk 48, n= 181 | 23 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 5, Wk 24, n= 172 | 22 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 5, Wk 48, n= 166 | 18.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 6, Wk 24, n= 159 | 21 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 6, Wk 48, n= 114 | 20 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 7, Wk 24, n= 111 | 20 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 7, Wk 48, n= 87 | 21 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 8, Wk 24, n= 54 | 17 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 8, Wk 48, n= 28 | 15.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 9, Wk 24, n= 2 | 7.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Exit, n= 207 | 22 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Baseline, n= 262 | 17 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 24, n= 251 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 48, n= 247 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 24, n= 246 | 14 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 48, n= 233 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 24, n= 218 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 48, n= 212 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 24, n= 211 | 14 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 48, n= 194 | 14 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 24, n= 189 | 11 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 48, n= 181 | 11 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 24, n= 174 | 10.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 48, n= 133 | 10 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 24, n= 122 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 48, n= 97 | 8 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 24, n= 60 | 6.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Yr 9, Wk 24, n= 2 | 17.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+/27BRIGHT/38BRIGHT SLE, Exit, n= 232 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Baseline, n= 258 | 16 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 1, Wk 24, n= 247 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 1, Wk 48, n= 244 | 11 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 2, Wk 24, n= 244 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 2, Wk 48, n= 233 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 3, Wk 24, n= 218 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 3, Wk 48, n= 211 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 4, Wk 24, n= 210 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 4, Wk 48, n= 193 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 5, Wk 24, n= 188 | 10.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 5, Wk 48, n= 181 | 10 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 6, Wk 24, n= 174 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 6, Wk 48, n= 133 | 8 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 7, Wk 24, n= 122 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 7, Wk 48, n= 97 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 8, Wk 24, n= 60 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 8, Wk 48, n= 29 | 4 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Yr 9, Wk 24, n= 2 | 16 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD19+20-27hi+ SLPC, Exit, n= 233 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Baseline, n= 261 | 95 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 3, Wk 24, n= 218 | 31 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 1, Wk 24, n= 251 | 64 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 1, Wk 48, n= 247 | 37 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 2, Wk 24, n= 246 | 32.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 2, Wk 48, n= 233 | 27 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 3, Wk 24, n= 218 | 24 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 3, Wk 48, n= 212 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 4, Wk 24, n= 211 | 8 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 4, Wk 48, n= 194 | 5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 5, Wk 24, n= 189 | 4 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 5, Wk 48, n= 181 | 3 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 6, Wk 24, n= 174 | 3 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 6, Wk 48, n= 133 | 3 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 7, Wk 24, n= 122 | 2 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 7, Wk 48, n= 97 | 2 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 8, Wk 24, n= 60 | 2 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 8, Wk 48, n= 29 | 1 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Yr 9, Wk 24, n= 2 | 1 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/138+ plasmacytoid, Exit, n= 232 | 3 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Baseline, n= 262 | 17 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 1, Wk 24, n= 251 | 30 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 1, Wk 48, n= 242 | 23 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 2, Wk 24, n= 238 | 17 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 2, Wk 48, n= 224 | 16 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 3, Wk 24, n= 212 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 7, Wk 48, n= 87 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 3, Wk 48, n= 202 | 11 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 4, Wk 24, n= 196 | 10.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 4, Wk 48, n= 181 | 9 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 5, Wk 24, n= 172 | 8.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 5, Wk 48, n= 166 | 7 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 6,Wk 24,n=158 | 7 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 6, Wk 48, n= 114 | 6 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 7, Wk 24, n= 111 | 6 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 7, Wk 48, n= 87 | 6 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 8, Wk 24, n= 54 | 5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 8, Wk 48, n= 28 | 6 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Yr 9, Wk 24, n= 2 | 2 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27+Memory, Exit, n= 207 | 8 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Baseline, n= 262 | 88 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 1, Wk 24, n= 251 | 36 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 1, Wk 48, n= 242 | 25 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 2, Wk 24, n= 238 | 21 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 2, Wk 48, n= 224 | 17 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 3, Wk 24, n= 212 | 16 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 3, Wk 48, n= 202 | 14 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 4, Wk 24, n= 196 | 15 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 4, Wk 48, n= 181 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 5, Wk 24, n= 172 | 12.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 5, Wk 48, n= 166 | 11 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 6, Wk 24, n= 159 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 6, Wk 48, n= 114 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 7, Wk 24, n= 111 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 8, Wk 24, n= 54 | 11.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 8, Wk 48, n= 28 | 12 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Yr 9, Wk 24, n= 2 | 5.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/27-naive, Exit, n= 207 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Baseline, n= 257 | 190 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 1, Wk 24, n= 247 | 131 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 1, Wk 48, n= 244 | 82 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 2, Wk 24, n= 244 | 74 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 2, Wk 48, n= 233 | 56 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 3, Wk 48, n= 211 | 22 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 4, Wk 24, n= 210 | 13 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 4, Wk 48, n= 193 | 8 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 5, Wk 24, n= 188 | 6 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 5, Wk 48, n= 181 | 4 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 6, Wk 24, n= 174 | 4 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 6, Wk 48, n= 133 | 3 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 7, Wk 24, n= 122 | 3 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 7, Wk 48, n= 97 | 2 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 8, Wk 24, n= 60 | 1.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 8, Wk 48, n= 29 | 1 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Yr 9, Wk 24, n= 2 | 0.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+/69+activated, Exit, n= 233 | 2 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Baseline, n= 261 | 41 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 1, Wk 24, n= 251 | 31 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 1, Wk 48, n= 247 | 24 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 2, Wk 24, n= 246 | 23 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 2, Wk 48, n= 233 | 20 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 3, Wk 24, n= 218 | 19 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 3, Wk 48, n= 212 | 16 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 4, Wk 24, n= 211 | 14 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 4, Wk 48, n= 194 | 7.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 5, Wk 24, n= 189 | 6 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 5, Wk 48, n= 181 | 6 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 6, Wk 24, n= 174 | 4 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 6, Wk 48, n= 133 | 4 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 7, Wk 24, n= 122 | 4.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 7, Wk 48, n= 97 | 4 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 8, Wk 24, n= 60 | 3 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 8, Wk 48, n= 29 | 2 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Yr 9, Wk 24, n= 2 | 8 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20-/138+plasma cells, Exit, n= 232 | 5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Baseline, n= 265 | 114 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 1, Wk 24, n= 253 | 69 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 1, Wk 48, n= 254 | 49 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 2, Wk 24, n= 247 | 37 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 2, Wk 48, n= 234 | 34 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 3, Wk 24, n= 220 | 30 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 3, Wk 48, n= 212 | 26 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 4, Wk 24, n= 211 | 25 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 4, Wk 48, n= 195 | 22 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 5, Wk 24, n= 190 | 19 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 5, Wk 48, n= 182 | 18 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 6, Wk 24, n= 175 | 19 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 6, Wk 48, n= 132 | 17.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 7, Wk 24, n= 122 | 18.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 7, Wk 48, n= 97 | 19 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 8, Wk 24, n= 60 | 16.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 8, Wk 48, n= 29 | 15 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Yr 9, Wk 24, n= 2 | 7.5 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | Total CD19+ B-cells (CD19+), Exit, n= 234 | 20 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 3, Wk 48, n= 202 | 26 Cell count |
| Belimumab 10 mg/kg IV | Observed B-cell Levels at Indicated Time Points. | CD20+, Yr 4, Wk 24, n= 196 | 27 Cell count |
Secondary
Observed Complement C3 and C4 Levels at Indicated Time Points
Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 \<90 milligram per deciliter (mg/dL) and C4 \<16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 440
Population: MITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Baseline, n= 86 | 76 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Exit, n=85 | 18 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 1, Week 24, n= 83 | 80 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 1, Week 48, n= 83 | 86 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 2, Week 24, n= 81 | 85 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 2, Week 48, n= 80 | 88.5 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 3, Week 24, n= 74 | 90.5 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 3, Week 48, n= 73 | 93 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 4, Week 24, n= 72 | 94 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 4, Week 48, n= 66 | 95 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 5, Week 24, n= 63 | 99 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 5, Week 48, n= 61 | 97 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 6, Week 24, n= 55 | 99 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 6, Week 48, n= 37 | 103 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 7, Week 24, n= 41 | 103 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 7, Week 48, n= 32 | 110 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 8, Week 24, n= 20 | 110.5 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Year 8, Week 48, n= 9 | 104 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C3, Exit, n= 74 | 103 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Baseline, n=98 | 10 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 1, Week 24, n=95 | 13 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 1, Week 48, n=93 | 15 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 2, Week 24, n=93 | 15 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 2, Week 48, n=94 | 16 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 3, Week 24, n=84 | 15.5 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 3, Week 48, n=83 | 16 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 4, Week 24, n=81 | 16 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 4, Week 48, n=71 | 17 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 5, Week 24, n=70 | 18 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 5, Week 48, n=70 | 18 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 6, Week 24, n=62 | 18 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 6, Week 48, n=45 | 18 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 7, Week 24, n=49 | 19 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 7, Week 48, n=35 | 19 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 8, Week 24, n=24 | 20.5 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 8, Week 48, n=12 | 18 Milligrams per deciliter |
| Belimumab 10 mg/kg IV | Observed Complement C3 and C4 Levels at Indicated Time Points | C4, Year 9, Week 24, n=1 | 22 Milligrams per deciliter |
Secondary
Percentage of Participants Achieving SRI Response at Indicated Time Points
The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:\>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of \<0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 440
Population: MIIT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 1 , Week 24, n= 229 | 41.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 1 , Week 48, n= 225 | 45.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 2 , Week 24, n= 227 | 49.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 2 , Week 48, n= 204 | 49 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 3 , Week 24, n= 211 | 51.2 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 3 , Week 48, n= 185 | 58.4 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 4 , Week 24, n= 188 | 56.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 4 , Week 48, n= 174 | 64.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 5 , Week 24, n= 168 | 66.7 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 5 , Week 48, n= 157 | 62.4 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 6 , Week 24, n= 164 | 69.5 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 6 , Week 48, n= 123 | 74 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 7 , Week 24, n= 119 | 75.6 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 7 , Week 48, n= 93 | 78.5 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 8 , Week 24, n= 63 | 66.7 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 8 , Week 48, n= 29 | 65.5 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants Achieving SRI Response at Indicated Time Points | Year 9 , Week 24, n= 2 | 0 Percentage of Participants |
Secondary
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (\>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).
Time frame: Up to Week 384
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 1, Week 48 | 50.4 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 2, Week 48 | 45.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 3, Week 48 | 44.4 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 4, Week 48 | 36.2 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 5, Week 48 | 40.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 6, Week 48 | 33.2 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 7, Week 48 | 26.1 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points | Year 8, Week 48 | 13.1 Percentage of Participants |
Secondary
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change \>0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).
Time frame: Up to Week 384
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 2, Week 48, n=256 | 12.1 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 4, Week 48, n=212 | 20.8 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 1, Week 48, n=263 | 5.7 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 3, Week 48, n=239 | 18 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 5, Week 48, n=195 | 22.6 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 6, Week 48, n=187 | 25.1 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 7, Week 48, n=126 | 30.2 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points | Year 8, Week 48, n=65 | 29.2 Percentage of Participants |
Secondary
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with \>= 50% reduction in proteinuria among participants with Baseline proteinuria \>0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 1, Week 24, n=34 | 41.2 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 1, Week 48, n=33 | 63.6 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 2, Week 24, n=33 | 60.6 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 2, Week 48, n=30 | 53.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 3, Week 24, n=31 | 74.2 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 3, Week 48, n=28 | 67.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 4, Week 24, n=25 | 88 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 4, Week 48, n=23 | 73.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 5, Week 24, n=23 | 73.9 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 5, Week 48, n=22 | 86.4 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 6, Week 24, n=22 | 77.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 6, Week 48, n=17 | 76.5 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 8, Week 48, n=1 | 100 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 9, Week 24, n=28 | 64.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 7, Week 24, n=14 | 78.6 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 7, Week 48, n=7 | 71.4 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. | Year 8, Week 24, n=4 | 75 Percentage of Participants |
Secondary
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to \<=7.5 mg/day from \>7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Week 432
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 1, Week 48, n= 81 | 21 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 2, Week 24, n= 78 | 38.5 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 2, Week 48, n= 76 | 40.8 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 3, Week 24, n= 64 | 50 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 3, Week 48, n= 63 | 41.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 4, Week 24, n= 65 | 43.1 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 4, Week 48, n= 62 | 37.1 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 5, Week 24, n= 57 | 33.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 5, Week 48, n= 57 | 38.6 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 6, Week 24, n= 55 | 34.5 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 6, Week 48, n= 47 | 42.6 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 7, Week 24, n= 42 | 38.1 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 7, Week 48, n= 38 | 39.5 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 8, Week 24, n= 24 | 50 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 8, Week 48, n= 12 | 58.3 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 9, Week 24, n= 2 | 100 Percentage of Participants |
| Belimumab 10 mg/kg IV | Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. | Year 1, Week 24, n= 80 | 2.5 Percentage of Participants |