A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)

时间窗: 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

时间窗: 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.

SAE Rates by System Organ Class (SOC) During the Study

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

时间窗: 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.

时间窗: 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.

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.

时间窗: 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.