Systemic Lupus Erythematosus
Conditions
Keywords
immunosuppressants, Systemic Lupus Erythematosus Disease Activity Index, Belimumab, Lupus Low Disease Activity State, Systemic Lupus Erythematosus
Brief summary
The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.
Interventions
DRUGBelimumab
Belimumab will be administered as SC injection once weekly via autoinjector in thigh or abdomen
DRUGRituximab
Rituximab will be administered as IV infusion of 1000mg at Week 4 and Week 6
DRUGRituximab-placebo
Saline will be administered as IV infusions at Week 4 and Week 6
DRUGStandard therapy (Including Immunosuppressants)
Standard therapy will contain stable SLE medications including immunosuppressant to be administered from baseline through Week 104.
DRUGStandard therapy (Excluding Immunosuppressants)
Standard therapy excluding Immunosuppressant will contain anti-malarials, NSAIDs, and/or corticosteroids with prednisone dose equivalent to \<= 5 mg/day will administered through Week 104.
DRUGSteroid Taper
Steroid taper will include prednisone doses equivalent to =\< 5 mg/day in all Arms through Week 104.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be \>=18 years of age at the time of signing the informed consent. * Subjects who have clinical diagnosis of SLE based on 4 or more of the 11 American College of Rheumatology (ACR) criteria. * Subjects who have a screening SLEDAI-2K score \>=6 (This refers to the total score. Serological activity, i.e., anti-double stranded deoxyribonucleic acid \[dsDNA\]) positivity and/or hypocomplementemia is not required to be present in SLEDAI-2K assessment, but are scored if present). * Subjects who have unequivocally positive autoantibody test results defined as an anti-nuclear (ANA) titer \>=1:80 and/or a positive anti-dsDNA (\>=30 International Units per milliliter \[IU/mL\]) serum antibody test from 2 independent time points as follows: Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results. Or, one positive historical test result and 1 positive test result during the screening period. * Subjects who are on a stable SLE treatment regimen consisting of any of these medications (alone or in combination) for a period of at least 30 days prior to Day 1 (i.e. day of first dose of study treatment) with the exception that switching one agent for another of the same class for tolerability or availability reasons, which will be allowed within 30 days of Day 1: Corticosteroids (prednisone or prednisone equivalent); For those subjects on alternating daily doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose; Any immunosuppressant or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (example \[e.g.\] tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, mizoribine, or thalidomide; Anti-malarials (e.g., hydroxychloroquine, chloroquine, quinacrine); Non steroidal anti-inflammatory drugs (NSAIDs). * Male and/or female. A female subject is eligible to participate if she is not pregnant not breastfeeding, and at least one of the these conditions applies: Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of belimumab, or at least 12 months after the last dose of rituximab or rituximab-placebo. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
* Symptomatic herpes zoster within 3 months prior to screening. * Evidence of active or latent tuberculosis (TB). Documentation may include medical history and examination, chest X-rays (posterior, anterior, and lateral), and TB testing: either a positive tuberculin skin test (TST; defined as a skin induration ≥5 mm at 48 to 72 hours, regardless of Baccillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) QuantiFERON-TB Gold Plus test. * Significant allergies to humanized monoclonal antibodies. * History of hypersensitivity to belimumab and/or rituximab or known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies. * Lymphoma, leukemia, or any malignancy within the past 5 years (yrs) except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 yrs. * Alanine transferase (ALT) greater than 2 times upper limit of normal (ULN). * Bilirubin greater than 1.5 times ULN (isolated bilirubin greater than 1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%). * Immunoglobulin A (IgA) deficiency (IgA level less than 10 milligram per deciliter \[mg/dL\]). * Immunoglobulin G (IgG) less than 250 mg/dL. For Germany only, IgG less than 400mg/dL. * Neutrophils less than 1.5 times 10\^9. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Severe heart failure (New York Heart Association Class IV) or other severe, uncontrolled cardiac disease. * QT interval corrected (QTc) greater than 450 millisecond (msec) or QTc greater than 480 msec in subjects with bundle branch block. * Subjects who have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. * Subjects who have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk. * Subjects who have an acute or chronic infection requiring management as : Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria); Hospitalization for treatment of infection within 60 days of Day 1; subjects who had infection requiring treatment with parenteral (IV or intramuscular \[IM\]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 1. Prophylactic anti-infective treatment is allowed. * Subjects who have severe lupus kidney disease (defined by proteinuria greater than 6 gram (g)/24 hours or equivalent using spot urine protein to creatinine ratio, or serum creatinine greater than 2.5 mg/dL), or have severe active nephritis requiring induction therapy not permitted by protocol (e.g., IV cyclophosphamide), or have required hemodialysis or high dose prednisone or equivalent (greater than 100 mg/day) within 90 days of Day 1. * Subjects who have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident \[CVA\], cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 1. * Subjects who have a planned surgical procedure, laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study. * Subjects who have evidence of serious suicide risk, including any history of suicidal behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last 2 months or who, in the investigator's opinion, pose a significant suicide risk. * Subjects who have a history of an anaphylaxis reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. * Subjects who have received live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the screening period or during the study. * Subjects who have received any of the these prior/concomitant therapy within 364 days of Day 1: Belimumab; Rituximab; Abatacept; Any B cell targeted therapy (anti-cluster of differentiation-20 \[CD\] agents other than rituximab, anti CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\], BLyS-receptor fusion protein \[BR3\], Trans-membrane activator and calcium-modulator and cytophilin ligand interactor \[TACI\] Fc, anti B-cell activating factor \[BAFF\] (LY2127399), anti-Interferon alpha agents or anti-BLyS other than belimumab); A biologic investigational agent other than B cell targeted therapy (e.g., abetimus sodium, anti CD40L antibody \[BG9588/ IDEC 1311\]). (Investigational agent applies to any drug not approved for sale in the country in which it is being used). * Subjects who have required 3 or more courses of systemic corticosteroids within 364 days of Day 1. (Topical or inhaled steroids are permitted). * Subjects who have received any of these within 90 days of Day 1: Anti- Tumor Necrosis Factor (Anti-TNF) therapy (e.g., adalimumab, etanercept, infliximab); Interleukin-1 receptor antagonist (anakinra); Intravenous immunoglobulin (IVIG); High dose prednisone or equivalent (greater than 100 mg/day); Plasmapheresis. * Subjects who have received any of the these within 60 days of Day 1: A non-biologic investigational agent (Investigational agent applies to any drug not approved for sale in the country in which it is being used); IV cyclophosphamide and, for Germany only, oral cyclophosphamide; Any steroid injection (e.g., intramuscular \[IM\], intraarticular, or IV). * Positive immunodeficiency virus (HIV) antibody test. * Positive serology for Hepatitis B (HB), defined as HB surface antigen positive (HBsAg+) OR HB core antibody positive (HBcAb+). * Positive Hepatitis C (HCV) antibody test. * Subjects who have current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 1. * Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study. * Unable to administer study treatment (belimumab) by SC injection and has no other reliable resource to administer the injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a State of Disease Control at Week 52 | Week 52 | Percentage of participants with a state of disease control (Independent blinded assessor \[IBA\]) was defined as the percentage of participants with a Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K)score less than or equal to(\<=)2 achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day at Week 52. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in previous 10 days,consisting 24 individual items in which signs and symptoms, laboratory tests and physician's assessment for each item within each of 9 organ systems were given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at the time of visit or in preceding 10 days. The SLEDAI-2K score was sum of all 24 individual items from the SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms) with higher scores representing increased disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a State of Disease Control at Week 104 | Week 104 | Percentage of participants with a state of disease control (IBA) was defined as the percentage of participants with a SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day at Week 104. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. |
| Percentage of Participants With a State of Disease Control by Visits | Weeks 12, 26, 40, 52, 64, 80 and 104 | Percentage of participants with a state of disease control (IBA) was defined as the percentage of participants with a SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. |
| Percentage of Participants With a State of Clinical Remission by Visits | Weeks 64, 80 and 104 | Percentage of participants with a state of clinical remission (IBA) was defined as percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days, consisting 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity |
| Percentage of Participants With a State of Complete Remission (CR) Sustained for at Least 24 Weeks During Week 52 to Week 104 | Week 52 to Week 104 | Percentage of participants with a state of CR (Principal Investigator \[PI\] assessed) was defined as percentage of participants with a SLEDAI-2K=0 achieved without immunosuppressants and with corticosteroids at prednisone equivalent dose of 0 mg/day,sustained for at least 24 weeks. Sustained CR was longest period a participant maintains CR without break calculated as last consecutive CR date minus first consecutive CR date plus 1. SLEDAI-2K consisted of 24 individual items within each 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at time of visit or in preceding 10 days. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms),higher scores indicates increased disease activity. Percentage of participants with a state of CR sustained for at least 24 weeks at any visit during Week 52 to Week 104 were reported. |
| Percentage of Participants With a State of Clinical Remission (CLR) Sustained for at Least 24 Weeks From Week 80 to Week 104 | From Week 80 to Week 104 | Percentage of participants with a state of CLR (PI assessed) at Week 104 was defined as percentage of participants with a clinical SLEDAI-2K score=0 (does not include anti-dsDNA and complement activity scores) achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day, sustained for at least 24 weeks(from Week 80 to Week 104). Sustained CLR is longest period a participant maintains CLR without a break, calculated as last consecutive CLR date minus first consecutive CLR date plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity. |
| Percentage of Participants With a State of Complete Remission by Visits | Weeks 60, 64, 72, 80, 88, 96 and 104 | Percentage of participants with a state of complete remission (PI assessed) was defined as the percentage of participants with a SLEDAI-2K score =0, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in the previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within for each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. |
| Time to First Severe Flare | Up to Week 104 | Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1. Time to first severe flare was measured by Modified SLE flare index which identifies whether a participant had experienced a mild/moderate or severe flare. Analysis of first severe flare was performed on the modified SLE Flare index that excludes severe flares that were triggered only by an increase is SLEDAI-2K score to greater than 12. |
| Time to First Flare | Up to Week 104 | Time to first SLE flare was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1. Time to first flare was measured by modified SLE flare index which identifies whether a participant had experienced a mild/moderate or severe flare. |
| Time to Disease Control Sustained for at Least 24 Weeks and Maintained Through Week 104 | Up to Week 104 | Disease control sustained for at least 24 weeks and maintained through Week 104 was defined as SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day. Time to disease control (PI assessed) was defined as the first visit of sustained disease control until Week 104 on or before Week 80 minus treatment start date (Day 1) plus 1. Sustained disease control was longest period a participant maintained disease control without a break. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K , ranges from 0 (no symptoms) to 105 (presence of all defined symptoms),higher scores representing increased disease activity. |
| Time to Clinical Remission Sustained for at Least 24 Weeks and Maintained Through Week 104 | Up to Week 104 | Clinical remission sustained for at least 24 weeks and maintained through Week 104 was defined as clinical SLEDAI-2K score=0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. Time to CLR (PI assessed) was defined as first visit of sustained CLR until Week 104 on or before Week 80 minus treatment start date (Day 1) plus 1. Sustained CLR was longest period a participant maintained clinical remission without a break. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity. |
| Duration of Disease Control | Up to Week 104 | Duration of disease control was defined as SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day. The duration of disease control (PI assessed) was the longest period between 2 visits that the participant was a disease control responder at all visits and calculated as the first visit of disease control minus last visit of disease control plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105 (presence of all defined symptoms),higher scores representing increased disease activity |
| Duration of Clinical Remission | Up to Week 104 | Clinical remission was defined as clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. The duration of clinical remission (PI assessed) was the longest period between 2 visits that the participant was a clinical remission responder at all visits and was calculated as the first visit of clinical remission minus last visit of clinical remission plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity. |
| Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104 | The SLEDAI-2K consisted of 24 individual items within 9 organ systems. Each item was given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of visit or in the preceding 10 days. Weighted scores for central nervous system (CNS) (7 items) was 8; for vascular (1 item) was 8; for Musculoskeletal (2 items) was 4; for Renal (4 items) was 4; for Mucocutaneous (3 items) was 2; for Cardiovascular and Respiratory (2 items) was 2; for Immunologic (2 items) was 2;for Constitutional (1 item) was 1 and for Hematologic (2 items) was 1. SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Percentage of Participants With a State of Clinical Remission at Week 64 | Week 64 | Percentage of participants with a state of clinical remission (IBA) was defined as percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-double stranded deoxyribonucleic \[dsDNA\] and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day at Week 64. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days, consisting 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity. |
| Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104 | SLEDAI-2K assessments consisted of 24 individual items with 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at time of analysis. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms). Higher scores indicates increased disease activity. A worsening was defined as an increase(compared to Baseline) in SLEDAI-2K score within same organ system at a post-Baseline visit. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with SLEDAI-2K organ worsening for following organ systems were reported;CNS total,Vascular total,Musculoskeletal total,Renal total,Mucocutaneous total,Cardio and Resp total,Immunologic total and Hematologic total. Constitutional organ system was removed from analysis and its one item (fever)moved to hematologic organ system. |
| Change From Baseline in Physician Global Assessment (PGA) by Visits | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104 | The Physician's Global Assessment (PGA) was a physician-reported visual analogue scale that provides an overall measure of the participant's current disease activity. Physician's Global Assessment was collected on a 10 centimeter (cm) visual analogue scale (VAS) by placing a mark on the scale between 0 (no disease activity) to 10 (maximum disease activity). The PGA score was then rescaled for reporting by multiplying the collected score by 3 divided by 10. Hence, the PGA score ranges from 0 to 3 with higher scores indicating greater disease activity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value. |
| Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 | Baseline (Day 1), Week 52 and Week 104 | The SLICC-ACR Damage Index measures irreversible (not related to active inflammation) changes occurring since the diagnosis of SLE ascertained by clinical assessment and present for at least 6 months. The questionnaire contains 39 items covering 12 different organ systems which were scored on a numerical scale between 0 (no damage) to 7 (increasing disease damage). Individual ranges for organ systems were; ocular: 0-2, neuropsychiatric: 0-6, renal: 0-3, pulmonary: 0-5, cardiovascular:0-6, peripheral vascular: 0-5, gastrointestinal:0-5, musculoskeletal: 0-6, skin: 0-3, endocrine (diabetes): 0-1, gonadal:0-1 and malignancies: 0-2. The SLICC-ACR score was calculated by taking sum of the individual scores for 12 organ systems which ranges from 0 (no damage) to 45 (increasing disease damage) where higher score indicates increasing disease damage severity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96 and 104 | Lupus low disease activity state (LLDAS) was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) SLEDAI-2K \<=4, with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity; (2) no new features of lupus disease activity compared with the previous assessment; (3) PGA (scale 0-3), \<=1; (4) current prednisolone (or equivalent) dose \<=7.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs. Percentage of participants that met the LLDAS response criteria were reported. |
| Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104 | Percentage of participants with a state of disease control was defined as the percentage of participants with a SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day, using the PI assessment of SLEDAI-2K. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K, ranges from 0 (no symptoms) to 105 (presence of all defined symptoms), higher scores representing increased disease activity. Percentage of participants with a state of disease control using the PI assessment of SLEDAI-2K were summarized. |
| Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Weeks 60, 64, 72, 80, 88, 96 and 104 | Percentage of participants with a state of clinical remission was defined as the percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants (which was allowed in Belimumab+ Standard therapy arm only) and with corticosteroids at a prednisone equivalent dose of 0 mg/day using the PI assessment of SLEDAI-2K. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity. Percentage of participants with a state of clinical remission using the PI assessment of SLEDAI-2K were summarized. |
| Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) | Up to Week 111 (including 8 weeks of safety follow-up) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Data for number of participants with SAE and non-SAE (\>=5 %) has been summarized. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Up to Week 104 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AESIs were Malignant Neoplasms, Post-Injection Systemic Reactions (PISR), All Infections of Special Interest (Opportunistic Infections (OI), Herpes Zoster (HZ), Tuberculosis (TB), and Sepsis), Depression (including mood disorders and anxiety)/suicide/self-injury and Deaths. Data for number of participants with AESIs has been summarized. |
| Change From Baseline in Patient Global Assessment (PtGA) by Visits | Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104 | The Patient's Global Assessment (PtGA) of Disease Activity is a single-item, participant reported scale developed for the assessment of the participant's overall rating of their disease activity due to SLE. The scale measures disease activity ranging from 0 (Very Well) to 10 (Very Poor) and the higher score indicates severe disease activity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value. |
| Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104 | LupusQoL is a SLE-specific health related qualify of life (HRQOL) instrument with 34 questions across 8 domains:Physical health(8 items),Pain(3 items),Planning(3 items),Intimate relationship(2 items),Burden to others(3 items),Emotional health(6 items),Body image(5 items),Fatigue(4 items). Questions were related to participants experience in prior 4 weeks.A 5-point Likert response format was used, ranging from 0(all of the time) to 4(never) for each question. Individual domain scores were reported which were calculated by taking sum of responses to all items within each domain. Individual domain scores range:Physical health(0-32),Pain(0-12),Planning(0-12),Intimate relationship(0-8),Burden to others(0-12),Emotional health(0-24),Body image(0-20),Fatigue(0-16). Higher score indicates better HRQOL. Baseline value was latest pre-dose assessment with a non-missing value including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104 | The FACIT-Fatigue scale was a 13-item questionnaire completed by the participant, which provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The higher score for the questions, the greater the fatigue. The total score was the sum of the responses from all questions (inverted for reversed items) multiplied by 13, then divided by the number of questions answered, ranging from 0 (worse fatigue) to 52 (no fatigue) where a higher score indicates an improvement in the participant's health status and decrease in the score indicates worse fatigue/quality of life. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value. |
| Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Weeks 8, 12, 26, 40, 52, 64, 72 and 104 | The FACIT-Fatigue scale was a 13-item questionnaire completed by the participant, which provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions, the greater the fatigue. The total score was the sum of the responses (inverted for reversed items) multiplied by 13, then divided by the number of questions answered, ranging from 0 (worse fatigue) to 52 (no fatigue) where a higher score indicates an improvement in the participant's health status and decrease in the score indicates worse fatigue/quality of life. A participant was considered to had an improvement exceeding the minimal clinically important difference if they had \>=4 points improvement in their FACIT-Fatigue Scale score from Baseline. Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the MCID (\>=4 points) were summarized. |
| Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104 | SLEDAI-2K assessments consisted of 24 individual items with 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at the time of analysis. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K ranges from 0(no symptoms) to 105(presence of all defined symptoms). Higher scores indicates increased disease activity. An improvement was defined as a decrease(compared to Baseline) in SLEDAI-2K score within same organ system at a post-Baseline visit. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for following organ systems was reported: CNS total, Vascular total, Musculoskeletal total, Renal total, Mucocutaneous total, Cardiovascular (Cardio) and Respiratory (Resp) total, Immunologic total and Hematologic total. Constitutional organ system was removed from analysis and its one item (fever)moved to hematologic organ system. |
Countries
Argentina, Brazil, Canada, France, Germany, Mexico, Netherlands, Russia, South Korea, Spain, United States
Participant flow
Recruitment details
This was a multicenter study conducted at 71 centers in 11 countries. This was a randomized, placebo-controlled, parallel study where participants received treatment in any one of the treatment arms.
Pre-assignment details
A total of 396 participants were screened, of which 104 were screen failures. A total of 292 participants were enrolled in the study (Intent-to-Treat Population: It comprised of all randomized participants who received at least one dose of study treatment \[Belimumab or Rituximab or Placebo\]).
Participants by arm
| Arm | Count |
|---|---|
| Belimumab + Placebo Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104. | 72 |
| Belimumab + Rituximab Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104. | 144 |
| Belimumab + Standard Therapy Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. | 76 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 6 | 1 |
| Overall Study | Lost to Follow-up | 2 | 3 | 2 |
| Overall Study | Physician Decision | 3 | 4 | 2 |
| Overall Study | Protocol Violation | 2 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 9 | 14 | 10 |
Baseline characteristics
| Characteristic | Belimumab + Placebo | Belimumab + Rituximab | Belimumab + Standard Therapy | Total |
|---|---|---|---|---|
| Age, Continuous | 40.6 Years STANDARD_DEVIATION 12.58 | 40.1 Years STANDARD_DEVIATION 11.45 | 41.0 Years STANDARD_DEVIATION 12.75 | 40.5 Years STANDARD_DEVIATION 12.04 |
| Race/Ethnicity, Customized African American/African Heritage | 21 Participants | 22 Participants | 13 Participants | 56 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 7 Participants | 14 Participants | 10 Participants | 31 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White -Arabic/North African Heritage | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 39 Participants | 100 Participants | 47 Participants | 186 Participants |
| Sex: Female, Male Female | 66 Participants | 129 Participants | 73 Participants | 268 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 3 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 72 | 2 / 144 | 0 / 76 |
| other Total, other adverse events | 48 / 72 | 109 / 144 | 53 / 76 |
| serious Total, serious adverse events | 10 / 72 | 32 / 144 | 15 / 76 |
Outcome results
Primary
Percentage of Participants With a State of Disease Control at Week 52
Percentage of participants with a state of disease control (Independent blinded assessor \[IBA\]) was defined as the percentage of participants with a Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K)score less than or equal to(\<=)2 achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day at Week 52. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in previous 10 days,consisting 24 individual items in which signs and symptoms, laboratory tests and physician's assessment for each item within each of 9 organ systems were given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at the time of visit or in preceding 10 days. The SLEDAI-2K score was sum of all 24 individual items from the SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: Week 52
Population: Modified Intent-to-Treat (MITT) Population comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or Placebo) and excluding participants from Arm 3 (Belimumab + Standard therapy) who were randomized prior to 07-Sep-2018.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control at Week 52 | 16.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control at Week 52 | 19.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control at Week 52 | 25.5 Percentage of participants |
p-value: 0.534295% CI: [0.6, 2.71]Regression, Logistic
95% CI: [0.32, 1.54]
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit
The FACIT-Fatigue scale was a 13-item questionnaire completed by the participant, which provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The higher score for the questions, the greater the fatigue. The total score was the sum of the responses from all questions (inverted for reversed items) multiplied by 13, then divided by the number of questions answered, ranging from 0 (worse fatigue) to 52 (no fatigue) where a higher score indicates an improvement in the participant's health status and decrease in the score indicates worse fatigue/quality of life. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 8; n=66, 132, 44 | 4.2 Scores on a scale | Standard Deviation 9.84 |
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 12; n=66, 133, 44 | 4.7 Scores on a scale | Standard Deviation 9.5 |
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 26; n=61, 115, 40 | 3.1 Scores on a scale | Standard Deviation 10.08 |
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 40; n=63, 122, 43 | 6.0 Scores on a scale | Standard Deviation 10.18 |
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 52; n=64, 120, 41 | 6.5 Scores on a scale | Standard Deviation 10.12 |
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 64;n=62, 117, 36 | 4.9 Scores on a scale | Standard Deviation 10.61 |
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 72; n=59, 107, 33 | 5.6 Scores on a scale | Standard Deviation 10.21 |
| Belimumab + Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 104; n=55, 111, 36 | 5.7 Scores on a scale | Standard Deviation 9.07 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 26; n=61, 115, 40 | 5.4 Scores on a scale | Standard Deviation 9.17 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 72; n=59, 107, 33 | 5.2 Scores on a scale | Standard Deviation 10.31 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 40; n=63, 122, 43 | 5.2 Scores on a scale | Standard Deviation 10.8 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 52; n=64, 120, 41 | 6.1 Scores on a scale | Standard Deviation 10.84 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 64;n=62, 117, 36 | 6.2 Scores on a scale | Standard Deviation 9.72 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 8; n=66, 132, 44 | 4.6 Scores on a scale | Standard Deviation 8.84 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 12; n=66, 133, 44 | 4.0 Scores on a scale | Standard Deviation 9.86 |
| Belimumab + Rituximab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 104; n=55, 111, 36 | 7.1 Scores on a scale | Standard Deviation 11.5 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 26; n=61, 115, 40 | 4.1 Scores on a scale | Standard Deviation 8.54 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 12; n=66, 133, 44 | 3.8 Scores on a scale | Standard Deviation 10.94 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 8; n=66, 132, 44 | 4.8 Scores on a scale | Standard Deviation 8.25 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 40; n=63, 122, 43 | 5.2 Scores on a scale | Standard Deviation 10.14 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 72; n=59, 107, 33 | 2.9 Scores on a scale | Standard Deviation 12.75 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 64;n=62, 117, 36 | 4.6 Scores on a scale | Standard Deviation 10.32 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 52; n=64, 120, 41 | 5.1 Scores on a scale | Standard Deviation 10.51 |
| Belimumab + Standard Therapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit | Week 104; n=55, 111, 36 | 3.1 Scores on a scale | Standard Deviation 10.3 |
Secondary
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit
LupusQoL is a SLE-specific health related qualify of life (HRQOL) instrument with 34 questions across 8 domains:Physical health(8 items),Pain(3 items),Planning(3 items),Intimate relationship(2 items),Burden to others(3 items),Emotional health(6 items),Body image(5 items),Fatigue(4 items). Questions were related to participants experience in prior 4 weeks.A 5-point Likert response format was used, ranging from 0(all of the time) to 4(never) for each question. Individual domain scores were reported which were calculated by taking sum of responses to all items within each domain. Individual domain scores range:Physical health(0-32),Pain(0-12),Planning(0-12),Intimate relationship(0-8),Burden to others(0-12),Emotional health(0-24),Body image(0-20),Fatigue(0-16). Higher score indicates better HRQOL. Baseline value was latest pre-dose assessment with a non-missing value including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 64; n=52, 98, 27 | 6.0 Scores on a scale | Standard Deviation 22.51 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 12; n=66, 133, 44 | 3.5 Scores on a scale | Standard Deviation 16.6 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 64; n=62, 117, 36 | 14.4 Scores on a scale | Standard Deviation 28.83 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 8; n=60, 114, 37 | 5.7 Scores on a scale | Standard Deviation 19.57 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 72; n=44, 93, 25 | 7.8 Scores on a scale | Standard Deviation 26.74 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 12; n=66, 133, 44 | 8.1 Scores on a scale | Standard Deviation 17.32 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 64; n=62, 117, 36 | 5.8 Scores on a scale | Standard Deviation 18.66 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 104; n=48, 94, 28 | 4.4 Scores on a scale | Standard Deviation 26.62 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 8; n=66, 132, 44 | 3.4 Scores on a scale | Standard Deviation 19.77 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 72; n=59, 107, 33 | 7.0 Scores on a scale | Standard Deviation 21.13 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 52; n=64, 120, 41 | 8.1 Scores on a scale | Standard Deviation 19.9 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 104; n=55, 111, 36 | 6.2 Scores on a scale | Standard Deviation 20.19 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 40; n=63, 122, 43 | 9.7 Scores on a scale | Standard Deviation 21.44 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 12; n=66, 133, 44 | 7.5 Scores on a scale | Standard Deviation 19.78 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 8; n=66,132, 44 | 9.8 Scores on a scale | Standard Deviation 17.02 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 26; n=61, 115, 40 | 7.0 Scores on a scale | Standard Deviation 22.42 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 12; n=58, 118, 39 | 1.9 Scores on a scale | Standard Deviation 23.23 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 72; n=59, 107, 33 | 8.8 Scores on a scale | Standard Deviation 21.39 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 40; n=63, 122, 43 | 12.3 Scores on a scale | Standard Deviation 23.18 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 12; n=66, 133, 44 | 8.2 Scores on a scale | Standard Deviation 18.48 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 12; n=66, 133, 44 | 4.5 Scores on a scale | Standard Deviation 23.03 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 64; n=62, 117, 36 | 10.2 Scores on a scale | Standard Deviation 21.89 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 104; n=55, 111, 36 | 13.8 Scores on a scale | Standard Deviation 25.82 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 8; n=66, 132, 44 | 5.8 Scores on a scale | Standard Deviation 19.67 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 72; n=59, 107, 33 | 13.1 Scores on a scale | Standard Deviation 24.91 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 26; n=61, 115, 40 | 3.4 Scores on a scale | Standard Deviation 25.2 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 26; n=61, 115, 40 | 8.6 Scores on a scale | Standard Deviation 20.23 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 26; n=56, 96, 33 | 5.8 Scores on a scale | Standard Deviation 20.62 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 40; n=63, 122, 43 | 11.6 Scores on a scale | Standard Deviation 29.08 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 52; n=64, 120, 41 | 10.2 Scores on a scale | Standard Deviation 21.48 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 40; n=63, 122, 43 | 11.9 Scores on a scale | Standard Deviation 22.33 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 52; n=64, 120, 41 | 11.6 Scores on a scale | Standard Deviation 28.66 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 104; n=55, 111, 36 | 18.9 Scores on a scale | Standard Deviation 25.93 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 72; n=59, 107, 33 | 9.2 Scores on a scale | Standard Deviation 30.78 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 64; n=62, 117, 36 | 7.8 Scores on a scale | Standard Deviation 24.42 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 52; n=64, 120, 41 | 13.9 Scores on a scale | Standard Deviation 24.26 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 52; n=64, 120, 41 | 14.2 Scores on a scale | Standard Deviation 21.17 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 26; n=61, 115, 40 | 3.3 Scores on a scale | Standard Deviation 18.74 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 104; n=55, 111, 36 | 12.1 Scores on a scale | Standard Deviation 30.76 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 40; n=54, 103, 35 | 8.9 Scores on a scale | Standard Deviation 25.42 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 40; n=63, 122, 43 | 8.5 Scores on a scale | Standard Deviation 19.53 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 40; n=50, 94, 30 | 4.3 Scores on a scale | Standard Deviation 28.75 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 64; n=62, 117, 36 | 8.1 Scores on a scale | Standard Deviation 20.75 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 8; n=51, 110, 36 | -1.2 Scores on a scale | Standard Deviation 21.83 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 52; n=51, 91, 30 | 4.7 Scores on a scale | Standard Deviation 29.36 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 64; n=62, 117, 36 | 10.5 Scores on a scale | Standard Deviation 21.94 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 104; n=55, 111, 36 | 6.8 Scores on a scale | Standard Deviation 20.2 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 64; n=47, 90, 25 | -4.5 Scores on a scale | Standard Deviation 28 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 8; n=66, 132, 44 | 5.2 Scores on a scale | Standard Deviation 18.33 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 12; n=52, 106, 36 | -2.6 Scores on a scale | Standard Deviation 25.16 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 72; n=59, 107, 33 | 12.1 Scores on a scale | Standard Deviation 22.74 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 52; n=55, 101, 33 | 7.9 Scores on a scale | Standard Deviation 25.77 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 104; n=40, 85,27 | -0.3 Scores on a scale | Standard Deviation 23.93 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 26; n=61, 115, 40 | 8.7 Scores on a scale | Standard Deviation 26.68 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 26; n=48, 86, 30 | -1.3 Scores on a scale | Standard Deviation 29.2 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 12; n=66, 133, 44 | 11.4 Scores on a scale | Standard Deviation 27.91 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 72; n=42, 83, 21 | 0.0 Scores on a scale | Standard Deviation 31.6 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 40; n=63, 122, 43 | 13.9 Scores on a scale | Standard Deviation 27.23 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 104; n=55, 111, 36 | 9.4 Scores on a scale | Standard Deviation 20.41 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 8; n=66, 132, 44 | 7.3 Scores on a scale | Standard Deviation 22.95 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 52; n=64, 120, 41 | 16.5 Scores on a scale | Standard Deviation 29.15 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 26; n=61,115, 40 | 7.7 Scores on a scale | Standard Deviation 19.84 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 8; n=66, 132, 44 | 3.0 Scores on a scale | Standard Deviation 15.2 |
| Belimumab + Placebo | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 72; n=59, 107, 33 | 17.1 Scores on a scale | Standard Deviation 28.68 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 26; n=61, 115, 40 | 17.2 Scores on a scale | Standard Deviation 21.54 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 8; n=66, 132, 44 | 6.4 Scores on a scale | Standard Deviation 16.87 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 12; n=66, 133, 44 | 8.4 Scores on a scale | Standard Deviation 23.65 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 12; n=66, 133, 44 | 4.5 Scores on a scale | Standard Deviation 19.67 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 52; n=64, 120, 41 | 17.6 Scores on a scale | Standard Deviation 23.62 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 26; n=61, 115, 40 | 10.5 Scores on a scale | Standard Deviation 27.42 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 72; n=59, 107, 33 | 6.2 Scores on a scale | Standard Deviation 19.05 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 52; n=64, 120, 41 | 14.9 Scores on a scale | Standard Deviation 27.03 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 104; n=55, 111, 36 | 9.3 Scores on a scale | Standard Deviation 19.67 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 8; n=60, 114, 37 | 8.9 Scores on a scale | Standard Deviation 19.26 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 12; n=58, 118, 39 | 10.1 Scores on a scale | Standard Deviation 20.73 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 26; n=56, 96, 33 | 9.0 Scores on a scale | Standard Deviation 25.03 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 104; n=55, 111, 36 | 15.0 Scores on a scale | Standard Deviation 29.25 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 40; n=54, 103, 35 | 8.2 Scores on a scale | Standard Deviation 24.82 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 52; n=55, 101, 33 | 9.1 Scores on a scale | Standard Deviation 24.07 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 64; n=52, 98, 27 | 11.3 Scores on a scale | Standard Deviation 23.08 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 26; n=61,115, 40 | 6.7 Scores on a scale | Standard Deviation 17.35 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 72; n=44, 93, 25 | 8.7 Scores on a scale | Standard Deviation 24.91 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 104; n=48, 94, 28 | 11.4 Scores on a scale | Standard Deviation 25.65 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 8; n=66,132, 44 | 9.2 Scores on a scale | Standard Deviation 18.4 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 40; n=63, 122, 43 | 6.7 Scores on a scale | Standard Deviation 20.85 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 12; n=66, 133, 44 | 7.0 Scores on a scale | Standard Deviation 17.96 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 26; n=61, 115, 40 | 11.4 Scores on a scale | Standard Deviation 20.12 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 40; n=63, 122, 43 | 10.3 Scores on a scale | Standard Deviation 22.41 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 52; n=64, 120, 41 | 7.8 Scores on a scale | Standard Deviation 20.63 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 52; n=64, 120, 41 | 12.0 Scores on a scale | Standard Deviation 20.95 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 64; n=62, 117, 36 | 14.0 Scores on a scale | Standard Deviation 20.35 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 64; n=62, 117, 36 | 9.3 Scores on a scale | Standard Deviation 20.73 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 72; n=59, 107, 33 | 13.1 Scores on a scale | Standard Deviation 18.31 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 8; n=66, 132, 44 | 6.0 Scores on a scale | Standard Deviation 15.08 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 104; n=55, 111, 36 | 14.3 Scores on a scale | Standard Deviation 20.18 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 72; n=59, 107, 33 | 17.0 Scores on a scale | Standard Deviation 22.66 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 12; n=66, 133, 44 | 5.8 Scores on a scale | Standard Deviation 17.15 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 40; n=63, 122, 43 | 9.5 Scores on a scale | Standard Deviation 19.29 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 72; n=59, 107, 33 | 9.1 Scores on a scale | Standard Deviation 18.84 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 52; n=64, 120, 41 | 10.0 Scores on a scale | Standard Deviation 20.16 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 104; n=55, 111, 36 | 19.0 Scores on a scale | Standard Deviation 22.59 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 64; n=62, 117, 36 | 10.2 Scores on a scale | Standard Deviation 18.6 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 8; n=66, 132, 44 | 8.0 Scores on a scale | Standard Deviation 18.21 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 104; n=55, 111, 36 | 10.6 Scores on a scale | Standard Deviation 19.96 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 12; n=66, 133, 44 | 13.0 Scores on a scale | Standard Deviation 20.81 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 72; n=59, 107, 33 | 14.4 Scores on a scale | Standard Deviation 28.77 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 26; n=61, 115, 40 | 10.5 Scores on a scale | Standard Deviation 17.27 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 40; n=63, 122, 43 | 18.0 Scores on a scale | Standard Deviation 22.7 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 64; n=62, 117, 36 | 17.4 Scores on a scale | Standard Deviation 23.59 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 12; n=66, 133, 44 | 7.6 Scores on a scale | Standard Deviation 20.15 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 26; n=61, 115, 40 | 9.9 Scores on a scale | Standard Deviation 21.28 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 64; n=62, 117, 36 | 14.5 Scores on a scale | Standard Deviation 23.65 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 40; n=63, 122, 43 | 12.2 Scores on a scale | Standard Deviation 22.3 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 8; n=66, 132, 44 | 11.4 Scores on a scale | Standard Deviation 18.55 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 52; n=64, 120, 41 | 12.6 Scores on a scale | Standard Deviation 23.89 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 72; n=59, 107, 33 | 11.4 Scores on a scale | Standard Deviation 20.97 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 104; n=55, 111, 36 | 14.2 Scores on a scale | Standard Deviation 20.77 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 26; n=48, 86, 30 | 8.9 Scores on a scale | Standard Deviation 24.32 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 40; n=50, 94, 30 | 7.7 Scores on a scale | Standard Deviation 25.01 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 52; n=51, 91, 30 | 6.6 Scores on a scale | Standard Deviation 22.54 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 8; n=51, 110, 36 | 5.2 Scores on a scale | Standard Deviation 20.63 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 64; n=47, 90, 25 | 11.0 Scores on a scale | Standard Deviation 25.41 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 72; n=42, 83, 21 | 8.6 Scores on a scale | Standard Deviation 23.82 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 12; n=52, 106, 36 | 4.6 Scores on a scale | Standard Deviation 23.42 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 104; n=40, 85,27 | 11.2 Scores on a scale | Standard Deviation 25.59 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 40; n=63, 122, 43 | 12.6 Scores on a scale | Standard Deviation 26.94 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 8; n=66, 132, 44 | 6.8 Scores on a scale | Standard Deviation 20.56 |
| Belimumab + Rituximab | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 64; n=62, 117, 36 | 17.0 Scores on a scale | Standard Deviation 26.67 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 104; n=55, 111, 36 | 9.7 Scores on a scale | Standard Deviation 24.25 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 12; n=66, 133, 44 | 6.4 Scores on a scale | Standard Deviation 20.06 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 26; n=61, 115, 40 | 11.6 Scores on a scale | Standard Deviation 19.19 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 104; n=55, 111, 36 | 7.2 Scores on a scale | Standard Deviation 23.33 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 8; n=66, 132, 44 | 10.4 Scores on a scale | Standard Deviation 21.87 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 12; n=66, 133, 44 | 6.1 Scores on a scale | Standard Deviation 28.44 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 52; n=64, 120, 41 | 15.7 Scores on a scale | Standard Deviation 27.34 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 64; n=62, 117, 36 | 13.2 Scores on a scale | Standard Deviation 26.9 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 72; n=59, 107, 33 | 11.9 Scores on a scale | Standard Deviation 29.02 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 8; n=66, 132, 44 | 10.0 Scores on a scale | Standard Deviation 27.88 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 12; n=66, 133, 44 | 7.8 Scores on a scale | Standard Deviation 27.81 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 64; n=62, 117, 36 | 7.2 Scores on a scale | Standard Deviation 30.55 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 72; n=59, 107, 33 | 6.6 Scores on a scale | Standard Deviation 31.02 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 104; n=55, 111, 36 | 8.8 Scores on a scale | Standard Deviation 34.96 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 8; n=66, 132, 44 | 10.6 Scores on a scale | Standard Deviation 23.46 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 12; n=66, 133, 44 | 6.4 Scores on a scale | Standard Deviation 29.9 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 64; n=62, 117, 36 | 12.3 Scores on a scale | Standard Deviation 28.21 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 72; n=59, 107, 33 | 11.1 Scores on a scale | Standard Deviation 27.85 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 26; n=61,115, 40 | 10.1 Scores on a scale | Standard Deviation 18.12 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 40; n=63, 122, 43 | 9.4 Scores on a scale | Standard Deviation 22.2 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 8; n=66, 132, 44 | 6.3 Scores on a scale | Standard Deviation 18.79 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 40; n=63, 122, 43 | 8.2 Scores on a scale | Standard Deviation 19.46 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 52; n=64, 120, 41 | 11.6 Scores on a scale | Standard Deviation 19.53 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 64; n=62, 117, 36 | 9.5 Scores on a scale | Standard Deviation 21.74 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Physical health; Week 72; n=59, 107, 33 | 8.5 Scores on a scale | Standard Deviation 22.59 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 26; n=61, 115, 40 | 13.1 Scores on a scale | Standard Deviation 22.79 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 40; n=63, 122, 43 | 12.6 Scores on a scale | Standard Deviation 29.17 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Pain; Week 104; n=55, 111, 36 | 12.5 Scores on a scale | Standard Deviation 27.92 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 26; n=61, 115, 40 | 12.1 Scores on a scale | Standard Deviation 27.86 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 40; n=63, 122, 43 | 10.7 Scores on a scale | Standard Deviation 26.62 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Planning; Week 52; n=64, 120, 41 | 14.0 Scores on a scale | Standard Deviation 28.35 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 8; n=51, 110, 36 | 7.6 Scores on a scale | Standard Deviation 19.66 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 12; n=52, 106, 36 | 7.6 Scores on a scale | Standard Deviation 27.1 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 26; n=48, 86, 30 | 14.2 Scores on a scale | Standard Deviation 28.38 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 40; n=50, 94, 30 | 15.8 Scores on a scale | Standard Deviation 30.43 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 52; n=51, 91, 30 | 15.8 Scores on a scale | Standard Deviation 30.78 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 64; n=47, 90, 25 | 12.5 Scores on a scale | Standard Deviation 29.76 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 72; n=42, 83, 21 | 5.4 Scores on a scale | Standard Deviation 39.44 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Intimate relationship; Week 104; n=40, 85,27 | 4.6 Scores on a scale | Standard Deviation 35.21 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 26; n=61, 115, 40 | 7.5 Scores on a scale | Standard Deviation 27.66 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 40; n=63, 122, 43 | 12.0 Scores on a scale | Standard Deviation 27.66 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 52; n=64, 120, 41 | 15.0 Scores on a scale | Standard Deviation 33.4 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Burden to others; Week 104; n=55, 111, 36 | 12.7 Scores on a scale | Standard Deviation 33.42 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 8; n=66, 132, 44 | 11.6 Scores on a scale | Standard Deviation 20.55 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 12; n=66, 133, 44 | 9.1 Scores on a scale | Standard Deviation 23.87 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 52; n=64, 120, 41 | 11.4 Scores on a scale | Standard Deviation 21.99 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 64; n=62, 117, 36 | 8.1 Scores on a scale | Standard Deviation 22.11 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 72; n=59, 107, 33 | 6.6 Scores on a scale | Standard Deviation 21.8 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Emotional health; Week 104; n=55, 111, 36 | 10.5 Scores on a scale | Standard Deviation 23 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 8; n=60, 114, 37 | 5.7 Scores on a scale | Standard Deviation 25.05 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 12; n=58, 118, 39 | 5.9 Scores on a scale | Standard Deviation 26.89 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 26; n=56, 96, 33 | 5.7 Scores on a scale | Standard Deviation 23.07 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 40; n=54, 103, 35 | 5.1 Scores on a scale | Standard Deviation 22.07 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 52; n=55, 101, 33 | 10.3 Scores on a scale | Standard Deviation 25.24 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 64; n=52, 98, 27 | 7.7 Scores on a scale | Standard Deviation 23.98 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 72; n=44, 93, 25 | 2.5 Scores on a scale | Standard Deviation 29.28 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Body image; Week 104; n=48, 94, 28 | 3.5 Scores on a scale | Standard Deviation 27.4 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 8; n=66,132, 44 | 8.5 Scores on a scale | Standard Deviation 24.3 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 12; n=66, 133, 44 | 10.4 Scores on a scale | Standard Deviation 28.11 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 26; n=61, 115, 40 | 11.9 Scores on a scale | Standard Deviation 20.21 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 40; n=63, 122, 43 | 11.3 Scores on a scale | Standard Deviation 24.75 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 52; n=64, 120, 41 | 16.6 Scores on a scale | Standard Deviation 25.3 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 64; n=62, 117, 36 | 10.8 Scores on a scale | Standard Deviation 25.21 |
| Belimumab + Standard Therapy | Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit | Fatigue; Week 72; n=59, 107, 33 | 11.6 Scores on a scale | Standard Deviation 25.87 |
Secondary
Change From Baseline in Patient Global Assessment (PtGA) by Visits
The Patient's Global Assessment (PtGA) of Disease Activity is a single-item, participant reported scale developed for the assessment of the participant's overall rating of their disease activity due to SLE. The scale measures disease activity ranging from 0 (Very Well) to 10 (Very Poor) and the higher score indicates severe disease activity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 104; n=55, 111, 36 | -1.61 Scores on a scale | Standard Deviation 2.589 |
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 8; n=66, 132, 44 | -0.96 Scores on a scale | Standard Deviation 2.751 |
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 12; n=66, 133, 44 | -0.69 Scores on a scale | Standard Deviation 2.237 |
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 64; n=62, 117, 36 | -1.41 Scores on a scale | Standard Deviation 2.985 |
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 52; n=64, 120, 41 | -1.74 Scores on a scale | Standard Deviation 2.752 |
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 26; n=61, 115, 40 | -0.95 Scores on a scale | Standard Deviation 2.765 |
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 72; n=59, 107, 33 | -1.46 Scores on a scale | Standard Deviation 3.209 |
| Belimumab + Placebo | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 40; n=63, 123, 43 | -1.77 Scores on a scale | Standard Deviation 2.624 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 8; n=66, 132, 44 | -1.06 Scores on a scale | Standard Deviation 2.141 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 52; n=64, 120, 41 | -1.82 Scores on a scale | Standard Deviation 2.631 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 64; n=62, 117, 36 | -1.96 Scores on a scale | Standard Deviation 2.595 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 40; n=63, 123, 43 | -1.60 Scores on a scale | Standard Deviation 2.809 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 104; n=55, 111, 36 | -2.00 Scores on a scale | Standard Deviation 2.739 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 12; n=66, 133, 44 | -1.07 Scores on a scale | Standard Deviation 2.29 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 72; n=59, 107, 33 | -1.81 Scores on a scale | Standard Deviation 2.609 |
| Belimumab + Rituximab | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 26; n=61, 115, 40 | -1.50 Scores on a scale | Standard Deviation 2.596 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 64; n=62, 117, 36 | -1.96 Scores on a scale | Standard Deviation 3.034 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 72; n=59, 107, 33 | -1.43 Scores on a scale | Standard Deviation 3.487 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 104; n=55, 111, 36 | -1.98 Scores on a scale | Standard Deviation 2.895 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 26; n=61, 115, 40 | -1.57 Scores on a scale | Standard Deviation 2.45 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 8; n=66, 132, 44 | -0.91 Scores on a scale | Standard Deviation 2.848 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 12; n=66, 133, 44 | -1.57 Scores on a scale | Standard Deviation 2.756 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 40; n=63, 123, 43 | -1.67 Scores on a scale | Standard Deviation 2.962 |
| Belimumab + Standard Therapy | Change From Baseline in Patient Global Assessment (PtGA) by Visits | Week 52; n=64, 120, 41 | -1.84 Scores on a scale | Standard Deviation 3.228 |
Secondary
Change From Baseline in Physician Global Assessment (PGA) by Visits
The Physician's Global Assessment (PGA) was a physician-reported visual analogue scale that provides an overall measure of the participant's current disease activity. Physician's Global Assessment was collected on a 10 centimeter (cm) visual analogue scale (VAS) by placing a mark on the scale between 0 (no disease activity) to 10 (maximum disease activity). The PGA score was then rescaled for reporting by multiplying the collected score by 3 divided by 10. Hence, the PGA score ranges from 0 to 3 with higher scores indicating greater disease activity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 28; n=63, 127, 43 | -0.781 Scores on a scale | Standard Deviation 0.5395 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 104; n=55, 114, 36 | -1.052 Scores on a scale | Standard Deviation 0.5095 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 60; n=61, 120, 37 | -0.836 Scores on a scale | Standard Deviation 0.6982 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 32; n=62, 124, 43 | -0.851 Scores on a scale | Standard Deviation 0.5989 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 24; n=62, 130, 43 | -0.770 Scores on a scale | Standard Deviation 0.5888 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 52; n=64, 122, 41 | -0.947 Scores on a scale | Standard Deviation 0.6918 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 36; n=64, 126, 43 | -0.916 Scores on a scale | Standard Deviation 0.6141 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 16; n=68, 132, 44 | -0.619 Scores on a scale | Standard Deviation 0.5475 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 48; n=59, 121, 40 | -0.885 Scores on a scale | Standard Deviation 0.6178 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 40; n=63, 126, 43 | -0.893 Scores on a scale | Standard Deviation 0.6157 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 8; n=66, 135, 44 | -0.535 Scores on a scale | Standard Deviation 0.5134 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 44; n=63, 124, 43 | -0.800 Scores on a scale | Standard Deviation 0.6764 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 88; n=59, 109, 36 | -1.060 Scores on a scale | Standard Deviation 0.6307 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 20; n=66, 130, 44 | -0.697 Scores on a scale | Standard Deviation 0.6157 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 4; n=72, 142, 45 | -0.285 Scores on a scale | Standard Deviation 0.4816 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 80; n=57, 112, 37 | -0.949 Scores on a scale | Standard Deviation 0.6909 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 96; n=54, 109, 35 | -1.016 Scores on a scale | Standard Deviation 0.6093 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 72; n=58, 110, 33 | -0.928 Scores on a scale | Standard Deviation 0.6838 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 26; n=62, 120, 40 | -0.786 Scores on a scale | Standard Deviation 0.5727 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 12; n=66, 137, 44 | -0.592 Scores on a scale | Standard Deviation 0.5265 |
| Belimumab + Placebo | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 64; n=62, 120, 36 | -0.876 Scores on a scale | Standard Deviation 0.6971 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 88; n=59, 109, 36 | -0.993 Scores on a scale | Standard Deviation 0.5733 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 4; n=72, 142, 45 | -0.247 Scores on a scale | Standard Deviation 0.464 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 8; n=66, 135, 44 | -0.520 Scores on a scale | Standard Deviation 0.5243 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 12; n=66, 137, 44 | -0.660 Scores on a scale | Standard Deviation 0.5776 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 16; n=68, 132, 44 | -0.717 Scores on a scale | Standard Deviation 0.5802 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 20; n=66, 130, 44 | -0.787 Scores on a scale | Standard Deviation 0.5445 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 24; n=62, 130, 43 | -0.766 Scores on a scale | Standard Deviation 0.5059 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 26; n=62, 120, 40 | -0.811 Scores on a scale | Standard Deviation 0.5445 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 28; n=63, 127, 43 | -0.817 Scores on a scale | Standard Deviation 0.536 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 32; n=62, 124, 43 | -0.864 Scores on a scale | Standard Deviation 0.5519 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 36; n=64, 126, 43 | -0.927 Scores on a scale | Standard Deviation 0.54 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 40; n=63, 126, 43 | -0.925 Scores on a scale | Standard Deviation 0.5621 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 44; n=63, 124, 43 | -0.905 Scores on a scale | Standard Deviation 0.5289 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 48; n=59, 121, 40 | -0.928 Scores on a scale | Standard Deviation 0.5627 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 52; n=64, 122, 41 | -0.938 Scores on a scale | Standard Deviation 0.6125 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 60; n=61, 120, 37 | -0.848 Scores on a scale | Standard Deviation 0.6085 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 64; n=62, 120, 36 | -0.943 Scores on a scale | Standard Deviation 0.5711 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 72; n=58, 110, 33 | -0.944 Scores on a scale | Standard Deviation 0.5708 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 80; n=57, 112, 37 | -0.954 Scores on a scale | Standard Deviation 0.6221 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 96; n=54, 109, 35 | -0.994 Scores on a scale | Standard Deviation 0.5669 |
| Belimumab + Rituximab | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 104; n=55, 114, 36 | -1.074 Scores on a scale | Standard Deviation 0.5166 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 28; n=63, 127, 43 | -0.980 Scores on a scale | Standard Deviation 0.6286 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 8; n=66, 135, 44 | -0.585 Scores on a scale | Standard Deviation 0.5793 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 60; n=61, 120, 37 | -1.206 Scores on a scale | Standard Deviation 0.5917 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 26; n=62, 120, 40 | -0.929 Scores on a scale | Standard Deviation 0.6631 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 104; n=55, 114, 36 | -1.085 Scores on a scale | Standard Deviation 0.5987 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 64; n=62, 120, 36 | -1.095 Scores on a scale | Standard Deviation 0.6365 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 24; n=62, 130, 43 | -0.965 Scores on a scale | Standard Deviation 0.6413 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 96; n=54, 109, 35 | -1.214 Scores on a scale | Standard Deviation 0.558 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 72; n=58, 110, 33 | -1.047 Scores on a scale | Standard Deviation 0.6088 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 20; n=66, 130, 44 | -0.786 Scores on a scale | Standard Deviation 0.6772 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 4; n=72, 142, 45 | -0.303 Scores on a scale | Standard Deviation 0.5464 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 80; n=57, 112, 37 | -1.138 Scores on a scale | Standard Deviation 0.5574 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 40; n=63, 126, 43 | -0.993 Scores on a scale | Standard Deviation 0.6711 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 16; n=68, 132, 44 | -0.759 Scores on a scale | Standard Deviation 0.6072 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 44; n=63, 124, 43 | -0.970 Scores on a scale | Standard Deviation 0.6065 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 36; n=64, 126, 43 | -0.917 Scores on a scale | Standard Deviation 0.5504 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 12; n=66, 137, 44 | -0.654 Scores on a scale | Standard Deviation 0.545 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 48; n=59, 121, 40 | -0.956 Scores on a scale | Standard Deviation 0.5175 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 32; n=62, 124, 43 | -1.005 Scores on a scale | Standard Deviation 0.6723 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 88; n=59, 109, 36 | -1.140 Scores on a scale | Standard Deviation 0.5514 |
| Belimumab + Standard Therapy | Change From Baseline in Physician Global Assessment (PGA) by Visits | Week 52; n=64, 122, 41 | -1.004 Scores on a scale | Standard Deviation 0.5527 |
Secondary
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed)
The SLEDAI-2K consisted of 24 individual items within 9 organ systems. Each item was given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of visit or in the preceding 10 days. Weighted scores for central nervous system (CNS) (7 items) was 8; for vascular (1 item) was 8; for Musculoskeletal (2 items) was 4; for Renal (4 items) was 4; for Mucocutaneous (3 items) was 2; for Cardiovascular and Respiratory (2 items) was 2; for Immunologic (2 items) was 2;for Constitutional (1 item) was 1 and for Hematologic (2 items) was 1. SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 28; n=62, 125, 43 | -3.7 Scores on a scale | Standard Deviation 3.79 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 4; n=69, 137, 43 | -1.4 Scores on a scale | Standard Deviation 2.75 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 60; n=57, 114, 37 | -5.0 Scores on a scale | Standard Deviation 4.15 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 32; n=61, 125, 43 | -4.7 Scores on a scale | Standard Deviation 3.87 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 16; n=65, 129, 43 | -3.4 Scores on a scale | Standard Deviation 4.12 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 52; n=62, 119, 39 | -5.3 Scores on a scale | Standard Deviation 4.62 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 36; n=61, 125, 43 | -5.0 Scores on a scale | Standard Deviation 4.43 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 104; n=50, 104, 34 | -5.1 Scores on a scale | Standard Deviation 3.69 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 48; n=59, 122, 40 | -4.5 Scores on a scale | Standard Deviation 4.16 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 40; n=62, 125, 43 | -4.6 Scores on a scale | Standard Deviation 4.14 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 88; n=49, 101, 34 | -5.3 Scores on a scale | Standard Deviation 4.61 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 44; n=62, 122, 43 | -4.7 Scores on a scale | Standard Deviation 4.71 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 20; n=63, 127, 44 | -3.8 Scores on a scale | Standard Deviation 4.06 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 96; n=49, 100, 34 | -5.6 Scores on a scale | Standard Deviation 4.35 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 80; n=46, 102, 36 | -5.4 Scores on a scale | Standard Deviation 4.58 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 24; n=61, 128, 43 | -4.0 Scores on a scale | Standard Deviation 3.71 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 12; n=63, 131, 43 | -2.8 Scores on a scale | Standard Deviation 3.5 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 72; n=49, 103, 30 | -5.2 Scores on a scale | Standard Deviation 4.32 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 26; n=61, 118, 40 | -4.1 Scores on a scale | Standard Deviation 3.61 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 8; n=63, 132, 43 | -3.2 Scores on a scale | Standard Deviation 3.59 |
| Belimumab + Placebo | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 64; n=60, 117, 36 | -5.1 Scores on a scale | Standard Deviation 4.16 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 88; n=49, 101, 34 | -6.5 Scores on a scale | Standard Deviation 4.29 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 4; n=69, 137, 43 | -0.8 Scores on a scale | Standard Deviation 3.39 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 8; n=63, 132, 43 | -2.9 Scores on a scale | Standard Deviation 4.09 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 12; n=63, 131, 43 | -3.6 Scores on a scale | Standard Deviation 4.32 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 16; n=65, 129, 43 | -4.4 Scores on a scale | Standard Deviation 4.62 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 20; n=63, 127, 44 | -5.0 Scores on a scale | Standard Deviation 4.44 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 24; n=61, 128, 43 | -5.0 Scores on a scale | Standard Deviation 4.45 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 26; n=61, 118, 40 | -5.4 Scores on a scale | Standard Deviation 4.79 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 28; n=62, 125, 43 | -5.1 Scores on a scale | Standard Deviation 4.74 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 32; n=61, 125, 43 | -5.7 Scores on a scale | Standard Deviation 5.03 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 36; n=61, 125, 43 | -5.6 Scores on a scale | Standard Deviation 5.21 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 40; n=62, 125, 43 | -5.8 Scores on a scale | Standard Deviation 4.83 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 44; n=62, 122, 43 | -6.1 Scores on a scale | Standard Deviation 4.47 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 48; n=59, 122, 40 | -6.2 Scores on a scale | Standard Deviation 4.59 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 52; n=62, 119, 39 | -6.1 Scores on a scale | Standard Deviation 4.42 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 60; n=57, 114, 37 | -5.8 Scores on a scale | Standard Deviation 5.17 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 64; n=60, 117, 36 | -6.2 Scores on a scale | Standard Deviation 4.96 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 72; n=49, 103, 30 | -6.6 Scores on a scale | Standard Deviation 4.5 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 80; n=46, 102, 36 | -6.5 Scores on a scale | Standard Deviation 4.79 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 96; n=49, 100, 34 | -7.0 Scores on a scale | Standard Deviation 4.44 |
| Belimumab + Rituximab | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 104; n=50, 104, 34 | -7.2 Scores on a scale | Standard Deviation 4.22 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 28; n=62, 125, 43 | -5.2 Scores on a scale | Standard Deviation 4.31 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 8; n=63, 132, 43 | -2.9 Scores on a scale | Standard Deviation 3.43 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 60; n=57, 114, 37 | -6.0 Scores on a scale | Standard Deviation 3.94 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 26; n=61, 118, 40 | -5.0 Scores on a scale | Standard Deviation 3.18 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 104; n=50, 104, 34 | -6.3 Scores on a scale | Standard Deviation 3.76 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 64; n=60, 117, 36 | -5.5 Scores on a scale | Standard Deviation 4.4 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 24; n=61, 128, 43 | -5.0 Scores on a scale | Standard Deviation 4 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 96; n=49, 100, 34 | -6.1 Scores on a scale | Standard Deviation 3.8 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 72; n=49, 103, 30 | -5.3 Scores on a scale | Standard Deviation 4.63 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 20; n=63, 127, 44 | -3.8 Scores on a scale | Standard Deviation 3.98 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 4; n=69, 137, 43 | -1.3 Scores on a scale | Standard Deviation 3.15 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 80; n=46, 102, 36 | -6.0 Scores on a scale | Standard Deviation 4.08 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 40; n=62, 125, 43 | -5.0 Scores on a scale | Standard Deviation 3.78 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 16; n=65, 129, 43 | -4.1 Scores on a scale | Standard Deviation 3.29 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 44; n=62, 122, 43 | -5.2 Scores on a scale | Standard Deviation 4.06 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 36; n=61, 125, 43 | -5.0 Scores on a scale | Standard Deviation 3.68 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 12; n=63, 131, 43 | -2.9 Scores on a scale | Standard Deviation 3.68 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 48; n=59, 122, 40 | -5.3 Scores on a scale | Standard Deviation 4.08 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 32; n=61, 125, 43 | -5.3 Scores on a scale | Standard Deviation 3.9 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 88; n=49, 101, 34 | -6.1 Scores on a scale | Standard Deviation 3.8 |
| Belimumab + Standard Therapy | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) | Week 52; n=62, 119, 39 | -5.6 Scores on a scale | Standard Deviation 4.02 |
Secondary
Duration of Clinical Remission
Clinical remission was defined as clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. The duration of clinical remission (PI assessed) was the longest period between 2 visits that the participant was a clinical remission responder at all visits and was calculated as the first visit of clinical remission minus last visit of clinical remission plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: Up to Week 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with at least one assessment where clinical remission was met were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab + Placebo | Duration of Clinical Remission | 31.0 Days |
| Belimumab + Rituximab | Duration of Clinical Remission | 73.0 Days |
| Belimumab + Standard Therapy | Duration of Clinical Remission | 176.0 Days |
Secondary
Duration of Disease Control
Duration of disease control was defined as SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day. The duration of disease control (PI assessed) was the longest period between 2 visits that the participant was a disease control responder at all visits and calculated as the first visit of disease control minus last visit of disease control plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105 (presence of all defined symptoms),higher scores representing increased disease activity
Time frame: Up to Week 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with at least one assessment where disease control was met were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab + Placebo | Duration of Disease Control | 49.5 Days |
| Belimumab + Rituximab | Duration of Disease Control | 116.0 Days |
| Belimumab + Standard Therapy | Duration of Disease Control | 116.0 Days |
Secondary
Number of Participants With Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AESIs were Malignant Neoplasms, Post-Injection Systemic Reactions (PISR), All Infections of Special Interest (Opportunistic Infections (OI), Herpes Zoster (HZ), Tuberculosis (TB), and Sepsis), Depression (including mood disorders and anxiety)/suicide/self-injury and Deaths. Data for number of participants with AESIs has been summarized.
Time frame: Up to Week 104
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belimumab + Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | Deaths | 1 Participants |
| Belimumab + Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | Depression/suicide/self-injury | 9 Participants |
| Belimumab + Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | PISR | 7 Participants |
| Belimumab + Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | Malignant Neoplasms | 1 Participants |
| Belimumab + Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | All Infections of Special Interest | 5 Participants |
| Belimumab + Rituximab | Number of Participants With Adverse Events of Special Interest (AESIs) | Depression/suicide/self-injury | 16 Participants |
| Belimumab + Rituximab | Number of Participants With Adverse Events of Special Interest (AESIs) | All Infections of Special Interest | 12 Participants |
| Belimumab + Rituximab | Number of Participants With Adverse Events of Special Interest (AESIs) | Deaths | 2 Participants |
| Belimumab + Rituximab | Number of Participants With Adverse Events of Special Interest (AESIs) | Malignant Neoplasms | 1 Participants |
| Belimumab + Rituximab | Number of Participants With Adverse Events of Special Interest (AESIs) | PISR | 19 Participants |
| Belimumab + Standard Therapy | Number of Participants With Adverse Events of Special Interest (AESIs) | Deaths | 0 Participants |
| Belimumab + Standard Therapy | Number of Participants With Adverse Events of Special Interest (AESIs) | Malignant Neoplasms | 1 Participants |
| Belimumab + Standard Therapy | Number of Participants With Adverse Events of Special Interest (AESIs) | PISR | 4 Participants |
| Belimumab + Standard Therapy | Number of Participants With Adverse Events of Special Interest (AESIs) | Depression/suicide/self-injury | 5 Participants |
| Belimumab + Standard Therapy | Number of Participants With Adverse Events of Special Interest (AESIs) | All Infections of Special Interest | 5 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Data for number of participants with SAE and non-SAE (\>=5 %) has been summarized.
Time frame: Up to Week 111 (including 8 weeks of safety follow-up)
Population: Intent-to-Treat Population comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or Placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belimumab + Placebo | Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) | SAE | 10 Participants |
| Belimumab + Placebo | Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) | non-SAE | 48 Participants |
| Belimumab + Rituximab | Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) | SAE | 32 Participants |
| Belimumab + Rituximab | Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) | non-SAE | 109 Participants |
| Belimumab + Standard Therapy | Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) | SAE | 15 Participants |
| Belimumab + Standard Therapy | Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) | non-SAE | 53 Participants |
Secondary
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed)
Lupus low disease activity state (LLDAS) was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) SLEDAI-2K \<=4, with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity; (2) no new features of lupus disease activity compared with the previous assessment; (3) PGA (scale 0-3), \<=1; (4) current prednisolone (or equivalent) dose \<=7.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs. Percentage of participants that met the LLDAS response criteria were reported.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96 and 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 60 | 26.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 28 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 8 | 9.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 32 | 29.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 16 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 52 | 27.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 36 | 30.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 88 | 23.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 48 | 26.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 40 | 22.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 104 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 44 | 30.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 80 | 18.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 20 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 72 | 22.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 24 | 12.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 12 | 8.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 64 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 26 | 22.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 96 | 20.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 88 | 24.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 12 | 9.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 4 | 2.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 8 | 1.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 16 | 16.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 20 | 25.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 24 | 22.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 26 | 25.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 28 | 25.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 32 | 31.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 36 | 34.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 40 | 33.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 44 | 37.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 48 | 37.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 52 | 34.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 60 | 23.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 64 | 30.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 72 | 31.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 80 | 26.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 96 | 30.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 104 | 32.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 26 | 34.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 4 | 2.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 60 | 36.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 24 | 36.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 104 | 38.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 64 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 20 | 19.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 96 | 36.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 72 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 16 | 19.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 28 | 34.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 80 | 34.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 40 | 38.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 12 | 6.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 44 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 36 | 29.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 8 | 10.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 48 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 32 | 36.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 88 | 29.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) | Week 52 | 29.8 Percentage of participants |
Secondary
Percentage of Participants With a State of Clinical Remission at Week 64
Percentage of participants with a state of clinical remission (IBA) was defined as percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-double stranded deoxyribonucleic \[dsDNA\] and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day at Week 64. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days, consisting 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: Week 64
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission at Week 64 | 5.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission at Week 64 | 6.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission at Week 64 | 10.6 Percentage of participants |
p-value: 0.858295% CI: [0.33, 3.78]Regression, Logistic
95% CI: [0.17, 1.7]
Secondary
Percentage of Participants With a State of Clinical Remission by Visits
Percentage of participants with a state of clinical remission (IBA) was defined as percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days, consisting 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity
Time frame: Weeks 64, 80 and 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission by Visits | Week 80 | 4.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission by Visits | Week 64 | 5.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission by Visits | Week 104 | 1.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission by Visits | Week 80 | 4.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission by Visits | Week 64 | 6.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission by Visits | Week 104 | 4.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission by Visits | Week 64 | 10.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission by Visits | Week 104 | 6.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission by Visits | Week 80 | 12.8 Percentage of participants |
Secondary
Percentage of Participants With a State of Clinical Remission (CLR) Sustained for at Least 24 Weeks From Week 80 to Week 104
Percentage of participants with a state of CLR (PI assessed) at Week 104 was defined as percentage of participants with a clinical SLEDAI-2K score=0 (does not include anti-dsDNA and complement activity scores) achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day, sustained for at least 24 weeks(from Week 80 to Week 104). Sustained CLR is longest period a participant maintains CLR without a break, calculated as last consecutive CLR date minus first consecutive CLR date plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: From Week 80 to Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission (CLR) Sustained for at Least 24 Weeks From Week 80 to Week 104 | 2.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission (CLR) Sustained for at Least 24 Weeks From Week 80 to Week 104 | 2.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission (CLR) Sustained for at Least 24 Weeks From Week 80 to Week 104 | 4.3 Percentage of participants |
Secondary
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit
Percentage of participants with a state of clinical remission was defined as the percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants (which was allowed in Belimumab+ Standard therapy arm only) and with corticosteroids at a prednisone equivalent dose of 0 mg/day using the PI assessment of SLEDAI-2K. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity. Percentage of participants with a state of clinical remission using the PI assessment of SLEDAI-2K were summarized.
Time frame: Weeks 60, 64, 72, 80, 88, 96 and 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 72 | 6.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 104 | 2.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 60 | 6.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 64 | 6.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 88 | 6.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 96 | 4.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 80 | 6.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 60 | 3.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 80 | 4.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 104 | 3.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 88 | 2.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 64 | 5.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 72 | 3.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 96 | 4.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 64 | 10.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 104 | 6.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 96 | 12.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 88 | 14.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 60 | 10.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 72 | 14.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit | Week 80 | 14.9 Percentage of participants |
Secondary
Percentage of Participants With a State of Complete Remission by Visits
Percentage of participants with a state of complete remission (PI assessed) was defined as the percentage of participants with a SLEDAI-2K score =0, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in the previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within for each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: Weeks 60, 64, 72, 80, 88, 96 and 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission by Visits | Week 64 | 5.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission by Visits | Week 88 | 2.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission by Visits | Week 80 | 2.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission by Visits | Week 60 | 5.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission by Visits | Week 104 | 1.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission by Visits | Week 96 | 1.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission by Visits | Week 72 | 4.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission by Visits | Week 80 | 1.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission by Visits | Week 60 | 0.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission by Visits | Week 64 | 0.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission by Visits | Week 72 | 0.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission by Visits | Week 88 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission by Visits | Week 96 | 0.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission by Visits | Week 104 | 0.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission by Visits | Week 88 | 4.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission by Visits | Week 64 | 6.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission by Visits | Week 104 | 4.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission by Visits | Week 96 | 6.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission by Visits | Week 80 | 8.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission by Visits | Week 72 | 6.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission by Visits | Week 60 | 6.4 Percentage of participants |
Secondary
Percentage of Participants With a State of Complete Remission (CR) Sustained for at Least 24 Weeks During Week 52 to Week 104
Percentage of participants with a state of CR (Principal Investigator \[PI\] assessed) was defined as percentage of participants with a SLEDAI-2K=0 achieved without immunosuppressants and with corticosteroids at prednisone equivalent dose of 0 mg/day,sustained for at least 24 weeks. Sustained CR was longest period a participant maintains CR without break calculated as last consecutive CR date minus first consecutive CR date plus 1. SLEDAI-2K consisted of 24 individual items within each 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at time of visit or in preceding 10 days. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms),higher scores indicates increased disease activity. Percentage of participants with a state of CR sustained for at least 24 weeks at any visit during Week 52 to Week 104 were reported.
Time frame: Week 52 to Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Complete Remission (CR) Sustained for at Least 24 Weeks During Week 52 to Week 104 | 2.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Complete Remission (CR) Sustained for at Least 24 Weeks During Week 52 to Week 104 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Complete Remission (CR) Sustained for at Least 24 Weeks During Week 52 to Week 104 | 6.4 Percentage of participants |
Secondary
Percentage of Participants With a State of Disease Control at Week 104
Percentage of participants with a state of disease control (IBA) was defined as the percentage of participants with a SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day at Week 104. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control at Week 104 | 6.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control at Week 104 | 11.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control at Week 104 | 21.3 Percentage of participants |
p-value: 0.361395% CI: [0.57, 4.72]Regression, Logistic
95% CI: [0.19, 1.09]
Secondary
Percentage of Participants With a State of Disease Control by Visits
Percentage of participants with a state of disease control (IBA) was defined as the percentage of participants with a SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: Weeks 12, 26, 40, 52, 64, 80 and 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control by Visits | Week 26 | 16.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control by Visits | Week 64 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control by Visits | Week 52 | 16.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control by Visits | Week 12 | 8.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control by Visits | Week 104 | 6.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control by Visits | Week 80 | 6.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control by Visits | Week 40 | 13.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control by Visits | Week 52 | 19.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control by Visits | Week 12 | 12.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control by Visits | Week 26 | 21.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control by Visits | Week 40 | 20.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control by Visits | Week 64 | 18.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control by Visits | Week 80 | 13.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control by Visits | Week 104 | 11.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control by Visits | Week 64 | 25.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control by Visits | Week 26 | 25.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control by Visits | Week 104 | 21.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control by Visits | Week 80 | 27.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control by Visits | Week 52 | 25.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control by Visits | Week 40 | 23.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control by Visits | Week 12 | 21.3 Percentage of participants |
Secondary
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit
Percentage of participants with a state of disease control was defined as the percentage of participants with a SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day, using the PI assessment of SLEDAI-2K. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K, ranges from 0 (no symptoms) to 105 (presence of all defined symptoms), higher scores representing increased disease activity. Percentage of participants with a state of disease control using the PI assessment of SLEDAI-2K were summarized.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 88 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 52 | 19.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 28 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 12 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 48 | 18.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 32 | 15.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 104 | 8.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 44 | 18.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 36 | 19.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 80 | 8.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 40 | 16.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 16 | 15.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 96 | 8.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 72 | 9.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 20 | 13.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 8 | 13.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 64 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 24 | 18.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 4 | 2.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 60 | 18.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 26 | 15.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 64 | 18.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 4 | 3.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 8 | 9.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 12 | 12.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 16 | 22.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 20 | 24.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 24 | 25.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 26 | 25.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 28 | 25.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 32 | 28.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 36 | 27.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 40 | 24.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 44 | 26.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 48 | 26.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 52 | 20.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 60 | 20.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 104 | 11.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 72 | 12.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 80 | 13.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 88 | 9.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 96 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 8 | 21.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 52 | 27.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 24 | 34.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 96 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 60 | 23.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 20 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 88 | 21.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 64 | 27.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 16 | 29.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 4 | 8.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 72 | 23.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 36 | 27.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 12 | 19.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 40 | 23.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 32 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 104 | 23.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 44 | 27.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 28 | 36.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 80 | 31.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 48 | 27.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit | Week 26 | 25.5 Percentage of participants |
Secondary
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4)
The FACIT-Fatigue scale was a 13-item questionnaire completed by the participant, which provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions, the greater the fatigue. The total score was the sum of the responses (inverted for reversed items) multiplied by 13, then divided by the number of questions answered, ranging from 0 (worse fatigue) to 52 (no fatigue) where a higher score indicates an improvement in the participant's health status and decrease in the score indicates worse fatigue/quality of life. A participant was considered to had an improvement exceeding the minimal clinically important difference if they had \>=4 points improvement in their FACIT-Fatigue Scale score from Baseline. Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the MCID (\>=4 points) were summarized.
Time frame: Weeks 8, 12, 26, 40, 52, 64, 72 and 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 8; n=66, 132, 44 | 47.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 12; n=66, 133, 44 | 56.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 26; n=61, 115, 40 | 47.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 40; n=63, 122, 43 | 54.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 52; n=64, 120, 41 | 60.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 64; n=62, 117, 36 | 51.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 72; n=59, 107, 33 | 57.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 104; n=55, 111, 36 | 56.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 26; n=61, 115, 40 | 56.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 72; n=59, 107, 33 | 57.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 40; n=63, 122, 43 | 54.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 52; n=64, 120, 41 | 58.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 64; n=62, 117, 36 | 59.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 8; n=66, 132, 44 | 51.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 12; n=66, 133, 44 | 50.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 104; n=55, 111, 36 | 62.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 26; n=61, 115, 40 | 45.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 12; n=66, 133, 44 | 52.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 8; n=66, 132, 44 | 59.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 40; n=63, 122, 43 | 53.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 72; n=59, 107, 33 | 42.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 64; n=62, 117, 36 | 52.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 52; n=64, 120, 41 | 56.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) | Week 104; n=55, 111, 36 | 44.4 Percentage of participants |
Secondary
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed)
SLEDAI-2K assessments consisted of 24 individual items with 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at the time of analysis. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K ranges from 0(no symptoms) to 105(presence of all defined symptoms). Higher scores indicates increased disease activity. An improvement was defined as a decrease(compared to Baseline) in SLEDAI-2K score within same organ system at a post-Baseline visit. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for following organ systems was reported: CNS total, Vascular total, Musculoskeletal total, Renal total, Mucocutaneous total, Cardiovascular (Cardio) and Respiratory (Resp) total, Immunologic total and Hematologic total. Constitutional organ system was removed from analysis and its one item (fever)moved to hematologic organ system.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles). Only participants with organ system involvement at Baseline were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 60; n= 3,7,0 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 16; n= 57,110,34 | 42.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 36; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 52; n= 3, 7, 0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 20; n= 57,110,34 | 47.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 32; n= 57,110,34 | 54.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 20; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 48; n= 3, 7, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 36; n= 57,110,34 | 61.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 40; n= 48, 104, 34 | 14.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 44; n= 3,7, 0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 44; n= 57,110,34 | 50.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 40; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 24; n= 3, 7, 0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 48; n= 57,110,34 | 57.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 4; n= 2,3,2 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 20; n= 3,7, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 52; n= 57,110,34 | 59.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 28; n= 48, 104, 34 | 18.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 16; n= 3, 7, 0 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 60; n= 57,110,34 | 54.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 44; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 12; n= 3, 7, 0 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 64; n= 57,110,34 | 56.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 36; n= 8, 19, 3 | 87.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 88; n= 57,110,34 | 57.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 26; n= 48, 104, 34 | 18.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 8; n= 3, 7, 0 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 96; n= 57,110,34 | 50.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 48; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 4; n= 3, 7, 0 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 104; n= 57,110,34 | 47.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 72; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 104; n= 59, 126, 43 | 61.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 4; n= 14,23,8 | 21.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 52; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 60; n=59, 126, 43 | 55.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 52; n=59, 126, 43 | 64.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 26; n= 14, 23, 8 | 28.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 4; n=48, 104, 34 | 12.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 48; n= 59, 126, 43 | 50.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 28; n= 14, 23, 8 | 21.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 80; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 40; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 32; n= 14, 23, 8 | 35.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 48; n= 8, 19, 3 | 37.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 32; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 36; n= 14, 23, 8 | 42.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 104; n= 3,7,0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 28; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 26; n=59, 126, 43 | 59.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 64; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 88; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 20; n= 59, 126, 43 | 50.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 32; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 12; n= 59, 126, 43 | 55.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 96; n= 3,7,0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 96; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 96; n= 14, 23, 8 | 35.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 60; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 88; n= 3,7,0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 104; n=2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 12; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 80; n=3,7,0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 4; n= 6,11,0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 8; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 8; n= 6,11,0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 64; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 12; n= 6,11,0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 52; n= 8, 19, 3 | 75.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 16; n= 6,11,0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 4; n= 8, 19, 3 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 20; n=6,11,0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 26; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 24; n= 6,11,0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 104; n=48, 104, 34 | 27.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 24; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 26; n= 6, 11, 0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 44; n= 8, 19, 3 | 87.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 88; n=48, 104, 34 | 31.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 32; n= 6,11, 0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 40; n= 6, 11,0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 16; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 80; n=48, 104, 34 | 22.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 60; n= 6, 11, 0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 28; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 64; n= 6, 11, 0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 8; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 80; n= 6, 11, 0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 88; n= 6, 11, 0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 72; n=48, 104, 34 | 29.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 104; n= 6, 11, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 32; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 4; n= 57, 110, 34 | 22.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 40; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 72; n= 3,7,0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 64; n=3,7,0 | 100 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 12; n= 57,110,34 | 36.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 52; n= 48, 104, 34 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 28; n= 6, 11,0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 36; n= 6, 11,0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 44; n= 6, 11, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 48; n= 6, 11, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 52; n= 6, 11, 0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 72; n= 6, 11, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 96; n= 6, 11, 0 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 8; n=57,110, 34 | 40.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 24; n= 57,110,34 | 42.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total;; Week 26; n=57,110,34 | 43.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 28; n= 57,110,34 | 49.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 40; n= 57,110,34 | 54.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 72; n= 57,110,34 | 47.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 80; n= 57,110,34 | 47.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 8; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 12; n= 14, 23, 8 | 28.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 16; n= 14, 23, 8 | 35.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 20; n= 14, 23, 8 | 57.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 24; n= 14, 23, 8 | 35.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 40; n=14, 23, 8 | 42.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 44; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 48; n=14, 23, 8 | 42.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 52; n= 14, 23, 8 | 64.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 60; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 72; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 80; n= 14, 23, 8 | 42.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 88; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 104; n= 14, 23, 8 | 35.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 4; n= 59, 126,43 | 30.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 8; n= 59,126,43 | 54.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 16; n= 59, 126, 43 | 57.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 24; n= 59, 126, 43 | 59.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 36; n= 59, 126, 43 | 66.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 44; n= 59, 126, 43 | 61.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 64; n=59, 126, 43 | 64.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 72; n=59, 126, 43 | 57.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 80; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 88; n= 59, 126, 43 | 59.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 96; n= 59, 126, 43 | 52.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 26; n=3, 7, 0 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 28; n= 3,7, 0 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 32; n= 3, 7, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 36; n= 3, 7, 0 | 66.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 40; n=3,7, 0 | 33.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 8; n= 48, 104, 34 | 16.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 12; n= 48, 104, 34 | 22.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 16; n= 48, 104, 34 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 20; n= 48, 104, 34 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 24; n= 48, 104, 34 | 22.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 32; n= 48, 104, 34 | 25.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 36; n= 48, 104, 34 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 44; n= 48, 104, 34 | 25.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 48; n= 48, 104, 34 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 60; n= 48, 104, 34 | 25.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 64; n= 48, 104, 34 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 96; n=48, 104, 34 | 20.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 12; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 16; n= 8, 19, 3 | 75.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 20; n= 8, 19, 3 | 87.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 24; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 26; n= 8, 19, 3 | 75.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 28; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 60; n= 8, 19, 3 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 64; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 72; n= 8, 19, 3 | 62.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 80; n= 8, 19, 3 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 88; n= 8, 19, 3 | 37.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 96; n= 8, 19, 3 | 50.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 104; n= 8, 19, 3 | 50.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 96; n= 6, 11, 0 | 63.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 60; n= 8, 19, 3 | 57.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 8; n=57,110, 34 | 40.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 20; n= 57,110,34 | 58.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 88; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 32; n= 48, 104, 34 | 40.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 24; n= 57,110,34 | 54.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 24; n= 59, 126, 43 | 61.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 52; n=59, 126, 43 | 64.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total;; Week 26; n=57,110,34 | 46.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 24; n= 3, 7, 0 | 100 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 8; n= 8, 19, 3 | 63.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 28; n= 57,110,34 | 53.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 26; n=3, 7, 0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 64; n= 57,110,34 | 55.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 36; n= 48, 104, 34 | 41.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 40; n= 57,110,34 | 58.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 24; n= 8, 19, 3 | 52.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 28; n= 3,7, 0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 4; n= 59, 126,43 | 28.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 32; n= 3, 7, 0 | 100 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 16; n= 8, 19, 3 | 63.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 80; n= 57,110,34 | 58.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 36; n= 3, 7, 0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 104; n= 8, 19, 3 | 63.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 8; n= 14, 23, 8 | 43.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 26; n= 8, 19, 3 | 36.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 44; n= 48, 104, 34 | 39.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 12; n= 14, 23, 8 | 52.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 40; n=3,7, 0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 4; n=48, 104, 34 | 10.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 16; n= 14, 23, 8 | 52.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 64; n=59, 126, 43 | 65.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 64; n= 8, 19, 3 | 68.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 20; n= 14, 23, 8 | 60.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 104; n= 14, 23, 8 | 69.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 48; n= 48, 104, 34 | 41.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 8; n= 48, 104, 34 | 17.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 40; n=14, 23, 8 | 69.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 36; n= 59, 126, 43 | 65.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 88; n= 8, 19, 3 | 57.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 44; n= 14, 23, 8 | 69.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 12; n= 48, 104, 34 | 24.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 60; n= 48, 104, 34 | 45.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 48; n=14, 23, 8 | 69.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 72; n=59, 126, 43 | 60.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 28; n= 8, 19, 3 | 57.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 52; n= 14, 23, 8 | 69.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 16; n= 48, 104, 34 | 30.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 96; n= 8, 19, 3 | 52.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 60; n= 14, 23, 8 | 65.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 72; n=48, 104, 34 | 36.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 40; n= 59, 126, 43 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 32; n= 6,11, 0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 72; n= 8, 19, 3 | 47.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 96; n= 14, 23, 8 | 78.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 96; n=48, 104, 34 | 33.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 80; n= 8, 19, 3 | 52.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 36; n= 6, 11,0 | 63.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 20; n= 48, 104, 34 | 36.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 80; n= 59, 126, 43 | 61.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 48; n= 6, 11, 0 | 63.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 12; n= 8, 19, 3 | 52.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 52; n= 6, 11, 0 | 63.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 64; n= 6, 11, 0 | 90.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 24; n= 48, 104, 34 | 34.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 20; n= 8, 19, 3 | 57.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 52; n= 8, 19, 3 | 52.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 48; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 4; n= 2,3,2 | 33.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 8; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 12; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 16; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 20; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 52; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 60; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 64; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 24; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 26; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 28; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 32; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 36; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 40; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 44; n= 2,3,2 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 72; n= 2,3,2 | 33.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 80; n= 2,3,2 | 33.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 88; n= 2,3,2 | 33.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 96; n= 2,3,2 | 33.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 104; n=2,3,2 | 33.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 4; n= 6,11,0 | 9.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 8; n= 6,11,0 | 36.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 12; n= 6,11,0 | 54.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 16; n= 6,11,0 | 54.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 20; n=6,11,0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 24; n= 6,11,0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 80; n= 6, 11, 0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 26; n= 6, 11, 0 | 63.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 28; n= 6, 11,0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 40; n= 6, 11,0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 44; n= 6, 11, 0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 60; n= 6, 11, 0 | 63.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 72; n= 6, 11, 0 | 81.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 88; n= 6, 11, 0 | 45.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 104; n= 6, 11, 0 | 72.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 4; n= 57, 110, 34 | 13.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 12; n= 57,110,34 | 44.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 16; n= 57,110,34 | 56.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 32; n= 57,110,34 | 63.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 36; n= 57,110,34 | 61.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 44; n= 57,110,34 | 60.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 48; n= 57,110,34 | 60.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 52; n= 57,110,34 | 59.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 60; n= 57,110,34 | 54.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 24; n= 14, 23, 8 | 60.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 88; n= 57,110,34 | 59.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 96; n= 57,110,34 | 60.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 104; n= 57,110,34 | 64.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 4; n= 14,23,8 | 30.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 26; n= 14, 23, 8 | 65.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 28; n= 14, 23, 8 | 56.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 32; n= 14, 23, 8 | 65.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 36; n= 14, 23, 8 | 65.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 64; n= 14, 23, 8 | 69.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 72; n= 14, 23, 8 | 65.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 80; n= 14, 23, 8 | 65.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 88; n= 14, 23, 8 | 73.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 8; n= 59,126,43 | 45.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 12; n= 59, 126, 43 | 57.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 16; n= 59, 126, 43 | 58.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 20; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 26; n=59, 126, 43 | 60.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 28; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 32; n= 59, 126, 43 | 65.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 44; n= 59, 126, 43 | 61.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 48; n= 59, 126, 43 | 66.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 60; n=59, 126, 43 | 65.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 96; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 104; n= 59, 126, 43 | 69.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 4; n= 3, 7, 0 | 42.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 8; n= 3, 7, 0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 12; n= 3, 7, 0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 16; n= 3, 7, 0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 20; n= 3,7, 0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 44; n= 3,7, 0 | 57.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 48; n= 3, 7, 0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 52; n= 3, 7, 0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 60; n= 3,7,0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 64; n=3,7,0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 72; n= 3,7,0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 80; n=3,7,0 | 85.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 88; n= 3,7,0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 96; n= 3,7,0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 104; n= 3,7,0 | 71.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 26; n= 48, 104, 34 | 39.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 28; n= 48, 104, 34 | 34.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 40; n= 48, 104, 34 | 44.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 52; n= 48, 104, 34 | 37.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 64; n= 48, 104, 34 | 43.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 80; n=48, 104, 34 | 31.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 88; n=48, 104, 34 | 29.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 104; n=48, 104, 34 | 40.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 4; n= 8, 19, 3 | 42.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 32; n= 8, 19, 3 | 57.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 36; n= 8, 19, 3 | 63.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 40; n= 8, 19, 3 | 52.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 44; n= 8, 19, 3 | 57.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 48; n= 8, 19, 3 | 63.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 72; n= 57,110,34 | 58.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 96; n=48, 104, 34 | 20.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 44; n= 57,110,34 | 76.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 36; n= 57,110,34 | 76.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 20; n= 2,3,2 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 32; n= 57,110,34 | 76.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 12; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 16; n= 57,110,34 | 67.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 104; n=48, 104, 34 | 20.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 12; n= 57,110,34 | 47.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 64; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 8; n=57,110, 34 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 48; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 4; n= 57, 110, 34 | 23.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 4; n= 8, 19, 3 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 104; n=2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 60; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 96; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 28; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 88; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 52; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 80; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 44; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 72; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 24; n= 48, 104, 34 | 20.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 44; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 32; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 26; n= 48, 104, 34 | 11.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 88; n= 14, 23, 8 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 40; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 8; n= 59,126,43 | 51.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 72; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 48; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 36; n= 2,3,2 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 16; n= 59, 126, 43 | 67.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 64; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 8; n= 2,3,2 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 20; n= 59, 126, 43 | 69.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 24; n= 59, 126, 43 | 69.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 60; n= 14, 23, 8 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 32; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 36; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 36; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 28; n= 59, 126, 43 | 69.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 32; n= 14, 23, 8 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 52; n= 48, 104, 34 | 26.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 36; n= 59, 126, 43 | 69.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 28; n= 14, 23, 8 | 37.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 16; n= 2,3,2 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 44; n= 59, 126, 43 | 69.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 26; n= 14, 23, 8 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 64; n= 48, 104, 34 | 26.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 48; n= 59, 126, 43 | 69.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 24; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 4; n= 14,23,8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 28; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 26; n= 2,3,2 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 96; n= 59, 126, 43 | 62.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 104; n= 57,110,34 | 67.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 4; n= 2,3,2 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 104; n= 59, 126, 43 | 60.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 96; n= 57,110,34 | 70.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 80; n=48, 104, 34 | 23.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 88; n= 57,110,34 | 67.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 24; n= 2,3,2 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 60; n= 57,110,34 | 67.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 40; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 52; n= 57,110,34 | 73.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 88; n=48, 104, 34 | 14.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 48; n= 57,110,34 | 73.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 96; n= 14, 23, 8 | 37.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 104; n= 14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 4; n= 59, 126,43 | 32.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 8; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 12; n= 59, 126, 43 | 55.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 72; n= 8, 19, 3 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 26; n=59, 126, 43 | 65.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 32; n= 59, 126, 43 | 74.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 12; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 40; n= 59, 126, 43 | 67.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 96; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 52; n=59, 126, 43 | 69.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 60; n=59, 126, 43 | 67.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 64; n=59, 126, 43 | 62.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 16; n= 8, 19, 3 | 66.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 72; n=59, 126, 43 | 58.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 80; n= 59, 126, 43 | 62.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 88; n= 59, 126, 43 | 67.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 20; n= 8, 19, 3 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 80; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 24; n= 8, 19, 3 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 104; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 4; n=48, 104, 34 | 17.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 26; n= 8, 19, 3 | 100 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 8; n= 48, 104, 34 | 17.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 12; n= 48, 104, 34 | 17.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 16; n= 48, 104, 34 | 11.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 52; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 20; n= 48, 104, 34 | 23.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 88; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 28; n= 48, 104, 34 | 20.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 20; n= 57,110,34 | 64.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 24; n= 57,110,34 | 70.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 32; n= 48, 104, 34 | 23.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total;; Week 26; n=57,110,34 | 73.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 60; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 28; n= 57,110,34 | 76.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 40; n= 57,110,34 | 73.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 64; n= 57,110,34 | 67.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 36; n= 48, 104, 34 | 17.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 72; n= 57,110,34 | 58.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 40; n= 48, 104, 34 | 23.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 80; n= 57,110,34 | 76.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 8; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 12; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 44; n= 48, 104, 34 | 38.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 16; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 20; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 48; n= 48, 104, 34 | 29.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 40; n=14, 23, 8 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 64; n= 8, 19, 3 | 33.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 44; n= 14, 23, 8 | 12.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 48; n=14, 23, 8 | 50.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 60; n= 48, 104, 34 | 20.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 52; n= 14, 23, 8 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 72; n=48, 104, 34 | 17.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 80; n= 14, 23, 8 | 50.0 Percentage of participants |
Secondary
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed)
SLEDAI-2K assessments consisted of 24 individual items with 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at time of analysis. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms). Higher scores indicates increased disease activity. A worsening was defined as an increase(compared to Baseline) in SLEDAI-2K score within same organ system at a post-Baseline visit. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with SLEDAI-2K organ worsening for following organ systems were reported;CNS total,Vascular total,Musculoskeletal total,Renal total,Mucocutaneous total,Cardio and Resp total,Immunologic total and Hematologic total. Constitutional organ system was removed from analysis and its one item (fever)moved to hematologic organ system.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104
Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles). Only participants with no organ system involvement at Baseline were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 48; n=51, 105, 35 | 5.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 64; n= 10, 16, 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 36; n= 14, 30, 11 | 7.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 80; n= 18, 29, 11 | 5.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 60; n= 9, 17, 4 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 40; n=15, 30, 11 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 64; n=54, 98, 32 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 104; n= 9, 17, 4 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 44; n=15, 29, 11 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 72; n= 17, 28, 9 | 23.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 96; n= 9, 15, 4 | 11.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 48; n= 14, 30, 10 | 7.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 52; n= 62, 120, 38 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 44; n= 60, 117, 43 | 1.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 52; n= 15, 30, 11 | 6.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 48; n= 58, 120,39 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 52; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 60; n= 14, 28, 11 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 64; n= 19, 33, 10 | 21.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 48; n=10, 16, 3 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 64; n=14, 29, 10 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 60; n=59, 117, 35 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 44; n= 10, 17, 4 | 10.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 72; n= 14, 27, 10 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 44; n=53, 107, 38 | 7.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 40; n= 10, 17, 4 | 20.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 80; n= 13, 26, 9 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 60; n= 18, 32, 10 | 16.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 36; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 88; n= 13, 25, 9 | 15.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 64; n=60, 117, 34 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 32; n= 10, 17, 4 | 10.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 96; n= 12, 26, 9 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 4; n= 69, 136, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 28; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 104; n= 13, 27, 9 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 52; n= 19, 32, 12 | 21.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 26; n= 10, 17, 4 | 20.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 4; n= 57, 117, 36 | 5.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 72; n= 56, 109, 31 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 24; n= 11, 17, 4 | 18.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 8; n=51, 110, 36 | 2.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 52; n=61, 116, 40 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 20; n= 12, 18, 4 | 25.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 12; n=53, 115, 35 | 1.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 48; n= 18, 33, 11 | 22.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 16; n= 12, 18, 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 16; n=53, 112, 35 | 7.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 80; n=55, 111, 35 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 12; n= 12, 18, 4 | 8.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 20; n= 49, 108, 36 | 8.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 40; n= 51, 108, 37 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 8; n= 12, 18, 4 | 8.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 24; n= 49, 111, 35 | 10.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 44; n= 18, 33, 12 | 22.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 4; n= 13, 18, 4 | 15.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 26; n= 49, 99, 33 | 6.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 88; n= 57, 107, 34 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 104; n= 44, 90, 30 | 6.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 28; n= 50, 106, 36 | 10.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 8; n= 64,132, 42 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 96; n= 43, 85, 29 | 4.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 32; n= 50,107, 36 | 6.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 40; n= 19, 33, 12 | 21.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 88; n= 44, 85, 29 | 13.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 36; n= 50, 107, 36 | 8.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 96; n=52, 107, 33 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 80; n= 41, 90, 29 | 14.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 40; n= 47, 106, 34 | 6.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 60; n= 58, 114, 37 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 72; n= 40, 89, 26 | 5.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 44; n= 49, 103, 35 | 6.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 36; n= 19, 34, 12 | 15.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 64; n= 50, 99, 29 | 2.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 48; n= 47, 101, 32 | 10.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 104; n= 53, 112, 34 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 60; n=47, 96, 30 | 6.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 52; n= 49, 103, 32 | 8.2 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 36; n= 53, 109, 40 | 5.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 32; n= 19, 33, 12 | 10.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 4; n= 65, 128, 45 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 12; n= 65, 134, 42 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 26; n= 18, 30, 12 | 5.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 8; n= 61, 124, 44 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 72; n= 47,96, 29 | 10.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 24; n= 18, 35, 12 | 5.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 12; n= 62, 126, 44 | 1.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 24; n= 53, 111, 37 | 3.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 16; n= 21, 35, 12 | 9.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 16; n=62, 122, 44 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 16; n= 65, 130, 42 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 12; n=21, 37,12 | 23.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 20; n=60, 120, 44 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 60; n=53, 101, 35 | 9.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 8; n=20, 37, 12 | 20.0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 24; n= 59, 119, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 20; n= 54, 108, 40 | 5.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 4; n=23, 37, 13 | 17.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 26; n=58, 109, 40 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 20; n= 63, 128, 42 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 104; n= 52, 109, 36 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 28; n= 61, 116, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 64; n= 59, 114, 36 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 96; n=51, 104, 35 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 32; n=59, 116, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 16; n=54, 107, 34 | 1.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 88; n= 56, 104, 36 | 1.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 36; n= 59, 116, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 24; n= 61, 127, 41 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 80; n= 54, 107, 37 | 1.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 40; n=59, 115, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 20; n= 19, 35, 12 | 15.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 72; n= 55, 106, 33 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 44; n= 59, 113, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 12; n= 55, 110, 38 | 1.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 40; n=60, 119, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 48; n= 57, 112, 40 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 26; n=61, 116, 38 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 32; n= 60, 120, 43 | 1.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 52; n=60, 112, 40 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 28; n= 19, 35, 12 | 15.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 28; n= 61, 120, 43 | 3.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 60; n= 58, 109, 37 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 8; n= 52, 109, 38 | 3.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 26; n=59, 112, 40 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 64; n=59, 109, 36 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 36; n= 60, 120, 43 | 1.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 24; n= 60, 123, 43 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 72; n=55, 101, 33 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 28; n=62, 124, 41 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 20; n= 63, 124, 44 | 1.6 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 80; n= 54, 104, 37 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 26; n= 53, 101, 37 | 9.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 16; n= 64, 126, 44 | 3.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 88; n=56, 102, 36 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 4; n= 59, 115, 40 | 5.1 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 12; n= 64, 130, 44 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 96; n=51, 101, 35 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 32; n= 61, 124, 41 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 104; n= 46, 94, 32 | 4.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 104; n=53, 105, 36 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 28; n= 52, 106, 39 | 7.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 96; n= 45, 90, 32 | 4.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 4; n=15, 33, 12 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 104; n= 17, 28, 12 | 11.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 48; n= 57, 116, 40 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 8; n= 15, 33, 12 | 6.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 36; n=61, 124, 41 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 88; n= 46, 88, 32 | 10.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 12; n= 15, 33, 12 | 13.3 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 52; n= 53, 103, 37 | 3.8 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 80; n= 45, 94, 35 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 16; n= 15, 32, 12 | 6.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 96; n= 16, 30, 11 | 12.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 8; n= 63, 128, 44 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 20; n= 15, 32, 12 | 6.7 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 40; n=61, 123, 41 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 4; n= 68, 132, 45 | 2.9 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 24; n= 15, 31, 11 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 32; n=52, 110, 38 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 88; n= 9, 16, 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 26; n= 15, 31, 11 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 88; n= 19, 29, 11 | 10.5 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 80; n= 9, 17, 4 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 28; n= 14, 31, 11 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 44; n= 61, 121, 41 | 0 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 72; n=10, 16, 4 | 20 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 32; n= 15, 30, 11 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 64; n=59, 109, 36 | 1.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 44; n= 60, 117, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 60; n= 58, 114, 37 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 4; n= 69, 136, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 8; n= 64,132, 42 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 12; n= 65, 134, 42 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 16; n= 65, 130, 42 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 20; n= 63, 128, 42 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 24; n= 61, 127, 41 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 26; n=61, 116, 38 | 0.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 28; n=62, 124, 41 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 32; n= 61, 124, 41 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 36; n=61, 124, 41 | 1.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 40; n=61, 123, 41 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 44; n= 61, 121, 41 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 48; n= 58, 120,39 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 52; n= 62, 120, 38 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 60; n=59, 117, 35 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 64; n=60, 117, 34 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 72; n= 56, 109, 31 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 80; n=55, 111, 35 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 88; n= 57, 107, 34 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 96; n=52, 107, 33 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 104; n= 53, 112, 34 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 4; n= 65, 128, 45 | 3.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 8; n= 61, 124, 44 | 2.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 12; n= 62, 126, 44 | 1.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 16; n=62, 122, 44 | 1.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 20; n=60, 120, 44 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 24; n= 59, 119, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 26; n=58, 109, 40 | 0.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 28; n= 61, 116, 43 | 1.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 32; n=59, 116, 43 | 2.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 36; n= 59, 116, 43 | 1.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 40; n=59, 115, 43 | 1.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 44; n= 59, 113, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 48; n= 57, 112, 40 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 52; n=60, 112, 40 | 0.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 60; n= 58, 109, 37 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 72; n=55, 101, 33 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 80; n= 54, 104, 37 | 1.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 88; n=56, 102, 36 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 96; n=51, 101, 35 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 104; n=53, 105, 36 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 4; n=15, 33, 12 | 12.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 8; n= 15, 33, 12 | 6.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 12; n= 15, 33, 12 | 6.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 16; n= 15, 32, 12 | 3.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 20; n= 15, 32, 12 | 6.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 24; n= 15, 31, 11 | 6.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 26; n= 15, 31, 11 | 3.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 28; n= 14, 31, 11 | 3.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 32; n= 15, 30, 11 | 6.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 36; n= 14, 30, 11 | 3.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 40; n=15, 30, 11 | 3.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 44; n=15, 29, 11 | 6.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 48; n= 14, 30, 10 | 3.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 52; n= 15, 30, 11 | 6.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 60; n= 14, 28, 11 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 64; n=14, 29, 10 | 3.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 72; n= 14, 27, 10 | 11.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 80; n= 13, 26, 9 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 88; n= 13, 25, 9 | 4.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 96; n= 12, 26, 9 | 3.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 104; n= 13, 27, 9 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 4; n= 57, 117, 36 | 6.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 8; n=51, 110, 36 | 3.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 12; n=53, 115, 35 | 3.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 16; n=53, 112, 35 | 4.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 20; n= 49, 108, 36 | 3.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 24; n= 49, 111, 35 | 3.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 26; n= 49, 99, 33 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 28; n= 50, 106, 36 | 1.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 32; n= 50,107, 36 | 2.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 36; n= 50, 107, 36 | 2.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 40; n= 47, 106, 34 | 4.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 44; n= 49, 103, 35 | 1.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 48; n= 47, 101, 32 | 5.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 52; n= 49, 103, 32 | 3.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 60; n=47, 96, 30 | 4.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 64; n= 50, 99, 29 | 2.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 72; n= 40, 89, 26 | 4.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 80; n= 41, 90, 29 | 3.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 88; n= 44, 85, 29 | 1.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 96; n= 43, 85, 29 | 1.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 104; n= 44, 90, 30 | 2.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 4; n= 13, 18, 4 | 5.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 8; n= 12, 18, 4 | 11.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 12; n= 12, 18, 4 | 16.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 16; n= 12, 18, 4 | 5.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 20; n= 12, 18, 4 | 5.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 24; n= 11, 17, 4 | 5.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 26; n= 10, 17, 4 | 11.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 28; n= 10, 17, 4 | 11.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 32; n= 10, 17, 4 | 5.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 36; n= 10, 17, 4 | 5.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 40; n= 10, 17, 4 | 11.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 44; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 48; n=10, 16, 3 | 6.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 52; n= 10, 17, 4 | 5.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 96; n= 9, 15, 4 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 104; n= 9, 17, 4 | 5.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 60; n= 9, 17, 4 | 11.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 64; n= 10, 16, 4 | 6.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 72; n=10, 16, 4 | 6.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 80; n= 9, 17, 4 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 88; n= 9, 16, 4 | 6.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 4; n= 68, 132, 45 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 80; n= 45, 94, 35 | 4.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 88; n= 46, 88, 32 | 9.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 48; n= 57, 116, 40 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 52; n=61, 116, 40 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 8; n= 63, 128, 44 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 96; n= 45, 90, 32 | 4.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 104; n= 46, 94, 32 | 6.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 12; n= 64, 130, 44 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 16; n= 64, 126, 44 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 20; n= 63, 124, 44 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 24; n= 60, 123, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 26; n=59, 112, 40 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 28; n= 61, 120, 43 | 0.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 32; n= 60, 120, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 36; n= 60, 120, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 40; n=60, 119, 43 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 64; n= 59, 114, 36 | 0.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 72; n= 55, 106, 33 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 80; n= 54, 107, 37 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 88; n= 56, 104, 36 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 96; n=51, 104, 35 | 1.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 104; n= 52, 109, 36 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 4; n=23, 37, 13 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 8; n=20, 37, 12 | 10.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 12; n=21, 37,12 | 8.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 16; n= 21, 35, 12 | 11.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 20; n= 19, 35, 12 | 11.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 24; n= 18, 35, 12 | 5.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 26; n= 18, 30, 12 | 6.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 28; n= 19, 35, 12 | 8.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 32; n= 19, 33, 12 | 12.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 36; n= 19, 34, 12 | 8.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 40; n= 19, 33, 12 | 6.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 44; n= 18, 33, 12 | 0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 48; n= 18, 33, 11 | 3.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 52; n= 19, 32, 12 | 3.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 60; n= 18, 32, 10 | 6.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 64; n= 19, 33, 10 | 6.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 72; n= 17, 28, 9 | 7.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 80; n= 18, 29, 11 | 6.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 88; n= 19, 29, 11 | 6.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 96; n= 16, 30, 11 | 13.3 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 104; n= 17, 28, 12 | 17.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 4; n= 59, 115, 40 | 3.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 8; n= 52, 109, 38 | 5.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 12; n= 55, 110, 38 | 4.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 16; n=54, 107, 34 | 2.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 20; n= 54, 108, 40 | 5.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 24; n= 53, 111, 37 | 2.7 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 26; n= 53, 101, 37 | 5.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 28; n= 52, 106, 39 | 3.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 32; n=52, 110, 38 | 4.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 36; n= 53, 109, 40 | 6.4 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 40; n= 51, 108, 37 | 10.2 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 44; n=53, 107, 38 | 6.5 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 48; n=51, 105, 35 | 4.8 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 52; n= 53, 103, 37 | 3.9 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 60; n=53, 101, 35 | 5.0 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 64; n=54, 98, 32 | 5.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 72; n= 47,96, 29 | 5.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 12; n= 15, 33, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 48; n= 58, 120,39 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 80; n= 45, 94, 35 | 5.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 8; n= 15, 33, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 60; n= 58, 114, 37 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 44; n= 60, 117, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 4; n=15, 33, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 72; n= 17, 28, 9 | 11.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 48; n= 57, 116, 40 | 2.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 44; n= 61, 121, 41 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 52; n=61, 116, 40 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 36; n= 53, 109, 40 | 2.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 88; n= 46, 88, 32 | 3.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 104; n=53, 105, 36 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 80; n= 18, 29, 11 | 18.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 96; n= 45, 90, 32 | 3.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 96; n=51, 101, 35 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 40; n=61, 123, 41 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 104; n= 46, 94, 32 | 6.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 8; n= 63, 128, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 88; n=56, 102, 36 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 4; n= 69, 136, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 12; n= 64, 130, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 80; n= 54, 104, 37 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 88; n= 19, 29, 11 | 18.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 16; n= 64, 126, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 72; n=55, 101, 33 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 36; n=61, 124, 41 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 20; n= 63, 124, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 64; n=59, 109, 36 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 40; n=60, 119, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 24; n= 60, 123, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 60; n= 58, 109, 37 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 96; n= 16, 30, 11 | 18.2 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 26; n=59, 112, 40 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 52; n=60, 112, 40 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 32; n= 61, 124, 41 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 28; n= 61, 120, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 48; n= 57, 112, 40 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 40; n= 51, 108, 37 | 5.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 32; n= 60, 120, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 104; n= 17, 28, 12 | 16.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 36; n= 60, 120, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 44; n= 59, 113, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 28; n=62, 124, 41 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 88; n= 9, 16, 4 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 64; n= 59, 114, 36 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 40; n=59, 115, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 4; n= 59, 115, 40 | 5.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 72; n= 55, 106, 33 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 36; n= 59, 116, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 26; n=61, 116, 38 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 80; n= 54, 107, 37 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 32; n=59, 116, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 60; n=53, 101, 35 | 5.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 88; n= 56, 104, 36 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 28; n= 61, 116, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 8; n= 52, 109, 38 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 96; n=51, 104, 35 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 26; n=58, 109, 40 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 24; n= 61, 127, 41 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 104; n= 52, 109, 36 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 24; n= 59, 119, 43 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 44; n=53, 107, 38 | 5.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 4; n=23, 37, 13 | 7.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 20; n=60, 120, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 12; n= 55, 110, 38 | 10.5 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 8; n=20, 37, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 16; n=62, 122, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 20; n= 63, 128, 42 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 12; n=21, 37,12 | 16.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total; Week 12; n= 62, 126, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 32; n=52, 110, 38 | 7.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 16; n= 21, 35, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 16; n=54, 107, 34 | 2.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 20; n= 19, 35, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 8; n= 61, 124, 44 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 16; n= 65, 130, 42 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 24; n= 18, 35, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 52; n= 49, 103, 32 | 3.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 48; n= 47, 101, 32 | 6.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Vascular Total;Week 4; n= 65, 128, 45 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 60; n=47, 96, 30 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 44; n= 49, 103, 35 | 2.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 72; n= 47,96, 29 | 3.4 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 64; n= 50, 99, 29 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 40; n= 47, 106, 34 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 26; n= 18, 30, 12 | 8.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 72; n= 40, 89, 26 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 36; n= 50, 107, 36 | 5.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 20; n= 54, 108, 40 | 5.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 80; n= 41, 90, 29 | 6.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 32; n= 50,107, 36 | 2.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 28; n= 19, 35, 12 | 16.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 88; n= 44, 85, 29 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 28; n= 50, 106, 36 | 2.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 104; n= 53, 112, 34 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 96; n= 43, 85, 29 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 26; n= 49, 99, 33 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 12; n= 65, 134, 42 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 104; n= 44, 90, 30 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 24; n= 49, 111, 35 | 2.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 32; n= 19, 33, 12 | 8.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 4; n= 13, 18, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 20; n= 49, 108, 36 | 8.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 96; n=52, 107, 33 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 8; n= 12, 18, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 16; n=53, 112, 35 | 2.9 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 48; n=51, 105, 35 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 12; n= 12, 18, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 12; n=53, 115, 35 | 8.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 36; n= 19, 34, 12 | 16.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 16; n= 12, 18, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 8; n=51, 110, 36 | 5.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 88; n= 57, 107, 34 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 20; n= 12, 18, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Renal Total; Week 4; n= 57, 117, 36 | 11.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 24; n= 53, 111, 37 | 2.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 24; n= 11, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 104; n= 13, 27, 9 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 40; n= 19, 33, 12 | 8.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 26; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 96; n= 12, 26, 9 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 80; n=55, 111, 35 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 28; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 88; n= 13, 25, 9 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 28; n= 52, 106, 39 | 5.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 32; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 80; n= 13, 26, 9 | 11.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 44; n= 18, 33, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 36; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 72; n= 14, 27, 10 | 10.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 72; n= 56, 109, 31 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 40; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 64; n=14, 29, 10 | 10.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 26; n= 53, 101, 37 | 10.8 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 44; n= 10, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 60; n= 14, 28, 11 | 9.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 48; n= 18, 33, 11 | 27.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 48; n=10, 16, 3 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 52; n= 15, 30, 11 | 9.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 64; n=60, 117, 34 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 48; n= 14, 30, 10 | 10.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 44; n=15, 29, 11 | 9.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 64; n=54, 98, 32 | 6.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 96; n= 9, 15, 4 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 40; n=15, 30, 11 | 9.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 52; n= 10, 17, 4 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 52; n= 19, 32, 12 | 8.3 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 104; n= 9, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 36; n= 14, 30, 11 | 9.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 60; n=59, 117, 35 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 60; n= 9, 17, 4 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 32; n= 15, 30, 11 | 9.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Hematologic Total; Week 52; n= 53, 103, 37 | 2.7 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 64; n= 10, 16, 4 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 28; n= 14, 31, 11 | 9.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 60; n= 18, 32, 10 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 72; n=10, 16, 4 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 26; n= 15, 31, 11 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 52; n= 62, 120, 38 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Mucocutaneous Total; Week 80; n= 9, 17, 4 | 25.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 24; n= 15, 31, 11 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | CNS Total; Week 8; n= 64,132, 42 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 20; n= 15, 32, 12 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Immunologic Total; Week 64; n= 19, 33, 10 | 20.0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Cardio and Resp Total; Week 4; n= 68, 132, 45 | 0 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) | Musculoskeletal Total; Week 16; n= 15, 32, 12 | 8.3 Percentage of participants |
Secondary
Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104
The SLICC-ACR Damage Index measures irreversible (not related to active inflammation) changes occurring since the diagnosis of SLE ascertained by clinical assessment and present for at least 6 months. The questionnaire contains 39 items covering 12 different organ systems which were scored on a numerical scale between 0 (no damage) to 7 (increasing disease damage). Individual ranges for organ systems were; ocular: 0-2, neuropsychiatric: 0-6, renal: 0-3, pulmonary: 0-5, cardiovascular:0-6, peripheral vascular: 0-5, gastrointestinal:0-5, musculoskeletal: 0-6, skin: 0-3, endocrine (diabetes): 0-1, gonadal:0-1 and malignancies: 0-2. The SLICC-ACR score was calculated by taking sum of the individual scores for 12 organ systems which ranges from 0 (no damage) to 45 (increasing disease damage) where higher score indicates increasing disease damage severity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1), Week 52 and Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab + Placebo | Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 | Week 52 | 1.4 Percentage of participants |
| Belimumab + Placebo | Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 | Week 104 | 5.6 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 | Week 52 | 2.1 Percentage of participants |
| Belimumab + Rituximab | Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 | Week 104 | 5.6 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 | Week 52 | 2.1 Percentage of participants |
| Belimumab + Standard Therapy | Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 | Week 104 | 6.4 Percentage of participants |
p-value: 0.710295% CI: [0.15, 15.7]Regression, Logistic
95% CI: [0.1, 10.71]
p-value: 0.864195% CI: [0.26, 3.15]Regression, Logistic
95% CI: [0.26, 5.64]
Secondary
Time to Clinical Remission Sustained for at Least 24 Weeks and Maintained Through Week 104
Clinical remission sustained for at least 24 weeks and maintained through Week 104 was defined as clinical SLEDAI-2K score=0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. Time to CLR (PI assessed) was defined as first visit of sustained CLR until Week 104 on or before Week 80 minus treatment start date (Day 1) plus 1. Sustained CLR was longest period a participant maintained clinical remission without a break. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.
Time frame: Up to Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab + Placebo | Time to Clinical Remission Sustained for at Least 24 Weeks and Maintained Through Week 104 | NA Days |
| Belimumab + Rituximab | Time to Clinical Remission Sustained for at Least 24 Weeks and Maintained Through Week 104 | NA Days |
| Belimumab + Standard Therapy | Time to Clinical Remission Sustained for at Least 24 Weeks and Maintained Through Week 104 | NA Days |
p-value: 0.843695% CI: [0.14, 5.05]Cox proportional hazards model
95% CI: [0.09, 3.14]
Secondary
Time to Disease Control Sustained for at Least 24 Weeks and Maintained Through Week 104
Disease control sustained for at least 24 weeks and maintained through Week 104 was defined as SLEDAI-2K score \<=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day. Time to disease control (PI assessed) was defined as the first visit of sustained disease control until Week 104 on or before Week 80 minus treatment start date (Day 1) plus 1. Sustained disease control was longest period a participant maintained disease control without a break. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K , ranges from 0 (no symptoms) to 105 (presence of all defined symptoms),higher scores representing increased disease activity.
Time frame: Up to Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab + Placebo | Time to Disease Control Sustained for at Least 24 Weeks and Maintained Through Week 104 | NA Days |
| Belimumab + Rituximab | Time to Disease Control Sustained for at Least 24 Weeks and Maintained Through Week 104 | NA Days |
| Belimumab + Standard Therapy | Time to Disease Control Sustained for at Least 24 Weeks and Maintained Through Week 104 | NA Days |
p-value: 0.512795% CI: [0.42, 5.78]Cox proportional hazards model
95% CI: [0.23, 2.1]
Secondary
Time to First Flare
Time to first SLE flare was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1. Time to first flare was measured by modified SLE flare index which identifies whether a participant had experienced a mild/moderate or severe flare.
Time frame: Up to Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab + Placebo | Time to First Flare | 168.0 Days |
| Belimumab + Rituximab | Time to First Flare | 170.0 Days |
| Belimumab + Standard Therapy | Time to First Flare | 168.0 Days |
p-value: 0.375795% CI: [0.64, 1.19]Cox proportional hazards model
95% CI: [0.71, 1.49]
Secondary
Time to First Severe Flare
Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1. Time to first severe flare was measured by Modified SLE flare index which identifies whether a participant had experienced a mild/moderate or severe flare. Analysis of first severe flare was performed on the modified SLE Flare index that excludes severe flares that were triggered only by an increase is SLEDAI-2K score to greater than 12.
Time frame: Up to Week 104
Population: Modified Intent-to-Treat (MITT) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab + Placebo | Time to First Severe Flare | 372.0 Days |
| Belimumab + Rituximab | Time to First Severe Flare | 379.0 Days |
| Belimumab + Standard Therapy | Time to First Severe Flare | 730.0 Days |
p-value: 0.21595% CI: [0.57, 1.13]Cox proportional hazards model
95% CI: [1.03, 2.63]