Glomerulonephritis, Membranous
Conditions
Keywords
IMGN, anti-PLA2R antibodies, pharmacokinetics, belimumab, Benlysta, Idiopathic Membranous Glomerulonephropathy, safety, GSK1550188, Lymphostat-B, membrane attack complex
Brief summary
This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R) autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the relationship between biomarkers, autoantibody status and clinical response. 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive IMGN followed by a further long term treatment period until subjects reach remission of proteinuria, up to a maximum of 2 years total treatment. All subjects will receive background supportive therapy throughout the study. The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000 milligrams per millimole (mg/mmol) \[greater than 10 grams(g)/24 hours (h)\], to compensate for loss of belimumab in the urine. Effects on mechanistic markers will be measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various other measures of kidney function. These will be compared to historical data. The pharmacokinetics of belimumab will be measured to confirm dosing in heavily proteinuric subjects. Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects will also be investigated. Safety will be assessed by adverse events (AE), clinical laboratory evaluations, and vital signs.
Interventions
DRUGbelimumab
10mg/kg administered intravenously
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent. * Histological diagnosis: Have clinical diagnosis of IMGN, as verified by biopsy (either by light microscope with immuno-fluorescence, or by electron microscope) in the last 7 years with non-active disease \>3 years (non-active defined as subject not on immunosuppressants and proteinuria \<2g per 24h) (biopsy results and slides should be available for independent evaluation). * Autoantibody: Have positive anti-PLA2R autoantibody test results at screening. * Proteinuria: Have clinically active disease (nephrotic range proteinuria) for at least 3 months prior to screening and no improvement (less than 30% reduction), despite supportive therapy (which should include maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may include statins, diuretics, dietary salt restriction). During screening proteinuria must be greater than 400mg/mmol by PCR (or greater than 4.0g per 24h) as measured from a 24 h urine collection and/or spot urine sample (early morning where possible) on 2 occasions at least 7 days apart. * Female Subjects: A female subject is eligible to participate if she is not pregnant or nursing and at least one of the following conditions apply: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 Milli-International Units per millilitre(MlU/mL) and estradiol less than 40 picograms per milliliter (less than 147 picomoles per liter) is confirmatory\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose
Exclusion criteria
* Non-Idiopathic membranous glomerulonephropathy (MGN) or other condition affecting the kidney: If the diagnosis of MGN is secondary to other conditions, or the subject has renal impairment from a condition that is not MGN. * Severely reduced or deteriorating kidney function: An eGFR at screening \< 40 millilitres (mL) /minute (min) /1.73 meter (m)\^2 (as determined by 4 variable version Modification of Diet in Renal Disease equation) or kidney function not stable (as defined by \> 15% decrease in eGFR in 3 months before screening, unless due to medication change). * Blood Pressure: Uncontrolled hypertension defined as blood pressure (BP) greater than 150/90 millimeters of mercury (mm Hg) (treatment target greater than and equal to 140/80) as assessed by either : Blood pressures measured 3 times on each of at least 2 clinic visits during screening, after the patient has sat quietly for at least 5 minutes, with greater than 50% of measurements being greater than 150/90 or average daytime blood pressure on a 24 hour ambulatory blood pressure monitor. * Prior Therapy: Have received treatment with the following therapies at the times specified prior to Day 0: Therapy - B-cell targeted therapy except rituximab (e.g., other anti- CD20 agents, anti-CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\], B lymphocyte stimulator-receptor fusion protein \[BR3\], transmembrane activator and calcium modulator and cyclophylin ligand interactor Fc, or belimumab), Time period: anytime; Therapy: Rituximab (Subjects with rituximab treatment between 1 and 2 years prior to Day 0 are eligible if there is documented evidence of B-cell repopulation to \>50% of pre-treatment levels.), Period: 2 years; Therapy: Abatacept and any other biologic investigational agent other than B cell targeted therapy (i.e. not approved for sale in the country in which it is being used), Time Period: 364 days; Therapy: Cyclophosphamide or chlorambucil 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis). (Topical or inhaled steroids are permitted.), Time Period: 180 days; Therapy: Anti-tumour necrosis factor (TNF) or anti-IL-6 therapy (e.g. adalimumab, etanercept, infliximab, tocilizumab). Interleukin-1 receptor antagonists (e.g. anakinra). Other immunosuppressive/immunomodulatory agents (e.g azathioprine, 6-mercaptopurine, mycophenolate mofetil (PO)/ mycophenolate mofetil hydrochloride (IV), mycophenolate sodium (PO), methotrexate, tacrolimus, sirolimus, thalidomide, leflunomide, mizoribine, ciclosporin). Intravenous immunoglobulin (IVIG). Plasmapheresis, leukapheresis, Time Period: 90 days; Therapy: A non-biologic investigational agent (i.e. not approved for sale in the country in which it is being used). Intravenous corticosteroid, Adrenocorticotropic hormone (ACTH). Adenocorticotropic hormone (ACTH), aliskiren A change in dose of \>50% for angiotensin pathway antihypertensive (e.g., ACE inhibitor, angiotensin receptor blocker), Time Period: 60 days; Therapy: A live vaccine. Greater than 30 milligrams per day (mg/day) corticosteroid, Time Period: 30 days; Therapy: Greater than 10mg/day corticosteroid. A change in dose of a corticosteroid. Note: Changes to inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed, Time Period: 14 days; * Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. * Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. * Acute or chronic infection: Have required management of acute or chronic infections, as follows: Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); Hospitalisation for treatment of infection within 60 days prior to Day 0; Use of parenteral (IV or intramuscular) antibiotics (anti-bacterials, anti-virals, anti-fungals, or anti-parasitic agents) within 60 days prior to Day 0. * Liver disease: Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Other diseases/conditions: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to IMGN (i.e., cardiovascular, pulmonary, haematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. or Have a planned surgical procedure or a history of any other medical disease (e.g. cardiopulmonary), laboratory abnormality, or condition (e.g. poor venous access) that, in the opinion of the investigator, makes the subject unsuitable for the study. * Positive serology: Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for hepatitis B surface (antigen) (HBsAg), anti-HBc and anti-HBs as follows:- Patients positive for HBsAg are excluded: Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody and with no history of Hepatitis B vaccination are excluded; Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies are excluded; Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody are excluded. Positive test for Hepatitis C antibody confirmed on the same sample with a Hepatitis C Recombinant Immunoblot Assay (RIBA) immunoblot assay if available. Subjects who are positive for Hepatitis C antibody and who have a positive or indeterminate result when the Hepatitis C RIBA immunoblot assay is performed on the same sample, or where the Hepatitis C RIBA assay is not available, will not be eligible to participate. * Liver function tests: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than and equal to 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin greater than 1.5xULN (isolated bilirubin greater than 1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%). * Immunodeficiency: Have an IgA deficiency \[immunoglobulin (Ig)A level \< 10 milligrams per deciliter (mg/dL)\] or have IgG level \< 250 mg/dL and have previously received any non-glucocorticoid immunosuppression during the previous 6 months. * Laboratory test abnormalities: Have clinically significant abnormalities in screening laboratory assessments (not related to the disease), as judged by investigator. * Drug sensitivity / Anaphylaxis: History of sensitivity or intolerance to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies. * Substance abuse: Evidence of current drug or alcohol abuse or dependence. * Blood donation: Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Proteinuria Levels at Week 28 | Baseline and Week 28 | Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed. |
| Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28 | Baseline and Week 28 | PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up | Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128. | Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Complete or Partial Remission | Baseline and Weeks 12, 28, 52, 76, 104 and 128 | Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3grams \[g\]/24 h) with no worsening in renal function (estimated glomerular filtration rate \[eGFR\] reduction from Baseline \<15 percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). |
| Time to Complete or Partial Remission | Baseline and up to Week 128/6 month follow up | Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15 percent ). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed. |
| Duration of Complete or Partial Remission | Baseline and up to Week 128/6 month follow up | Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated. |
| Number of Participants With PLA2R Autoantibody Remission | Baseline and Weeks 12, 28, 52, 76, 104 and 128 | Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles). |
| Time to Anti-PLA2R Autoantibody Remission | Baseline and up to Week 128/6 month follow up | Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent. |
| Number of Participants With Anti-PLA2R Autoantibody Relapse | Baseline and up to Week 128/6 month follow up | Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles). |
| eGFR Levels at the Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up. | eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in eGFR Levels at the Indicated Time Points | Baseline and up to Week 128/6 month follow up | eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Serum Creatinine Levels at the Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up | Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Serum Creatinine Levels at the Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up | Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Serum Albumin Levels at Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up. | Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Levels of Serum Albumin at the Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up | Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Serum Cholesterol Levels at Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up | Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Serum Cholesterol at the Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up | Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up | Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Serum IgG at the Indicated Time Points | Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up | Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Edema and Edema Extending Beyond Calf | Baseline and Weeks 12, 28, 52, 76, and 104 | Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles). |
| Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points | Baseline and up to 4 week post last dose | The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times. |
| Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Baseline and up to 4 week post last dose | Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose. |
| Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2]) | Baseline and up to 4 week post last dose | The AUC(0-2) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis were collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results will be posted at later date following post hoc analysis. |
| Summary of Total Amount of Urine Excreted Ae(0-24) | Baseline and Up to 4 week post last dose | PK parameters from the urine concentration data: urine Ae(0-24) were assessed. 24 h urine collections for PK analysis were collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach was undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis was conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. Several samples were taken pre-dose at Day 0 and some at week 12 incorrectly which affects interpretation. |
| Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Baseline and up to Week 104/4 week post last dose | Health-related quality of life was assessed through participant self-completion of the short form health survey (SF-36 version \[v2\]), a general health related quality of life metrics. Norm-based Scores (NBS) for physical functioning, role emotional, role physical were assessed. The remaining SF-36 component scores require re-scaling and therefore will be added at a later date. SF-36 was administered prior to any procedures at Weeks 12, 28, 52, 76 and 104/4 week post last dose. Item score were recorded and higher score represented better health status. Baseline is defined as Day 0 pre dose value and change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants available at the specified time points were analyzed (represented by n=X in category titles). |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline and up to Week 128/6 month follow up | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, is a congenital anomaly/birth defect, may require medical or surgical intervention, is associated with liver injury and impaired liver function. |
| Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Baseline and up to Week 116/16 week follow-up visit | Blood samples were collected from participants for evaluation of clinical chemistry and hematology parameters. The clinical chemistry parameters included albumin, alkaline phosphatase (alk.phosph.), alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin, calcium, cholesterol, chloride, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, lactate dehydrogenase (LD), magnesium, sodium, phosphorus, total protein, blood urea nitrogen (BUN) and uric acid. The hematology parameters included basophils, eosinophil, hemoglobin, hematocrit, lymphocytes, monocytes, total neutrophils, platelets, red blood cells (RBC) count and white blood cells (WBC) count. Participants were counted in the category that their value changes to (low or high) for the specific time points. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Urinalysis Dipstick Findings | Baseline and up to Week 116/16 Week follow up | Urine samples were collected for urinalysis by dipstick method from Baseline up to Week 116/16 months follow up and number of participants with findings were presented for Baseline, Week 12, 28, 52, 76, 104/4 weeks post last-dose and Week 116/16 week follow up (WF). The urinalysis parameters included occult blood, glucose, ketones, protein. The findings were presented as trace or 1/10 g/100 milliliter (dL), trace, negative, 4+, 3+, 3+ or 1 g/dL, 2+ or 1/2 g/dL, 2+, 1+ or 1/4 g/dL and 1+. Only participants present at the specific time points were presented (represented by n=X in the category titles). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to week 116/16 week follow-up visit | SBP and DBP were measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week follow-up visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Pulse Rate | Baseline and up to Week 116/16 week follow-up visit | Pulse rate was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Temperature | Baseline and up to Week 116/16 week follow-up visit | Temperature was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Number of Participants With Positive Immunogenicity Findings | Baseline and up to Week 116/16 week follow-up visit | Blood samples of participants were collected pre-dose on Weeks 0, 12, 28, 40, 52, 76, 4 week post last dose and 16 week post last dose visit for belimumab immunogenicity assay. No participants showed positive immunogenicity findings. |
| Urine Membrane Attack Complex (MAC) Levels | Baseline and up to 4 week post last dose | Urine membrane attack complex was assayed quantitatively by ELISA method. Urine MAC samples were collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results were normalized using urine creatinine concentration to adjust for urine dilution. Endpoint was moved to 'Exploratory' in Protocol amendment 5 as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed |
| Change From Baseline in Urine Membrane Attack Complex (MAC) | Baseline and up to 4 week post last dose | Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). Endpoint was changed to 'exploratory' as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed. |
| Proteinuria Levels at the Indicated Time Points | Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up | Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Cytokines/Chemokine | Baseline and up to Week 104/4 week post last dose | Cytokine/chemokine associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification were used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Endpoint was moved to 'Exploratory' in Protocol amendment 5 as benefits of assessing cytokines was deemed low. Samples were not analyzed. |
| Serum BLys Levels | Baseline and Week 116/16 week follow-up visit | Free BLyS protein were analyzed using an ELISA. Serum samples were collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. |
| Urine BLys Levels as a Ratio to Creatinine | Baseline and Week 116/16 week follow-up visit | B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS: creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. Only raw BLyS values available and unable to be assessed due to lack of comparison to a creatinine as a urine concentration marker. |
| Change From Baseline in B Cell and T Cell Markers Concentration | Baseline and up to Week 128/6 month post last dose | B cell Facs panels were used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel were used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Proteinuria Levels at the Indicated Time Points | Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up | Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
Countries
United Kingdom
Participant flow
Recruitment details
Eligible participants were recruited from July 2012 until March 2014, into this 2 part study of a initial treatment phase, a long term treatment phase, and then followed up for a further 6 months. Results have previously been presented for the initial treatment phase, up to the Week 28 and are now presented for the completed study.
Pre-assignment details
Screening occurred within 35 days and no less than 14 days before the first scheduled study treatment dose. Total 21 participants were screened; 14 were randomized and entered the initial treatment phase while 11 participants entered the long-term treatment phase. Common reasons for screen failures were insufficient, or improvements in proteinuria.
Participants by arm
| Arm | Count |
|---|---|
| Belimumab 10 mg/kg IV Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Other: Reached stopping criteria | 1 |
| Overall Study | Other:Treatment stopped due to remission | 1 |
Baseline characteristics
| Characteristic | Belimumab 10 mg/kg IV |
|---|---|
| Age, Continuous | 46.1 Years STANDARD_DEVIATION 13.3 |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 4 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White- White/Caucasian/European Heritage | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 3 / 14 |
Outcome results
Primary
Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28
PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.
Time frame: Baseline and Week 28
Population: ITT Population. Only those participants available at the indicated time point (Week 28) were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28 | 0.2666 Ratio | Geometric Coefficient of Variation 171 |
95% CI: [0.12, 0.58]
Primary
Change From Baseline in Proteinuria Levels at Week 28
Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.
Time frame: Baseline and Week 28
Population: Intent-to-Treat (ITT) Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Proteinuria Levels at Week 28 | 0.7552 Ratio | Geometric Coefficient of Variation 45 |
95% CI: [0.57, 1.01]
Secondary
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points
Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Baseline, n=14 | 168.3 relative units per milliliter (RU/mL) | Geometric Coefficient of Variation 138.9 |
| Belimumab 10 mg/kg IV | Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Week 12, n=13 | 91.0 relative units per milliliter (RU/mL) | Geometric Coefficient of Variation 200.4 |
| Belimumab 10 mg/kg IV | Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Week 28, n=11 | 46.4 relative units per milliliter (RU/mL) | Geometric Coefficient of Variation 319.6 |
| Belimumab 10 mg/kg IV | Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Week 52, n=9 | 12.9 relative units per milliliter (RU/mL) | Geometric Coefficient of Variation 358.4 |
| Belimumab 10 mg/kg IV | Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Week 76, n=8 | 7.5 relative units per milliliter (RU/mL) | Geometric Coefficient of Variation 140.4 |
| Belimumab 10 mg/kg IV | Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Week 104, n=10 | 3.7 relative units per milliliter (RU/mL) | Geometric Coefficient of Variation 72.7 |
| Belimumab 10 mg/kg IV | Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points | Week 128, n=8 | 4.4 relative units per milliliter (RU/mL) | Geometric Coefficient of Variation 112 |
Secondary
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points
Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128.
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points | Week 12; n= 13 | 0.5362 Ratio | Geometric Coefficient of Variation 58.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points | Week 28; n= 11 | 0.2666 Ratio | Geometric Coefficient of Variation 171 |
| Belimumab 10 mg/kg IV | Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points | Week 52; n= 9 | 0.0737 Ratio | Geometric Coefficient of Variation 130.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points | Week 76; n= 8 | 0.0436 Ratio | Geometric Coefficient of Variation 102.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points | Week 104; n= 10 | 0.0212 Ratio | Geometric Coefficient of Variation 169.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points | Week 128; n= 8 | 0.0284 Ratio | Geometric Coefficient of Variation 243.7 |
Secondary
Change From Baseline in B Cell and T Cell Markers Concentration
B cell Facs panels were used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel were used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to Week 128/6 month post last dose
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19lo CD38hi CD27hi; Week 104; n= 10 | 0.2615 Ratio | Geometric Coefficient of Variation 238.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+; Week 8; n= 12 | 1.9195 Ratio | Geometric Coefficient of Variation 69.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD; Week 28; n= 10 | 3.2313 Ratio | Geometric Coefficient of Variation 51.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD; 6 month follow up; n= 7 | 0.2413 Ratio | Geometric Coefficient of Variation 163.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD-; Week 8; n= 12 | 1.8846 Ratio | Geometric Coefficient of Variation 67.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD-; Week 16; n= 11 | 2.2113 Ratio | Geometric Coefficient of Variation 70.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi xIL-7Rlo; Week 28; n= 10 | 0.7010 Ratio | Geometric Coefficient of Variation 961.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+; Week 8; n= 12 | 0.7221 Ratio | Geometric Coefficient of Variation 82.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+; Week 16; n= 11 | 0.9209 Ratio | Geometric Coefficient of Variation 63.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+; Week 28; n= 10 | 1.0049 Ratio | Geometric Coefficient of Variation 71.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+; Week 104; n= 10 | 0.5193 Ratio | Geometric Coefficient of Variation 156.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+; 6 month follow up; n= 7 | 0.3828 Ratio | Geometric Coefficient of Variation 185.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24b+ CD38b+ CD27-; Week 8; n= 12 | 0.2352 Ratio | Geometric Coefficient of Variation 340 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24b+ CD38b+ CD27-; Week 16; n= 11 | 0.6228 Ratio | Geometric Coefficient of Variation 316.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24b+ CD38b+ CD27-; Week 28; n= 10 | 0.6119 Ratio | Geometric Coefficient of Variation 656 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24b+ CD38b+ CD27-; Week 104; n= 10 | 0.3582 Ratio | Geometric Coefficient of Variation 405.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24b+ CD38b+ CD27-; 6 month follow up; n= 7 | 1.6471 Ratio | Geometric Coefficient of Variation 534 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27- IgD+; Week 8; n= 12 | 0.3490 Ratio | Geometric Coefficient of Variation 131.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27- IgD+; Week 16; n= 11 | 0.4486 Ratio | Geometric Coefficient of Variation 94.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27- IgD+; Week 28; n= 10 | 0.4561 Ratio | Geometric Coefficient of Variation 82.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27- IgD+; Week 104; n= 10 | 0.1808 Ratio | Geometric Coefficient of Variation 298.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27- IgD+; 6 month follow up; n= 7 | 0.3278 Ratio | Geometric Coefficient of Variation 189.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27-; Week 8; n= 12 | 0.4074 Ratio | Geometric Coefficient of Variation 109.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27-; Week 16; n= 11 | 0.5079 Ratio | Geometric Coefficient of Variation 88.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27-; Week 28; n= 10 | 0.5165 Ratio | Geometric Coefficient of Variation 76.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27-; Week 104; n= 10 | 0.2602 Ratio | Geometric Coefficient of Variation 236.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD27-; 6 month follow up; n= 7 | 0.3756 Ratio | Geometric Coefficient of Variation 186 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19lo CD38hi CD27hi; Week 8; n= 12 | 0.5982 Ratio | Geometric Coefficient of Variation 555.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19lo CD38hi CD27hi; Week 16; n= 11 | 0.4128 Ratio | Geometric Coefficient of Variation 1085.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19lo CD38hi CD27hi; Week 28; n= 10 | 0.4481 Ratio | Geometric Coefficient of Variation 651.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19lo CD38hi CD27hi; 6 month follow up; n= 7 | 0.0647 Ratio | Geometric Coefficient of Variation 1269.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24+ CD27+ ; Week 8; n= 12 | 2.0747 Ratio | Geometric Coefficient of Variation 65.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24+ CD27+ ; Week 16; n= 11 | 2.4161 Ratio | Geometric Coefficient of Variation 61.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24+ CD27+ ; Week 28; n= 10 | 3.1294 Ratio | Geometric Coefficient of Variation 64.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24+ CD27+ ; Week 104; n= 10 | 0.6089 Ratio | Geometric Coefficient of Variation 104014.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+ CD24+ CD27+ ; 6 month follow up; n= 7 | 0.7952 Ratio | Geometric Coefficient of Variation 328.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+; Week 16; n= 11 | 2.3132 Ratio | Geometric Coefficient of Variation 62.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+; Week 28; n= 10 | 3.1352 Ratio | Geometric Coefficient of Variation 65.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+; Week 104; n= 10 | 1.3273 Ratio | Geometric Coefficient of Variation 127.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+; 6 month follow up; n= 7 | 0.3338 Ratio | Geometric Coefficient of Variation 158.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD; Week 8; n= 12 | 1.9365 Ratio | Geometric Coefficient of Variation 69.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD; Week 16; n= 11 | 2.3147 Ratio | Geometric Coefficient of Variation 75.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD; Week 104; n= 10 | 1.2814 Ratio | Geometric Coefficient of Variation 102.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD-; Week 28; n= 10 | 3.0478 Ratio | Geometric Coefficient of Variation 73.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD-; Week 104; n= 10 | 1.3051 Ratio | Geometric Coefficient of Variation 147.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD19+CD27+IgD-; 6 month follow up; n= 7 | 0.3440 Ratio | Geometric Coefficient of Variation 163.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi CD45RA- IL7Rhi; Week 8; n= 12 | 0.7010 Ratio | Geometric Coefficient of Variation 86.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi CD45RA- IL7Rhi; Week 16; n= 10 | 0.5340 Ratio | Geometric Coefficient of Variation 221.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi CD45RA- IL7Rhi; Week 28; n= 9 | 0.5718 Ratio | Geometric Coefficient of Variation 669.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi CD45RA- IL7Rhi; Week 104; n= 10 | 4.1865 Ratio | Geometric Coefficient of Variation 509.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi CD45RA- IL7Rh; 6 month follow up; n= 7 | 1.8067 Ratio | Geometric Coefficient of Variation 1456.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA- IL-7Rhi; Week 8; n= 12 | 1.4174 Ratio | Geometric Coefficient of Variation 19513.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA- IL-7Rhi; Week 16; n= 10 | 1.8613 Ratio | Geometric Coefficient of Variation 99527.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA- IL-7Rhi; Week 28; n=9 | 2.8378 Ratio | Geometric Coefficient of Variation 49940.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA- IL-7Rhi; Week 104; n= 10 | 0.1517 Ratio | Geometric Coefficient of Variation 33534.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA- IL-7Rhi; 6 month follow-up; n= 7 | 0.3532 Ratio | Geometric Coefficient of Variation 966.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi xIL-7Rlo; Week 8; n= 12 | 0.7285 Ratio | Geometric Coefficient of Variation 85.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi xIL-7Rlo; Week 16; n= 11 | 0.6232 Ratio | Geometric Coefficient of Variation 317.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi xIL-7Rlo; Week 104; n= 10 | 3.1025 Ratio | Geometric Coefficient of Variation 932.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi xIL-7Rlo; 6 month follow-up; n= 7 | 2.0827 Ratio | Geometric Coefficient of Variation 832.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi IL-7Rlo; Week 8; 12 | 2.3001 Ratio | Geometric Coefficient of Variation 29702.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi IL-7Rlo; Week 16; n= 10 | 2.9023 Ratio | Geometric Coefficient of Variation 136702.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi IL-7Rlo; Week 28; n= 9 | 3.3453 Ratio | Geometric Coefficient of Variation 35372.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi IL-7Rlo; Week 104; n= 10 | 0.3410 Ratio | Geometric Coefficient of Variation 72506.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD25hi IL-7Rlo; 6 month follow up; n= 7 | 0.9978 Ratio | Geometric Coefficient of Variation 32.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA-; Week 8; n= 12 | 0.7532 Ratio | Geometric Coefficient of Variation 44.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA-; Week 16; n= 11 | 0.7638 Ratio | Geometric Coefficient of Variation 55.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA-; Week 28; n= 10 | 0.9032 Ratio | Geometric Coefficient of Variation 71.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA-; 104; n= 10 | 0.9750 Ratio | Geometric Coefficient of Variation 95.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in B Cell and T Cell Markers Concentration | CD4+ CD45RA-; 6 month follow up; n= 7 | 1.0792 Ratio | Geometric Coefficient of Variation 90 |
Secondary
Change From Baseline in Cytokines/Chemokine
Cytokine/chemokine associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification were used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Endpoint was moved to 'Exploratory' in Protocol amendment 5 as benefits of assessing cytokines was deemed low. Samples were not analyzed.
Time frame: Baseline and up to Week 104/4 week post last dose
Population: ITT Population
Secondary
Change From Baseline in eGFR Levels at the Indicated Time Points
eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to Week 128/6 month follow up
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 8, n= 13 | 0.9035 Ratio | Geometric Coefficient of Variation 16.2 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 32, n= 9 | 1.0099 Ratio | Geometric Coefficient of Variation 19.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 80, n=8 | 1.0431 Ratio | Geometric Coefficient of Variation 21.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 100, n=8 | 1.1122 Ratio | Geometric Coefficient of Variation 24.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 2, n=14 | 0.9954 Ratio | Geometric Coefficient of Variation 10.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 4, n= 13 | 0.9190 Ratio | Geometric Coefficient of Variation 16.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 12, n= 13 | 0.9339 Ratio | Geometric Coefficient of Variation 17.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 16, n= 12 | 0.9521 Ratio | Geometric Coefficient of Variation 12.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 20, n= 8 | 0.9819 Ratio | Geometric Coefficient of Variation 11.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 24, n= 11 | 0.9274 Ratio | Geometric Coefficient of Variation 17.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 28, n= 11 | 0.9694 Ratio | Geometric Coefficient of Variation 21.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 36, n= 11 | 0.9692 Ratio | Geometric Coefficient of Variation 17.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 40, n= 11 | 0.9425 Ratio | Geometric Coefficient of Variation 20.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 44, n= 10 | 0.9531 Ratio | Geometric Coefficient of Variation 22.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 48, n= 8 | 0.9929 Ratio | Geometric Coefficient of Variation 23.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 52, n= 7 | 0.9290 Ratio | Geometric Coefficient of Variation 27.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 56, n= 9 | 1.0181 Ratio | Geometric Coefficient of Variation 21.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 60, n= 9 | 0.9805 Ratio | Geometric Coefficient of Variation 26.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 64, n=9 | 1.0217 Ratio | Geometric Coefficient of Variation 23.5 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 68, n=8 | 1.0233 Ratio | Geometric Coefficient of Variation 24.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 72, n=8 | 1.0168 Ratio | Geometric Coefficient of Variation 28.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 76, n=8 | 1.0055 Ratio | Geometric Coefficient of Variation 33.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 84, n=8 | 0.9959 Ratio | Geometric Coefficient of Variation 25.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 88, n=8 | 1.0529 Ratio | Geometric Coefficient of Variation 16.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 92, n=8 | 1.0052 Ratio | Geometric Coefficient of Variation 26.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 96, n=8 | 1.1204 Ratio | Geometric Coefficient of Variation 22.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 104, n=10 | 1.0480 Ratio | Geometric Coefficient of Variation 23.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 116; n= 8 | 1.0373 Ratio | Geometric Coefficient of Variation 19.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in eGFR Levels at the Indicated Time Points | Week 128, n=9 | 0.9971 Ratio | Geometric Coefficient of Variation 35.2 |
Secondary
Change From Baseline in Levels of Serum Albumin at the Indicated Time Points
Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Levels of Serum Albumin at the Indicated Time Points | Week 12; n= 13 | 1.0324 ratio | Geometric Coefficient of Variation 15 |
| Belimumab 10 mg/kg IV | Change From Baseline in Levels of Serum Albumin at the Indicated Time Points | Week 28; n= 11 | 1.1211 ratio | Geometric Coefficient of Variation 16.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in Levels of Serum Albumin at the Indicated Time Points | Week 52; n= 7 | 1.2828 ratio | Geometric Coefficient of Variation 28.1 |
| Belimumab 10 mg/kg IV | Change From Baseline in Levels of Serum Albumin at the Indicated Time Points | Week 76; n= 8 | 1.3695 ratio | Geometric Coefficient of Variation 23.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in Levels of Serum Albumin at the Indicated Time Points | Week 104; n= 10 | 1.5879 ratio | Geometric Coefficient of Variation 19.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in Levels of Serum Albumin at the Indicated Time Points | Week 128; n= 9 | 1.5799 ratio | Geometric Coefficient of Variation 24.7 |
Secondary
Change From Baseline in Proteinuria Levels at the Indicated Time Points
Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up
Population: ITT Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Proteinuria Levels at the Indicated Time Points | Week 76; n= 8 | 0.4177 Ratio | Geometric Coefficient of Variation 54.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Proteinuria Levels at the Indicated Time Points | Week 12; n= 13 | 0.9437 Ratio | Geometric Coefficient of Variation 39.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Proteinuria Levels at the Indicated Time Points | Week 28; n= 11 | 0.7552 Ratio | Geometric Coefficient of Variation 45 |
| Belimumab 10 mg/kg IV | Change From Baseline in Proteinuria Levels at the Indicated Time Points | Week 52; n= 9 | 0.5297 Ratio | Geometric Coefficient of Variation 206.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in Proteinuria Levels at the Indicated Time Points | Week 104; n= 10 | 0.1874 Ratio | Geometric Coefficient of Variation 189.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Proteinuria Levels at the Indicated Time Points | Week 128; n= 9 | 0.1118 Ratio | Geometric Coefficient of Variation 139.1 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to Week 116/16 week follow-up visit
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Pulse Rate | Week 76; n= 8 | -2.3 Beats per minute | Standard Deviation 15.77 |
| Belimumab 10 mg/kg IV | Change From Baseline in Pulse Rate | Week 12; n= 12 | -0.7 Beats per minute | Standard Deviation 11.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in Pulse Rate | Week 28; n= 11 | 1.0 Beats per minute | Standard Deviation 7.9 |
| Belimumab 10 mg/kg IV | Change From Baseline in Pulse Rate | Week 52; n= 9 | -1.7 Beats per minute | Standard Deviation 13.11 |
| Belimumab 10 mg/kg IV | Change From Baseline in Pulse Rate | 4 Week post last dose; n= 10 | -2.8 Beats per minute | Standard Deviation 15.33 |
| Belimumab 10 mg/kg IV | Change From Baseline in Pulse Rate | 16 Week follow up; n= 9 | -0.9 Beats per minute | Standard Deviation 16.72 |
| Belimumab 10 mg/kg IV | Change From Baseline in Pulse Rate | Week 104 withdrawn visit; n= 2 | 5.0 Beats per minute | Standard Deviation 7.07 |
Secondary
Change From Baseline in Serum Cholesterol at the Indicated Time Points
Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Cholesterol at the Indicated Time Points | Week 12; n= 13 | 0.9238 mmol/L | Geometric Coefficient of Variation 16.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Cholesterol at the Indicated Time Points | Week 28; n= 11 | 0.8896 mmol/L | Geometric Coefficient of Variation 14.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Cholesterol at the Indicated Time Points | Week 52; n= 7 | 0.8571 mmol/L | Geometric Coefficient of Variation 16.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Cholesterol at the Indicated Time Points | Week 76; n= 8 | 0.7111 mmol/L | Geometric Coefficient of Variation 15 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Cholesterol at the Indicated Time Points | Week 104; n= 10 | 0.6851 mmol/L | Geometric Coefficient of Variation 17.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Cholesterol at the Indicated Time Points | Week 128; n= 9 | 0.6140 mmol/L | Geometric Coefficient of Variation 15.7 |
Secondary
Change From Baseline in Serum Creatinine Levels at the Indicated Time Points
Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Creatinine Levels at the Indicated Time Points | Week 12; n= 13 | 1.0530 Ratio | Geometric Coefficient of Variation 14.8 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Creatinine Levels at the Indicated Time Points | Week 28; n= 11 | 1.0202 Ratio | Geometric Coefficient of Variation 18.6 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Creatinine Levels at the Indicated Time Points | Week 52; n= 7 | 1.0581 Ratio | Geometric Coefficient of Variation 23.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Creatinine Levels at the Indicated Time Points | Week 76; n= 8 | 0.9818 Ratio | Geometric Coefficient of Variation 28.7 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Creatinine Levels at the Indicated Time Points | Week 128; n= 9 | 0.9874 Ratio | Geometric Coefficient of Variation 30.4 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum Creatinine Levels at the Indicated Time Points | Week 104; n= 10 | 0.9467 Ratio | Geometric Coefficient of Variation 20.1 |
Secondary
Change From Baseline in Serum IgG at the Indicated Time Points
Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Serum IgG at the Indicated Time Points | Week 104; n= 10 | 3.613 Ratio | Standard Deviation 2.5488 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum IgG at the Indicated Time Points | Week 12; n= 13 | 0.055 Ratio | Standard Deviation 0.6625 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum IgG at the Indicated Time Points | Week 28; n= 11 | 0.469 Ratio | Standard Deviation 1.4287 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum IgG at the Indicated Time Points | Week 52; n= 8 | 1.525 Ratio | Standard Deviation 2.4411 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum IgG at the Indicated Time Points | Week 76; n= 8 | 1.619 Ratio | Standard Deviation 1.6681 |
| Belimumab 10 mg/kg IV | Change From Baseline in Serum IgG at the Indicated Time Points | Week 128; n= 9 | 4.334 Ratio | Standard Deviation 2.0289 |
Secondary
Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score
Health-related quality of life was assessed through participant self-completion of the short form health survey (SF-36 version \[v2\]), a general health related quality of life metrics. Norm-based Scores (NBS) for physical functioning, role emotional, role physical were assessed. The remaining SF-36 component scores require re-scaling and therefore will be added at a later date. SF-36 was administered prior to any procedures at Weeks 12, 28, 52, 76 and 104/4 week post last dose. Item score were recorded and higher score represented better health status. Baseline is defined as Day 0 pre dose value and change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time frame: Baseline and up to Week 104/4 week post last dose
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Physical functioning, Week 12; n= 12 | -4.034 Scores on a scale | Standard Deviation 5.1907 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Physical functioning, Week 28; n= 11 | -0.765 Scores on a scale | Standard Deviation 3.678 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Physical functioning, Week 52; n= 9 | 0.468 Scores on a scale | Standard Deviation 7.3489 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Physical functioning, Week 76; n= 7 | 0.601 Scores on a scale | Standard Deviation 7.9409 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Physical functioning 4 Week post final dose;n=11 | 0.765 Scores on a scale | Standard Deviation 11.7275 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role emotional, Week 12; n= 12 | -0.000 Scores on a scale | Standard Deviation 10.4831 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role emotional, Week 28; n= 11 | 1.413 Scores on a scale | Standard Deviation 15.1824 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role emotional, Week 52; n= 9 | 3.023 Scores on a scale | Standard Deviation 11.4621 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role emotional, Week 76; n= 7 | 3.332 Scores on a scale | Standard Deviation 7.2475 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role emotional, 4 Week post final dose; n= 11 | 6.007 Scores on a scale | Standard Deviation 10.0413 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role physical, Week 12; n= 12 | 0.816 Scores on a scale | Standard Deviation 11.0681 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role physical, Week 28; n= 11 | 3.340 Scores on a scale | Standard Deviation 8.4324 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role physical, Week 52; n= 9 | 3.537 Scores on a scale | Standard Deviation 9.1726 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role physical, Week 76; n= 7 | 7.697 Scores on a scale | Standard Deviation 12.2803 |
| Belimumab 10 mg/kg IV | Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score | Role physical 4 Week post final dose; n= 11 | 5.789 Scores on a scale | Standard Deviation 11.4489 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week follow-up visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to week 116/16 week follow-up visit
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 12; SBP; n= 12 | -4.2 millimeter of mercury (mmHg) | Standard Deviation 17.23 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 28; SBP; n= 11 | -5.8 millimeter of mercury (mmHg) | Standard Deviation 18.14 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 52; SBP; n= 9 | -1.9 millimeter of mercury (mmHg) | Standard Deviation 18.66 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 76; SBP; n= 8 | -1.3 millimeter of mercury (mmHg) | Standard Deviation 11.3 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 4 Week post last dose; SBP; n= 10 | -12.2 millimeter of mercury (mmHg) | Standard Deviation 11.78 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 16 Week follow up; SBP; n= 9 | -7.4 millimeter of mercury (mmHg) | Standard Deviation 15.72 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 104 withdrawn visit; SBP; n= 2 | -1.0 millimeter of mercury (mmHg) | Standard Deviation 5.66 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 12; DBP; n= 12 | 3.8 millimeter of mercury (mmHg) | Standard Deviation 12.94 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 28; DBP; n= 11 | 0.8 millimeter of mercury (mmHg) | Standard Deviation 10.75 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 52; DBP; n= 9 | 1.2 millimeter of mercury (mmHg) | Standard Deviation 11.87 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 76; DBP; n= 8 | 2.8 millimeter of mercury (mmHg) | Standard Deviation 9.68 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 4 Week post last dose; DBP; n= 10 | -3.3 millimeter of mercury (mmHg) | Standard Deviation 9.87 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 16 Week follow up; DBP; n= 9 | 2.4 millimeter of mercury (mmHg) | Standard Deviation 14.98 |
| Belimumab 10 mg/kg IV | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 104 withdrawn visit; DBP; n= 2 | 5.5 millimeter of mercury (mmHg) | Standard Deviation 2.12 |
Secondary
Change From Baseline in Temperature
Temperature was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to Week 116/16 week follow-up visit
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Change From Baseline in Temperature | Week 28; n= 11 | -0.00 Celsius | Standard Deviation 0.453 |
| Belimumab 10 mg/kg IV | Change From Baseline in Temperature | Week 52; n= 9 | -0.11 Celsius | Standard Deviation 0.639 |
| Belimumab 10 mg/kg IV | Change From Baseline in Temperature | Week 12; n= 12 | -0.09 Celsius | Standard Deviation 0.591 |
| Belimumab 10 mg/kg IV | Change From Baseline in Temperature | Week 76; n= 8 | -0.17 Celsius | Standard Deviation 0.486 |
| Belimumab 10 mg/kg IV | Change From Baseline in Temperature | 4 Week post last dose; n= 8 | -0.06 Celsius | Standard Deviation 0.604 |
| Belimumab 10 mg/kg IV | Change From Baseline in Temperature | 16 Week follow up; n= 6 | 0.30 Celsius | Standard Deviation 0.424 |
| Belimumab 10 mg/kg IV | Change From Baseline in Temperature | Week 104 withdrawn visit; n= 2 | 0.15 Celsius | Standard Deviation 0.353 |
Secondary
Change From Baseline in Urine Membrane Attack Complex (MAC)
Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). Endpoint was changed to 'exploratory' as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed.
Time frame: Baseline and up to 4 week post last dose
Population: ITT Population
Secondary
Duration of Complete or Partial Remission
Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.
Time frame: Baseline and up to Week 128/6 month follow up
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Duration of Complete or Partial Remission | Complete remission; n= 1 | 365.0 Days | — |
| Belimumab 10 mg/kg IV | Duration of Complete or Partial Remission | Partial remission; n= 9 | 378.6 Days | Standard Deviation 186.15 |
Secondary
eGFR Levels at the Indicated Time Points
eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | eGFR Levels at the Indicated Time Points | Week 28; n= 11 | 65.0866 milliliter/minute (mL/min/1.73meter^2) | Geometric Coefficient of Variation 36.1 |
| Belimumab 10 mg/kg IV | eGFR Levels at the Indicated Time Points | Baseline; n= 14 | 69.8170 milliliter/minute (mL/min/1.73meter^2) | Geometric Coefficient of Variation 32.9 |
| Belimumab 10 mg/kg IV | eGFR Levels at the Indicated Time Points | Week 12; n= 13 | 66.2639 milliliter/minute (mL/min/1.73meter^2) | Geometric Coefficient of Variation 35.4 |
| Belimumab 10 mg/kg IV | eGFR Levels at the Indicated Time Points | Week 52; n= 7 | 65.1308 milliliter/minute (mL/min/1.73meter^2) | Geometric Coefficient of Variation 45 |
| Belimumab 10 mg/kg IV | eGFR Levels at the Indicated Time Points | Week 76; n= 8 | 61.6732 milliliter/minute (mL/min/1.73meter^2) | Geometric Coefficient of Variation 47.1 |
| Belimumab 10 mg/kg IV | eGFR Levels at the Indicated Time Points | Week 104; n= 10 | 69.7692 milliliter/minute (mL/min/1.73meter^2) | Geometric Coefficient of Variation 39.1 |
| Belimumab 10 mg/kg IV | eGFR Levels at the Indicated Time Points | Week 128; n= 9 | 64.7984 milliliter/minute (mL/min/1.73meter^2) | Geometric Coefficient of Variation 39.2 |
Secondary
Number of Participants With Abnormal Clinical Chemistry and Hematology Values
Blood samples were collected from participants for evaluation of clinical chemistry and hematology parameters. The clinical chemistry parameters included albumin, alkaline phosphatase (alk.phosph.), alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin, calcium, cholesterol, chloride, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, lactate dehydrogenase (LD), magnesium, sodium, phosphorus, total protein, blood urea nitrogen (BUN) and uric acid. The hematology parameters included basophils, eosinophil, hemoglobin, hematocrit, lymphocytes, monocytes, total neutrophils, platelets, red blood cells (RBC) count and white blood cells (WBC) count. Participants were counted in the category that their value changes to (low or high) for the specific time points. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to Week 116/16 week follow-up visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; 16 week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; 16 week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 12; to high; n= 13 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; 16 week follow-up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 104; to high; n= 10 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; 16 week follow up; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 76; to low; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 104; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 28; to high; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 104; to low; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 52; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 104; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 52; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; 16 week follow up; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 12; to high; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 104; to high; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 28; to high; n= 11 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 52; to low; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 104; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 28; to low; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Albumin; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Alk.phosph.; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | ALT; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 28; to high; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | AST; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; 16 Week follow up; to high; n=8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Direct bilirubin; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total bilirubin; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 104; to high; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; Week 104; to low; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Calcium; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Cholesterol; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 12; to high; n= 13 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 28; to high; n= 11 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Chloride; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 12; to low; n= 13 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 28; to low; n= 11 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; Week 104; to low; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Carbon dioxide; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 76; to high; n= 8 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 76; to low; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Creatinine; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; 16 Week follow up; to high; n=8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | GGT; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 12; to high; n= 13 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 28; to high; n= 11 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 52; to high; n= 7 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 76; to high; n= 8 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 28; to high; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 28; to low; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 104; to high; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; 16 Week follow up; to high; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 12; to high; n= 13 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Glucose; 16 Week follow up; to low; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 28; to high; n= 11 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Potassium; Week 12; to high; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 52; to high; n= 7 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 76; to high; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD;Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD;Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | LD; 16 week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 12; to high; n= 13 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Magnesium; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 52; to low; n= 7 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 76; to low; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; 16 week follow p; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Sodium; 16 week follow up; to low; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 12; to high; n= 13 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 28; to high; n= 11 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus;Week 104; to high; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus;Week 104; to low; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; 16 week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Phosphorus; 16 week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 52; to high; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 52; to low; n= 7 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; 16 Week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Total protein; 16 Week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 12; to high; n= 13 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 12; to low; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 52; to high; n= 7 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 52; to low; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 76; to high; n= 8 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 104; to high; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; 16 week follow up; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | BUN; 16 week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 12; to high; n= 13 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 12; to low; n= 13 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 28; to high; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 52; to high; n= 7 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 76; to high; n= 8 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; Week 104; to low; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; 16 week follow up; to high; n= 8 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Uric acid; 16 week follow up; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 52; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 104; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Basophils; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 12; to high; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 28; to high; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 52; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 76; to high; n= 8 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 104; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Eosinophils; 16 week follow up; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 52; to low; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; Week 104; to low; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hemoglobin; 16 week follow up; to low; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 52; to low; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; Week 104; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Hematocrit; 16 week follow up; to low; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Lymphocytes; 16 week follow up; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 12; to high; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; Week 104; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Monocytes; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 52; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; 16 week follow up; to high; n=9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Neutrophils; 16 week follow up; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 12; to high; n= 12 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 12; to low; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 52; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 104; to high; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; 16 week follow up; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | Platelet count; 16 week follow up; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 12; to low; n= 12 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 28; to low; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | RBC; 16 week follow up; to low; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 12; to high; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 28; to high; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 52; to high; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 28; to low; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 52; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 76; to high; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 76; to low; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 104; to high; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; Week 104; to low; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; 16 week follow up; to high; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Abnormal Clinical Chemistry and Hematology Values | WBC; 16 week follow up; to low; n= 9 | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, is a congenital anomaly/birth defect, may require medical or surgical intervention, is associated with liver injury and impaired liver function.
Time frame: Baseline and up to Week 128/6 month follow up
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 14 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 3 Participants |
Secondary
Number of Participants With Anti-PLA2R Autoantibody Relapse
Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time frame: Baseline and up to Week 128/6 month follow up
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Anti-PLA2R Autoantibody Relapse | Week 128; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Anti-PLA2R Autoantibody Relapse | Week 12; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Anti-PLA2R Autoantibody Relapse | Week 28; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Anti-PLA2R Autoantibody Relapse | Week 52; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Anti-PLA2R Autoantibody Relapse | Week 76; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Anti-PLA2R Autoantibody Relapse | Week 104; n= 10 | 0 Participants |
Secondary
Number of Participants With Complete or Partial Remission
Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3grams \[g\]/24 h) with no worsening in renal function (estimated glomerular filtration rate \[eGFR\] reduction from Baseline \<15 percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 28; Partial remission; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 28; Complete remission; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 52; Partial remission; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 52; Complete remission; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 76; Partial remission; n= 8 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 76; Complete remission; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 104; Partial remission; n= 10 | 6 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 104; Complete remission; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 128; Partial remission; n= 9 | 6 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 128; Complete remission; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 12; Partial remission; n= 13 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Complete or Partial Remission | Week 12; Complete remission; n= 13 | 0 Participants |
Secondary
Number of Participants With Edema and Edema Extending Beyond Calf
Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, and 104
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 0; oedema; n= 14 | 13 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 0; oedema extending beyond calf; n= 14 | 5 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 12; oedema; n= 12 | 9 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 12; Oedema extending beyond calf; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 28;Oedema; n= 11 | 7 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 28; Oedema extending beyond calf; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 52; oedema; n= 9 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 52;Oedema extending beyond calf; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 76;Oedema; n=8 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 76;Oedema extending beyond calf; n= 8 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | 4 Week post final dose (PFD); Oedema; n=10 | 6 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | 4 Week PFD; Oedema extending beyond calf; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 104 withdrawn (WD); Oedema; n= 1 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Edema and Edema Extending Beyond Calf | Week 104 WD;Oedema extending beyond calf; n= 1 | 0 Participants |
Secondary
Number of Participants With PLA2R Autoantibody Remission
Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 52; partial response; n= 9 | 5 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 104; full response; n= 10 | 10 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 12; full response; n= 13 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 12; partial response; n= 13 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 28; full response; n= 11 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 28; partial response; n= 11 | 6 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 52; full response; n= 9 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 76; full response; n= 8 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 76; partial response; n= 8 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 104; partial response; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 128; Full response; n= 8 | 8 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With PLA2R Autoantibody Remission | Week 128; partial response; n= 8 | 0 Participants |
Secondary
Number of Participants With Positive Immunogenicity Findings
Blood samples of participants were collected pre-dose on Weeks 0, 12, 28, 40, 52, 76, 4 week post last dose and 16 week post last dose visit for belimumab immunogenicity assay. No participants showed positive immunogenicity findings.
Time frame: Baseline and up to Week 116/16 week follow-up visit
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Positive Immunogenicity Findings | 0 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Findings
Urine samples were collected for urinalysis by dipstick method from Baseline up to Week 116/16 months follow up and number of participants with findings were presented for Baseline, Week 12, 28, 52, 76, 104/4 weeks post last-dose and Week 116/16 week follow up (WF). The urinalysis parameters included occult blood, glucose, ketones, protein. The findings were presented as trace or 1/10 g/100 milliliter (dL), trace, negative, 4+, 3+, 3+ or 1 g/dL, 2+ or 1/2 g/dL, 2+, 1+ or 1/4 g/dL and 1+. Only participants present at the specific time points were presented (represented by n=X in the category titles).
Time frame: Baseline and up to Week 116/16 Week follow up
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood; negative; n= 12 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood; 4+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; Trace or 1/10 g/DL; n= 12 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12;glucose; Trace; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; 4+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; 3+ OR 1 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; 2+ ; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; Trace or 1/10 g/DL; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52;glucose; Trace; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; 3+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76;glucose; Trace; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein; 2+ ; n= 10 | 6 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; 2+ OR 1/2 G/DL; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; 2+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; 1+ OR 1/4 G/DL; n=9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; 1+; n=9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; 2+ OR 1/2 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; 2+; n= 9 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein; 2+ OR 1/2 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein; 2+ ; n= 7 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein;1+ OR 1/4 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein; 1+; n= 7 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; occult blood; Trace or 1/10 g/DL;n=10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104;Occult Blood; Trace; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood; negative; n= 10 | 8 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood; 4+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood; 3+ OR 1 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood; 3+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood; 2+ OR 1/2 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood; 2+ ; n=10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood;1+ OR 1/4 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Occult Blood; 1+; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; Trace or 1/10 g/DL; n= 10 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104 ;glucose; Trace; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; negative; n= 10 | 7 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; 4+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; 3+ OR 1 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; 3+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; 2+ OR 1/2 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; 2+ ; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose;1+ OR 1/4 G/DL; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; glucose; 1+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; Trace or 1/10 g/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; Trace; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; negative; n= 10 | 10 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; 4+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; 3+ OR 1 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; 3+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; 2+ OR 1/2 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; 2+ ; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones;1+ OR 1/4 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; ketones; 1+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; protein; Trace or 1/10 g/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein; Trace; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein; negative; n= 10 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; protein; 4+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein; 3+ OR 1 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein; 3+; n= 10 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein; 2+ OR 1/2 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein;1+ OR 1/4 G/DL; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 104; Protein; 1+; n= 10 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; TRACE OR 1/10 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; TRACE; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; NEGATIVE; n= 9 | 6 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; 3+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; 2+ OR 1/2 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; 2+; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; 1+ OR 1/4 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Occult blood; 1+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; TRACE OR 1/10 G/DL; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; TRACE; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; negative; n= 9 | 7 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Glucose; 3+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; TRACE OR 1/10 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; TRACE; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; negative; n= 9 | 9 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; 3+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; 2+ OR 1/2 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; 2+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; 1+ OR 1/4 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Ketones; 1+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; TRACE OR 1/10 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; TRACE; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; negative; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; 3+; n= 9 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; 1+ OR 1/4 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | 16 WF; Protein; 1+; n= 9 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood;1+ OR 1/4 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; occult blood; Trace or 1/10 g/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12;Occult Blood; Trace; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood; 3+ OR 1 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood; 3+; n= 12 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood; 2+ OR 1/2 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood; 2+ ; n= 12 | 6 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Occult Blood; 1+; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; negative; n= 12 | 8 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; 4+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; 3+ OR 1 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; 3+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; 2+ OR 1/2 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; 2+ ; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose;1+ OR 1/4 G/DL; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; glucose; 1+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; Trace or 1/10 g/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; Trace; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; negative; n= 12 | 12 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; 3+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; 2+ OR 1/2 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; 2+ ; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones;1+ OR 1/4 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; ketones; 1+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; protein; Trace or 1/10 g/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; Trace; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; negative; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; 4+; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; 3+ OR 1 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; 3+; n= 12 | 8 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; 2+ OR 1/2 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; 2+ ; n= 12 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein;1+ OR 1/4 G/DL; n= 12 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 12; Protein; 1+; n= 12 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; occult blood; Trace or 1/10 g/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28;Occult Blood; Trace; n= 11 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood; negative; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood; 4+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood; 3+ OR 1 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood; 3+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood; 2+ OR 1/2 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood; 2+ ; n= 11 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood;1+ OR 1/4 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Occult Blood; 1+; n= 11 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; Trace or 1/10 g/DL; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28;glucose; Trace; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; negative; n= 11 | 9 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; 4+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; 3+ OR 1 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; 3+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; 2+ OR 1/2 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose;1+ OR 1/4 G/DL; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; glucose; 1+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; Trace or 1/10 g/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; Trace; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; negative; n= 11 | 11 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; 4+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; 3+ OR 1 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; 3+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; 2+ OR 1/2 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; 2+ ; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones;1+ OR 1/4 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; ketones; 1+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; protein; Trace or 1/10 g/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein; Trace; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein; negative; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; protein; 4+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein; 3+ OR 1 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein; 3+; n= 11 | 10 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein; 2+ OR 1/2 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein; 2+ ; n= 11 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein;1+ OR 1/4 G/DL; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 28; Protein; 1+; n= 11 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; occult blood; Trace or 1/10 g/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52;Occult Blood; Trace; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood; negative; n= 9 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood; 3+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood; 2+ OR 1/2 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood; 2+ ; n= 9 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood;1+ OR 1/4 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Occult Blood; 1+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; negative; n= 9 | 7 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; 2+ OR 1/2 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; 2+ ; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose;1+ OR 1/4 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; glucose; 1+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; Trace or 1/10 g/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; Trace; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; negative; n= 9 | 9 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; 3+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; 2+ OR 1/2 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; 2+ ; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones;1+ OR 1/4 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; ketones; 1+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; protein; Trace or 1/10 g/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein; Trace; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; Trace; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein; negative; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; protein; 4+; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein; 3+ OR 1 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein; 3+; n= 9 | 4 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein; 2+ OR 1/2 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein; 2+ ; n= 9 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein;1+ OR 1/4 G/DL; n= 9 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 52; Protein; 1+; n= 9 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; occult blood; Trace or 1/10 g/DL;n=7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76;Occult Blood; Trace; n= 7 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood; negative; n= 7 | 3 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood; 4+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood; 3+ OR 1 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood; 3+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood; 2+ OR 1/2 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood; 2+ ; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood;1+ OR 1/4 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Occult Blood; 1+; n= 7 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; Trace or 1/10 g/DL; n= 7 | 2 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; negative; n= 7 | 5 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; 4+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; 3+ OR 1 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; 3+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; 2+ OR 1/2 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; 2+ ; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose;1+ OR 1/4 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; glucose; 1+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; Trace or 1/10 g/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; negative; n= 7 | 7 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; 4+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; 3+ OR 1 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; 3+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; 2+ OR 1/2 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; 2+ ; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones;1+ OR 1/4 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; ketones; 1+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; protein; Trace or 1/10 g/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein; Trace; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein; 3+ OR 1 G/DL; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein; negative; n= 7 | 1 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; protein; 4+; n= 7 | 0 Participants |
| Belimumab 10 mg/kg IV | Number of Participants With Urinalysis Dipstick Findings | Week 76; Protein; 3+; n= 7 | 1 Participants |
Secondary
Proteinuria Levels at the Indicated Time Points
Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Proteinuria Levels at the Indicated Time Points | Baseline, n=14 | 724.3157 milligrams per millimole (mg/mmol) | Geometric Coefficient of Variation 40.2 |
| Belimumab 10 mg/kg IV | Proteinuria Levels at the Indicated Time Points | Week 12, n=13 | 670.8655 milligrams per millimole (mg/mmol) | Geometric Coefficient of Variation 46.9 |
| Belimumab 10 mg/kg IV | Proteinuria Levels at the Indicated Time Points | Week 28, n=11 | 498.1255 milligrams per millimole (mg/mmol) | Geometric Coefficient of Variation 40.9 |
| Belimumab 10 mg/kg IV | Proteinuria Levels at the Indicated Time Points | Week 52, n=9 | 356.4209 milligrams per millimole (mg/mmol) | Geometric Coefficient of Variation 174.8 |
| Belimumab 10 mg/kg IV | Proteinuria Levels at the Indicated Time Points | Week 76, n=8 | 274.9714 milligrams per millimole (mg/mmol) | Geometric Coefficient of Variation 70.4 |
| Belimumab 10 mg/kg IV | Proteinuria Levels at the Indicated Time Points | Week 104, n=10 | 129.9761 milligrams per millimole (mg/mmol) | Geometric Coefficient of Variation 186 |
| Belimumab 10 mg/kg IV | Proteinuria Levels at the Indicated Time Points | Week 128, n=9 | 75.2359 milligrams per millimole (mg/mmol) | Geometric Coefficient of Variation 136.4 |
Secondary
Serum Albumin Levels at Indicated Time Points
Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Serum Albumin Levels at Indicated Time Points | Week 104; n= 10 | 39.1015 grams per liter (g/L) | Geometric Coefficient of Variation 7.5 |
| Belimumab 10 mg/kg IV | Serum Albumin Levels at Indicated Time Points | Week 128; n= 9 | 39.2009 grams per liter (g/L) | Geometric Coefficient of Variation 8.8 |
| Belimumab 10 mg/kg IV | Serum Albumin Levels at Indicated Time Points | Baseline; n= 14 | 23.3306 grams per liter (g/L) | Geometric Coefficient of Variation 22.7 |
| Belimumab 10 mg/kg IV | Serum Albumin Levels at Indicated Time Points | Week 12; n= 13 | 24.4204 grams per liter (g/L) | Geometric Coefficient of Variation 27.5 |
| Belimumab 10 mg/kg IV | Serum Albumin Levels at Indicated Time Points | Week 28; n= 11 | 27.8397 grams per liter (g/L) | Geometric Coefficient of Variation 23.4 |
| Belimumab 10 mg/kg IV | Serum Albumin Levels at Indicated Time Points | Week 52; n= 7 | 31.9927 grams per liter (g/L) | Geometric Coefficient of Variation 18.3 |
| Belimumab 10 mg/kg IV | Serum Albumin Levels at Indicated Time Points | Week 76; n= 8 | 33.9484 grams per liter (g/L) | Geometric Coefficient of Variation 10.9 |
Secondary
Serum BLys Levels
Free BLyS protein were analyzed using an ELISA. Serum samples were collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit.
Time frame: Baseline and Week 116/16 week follow-up visit
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Serum BLys Levels | Day 0; n= 14 | 969.9595 pg/mL | Geometric Coefficient of Variation 16.8 |
| Belimumab 10 mg/kg IV | Serum BLys Levels | 16 week follow up; n= 8 | 12357.5558 pg/mL | Geometric Coefficient of Variation 123.3 |
Secondary
Serum Cholesterol Levels at Indicated Time Points
Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Serum Cholesterol Levels at Indicated Time Points | Baseline; n= 14 | 7.6423 millimoles per liter (mmol/L) | Geometric Coefficient of Variation 36 |
| Belimumab 10 mg/kg IV | Serum Cholesterol Levels at Indicated Time Points | Week 12; n= 13 | 7.2336 millimoles per liter (mmol/L) | Geometric Coefficient of Variation 31.5 |
| Belimumab 10 mg/kg IV | Serum Cholesterol Levels at Indicated Time Points | Week 28; n= 11 | 6.2740 millimoles per liter (mmol/L) | Geometric Coefficient of Variation 23.1 |
| Belimumab 10 mg/kg IV | Serum Cholesterol Levels at Indicated Time Points | Week 52; n= 7 | 5.8724 millimoles per liter (mmol/L) | Geometric Coefficient of Variation 18.6 |
| Belimumab 10 mg/kg IV | Serum Cholesterol Levels at Indicated Time Points | Week 76; n= 8 | 5.0211 millimoles per liter (mmol/L) | Geometric Coefficient of Variation 18.4 |
| Belimumab 10 mg/kg IV | Serum Cholesterol Levels at Indicated Time Points | Week 104; n= 10 | 4.8001 millimoles per liter (mmol/L) | Geometric Coefficient of Variation 24.5 |
| Belimumab 10 mg/kg IV | Serum Cholesterol Levels at Indicated Time Points | Week 128; n= 9 | 4.2407 millimoles per liter (mmol/L) | Geometric Coefficient of Variation 12.7 |
Secondary
Serum Creatinine Levels at the Indicated Time Points
Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Serum Creatinine Levels at the Indicated Time Points | Baseline; n= 14 | 97.1658 micromoles/liter (µmol/L) | Geometric Coefficient of Variation 22.8 |
| Belimumab 10 mg/kg IV | Serum Creatinine Levels at the Indicated Time Points | Week 12; n= 13 | 100.6421 micromoles/liter (µmol/L) | Geometric Coefficient of Variation 26.8 |
| Belimumab 10 mg/kg IV | Serum Creatinine Levels at the Indicated Time Points | Week 28; n= 11 | 99.9535 micromoles/liter (µmol/L) | Geometric Coefficient of Variation 24.8 |
| Belimumab 10 mg/kg IV | Serum Creatinine Levels at the Indicated Time Points | Week 52; n= 7 | 96.6583 micromoles/liter (µmol/L) | Geometric Coefficient of Variation 30.2 |
| Belimumab 10 mg/kg IV | Serum Creatinine Levels at the Indicated Time Points | Week 76; n= 8 | 103.0265 micromoles/liter (µmol/L) | Geometric Coefficient of Variation 32.8 |
| Belimumab 10 mg/kg IV | Serum Creatinine Levels at the Indicated Time Points | Week 104; n= 10 | 92.4547 micromoles/liter (µmol/L) | Geometric Coefficient of Variation 29.6 |
| Belimumab 10 mg/kg IV | Serum Creatinine Levels at the Indicated Time Points | Week 128; n= 9 | 97.7260 micromoles/liter (µmol/L) | Geometric Coefficient of Variation 29.7 |
Secondary
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points
Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Baseline; n= 14 | 4.026 g/L | Standard Deviation 1.681 |
| Belimumab 10 mg/kg IV | Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Week 12; n= 13 | 3.871 g/L | Standard Deviation 1.5266 |
| Belimumab 10 mg/kg IV | Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Week 28; n= 11 | 4.405 g/L | Standard Deviation 1.7833 |
| Belimumab 10 mg/kg IV | Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Week 52; n= 8 | 5.823 g/L | Standard Deviation 2.2572 |
| Belimumab 10 mg/kg IV | Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Week 76; n= 8 | 6.050 g/L | Standard Deviation 2.1103 |
| Belimumab 10 mg/kg IV | Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Week 104; n= 10 | 7.611 g/L | Standard Deviation 2.8301 |
| Belimumab 10 mg/kg IV | Serum Immunoglobulin G (IgG) Levels at Indicated Time Points | Week 128; n= 9 | 8.609 g/L | Standard Deviation 2.2597 |
Secondary
Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2])
The AUC(0-2) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis were collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results will be posted at later date following post hoc analysis.
Time frame: Baseline and up to 4 week post last dose
Population: PK Population
Secondary
Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points
The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times.
Time frame: Baseline and up to 4 week post last dose
Population: PK Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points | Day 0, 5 minutes; n= 13 | 267996.0 nanograms per milliliter (ng/mL) | Standard Deviation 70598.02 |
| Belimumab 10 mg/kg IV | Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points | Week 28, 5 minutes; n= 11 | 312462.2 nanograms per milliliter (ng/mL) | Standard Deviation 95171.16 |
Secondary
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points
Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose.
Time frame: Baseline and up to 4 week post last dose
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 40; n= 10 | 40800.6 ng/mL | Standard Deviation 28847.86 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 52; n= 9 | 38375.9 ng/mL | Standard Deviation 14136.23 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 4; n= 12 | 41220.9 ng/mL | Standard Deviation 35720.14 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 2; n= 14 | 29940.8 ng/mL | Standard Deviation 20918.28 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 8; n= 13 | 30350.9 ng/mL | Standard Deviation 25505.7 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 12; n= 11 | 30913.7 ng/mL | Standard Deviation 30681.42 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 28; n= 11 | 34904.7 ng/mL | Standard Deviation 26388.6 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | Pre-infusion; Week 76; n= 8 | 65655.8 ng/mL | Standard Deviation 32873.33 |
| Belimumab 10 mg/kg IV | Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points | 4 Weeks post last-dose; n= 9 | 60497.3 ng/mL | Standard Deviation 28074.37 |
Secondary
Summary of Total Amount of Urine Excreted Ae(0-24)
PK parameters from the urine concentration data: urine Ae(0-24) were assessed. 24 h urine collections for PK analysis were collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach was undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis was conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. Several samples were taken pre-dose at Day 0 and some at week 12 incorrectly which affects interpretation.
Time frame: Baseline and Up to 4 week post last dose
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg IV | Summary of Total Amount of Urine Excreted Ae(0-24) | Week 76; n= 8 | 145645.34 ng/hour | Standard Deviation 267292.225 |
| Belimumab 10 mg/kg IV | Summary of Total Amount of Urine Excreted Ae(0-24) | Day 0; n= 14 | 105826.23 ng/hour | Standard Deviation 178943.857 |
| Belimumab 10 mg/kg IV | Summary of Total Amount of Urine Excreted Ae(0-24) | Week 12; n= 12 | 95188.14 ng/hour | Standard Deviation 130217.976 |
| Belimumab 10 mg/kg IV | Summary of Total Amount of Urine Excreted Ae(0-24) | Week 28; n= 11 | 92997.94 ng/hour | Standard Deviation 110142.599 |
| Belimumab 10 mg/kg IV | Summary of Total Amount of Urine Excreted Ae(0-24) | Week 52; n= 9 | 219367.96 ng/hour | Standard Deviation 391752.377 |
| Belimumab 10 mg/kg IV | Summary of Total Amount of Urine Excreted Ae(0-24) | 4 Week post last dose; n= 6 | 7909.34 ng/hour | Standard Deviation 16771.559 |
Secondary
Time to Anti-PLA2R Autoantibody Remission
Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.
Time frame: Baseline and up to Week 128/6 month follow up
Population: ITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Belimumab 10 mg/kg IV | Time to Anti-PLA2R Autoantibody Remission | Partial response | 16.20 Weeks |
| Belimumab 10 mg/kg IV | Time to Anti-PLA2R Autoantibody Remission | Complete response | 82.00 Weeks |
Secondary
Time to Complete or Partial Remission
Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15 percent ). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed.
Time frame: Baseline and up to Week 128/6 month follow up
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab 10 mg/kg IV | Time to Complete or Partial Remission | 68.20 Weeks |
Secondary
Urine BLys Levels as a Ratio to Creatinine
B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS: creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. Only raw BLyS values available and unable to be assessed due to lack of comparison to a creatinine as a urine concentration marker.
Time frame: Baseline and Week 116/16 week follow-up visit
Population: ITT Population
Secondary
Urine Membrane Attack Complex (MAC) Levels
Urine membrane attack complex was assayed quantitatively by ELISA method. Urine MAC samples were collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results were normalized using urine creatinine concentration to adjust for urine dilution. Endpoint was moved to 'Exploratory' in Protocol amendment 5 as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed
Time frame: Baseline and up to 4 week post last dose
Population: ITT Population