Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Belimumab, Pharmacodynamics, safety tolerability, Pharmacokinetics, Chinese subjects
Brief summary
In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the treatment of SLE. Subjects will be followed for 84 days after the administration of drug.
Interventions
DRUGBelimumab
Belimumab will be provided as white uniform lyophilized cake in vials with unit dose strength of 400 mg/vial plus excipients (citric acid/sodium citrate/sucrose/polysorbate) for reconstitution in 4.8 milliliter sterile water for injection (SWFI). Belimumab will be administered as 10 mg/kg intravenous infusion for over 1 hour on Day 0.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who give consent to this study participation and sign informed consent form. * Subjects at least 18 years of age inclusive at screening visit. * SLE Classification: Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation. * SLE Treatment: Be on either no SLE medication or a stable SLE treatment regimen of any medication (alone or in combination) for a period of at least 2 months prior to Day 0; corticosteroids (prednisone or prednisone equivalent, up to 40 mg/day); immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), mizoribine, calcineurin inhibitors (example \[e.g.\], tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide; anti-malarials (e.g., hydroxychloroquine, chloroquine, quinacrine) and non-steroidal anti-inflammatory drugs (NSAIDs). * The subjects with positive test for anti-nuclear antibody (ANA) or anti-double stranded deoxyribonucleic acid (DNA) serum antibody. * Males and females: A female subject is eligible to enter the study if she is: not pregnant or nursing; of non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea \[even severe\], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to one of the following: complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product (IP) until study complete; or consistent and correct use of one of the following acceptable methods of birth control for 1 month prior to the start of the IP and for 16 weeks after the last dose of IP: any intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1 percent (%) per year; oral contraceptives; double barrier method with vaginal spermicidal agent: condom and an occlusive cap (cervical cap/vault or diaphragm) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; injectable progesterone; percutaneous contraceptive patch; male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject. * Based on single or averaged corrected QT (QTc) interval values of triplicate ECGs obtained over a brief recording period: \[QTc corrected by Bazett's (QTcB) or QTc corrected by Fridericia's (QTcF) formula\] \<450 milliseconds (msec); or QTcB or QTcF \<480 msec in subjects with bundle branch block.
Exclusion criteria
* B-cell Therapy: Have received treatment with any B cell targeted therapy (e.g., rituximab, other anti-CD20 agents, anti-CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\], BLyS-receptor fusion protein \[BR3\], Transmembrane activator and calcium-modulator and cytophilin ligand interactor \[TACI\] Fc, or belimumab) at any time. * The subject has received a biologic investigational or non-investigational agent within 12 months prior to Day 0. * Received IV immunoglobulin (Ig), plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (\>60 mg/day) within 6 months prior to Day 0. * The subject has received a non-biologic investigational agent within 2 months prior to Day 0. * The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational agent. * The subject has severe lupus kidney disease (defined by proteinuria \>6 grams \[g\]/24 hours) within 6 months prior to the Screening visit. * History of renal transplant. * Active central nervous system (CNS) lupus \[including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis\] requiring medical intervention within 6 months prior to Screening visit. * Infections: 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); hospitalization for treatment of infection within 2 months prior to Day 0; use of parenteral (IV or intramuscular \[IM\]) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 2 months prior to Day 0. * The subject has hypogammaglobulinemia or immunoglobulin A (IgA) deficiency (IgA level \<10 mg/deciliter \[dL\]). * Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies. * Uncontrolled other diseases: History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. * Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study. * The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator. * Have evidence of current drug or alcohol abuse or dependence. * AST and ALT \>=2x upper limit of normal (ULN); ALP and bilirubin \>1.5xULN (isolated bilirubin \>1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV. * History of or positive test at screening visit for any of Hepatitis B surface antigen (HBsAg), anti- Hepatitis B core antibody (HBcAb) or anti-hepatitis C virus antibodies (HCVAb). If only anti-HBcAb result is positive, hepatitis B virus (HBV)-(DNA) test will be performed. If HBV-DNA results in negative, the patient is eligible. * Laboratory Abnormalities: Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed: * Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment. * Stable Grade 3/4 proteinuria (=\<6 g/24 hour equivalent by spot urine protein to creatinine ratio allowed). * Stable Grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition. * Stable Grade 3 neutropenia or stable Grade 3 white blood cell count. * Subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who, in the investigator's opinion, pose a significant suicide risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Belimumab | Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose | Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab. |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab | Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose | Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab. |
| Terminal Phase Half-life (t1/2) of Belimumab | Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose | Blood samples were collected at the indicated time points to calculate t1/2 of belimumab. |
| Terminal Phase Rate Constant (Lambda z) of Belimumab | Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose | Blood samples were collected at the indicated time points to calculate lambda z of belimumab. |
| Systemic Clearance (CL) of Belimumab | Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose | Blood samples were collected at the indicated time points to calculate CL of belimumab. |
| Volume of Distribution (Vz) of Belimumab | Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose | Blood samples were collected at the indicated time points to calculate Vz of belimumab. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Day 84 | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. 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, or is a congenital anomaly/birth defect or is medically significant, or associated with liver injury and impaired liver function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Baseline (pre-dose on Day 0) to Day 84 | Clinical chemistry parameters included calcium, calcium corrected, carbon dioxide, chloride, magnesium, phosphate, potassium, sodium, urea and glucose. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Baseline (pre-dose on Day 0) to Day 84 | Hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | Baseline (pre-dose on Day 0) to Day 84 | Hematology parameter included erythrocytes. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | Baseline (pre-dose on Day 0) to Day 84 | Hematology parameter included hematocrit. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (pre-dose on Day 0) to Day 84 | Vital signs included SBP and DBP. SBP and DBP were measured with the participant in the sitting position. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Number of Participants With Positive Urinalysis Dipstick Results | Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 | Urinalysis was done by the dipstick method to detect the presence of protein, glucose, ketones and occult blood in urine. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood, urine protein and urine ketones can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample; results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per Liter (g/L), 2+ or 1/2 g/L, 3+ or 1 g/L and 4+ indicating proportional concentrations in the urine sample. \*a indicates two participants did not take the urinalysis test at Day 14 on scheduled date but took an unscheduled sample at the next visit (Day 21) and \*b indicates one participant did not take the urinalysis test at Day 28 on scheduled date but took an unscheduled sample at the next visit (Day 42). Only those participants with positive results have been presented. |
| Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | Baseline (pre-dose on Day 0) to Day 84 | Immunoglobulin B cell subsets included CD19 and CD 20+. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\]. Pharmacodynamic population comprised of participants who received the study medication and for whom pharmacodynamic data was available. |
| Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | Baseline (pre-dose on Day 0) to Day 84 | Immunoglobulin B cell subset included CD20+/27+ memory and CD20+/27-naïve. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\]. |
| Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Baseline (pre-dose on Day 0) to Day 84 | Immunoglobulin B cell subset inlcuded Norm CD19+/27Br/38Br SLE subset, Norm CD20+/138+plasmacytoid, Norm CD20+/69+activated and Norm CD20-/CD138+plasma cell. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\]. |
| Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | Baseline (pre-dose on Day 0) to Day 84 | Hematology parameter included hemoglobin. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Baseline (pre-dose on Day 0) to Day 84 | Vital signs included pulse rate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Vital Sign- Temperature | Baseline (pre-dose on Day 0) to Day 84 | Vital signs included temperature. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings | Up to Day 84 | ECG parameters included heart rate, PR interval, QRS interval, QT interval and corrected QT (QTc) interval. Number of participants with abnormal-clinically significant 12-lead ECG findings are presented. |
| Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | Baseline (pre-dose on Day 0) to Day 84 | Clinical chemistry parameters included ALT, ALP, AST, GGT and lactate dehydrogenase. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Baseline (pre-dose on Day 0) to Day 84 | Clinical chemistry parameters included albumin and protein. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
| Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Baseline (pre-dose on Day 0) to Day 84 | Clinical chemistry parameters included bilirubin, creatinine, direct bilirubin, indirect bilirubin and urate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. |
Countries
China
Participant flow
Recruitment details
A total of 20 participants with Systemic Lupus Erythematosus (SLE) were enrolled. The study was conducted at 2 centers in China from 23-Jan-2017 to 08-Sep-2017.
Pre-assignment details
A total of 25 participants were screened, of which 5 participants were screen failures. The reason for screen failures were: did not meet inclusion/exclusion criteria (4 participants) and investigator discretion (1 participant).
Participants by arm
| Arm | Count |
|---|---|
| Belimumab 10 mg/kg Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Belimumab 10 mg/kg |
|---|---|
| Age, Continuous | 37.4 Years STANDARD_DEVIATION 14.07 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 20 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 11 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab
Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab.
Time frame: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose
Population: PK Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab | AUC(0 to t) | 2395.3030 Day*micrograms/milliliter | Geometric Coefficient of Variation 23.2924 |
| Belimumab 10 mg/kg | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab | AUC(0 to inf) | 2461.8013 Day*micrograms/milliliter | Geometric Coefficient of Variation 24.7125 |
Primary
Maximum Observed Concentration (Cmax) of Belimumab
Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab.
Time frame: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose
Population: Pharmacokinetic (PK) Parameter Population, which comprised of all those participants who received a dose of belimumab and for whom PK parameters could be calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 10 mg/kg | Maximum Observed Concentration (Cmax) of Belimumab | 221.3532 Micrograms per milliliter | Geometric Coefficient of Variation 12.8405 |
Primary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. 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, or is a congenital anomaly/birth defect or is medically significant, or associated with liver injury and impaired liver function.
Time frame: Up to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belimumab 10 mg/kg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 12 Participants |
| Belimumab 10 mg/kg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 1 Participants |
Primary
Systemic Clearance (CL) of Belimumab
Blood samples were collected at the indicated time points to calculate CL of belimumab.
Time frame: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 10 mg/kg | Systemic Clearance (CL) of Belimumab | 4.0621 (Milliliters/day)/kilogram | Geometric Coefficient of Variation 24.7125 |
Primary
Terminal Phase Half-life (t1/2) of Belimumab
Blood samples were collected at the indicated time points to calculate t1/2 of belimumab.
Time frame: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 10 mg/kg | Terminal Phase Half-life (t1/2) of Belimumab | 14.6283 Days | Geometric Coefficient of Variation 35.4339 |
Primary
Terminal Phase Rate Constant (Lambda z) of Belimumab
Blood samples were collected at the indicated time points to calculate lambda z of belimumab.
Time frame: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose
Population: PK Parameter Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 10 mg/kg | Terminal Phase Rate Constant (Lambda z) of Belimumab | 0.0474 1/day | Geometric Coefficient of Variation 35.4339 |
Primary
Volume of Distribution (Vz) of Belimumab
Blood samples were collected at the indicated time points to calculate Vz of belimumab.
Time frame: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 10 mg/kg | Volume of Distribution (Vz) of Belimumab | 85.7265 Milliliters/kilogram | Geometric Coefficient of Variation 21.6704 |
Secondary
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
Clinical chemistry parameters included ALT, ALP, AST, GGT and lactate dehydrogenase. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALP: Day 14 | -5.6 International units per Liter (IU/L) | Standard Deviation 10.72 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALP: Day 28 | -3.4 International units per Liter (IU/L) | Standard Deviation 8.8 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALP: Day 56 | -7.2 International units per Liter (IU/L) | Standard Deviation 9.26 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALP: Day 84 | -7.3 International units per Liter (IU/L) | Standard Deviation 11.8 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | AST: Day 0 (24 hours) | -1.9 International units per Liter (IU/L) | Standard Deviation 2.48 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | AST: Day 14 | -1.8 International units per Liter (IU/L) | Standard Deviation 8.58 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | AST: Day 28 | -2.6 International units per Liter (IU/L) | Standard Deviation 8.46 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | AST: Day 56 | -2.8 International units per Liter (IU/L) | Standard Deviation 6.15 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | AST: Day 84 | -3.6 International units per Liter (IU/L) | Standard Deviation 6.86 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | GGT: Day 0 (24 hours) | -1.5 International units per Liter (IU/L) | Standard Deviation 2.33 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | GGT: Day 14 | -0.5 International units per Liter (IU/L) | Standard Deviation 7.34 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | GGT: Day 28 | 0.5 International units per Liter (IU/L) | Standard Deviation 7.22 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | GGT: Day 56 | -4.1 International units per Liter (IU/L) | Standard Deviation 6.08 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | GGT: Day 84 | -3.3 International units per Liter (IU/L) | Standard Deviation 8.44 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | Lactate dehydrogenase: Day 0 (24 hours) | -8.1 International units per Liter (IU/L) | Standard Deviation 10.56 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | Lactate dehydrogenase: Day 14 | -3.2 International units per Liter (IU/L) | Standard Deviation 18.88 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | Lactate dehydrogenase: Day 28 | -1.4 International units per Liter (IU/L) | Standard Deviation 22.3 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | Lactate dehydrogenase: Day 56 | 1.3 International units per Liter (IU/L) | Standard Deviation 24.3 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | Lactate dehydrogenase: Day 84 | 1.5 International units per Liter (IU/L) | Standard Deviation 20.68 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALT: Day 0 (24 hours) | -1.6 International units per Liter (IU/L) | Standard Deviation 3.46 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALT: Day 14 | -1.3 International units per Liter (IU/L) | Standard Deviation 11.93 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALT: Day 28 | -3.2 International units per Liter (IU/L) | Standard Deviation 12.34 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALT: Day 56 | -5.0 International units per Liter (IU/L) | Standard Deviation 12.18 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALT: Day 84 | -5.5 International units per Liter (IU/L) | Standard Deviation 11.84 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase | ALP: Day 0 (24 hours) | -3.9 International units per Liter (IU/L) | Standard Deviation 3.56 |
Secondary
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Clinical chemistry parameters included albumin and protein. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Albumin: Day 0 (24 hours) | -1.4 Grams per liter (g/L) | Standard Deviation 1.88 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Albumin: Day 14 | -1.1 Grams per liter (g/L) | Standard Deviation 3.08 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Albumin: Day 28 | -0.6 Grams per liter (g/L) | Standard Deviation 2.68 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Albumin: Day 56 | -0.5 Grams per liter (g/L) | Standard Deviation 3.14 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Albumin: Day 84 | -0.6 Grams per liter (g/L) | Standard Deviation 3.1 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Protein: Day 0 (24 hours) | -3.8 Grams per liter (g/L) | Standard Deviation 2.67 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Protein: Day 14 | -3.2 Grams per liter (g/L) | Standard Deviation 5.12 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Protein: Day 28 | -3.3 Grams per liter (g/L) | Standard Deviation 4.47 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Protein: Day 56 | -3.8 Grams per liter (g/L) | Standard Deviation 5.41 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | Protein: Day 84 | -3.8 Grams per liter (g/L) | Standard Deviation 4.23 |
Secondary
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Clinical chemistry parameters included bilirubin, creatinine, direct bilirubin, indirect bilirubin and urate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Bilirubin: Day 0 (24 hours) | -2.8 Micromoles per Liter (µmol/L) | Standard Deviation 3.07 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Bilirubin: Day 14 | -2.4 Micromoles per Liter (µmol/L) | Standard Deviation 4.48 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Bilirubin: Day 28 | -3.4 Micromoles per Liter (µmol/L) | Standard Deviation 4.55 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Bilirubin: Day 56 | -3.2 Micromoles per Liter (µmol/L) | Standard Deviation 5.17 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Bilirubin: Day 84 | -2.1 Micromoles per Liter (µmol/L) | Standard Deviation 4.83 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Creatinine: Day 0 (24 hours) | -0.18 Micromoles per Liter (µmol/L) | Standard Deviation 4.479 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Creatinine: Day 14 | -0.80 Micromoles per Liter (µmol/L) | Standard Deviation 5.502 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Creatinine: Day 28 | -0.43 Micromoles per Liter (µmol/L) | Standard Deviation 6.698 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Creatinine: Day 56 | -0.25 Micromoles per Liter (µmol/L) | Standard Deviation 5.962 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Creatinine: Day 84 | -0.18 Micromoles per Liter (µmol/L) | Standard Deviation 6.062 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Direct bilirubin: Day 0 (24 hours) | -0.4 Micromoles per Liter (µmol/L) | Standard Deviation 1.05 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Direct bilirubin: Day 14 | 0.1 Micromoles per Liter (µmol/L) | Standard Deviation 1.37 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Direct bilirubin: Day 28 | -0.6 Micromoles per Liter (µmol/L) | Standard Deviation 1.14 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Direct bilirubin: Day 56 | -0.6 Micromoles per Liter (µmol/L) | Standard Deviation 1.47 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Direct bilirubin: Day 84 | -0.2 Micromoles per Liter (µmol/L) | Standard Deviation 1.28 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Indirect bilirubin: Day 0 (24 hours) | -2.4 Micromoles per Liter (µmol/L) | Standard Deviation 2.87 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Indirect bilirubin: Day 14 | -2.5 Micromoles per Liter (µmol/L) | Standard Deviation 4.1 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Indirect bilirubin: Day 28 | -2.8 Micromoles per Liter (µmol/L) | Standard Deviation 4.12 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Indirect bilirubin: Day 56 | -2.6 Micromoles per Liter (µmol/L) | Standard Deviation 4.26 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Indirect bilirubin: Day 84 | -1.9 Micromoles per Liter (µmol/L) | Standard Deviation 4.79 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Urate: Day 0 (24 hours) | -14.5 Micromoles per Liter (µmol/L) | Standard Deviation 21.88 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Urate: Day 14 | -10.5 Micromoles per Liter (µmol/L) | Standard Deviation 34.41 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Urate: Day 28 | -13.5 Micromoles per Liter (µmol/L) | Standard Deviation 47.49 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Urate: Day 56 | -2.5 Micromoles per Liter (µmol/L) | Standard Deviation 49.93 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | Urate: Day 84 | -7.5 Micromoles per Liter (µmol/L) | Standard Deviation 50.67 |
Secondary
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Clinical chemistry parameters included calcium, calcium corrected, carbon dioxide, chloride, magnesium, phosphate, potassium, sodium, urea and glucose. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium: Day 0 (24 hours) | -0.040 Millimoles per Liter (mmol/L) | Standard Deviation 0.0599 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium: Day 14 | -0.020 Millimoles per Liter (mmol/L) | Standard Deviation 0.1049 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium: Day 28 | 0.004 Millimoles per Liter (mmol/L) | Standard Deviation 0.0848 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium: Day 56 | -0.020 Millimoles per Liter (mmol/L) | Standard Deviation 0.1054 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium: Day 84 | -0.027 Millimoles per Liter (mmol/L) | Standard Deviation 0.0909 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium Corrected: Day 0 (24 hours) | -0.010 Millimoles per Liter (mmol/L) | Standard Deviation 0.0466 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium Corrected: Day 14 | 0.003 Millimoles per Liter (mmol/L) | Standard Deviation 0.0663 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium Corrected: Day 28 | 0.017 Millimoles per Liter (mmol/L) | Standard Deviation 0.0578 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium Corrected: Day 56 | -0.007 Millimoles per Liter (mmol/L) | Standard Deviation 0.0694 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Calcium Corrected: Day 84 | -0.016 Millimoles per Liter (mmol/L) | Standard Deviation 0.0501 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Carbon dioxide: Day 0 (24 hours) | -0.3 Millimoles per Liter (mmol/L) | Standard Deviation 1.86 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Carbon dioxide: Day 14 | -0.2 Millimoles per Liter (mmol/L) | Standard Deviation 2.32 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Carbon dioxide: Day 28 | 0.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.09 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Carbon dioxide: Day 56 | -0.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.33 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Carbon dioxide: Day 84 | -0.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.64 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Chloride: Day 0 (24 hours) | 1.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.12 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Chloride: Day 14 | 0.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.05 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Chloride: Day 28 | 0.4 Millimoles per Liter (mmol/L) | Standard Deviation 1.53 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Chloride: Day 56 | 1.3 Millimoles per Liter (mmol/L) | Standard Deviation 1.63 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Chloride: Day 84 | 1.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.74 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Magnesium: Day 0 (24 hours) | -0.044 Millimoles per Liter (mmol/L) | Standard Deviation 0.0564 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Magnesium: Day 14 | -0.046 Millimoles per Liter (mmol/L) | Standard Deviation 0.0623 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Magnesium: Day 28 | -0.049 Millimoles per Liter (mmol/L) | Standard Deviation 0.0709 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Magnesium: Day 56 | -0.029 Millimoles per Liter (mmol/L) | Standard Deviation 0.075 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Magnesium: Day 84 | -0.034 Millimoles per Liter (mmol/L) | Standard Deviation 0.0751 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Phosphate: Day 0 (24 hours) | -0.085 Millimoles per Liter (mmol/L) | Standard Deviation 0.1299 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Phosphate: Day 14 | -0.132 Millimoles per Liter (mmol/L) | Standard Deviation 0.2104 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Phosphate: Day 28 | -0.135 Millimoles per Liter (mmol/L) | Standard Deviation 0.2201 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Phosphate: Day 56 | -0.140 Millimoles per Liter (mmol/L) | Standard Deviation 0.2037 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Phosphate: Day 84 | -0.152 Millimoles per Liter (mmol/L) | Standard Deviation 0.1509 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Potassium: Day 0 (24 hours) | -0.10 Millimoles per Liter (mmol/L) | Standard Deviation 0.333 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Potassium: Day 14 | -0.04 Millimoles per Liter (mmol/L) | Standard Deviation 0.355 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Potassium: Day 28 | -0.11 Millimoles per Liter (mmol/L) | Standard Deviation 0.335 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Potassium: Day 56 | -0.13 Millimoles per Liter (mmol/L) | Standard Deviation 0.37 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Potassium: Day 84 | -0.29 Millimoles per Liter (mmol/L) | Standard Deviation 0.356 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Sodium: Day 0 (24 hours) | 0.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.24 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Sodium: Day 14 | 0.3 Millimoles per Liter (mmol/L) | Standard Deviation 1.59 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Sodium: Day 28 | 0.1 Millimoles per Liter (mmol/L) | Standard Deviation 1.28 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Sodium: Day 56 | 0.8 Millimoles per Liter (mmol/L) | Standard Deviation 1.68 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Sodium: Day 84 | 0.8 Millimoles per Liter (mmol/L) | Standard Deviation 1.67 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Urea: Day 0 (24 hours) | 0.20 Millimoles per Liter (mmol/L) | Standard Deviation 0.733 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Urea: Day 14 | 0.38 Millimoles per Liter (mmol/L) | Standard Deviation 1.122 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Urea: Day 28 | 0.10 Millimoles per Liter (mmol/L) | Standard Deviation 1.382 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Urea: Day 56 | -0.13 Millimoles per Liter (mmol/L) | Standard Deviation 0.793 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Urea: Day 84 | -0.20 Millimoles per Liter (mmol/L) | Standard Deviation 1.152 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Glucose: Day 0 (24 hours) | 0.98 Millimoles per Liter (mmol/L) | Standard Deviation 3.248 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Glucose: Day 14 | 1.66 Millimoles per Liter (mmol/L) | Standard Deviation 2.094 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Glucose: Day 28 | 0.33 Millimoles per Liter (mmol/L) | Standard Deviation 2.23 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Glucose: Day 56 | 0.19 Millimoles per Liter (mmol/L) | Standard Deviation 2.093 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | Glucose: Day 84 | 0.57 Millimoles per Liter (mmol/L) | Standard Deviation 2.749 |
Secondary
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils: Day 0 (24 hours) | -0.006 10^9 cells/Liter | Standard Deviation 0.011 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils: Day 14 | -0.011 10^9 cells/Liter | Standard Deviation 0.0176 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils: Day 28 | -0.013 10^9 cells/Liter | Standard Deviation 0.0186 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils: Day 56 | -0.008 10^9 cells/Liter | Standard Deviation 0.0162 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils: Day 84 | -0.005 10^9 cells/Liter | Standard Deviation 0.0115 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils: Day 0 (24 hours) | -0.019 10^9 cells/Liter | Standard Deviation 0.0506 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils: Day 14 | -0.024 10^9 cells/Liter | Standard Deviation 0.0564 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils: Day 28 | -0.006 10^9 cells/Liter | Standard Deviation 0.0535 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils: Day 56 | -0.022 10^9 cells/Liter | Standard Deviation 0.0595 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils: Day 84 | -0.028 10^9 cells/Liter | Standard Deviation 0.067 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes: Day 0 (24 hours) | 0.29 10^9 cells/Liter | Standard Deviation 0.899 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes: Day 14 | 0.09 10^9 cells/Liter | Standard Deviation 1.403 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes: Day 28 | 1.00 10^9 cells/Liter | Standard Deviation 1.589 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes: Day 56 | 0.54 10^9 cells/Liter | Standard Deviation 1.337 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes: Day 84 | -0.04 10^9 cells/Liter | Standard Deviation 1.754 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes: Day 0 (24 hours) | -0.068 10^9 cells/Liter | Standard Deviation 0.5214 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes: Day 14 | -0.180 10^9 cells/Liter | Standard Deviation 0.6718 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes: Day 28 | -0.364 10^9 cells/Liter | Standard Deviation 0.6746 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes: Day 56 | -0.287 10^9 cells/Liter | Standard Deviation 0.5812 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes: Day 84 | -0.257 10^9 cells/Liter | Standard Deviation 0.5697 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes: Day 0 (24 hours) | 0.005 10^9 cells/Liter | Standard Deviation 0.13 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes: Day 14 | -0.025 10^9 cells/Liter | Standard Deviation 0.1575 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes: Day 28 | -0.077 10^9 cells/Liter | Standard Deviation 0.2568 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes: Day 56 | -0.076 10^9 cells/Liter | Standard Deviation 0.1574 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes: Day 84 | -0.059 10^9 cells/Liter | Standard Deviation 0.1878 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils: Day 0 (24 hours) | 0.389 10^9 cells/Liter | Standard Deviation 0.9085 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils: Day 14 | 0.332 10^9 cells/Liter | Standard Deviation 1.8713 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils: Day 28 | 1.464 10^9 cells/Liter | Standard Deviation 1.975 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils: Day 56 | 0.932 10^9 cells/Liter | Standard Deviation 1.3943 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils: Day 84 | 0.305 10^9 cells/Liter | Standard Deviation 1.7297 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets: Day 0 (24 hours) | -6.3 10^9 cells/Liter | Standard Deviation 12.68 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets: Day 14 | 2.1 10^9 cells/Liter | Standard Deviation 26.11 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets: Day 28 | 10.0 10^9 cells/Liter | Standard Deviation 30.14 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets: Day 56 | 1.0 10^9 cells/Liter | Standard Deviation 20.84 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets: Day 84 | -4.1 10^9 cells/Liter | Standard Deviation 29.04 |
Secondary
Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes
Hematology parameter included erythrocytes. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | Day 0 (24 hours) | -0.12 10^12 cells/Liter | Standard Deviation 0.158 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | Day 14 | -0.19 10^12 cells/Liter | Standard Deviation 0.246 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | Day 28 | -0.13 10^12 cells/Liter | Standard Deviation 0.205 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | Day 56 | -0.16 10^12 cells/Liter | Standard Deviation 0.239 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | Day 84 | -0.18 10^12 cells/Liter | Standard Deviation 0.282 |
Secondary
Change From Baseline to Day 84 in Hematology Parameter- Hematocrit
Hematology parameter included hematocrit. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | Day 84 | -0.0126 Proportion of red blood cells in blood | Standard Deviation 0.0313 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | Day 0 (24 hours) | -0.0112 Proportion of red blood cells in blood | Standard Deviation 0.017 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | Day 14 | -0.0176 Proportion of red blood cells in blood | Standard Deviation 0.0272 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | Day 28 | 0.0006 Proportion of red blood cells in blood | Standard Deviation 0.031 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | Day 56 | -0.0060 Proportion of red blood cells in blood | Standard Deviation 0.0226 |
Secondary
Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin
Hematology parameter included hemoglobin. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | Day 0 (24 hours) | -3.7 Grams per Liter (g/L) | Standard Deviation 4.83 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | Day 14 | -5.0 Grams per Liter (g/L) | Standard Deviation 7.14 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | Day 28 | -4.0 Grams per Liter (g/L) | Standard Deviation 5.55 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | Day 56 | -5.0 Grams per Liter (g/L) | Standard Deviation 8.04 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | Day 84 | -5.7 Grams per Liter (g/L) | Standard Deviation 10.11 |
Secondary
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Vital signs included pulse rate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 0 (5 minutes post-dose) | -1.2 Beats per minute | Standard Deviation 11.13 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 0 (1 hour post-dose) | -1.6 Beats per minute | Standard Deviation 8.43 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 0 (6 hours post-dose) | 2.6 Beats per minute | Standard Deviation 12.14 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 0 (24 hours post-dose) | 2.3 Beats per minute | Standard Deviation 11.08 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 1 | 5.7 Beats per minute | Standard Deviation 11.09 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 7 | 4.7 Beats per minute | Standard Deviation 11.82 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 14 | 6.9 Beats per minute | Standard Deviation 10.55 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 21 | 5.0 Beats per minute | Standard Deviation 8.9 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 28 | 7.6 Beats per minute | Standard Deviation 10.02 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 42 | 8.3 Beats per minute | Standard Deviation 12.06 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 56 | 4.1 Beats per minute | Standard Deviation 10.8 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | Day 84 | 3.2 Beats per minute | Standard Deviation 14.21 |
Secondary
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital signs included SBP and DBP. SBP and DBP were measured with the participant in the sitting position. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 0 (5 minutes post-dose) | -0.5 Millimeters of mercury | Standard Deviation 6.35 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 0 (1 hour post-dose) | -1.5 Millimeters of mercury | Standard Deviation 12.51 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 0 (6 hours post-dose) | -2.1 Millimeters of mercury | Standard Deviation 8.57 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 0 (24 hours post-dose) | -0.1 Millimeters of mercury | Standard Deviation 7.95 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 1 | 2.2 Millimeters of mercury | Standard Deviation 8.37 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 7 | 1.1 Millimeters of mercury | Standard Deviation 7.91 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 14 | 0.5 Millimeters of mercury | Standard Deviation 8.65 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 21 | 0.1 Millimeters of mercury | Standard Deviation 6.91 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 28 | 0.2 Millimeters of mercury | Standard Deviation 8.86 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 42 | -3.2 Millimeters of mercury | Standard Deviation 7.99 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 56 | -0.8 Millimeters of mercury | Standard Deviation 8.85 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 84 | -0.6 Millimeters of mercury | Standard Deviation 11.06 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 0 (5 minutes post-dose) | 0.8 Millimeters of mercury | Standard Deviation 9.92 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 0 (1 hour post-dose) | -2.5 Millimeters of mercury | Standard Deviation 11.44 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 0 (6 hours post-dose) | -4.5 Millimeters of mercury | Standard Deviation 12.15 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 0 (24 hours post-dose) | -3.7 Millimeters of mercury | Standard Deviation 11.76 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 1 | -2.4 Millimeters of mercury | Standard Deviation 10.92 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 7 | 0.7 Millimeters of mercury | Standard Deviation 10.65 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 14 | -1.0 Millimeters of mercury | Standard Deviation 12.09 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 21 | -4.4 Millimeters of mercury | Standard Deviation 12.05 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 28 | -1.5 Millimeters of mercury | Standard Deviation 14.01 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 42 | -7.4 Millimeters of mercury | Standard Deviation 9.26 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 56 | -4.0 Millimeters of mercury | Standard Deviation 11.14 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 84 | -7.4 Millimeters of mercury | Standard Deviation 14.91 |
Secondary
Change From Baseline to Day 84 in Vital Sign- Temperature
Vital signs included temperature. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 84 | 0.38 Celsius | Standard Deviation 0.434 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 0 (5 minutes post-dose) | 0.21 Celsius | Standard Deviation 0.485 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 0 (1 hour post-dose) | 0.17 Celsius | Standard Deviation 0.473 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 0 (6 hours post-dose) | 0.20 Celsius | Standard Deviation 0.552 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 0 (24 hours post-dose) | 0.40 Celsius | Standard Deviation 0.617 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 1 | 0.24 Celsius | Standard Deviation 0.486 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 7 | 0.40 Celsius | Standard Deviation 0.793 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 14 | 0.40 Celsius | Standard Deviation 0.504 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 21 | 0.41 Celsius | Standard Deviation 0.454 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 28 | 0.37 Celsius | Standard Deviation 0.457 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 42 | 0.53 Celsius | Standard Deviation 0.595 |
| Belimumab 10 mg/kg | Change From Baseline to Day 84 in Vital Sign- Temperature | Day 56 | 0.52 Celsius | Standard Deviation 0.473 |
Secondary
Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings
ECG parameters included heart rate, PR interval, QRS interval, QT interval and corrected QT (QTc) interval. Number of participants with abnormal-clinically significant 12-lead ECG findings are presented.
Time frame: Up to Day 84
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Belimumab 10 mg/kg | Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings | 0 Participants |
Secondary
Number of Participants With Positive Urinalysis Dipstick Results
Urinalysis was done by the dipstick method to detect the presence of protein, glucose, ketones and occult blood in urine. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood, urine protein and urine ketones can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample; results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per Liter (g/L), 2+ or 1/2 g/L, 3+ or 1 g/L and 4+ indicating proportional concentrations in the urine sample. \*a indicates two participants did not take the urinalysis test at Day 14 on scheduled date but took an unscheduled sample at the next visit (Day 21) and \*b indicates one participant did not take the urinalysis test at Day 28 on scheduled date but took an unscheduled sample at the next visit (Day 42). Only those participants with positive results have been presented.
Time frame: Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 14, Trace | 4 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 14, 1+ | 2 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Glucose: Day 14, 1+ or 1/4 g/L | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Glucose: Day 14, 2+ or 1/2 g/L | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Glucose: Day 14, Trace | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Glucose: Day 28, 1+ or 1/4 g/L | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Glucose: Day 56, 1+ or 1/4 g/L | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 0 (24 hours), Trace | 5 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 0 (24 hours), 1+ | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 0 (24 hours), 3+ | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 14, 2+ | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 21*a, Trace | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 28, Trace | 6 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 28, 2+ | 2 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 56, Trace | 5 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 56, 1+ | 2 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 56, 2+ | 2 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 84, Trace | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 84, 1+ | 3 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Occult Blood: Day 84, 2+ | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 0 (24 hours), 2+ | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 14, Trace | 3 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 14, 1+ | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 28, 2+ | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 42*b, Trace | 1 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 56, Trace | 2 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 84, Trace | 3 Participants |
| Belimumab 10 mg/kg | Number of Participants With Positive Urinalysis Dipstick Results | Protein: Day 84, 2+ | 1 Participants |
Secondary
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
Immunoglobulin B cell subset included CD20+/27+ memory and CD20+/27-naïve. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\].
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27+ memory: Day 14, n=20 | 186.4701 Percent change | Standard Deviation 199.5187 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27+ memory: Day 28, n=20 | 118.1433 Percent change | Standard Deviation 135.2351 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27+ memory: Day 42, n=19 | 91.2965 Percent change | Standard Deviation 125.1803 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27+ memory: Day 56, n=20 | 135.8139 Percent change | Standard Deviation 167.0084 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27+ memory: Day 84, n=20 | 70.6332 Percent change | Standard Deviation 108.1058 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27-naïve: Day 14, n=20 | 4.0530 Percent change | Standard Deviation 61.8752 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27-naïve: Day 28, n=20 | -15.9190 Percent change | Standard Deviation 48.8363 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27-naïve: Day 42, n=19 | -17.0090 Percent change | Standard Deviation 61.5514 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27-naïve: Day 56, n=20 | -40.2078 Percent change | Standard Deviation 37.1774 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | CD20+/27-naïve: Day 84, n=20 | -42.6608 Percent change | Standard Deviation 43.869 |
Secondary
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
Immunoglobulin B cell subsets included CD19 and CD 20+. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\]. Pharmacodynamic population comprised of participants who received the study medication and for whom pharmacodynamic data was available.
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD19: Day 14, n=20 | 26.6444 Percent change | Standard Deviation 78.2275 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD19: Day 28, n=20 | -4.1141 Percent change | Standard Deviation 49.0574 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD19: Day 42, n=19 | -12.6852 Percent change | Standard Deviation 46.6312 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD19: Day 56, n=20 | -20.4908 Percent change | Standard Deviation 44.2536 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD19: Day 84, n=20 | -27.0912 Percent change | Standard Deviation 49.5965 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD20+: Day 14, n=20 | 35.3407 Percent change | Standard Deviation 100.7209 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD20+: Day 28, n=20 | 0.3444 Percent change | Standard Deviation 54.1435 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD20+: Day 42, n=19 | -8.6327 Percent change | Standard Deviation 52.1804 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD20+: Day 56, n=20 | -20.6313 Percent change | Standard Deviation 42.8535 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | CD20+: Day 84, n=20 | -23.7421 Percent change | Standard Deviation 62.8031 |
Secondary
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Immunoglobulin B cell subset inlcuded Norm CD19+/27Br/38Br SLE subset, Norm CD20+/138+plasmacytoid, Norm CD20+/69+activated and Norm CD20-/CD138+plasma cell. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\].
Time frame: Baseline (pre-dose on Day 0) to Day 84
Population: Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD19+/27Br/38Br SLE subset: Day 14, n=20 | 5.3271 Percent change | Standard Deviation 85.7472 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD19+/27Br/38Br SLE subset: Day 28, n=20 | -4.4623 Percent change | Standard Deviation 91.3321 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD19+/27Br/38Br SLE subset: Day 42, n=19 | 17.2492 Percent change | Standard Deviation 132.2146 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD19+/27Br/38Br SLE subset: Day 56, n=20 | 48.1481 Percent change | Standard Deviation 148.1877 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD19+/27Br/38Br SLE subset: Day 84, n=20 | 24.9838 Percent change | Standard Deviation 118.1567 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/138+plasmacytoid: Day 14, n=19 | 200.6464 Percent change | Standard Deviation 702.0072 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/138+plasmacytoid: Day 28, n=19 | 255.8559 Percent change | Standard Deviation 1010.9303 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/138+plasmacytoid: Day 42, n=18 | 2.7891 Percent change | Standard Deviation 145.0411 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/138+plasmacytoid: Day 56, n=19 | 20.1061 Percent change | Standard Deviation 220.7714 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/138+plasmacytoid: Day 84, n=19 | -44.0743 Percent change | Standard Deviation 65.0501 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/69+activated: Day 14, n=19 | -0.9711 Percent change | Standard Deviation 196.9956 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/69+activated: Day 28, n=19 | 106.5032 Percent change | Standard Deviation 379.958 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/69+activated: Day 42, n=18 | 9.8018 Percent change | Standard Deviation 138.7995 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/69+activated: Day 56, n=19 | 15.6984 Percent change | Standard Deviation 132.7055 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20+/69+activated: Day 84, n=19 | -18.3523 Percent change | Standard Deviation 120.1047 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20-/CD138+plasma cells: Day 14, n=20 | 24.3489 Percent change | Standard Deviation 151.0876 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20-/CD138+plasma cells: Day 28, n=20 | 21.4906 Percent change | Standard Deviation 180.2169 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20-/CD138+plasma cells: Day 42, n=19 | -6.6055 Percent change | Standard Deviation 129.1377 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20-/CD138+plasma cells: Day 56, n=20 | 3.0692 Percent change | Standard Deviation 175.5913 |
| Belimumab 10 mg/kg | Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment | Norm CD20-/CD138+plasma cells: Day 84, n=20 | -51.0462 Percent change | Standard Deviation 38.0848 |