Healthy
Conditions
Keywords
Belimumab, Injections, Subcutaneous, Drug Administration Routes, Injections, Lupus Erythematosus, Systemic, Lupus, SLE, Systemic Lupus Erythematosus, Antibodies, Autoimmune Disease, Biological Therapy, Immune System Diseases, Pharmacokinetics, Biological Availability
Brief summary
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in healthy subjects.
Detailed description
This study is designed to evaluate the absolute bioavailability, pharmacokinetics, tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of belimumab administered subcutaneously (SC) to healthy subjects.
Interventions
BIOLOGICALSingle Dose Group: Belimumab IV 240 mg
Belimumab IV 240 mg administered on Day 0
BIOLOGICALSingle Dose Group: Belimumab SC 2 x 120 mg
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
BIOLOGICALSingle Dose Group: Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
BIOLOGICALSingle Dose Group: Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
BIOLOGICALMultiple Dose Group: Belimumab SC 2 x 120 mg weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
BIOLOGICALMultiple Dose Group: Belimumab SC 1 x 200 mg weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
Sponsors
GlaxoSmithKline
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy subjects defined as no clinically relevant abnormalities identified by a detailed medical history, full physical exam, 12-lead electrocardiogram (ECG), and clinical laboratory tests. * Body weight between 45 to 120 kg (99 to 264 lbs). * Must agree to use effective contraception throughout the study and for 14 weeks after administration of belimumab. * Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures. Key
Exclusion criteria
* Pregnant or nursing. * Test positive for drugs or alcohol or have had a drug or alcohol dependence within the past year. * Have used any prescription medicines within the past 30 days or herbal/botanical supplements within the past 7 days or anticipate use during the study. May use prescription contraceptives, hormone replacement therapy, and over-the-counter medicines such as antihistamines or nutritional support such as vitamins, minerals, or amino acids. * Have received a live vaccine within the past 30 days or anticipate receipt of a live vaccine during the study and within 4 months after last injection of belimumab. * Have a history of an allergic or anaphylactic reaction to drugs, food, or insect bite or sting requiring medical intervention. * Have a history of allergic reaction to contrast agents or biological medicines. * Have participated in a clinical trial and received an experimental medicine within the past 60 days. * Have received treatment with a B cell targeted therapy at any time. * Have required management of an infection within the past 14 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 | — |
| Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 | — |
| Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 | AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile. |
| Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 | Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half. |
| Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 | Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 | — |
| Number of Participants Who Experienced Adverse Events | Up to Day 119 | Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups). |
| Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 | — |
| Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 | AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile. |
| Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 | Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half. |
| Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 | Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Belimumab IV 240 mg Belimumab IV 240 mg administered on Day 0 | 19 |
| Belimumab SC 2 x 120 mg Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0 | 20 |
| Belimumab SC 1 x 240 mg Belimumab SC 240 mg x 1 injection on Day 0 | 20 |
| Belimumab SC 1 x 200 mg Belimumab SC 200 mg x 1 injection on Day 0 | 19 |
| Belimumab SC 2 x 120 mg Weekly Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21 | 20 |
| Belimumab SC 1 x 200 mg Weekly Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21 | 20 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lack of compliance | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Belimumab IV 240 mg | Belimumab SC 2 x 120 mg | Belimumab SC 1 x 240 mg | Belimumab SC 1 x 200 mg | Belimumab SC 2 x 120 mg Weekly | Belimumab SC 1 x 200 mg Weekly | Total |
|---|---|---|---|---|---|---|---|
| Age Continuous | 37.3 years STANDARD_DEVIATION 12.1 | 33.4 years STANDARD_DEVIATION 11.4 | 35.2 years STANDARD_DEVIATION 12.1 | 36.1 years STANDARD_DEVIATION 9.4 | 33.7 years STANDARD_DEVIATION 9.5 | 37.4 years STANDARD_DEVIATION 9.7 | 35.5 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 19 participants | 20 participants | 20 participants | 19 participants | 20 participants | 20 participants | 118 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 11 Participants | 8 Participants | 11 Participants | 10 Participants | 65 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 9 Participants | 11 Participants | 9 Participants | 10 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 19 | 11 / 20 | 16 / 20 | 14 / 19 | 17 / 20 | 19 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 | 0 / 20 | 0 / 19 | 1 / 20 | 1 / 20 |
Outcome results
Primary
Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Belimumab IV 240 mg | Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC | NA percentage bioavailability |
| Belimumab SC 2 x 120 mg | Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC | 76.1 percentage bioavailability |
| Belimumab SC 1 x 240 mg | Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC | 81.8 percentage bioavailability |
| Belimumab SC 1 x 200 mg | Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC | 73.5 percentage bioavailability |
Primary
Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC
AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab IV 240 mg | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC | 1030 µg∙day/mL | Geometric Coefficient of Variation 32.1 |
| Belimumab SC 2 x 120 mg | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC | 788 µg∙day/mL | Geometric Coefficient of Variation 36.1 |
| Belimumab SC 1 x 240 mg | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC | 812 µg∙day/mL | Geometric Coefficient of Variation 36.2 |
| Belimumab SC 1 x 200 mg | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC | 612 µg∙day/mL | Geometric Coefficient of Variation 37.9 |
Primary
Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab IV 240 mg | Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC | 86.2 µg/mL | Geometric Coefficient of Variation 20 |
| Belimumab SC 2 x 120 mg | Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC | 32.7 µg/mL | Geometric Coefficient of Variation 29 |
| Belimumab SC 1 x 240 mg | Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC | 31.6 µg/mL | Geometric Coefficient of Variation 27.9 |
| Belimumab SC 1 x 200 mg | Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC | 24.3 µg/mL | Geometric Coefficient of Variation 40.3 |
Primary
Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab IV 240 mg | Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC | 18.2 days | Standard Deviation 6.3 |
| Belimumab SC 2 x 120 mg | Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC | 15.9 days | Standard Deviation 5.3 |
| Belimumab SC 1 x 240 mg | Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC | 18.2 days | Standard Deviation 6 |
| Belimumab SC 1 x 200 mg | Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC | 16.0 days | Standard Deviation 5.1 |
Primary
Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belimumab IV 240 mg | Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) | 0.09 days |
| Belimumab SC 2 x 120 mg | Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) | 3.9 days |
| Belimumab SC 1 x 240 mg | Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) | 4.9 days |
| Belimumab SC 1 x 200 mg | Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) | 5.9 days |
Secondary
Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Belimumab IV 240 mg | Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab | 74.7 percentage bioavailability |
| Belimumab SC 2 x 120 mg | Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab | 77.9 percentage bioavailability |
Secondary
Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab
AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab IV 240 mg | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab | 763 µg∙day/mL | Geometric Coefficient of Variation 29.8 |
| Belimumab SC 2 x 120 mg | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab | 661 µg∙day/mL | Geometric Coefficient of Variation 31.2 |
Secondary
Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab IV 240 mg | Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab | 21.6 µg/mL | Geometric Coefficient of Variation 23.2 |
| Belimumab SC 2 x 120 mg | Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab | 19.5 µg/mL | Geometric Coefficient of Variation 25.1 |
Secondary
Number of Participants Who Experienced Adverse Events
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
Time frame: Up to Day 119
Population: Analyses were performed on the as-treated population, defined as the set of all participants who received at least 1 partial or full dose of treatment with the assignment to treatment group that was based on the actual treatment administered to the participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab IV 240 mg | Number of Participants Who Experienced Adverse Events | At least 1 serious AE | 0 participants |
| Belimumab IV 240 mg | Number of Participants Who Experienced Adverse Events | At least 1 AE | 14 participants |
| Belimumab IV 240 mg | Number of Participants Who Experienced Adverse Events | An AE resulting in death | 0 participants |
| Belimumab SC 2 x 120 mg | Number of Participants Who Experienced Adverse Events | An AE resulting in death | 0 participants |
| Belimumab SC 2 x 120 mg | Number of Participants Who Experienced Adverse Events | At least 1 serious AE | 0 participants |
| Belimumab SC 2 x 120 mg | Number of Participants Who Experienced Adverse Events | At least 1 AE | 11 participants |
| Belimumab SC 1 x 240 mg | Number of Participants Who Experienced Adverse Events | At least 1 serious AE | 0 participants |
| Belimumab SC 1 x 240 mg | Number of Participants Who Experienced Adverse Events | At least 1 AE | 16 participants |
| Belimumab SC 1 x 240 mg | Number of Participants Who Experienced Adverse Events | An AE resulting in death | 0 participants |
| Belimumab SC 1 x 200 mg | Number of Participants Who Experienced Adverse Events | An AE resulting in death | 0 participants |
| Belimumab SC 1 x 200 mg | Number of Participants Who Experienced Adverse Events | At least 1 serious AE | 0 participants |
| Belimumab SC 1 x 200 mg | Number of Participants Who Experienced Adverse Events | At least 1 AE | 14 participants |
| Belimumab SC 2 x 120 mg Weekly | Number of Participants Who Experienced Adverse Events | At least 1 AE | 18 participants |
| Belimumab SC 2 x 120 mg Weekly | Number of Participants Who Experienced Adverse Events | An AE resulting in death | 0 participants |
| Belimumab SC 2 x 120 mg Weekly | Number of Participants Who Experienced Adverse Events | At least 1 serious AE | 1 participants |
| Belimumab SC 1 x 200 mg Weekly | Number of Participants Who Experienced Adverse Events | An AE resulting in death | 0 participants |
| Belimumab SC 1 x 200 mg Weekly | Number of Participants Who Experienced Adverse Events | At least 1 serious AE | 1 participants |
| Belimumab SC 1 x 200 mg Weekly | Number of Participants Who Experienced Adverse Events | At least 1 AE | 19 participants |
Secondary
Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab IV 240 mg | Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab | 20.3 days | Standard Deviation 5.2 |
| Belimumab SC 2 x 120 mg | Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab | 19.8 days | Standard Deviation 4.9 |
Secondary
Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab
Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119
Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belimumab IV 240 mg | Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab | 5.8 days | Standard Deviation 1.5 |
| Belimumab SC 2 x 120 mg | Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab | 5.5 days | Standard Deviation 1.2 |