Systemic Lupus Erythematosus
Conditions
Keywords
Belimumab, Pediatric, Pharmacokinetics, Systemic Lupus Erythematosus
Brief summary
This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study (NCT04908865)
Interventions
BIOLOGICALBelimumab
Belimumab will be administered
DRUGStandard of care
Standard of care will be administered
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants between 5 and 17 years of age inclusive, at the time of informed consent * Chinese pediatric participants with SLE, who have completed 48 weeks treatment in study 213560 and who, in the opinion of the investigator, may benefit from treatment with GSK1550188. * Body weight greater than equal to \>=15 kilograms (kg), at the time of signing the informed consent. * Male and/or female: 1. No contraceptive measures are required for male participants. 2. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: i) Is a woman of non-childbearing potential OR ii) Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of \<1% * Participant signs and dates a written age-appropriate assent form (in accordance with applicable regulations) and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent (including consent for the use and disclosure of research-related health information) that the participant will comply with the study protocol procedures (including required study visits).
Exclusion criteria
* Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an Adverse events (AE) in 213560 study that could, in the opinion of the principal investigator, put the participant at undue risk. * Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions that, in the opinion of the principal investigator, makes the participant unsuitable for the study. * Have an estimated glomerular filtration rate as calculated by Schwartz Formula of less than 30 milliliter per minute (mL/min). * Have an Immunoglobulin A (IgA) deficiency (IgA level \<10 milli gram per deciliter \[mg/dL\]). * Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed: 1. Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition. 2. Any grade proteinuria 3. Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the alanine transaminase (ALT) and/or aspartate aminotransferase (AST) must be \<= Grade 2. 4. Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE. * Developing a positive test for Human immunodeficiency virus (HIV) antibody after inclusion into 213560, per investigator's discretion according to clinical need. * Developing hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) OR Hepatitis B core antibody positive (HBcAb+) after inclusion into 213560, per investigator's discretion according to clinical need. * Developing a positive test for Hepatitis C antibody after inclusion into 213560, per investigator's discretion according to clinical need. * Have received a live or live-attenuated vaccine within 30 Days of Day 1. * Are unable or unlikely, in the opinion of the investigator, to administer belimumab by SC injection and have no reliable source to administer the injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Greater Than or Equal to (>=) 50 Kilograms (kg) | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of belimumab. AUCss,0-tau of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 30 kg and Less Than (<) 50 kg | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 | Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 30 kg and \< 50 kg has been reported. |
| Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 | Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 30 kg and \< 50 kg has been reported. |
| Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 30 kg and \< 50 kg has been reported. |
| Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg | Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. |
| Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81 | Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 30 kg and \< 50 kg has been reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 | Up to Week 12 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per medical and scientific judgement of the Investigator. AESIs defined in the protocol included post-injection systemic reactions and hypersensitivity reactions, infections of special interest, malignancies, and depression, suicidality, or self-injury. Number of participants with AEs, SAEs, and AESIs has been reported. |
Countries
China
Participant flow
Recruitment details
A total of 16 participants were enrolled in this study.
Pre-assignment details
Participants who had completed 48 weeks of intravenous (IV) belimumab treatment in study 213560 (NCT04908865) were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Belimumab 200 mg/mL Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 mg/mL as an SC injection over 12 weeks along with SOC therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing \>= 50 kg received belimumab every week, participants weighing between 30 kg and \< 50 kg received belimumab every 10 days, and participants weighing between 15 kg and \< 30 kg received belimumab every 2 weeks. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Belimumab 200 mg/mL |
|---|---|
| Age, Continuous | 12.9 YEARS STANDARD_DEVIATION 2.55 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 16 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 13 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 15 kg and < 30 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Belimumab 200 mg/mL Every Week | Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | 1365.23 Days*micrograms per milliliter |
Primary
Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 30 kg and Less Than (<) 50 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 30 kg and \< 50 kg has been reported.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 30 kg and Less Than (<) 50 kg | 807.57 Days*micrograms per milliliter | Geometric Coefficient of Variation 17.44 |
Primary
Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Greater Than or Equal to (>=) 50 Kilograms (kg)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of belimumab. AUCss,0-tau of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Greater Than or Equal to (>=) 50 Kilograms (kg) | 633.26 Days*micrograms per milliliter | Geometric Coefficient of Variation 27.5 |
Primary
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg | 90.47 Micrograms per milliliter | Geometric Coefficient of Variation 27.5 |
Primary
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Belimumab 200 mg/mL Every Week | Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | 97.52 Micrograms per milliliter |
Primary
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 30 kg and \< 50 kg has been reported.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | 80.76 Micrograms per milliliter | Geometric Coefficient of Variation 17.44 |
Primary
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg | 93.36 Micrograms per milliliter | Geometric Coefficient of Variation 25.8 |
Primary
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Belimumab 200 mg/mL Every Week | Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | 109.59 Micrograms per milliliter |
Primary
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 30 kg and \< 50 kg has been reported.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | 87.15 Micrograms per milliliter | Geometric Coefficient of Variation 15.91 |
Primary
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing \>= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg | 82.63 Micrograms per milliliter | Geometric Coefficient of Variation 28.69 |
Primary
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 15 kg and \< 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85.
Time frame: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Belimumab 200 mg/mL Every Week | Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg | 80.95 Micrograms per milliliter |
Primary
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 30 kg and \< 50 kg has been reported.
Time frame: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
Population: PK Analysis Set included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg | 70.71 Micrograms per milliliter | Geometric Coefficient of Variation 20.14 |
Secondary
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per medical and scientific judgement of the Investigator. AESIs defined in the protocol included post-injection systemic reactions and hypersensitivity reactions, infections of special interest, malignancies, and depression, suicidality, or self-injury. Number of participants with AEs, SAEs, and AESIs has been reported.
Time frame: Up to Week 12
Population: Intent-to-Treat (ITT) Analysis Set included all participants assigned treatment who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belimumab 200 mg/mL Every Week | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 | AEs | 13 Participants |
| Belimumab 200 mg/mL Every Week | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 | SAEs | 0 Participants |
| Belimumab 200 mg/mL Every Week | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 | AESIs | 0 Participants |