Lupus Nephritis
Conditions
Keywords
Antibodies, Systemic Lupus Erythematosus, Autoimmune Disease, Glomerulonephritis, Belimumab, Lupus, Nephritis, Kidney Diseases, SLE
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Detailed description
Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is 1 to 1 which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.
Interventions
BIOLOGICALPlacebo plus standard therapy
Placebo plus standard therapy
BIOLOGICALBelimumab 10 mg/kg plus standard therapy
Belimumab 10 mg/kg plus standard therapy
DRUGStandard therapy
The standard therapies allowed in this study are: \- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy OR \- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy
Sponsors
GlaxoSmithKline
Human Genome Sciences Inc., a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria. * Biopsy confirmed active lupus nephritis. * Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications. * Autoantibody-positive. Key
Exclusion criteria
* Pregnant or nursing. * On dialysis within the past year. * Treatment with belimumab within the past year . * Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study. * Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year. * Severe active central nervous system (CNS) lupus. * Required management of acute or chronic infections within the past 60 days. * Current drug or alcohol abuse or dependence. * Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * History of severe allergic reaction to contrast agents or biological medicines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 | Week 104 | PERR is defined as urinary protein creatinine ratio \<=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or \>=60 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented. |
| Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) | From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose) | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported. |
| Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose) | An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 | Week 104 | ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was \<0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is \>=50% decrease from Baseline in uPCR and one of the following: value \<1 if Baseline \<=3, or value \<3 if the Baseline was \>3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented. |
| Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104 | Week 104 | CRR is defined as urinary protein creatinine ratio \<0.5, eGRF was not more than 10% below the pre-flare value or \>=90 mL/min/1.73m\^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented. |
| Double-blind Period: Number of Participants Reporting AESI | Up to Week 104 | An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed. |
| Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs | Up to Week 104 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported. |
| Double-blind Period: Percentage of Participants With PERR at Week 52 | Week 52 | PERR is defined as urinary protein creatinine ratio \<=0.7, eGRF was not more than 20% below the pre-flare value or \>=60 mL/min/1.73m\^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented. |
| Double-blind Period: Number of Participants With Time to Death or Renal Related Event | Up to Week 104 | Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented. |
Countries
Argentina, Belgium, Brazil, Canada, China, Colombia, Czechia, France, Germany, Hong Kong, Hungary, Mexico, Netherlands, Philippines, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Participant flow
Recruitment details
This study evaluated safety and efficacy of intravenous (IV) belimumab 10 mg/kg plus standard of care (SoC) compared to placebo plus SoC in adult participants with active lupus nephritis. This was a Phase 3, multi-center, multi-national study consisting of a randomized, double-blind, placebo-controlled period and an open-label extension period. The study was conducted in 21 countries.
Pre-assignment details
A total of 797 participants were screened of which 349 participants failed screening and 448 participants were randomized in double-blind period. In open-label period, a total of 257 participants were enrolled of which 2 participants did not receive open-label study treatment and 255 participants received open-label belimumab.
Participants by arm
| Arm | Count |
|---|---|
| Placebo to Belimumab 10 mg/kg Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids \[HDCS\] plus Cyclophosphamide \[CYC\] versus \[vs.\] HDCS plus Mycophenolate Mofetil \[MMF\]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. | 224 |
| Belimumab 10 mg/kg to Belimumab 10 Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period. | 224 |
| Total | 448 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Period (Up to Week 104) | Adverse Event | 10 | 7 |
| Double-blind Period (Up to Week 104) | Lack of Efficacy | 2 | 1 |
| Double-blind Period (Up to Week 104) | Lost to Follow-up | 5 | 4 |
| Double-blind Period (Up to Week 104) | Physician Decision | 11 | 5 |
| Double-blind Period (Up to Week 104) | Protocol Violation | 0 | 2 |
| Double-blind Period (Up to Week 104) | Withdrawal by Subject | 26 | 19 |
| Open-label Period (Up to Week 28) | Adverse Event | 1 | 4 |
| Open-label Period (Up to Week 28) | Lost to Follow-up | 0 | 1 |
| Open-label Period (Up to Week 28) | Protocol Violation | 0 | 1 |
| Open-label Period (Up to Week 28) | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Belimumab 10 mg/kg to Belimumab 10 | Placebo to Belimumab 10 mg/kg |
|---|---|---|---|
| Age, Continuous | 33.4 Years STANDARD_DEVIATION 10.68 | 33.7 Years STANDARD_DEVIATION 10.73 | 33.0 Years STANDARD_DEVIATION 10.64 |
| Race/Ethnicity, Customized American Indian (AI) or Alaska Native (AN) | 10 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage (H) | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian-Japanese/East Asian/Southeast Asian H | 219 Participants | 112 Participants | 107 Participants |
| Race/Ethnicity, Customized Black or African American (AA) | 61 Participants | 30 Participants | 31 Participants |
| Race/Ethnicity, Customized Mixed Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple-AA/African H and AI or AN and White | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple-Asian and White | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian/Arabic/North African H | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White/Caucasian/European H | 143 Participants | 72 Participants | 71 Participants |
| Sex: Female, Male Female | 394 Participants | 198 Participants | 196 Participants |
| Sex: Female, Male Male | 54 Participants | 26 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 224 | 6 / 224 | 1 / 123 | 0 / 132 |
| other Total, other adverse events | 191 / 224 | 186 / 224 | 34 / 123 | 39 / 132 |
| serious Total, serious adverse events | 78 / 224 | 65 / 224 | 5 / 123 | 10 / 132 |
Outcome results
Primary
Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104
PERR is defined as urinary protein creatinine ratio \<=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or \>=60 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.
Time frame: Week 104
Population: mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 | 32.3 Percentage of participants |
| Belimumab 10 mg/kg | Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 | 43.0 Percentage of participants |
p-value: 0.031195% CI: [1.04, 2.32]Regression, Logistic
Primary
Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
Time frame: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Population: Safety Open-Label Population comprised of all participants who received at least one dose of open-label treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 76 Participants |
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 5 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 92 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 10 Participants |
Primary
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.
Time frame: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Population: Safety Open-Label Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Malignancies including NMSC | 0 Participants |
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | All infections of special interest | 2 Participants |
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Malignancies excluding NMSC | 0 Participants |
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Depression/suicide/self-injury | 2 Participants |
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | PISR | 4 Participants |
| Placebo | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Deaths | 1 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | PISR | 5 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Deaths | 0 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Malignancies including NMSC | 0 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Malignancies excluding NMSC | 0 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | All infections of special interest | 6 Participants |
| Belimumab 10 mg/kg | Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI) | Depression/suicide/self-injury | 4 Participants |
Secondary
Double-blind Period: Number of Participants Reporting AESI
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed.
Time frame: Up to Week 104
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Double-blind Period: Number of Participants Reporting AESI | Deaths | 3 Participants |
| Placebo | Double-blind Period: Number of Participants Reporting AESI | Malignancies excluding NMSC | 0 Participants |
| Placebo | Double-blind Period: Number of Participants Reporting AESI | Malignancies including NMSC | 0 Participants |
| Placebo | Double-blind Period: Number of Participants Reporting AESI | PISR | 29 Participants |
| Placebo | Double-blind Period: Number of Participants Reporting AESI | All infections of special interest | 34 Participants |
| Placebo | Double-blind Period: Number of Participants Reporting AESI | Depression/suicide/self-injury | 16 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting AESI | All infections of special interest | 30 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting AESI | Deaths | 4 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting AESI | PISR | 26 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting AESI | Malignancies excluding NMSC | 2 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting AESI | Depression/suicide/self-injury | 11 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting AESI | Malignancies including NMSC | 3 Participants |
Secondary
Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported.
Time frame: Up to Week 104
Population: Safety Population comprised of all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs | Any AE | 211 Participants |
| Placebo | Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs | Any SAE | 67 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs | Any AE | 214 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs | Any SAE | 58 Participants |
Secondary
Double-blind Period: Number of Participants With Time to Death or Renal Related Event
Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.
Time frame: Up to Week 104
Population: mITT Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Double-blind Period: Number of Participants With Time to Death or Renal Related Event | 63 Participants |
| Belimumab 10 mg/kg | Double-blind Period: Number of Participants With Time to Death or Renal Related Event | 35 Participants |
p-value: 0.001495% CI: [0.34, 0.77]Cox proportional hazards model
Secondary
Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104
CRR is defined as urinary protein creatinine ratio \<0.5, eGRF was not more than 10% below the pre-flare value or \>=90 mL/min/1.73m\^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.
Time frame: Week 104
Population: mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104 | 19.7 Percentage of participants |
| Belimumab 10 mg/kg | Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104 | 30.0 Percentage of participants |
p-value: 0.016795% CI: [1.11, 2.74]Regression, Logistic
Secondary
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104
ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was \<0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is \>=50% decrease from Baseline in uPCR and one of the following: value \<1 if Baseline \<=3, or value \<3 if the Baseline was \>3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.
Time frame: Week 104
Population: mITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 | PRR | 17.0 Percentage of participants |
| Placebo | Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 | CRR | 19.7 Percentage of participants |
| Placebo | Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 | Non responder | 63.2 Percentage of participants |
| Belimumab 10 mg/kg | Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 | Non responder | 52.5 Percentage of participants |
| Belimumab 10 mg/kg | Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 | CRR | 30.0 Percentage of participants |
| Belimumab 10 mg/kg | Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104 | PRR | 17.5 Percentage of participants |
p-value: 0.0096Rank ANCOVA
Secondary
Double-blind Period: Percentage of Participants With PERR at Week 52
PERR is defined as urinary protein creatinine ratio \<=0.7, eGRF was not more than 20% below the pre-flare value or \>=60 mL/min/1.73m\^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.
Time frame: Week 52
Population: mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Double-blind Period: Percentage of Participants With PERR at Week 52 | 35.4 Percentage of participants |
| Belimumab 10 mg/kg | Double-blind Period: Percentage of Participants With PERR at Week 52 | 46.6 Percentage of participants |
p-value: 0.024595% CI: [1.06, 2.38]Regression, Logistic