Trial Outcomes & Findings for Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (NCT NCT01632241)

Last Updated: 2021-09-08

Results Overview

SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in Lupus National Assessment(SELENA)SLEDAI\[SS\] score (with modified SLEDAI-2K scoring for proteinuria \[PU\]), no worsening (increase of \<0.30 points from Baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics(BILAG)A organ domain score \[ODS\] or 2 new BILAG B ODS compared with Baseline. Drop-outs and treatment failures were set to non-responders. Analysis performed using a logistic regression model for comparison between belimumab and placebo with covariates treatment group, Baseline SS score (with modified SLEDAI-2K scoring for PU) (\<=9 versus \[vs.\] \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (United States \[US\]/Canada vs. Rest of World). The Modified Intention-To-Treat (mITT) population comprised of safety population excluding participants who had any assessment at 3 sites (202196, 202513 or 107286).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

503 participants

Primary outcome timeframe

Week 52

Results posted on

2021-09-08

Participant Flow

This study evaluated the efficacy and safety of belimumab compared with placebo in adult participants with Systemic Lupus Erythematosus (SLE). This was a multicenter study conducted at United States (88 centers), United Kingdom (6), South Africa (5), France (4), Columbia (6) and Brazil (18).

A total of 503 participants were randomized of which 496 received at-least one dose of study medication during double-blinded phase (7 participants were randomized but not treated as they were randomized in error). A total of 359 out of 373 participants who completed double-blinded phase opted to continue optional open-label (OL) extension phase.

Participant milestones

Participant milestones
Measure	Placebo to Belimumab 10 mg/kg In double-blinded phase, participants received matching placebo to belimumab administered as intravenous (IV) infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 milligram per kilogram (mg/kg) administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.	Belimumab 10 mg/kg to Belimumab 10 mg/kg In double-blinded phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Double-blinded (Up to Week 52) STARTED	165	331
Double-blinded (Up to Week 52) COMPLETED	121	252
Double-blinded (Up to Week 52) NOT COMPLETED	44	79
Open-label (Week 52 to Week 76) STARTED	117	242
Open-label (Week 52 to Week 76) COMPLETED	107	220
Open-label (Week 52 to Week 76) NOT COMPLETED	10	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo to Belimumab 10 mg/kg In double-blinded phase, participants received matching placebo to belimumab administered as intravenous (IV) infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 milligram per kilogram (mg/kg) administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.	Belimumab 10 mg/kg to Belimumab 10 mg/kg In double-blinded phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.
Double-blinded (Up to Week 52) Site Closed	3	5
Double-blinded (Up to Week 52) Protocol Violation	2	6
Double-blinded (Up to Week 52) Lost to Follow-up	1	8
Double-blinded (Up to Week 52) Physician Decision	9	12
Double-blinded (Up to Week 52) Lack of Efficacy	9	15
Double-blinded (Up to Week 52) Withdrawal by Subject	10	14
Double-blinded (Up to Week 52) Adverse Event	10	19
Open-label (Week 52 to Week 76) Withdrawal by Subject	5	2
Open-label (Week 52 to Week 76) Physician Decision	1	4
Open-label (Week 52 to Week 76) Lost to Follow-up	1	4
Open-label (Week 52 to Week 76) Site Closed	2	8
Open-label (Week 52 to Week 76) Protocol Violation	0	2
Open-label (Week 52 to Week 76) Lack of Efficacy	0	2
Open-label (Week 52 to Week 76) Adverse Event	1	0

Baseline Characteristics

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo to Belimumab 10 mg/kg n=165 Participants In double-blinded phase, participants received matching placebo to belimumab administered as intravenous (IV) infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 milligram per kilogram (mg/kg) administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.	Belimumab 10 mg/kg to Belimumab 10 mg/kg n=331 Participants In double-blinded phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. In open-label phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76.	Total n=496 Participants Total of all reporting groups
Age, Continuous	39.5 Years STANDARD_DEVIATION 12.06 • n=5 Participants	38.7 Years STANDARD_DEVIATION 11.00 • n=7 Participants	38.9 Years STANDARD_DEVIATION 11.36 • n=5 Participants
Sex: Female, Male Female	158 Participants n=5 Participants	322 Participants n=7 Participants	480 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	165 Participants n=5 Participants	331 Participants n=7 Participants	496 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: mITT Population. One participant in the mITT population Belimumab 10 mg/kg arm did not have a screening or Baseline PGA assessment; therefore, this participant did not contribute to the SRI/component analysis.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=149 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=298 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase]	41.6 Percentage of participants	48.7 Percentage of participants

PRIMARY outcome

Timeframe: Week 24 of OL phase (Week 76)

Population: mITT OL population comprised of Intent-to-Treat (ITT) OL population (all randomized participants who received at least one dose of OL treatment) excluding participants who had any assessment at 3 sites (202196, 202513 or 107286). Only those participants with data available at the specified data points were analyzed.

SRI response is defined as \>=4 point reduction, from OL Baseline in SS score (with the modified SLEDAI-2K scoring for PU), no worsening (increase of \<0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the OL phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the OL phase, Baseline was defined as Day 1 of the double-blind phase.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=69 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=208 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase	18.8 Percentage of participants	73.6 Percentage of participants

PRIMARY outcome

Timeframe: Week 52 to Week 84

Population: Intent-to-Treat (ITT) OL Population comprised of all randomized participants who received atleast one dose of open label treatment.

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had common nSAEs (\>=5%) and any SAEs are presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=117 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=242 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] nSAEs	23 Participants	49 Participants
Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] SAEs	6 Participants	13 Participants

PRIMARY outcome

Timeframe: Week 52 to Week 84

Population: ITT OL Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=117 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=242 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Severe AEs [OL Phase]	10 Participants	9 Participants

PRIMARY outcome

Timeframe: Week 52 to Week 84

Population: ITT OL Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to treatment discontinuation have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=117 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=242 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase]	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 52 to Week 84

Population: ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the assessment of hematology parameters. The parameters assessed were activated partial thromboplastin time (APTT), hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to Division of Microbiology and Infectious Diseases (DMID \[Modified from DMID Adult Toxicity Tables, 2001\]) AE Severity Grading. Number of participants with worst toxicity Grade 3 or 4 for hematology parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=115 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=235 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] APTT, Grade 3, n=93,203	0 Participants	1 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] APTT, Grade 4, n=93,203	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Hemoglobin, Grade 3, n=115,235	4 Participants	6 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Hemoglobin, Grade 4, n=115,235	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Leukocytes, Grade 3, n=114,235	0 Participants	6 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Leukocytes, Grade 4, n=114,235	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Neutrophils, Grade 3, n=114,234	2 Participants	6 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Neutrophils, Grade 4, n=114,234	0 Participants	1 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Platelets, Grade 3, n=115,235	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Platelets, Grade 4, n=115,235	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Prothrombin time, Grade 3, n=93, 204	3 Participants	2 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Prothrombin time, Grade 4, n=93, 204	1 Participants	3 Participants

PRIMARY outcome

Timeframe: Week 52 to Week 84

Population: ITT OL Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the assessment of liver function and other chemistry parameters. The parameters assessed were alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), bilirubin, albumin, creatinine, hyperglycemia, hypoglycemia and urate. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for liver function and other chemistry parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=115 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=236 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] GGT, Grade 3	0 Participants	1 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] GGT, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Hypoglycemia, Grade 3	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Hyperglycemia, Grade 3	1 Participants	4 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Urate, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] AST, Grade 3	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] AST, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Bilirubin, Grade 3	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] ALP, Grade 3	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] ALP, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] ALT, Grade 3	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] ALT, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Albumin, Grade 3	0 Participants	2 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Albumin, Grade 4	1 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Creatinine, Grade 3	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Hypoglycemia, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Hyperglycemia, Grade 4	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Urate, Grade 3	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 52 to Week 84

Population: ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=115 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=234 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase] Protein, Grade 4, n=115,234	0 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase] Protein/Creatinine, Grade 3,n=112,227	5 Participants	5 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase] Protein/Creatinine, Grade 4, n=112,227	3 Participants	0 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase] Protein, Grade 3, n=115, 234	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 52 to Week 84

Population: ITT OL Population. Only those participants with data available at the specified data points were analyzed.

Serum samples were obtained for the measurement of immunoglobulin G. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 of immunoglobulin G have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=117 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=239 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Worst Toxicity Grade of 3 or 4 of Immunoglobulins [OL Phase] Grade 3	0 Participants	1 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 of Immunoglobulins [OL Phase] Grade 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52

SRI is defined as \>=4 point reduction, from Baseline in SS score, no worsening (increase of \<0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Drop-outs and Treatment failures were set to non-responders. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SS score (\<=9 vs. \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=149 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=298 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Percentage of Participants Achieving SRI-SS Response Rate at Week 52 [DB Phase]	41.6 Percentage of participants	49.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24 of OL phase (Week 76)

Population: mITT OL Population. Only those participants with data available at the specified data points were analyzed.

SRI response is defined as \>=4 point reduction, from OL Baseline in SS scoring for PU, no worsening (increase of \<0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the open-label phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the open-label phase, Baseline was defined as Day 1 of the double-blind phase.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=67 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=208 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Percentage of Participants Achieving SRI-SS Response Rate With the SELENA SLEDAI for Scoring of Proteinuria at Week 24 of OL Phase	19.4 Percentage of participants	73.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 52 Weeks

Population: mITT Population

Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SS SLE flare index that excludes severe flares (SF) that were triggered only by an increase in SS score to \>12 (this may only represent a modest increase in disease activity). Treatment failures were imputed as SF. For participants who died, data were censored at date of death if no SF occurred before death. Only post-Baseline SF were considered. Analysis was performed using Cox proportional hazards model for the comparison between belimumab and placebo adjusting for Baseline SS-S2K score (\<=9 vs. \>=10), baseline complement levels (at least 1 C3/C4 low vs. no C3/C4 low), and region (US/Canada vs. Rest of World). Median and inter-Quartile range (1st and 3rd Quartiles) have been presented.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=149 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=299 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Time to First Severe Flare (as Measured by the Modified SLE Flare Index) up to 52 Weeks [DB Phase]	NA Days Interval 346.0 to NA indicated data was not available because the number of events was too low to estimate the value.	NA Days NA indicated data was not available because the number of events was too low to estimate the value.

SECONDARY outcome

Timeframe: Up to Week 24 of OL Phase (Week 76)

Population: mITT OL Population

Time to first severe SLE flare is defined as the number of days from OL treatment start date until the participant met an event (event date - OL treatment start date +1). Analyses of severe SLE flare was performed on modified SS SLE flare index that excludes SF that were triggered only by an increase in SS score to \>12. For participants who died, data were censored at date of death if no SF occurred before death. Only post first OL treatment SF were considered. Median and inter-Quartile range (25th and 75th percentile) have been presented.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=109 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=225 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Time to First Severe Flare (as Measured by the Modified SLE Flare Index) [OL Phase]	NA Days NA indicated data was not available because the number of events was too low to estimate the value.	232 Days Interval 232.0 to NA indicated data was not available because the number of events was too low to estimate the value.

SECONDARY outcome

Timeframe: Baseline and Week 40 through Week 52

Population: mITT Population. Only participants with Baseline prednisone dose \>7.5 mg/day were included.

Average (avg.) daily prednisone (PRED.) dose was calculated taking into account all steroids taken intravenously, intramuscularly, subcutaneously, intradermally and orally for both Systemic Lupus Erythema (SLE) and non-SLE reasons. A responder was defined as having a PRED. reduction \[REDN.\] by \>=25% from Baseline to \<=7.5 mg/day during Weeks 40 through 52. Drop-outs and Treatment failures were imputed as having no REDN. in PRED. (if Baseline PRED. \>7.5 mg/day). At Baseline, the avg. daily prednisone dose \[PD\] was the sum of all PDs over 7 consecutive days \[excluding Day 0\], divided (DIV.) by 7. For analysis, the avg. PD was the total PD during Weeks 40 through 52 DIV. by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline PD, Baseline SS-S2K score, (\<=9 vs \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World).

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=95 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=184 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Percent of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Week 40 Through 52, in Participants Receiving Greater Than 7.5 mg/Day at Baseline [DB Phase]	12.6 Percentage of participants	14.7 Percentage of participants

SECONDARY outcome

Timeframe: OL Baseline and Week 28 of OL Phase (Week 80)

Population: mITT OL Population. Only those participants with data available at the specified data points were analyzed.

Average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, subcutaneously, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as a participant who decreased their daily prednisone dose to \<=7.5 mg/day from an OL Baseline dose \>7.5 mg/day. The OL Baseline was defined as the last available value prior to the initiation of treatment with belimumab. The average daily prednisone dose was the sum of all PDs over 7 consecutive days including OL Week 28 divided by 7. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=54 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=138 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Percent of Participants Whose Average Prednisone Dose Had Been Reduced to <=7.5 mg/Day in Participants Receiving Greater Than 7.5 mg/Day at Pre-belimumab Baseline (at Week 28 of OL Phase)	14.8 Percentage of participants	31.9 Percentage of participants

SECONDARY outcome

Timeframe: Up to 52 Weeks

Population: Safety Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Safety population was defined as all participants who were randomized and treated with at least one dose of study treatment. Number of participants who had common nSAEs (\>=5%) and any SAEs are presented.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=165 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=331 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With nSAEs and SAEs [DB Phase] nSAE	77 Participants	196 Participants
Number of Participants With nSAEs and SAEs [DB Phase] SAE	31 Participants	36 Participants

SECONDARY outcome

Timeframe: Up to 52 Weeks

Population: Safety Population

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=165 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=331 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Severe AEs [DB Phase]	37 Participants	46 Participants

SECONDARY outcome

Timeframe: Up to 52 Weeks

Population: Safety Population

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=165 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=331 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With AEs Leading to Treatment Discontinuation [DB Phase]	12 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the assessment of hematology parameters up to 52 Weeks. The parameters assessed were APTT, hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for hematology parameters have been presented.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=161 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=327 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] APTT, Grade 3, n=159,318	0 Participants	3 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Hemoglobin, Grade 4, n=161,327	1 Participants	0 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Prothrombin time, Grade 4, n=159,318	2 Participants	6 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] APTT, Grade 4, n=159,318	0 Participants	2 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Hemoglobin, Grade 3, n=161,327	5 Participants	15 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Leukocytes, Grade 3, n=161,327	3 Participants	17 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Leukocytes, Grade 4, n=161,327	1 Participants	0 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Neutrophils, Grade 3, n=161,327	9 Participants	28 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Neutrophils, Grade 4, n=161,327	1 Participants	5 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Platelets, Grade 3, n=161,327	1 Participants	1 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Platelets, Grade 4, n=161,327	0 Participants	1 Participants
Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase] Prothrombin time, Grade 3, n=159, 318	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the assessment of liver function and other chemistry parameters up to 52 Weeks. The parameters assessed were ALT, AST, GGT, albumin, hyperglycemia and hypoglycemia. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Only those participants with worst toxicity Grade of 3 or 4 for other chemistry parameters have been presented.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=161 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=327 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] AST, Grade 3	0 Participants	2 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] GGT, Grade 3	6 Participants	6 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] ALT, Grade 3	0 Participants	2 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] GGT, Grade 4	0 Participants	1 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] Albumin, Grade 3	5 Participants	3 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] Albumin, Grade 4	1 Participants	1 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] Hyperglycemia, Grade 3	4 Participants	7 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] Hyperglycemia, Grade 4	1 Participants	1 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] Hypoglycemia, Grade 3	0 Participants	4 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase] Hypoglycemia, Grade 4	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 52 Weeks. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Only those participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented.

Outcome measures

Outcome measures
Measure	Placebo (DB Phase) n=161 Participants In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=324 Participants In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.
Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [DB Phase] Protein, Grade 3, n=161, 324	0 Participants	1 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [DB Phase] Protein/creatinine, Grade 3,n=161,322	8 Participants	25 Participants
Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [DB Phase] Protein/creatinine, Grade 4, n=161,322	12 Participants	11 Participants

Adverse Events

Placebo (DB Phase)

Serious events: 31 serious events

Other events: 77 other events

Deaths: 0 deaths

Belimumab 10 mg/kg (DB Phase)

Serious events: 36 serious events

Other events: 196 other events

Deaths: 2 deaths

Placebo to Belimumab 10 mg/kg (OL Phase)

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)

Serious events: 13 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo (DB Phase) n=165 participants at risk In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks.	Belimumab 10 mg/kg (DB Phase) n=331 participants at risk In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks.	Placebo to Belimumab 10 mg/kg (OL Phase) n=117 participants at risk In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76	Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) n=242 participants at risk In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76
Infections and infestations Upper respiratory tract infection	8.5% 14/165 • Number of events 20 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	14.5% 48/331 • Number of events 58 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	3.4% 4/117 • Number of events 6 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	8.3% 20/242 • Number of events 21 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Infections and infestations Urinary tract infection	11.5% 19/165 • Number of events 24 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	13.0% 43/331 • Number of events 57 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	6.0% 7/117 • Number of events 7 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	5.4% 13/242 • Number of events 15 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Nervous system disorders Headache	10.9% 18/165 • Number of events 25 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	11.8% 39/331 • Number of events 47 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Infections and infestations Influenza	10.3% 17/165 • Number of events 23 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	8.5% 28/331 • Number of events 35 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	6.0% 7/117 • Number of events 8 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	6.6% 16/242 • Number of events 18 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Gastrointestinal disorders Diarrhoea	5.5% 9/165 • Number of events 12 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	9.4% 31/331 • Number of events 34 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Infections and infestations Sinusitis	5.5% 9/165 • Number of events 9 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	7.9% 26/331 • Number of events 33 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Gastrointestinal disorders Nausea	9.1% 15/165 • Number of events 21 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	5.4% 18/331 • Number of events 29 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Psychiatric disorders Insomnia	6.1% 10/165 • Number of events 10 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	5.4% 18/331 • Number of events 18 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Musculoskeletal and connective tissue disorders Back pain	6.1% 10/165 • Number of events 12 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	4.8% 16/331 • Number of events 17 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	6.0% 7/117 • Number of events 7 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	1.2% 3/242 • Number of events 3 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Gastrointestinal disorders Vomiting	4.2% 7/165 • Number of events 8 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	5.7% 19/331 • Number of events 21 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 7/165 • Number of events 7 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	5.4% 18/331 • Number of events 23 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Psychiatric disorders Depression	5.5% 9/165 • Number of events 9 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	4.5% 15/331 • Number of events 15 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.
Vascular disorders Hypertension	2.4% 4/165 • Number of events 5 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	5.4% 18/331 • Number of events 21 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/117 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.	0.00% 0/242 • nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). nSAEs and SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment for Double Blind phase and ITT OL Population which comprised of all randomized participants who received at least 1 dose of OL treatment for OL phase.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER