Trial Outcomes & Findings for GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia (NCT NCT01345253)

Last Updated: 2019-10-04

Results Overview

SRI response is a composite index, defined as the percent of participants with \>=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of \< 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

709 participants

Primary outcome timeframe

Week 52

Results posted on

2019-10-04

Participant Flow

This study consisted of a 52 week blinded treatment period in Northeast Asia (China, Japan, Korea) which was followed by an optional open-label (OL) extension period in China for evaluation of belimumab in participants (par.) with active systemic lupus erythematosus (SLE).

A total of 707 par. were randomized, 705 received at least 1 dose of investigational product (Safety Population), 677 par. were included in the primary efficacy population (MITT Population) of which 663 were evaluable for the primary endpoint. The participant flow and baseline characteristics are presented for MITT Population (Pop).

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Double-blind (DB) Phase (52 Weeks) STARTED	226	451
Double-blind (DB) Phase (52 Weeks) COMPLETED	170	372
Double-blind (DB) Phase (52 Weeks) NOT COMPLETED	56	79
Open-label Phase (Up to Year 5 Week 44) STARTED	134	290
Open-label Phase (Up to Year 5 Week 44) COMPLETED	69	146
Open-label Phase (Up to Year 5 Week 44) NOT COMPLETED	65	144

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Double-blind (DB) Phase (52 Weeks) Adverse Event	22	27
Double-blind (DB) Phase (52 Weeks) Lack of Efficacy	11	7
Double-blind (DB) Phase (52 Weeks) Protocol Violation	1	5
Double-blind (DB) Phase (52 Weeks) Met Protocol Defined Stopping Criteria	6	1
Double-blind (DB) Phase (52 Weeks) Lost to Follow-up	3	8
Double-blind (DB) Phase (52 Weeks) Physician Decision	4	12
Double-blind (DB) Phase (52 Weeks) Withdrawal by Subject	9	19
Open-label Phase (Up to Year 5 Week 44) Adverse Event	7	18
Open-label Phase (Up to Year 5 Week 44) Death	0	1
Open-label Phase (Up to Year 5 Week 44) Lack of Efficacy	3	7
Open-label Phase (Up to Year 5 Week 44) Protocol Violation	2	5
Open-label Phase (Up to Year 5 Week 44) Lost to Follow-up	4	6
Open-label Phase (Up to Year 5 Week 44) Physician Decision	11	24
Open-label Phase (Up to Year 5 Week 44) Withdrawal by Subject	37	82
Open-label Phase (Up to Year 5 Week 44) Not Recorded	1	1

Baseline Characteristics

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=226 Participants Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg n=451 Participants Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.	Total n=677 Participants Total of all reporting groups
Age, Continuous	31.7 Years STANDARD_DEVIATION 9.18 • n=99 Participants	32.3 Years STANDARD_DEVIATION 9.65 • n=107 Participants	32.1 Years STANDARD_DEVIATION 9.50 • n=206 Participants
Sex: Female, Male Female	210 Participants n=99 Participants	419 Participants n=107 Participants	629 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	32 Participants n=107 Participants	48 Participants n=206 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	195 Participants n=99 Participants	403 Participants n=107 Participants	598 Participants n=206 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	24 Participants n=99 Participants	40 Participants n=107 Participants	64 Participants n=206 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Race/Ethnicity, Customized Asian - Mixed Race	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.

Outcome measures

Outcome measures
Measure	Placebo n=217 Participants Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg n=446 Participants Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.	40.1 Percentage of participants	53.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: MITT Population. Only those participants available at the specified time points were analyzed.

The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.

Outcome measures

Outcome measures
Measure	Placebo n=218 Participants Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg n=447 Participants Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.	42.2 Percentage of participants	55.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: MITT Population. Only those participants available at the specified time point were analyzed.

SRI7 response is defined as the percent of participants with \>=7 point reduction from Baseline in SELENA SLEDAI score and 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 at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg n=367 Participants Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.	23.5 Percentage of participants	32.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: MITT Population

Number of days of daily prednisone dose \<=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone \>7.5 mg/day at Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=184 Participants Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg n=352 Participants Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.	0.0 Days Interval 0.0 to 172.0	0.0 Days Interval 0.0 to 213.5

SECONDARY outcome

Timeframe: 52 weeks

Population: MITT Population

Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to \>12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).

Outcome measures

Outcome measures
Measure	Placebo n=226 Participants Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg n=451 Participants Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.	NA Days Due to low event rates of participants in both treatment groups having severe SFI flares, the median time and interquartile range could not be estimated.	NA Days Due to low event rates of participants in both treatment groups having severe SFI flares, the median time and interquartile range could not be estimated.

SECONDARY outcome

Timeframe: Weeks 24 and 48 for Years 2, 3, 4, 5 and 6

Population: Efficacy Population: all participants in China who received at least 1 dose of belimumab during open-label phase, exclusive of site 086485. Only those participants available at the specified time points were analyzed (represented by n=x).

SRI response is a composite index, defined as the percent of participants with \>=4 point reduction from Baseline in SELENA SLEDAI score and 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 at time of assessment. Excludes participants with a SELENA SLEDAI score \<4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.

Outcome measures

Outcome measures
Measure	Placebo n=399 Participants Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Belimumab 10 mg/kg Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 24, Year 2, n=326	66.0 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 48, Year 2, n=299	69.6 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 24, Year 3, n=271	72.3 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 48, Year 3, n=247	70.9 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 24, Year 4, n=233	71.7 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 48, Year 4, n=194	76.8 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 24, Year 5, n= 156	81.4 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 48, Year 5, n= 82	80.5 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 24, Year 6, n= 36	86.1 Percentage of participants	—
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase Week 48, Year 6, n= 5	60.0 Percentage of participants	—

Adverse Events

Placebo (Double-blind Phase)

Serious events: 43 serious events

Other events: 108 other events

Deaths: 1 deaths

Belimumab 10 mg/kg (Double-blind Phase)

Serious events: 58 serious events

Other events: 207 other events

Deaths: 0 deaths

Belimumab 10 mg/kg (Open-label Phase)

Serious events: 96 serious events

Other events: 263 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo (Double-blind Phase) n=235 participants at risk Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.	Belimumab 10 mg/kg (Double-blind Phase) n=470 participants at risk Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.	Belimumab 10 mg/kg (Open-label Phase) n=424 participants at risk All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.
Infections and infestations Upper respiratory tract infection	16.6% 39/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	13.8% 65/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	35.1% 149/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Infections and infestations Nasopharyngitis	11.1% 26/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	11.9% 56/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	5.7% 24/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Infections and infestations Viral upper respiratory tract infection	6.4% 15/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	7.0% 33/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	13.9% 59/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Infections and infestations Upper respiratory tract infection bacterial	5.1% 12/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	3.4% 16/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	8.7% 37/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Gastrointestinal disorders Diarrhoea	6.0% 14/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	6.0% 28/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	6.6% 28/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
General disorders Pyrexia	7.2% 17/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	6.0% 28/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	8.5% 36/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 16/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	6.4% 30/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	7.1% 30/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Nervous system disorders Headache	6.8% 16/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	4.9% 23/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	4.7% 20/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Infections and infestations Urinary tract infection	4.7% 11/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	4.5% 21/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	9.7% 41/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Infections and infestations Herpes zoster	4.3% 10/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	4.9% 23/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	8.0% 34/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Infections and infestations Urinary tract infection bacterial	0.85% 2/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	4.3% 20/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	5.4% 23/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.
Metabolism and nutrition disorders Hypokalaemia	3.4% 8/235 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	2.3% 11/470 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.	5.7% 24/424 • Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44. SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.

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