Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE (NCT NCT03312907)

NCT ID: NCT03312907

Last Updated: 2025-02-18

Results Overview

Percentage of participants with a state of disease control (Independent blinded assessor \[IBA\]) was defined as the percentage of participants with a Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K)score less than or equal to(\<=)2 achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day at Week 52. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in previous 10 days,consisting 24 individual items in which signs and symptoms, laboratory tests and physician's assessment for each item within each of 9 organ systems were given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at the time of visit or in preceding 10 days. The SLEDAI-2K score was sum of all 24 individual items from the SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms) with higher scores representing increased disease activity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 292 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2025-02-18

Participant Flow

This was a multicenter study conducted at 71 centers in 11 countries. This was a randomized, placebo-controlled, parallel study where participants received treatment in any one of the treatment arms.

A total of 396 participants were screened, of which 104 were screen failures. A total of 292 participants were enrolled in the study (Intent-to-Treat Population: It comprised of all randomized participants who received at least one dose of study treatment [Belimumab or Rituximab or Placebo]).

Participant milestones

Measure	Belimumab + Placebo Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Overall Study STARTED	72	144	76
Overall Study COMPLETED	55	114	57
Overall Study NOT COMPLETED	17	30	19

Reasons for withdrawal

Measure	Belimumab + Placebo Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Overall Study Adverse Event	1	6	1
Overall Study Protocol Violation	2	3	4
Overall Study Lost to Follow-up	2	3	2
Overall Study Physician Decision	3	4	2
Overall Study Withdrawal by Subject	9	14	10

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE

Baseline characteristics by cohort

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=76 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.	Total n=292 Participants Total of all reporting groups
Age, Continuous	40.6 Years STANDARD_DEVIATION 12.58 • n=5 Participants	40.1 Years STANDARD_DEVIATION 11.45 • n=7 Participants	41.0 Years STANDARD_DEVIATION 12.75 • n=5 Participants	40.5 Years STANDARD_DEVIATION 12.04 • n=4 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	129 Participants n=7 Participants	73 Participants n=5 Participants	268 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	24 Participants n=4 Participants
Race/Ethnicity, Customized White -Arabic/North African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	39 Participants n=5 Participants	100 Participants n=7 Participants	47 Participants n=5 Participants	186 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	7 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized African American/African Heritage	21 Participants n=5 Participants	22 Participants n=7 Participants	13 Participants n=5 Participants	56 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Modified Intent-to-Treat (MITT) Population comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or Placebo) and excluding participants from Arm 3 (Belimumab + Standard therapy) who were randomized prior to 07-Sep-2018.

Percentage of participants with a state of disease control (Independent blinded assessor [IBA]) was defined as the percentage of participants with a Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K)score less than or equal to(<=)2 achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of <=5 mg/day at Week 52. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in previous 10 days,consisting 24 individual items in which signs and symptoms, laboratory tests and physician's assessment for each item within each of 9 organ systems were given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at the time of visit or in preceding 10 days. The SLEDAI-2K score was sum of all 24 individual items from the SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Disease Control at Week 52	16.7 Percentage of participants Interval 8.1 to 25.3	19.4 Percentage of participants Interval 13.0 to 25.9	25.5 Percentage of participants Interval 13.1 to 38.0

SECONDARY outcome

Timeframe: Week 64

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of clinical remission (IBA) was defined as percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-double stranded deoxyribonucleic [dsDNA] and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day at Week 64. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days, consisting 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Clinical Remission at Week 64	5.6 Percentage of participants Interval 0.3 to 10.8	6.3 Percentage of participants Interval 2.3 to 10.2	10.6 Percentage of participants Interval 1.8 to 19.5

SECONDARY outcome

Timeframe: Week 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of disease control (IBA) was defined as the percentage of participants with a SLEDAI-2K score <=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of <=5 mg/day at Week 104. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Disease Control at Week 104	6.9 Percentage of participants Interval 1.1 to 12.8	11.1 Percentage of participants Interval 6.0 to 16.2	21.3 Percentage of participants Interval 9.6 to 33.0

SECONDARY outcome

Timeframe: Weeks 12, 26, 40, 52, 64, 80 and 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of disease control (IBA) was defined as the percentage of participants with a SLEDAI-2K score <=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of <=5 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Disease Control by Visits Week 12	8.3 Percentage of participants Interval 1.9 to 14.7	12.5 Percentage of participants Interval 7.1 to 17.9	21.3 Percentage of participants Interval 9.6 to 33.0
Percentage of Participants With a State of Disease Control by Visits Week 26	16.7 Percentage of participants Interval 8.1 to 25.3	21.5 Percentage of participants Interval 14.8 to 28.2	25.5 Percentage of participants Interval 13.1 to 38.0
Percentage of Participants With a State of Disease Control by Visits Week 40	13.9 Percentage of participants Interval 5.9 to 21.9	20.8 Percentage of participants Interval 14.2 to 27.5	23.4 Percentage of participants Interval 11.3 to 35.5
Percentage of Participants With a State of Disease Control by Visits Week 52	16.7 Percentage of participants Interval 8.1 to 25.3	19.4 Percentage of participants Interval 13.0 to 25.9	25.5 Percentage of participants Interval 13.1 to 38.0
Percentage of Participants With a State of Disease Control by Visits Week 64	11.1 Percentage of participants Interval 3.9 to 18.4	18.1 Percentage of participants Interval 11.8 to 24.3	25.5 Percentage of participants Interval 13.1 to 38.0
Percentage of Participants With a State of Disease Control by Visits Week 80	6.9 Percentage of participants Interval 1.1 to 12.8	13.2 Percentage of participants Interval 7.7 to 18.7	27.7 Percentage of participants Interval 14.9 to 40.4
Percentage of Participants With a State of Disease Control by Visits Week 104	6.9 Percentage of participants Interval 1.1 to 12.8	11.1 Percentage of participants Interval 6.0 to 16.2	21.3 Percentage of participants Interval 9.6 to 33.0

SECONDARY outcome

Timeframe: Weeks 64, 80 and 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of clinical remission (IBA) was defined as percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring SLE disease activity in previous 10 days, consisting 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Clinical Remission by Visits Week 64	5.6 Percentage of participants Interval 0.3 to 10.8	6.3 Percentage of participants Interval 2.3 to 10.2	10.6 Percentage of participants Interval 1.8 to 19.5
Percentage of Participants With a State of Clinical Remission by Visits Week 80	4.2 Percentage of participants Interval 0.0 to 8.8	4.2 Percentage of participants Interval 0.9 to 7.4	12.8 Percentage of participants Interval 3.2 to 22.3
Percentage of Participants With a State of Clinical Remission by Visits Week 104	1.4 Percentage of participants Interval 0.0 to 4.1	4.2 Percentage of participants Interval 0.9 to 7.4	6.4 Percentage of participants Interval 0.0 to 13.4

SECONDARY outcome

Timeframe: Week 52 to Week 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of CR (Principal Investigator [PI] assessed) was defined as percentage of participants with a SLEDAI-2K=0 achieved without immunosuppressants and with corticosteroids at prednisone equivalent dose of 0 mg/day,sustained for at least 24 weeks. Sustained CR was longest period a participant maintains CR without break calculated as last consecutive CR date minus first consecutive CR date plus 1. SLEDAI-2K consisted of 24 individual items within each 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at time of visit or in preceding 10 days. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms),higher scores indicates increased disease activity. Percentage of participants with a state of CR sustained for at least 24 weeks at any visit during Week 52 to Week 104 were reported.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Complete Remission (CR) Sustained for at Least 24 Weeks During Week 52 to Week 104	2.8 Percentage of participants Interval 0.0 to 6.6	0 Percentage of participants NA indicates that data was not available as confidence interval could not be calculated as there was no participant with a state of complete remission.	6.4 Percentage of participants Interval 0.0 to 13.4

SECONDARY outcome

Timeframe: From Week 80 to Week 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of CLR (PI assessed) at Week 104 was defined as percentage of participants with a clinical SLEDAI-2K score=0 (does not include anti-dsDNA and complement activity scores) achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day, sustained for at least 24 weeks(from Week 80 to Week 104). Sustained CLR is longest period a participant maintains CLR without a break, calculated as last consecutive CLR date minus first consecutive CLR date plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Clinical Remission (CLR) Sustained for at Least 24 Weeks From Week 80 to Week 104	2.8 Percentage of participants Interval 0.0 to 6.6	2.1 Percentage of participants Interval 0.0 to 4.4	4.3 Percentage of participants Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Weeks 60, 64, 72, 80, 88, 96 and 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of complete remission (PI assessed) was defined as the percentage of participants with a SLEDAI-2K score =0, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in the previous 10 days which consisted of 24 individual items in which signs and symptoms, laboratory tests, and physician's assessment for each item within for each of 9 organ systems were given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of the visit or in the preceding 10 days. The SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Complete Remission by Visits Week 60	5.6 Percentage of participants Interval 0.3 to 10.8	0.7 Percentage of participants Interval 0.0 to 2.1	6.4 Percentage of participants Interval 0.0 to 13.4
Percentage of Participants With a State of Complete Remission by Visits Week 64	5.6 Percentage of participants Interval 0.3 to 10.8	0.7 Percentage of participants Interval 0.0 to 2.1	6.4 Percentage of participants Interval 0.0 to 13.4
Percentage of Participants With a State of Complete Remission by Visits Week 72	4.2 Percentage of participants Interval 0.0 to 8.8	0.7 Percentage of participants Interval 0.0 to 2.1	6.4 Percentage of participants Interval 0.0 to 13.4
Percentage of Participants With a State of Complete Remission by Visits Week 80	2.8 Percentage of participants Interval 0.0 to 6.6	1.4 Percentage of participants Interval 0.0 to 3.3	8.5 Percentage of participants Interval 0.5 to 16.5
Percentage of Participants With a State of Complete Remission by Visits Week 88	2.8 Percentage of participants Interval 0.0 to 6.6	0 Percentage of participants NA indicates that data was not available as confidence interval could not be calculated as there was no participant with a state of complete remission.	4.3 Percentage of participants Interval 0.0 to 10.0
Percentage of Participants With a State of Complete Remission by Visits Week 96	1.4 Percentage of participants Interval 0.0 to 4.1	0.7 Percentage of participants Interval 0.0 to 2.1	6.4 Percentage of participants Interval 0.0 to 13.4
Percentage of Participants With a State of Complete Remission by Visits Week 104	1.4 Percentage of participants Interval 0.0 to 4.1	0.7 Percentage of participants Interval 0.0 to 2.1	4.3 Percentage of participants Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Up to Week 104

Population: Modified Intent-to-Treat (MITT) Population

Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1. Time to first severe flare was measured by Modified SLE flare index which identifies whether a participant had experienced a mild/moderate or severe flare. Analysis of first severe flare was performed on the modified SLE Flare index that excludes severe flares that were triggered only by an increase is SLEDAI-2K score to greater than 12.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Time to First Severe Flare	372.0 Days Interval 202.0 to 485.0	379.0 Days Interval 198.0 to NA indicates that data was not available as only \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	730.0 Days Interval 210.0 to NA indicates that data was not available as only \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Week 104

Population: Modified Intent-to-Treat (MITT) Population

Time to first SLE flare was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1. Time to first flare was measured by modified SLE flare index which identifies whether a participant had experienced a mild/moderate or severe flare.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Time to First Flare	168.0 Days Interval 92.0 to 257.0	170.0 Days Interval 57.0 to 365.0	168.0 Days Interval 91.0 to 337.0

SECONDARY outcome

Timeframe: Up to Week 104

Population: Modified Intent-to-Treat (MITT) Population

Disease control sustained for at least 24 weeks and maintained through Week 104 was defined as SLEDAI-2K score <=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of <=5 mg/day. Time to disease control (PI assessed) was defined as the first visit of sustained disease control until Week 104 on or before Week 80 minus treatment start date (Day 1) plus 1. Sustained disease control was longest period a participant maintained disease control without a break. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K , ranges from 0 (no symptoms) to 105 (presence of all defined symptoms),higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Time to Disease Control Sustained for at Least 24 Weeks and Maintained Through Week 104	NA Days NA indicates that data was not available as only \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.	NA Days NA indicates that data was not available as only \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.	NA Days NA indicates that data was not available as only \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.

SECONDARY outcome

Timeframe: Up to Week 104

Population: Modified Intent-to-Treat (MITT) Population

Clinical remission sustained for at least 24 weeks and maintained through Week 104 was defined as clinical SLEDAI-2K score=0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. Time to CLR (PI assessed) was defined as first visit of sustained CLR until Week 104 on or before Week 80 minus treatment start date (Day 1) plus 1. Sustained CLR was longest period a participant maintained clinical remission without a break. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Time to Clinical Remission Sustained for at Least 24 Weeks and Maintained Through Week 104	NA Days NA indicates that data was not available as only \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.	NA Days NA indicates that data was not available as only \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.	NA Days NA indicates that data was not available as only \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.

SECONDARY outcome

Timeframe: Up to Week 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with at least one assessment where disease control was met were analyzed.

Duration of disease control was defined as SLEDAI-2K score <=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of <=5 mg/day. The duration of disease control (PI assessed) was the longest period between 2 visits that the participant was a disease control responder at all visits and calculated as the first visit of disease control minus last visit of disease control plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105 (presence of all defined symptoms),higher scores representing increased disease activity

Outcome measures

Measure	Belimumab + Placebo n=34 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=77 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=31 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Duration of Disease Control	49.5 Days Interval 1.0 to 172.0	116.0 Days Interval 21.0 to 265.0	116.0 Days Interval 23.0 to 351.0

SECONDARY outcome

Timeframe: Up to Week 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with at least one assessment where clinical remission was met were analyzed.

Clinical remission was defined as clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of 0 mg/day. The duration of clinical remission (PI assessed) was the longest period between 2 visits that the participant was a clinical remission responder at all visits and was calculated as the first visit of clinical remission minus last visit of clinical remission plus 1. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity.

Outcome measures

Measure	Belimumab + Placebo n=13 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=22 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=11 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Duration of Clinical Remission	31.0 Days Interval 1.0 to 253.0	73.0 Days Interval 29.0 to 225.0	176.0 Days Interval 85.0 to 279.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

The SLEDAI-2K consisted of 24 individual items within 9 organ systems. Each item was given a weighted score (1 to 8 with higher score indicating increased activity) and summed if present at the time of visit or in the preceding 10 days. Weighted scores for central nervous system (CNS) (7 items) was 8; for vascular (1 item) was 8; for Musculoskeletal (2 items) was 4; for Renal (4 items) was 4; for Mucocutaneous (3 items) was 2; for Cardiovascular and Respiratory (2 items) was 2; for Immunologic (2 items) was 2;for Constitutional (1 item) was 1 and for Hematologic (2 items) was 1. SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K which ranges from 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 88; n=49, 101, 34	-5.3 Scores on a scale Standard Deviation 4.61	-6.5 Scores on a scale Standard Deviation 4.29	-6.1 Scores on a scale Standard Deviation 3.80
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 96; n=49, 100, 34	-5.6 Scores on a scale Standard Deviation 4.35	-7.0 Scores on a scale Standard Deviation 4.44	-6.1 Scores on a scale Standard Deviation 3.80
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 104; n=50, 104, 34	-5.1 Scores on a scale Standard Deviation 3.69	-7.2 Scores on a scale Standard Deviation 4.22	-6.3 Scores on a scale Standard Deviation 3.76
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 4; n=69, 137, 43	-1.4 Scores on a scale Standard Deviation 2.75	-0.8 Scores on a scale Standard Deviation 3.39	-1.3 Scores on a scale Standard Deviation 3.15
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 8; n=63, 132, 43	-3.2 Scores on a scale Standard Deviation 3.59	-2.9 Scores on a scale Standard Deviation 4.09	-2.9 Scores on a scale Standard Deviation 3.43
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 12; n=63, 131, 43	-2.8 Scores on a scale Standard Deviation 3.50	-3.6 Scores on a scale Standard Deviation 4.32	-2.9 Scores on a scale Standard Deviation 3.68
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 16; n=65, 129, 43	-3.4 Scores on a scale Standard Deviation 4.12	-4.4 Scores on a scale Standard Deviation 4.62	-4.1 Scores on a scale Standard Deviation 3.29
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 20; n=63, 127, 44	-3.8 Scores on a scale Standard Deviation 4.06	-5.0 Scores on a scale Standard Deviation 4.44	-3.8 Scores on a scale Standard Deviation 3.98
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 24; n=61, 128, 43	-4.0 Scores on a scale Standard Deviation 3.71	-5.0 Scores on a scale Standard Deviation 4.45	-5.0 Scores on a scale Standard Deviation 4.00
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 26; n=61, 118, 40	-4.1 Scores on a scale Standard Deviation 3.61	-5.4 Scores on a scale Standard Deviation 4.79	-5.0 Scores on a scale Standard Deviation 3.18
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 28; n=62, 125, 43	-3.7 Scores on a scale Standard Deviation 3.79	-5.1 Scores on a scale Standard Deviation 4.74	-5.2 Scores on a scale Standard Deviation 4.31
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 32; n=61, 125, 43	-4.7 Scores on a scale Standard Deviation 3.87	-5.7 Scores on a scale Standard Deviation 5.03	-5.3 Scores on a scale Standard Deviation 3.90
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 36; n=61, 125, 43	-5.0 Scores on a scale Standard Deviation 4.43	-5.6 Scores on a scale Standard Deviation 5.21	-5.0 Scores on a scale Standard Deviation 3.68
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 40; n=62, 125, 43	-4.6 Scores on a scale Standard Deviation 4.14	-5.8 Scores on a scale Standard Deviation 4.83	-5.0 Scores on a scale Standard Deviation 3.78
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 44; n=62, 122, 43	-4.7 Scores on a scale Standard Deviation 4.71	-6.1 Scores on a scale Standard Deviation 4.47	-5.2 Scores on a scale Standard Deviation 4.06
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 48; n=59, 122, 40	-4.5 Scores on a scale Standard Deviation 4.16	-6.2 Scores on a scale Standard Deviation 4.59	-5.3 Scores on a scale Standard Deviation 4.08
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 52; n=62, 119, 39	-5.3 Scores on a scale Standard Deviation 4.62	-6.1 Scores on a scale Standard Deviation 4.42	-5.6 Scores on a scale Standard Deviation 4.02
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 60; n=57, 114, 37	-5.0 Scores on a scale Standard Deviation 4.15	-5.8 Scores on a scale Standard Deviation 5.17	-6.0 Scores on a scale Standard Deviation 3.94
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 64; n=60, 117, 36	-5.1 Scores on a scale Standard Deviation 4.16	-6.2 Scores on a scale Standard Deviation 4.96	-5.5 Scores on a scale Standard Deviation 4.40
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 72; n=49, 103, 30	-5.2 Scores on a scale Standard Deviation 4.32	-6.6 Scores on a scale Standard Deviation 4.50	-5.3 Scores on a scale Standard Deviation 4.63
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score by Visit (PI Assessed) Week 80; n=46, 102, 36	-5.4 Scores on a scale Standard Deviation 4.58	-6.5 Scores on a scale Standard Deviation 4.79	-6.0 Scores on a scale Standard Deviation 4.08

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles). Only participants with organ system involvement at Baseline were included.

SLEDAI-2K assessments consisted of 24 individual items with 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at the time of analysis. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K ranges from 0(no symptoms) to 105(presence of all defined symptoms). Higher scores indicates increased disease activity. An improvement was defined as a decrease(compared to Baseline) in SLEDAI-2K score within same organ system at a post-Baseline visit. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for following organ systems was reported: CNS total, Vascular total, Musculoskeletal total, Renal total, Mucocutaneous total, Cardiovascular (Cardio) and Respiratory (Resp) total, Immunologic total and Hematologic total. Constitutional organ system was removed from analysis and its one item (fever)moved to hematologic organ system.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 4; n= 2,3,2	0 Percentage of participants	33.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 8; n= 2,3,2	50.0 Percentage of participants	66.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 12; n= 2,3,2	50.0 Percentage of participants	66.7 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 16; n= 2,3,2	50.0 Percentage of participants	66.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 20; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 24; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 26; n= 2,3,2	50.0 Percentage of participants	66.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 28; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 32; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 36; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 40; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 44; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 48; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 52; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 60; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 64; n= 2,3,2	100 Percentage of participants	66.7 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 72; n= 2,3,2	100 Percentage of participants	33.3 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 80; n= 2,3,2	100 Percentage of participants	33.3 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 88; n= 2,3,2	100 Percentage of participants	33.3 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 96; n= 2,3,2	100 Percentage of participants	33.3 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) CNS Total; Week 104; n=2,3,2	100 Percentage of participants	33.3 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 4; n= 6,11,0	50.0 Percentage of participants	9.1 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 8; n= 6,11,0	33.3 Percentage of participants	36.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 12; n= 6,11,0	50.0 Percentage of participants	54.5 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 16; n= 6,11,0	50.0 Percentage of participants	54.5 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 20; n=6,11,0	50.0 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 24; n= 6,11,0	50.0 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 26; n= 6, 11, 0	50.0 Percentage of participants	63.6 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 28; n= 6, 11,0	33.3 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 32; n= 6,11, 0	50.0 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 36; n= 6, 11,0	50.0 Percentage of participants	63.6 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 40; n= 6, 11,0	33.3 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 44; n= 6, 11, 0	33.3 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 48; n= 6, 11, 0	33.3 Percentage of participants	63.6 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 52; n= 6, 11, 0	66.7 Percentage of participants	63.6 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 60; n= 6, 11, 0	50.0 Percentage of participants	63.6 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 64; n= 6, 11, 0	50.0 Percentage of participants	90.9 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 72; n= 6, 11, 0	33.3 Percentage of participants	81.8 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 80; n= 6, 11, 0	50.0 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 88; n= 6, 11, 0	50.0 Percentage of participants	45.5 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 96; n= 6, 11, 0	50.0 Percentage of participants	63.6 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 104; n= 6, 11, 0	33.3 Percentage of participants	72.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 4; n= 57, 110, 34	22.8 Percentage of participants	13.6 Percentage of participants	23.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 8; n=57,110, 34	40.4 Percentage of participants	40.0 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 12; n= 57,110,34	36.8 Percentage of participants	44.5 Percentage of participants	47.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 16; n= 57,110,34	42.1 Percentage of participants	56.4 Percentage of participants	67.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 20; n= 57,110,34	47.4 Percentage of participants	58.2 Percentage of participants	64.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 24; n= 57,110,34	42.1 Percentage of participants	54.5 Percentage of participants	70.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total;; Week 26; n=57,110,34	43.9 Percentage of participants	46.4 Percentage of participants	73.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 28; n= 57,110,34	49.1 Percentage of participants	53.6 Percentage of participants	76.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 32; n= 57,110,34	54.4 Percentage of participants	63.6 Percentage of participants	76.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 36; n= 57,110,34	61.4 Percentage of participants	61.8 Percentage of participants	76.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 40; n= 57,110,34	54.4 Percentage of participants	58.2 Percentage of participants	73.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 44; n= 57,110,34	50.9 Percentage of participants	60.0 Percentage of participants	76.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 48; n= 57,110,34	57.9 Percentage of participants	60.9 Percentage of participants	73.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 52; n= 57,110,34	59.6 Percentage of participants	59.1 Percentage of participants	73.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 60; n= 57,110,34	54.4 Percentage of participants	54.5 Percentage of participants	67.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 64; n= 57,110,34	56.1 Percentage of participants	55.5 Percentage of participants	67.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 72; n= 57,110,34	47.4 Percentage of participants	58.2 Percentage of participants	58.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 80; n= 57,110,34	47.4 Percentage of participants	58.2 Percentage of participants	76.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 88; n= 57,110,34	57.9 Percentage of participants	59.1 Percentage of participants	67.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 96; n= 57,110,34	50.9 Percentage of participants	60.9 Percentage of participants	70.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 104; n= 57,110,34	47.4 Percentage of participants	64.5 Percentage of participants	67.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 4; n= 14,23,8	21.4 Percentage of participants	30.4 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 8; n= 14, 23, 8	50.0 Percentage of participants	43.5 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 12; n= 14, 23, 8	28.6 Percentage of participants	52.2 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 16; n= 14, 23, 8	35.7 Percentage of participants	52.2 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 20; n= 14, 23, 8	57.1 Percentage of participants	60.9 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 24; n= 14, 23, 8	35.7 Percentage of participants	60.9 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 26; n= 14, 23, 8	28.6 Percentage of participants	65.2 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 28; n= 14, 23, 8	21.4 Percentage of participants	56.5 Percentage of participants	37.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 32; n= 14, 23, 8	35.7 Percentage of participants	65.2 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 36; n= 14, 23, 8	42.9 Percentage of participants	65.2 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 40; n=14, 23, 8	42.9 Percentage of participants	69.6 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 44; n= 14, 23, 8	50.0 Percentage of participants	69.6 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 48; n=14, 23, 8	42.9 Percentage of participants	69.6 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 52; n= 14, 23, 8	64.3 Percentage of participants	69.6 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 60; n= 14, 23, 8	50.0 Percentage of participants	65.2 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 64; n= 14, 23, 8	50.0 Percentage of participants	69.6 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 72; n= 14, 23, 8	50.0 Percentage of participants	65.2 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 80; n= 14, 23, 8	42.9 Percentage of participants	65.2 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 88; n= 14, 23, 8	50.0 Percentage of participants	73.9 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 96; n= 14, 23, 8	35.7 Percentage of participants	78.3 Percentage of participants	37.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Renal Total; Week 104; n= 14, 23, 8	35.7 Percentage of participants	69.6 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 4; n= 59, 126,43	30.5 Percentage of participants	28.6 Percentage of participants	32.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 8; n= 59,126,43	54.2 Percentage of participants	45.2 Percentage of participants	51.2 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 12; n= 59, 126, 43	55.9 Percentage of participants	57.1 Percentage of participants	55.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 16; n= 59, 126, 43	57.6 Percentage of participants	58.7 Percentage of participants	67.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 20; n= 59, 126, 43	50.8 Percentage of participants	62.7 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 24; n= 59, 126, 43	59.3 Percentage of participants	61.9 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 26; n=59, 126, 43	59.3 Percentage of participants	60.3 Percentage of participants	65.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 28; n= 59, 126, 43	62.7 Percentage of participants	62.7 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 32; n= 59, 126, 43	62.7 Percentage of participants	65.1 Percentage of participants	74.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 36; n= 59, 126, 43	66.1 Percentage of participants	65.9 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 40; n= 59, 126, 43	62.7 Percentage of participants	66.7 Percentage of participants	67.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 44; n= 59, 126, 43	61.0 Percentage of participants	61.1 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 48; n= 59, 126, 43	50.8 Percentage of participants	66.7 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 52; n=59, 126, 43	64.4 Percentage of participants	64.3 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 60; n=59, 126, 43	55.9 Percentage of participants	65.1 Percentage of participants	67.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 64; n=59, 126, 43	64.4 Percentage of participants	65.9 Percentage of participants	62.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 72; n=59, 126, 43	57.6 Percentage of participants	60.3 Percentage of participants	58.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 80; n= 59, 126, 43	62.7 Percentage of participants	61.9 Percentage of participants	62.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 88; n= 59, 126, 43	59.3 Percentage of participants	62.7 Percentage of participants	67.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 96; n= 59, 126, 43	52.5 Percentage of participants	62.7 Percentage of participants	62.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 104; n= 59, 126, 43	61.0 Percentage of participants	69.0 Percentage of participants	60.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 4; n= 3, 7, 0	0 Percentage of participants	42.9 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 8; n= 3, 7, 0	0 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 12; n= 3, 7, 0	0 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 16; n= 3, 7, 0	0 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 20; n= 3,7, 0	33.3 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 24; n= 3, 7, 0	66.7 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 26; n=3, 7, 0	0 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 28; n= 3,7, 0	0 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 32; n= 3, 7, 0	33.3 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 36; n= 3, 7, 0	66.7 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 40; n=3,7, 0	33.3 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 44; n= 3,7, 0	66.7 Percentage of participants	57.1 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 48; n= 3, 7, 0	33.3 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 52; n= 3, 7, 0	66.7 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 60; n= 3,7,0	100 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 64; n=3,7,0	100 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 72; n= 3,7,0	66.7 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 80; n=3,7,0	66.7 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 88; n= 3,7,0	66.7 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 96; n= 3,7,0	66.7 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 104; n= 3,7,0	66.7 Percentage of participants	71.4 Percentage of participants	—
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 4; n=48, 104, 34	12.5 Percentage of participants	10.6 Percentage of participants	17.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 8; n= 48, 104, 34	16.7 Percentage of participants	17.3 Percentage of participants	17.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 12; n= 48, 104, 34	22.9 Percentage of participants	24.0 Percentage of participants	17.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 16; n= 48, 104, 34	20.8 Percentage of participants	30.8 Percentage of participants	11.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 20; n= 48, 104, 34	20.8 Percentage of participants	36.5 Percentage of participants	23.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 24; n= 48, 104, 34	22.9 Percentage of participants	34.6 Percentage of participants	20.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 26; n= 48, 104, 34	18.8 Percentage of participants	39.4 Percentage of participants	11.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 28; n= 48, 104, 34	18.8 Percentage of participants	34.6 Percentage of participants	20.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 32; n= 48, 104, 34	25.0 Percentage of participants	40.4 Percentage of participants	23.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 36; n= 48, 104, 34	20.8 Percentage of participants	41.3 Percentage of participants	17.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 40; n= 48, 104, 34	14.6 Percentage of participants	44.2 Percentage of participants	23.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 44; n= 48, 104, 34	25.0 Percentage of participants	39.4 Percentage of participants	38.2 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 48; n= 48, 104, 34	20.8 Percentage of participants	41.3 Percentage of participants	29.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 52; n= 48, 104, 34	20.8 Percentage of participants	37.5 Percentage of participants	26.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 60; n= 48, 104, 34	25.0 Percentage of participants	45.2 Percentage of participants	20.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 64; n= 48, 104, 34	20.8 Percentage of participants	43.3 Percentage of participants	26.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 72; n=48, 104, 34	29.2 Percentage of participants	36.5 Percentage of participants	17.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 80; n=48, 104, 34	22.9 Percentage of participants	31.7 Percentage of participants	23.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 88; n=48, 104, 34	31.3 Percentage of participants	29.8 Percentage of participants	14.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 96; n=48, 104, 34	20.8 Percentage of participants	33.7 Percentage of participants	20.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 104; n=48, 104, 34	27.1 Percentage of participants	40.4 Percentage of participants	20.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 4; n= 8, 19, 3	50.0 Percentage of participants	42.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 8; n= 8, 19, 3	62.5 Percentage of participants	63.2 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 12; n= 8, 19, 3	62.5 Percentage of participants	52.6 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 16; n= 8, 19, 3	75.0 Percentage of participants	63.2 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 20; n= 8, 19, 3	87.5 Percentage of participants	57.9 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 24; n= 8, 19, 3	62.5 Percentage of participants	52.6 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 26; n= 8, 19, 3	75.0 Percentage of participants	36.8 Percentage of participants	100 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 28; n= 8, 19, 3	62.5 Percentage of participants	57.9 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 32; n= 8, 19, 3	62.5 Percentage of participants	57.9 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 36; n= 8, 19, 3	87.5 Percentage of participants	63.2 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 40; n= 8, 19, 3	62.5 Percentage of participants	52.6 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 44; n= 8, 19, 3	87.5 Percentage of participants	57.9 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 48; n= 8, 19, 3	37.5 Percentage of participants	63.2 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 52; n= 8, 19, 3	75.0 Percentage of participants	52.6 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 60; n= 8, 19, 3	50.0 Percentage of participants	57.9 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 64; n= 8, 19, 3	62.5 Percentage of participants	68.4 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 72; n= 8, 19, 3	62.5 Percentage of participants	47.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 80; n= 8, 19, 3	50.0 Percentage of participants	52.6 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 88; n= 8, 19, 3	37.5 Percentage of participants	57.9 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 96; n= 8, 19, 3	50.0 Percentage of participants	52.6 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Improvement Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 104; n= 8, 19, 3	50.0 Percentage of participants	63.2 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles). Only participants with no organ system involvement at Baseline were included.

SLEDAI-2K assessments consisted of 24 individual items with 9 organ systems. Each item was given a weighted score(1 to 8 with higher score indicating increased activity)and summed if present at time of analysis. SLEDAI-2K score was sum of all 24 individual items from SLEDAI-2K, ranges from 0(no symptoms) to 105(presence of all defined symptoms). Higher scores indicates increased disease activity. A worsening was defined as an increase(compared to Baseline) in SLEDAI-2K score within same organ system at a post-Baseline visit. Baseline value was latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with SLEDAI-2K organ worsening for following organ systems were reported;CNS total,Vascular total,Musculoskeletal total,Renal total,Mucocutaneous total,Cardio and Resp total,Immunologic total and Hematologic total. Constitutional organ system was removed from analysis and its one item (fever)moved to hematologic organ system.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 16; n=54, 107, 34	1.9 Percentage of participants	2.8 Percentage of participants	2.9 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 20; n= 54, 108, 40	5.6 Percentage of participants	5.6 Percentage of participants	5.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 4; n= 69, 136, 43	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 8; n= 64,132, 42	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 12; n= 65, 134, 42	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 16; n= 65, 130, 42	0 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 20; n= 63, 128, 42	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 24; n= 61, 127, 41	0 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 26; n=61, 116, 38	0 Percentage of participants	0.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 28; n=62, 124, 41	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 32; n= 61, 124, 41	0 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 36; n=61, 124, 41	0 Percentage of participants	1.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 40; n=61, 123, 41	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 44; n= 61, 121, 41	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 48; n= 58, 120,39	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 52; n= 62, 120, 38	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 60; n=59, 117, 35	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 64; n=60, 117, 34	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 72; n= 56, 109, 31	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 80; n=55, 111, 35	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 88; n= 57, 107, 34	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 96; n=52, 107, 33	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) CNS Total; Week 104; n= 53, 112, 34	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 4; n= 65, 128, 45	0 Percentage of participants	3.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 8; n= 61, 124, 44	0 Percentage of participants	2.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 12; n= 62, 126, 44	1.6 Percentage of participants	1.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 16; n=62, 122, 44	0 Percentage of participants	1.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 20; n=60, 120, 44	0 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 24; n= 59, 119, 43	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total; Week 26; n=58, 109, 40	0 Percentage of participants	0.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 28; n= 61, 116, 43	0 Percentage of participants	1.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 32; n=59, 116, 43	0 Percentage of participants	2.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 36; n= 59, 116, 43	0 Percentage of participants	1.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 40; n=59, 115, 43	0 Percentage of participants	1.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 44; n= 59, 113, 43	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 48; n= 57, 112, 40	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 52; n=60, 112, 40	0 Percentage of participants	0.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 60; n= 58, 109, 37	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 64; n=59, 109, 36	0 Percentage of participants	1.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 72; n=55, 101, 33	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 80; n= 54, 104, 37	0 Percentage of participants	1.0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 88; n=56, 102, 36	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 96; n=51, 101, 35	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Vascular Total;Week 104; n=53, 105, 36	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 4; n=15, 33, 12	0 Percentage of participants	12.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 8; n= 15, 33, 12	6.7 Percentage of participants	6.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 12; n= 15, 33, 12	13.3 Percentage of participants	6.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 16; n= 15, 32, 12	6.7 Percentage of participants	3.1 Percentage of participants	8.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 20; n= 15, 32, 12	6.7 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 24; n= 15, 31, 11	0 Percentage of participants	6.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 26; n= 15, 31, 11	0 Percentage of participants	3.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 28; n= 14, 31, 11	0 Percentage of participants	3.2 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 32; n= 15, 30, 11	0 Percentage of participants	6.7 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 36; n= 14, 30, 11	7.1 Percentage of participants	3.3 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 40; n=15, 30, 11	0 Percentage of participants	3.3 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 44; n=15, 29, 11	0 Percentage of participants	6.9 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 48; n= 14, 30, 10	7.1 Percentage of participants	3.3 Percentage of participants	10.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 52; n= 15, 30, 11	6.7 Percentage of participants	6.7 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 60; n= 14, 28, 11	0 Percentage of participants	0 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 64; n=14, 29, 10	0 Percentage of participants	3.4 Percentage of participants	10.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 72; n= 14, 27, 10	0 Percentage of participants	11.1 Percentage of participants	10.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 80; n= 13, 26, 9	0 Percentage of participants	0 Percentage of participants	11.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 88; n= 13, 25, 9	15.4 Percentage of participants	4.0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 96; n= 12, 26, 9	0 Percentage of participants	3.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Musculoskeletal Total; Week 104; n= 13, 27, 9	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 4; n= 57, 117, 36	5.3 Percentage of participants	6.0 Percentage of participants	11.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 8; n=51, 110, 36	2.0 Percentage of participants	3.6 Percentage of participants	5.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 12; n=53, 115, 35	1.9 Percentage of participants	3.5 Percentage of participants	8.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 16; n=53, 112, 35	7.5 Percentage of participants	4.5 Percentage of participants	2.9 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 20; n= 49, 108, 36	8.2 Percentage of participants	3.7 Percentage of participants	8.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 24; n= 49, 111, 35	10.2 Percentage of participants	3.6 Percentage of participants	2.9 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 26; n= 49, 99, 33	6.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 28; n= 50, 106, 36	10.0 Percentage of participants	1.9 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 32; n= 50,107, 36	6.0 Percentage of participants	2.8 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 36; n= 50, 107, 36	8.0 Percentage of participants	2.8 Percentage of participants	5.6 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 40; n= 47, 106, 34	6.4 Percentage of participants	4.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 44; n= 49, 103, 35	6.1 Percentage of participants	1.0 Percentage of participants	2.9 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 48; n= 47, 101, 32	10.6 Percentage of participants	5.9 Percentage of participants	6.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 52; n= 49, 103, 32	8.2 Percentage of participants	3.9 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 60; n=47, 96, 30	6.4 Percentage of participants	4.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 64; n= 50, 99, 29	2.0 Percentage of participants	2.0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 72; n= 40, 89, 26	5.0 Percentage of participants	4.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 80; n= 41, 90, 29	14.6 Percentage of participants	3.3 Percentage of participants	6.9 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 88; n= 44, 85, 29	13.6 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 96; n= 43, 85, 29	4.7 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Renal Total; Week 104; n= 44, 90, 30	6.8 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 4; n= 13, 18, 4	15.4 Percentage of participants	5.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 8; n= 12, 18, 4	8.3 Percentage of participants	11.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 12; n= 12, 18, 4	8.3 Percentage of participants	16.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 16; n= 12, 18, 4	0 Percentage of participants	5.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 20; n= 12, 18, 4	25.0 Percentage of participants	5.6 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 24; n= 11, 17, 4	18.2 Percentage of participants	5.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 26; n= 10, 17, 4	20.0 Percentage of participants	11.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 28; n= 10, 17, 4	0 Percentage of participants	11.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 32; n= 10, 17, 4	10.0 Percentage of participants	5.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 36; n= 10, 17, 4	0 Percentage of participants	5.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 40; n= 10, 17, 4	20.0 Percentage of participants	11.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 44; n= 10, 17, 4	10.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 48; n=10, 16, 3	0 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 52; n= 10, 17, 4	0 Percentage of participants	5.9 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 60; n= 9, 17, 4	11.1 Percentage of participants	11.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 64; n= 10, 16, 4	0 Percentage of participants	6.3 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 72; n=10, 16, 4	20 Percentage of participants	6.3 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 80; n= 9, 17, 4	0 Percentage of participants	0 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 88; n= 9, 16, 4	0 Percentage of participants	6.3 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 96; n= 9, 15, 4	11.1 Percentage of participants	0 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Mucocutaneous Total; Week 104; n= 9, 17, 4	11.1 Percentage of participants	5.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 4; n= 68, 132, 45	2.9 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 8; n= 63, 128, 44	0 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 12; n= 64, 130, 44	0 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 16; n= 64, 126, 44	3.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 20; n= 63, 124, 44	1.6 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 24; n= 60, 123, 43	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 26; n=59, 112, 40	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 28; n= 61, 120, 43	3.3 Percentage of participants	0.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 32; n= 60, 120, 43	1.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 36; n= 60, 120, 43	1.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 40; n=60, 119, 43	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 44; n= 60, 117, 43	1.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 48; n= 57, 116, 40	0 Percentage of participants	0 Percentage of participants	2.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 52; n=61, 116, 40	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 60; n= 58, 114, 37	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 64; n= 59, 114, 36	0 Percentage of participants	0.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 72; n= 55, 106, 33	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 80; n= 54, 107, 37	1.9 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 88; n= 56, 104, 36	1.8 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 96; n=51, 104, 35	0 Percentage of participants	1.0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Cardio and Resp Total; Week 104; n= 52, 109, 36	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 4; n=23, 37, 13	17.4 Percentage of participants	0 Percentage of participants	7.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 8; n=20, 37, 12	20.0 Percentage of participants	10.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 12; n=21, 37,12	23.8 Percentage of participants	8.1 Percentage of participants	16.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 16; n= 21, 35, 12	9.5 Percentage of participants	11.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 20; n= 19, 35, 12	15.8 Percentage of participants	11.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 24; n= 18, 35, 12	5.6 Percentage of participants	5.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 26; n= 18, 30, 12	5.6 Percentage of participants	6.7 Percentage of participants	8.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 28; n= 19, 35, 12	15.8 Percentage of participants	8.6 Percentage of participants	16.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 32; n= 19, 33, 12	10.5 Percentage of participants	12.1 Percentage of participants	8.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 36; n= 19, 34, 12	15.8 Percentage of participants	8.8 Percentage of participants	16.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 40; n= 19, 33, 12	21.1 Percentage of participants	6.1 Percentage of participants	8.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 44; n= 18, 33, 12	22.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 48; n= 18, 33, 11	22.2 Percentage of participants	3.0 Percentage of participants	27.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 52; n= 19, 32, 12	21.1 Percentage of participants	3.1 Percentage of participants	8.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 60; n= 18, 32, 10	16.7 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 64; n= 19, 33, 10	21.1 Percentage of participants	6.1 Percentage of participants	20.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 72; n= 17, 28, 9	23.5 Percentage of participants	7.1 Percentage of participants	11.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 80; n= 18, 29, 11	5.6 Percentage of participants	6.9 Percentage of participants	18.2 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 88; n= 19, 29, 11	10.5 Percentage of participants	6.9 Percentage of participants	18.2 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 96; n= 16, 30, 11	12.5 Percentage of participants	13.3 Percentage of participants	18.2 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Immunologic Total; Week 104; n= 17, 28, 12	11.8 Percentage of participants	17.9 Percentage of participants	16.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 4; n= 59, 115, 40	5.1 Percentage of participants	3.5 Percentage of participants	5.0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 8; n= 52, 109, 38	3.8 Percentage of participants	5.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 12; n= 55, 110, 38	1.8 Percentage of participants	4.5 Percentage of participants	10.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 24; n= 53, 111, 37	3.8 Percentage of participants	2.7 Percentage of participants	2.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 26; n= 53, 101, 37	9.4 Percentage of participants	5.0 Percentage of participants	10.8 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 28; n= 52, 106, 39	7.7 Percentage of participants	3.8 Percentage of participants	5.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 32; n=52, 110, 38	0 Percentage of participants	4.5 Percentage of participants	7.9 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 36; n= 53, 109, 40	5.7 Percentage of participants	6.4 Percentage of participants	2.5 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 40; n= 51, 108, 37	0 Percentage of participants	10.2 Percentage of participants	5.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 44; n=53, 107, 38	7.5 Percentage of participants	6.5 Percentage of participants	5.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 48; n=51, 105, 35	5.9 Percentage of participants	4.8 Percentage of participants	0 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 52; n= 53, 103, 37	3.8 Percentage of participants	3.9 Percentage of participants	2.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 60; n=53, 101, 35	9.4 Percentage of participants	5.0 Percentage of participants	5.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 64; n=54, 98, 32	11.1 Percentage of participants	5.1 Percentage of participants	6.3 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 72; n= 47,96, 29	10.6 Percentage of participants	5.2 Percentage of participants	3.4 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 80; n= 45, 94, 35	0 Percentage of participants	4.3 Percentage of participants	5.7 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 88; n= 46, 88, 32	10.9 Percentage of participants	9.1 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 96; n= 45, 90, 32	4.4 Percentage of participants	4.4 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With SLEDAI-2K Organ Worsening Compared to Baseline by Visits (PI Assessed) Hematologic Total; Week 104; n= 46, 94, 32	4.3 Percentage of participants	6.4 Percentage of participants	6.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

The Physician's Global Assessment (PGA) was a physician-reported visual analogue scale that provides an overall measure of the participant's current disease activity. Physician's Global Assessment was collected on a 10 centimeter (cm) visual analogue scale (VAS) by placing a mark on the scale between 0 (no disease activity) to 10 (maximum disease activity). The PGA score was then rescaled for reporting by multiplying the collected score by 3 divided by 10. Hence, the PGA score ranges from 0 to 3 with higher scores indicating greater disease activity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 4; n=72, 142, 45	-0.285 Scores on a scale Standard Deviation 0.4816	-0.247 Scores on a scale Standard Deviation 0.4640	-0.303 Scores on a scale Standard Deviation 0.5464
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 8; n=66, 135, 44	-0.535 Scores on a scale Standard Deviation 0.5134	-0.520 Scores on a scale Standard Deviation 0.5243	-0.585 Scores on a scale Standard Deviation 0.5793
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 12; n=66, 137, 44	-0.592 Scores on a scale Standard Deviation 0.5265	-0.660 Scores on a scale Standard Deviation 0.5776	-0.654 Scores on a scale Standard Deviation 0.5450
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 16; n=68, 132, 44	-0.619 Scores on a scale Standard Deviation 0.5475	-0.717 Scores on a scale Standard Deviation 0.5802	-0.759 Scores on a scale Standard Deviation 0.6072
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 20; n=66, 130, 44	-0.697 Scores on a scale Standard Deviation 0.6157	-0.787 Scores on a scale Standard Deviation 0.5445	-0.786 Scores on a scale Standard Deviation 0.6772
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 24; n=62, 130, 43	-0.770 Scores on a scale Standard Deviation 0.5888	-0.766 Scores on a scale Standard Deviation 0.5059	-0.965 Scores on a scale Standard Deviation 0.6413
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 26; n=62, 120, 40	-0.786 Scores on a scale Standard Deviation 0.5727	-0.811 Scores on a scale Standard Deviation 0.5445	-0.929 Scores on a scale Standard Deviation 0.6631
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 28; n=63, 127, 43	-0.781 Scores on a scale Standard Deviation 0.5395	-0.817 Scores on a scale Standard Deviation 0.5360	-0.980 Scores on a scale Standard Deviation 0.6286
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 32; n=62, 124, 43	-0.851 Scores on a scale Standard Deviation 0.5989	-0.864 Scores on a scale Standard Deviation 0.5519	-1.005 Scores on a scale Standard Deviation 0.6723
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 36; n=64, 126, 43	-0.916 Scores on a scale Standard Deviation 0.6141	-0.927 Scores on a scale Standard Deviation 0.5400	-0.917 Scores on a scale Standard Deviation 0.5504
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 40; n=63, 126, 43	-0.893 Scores on a scale Standard Deviation 0.6157	-0.925 Scores on a scale Standard Deviation 0.5621	-0.993 Scores on a scale Standard Deviation 0.6711
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 44; n=63, 124, 43	-0.800 Scores on a scale Standard Deviation 0.6764	-0.905 Scores on a scale Standard Deviation 0.5289	-0.970 Scores on a scale Standard Deviation 0.6065
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 48; n=59, 121, 40	-0.885 Scores on a scale Standard Deviation 0.6178	-0.928 Scores on a scale Standard Deviation 0.5627	-0.956 Scores on a scale Standard Deviation 0.5175
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 52; n=64, 122, 41	-0.947 Scores on a scale Standard Deviation 0.6918	-0.938 Scores on a scale Standard Deviation 0.6125	-1.004 Scores on a scale Standard Deviation 0.5527
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 60; n=61, 120, 37	-0.836 Scores on a scale Standard Deviation 0.6982	-0.848 Scores on a scale Standard Deviation 0.6085	-1.206 Scores on a scale Standard Deviation 0.5917
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 64; n=62, 120, 36	-0.876 Scores on a scale Standard Deviation 0.6971	-0.943 Scores on a scale Standard Deviation 0.5711	-1.095 Scores on a scale Standard Deviation 0.6365
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 72; n=58, 110, 33	-0.928 Scores on a scale Standard Deviation 0.6838	-0.944 Scores on a scale Standard Deviation 0.5708	-1.047 Scores on a scale Standard Deviation 0.6088
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 80; n=57, 112, 37	-0.949 Scores on a scale Standard Deviation 0.6909	-0.954 Scores on a scale Standard Deviation 0.6221	-1.138 Scores on a scale Standard Deviation 0.5574
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 88; n=59, 109, 36	-1.060 Scores on a scale Standard Deviation 0.6307	-0.993 Scores on a scale Standard Deviation 0.5733	-1.140 Scores on a scale Standard Deviation 0.5514
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 96; n=54, 109, 35	-1.016 Scores on a scale Standard Deviation 0.6093	-0.994 Scores on a scale Standard Deviation 0.5669	-1.214 Scores on a scale Standard Deviation 0.5580
Change From Baseline in Physician Global Assessment (PGA) by Visits Week 104; n=55, 114, 36	-1.052 Scores on a scale Standard Deviation 0.5095	-1.074 Scores on a scale Standard Deviation 0.5166	-1.085 Scores on a scale Standard Deviation 0.5987

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 52 and Week 104

Population: Modified Intent-to-Treat (MITT) Population

The SLICC-ACR Damage Index measures irreversible (not related to active inflammation) changes occurring since the diagnosis of SLE ascertained by clinical assessment and present for at least 6 months. The questionnaire contains 39 items covering 12 different organ systems which were scored on a numerical scale between 0 (no damage) to 7 (increasing disease damage). Individual ranges for organ systems were; ocular: 0-2, neuropsychiatric: 0-6, renal: 0-3, pulmonary: 0-5, cardiovascular:0-6, peripheral vascular: 0-5, gastrointestinal:0-5, musculoskeletal: 0-6, skin: 0-3, endocrine (diabetes): 0-1, gonadal:0-1 and malignancies: 0-2. The SLICC-ACR score was calculated by taking sum of the individual scores for 12 organ systems which ranges from 0 (no damage) to 45 (increasing disease damage) where higher score indicates increasing disease damage severity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 Week 52	1.4 Percentage of participants Interval 0.0 to 4.1	2.1 Percentage of participants Interval 0.0 to 4.4	2.1 Percentage of participants Interval 0.0 to 6.3
Percentage of Participants With Systemic Lupus International Collaborating Clinics (SLICC) -American College of Rheumatology (ACR) Damage Index Worsening Compared With Baseline at Week 52 and Week 104 Week 104	5.6 Percentage of participants Interval 0.3 to 10.8	5.6 Percentage of participants Interval 1.8 to 9.3	6.4 Percentage of participants Interval 0.0 to 13.4

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96 and 104

Population: Modified Intent-to-Treat (MITT) Population

Lupus low disease activity state (LLDAS) was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity; (2) no new features of lupus disease activity compared with the previous assessment; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs. Percentage of participants that met the LLDAS response criteria were reported.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 4	0 Percentage of participants NA indicates that data was not available as there was no participant who met the LLDAS response criteria. Hence, 95% CI could not be calculated.	2.1 Percentage of participants Interval 0.0 to 4.4	2.1 Percentage of participants Interval 0.0 to 6.3
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 8	9.7 Percentage of participants Interval 2.9 to 16.6	1.4 Percentage of participants Interval 0.0 to 3.3	10.6 Percentage of participants Interval 1.8 to 19.5
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 12	8.3 Percentage of participants Interval 1.9 to 14.7	9.7 Percentage of participants Interval 4.9 to 14.6	6.4 Percentage of participants Interval 0.0 to 13.4
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 16	11.1 Percentage of participants Interval 3.9 to 18.4	16.7 Percentage of participants Interval 10.6 to 22.8	19.1 Percentage of participants Interval 7.9 to 30.4
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 20	11.1 Percentage of participants Interval 3.9 to 18.4	25.7 Percentage of participants Interval 18.6 to 32.8	19.1 Percentage of participants Interval 7.9 to 30.4
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 24	12.5 Percentage of participants Interval 4.9 to 20.1	22.2 Percentage of participants Interval 15.4 to 29.0	36.2 Percentage of participants Interval 22.4 to 49.9
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 26	22.2 Percentage of participants Interval 12.6 to 31.8	25.7 Percentage of participants Interval 18.6 to 32.8	34.0 Percentage of participants Interval 20.5 to 47.6
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 28	20.8 Percentage of participants Interval 11.5 to 30.2	25.0 Percentage of participants Interval 17.9 to 32.1	34.0 Percentage of participants Interval 20.5 to 47.6
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 32	29.2 Percentage of participants Interval 18.7 to 39.7	31.9 Percentage of participants Interval 24.3 to 39.6	36.2 Percentage of participants Interval 22.4 to 49.9
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 36	30.6 Percentage of participants Interval 19.9 to 41.2	34.0 Percentage of participants Interval 26.3 to 41.8	29.8 Percentage of participants Interval 16.7 to 42.9
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 40	22.2 Percentage of participants Interval 12.6 to 31.8	33.3 Percentage of participants Interval 25.6 to 41.0	38.3 Percentage of participants Interval 24.4 to 52.2
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 44	30.6 Percentage of participants Interval 19.9 to 41.2	37.5 Percentage of participants Interval 29.6 to 45.4	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 48	26.4 Percentage of participants Interval 16.2 to 36.6	37.5 Percentage of participants Interval 29.6 to 45.4	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 52	27.8 Percentage of participants Interval 17.4 to 38.1	34.0 Percentage of participants Interval 26.3 to 41.8	29.8 Percentage of participants Interval 16.7 to 42.9
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 60	26.4 Percentage of participants Interval 16.2 to 36.6	23.6 Percentage of participants Interval 16.7 to 30.5	36.2 Percentage of participants Interval 22.4 to 49.9
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 64	20.8 Percentage of participants Interval 11.5 to 30.2	30.6 Percentage of participants Interval 23.0 to 38.1	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 72	22.2 Percentage of participants Interval 12.6 to 31.8	31.3 Percentage of participants Interval 23.7 to 38.8	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 80	18.1 Percentage of participants Interval 9.2 to 26.9	26.4 Percentage of participants Interval 19.2 to 33.6	34.0 Percentage of participants Interval 20.5 to 47.6
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 88	23.6 Percentage of participants Interval 13.8 to 33.4	24.3 Percentage of participants Interval 17.3 to 31.3	29.8 Percentage of participants Interval 16.7 to 42.9
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 96	20.8 Percentage of participants Interval 11.5 to 30.2	30.6 Percentage of participants Interval 23.0 to 38.1	36.2 Percentage of participants Interval 22.4 to 49.9
Percentage of Participants That Met the Lupus Low Disease Activity State (LLDAS) Response Criteria by Visits (PI Assessed) Week 104	20.8 Percentage of participants Interval 11.5 to 30.2	32.6 Percentage of participants Interval 25.0 to 40.3	38.3 Percentage of participants Interval 24.4 to 52.2

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48, 52, 60, 64, 72, 80, 88, 96, 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of disease control was defined as the percentage of participants with a SLEDAI-2K score <=2, achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of <=5 mg/day, using the PI assessment of SLEDAI-2K. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. SLEDAI-2K score was the sum of all 24 individual items from SLEDAI-2K, ranges from 0 (no symptoms) to 105 (presence of all defined symptoms), higher scores representing increased disease activity. Percentage of participants with a state of disease control using the PI assessment of SLEDAI-2K were summarized.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 4	2.8 Percentage of participants Interval 0.0 to 6.6	3.5 Percentage of participants Interval 0.5 to 6.5	8.5 Percentage of participants Interval 0.5 to 16.5
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 8	13.9 Percentage of participants Interval 5.9 to 21.9	9.0 Percentage of participants Interval 4.3 to 13.7	21.3 Percentage of participants Interval 9.6 to 33.0
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 12	11.1 Percentage of participants Interval 3.9 to 18.4	12.5 Percentage of participants Interval 7.1 to 17.9	19.1 Percentage of participants Interval 7.9 to 30.4
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 16	15.3 Percentage of participants Interval 7.0 to 23.6	22.2 Percentage of participants Interval 15.4 to 29.0	29.8 Percentage of participants Interval 16.7 to 42.9
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 20	13.9 Percentage of participants Interval 5.9 to 21.9	24.3 Percentage of participants Interval 17.3 to 31.3	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 24	18.1 Percentage of participants Interval 9.2 to 26.9	25.0 Percentage of participants Interval 17.9 to 32.1	34.0 Percentage of participants Interval 20.5 to 47.6
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 26	15.3 Percentage of participants Interval 7.0 to 23.6	25.7 Percentage of participants Interval 18.6 to 32.8	25.5 Percentage of participants Interval 13.1 to 38.0
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 28	11.1 Percentage of participants Interval 3.9 to 18.4	25.7 Percentage of participants Interval 18.6 to 32.8	36.2 Percentage of participants Interval 22.4 to 49.9
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 32	15.3 Percentage of participants Interval 7.0 to 23.6	28.5 Percentage of participants Interval 21.1 to 35.8	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 36	19.4 Percentage of participants Interval 10.3 to 28.6	27.8 Percentage of participants Interval 20.5 to 35.1	27.7 Percentage of participants Interval 14.9 to 40.4
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 40	16.7 Percentage of participants Interval 8.1 to 25.3	24.3 Percentage of participants Interval 17.3 to 31.3	23.4 Percentage of participants Interval 11.3 to 35.5
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 44	18.1 Percentage of participants Interval 9.2 to 26.9	26.4 Percentage of participants Interval 19.2 to 33.6	27.7 Percentage of participants Interval 14.9 to 40.4
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 48	18.1 Percentage of participants Interval 9.2 to 26.9	26.4 Percentage of participants Interval 19.2 to 33.6	27.7 Percentage of participants Interval 14.9 to 40.4
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 52	19.4 Percentage of participants Interval 10.3 to 28.6	20.1 Percentage of participants Interval 13.6 to 26.7	27.7 Percentage of participants Interval 14.9 to 40.4
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 60	18.1 Percentage of participants Interval 9.2 to 26.9	20.8 Percentage of participants Interval 14.2 to 27.5	23.4 Percentage of participants Interval 11.3 to 35.5
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 64	11.1 Percentage of participants Interval 3.9 to 18.4	18.1 Percentage of participants Interval 11.8 to 24.3	27.7 Percentage of participants Interval 14.9 to 40.4
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 72	9.7 Percentage of participants Interval 2.9 to 16.6	12.5 Percentage of participants Interval 7.1 to 17.9	23.4 Percentage of participants Interval 11.3 to 35.5
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 80	8.3 Percentage of participants Interval 1.9 to 14.7	13.2 Percentage of participants Interval 7.7 to 18.7	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 88	11.1 Percentage of participants Interval 3.9 to 18.4	9.7 Percentage of participants Interval 4.9 to 14.6	21.3 Percentage of participants Interval 9.6 to 33.0
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 96	8.3 Percentage of participants Interval 1.9 to 14.7	12.5 Percentage of participants Interval 7.1 to 17.9	31.9 Percentage of participants Interval 18.6 to 45.2
Percentage of Participants With a State of Disease Control Using the PI Assessment of SLEDAI-2K by Visit Week 104	8.3 Percentage of participants Interval 1.9 to 14.7	11.8 Percentage of participants Interval 6.5 to 17.1	23.4 Percentage of participants Interval 11.3 to 35.5

SECONDARY outcome

Timeframe: Weeks 60, 64, 72, 80, 88, 96 and 104

Population: Modified Intent-to-Treat (MITT) Population

Percentage of participants with a state of clinical remission was defined as the percentage of participants with a clinical SLEDAI-2K score =0 (does not include anti-dsDNA and complement activity scores), achieved without immunosuppressants (which was allowed in Belimumab+ Standard therapy arm only) and with corticosteroids at a prednisone equivalent dose of 0 mg/day using the PI assessment of SLEDAI-2K. SLEDAI-2K consisted of 24 individual items within each of 9 organ systems. Each item was given a weighted score (1 to 8, higher score indicates increased activity) and summed if present at the time of visit or in preceding 10 days. The clinical SLEDAI-2K score was sum of 22 out of all 24 individual items from the SLEDAI-2K and ranges from 0 (no symptoms) to 101 (presence of all defined symptoms) with higher scores representing increased disease activity. Percentage of participants with a state of clinical remission using the PI assessment of SLEDAI-2K were summarized.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit Week 60	6.9 Percentage of participants Interval 1.1 to 12.8	3.5 Percentage of participants Interval 0.5 to 6.5	10.6 Percentage of participants Interval 1.8 to 19.5
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit Week 64	6.9 Percentage of participants Interval 1.1 to 12.8	5.6 Percentage of participants Interval 1.8 to 9.3	10.6 Percentage of participants Interval 1.8 to 19.5
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit Week 72	6.9 Percentage of participants Interval 1.1 to 12.8	3.5 Percentage of participants Interval 0.5 to 6.5	14.9 Percentage of participants Interval 4.7 to 25.1
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit Week 80	6.9 Percentage of participants Interval 1.1 to 12.8	4.2 Percentage of participants Interval 0.9 to 7.4	14.9 Percentage of participants Interval 4.7 to 25.1
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit Week 88	6.9 Percentage of participants Interval 1.1 to 12.8	2.1 Percentage of participants Interval 0.0 to 4.4	14.9 Percentage of participants Interval 4.7 to 25.1
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit Week 96	4.2 Percentage of participants Interval 0.0 to 8.8	4.2 Percentage of participants Interval 0.9 to 7.4	12.8 Percentage of participants Interval 3.2 to 22.3
Percentage of Participants With a State of Clinical Remission Using the PI Assessment of SLEDAI-2K by Visit Week 104	2.8 Percentage of participants Interval 0.0 to 6.6	3.5 Percentage of participants Interval 0.5 to 6.5	6.4 Percentage of participants Interval 0.0 to 13.4

SECONDARY outcome

Timeframe: Up to Week 111 (including 8 weeks of safety follow-up)

Population: Intent-to-Treat Population comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or Placebo).

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Data for number of participants with SAE and non-SAE (>=5 %) has been summarized.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=76 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) SAE	10 Participants	32 Participants	15 Participants
Number of Participants With Serious Adverse Events (SAE) and Non-serious AE (Non-SAE) non-SAE	48 Participants	109 Participants	53 Participants

SECONDARY outcome

Timeframe: Up to Week 104

Population: Intent-to-Treat Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AESIs were Malignant Neoplasms, Post-Injection Systemic Reactions (PISR), All Infections of Special Interest (Opportunistic Infections (OI), Herpes Zoster (HZ), Tuberculosis (TB), and Sepsis), Depression (including mood disorders and anxiety)/suicide/self-injury and Deaths. Data for number of participants with AESIs has been summarized.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=76 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Number of Participants With Adverse Events of Special Interest (AESIs) Deaths	1 Participants	2 Participants	0 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) Malignant Neoplasms	1 Participants	1 Participants	1 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) PISR	7 Participants	19 Participants	4 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) All Infections of Special Interest	5 Participants	12 Participants	5 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) Depression/suicide/self-injury	9 Participants	16 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

The Patient's Global Assessment (PtGA) of Disease Activity is a single-item, participant reported scale developed for the assessment of the participant's overall rating of their disease activity due to SLE. The scale measures disease activity ranging from 0 (Very Well) to 10 (Very Poor) and the higher score indicates severe disease activity. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 8; n=66, 132, 44	-0.96 Scores on a scale Standard Deviation 2.751	-1.06 Scores on a scale Standard Deviation 2.141	-0.91 Scores on a scale Standard Deviation 2.848
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 12; n=66, 133, 44	-0.69 Scores on a scale Standard Deviation 2.237	-1.07 Scores on a scale Standard Deviation 2.290	-1.57 Scores on a scale Standard Deviation 2.756
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 26; n=61, 115, 40	-0.95 Scores on a scale Standard Deviation 2.765	-1.50 Scores on a scale Standard Deviation 2.596	-1.57 Scores on a scale Standard Deviation 2.450
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 40; n=63, 123, 43	-1.77 Scores on a scale Standard Deviation 2.624	-1.60 Scores on a scale Standard Deviation 2.809	-1.67 Scores on a scale Standard Deviation 2.962
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 52; n=64, 120, 41	-1.74 Scores on a scale Standard Deviation 2.752	-1.82 Scores on a scale Standard Deviation 2.631	-1.84 Scores on a scale Standard Deviation 3.228
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 64; n=62, 117, 36	-1.41 Scores on a scale Standard Deviation 2.985	-1.96 Scores on a scale Standard Deviation 2.595	-1.96 Scores on a scale Standard Deviation 3.034
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 72; n=59, 107, 33	-1.46 Scores on a scale Standard Deviation 3.209	-1.81 Scores on a scale Standard Deviation 2.609	-1.43 Scores on a scale Standard Deviation 3.487
Change From Baseline in Patient Global Assessment (PtGA) by Visits Week 104; n=55, 111, 36	-1.61 Scores on a scale Standard Deviation 2.589	-2.00 Scores on a scale Standard Deviation 2.739	-1.98 Scores on a scale Standard Deviation 2.895

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

LupusQoL is a SLE-specific health related qualify of life (HRQOL) instrument with 34 questions across 8 domains:Physical health(8 items),Pain(3 items),Planning(3 items),Intimate relationship(2 items),Burden to others(3 items),Emotional health(6 items),Body image(5 items),Fatigue(4 items). Questions were related to participants experience in prior 4 weeks.A 5-point Likert response format was used, ranging from 0(all of the time) to 4(never) for each question. Individual domain scores were reported which were calculated by taking sum of responses to all items within each domain. Individual domain scores range:Physical health(0-32),Pain(0-12),Planning(0-12),Intimate relationship(0-8),Burden to others(0-12),Emotional health(0-24),Body image(0-20),Fatigue(0-16). Higher score indicates better HRQOL. Baseline value was latest pre-dose assessment with a non-missing value including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 8; n=66, 132, 44	3.0 Scores on a scale Standard Deviation 15.20	6.0 Scores on a scale Standard Deviation 15.08	6.3 Scores on a scale Standard Deviation 18.79
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 12; n=66, 133, 44	3.5 Scores on a scale Standard Deviation 16.60	5.8 Scores on a scale Standard Deviation 17.15	6.4 Scores on a scale Standard Deviation 20.06
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 26; n=61, 115, 40	3.3 Scores on a scale Standard Deviation 18.74	10.5 Scores on a scale Standard Deviation 17.27	11.6 Scores on a scale Standard Deviation 19.19
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 40; n=63, 122, 43	8.5 Scores on a scale Standard Deviation 19.53	9.5 Scores on a scale Standard Deviation 19.29	8.2 Scores on a scale Standard Deviation 19.46
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 52; n=64, 120, 41	8.1 Scores on a scale Standard Deviation 19.90	10.0 Scores on a scale Standard Deviation 20.16	11.6 Scores on a scale Standard Deviation 19.53
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 64; n=62, 117, 36	5.8 Scores on a scale Standard Deviation 18.66	10.2 Scores on a scale Standard Deviation 18.60	9.5 Scores on a scale Standard Deviation 21.74
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 72; n=59, 107, 33	7.0 Scores on a scale Standard Deviation 21.13	9.1 Scores on a scale Standard Deviation 18.84	8.5 Scores on a scale Standard Deviation 22.59
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Physical health; Week 104; n=55, 111, 36	6.2 Scores on a scale Standard Deviation 20.19	10.6 Scores on a scale Standard Deviation 19.96	7.2 Scores on a scale Standard Deviation 23.33
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 8; n=66, 132, 44	5.8 Scores on a scale Standard Deviation 19.67	11.4 Scores on a scale Standard Deviation 18.55	10.4 Scores on a scale Standard Deviation 21.87
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 12; n=66, 133, 44	7.5 Scores on a scale Standard Deviation 19.78	13.0 Scores on a scale Standard Deviation 20.81	6.1 Scores on a scale Standard Deviation 28.44
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 26; n=61, 115, 40	7.0 Scores on a scale Standard Deviation 22.42	17.2 Scores on a scale Standard Deviation 21.54	13.1 Scores on a scale Standard Deviation 22.79
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 40; n=63, 122, 43	12.3 Scores on a scale Standard Deviation 23.18	18.0 Scores on a scale Standard Deviation 22.70	12.6 Scores on a scale Standard Deviation 29.17
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 52; n=64, 120, 41	13.9 Scores on a scale Standard Deviation 24.26	17.6 Scores on a scale Standard Deviation 23.62	15.7 Scores on a scale Standard Deviation 27.34
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 64; n=62, 117, 36	10.2 Scores on a scale Standard Deviation 21.89	17.4 Scores on a scale Standard Deviation 23.59	13.2 Scores on a scale Standard Deviation 26.90
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 72; n=59, 107, 33	13.1 Scores on a scale Standard Deviation 24.91	17.0 Scores on a scale Standard Deviation 22.66	11.9 Scores on a scale Standard Deviation 29.02
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Pain; Week 104; n=55, 111, 36	13.8 Scores on a scale Standard Deviation 25.82	19.0 Scores on a scale Standard Deviation 22.59	12.5 Scores on a scale Standard Deviation 27.92
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 8; n=66, 132, 44	3.4 Scores on a scale Standard Deviation 19.77	8.0 Scores on a scale Standard Deviation 18.21	10.0 Scores on a scale Standard Deviation 27.88
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 12; n=66, 133, 44	4.5 Scores on a scale Standard Deviation 23.03	7.6 Scores on a scale Standard Deviation 20.15	7.8 Scores on a scale Standard Deviation 27.81
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 26; n=61, 115, 40	3.4 Scores on a scale Standard Deviation 25.20	9.9 Scores on a scale Standard Deviation 21.28	12.1 Scores on a scale Standard Deviation 27.86
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 40; n=63, 122, 43	11.6 Scores on a scale Standard Deviation 29.08	12.2 Scores on a scale Standard Deviation 22.30	10.7 Scores on a scale Standard Deviation 26.62
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 52; n=64, 120, 41	11.6 Scores on a scale Standard Deviation 28.66	12.6 Scores on a scale Standard Deviation 23.89	14.0 Scores on a scale Standard Deviation 28.35
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 64; n=62, 117, 36	7.8 Scores on a scale Standard Deviation 24.42	14.5 Scores on a scale Standard Deviation 23.65	7.2 Scores on a scale Standard Deviation 30.55
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 72; n=59, 107, 33	9.2 Scores on a scale Standard Deviation 30.78	11.4 Scores on a scale Standard Deviation 20.97	6.6 Scores on a scale Standard Deviation 31.02
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Planning; Week 104; n=55, 111, 36	12.1 Scores on a scale Standard Deviation 30.76	14.2 Scores on a scale Standard Deviation 20.77	8.8 Scores on a scale Standard Deviation 34.96
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 8; n=51, 110, 36	-1.2 Scores on a scale Standard Deviation 21.83	5.2 Scores on a scale Standard Deviation 20.63	7.6 Scores on a scale Standard Deviation 19.66
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 12; n=52, 106, 36	-2.6 Scores on a scale Standard Deviation 25.16	4.6 Scores on a scale Standard Deviation 23.42	7.6 Scores on a scale Standard Deviation 27.10
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 26; n=48, 86, 30	-1.3 Scores on a scale Standard Deviation 29.20	8.9 Scores on a scale Standard Deviation 24.32	14.2 Scores on a scale Standard Deviation 28.38
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 40; n=50, 94, 30	4.3 Scores on a scale Standard Deviation 28.75	7.7 Scores on a scale Standard Deviation 25.01	15.8 Scores on a scale Standard Deviation 30.43
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 52; n=51, 91, 30	4.7 Scores on a scale Standard Deviation 29.36	6.6 Scores on a scale Standard Deviation 22.54	15.8 Scores on a scale Standard Deviation 30.78
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 64; n=47, 90, 25	-4.5 Scores on a scale Standard Deviation 28.00	11.0 Scores on a scale Standard Deviation 25.41	12.5 Scores on a scale Standard Deviation 29.76
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 72; n=42, 83, 21	0.0 Scores on a scale Standard Deviation 31.60	8.6 Scores on a scale Standard Deviation 23.82	5.4 Scores on a scale Standard Deviation 39.44
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Intimate relationship; Week 104; n=40, 85,27	-0.3 Scores on a scale Standard Deviation 23.93	11.2 Scores on a scale Standard Deviation 25.59	4.6 Scores on a scale Standard Deviation 35.21
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 8; n=66, 132, 44	7.3 Scores on a scale Standard Deviation 22.95	6.8 Scores on a scale Standard Deviation 20.56	10.6 Scores on a scale Standard Deviation 23.46
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 12; n=66, 133, 44	11.4 Scores on a scale Standard Deviation 27.91	8.4 Scores on a scale Standard Deviation 23.65	6.4 Scores on a scale Standard Deviation 29.90
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 26; n=61, 115, 40	8.7 Scores on a scale Standard Deviation 26.68	10.5 Scores on a scale Standard Deviation 27.42	7.5 Scores on a scale Standard Deviation 27.66
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 40; n=63, 122, 43	13.9 Scores on a scale Standard Deviation 27.23	12.6 Scores on a scale Standard Deviation 26.94	12.0 Scores on a scale Standard Deviation 27.66
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 52; n=64, 120, 41	16.5 Scores on a scale Standard Deviation 29.15	14.9 Scores on a scale Standard Deviation 27.03	15.0 Scores on a scale Standard Deviation 33.40
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 64; n=62, 117, 36	14.4 Scores on a scale Standard Deviation 28.83	17.0 Scores on a scale Standard Deviation 26.67	12.3 Scores on a scale Standard Deviation 28.21
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 72; n=59, 107, 33	17.1 Scores on a scale Standard Deviation 28.68	14.4 Scores on a scale Standard Deviation 28.77	11.1 Scores on a scale Standard Deviation 27.85
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Burden to others; Week 104; n=55, 111, 36	18.9 Scores on a scale Standard Deviation 25.93	15.0 Scores on a scale Standard Deviation 29.25	12.7 Scores on a scale Standard Deviation 33.42
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 8; n=66, 132, 44	5.2 Scores on a scale Standard Deviation 18.33	6.4 Scores on a scale Standard Deviation 16.87	11.6 Scores on a scale Standard Deviation 20.55
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 12; n=66, 133, 44	8.1 Scores on a scale Standard Deviation 17.32	4.5 Scores on a scale Standard Deviation 19.67	9.1 Scores on a scale Standard Deviation 23.87
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 26; n=61,115, 40	7.7 Scores on a scale Standard Deviation 19.84	6.7 Scores on a scale Standard Deviation 17.35	10.1 Scores on a scale Standard Deviation 18.12
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 40; n=63, 122, 43	9.7 Scores on a scale Standard Deviation 21.44	6.7 Scores on a scale Standard Deviation 20.85	9.4 Scores on a scale Standard Deviation 22.20
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 52; n=64, 120, 41	10.2 Scores on a scale Standard Deviation 21.48	7.8 Scores on a scale Standard Deviation 20.63	11.4 Scores on a scale Standard Deviation 21.99
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 64; n=62, 117, 36	8.1 Scores on a scale Standard Deviation 20.75	9.3 Scores on a scale Standard Deviation 20.73	8.1 Scores on a scale Standard Deviation 22.11
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 72; n=59, 107, 33	8.8 Scores on a scale Standard Deviation 21.39	6.2 Scores on a scale Standard Deviation 19.05	6.6 Scores on a scale Standard Deviation 21.80
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Emotional health; Week 104; n=55, 111, 36	6.8 Scores on a scale Standard Deviation 20.20	9.3 Scores on a scale Standard Deviation 19.67	10.5 Scores on a scale Standard Deviation 23.00
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 8; n=60, 114, 37	5.7 Scores on a scale Standard Deviation 19.57	8.9 Scores on a scale Standard Deviation 19.26	5.7 Scores on a scale Standard Deviation 25.05
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 12; n=58, 118, 39	1.9 Scores on a scale Standard Deviation 23.23	10.1 Scores on a scale Standard Deviation 20.73	5.9 Scores on a scale Standard Deviation 26.89
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 26; n=56, 96, 33	5.8 Scores on a scale Standard Deviation 20.62	9.0 Scores on a scale Standard Deviation 25.03	5.7 Scores on a scale Standard Deviation 23.07
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 40; n=54, 103, 35	8.9 Scores on a scale Standard Deviation 25.42	8.2 Scores on a scale Standard Deviation 24.82	5.1 Scores on a scale Standard Deviation 22.07
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 52; n=55, 101, 33	7.9 Scores on a scale Standard Deviation 25.77	9.1 Scores on a scale Standard Deviation 24.07	10.3 Scores on a scale Standard Deviation 25.24
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 64; n=52, 98, 27	6.0 Scores on a scale Standard Deviation 22.51	11.3 Scores on a scale Standard Deviation 23.08	7.7 Scores on a scale Standard Deviation 23.98
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 72; n=44, 93, 25	7.8 Scores on a scale Standard Deviation 26.74	8.7 Scores on a scale Standard Deviation 24.91	2.5 Scores on a scale Standard Deviation 29.28
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Body image; Week 104; n=48, 94, 28	4.4 Scores on a scale Standard Deviation 26.62	11.4 Scores on a scale Standard Deviation 25.65	3.5 Scores on a scale Standard Deviation 27.40
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 8; n=66,132, 44	9.8 Scores on a scale Standard Deviation 17.02	9.2 Scores on a scale Standard Deviation 18.40	8.5 Scores on a scale Standard Deviation 24.30
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 12; n=66, 133, 44	8.2 Scores on a scale Standard Deviation 18.48	7.0 Scores on a scale Standard Deviation 17.96	10.4 Scores on a scale Standard Deviation 28.11
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 26; n=61, 115, 40	8.6 Scores on a scale Standard Deviation 20.23	11.4 Scores on a scale Standard Deviation 20.12	11.9 Scores on a scale Standard Deviation 20.21
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 40; n=63, 122, 43	11.9 Scores on a scale Standard Deviation 22.33	10.3 Scores on a scale Standard Deviation 22.41	11.3 Scores on a scale Standard Deviation 24.75
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 52; n=64, 120, 41	14.2 Scores on a scale Standard Deviation 21.17	12.0 Scores on a scale Standard Deviation 20.95	16.6 Scores on a scale Standard Deviation 25.30
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 64; n=62, 117, 36	10.5 Scores on a scale Standard Deviation 21.94	14.0 Scores on a scale Standard Deviation 20.35	10.8 Scores on a scale Standard Deviation 25.21
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 72; n=59, 107, 33	12.1 Scores on a scale Standard Deviation 22.74	13.1 Scores on a scale Standard Deviation 18.31	11.6 Scores on a scale Standard Deviation 25.87
Change From Baseline in Lupus Quality of Life (LupusQoL) Domain Scores by Visit Fatigue; Week 104; n=55, 111, 36	9.4 Scores on a scale Standard Deviation 20.41	14.3 Scores on a scale Standard Deviation 20.18	9.7 Scores on a scale Standard Deviation 24.25

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 8, 12, 26, 40, 52, 64, 72 and 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

The FACIT-Fatigue scale was a 13-item questionnaire completed by the participant, which provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The higher score for the questions, the greater the fatigue. The total score was the sum of the responses from all questions (inverted for reversed items) multiplied by 13, then divided by the number of questions answered, ranging from 0 (worse fatigue) to 52 (no fatigue) where a higher score indicates an improvement in the participant's health status and decrease in the score indicates worse fatigue/quality of life. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as the post-dose visit value minus Baseline value.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 8; n=66, 132, 44	4.2 Scores on a scale Standard Deviation 9.84	4.6 Scores on a scale Standard Deviation 8.84	4.8 Scores on a scale Standard Deviation 8.25
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 12; n=66, 133, 44	4.7 Scores on a scale Standard Deviation 9.50	4.0 Scores on a scale Standard Deviation 9.86	3.8 Scores on a scale Standard Deviation 10.94
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 26; n=61, 115, 40	3.1 Scores on a scale Standard Deviation 10.08	5.4 Scores on a scale Standard Deviation 9.17	4.1 Scores on a scale Standard Deviation 8.54
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 40; n=63, 122, 43	6.0 Scores on a scale Standard Deviation 10.18	5.2 Scores on a scale Standard Deviation 10.80	5.2 Scores on a scale Standard Deviation 10.14
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 52; n=64, 120, 41	6.5 Scores on a scale Standard Deviation 10.12	6.1 Scores on a scale Standard Deviation 10.84	5.1 Scores on a scale Standard Deviation 10.51
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 64;n=62, 117, 36	4.9 Scores on a scale Standard Deviation 10.61	6.2 Scores on a scale Standard Deviation 9.72	4.6 Scores on a scale Standard Deviation 10.32
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 72; n=59, 107, 33	5.6 Scores on a scale Standard Deviation 10.21	5.2 Scores on a scale Standard Deviation 10.31	2.9 Scores on a scale Standard Deviation 12.75
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score by Visit Week 104; n=55, 111, 36	5.7 Scores on a scale Standard Deviation 9.07	7.1 Scores on a scale Standard Deviation 11.50	3.1 Scores on a scale Standard Deviation 10.30

SECONDARY outcome

Timeframe: Weeks 8, 12, 26, 40, 52, 64, 72 and 104

Population: Modified Intent-to-Treat (MITT) Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

The FACIT-Fatigue scale was a 13-item questionnaire completed by the participant, which provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions, the greater the fatigue. The total score was the sum of the responses (inverted for reversed items) multiplied by 13, then divided by the number of questions answered, ranging from 0 (worse fatigue) to 52 (no fatigue) where a higher score indicates an improvement in the participant's health status and decrease in the score indicates worse fatigue/quality of life. A participant was considered to had an improvement exceeding the minimal clinically important difference if they had >=4 points improvement in their FACIT-Fatigue Scale score from Baseline. Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the MCID (>=4 points) were summarized.

Outcome measures

Measure	Belimumab + Placebo n=72 Participants Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 Participants Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=47 Participants Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 8; n=66, 132, 44	47.0 Percentage of participants Interval 34.9 to 59.0	51.5 Percentage of participants Interval 43.0 to 60.0	59.1 Percentage of participants Interval 44.6 to 73.6
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 12; n=66, 133, 44	56.1 Percentage of participants Interval 44.1 to 68.0	50.4 Percentage of participants Interval 41.9 to 58.9	52.3 Percentage of participants Interval 37.5 to 67.0
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 26; n=61, 115, 40	47.5 Percentage of participants Interval 35.0 to 60.1	56.5 Percentage of participants Interval 47.5 to 65.6	45.0 Percentage of participants Interval 29.6 to 60.4
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 40; n=63, 122, 43	54.0 Percentage of participants Interval 41.7 to 66.3	54.1 Percentage of participants Interval 45.3 to 62.9	53.5 Percentage of participants Interval 38.6 to 68.4
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 52; n=64, 120, 41	60.9 Percentage of participants Interval 49.0 to 72.9	58.3 Percentage of participants Interval 49.5 to 67.2	56.1 Percentage of participants Interval 40.9 to 71.3
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 64; n=62, 117, 36	51.6 Percentage of participants Interval 39.2 to 64.1	59.8 Percentage of participants Interval 50.9 to 68.7	52.8 Percentage of participants Interval 36.5 to 69.1
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 72; n=59, 107, 33	57.6 Percentage of participants Interval 45.0 to 70.2	57.0 Percentage of participants Interval 47.6 to 66.4	42.4 Percentage of participants Interval 25.6 to 59.3
Percentage of Participants With Improvement in FACIT-Fatigue Score Exceeding the Minimal Clinically Important Difference (MCID, Greater Than or Equal to [>=]4) Week 104; n=55, 111, 36	56.4 Percentage of participants Interval 43.3 to 69.5	62.2 Percentage of participants Interval 53.1 to 71.2	44.4 Percentage of participants Interval 28.2 to 60.7

Adverse Events

Belimumab + Placebo

Serious events: 10 serious events

Other events: 48 other events

Deaths: 1 deaths

Belimumab + Rituximab

Serious events: 32 serious events

Other events: 109 other events

Deaths: 2 deaths

Belimumab + Standard Therapy

Serious events: 15 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Belimumab + Placebo n=72 participants at risk Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 participants at risk Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=76 participants at risk Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Immune system disorders Allergy to vaccine	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
General disorders Chest pain	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Renal and urinary disorders Nephrolithiasis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Pneumonia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Psychiatric disorders Suicidal behaviour	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Urinary tract infection	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.4% 2/144 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Vascular disorders Vasculitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.4% 2/144 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Abdominal pain lower	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Surgical and medical procedures Abortion induced	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Acute sinusitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Psychiatric disorders Adjustment disorder	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Anaemia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Immune system disorders Anaphylactic reaction	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Skin and subcutaneous tissue disorders Angioedema	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Appendicitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Arthritis bacterial	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Cardiac disorders Atrial fibrillation	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Bartholinitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations COVID-19 pneumonia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Cardiac disorders Cardiac failure congestive	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Cellulitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Diarrhoea	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Gangrene	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Gastritis	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Gastritis viral	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Gastroenteritis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Nervous system disorders Hemiparesis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Hepatitis A	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Hiatus hernia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Hyperplasia of thymic epithelium	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Influenza	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Vascular disorders Jugular vein thrombosis	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Latent tuberculosis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Leukocytosis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Lymphadenopathy	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Cardiac disorders Myocarditis	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Nervous system disorders Nervous system disorder	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Renal and urinary disorders Neurogenic bladder	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Nervous system disorders Neuropsychiatric lupus	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Neutropenia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Eye disorders Ocular myasthenia	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Orchitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Injury, poisoning and procedural complications Overdose	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Skin and subcutaneous tissue disorders Pemphigoid	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Cardiac disorders Pericarditis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Cardiac disorders Pleuropericarditis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Injury, poisoning and procedural complications Poisoning deliberate	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Pyelonephritis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
General disorders Pyrexia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Respiratory tract infection viral	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Sepsis	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Septic shock	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Respiratory, thoracic and mediastinal disorders Shrinking lung syndrome	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Sinusitis	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Spinal cord abscess	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
General disorders Sudden death	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Psychiatric disorders Suicidal ideation	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Psychiatric disorders Suicide attempt	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Vascular disorders Thrombophlebitis superficial	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Ear and labyrinth disorders Tinnitus	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Reproductive system and breast disorders Uterine polyp	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Vascular disorders Vasculitis necrotising	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Volvulus	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.69% 1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/76 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	0.00% 0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .

Other adverse events

Measure	Belimumab + Placebo n=72 participants at risk Participants received Belimumab 200 milligrams (mg) administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab-placebo administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Rituximab n=144 participants at risk Participants received Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Participants also received rituximab 1000 mg administered by IV infusions at Weeks 4 and 6 in double blind manner. Participants received standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Participants did not receive treatment after 52 weeks and were in observation until Week 104.	Belimumab + Standard Therapy n=76 participants at risk Participants received open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Participants also received standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.
Nervous system disorders Headache	18.1% 13/72 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	20.8% 30/144 • Number of events 44 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	10.5% 8/76 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Urinary tract infection	16.7% 12/72 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	16.0% 23/144 • Number of events 27 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	13.2% 10/76 • Number of events 27 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Nasopharyngitis	12.5% 9/72 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	16.0% 23/144 • Number of events 32 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	14.5% 11/76 • Number of events 18 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Upper respiratory tract infection	6.9% 5/72 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	15.3% 22/144 • Number of events 31 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	11.8% 9/76 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 5/72 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	8.3% 12/144 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	13.2% 10/76 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Bronchitis	8.3% 6/72 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	6.9% 10/144 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	9.2% 7/76 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Nausea	2.8% 2/72 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	12.5% 18/144 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.6% 2/76 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Respiratory, thoracic and mediastinal disorders Cough	5.6% 4/72 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	6.2% 9/144 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Diarrhoea	8.3% 6/72 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	4.2% 6/144 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	6.6% 5/76 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Influenza	12.5% 9/72 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.8% 4/144 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Back pain	5.6% 4/72 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.6% 8/144 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Oral herpes	4.2% 3/72 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	6.2% 9/144 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	3.9% 3/76 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Vomiting	2.8% 2/72 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	7.6% 11/144 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.6% 2/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
General disorders Pyrexia	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	6.9% 10/144 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	3.9% 3/76 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Abdominal pain upper	6.9% 5/72 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	4.9% 7/144 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Blood and lymphatic system disorders Neutropenia	2.8% 2/72 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	4.9% 7/144 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Sinusitis	5.6% 4/72 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	4.9% 7/144 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.6% 2/76 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Abdominal pain	2.8% 2/72 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	6.2% 9/144 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Psychiatric disorders Depression	2.8% 2/72 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	4.2% 6/144 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Vascular disorders Hypertension	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	4.9% 7/144 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
General disorders Chest pain	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	4.2% 6/144 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
General disorders Fatigue	6.9% 5/72 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	3.5% 5/144 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.3% 1/76 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	8.3% 6/72 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.1% 3/144 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.6% 2/76 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Infections and infestations Pharyngitis	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.8% 4/144 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Gastrointestinal disorders Dyspepsia	0.00% 0/72 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	2.8% 4/144 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.4% 1/72 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	1.4% 2/144 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .	5.3% 4/76 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to Week 111 (including 8 weeks of safety follow-up). Intent-To-Treat (ITT) Population was used to assess the all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who received at least one dose of study treatment (Belimumab or Rituximab or placebo) .

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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