BLISS-SC: A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

• Sponsor: Human Genome Sciences Inc., a GSK Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01484496
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 839
• Locations: 207
• Arms: 2
• Duration (Months): 46.5
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Biological: Placebo; Biological: Belimumab 200 mg SC; Drug: Standard therapy	Phase 3

Detailed Description

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

Study Design

• Study Type: Interventional
• Actual Enrollment: 839 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
• Study Start Date: Nov 16, 2011
• Actual Primary Completion Date: Feb 13, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo plus standard therapy Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.	Biological: Placebo; Placebo; Drug: Standard therapy; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Experimental: Belimumab 200 mg SC plus standard therapy Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.	Biological: Belimumab 200 mg SC; Belimumab 200 mg SC; Other Names: BENLYSTA™ ; Drug: Standard therapy; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.

Outcome Measures

Primary Outcome Measures

1. Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 [Week 52]

   SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).

Secondary Outcome Measures

1. Time to First Severe Flare (as Measured by the Modified SLE Flare Index) [Baseline (Day 0, prior to dosing) to Week 52]

   Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.

2. Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline [Baseline (Day 0, prior to dosing), Weeks 40 through Week 52]

   For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. At least 18 years of age.

2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.

3. Active SLE disease.

4. Autoantibody-positive.

5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

1. Pregnant or nursing.

2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).

3. Have received treatment an investigational biological agent in the past year.

4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.

5. Have severe active lupus kidney disease.

6. Have severe active central nervous system (CNS) lupus.

7. Have required management of acute or chronic infections within the past 60 days.

8. Have current drug or alcohol abuse or dependence.

9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis

1. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35294
2	GSK Investigational Site	Peoria	Arizona	United States	85381
3	GSK Investigational Site	Tucson	Arizona	United States	85712
4	GSK Investigational Site	Tucson	Arizona	United States	85724
5	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
6	GSK Investigational Site	La Jolla	California	United States	92037-0943
7	GSK Investigational Site	Long Beach	California	United States	90806
8	GSK Investigational Site	Los Angeles	California	United States	90033
9	GSK Investigational Site	San Diego	California	United States	92120
10	GSK Investigational Site	San Francisco	California	United States	94118
11	GSK Investigational Site	San Jose	California	United States	95126-1650
12	GSK Investigational Site	San Leandro	California	United States	94578
13	GSK Investigational Site	Tustin	California	United States	92780
14	GSK Investigational Site	Upland	California	United States	91786
15	GSK Investigational Site	Bridgeport	Connecticut	United States	06606
16	GSK Investigational Site	Aventura	Florida	United States	33180
17	GSK Investigational Site	Boca Raton	Florida	United States	33432
18	GSK Investigational Site	Boca Raton	Florida	United States	33486
19	GSK Investigational Site	Coral Gables	Florida	United States	33134
20	GSK Investigational Site	Fort Lauderdale	Florida	United States	33334
21	GSK Investigational Site	Miami	Florida	United States	33136
22	GSK Investigational Site	Orlando	Florida	United States	32804
23	GSK Investigational Site	Orlando	Florida	United States	32806-6264
24	GSK Investigational Site	Plantation	Florida	United States	33324
25	GSK Investigational Site	Tampa	Florida	United States	33614
26	GSK Investigational Site	Atlanta	Georgia	United States	30303
27	GSK Investigational Site	Atlanta	Georgia	United States	30342
28	GSK Investigational Site	Duluth	Georgia	United States	30096
29	GSK Investigational Site	Lawrenceville	Georgia	United States	30045
30	GSK Investigational Site	Marietta	Georgia	United States	30060
31	GSK Investigational Site	Boise	Idaho	United States	83704
32	GSK Investigational Site	Springfield	Illinois	United States	62704
33	GSK Investigational Site	Baton Rouge	Louisiana	United States	70809
34	GSK Investigational Site	New Orleans	Louisiana	United States	70121
35	GSK Investigational Site	Baltimore	Maryland	United States	21205
36	GSK Investigational Site	Cumberland	Maryland	United States	21502
37	GSK Investigational Site	Hagerstown	Maryland	United States	21740
38	GSK Investigational Site	Boston	Massachusetts	United States	02115
39	GSK Investigational Site	Boston	Massachusetts	United States	02118
40	GSK Investigational Site	Detroit	Michigan	United States	48202
41	GSK Investigational Site	Saint Clair Shores	Michigan	United States	48081
42	GSK Investigational Site	Jackson	Mississippi	United States	39202
43	GSK Investigational Site	Saint Louis	Missouri	United States	63110
44	GSK Investigational Site	Las Cruces	New Mexico	United States	88011
45	GSK Investigational Site	Brooklyn	New York	United States	11203
46	GSK Investigational Site	Lake Success	New York	United States	11042
47	GSK Investigational Site	Manhasset	New York	United States	11030
48	GSK Investigational Site	New York	New York	United States	10016
49	GSK Investigational Site	Smithtown	New York	United States	11787
50	GSK Investigational Site	Chapel Hill	North Carolina	United States	27599-7280
51	GSK Investigational Site	Charlotte	North Carolina	United States	28207
52	GSK Investigational Site	Charlotte	North Carolina	United States	28210
53	GSK Investigational Site	Durham	North Carolina	United States	27710
54	GSK Investigational Site	Greenville	North Carolina	United States	27834
55	GSK Investigational Site	Cleveland	Ohio	United States	44109
56	GSK Investigational Site	Columbus	Ohio	United States	43203
57	GSK Investigational Site	Dayton	Ohio	United States	45417
58	GSK Investigational Site	Toledo	Ohio	United States	43614
59	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73103
60	GSK Investigational Site	Tulsa	Oklahoma	United States	74104
61	GSK Investigational Site	Bethlehem	Pennsylvania	United States	18015
62	GSK Investigational Site	Duncansville	Pennsylvania	United States	16635
63	GSK Investigational Site	Wyomissing	Pennsylvania	United States	19610
64	GSK Investigational Site	Charleston	South Carolina	United States	29406
65	GSK Investigational Site	Charleston	South Carolina	United States	29425
66	GSK Investigational Site	Greenville	South Carolina	United States	29601
67	GSK Investigational Site	Orangeburg	South Carolina	United States	29118
68	GSK Investigational Site	Jackson	Tennessee	United States	38305
69	GSK Investigational Site	Memphis	Tennessee	United States	38119
70	GSK Investigational Site	Allentown	Texas	United States	75013
71	GSK Investigational Site	Austin	Texas	United States	78705
72	GSK Investigational Site	Austin	Texas	United States	78758
73	GSK Investigational Site	Dallas	Texas	United States	75231
74	GSK Investigational Site	Houston	Texas	United States	77004
75	GSK Investigational Site	Houston	Texas	United States	77008
76	GSK Investigational Site	Houston	Texas	United States	77034
77	GSK Investigational Site	Houston	Texas	United States	77074
78	GSK Investigational Site	Nassau Bay	Texas	United States	77058
79	GSK Investigational Site	Arlington	Virginia	United States	22205-3606
80	GSK Investigational Site	Seattle	Washington	United States	98133
81	GSK Investigational Site	Milwaukee	Wisconsin	United States	53226
82	GSK Investigational Site	Pennsylvania	Wyoming	United States	19610
83	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1181ACI
84	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1419AHN
85	GSK Investigational Site	La Plata	Buenos Aires	Argentina	B1902COS
86	GSK Investigational Site	Ciudad Autonoma Buenos Aires		Argentina	C1015ABO
87	GSK Investigational Site	Ciudad Autonoma Buenos Aires		Argentina	C1426AAL
88	GSK Investigational Site	Vienna		Austria	A-1100
89	GSK Investigational Site	Brussels		Belgium	1090
90	GSK Investigational Site	Bruxelles		Belgium	1200
91	GSK Investigational Site	Liège		Belgium	4000
92	GSK Investigational Site	Cuiaba	Mato Grosso	Brazil	78005-000
93	GSK Investigational Site	Juiz de Fora	Minas Gerais	Brazil	36038-330
94	GSK Investigational Site	Curitiba	Paraná	Brazil	80440-080
95	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90035-903
96	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90110-270
97	GSK Investigational Site	Rio de Janeiro		Brazil	21941-913
98	GSK Investigational Site	Salvador		Brazil	40050-410
99	GSK Investigational Site	São Paulo		Brazil	04032-060
100	GSK Investigational Site	Plovdiv		Bulgaria	4002
101	GSK Investigational Site	Ruse		Bulgaria	7002
102	GSK Investigational Site	Sofia		Bulgaria	1784
103	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	7501126
104	GSK Investigational Site	Santiago		Chile	7500000
105	GSK Investigational Site	Viña del Mar		Chile	2570017
106	GSK Investigational Site	Barranquilla		Colombia
107	GSK Investigational Site	Bogota		Colombia
108	GSK Investigational Site	Bucaramanga		Colombia
109	GSK Investigational Site	Medellin		Colombia
110	GSK Investigational Site	Osijek		Croatia	31000
111	GSK Investigational Site	Rijeka		Croatia	51000
112	GSK Investigational Site	Zagreb		Croatia	10000
113	GSK Investigational Site	Praha 2		Czechia	128 50
114	GSK Investigational Site	Zlin		Czechia	760 01
115	GSK Investigational Site	Koebenhavn		Denmark	2100
116	GSK Investigational Site	Odense C		Denmark	5000
117	GSK Investigational Site	Paris cedex 13		France	75651
118	GSK Investigational Site	Paris		France	75679
119	GSK Investigational Site	Pessac Cedex		France	33604
120	GSK Investigational Site	Strasbourg cedex		France	67091
121	GSK Investigational Site	Suresnes		France	92150
122	GSK Investigational Site	Vandoeuvre les Nancy		France	54511
123	GSK Investigational Site	Wuerzburg	Bayern	Germany	97080
124	GSK Investigational Site	Bad Nauheim	Hessen	Germany	61231
125	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
126	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen	Germany	40225
127	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55131
128	GSK Investigational Site	Frankfurt		Germany	60590
129	GSK Investigational Site	Hamburg		Germany	22081
130	GSK Investigational Site	Debrecen		Hungary	4032
131	GSK Investigational Site	Zalaegerszeg		Hungary	8900
132	GSK Investigational Site	Pisa	Toscana	Italy	56126
133	GSK Investigational Site	Padova	Veneto	Italy	35128
134	GSK Investigational Site	Genova		Italy	16132
135	GSK Investigational Site	Fukuoka		Japan	807-8555
136	GSK Investigational Site	Fukuoka		Japan	810-8563
137	GSK Investigational Site	Hokkaido		Japan	060-8604
138	GSK Investigational Site	Hokkaido		Japan	060-8648
139	GSK Investigational Site	Miyagi		Japan	980-8574
140	GSK Investigational Site	Nagasaki		Japan	857-1195
141	GSK Investigational Site	Okinawa		Japan	901-0243
142	GSK Investigational Site	Shizuoka		Japan	430-8558
143	GSK Investigational Site	Tokyo		Japan	104-8560
144	GSK Investigational Site	Tokyo		Japan	160-8582
145	GSK Investigational Site	Tokyo		Japan	162-8655
146	GSK Investigational Site	Kuala Lumpur		Malaysia	59100
147	GSK Investigational Site	Seremban, Negeri Sembilan		Malaysia	70300
148	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44158
149	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44690
150	GSK Investigational Site	Cuernavaca	Morelos	Mexico	62270
151	GSK Investigational Site	Merida	Yucatán	Mexico	97130
152	GSK Investigational Site	Mexico		Mexico	06700
153	GSK Investigational Site	Mexico		Mexico	3100
154	GSK Investigational Site	San Luis Potosi		Mexico	78240
155	GSK Investigational Site	Cebu City		Philippines	6000
156	GSK Investigational Site	Davao City		Philippines	8000
157	GSK Investigational Site	Iloilo City		Philippines	5000
158	GSK Investigational Site	Las Pinas		Philippines	1740
159	GSK Investigational Site	Manila		Philippines	1000
160	GSK Investigational Site	Manila		Philippines	1015
161	GSK Investigational Site	Quezon City		Philippines	1102
162	GSK Investigational Site	Quezon City		Philippines	1118
163	GSK Investigational Site	Bydgoszcz		Poland	85-168
164	GSK Investigational Site	Katowice		Poland	40-635
165	GSK Investigational Site	Krakow		Poland	31-066
166	GSK Investigational Site	Wroclaw		Poland	50-556
167	GSK Investigational Site	Almada		Portugal	2801-915
168	GSK Investigational Site	Amadora		Portugal	2720-276
169	GSK Investigational Site	Coimbra		Portugal	3000-075
170	GSK Investigational Site	Lisboa		Portugal	1649-035
171	GSK Investigational Site	Porto		Portugal	4099-001
172	GSK Investigational Site	Bucharest		Romania	020125
173	GSK Investigational Site	Bucharest		Romania	11172
174	GSK Investigational Site	Bucuresti		Romania	020475
175	GSK Investigational Site	Moscow		Russian Federation	115522
176	GSK Investigational Site	Saint-Petersburg		Russian Federation	190068
177	GSK Investigational Site	Yaroslavl		Russian Federation	150030
178	GSK Investigational Site	Belgrade		Serbia	11000
179	GSK Investigational Site	Belgrade		Serbia	11080
180	GSK Investigational Site	Singapore		Singapore	529889
181	GSK Investigational Site	Barcelona		Spain	08036
182	GSK Investigational Site	Barcelona		Spain	8035
183	GSK Investigational Site	Granada		Spain	18012
184	GSK Investigational Site	Göteborg		Sweden	SE-413 45
185	GSK Investigational Site	Lund		Sweden	SE-221 85
186	GSK Investigational Site	Stockholm		Sweden	SE-171 76
187	GSK Investigational Site	Gueishan Township,Taoyuan County		Taiwan	333
188	GSK Investigational Site	Kaohsiung		Taiwan	807
189	GSK Investigational Site	Kaohsiung		Taiwan	813
190	GSK Investigational Site	Kaohsiung		Taiwan	833
191	GSK Investigational Site	Taichung		Taiwan	404
192	GSK Investigational Site	Taipei		Taiwan	100
193	GSK Investigational Site	Bangkok		Thailand	10400
194	GSK Investigational Site	Bangkok		Thailand	10700
195	GSK Investigational Site	Chiangmai		Thailand	50200
196	GSK Investigational Site	Rajathevee		Thailand	10400
197	GSK Investigational Site	Ratchatewi		Thailand	10400
198	GSK Investigational Site	Songkla		Thailand	90110
199	GSK Investigational Site	Kharkiv		Ukraine	61039
200	GSK Investigational Site	Kyiv		Ukraine	01601
201	GSK Investigational Site	Odesa		Ukraine	65026
202	GSK Investigational Site	Poltava		Ukraine	36011
203	GSK Investigational Site	Vinnytsia		Ukraine	21018
204	GSK Investigational Site	Zaporizhzhia		Ukraine	69600
205	GSK Investigational Site	Coventry	Warwickshire	United Kingdom	CV2 2DX
206	GSK Investigational Site	Birmingham		United Kingdom	B15 2TH
207	GSK Investigational Site	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

• Human Genome Sciences Inc., a GSK Company
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: Human Genome Sciences Inc., a GSK Company
• ClinicalTrials.gov Identifier: NCT01484496
• Other Study ID Numbers: 112341; 2011-003814-18; HGS1006-C1115
• First Posted: Dec 2, 2011
• Last Update Posted: Jun 6, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Human Genome Sciences Inc., a GSK Company: Subcutaneous; Lupus; Systemic Lupus Erythematosus; SLE; Belimumab; Autoimmune Disease; Antibodies
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Belimumab

Study Results

Participant Flow

Recruitment Details	Participants (Par.) with active systemic lupus erythematosus (SLE) and who were on appropriate stable standard SLE therapy for a period of at least 30 days prior to Day 0 before entering the study were eligible for participation in the study.
Pre-assignment Detail	A total of 1427 par. were screened, out of these 588 par. were screen failures and 839 par. were randomized, of which 836 par. received at least one dose of study treatment. Par. who successfully completed the initial 52-week Double-blind Phase had a choice to enter into a 6-month Open-label Extension Phase of this study.

Arm/Group Title	Placebo SC	Belimumab 200 mg SC	Open-Label - Placebo SC to Belimumab 200 mg SC	Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
Arm/Group Description	Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly
Period Title: Period 1
STARTED	280	556	0	0
COMPLETED	214	463	0	0
NOT COMPLETED	66	93	0	0
Period Title: Period 1
STARTED	0	0	206	456
COMPLETED	0	0	191	434
NOT COMPLETED	0	0	15	22

Baseline Characteristics

Arm/Group Title	Placebo SC	Belimumab 200 mg SC	Total
Arm/Group Description	Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Total of all reporting groups
Overall Participants	280	556	836
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.6 (12.61)	38.1 (12.10)	38.6 (12.29)
Sex: Female, Male (Count of Participants)
Female	268 95.7%	521 93.7%	789 94.4%
Male	12 4.3%	35 6.3%	47 5.6%
Race/Ethnicity, Customized (participants) [Number]
White/Caucasian/European Heritage	160 57.1%	326 58.6%	486 58.1%
Middle East/North African Heritage	6 2.1%	10 1.8%	16 1.9%
Central Asian Heritage	0 0%	2 0.4%	2 0.2%
East Asian Heritage	15 5.4%	29 5.2%	44 5.3%
Japanese Heritage	16 5.7%	13 2.3%	29 3.5%
South Asian Heritage	0 0%	2 0.4%	2 0.2%
Southeast Asian Heritage	32 11.4%	73 13.1%	105 12.6%
African American/African Heritage	30 10.7%	56 10.1%	86 10.3%
American Indian or Alaska Native	21 7.5%	43 7.7%	64 7.7%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.4%	2 0.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Description	SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included.

Arm/Group Title	Placebo SC	Belimumab 200 mg SC
Arm/Group Description	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Measure Participants	279	554
Number [Percentage of par.]	48.4	61.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo SC, Belimumab 200 mg SC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.68
	Confidence Interval	(2-Sided) 95%; 1.25 to 2.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Description	Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.
Time Frame	Baseline (Day 0, prior to dosing) to Week 52

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at that particular timepoints were analyzed.

Arm/Group Title	Placebo SC	Belimumab 200 mg SC
Arm/Group Description	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Measure Participants	51	59
Median (Full Range) [Days]	118	171

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo SC, Belimumab 200 mg SC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95%; 0.35 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline
Description	For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Time Frame	Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

Outcome Measure Data

Analysis Population Description

ITT population. Only par. with Baseline prednisone dose >7.5 mg/day were included.

Arm/Group Title	Placebo SC	Belimumab 200 mg SC
Arm/Group Description	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Measure Participants	168	335
Number [Percentage of par.]	11.9	18.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo SC, Belimumab 200 mg SC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0732
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.65
	Confidence Interval	(2-Sided) 95%; 0.95 to 2.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period.
Adverse Event Reporting Description	SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Arm/Group Title	Placebo SC		Belimumab 200 mg SC		Open-Label - Placebo SC to Belimumab 200 mg SC		Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
Arm/Group Description	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.		Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.		Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.		Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
All Cause Mortality
	Placebo SC		Belimumab 200 mg SC		Open-Label - Placebo SC to Belimumab 200 mg SC		Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/280 (0.7%)		3/556 (0.5%)		0/206 (0%)		0/456 (0%)
Serious Adverse Events
	Placebo SC		Belimumab 200 mg SC		Open-Label - Placebo SC to Belimumab 200 mg SC		Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/280 (15.7%)		60/556 (10.8%)		14/206 (6.8%)		25/456 (5.5%)
Blood and lymphatic system disorders
Thrombocytopenia	3/280 (1.1%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Anaemia	1/280 (0.4%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Disseminated intravascular coagulation	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Febrile neutropenia	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Hypochromic anaemia	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Antiphospholipid syndrome	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Iron deficiency anaemia	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Cardiac disorders
Myocardial infarction	0/280 (0%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Cardiac arrest	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Cardiac failure congestive	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Coronary artery disease	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Mitral valve incompetence	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Pericarditis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Ear and labyrinth disorders
Vertigo	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Eye disorders
Cataract	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Exfoliation syndrome	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Eyelid oedema	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Gastrointestinal disorders
Abdominal pain	1/280 (0.4%)		1/556 (0.2%)		0/206 (0%)		1/456 (0.2%)
Dysphagia	2/280 (0.7%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Small intestinal obstruction	0/280 (0%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Abdominal hernia	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Abdominal pain upper	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Diarrhoea	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Haemorrhoids thrombosed	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Mouth ulceration	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Pancreatitis chronic	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		1/456 (0.2%)
Vomiting	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Large intestine perforation	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Gastric ulcer	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Lip swelling	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
General disorders
Non-cardiac chest pain	1/280 (0.4%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Pyrexia	0/280 (0%)		3/556 (0.5%)		0/206 (0%)		0/456 (0%)
Peripheral swelling	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Systemic inflammatory response syndrome	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Hepatobiliary disorders
Cholecystitis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Cholecystitis chronic	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Immune system disorders
Drug hypersensitivity	0/280 (0%)		1/556 (0.2%)		1/206 (0.5%)		0/456 (0%)
Infections and infestations
Cellulitis	2/280 (0.7%)		3/556 (0.5%)		0/206 (0%)		1/456 (0.2%)
Pneumonia	1/280 (0.4%)		4/556 (0.7%)		1/206 (0.5%)		1/456 (0.2%)
Pneumonia bacterial	2/280 (0.7%)		3/556 (0.5%)		0/206 (0%)		0/456 (0%)
Urosepsis	0/280 (0%)		3/556 (0.5%)		0/206 (0%)		0/456 (0%)
Bacterial sepsis	0/280 (0%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Urinary tract infection bacterial	0/280 (0%)		2/556 (0.4%)		0/206 (0%)		1/456 (0.2%)
Amoebic dysentery	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Bronchitis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Corynebacterium sepsis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Dengue fever	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Diarrhoea infectious	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Escherichia urinary tract infection	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
External ear cellulitis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Gastroenteritis viral	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Herpes virus infection	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Herpes zoster	0/280 (0%)		1/556 (0.2%)		2/206 (1%)		0/456 (0%)
Meningitis bacterial	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Oral candidiasis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Osteomyelitis bacterial	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Perirectal abscess	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Pulmonary tuberculosis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Pyelonephritis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Pyelonephritis acute	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		1/456 (0.2%)
Respiratory syncytial virus bronchitis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Salmonellosis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Septic shock	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Subcutaneous abscess	1/280 (0.4%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Tuberculosis of central nervous system	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Urinary tract infection	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Viral upper respiratory tract infection	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Abdominal abscess	0/280 (0%)		0/556 (0%)		2/206 (1%)		0/456 (0%)
Appendicitis	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Bronchitis viral	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Mycobacterial infection	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Paraspinal abscess	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Arthritis infective	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Cystitis bacterial	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Gastroenteritis	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Staphylococcal sepsis	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Tuberculosis	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Urinary tract infection staphylococcal	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Injury, poisoning and procedural complications
Procedural vomiting	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Ankle fracture	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Humerus fracture	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Rib fracture	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Investigations
Hepatic enzyme increased	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
International normalised ratio increased	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Liver function test abnormal	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Troponin increased	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Metabolism and nutrition disorders
Electrolyte imbalance	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Hypernatraemia	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Metabolic acidosis	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Dehydration	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Musculoskeletal and connective tissue disorders
SLE arthritis	1/280 (0.4%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Arthralgia	0/280 (0%)		1/556 (0.2%)		1/206 (0.5%)		0/456 (0%)
Back pain	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Costochondritis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Musculoskeletal chest pain	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Neck pain	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Osteoarthritis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Pain in extremity	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Polyarthritis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Synovitis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Endometrial cancer	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Intraductal proliferative breast lesion	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Lipoma of breast	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Thyroid neoplasm	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Nervous system disorders
Cerebrovascular accident	1/280 (0.4%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Headache	2/280 (0.7%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Neuropsychiatric lupus	0/280 (0%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Syncope	1/280 (0.4%)		1/556 (0.2%)		0/206 (0%)		1/456 (0.2%)
Generalised tonic-clonic seizure	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Haemorrhage intracranial	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Intracranial venous sinus thrombosis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Lupus encephalitis	1/280 (0.4%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Transient ischaemic attack	0/280 (0%)		1/556 (0.2%)		1/206 (0.5%)		0/456 (0%)
Vocal cord paralysis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Central nervous system lupus	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/280 (0%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Psychiatric disorders
Suicidal ideation	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Depression	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Suicide attempt	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Renal and urinary disorders
Renal failure acute	0/280 (0%)		4/556 (0.7%)		0/206 (0%)		0/456 (0%)
Lupus nephritis	1/280 (0.4%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Nephritis	1/280 (0.4%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Nephrotic syndrome	2/280 (0.7%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Nephritic syndrome	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Nephrolithiasis	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Proteinuria	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Renal tubular necrosis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Acute kidney injury	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		2/456 (0.4%)
Haematuria	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Reproductive system and breast disorders
Cervical dysplasia	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Cystocele	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Ovarian cyst	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Uterine polyp	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Uterine prolapse	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Vaginal haemorrhage	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Polycystic ovaries	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Respiratory, thoracic and mediastinal disorders
Pleurisy	1/280 (0.4%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Acute respiratory failure	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		1/456 (0.2%)
Alveolitis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Dyspnoea	1/280 (0.4%)		0/556 (0%)		1/206 (0.5%)		1/456 (0.2%)
Pulmonary arterial hypertension	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Pulmonary haemorrhage	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Lupus pleurisy	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Pleuritic pain	0/280 (0%)		0/556 (0%)		1/206 (0.5%)		0/456 (0%)
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash	1/280 (0.4%)		2/556 (0.4%)		0/206 (0%)		0/456 (0%)
Angioedema	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Drug eruption	1/280 (0.4%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Skin ulcer	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Urticaria	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		1/456 (0.2%)
Rash pruritic	0/280 (0%)		0/556 (0%)		0/206 (0%)		1/456 (0.2%)
Vascular disorders
Deep vein thrombosis	1/280 (0.4%)		1/556 (0.2%)		1/206 (0.5%)		2/456 (0.4%)
Lupus vasculitis	2/280 (0.7%)		0/556 (0%)		0/206 (0%)		0/456 (0%)
Hypertension	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Orthostatic hypotension	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Thrombosis	0/280 (0%)		1/556 (0.2%)		0/206 (0%)		0/456 (0%)
Other (Not Including Serious) Adverse Events
	Placebo SC		Belimumab 200 mg SC		Open-Label - Placebo SC to Belimumab 200 mg SC		Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	218/280 (77.9%)		403/556 (72.5%)		42/206 (20.4%)		78/456 (17.1%)
Gastrointestinal disorders
Nausea	22/280 (7.9%)		38/556 (6.8%)		1/206 (0.5%)		5/456 (1.1%)
Diarrhoea	14/280 (5%)		27/556 (4.9%)		3/206 (1.5%)		8/456 (1.8%)
Infections and infestations
Viral upper respiratory tract infection	24/280 (8.6%)		48/556 (8.6%)		9/206 (4.4%)		17/456 (3.7%)
Nasopharyngitis	22/280 (7.9%)		38/556 (6.8%)		9/206 (4.4%)		7/456 (1.5%)
Urinary tract infection bacterial	18/280 (6.4%)		41/556 (7.4%)		2/206 (1%)		14/456 (3.1%)
Upper respiratory tract infection bacterial	14/280 (5%)		30/556 (5.4%)		3/206 (1.5%)		9/456 (2%)
Musculoskeletal and connective tissue disorders
Back pain	15/280 (5.4%)		28/556 (5%)		4/206 (1.9%)		5/456 (1.1%)
Arthralgia	11/280 (3.9%)		31/556 (5.6%)		6/206 (2.9%)		11/456 (2.4%)
Nervous system disorders
Headache	25/280 (8.9%)		57/556 (10.3%)		4/206 (1.9%)		10/456 (2.2%)
Psychiatric disorders
Insomnia	20/280 (7.1%)		18/556 (3.2%)		0/206 (0%)		1/456 (0.2%)
Respiratory, thoracic and mediastinal disorders
Cough	19/280 (6.8%)		22/556 (4%)		1/206 (0.5%)		8/456 (1.8%)
Vascular disorders
Hypertension	14/280 (5%)		25/556 (4.5%)		4/206 (1.9%)		2/456 (0.4%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.