Trial Outcomes & Findings for A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (NCT NCT00410384)

Last Updated: 2017-02-01

Results Overview

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

819 participants

Primary outcome timeframe

Baseline, 52 Weeks

Results posted on

2017-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Study STARTED	275	271	273
Overall Study COMPLETED	186	199	191
Overall Study NOT COMPLETED	89	72	82

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Study Withdrawal by Subject	28	17	20
Overall Study Adverse Event	23	18	23
Overall Study Lack of Efficacy	20	12	17
Overall Study Lack of Compliance	2	2	2
Overall Study Lost to Follow-up	4	6	6
Overall Study Protocol Violation	6	6	6
Overall Study Physician Decision	3	3	4
Overall Study Other	3	8	4

Baseline Characteristics

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=275 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Total n=819 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 11.9 • n=5 Participants	40.0 years STANDARD_DEVIATION 11.4 • n=7 Participants	40.5 years STANDARD_DEVIATION 11.1 • n=5 Participants	40.2 years STANDARD_DEVIATION 11.5 • n=4 Participants
Age, Customized ≤ 45 years	189 participants n=5 Participants	184 participants n=7 Participants	178 participants n=5 Participants	551 participants n=4 Participants
Age, Customized Between 45 and 65 years	77 participants n=5 Participants	83 participants n=7 Participants	92 participants n=5 Participants	252 participants n=4 Participants
Age, Customized ≥ 65 years	9 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	16 participants n=4 Participants
Gender Female	252 Participants n=5 Participants	253 Participants n=7 Participants	259 Participants n=5 Participants	764 Participants n=4 Participants
Gender Male	23 Participants n=5 Participants	18 Participants n=7 Participants	14 Participants n=5 Participants	55 Participants n=4 Participants
Region of Enrollment North America	145 participants n=5 Participants	155 participants n=7 Participants	136 participants n=5 Participants	436 participants n=4 Participants
Region of Enrollment Europe	100 participants n=5 Participants	90 participants n=7 Participants	105 participants n=5 Participants	295 participants n=4 Participants
Region of Enrollment Central America	30 participants n=5 Participants	26 participants n=7 Participants	32 participants n=5 Participants	88 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 52 Weeks

Population: Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
SLE Responder Index (SRI) Response Rate at Week 52	33.5 Percentage of participants	40.6 Percentage of participants	43.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 76 Weeks

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 76 data.

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
SRI Response Rate at Week 76	32.4 Percentage of participants	39.1 Percentage of participants	38.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 52 Weeks

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.	35.3 Percentage of participants	42.8 Percentage of participants	46.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.

The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Mean Change in Physician's Global Assessment (PGA) at Week 24.	-0.49 Scores on a 3-point scale Standard Error 0.04	-0.47 Scores on a 3-point scale Standard Error 0.04	-0.44 Scores on a 3-point scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.

The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.	3.35 Scores on a scale Standard Error 0.51	3.78 Scores on a scale Standard Error 0.46	3.21 Scores on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline, Weeks 40-52

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose \> 7.5 mg/day.

Outcome measures

Outcome measures
Measure	Placebo n=126 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=130 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=120 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52	12.7 Percentage of participants Interval 0.78 to	19.2 Percentage of participants	17.5 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 80 Weeks

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Adverse Event (AE) Overview Percent of patients with an AE resulting in death	0.0 Percentage of participants	0.7 Percentage of participants	0.4 Percentage of participants
Adverse Event (AE) Overview Percent of patients with at least 1 AE	92.0 Percentage of participants	93.4 Percentage of participants	92.7 Percentage of participants
Adverse Event (AE) Overview Percent of patients with at least 1 Serious AE	19.6 Percentage of participants	23.2 Percentage of participants	22.3 Percentage of participants

Adverse Events

Placebo

Serious events: 54 serious events

Other events: 213 other events

Deaths: 0 deaths

Belimumab 1 mg/kg

Serious events: 63 serious events

Other events: 217 other events

Deaths: 0 deaths

Belimumab 10 mg/kg

Serious events: 61 serious events

Other events: 219 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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

Serious adverse events
Measure	Placebo n=275 participants at risk Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 participants at risk Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 participants at risk Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Hepatobiliary disorders Autoimmune hepatitis	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Anaemia	0.73% 2/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.74% 2/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	1.5% 4/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Haemolytic anaemia	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Leukopenia	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Neutropenia	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Spontaneous haematoma	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Thrombocytopenia	0.73% 2/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Thymus enlargement	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Acute myocardial infarction	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Angina pectoris	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.73% 2/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Atrial fibrillation	0.73% 2/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Bradyarrhythmia	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Bradycardia	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Cardiac arrest	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Cardiac failure	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Mitral valve incompetence	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Myocardial infarction	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Myocardial ischaemia	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Pericardial effusion	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Pericarditis	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Pericarditis lupus	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Cardiac disorders Prinzmetal angina	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Ear and labyrinth disorders Vertigo	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Endocrine disorders Hyperthyroidism	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Eye disorders Chorioretinopathy	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Eye disorders Diplopia	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Abdominal adhesions	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Abdominal pain	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	1.1% 3/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Diarrhoea	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Food poisoning	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Gastric ulcer	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Gastritis	0.73% 2/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Haematemesis	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Ileus	0.36% 1/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.37% 1/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	0.00% 0/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).

Other adverse events
Measure	Placebo n=275 participants at risk Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 1 mg/kg n=271 participants at risk Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.	Belimumab 10 mg/kg n=273 participants at risk Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Infections and infestations Urinary tract infection	14.9% 41/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	18.5% 50/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	15.0% 41/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Anaemia	6.2% 17/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	2.6% 7/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	2.6% 7/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Abdominal pain	5.5% 15/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	6.3% 17/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	6.6% 18/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Abdominal pain upper	3.3% 9/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.0% 19/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	4.0% 11/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Diarrhoea	10.2% 28/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	12.5% 34/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	12.1% 33/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Gastrooesophageal reflux disease	2.2% 6/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.9% 16/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	2.2% 6/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Nausea	9.8% 27/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	15.5% 42/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	16.5% 45/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Vomiting	6.5% 18/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	6.6% 18/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	8.8% 24/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
General disorders Fatigue	8.7% 24/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.6% 26/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.7% 21/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
General disorders Oedema peripheral	7.6% 21/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.6% 26/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.2% 25/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
General disorders Pyrexia	6.9% 19/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	8.1% 22/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.9% 27/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Bronchitis	7.3% 20/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.0% 19/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	11.0% 30/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Gastroenteritis	4.0% 11/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.5% 15/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.1% 14/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Influenza	4.4% 12/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.0% 19/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	2.9% 8/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Nasopharyngitis	8.7% 24/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	10.7% 29/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	15.8% 43/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Oral herpes	2.9% 8/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.5% 15/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	4.0% 11/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Pharyngitis	5.1% 14/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.9% 16/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.9% 16/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Sinusitis	10.2% 28/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.7% 21/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	11.4% 31/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Upper respiratory tract infection	21.1% 58/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	19.6% 53/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	19.8% 54/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Viral upper respiratory tract infection	4.4% 12/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	6.3% 17/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	4.8% 13/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Infections and infestations Vulvovaginal mycotic infection	5.5% 15/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	6.6% 18/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.5% 15/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders Arthralgia	15.3% 42/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	15.5% 42/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	15.0% 41/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders Back pain	7.3% 20/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.2% 25/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.9% 27/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders Myalgia	7.6% 21/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	8.9% 24/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.0% 19/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders Pain in extremity	4.7% 13/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	4.4% 12/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	8.8% 24/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders SLE arthritis	5.1% 14/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	2.6% 7/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	3.3% 9/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Nervous system disorders Dizziness	4.0% 11/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.2% 14/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.9% 16/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Nervous system disorders Headache	13.8% 38/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	20.7% 56/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	15.8% 43/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Psychiatric disorders Anxiety	3.6% 10/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.9% 16/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	2.2% 6/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Psychiatric disorders Depression	3.6% 10/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.2% 14/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.0% 19/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Psychiatric disorders Insomnia	4.7% 13/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.6% 26/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	6.2% 17/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Respiratory, thoracic and mediastinal disorders Cough	5.5% 15/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.7% 21/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	9.5% 26/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Skin and subcutaneous tissue disorders Rash	4.4% 12/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	6.3% 17/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	7.3% 20/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
Vascular disorders Hypertension	7.3% 20/275 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	4.8% 13/271 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).	5.5% 15/273 • Up to 80 weeks Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).