Trial Outcomes & Findings for BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115 (NCT NCT01597622)

Last Updated: 2020-03-27

Results Overview

Any untoward medical occurrence in participant, temporally associated with use of medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death,life threatening,requires hospitalization or prolongation of existing hospitalization,results in disability/incapacity,congenital anomaly/birth defect,medically important were categorized as SAE. Number of participants who had any AE(includes those having non-serious and/or serious AEs) or any SAE are presented.Treatment-emergent AEs are defined as AEs that started on or after first dose of belimumab treatment and for those participants who were randomized to placebo in parent study,ongoing AEs that started before first open-label belimumab dose(in either C1115 open-label extension or BEL114333),worsened (severity,seriousness,relatedness) at any point during the open-label treatment.Timeframe includes exposure in parent study/upto16 weeks post infusion in current study(114333).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

142 participants

Primary outcome timeframe

Up to 6 calendar years and 9 months

Results posted on

2020-03-27

Participant Flow

This was multicenter, open-label continuation study of belimumab plus standard of care (SOC) in Systemic Lupus Erythematosus (SLE) participants who completed study BEL113750 (NCT01345253) in Northeast Asia (Japan and Korea) \& participants who completed the open-label extension of C1115 (NCT01484496) in Japan to assess long term safety \& efficacy.

Total 143 participants were screened for this study and 142 participants were enrolled and received study treatment in current study. BEL113750, a 52 week double-blind study; C1115, a 52 week double-blind study followed by a 6 month open-label extension.

Participant milestones

Participant milestones
Measure	Open-label Belimumab 10 mg/kg Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator.
Overall Study STARTED	142
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Belimumab 10 mg/kg Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator.
Overall Study Adverse Event	7
Overall Study Lack of Efficacy	3
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1
Overall Study Investigator Discretion	5
Overall Study Withdrawal by Subject	20
Overall Study Death	1

Baseline Characteristics

BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Belimumab 10 mg/kg n=142 Participants Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Age, Continuous	34.6 Years STANDARD_DEVIATION 9.28 • n=93 Participants
Sex: Female, Male Female	129 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=93 Participants
Race/Ethnicity, Customized Japanese Heritage	71 Participants n=93 Participants
Race/Ethnicity, Customized East Asian Heritage	68 Participants n=93 Participants
Race/Ethnicity, Customized Southeast Asian Heritage	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 6 calendar years and 9 months

Population: Safety Population. All participants in the Enrolled population who received at least one IV dose of belimumab during current study.

Outcome measures

Outcome measures
Measure	Open-label Belimumab 10 mg/kg n=142 Participants Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Any SAEs	48 Participants
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Any AEs	139 Participants

SECONDARY outcome

Timeframe: Study Years 1 to 7: At Week 24 and 48 Visits, Year 8: only Week 24 Visit

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

SRI response is composite index, defined as percent of participants with\>=4 point reduction from Baseline in safety of estrogen in lupus national assessment systemic lupus erythematosus disease activity index (SELENA-SLEDAI) score and no worsening (increase of \<0.30 points from Baseline) in physicians global assessment(PGA) \&no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0(no activity) to 3(severe activity). BILAG has no range. Baseline is last available value prior to first belimumab exposure. Year 8 Week 24 visit is the Exit Visit obtained by slotting the Exit Visit to Week 24. Timeframe includes exposure in parent study/upto 4 weeks post infusion (Exit visit) in current study (114333).

Outcome measures

Outcome measures
Measure	Open-label Belimumab 10 mg/kg n=142 Participants Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 1 Week 24, n=136	47.8 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 1, Week 48, n=133	51.1 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 2, Week 24, n=129	55.0 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 2, Week 48, n=121	53.7 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 3, Week 24, n=103	57.3 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 3, Week 48, n=88	68.2 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 4, Week 24, n=80	67.5 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 4, Week 48, n=60	76.7 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 5, Week 24, n=32	71.9 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 5, Week 48, n=29	69.0 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 6, Week 24, n=24	66.7 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 6, Week 48, n=22	68.2 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 7, Week 24, n=18	83.3 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 7, Week 48, n=13	84.6 Percentage of Participants
Percentage of SLE Responder Index (SRI) Responders by Study Visit Year 8, Week 24, n=1	100 Percentage of Participants

Adverse Events

Open-label Belimumab 10 mg/kg

Serious events: 48 serious events

Other events: 134 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Open-label Belimumab 10 mg/kg n=142 participants at risk Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Infections and infestations Cellulitis	2.1% 3/142 • Number of events 3 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Herpes zoster	2.1% 3/142 • Number of events 3 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Endocarditis	1.4% 2/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Pyelonephritis acute	1.4% 2/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Abscess jaw	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Atypical pneumonia	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Bacterial pyelonephritis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Escherichia urinary tract infection	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations External ear cellulitis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Gastroenteritis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Gastroenteritis salmonella	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Genital herpes zoster	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Herpes dermatitis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Herpes simplex pharyngitis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Infectious colitis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Oral herpes	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Pelvic inflammatory disease	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Pneumonia	0.70% 1/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Pneumonia bacterial	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Skin infection	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Tonsillitis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Tuberculous pleurisy	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Viral upper respiratory tract infection	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Contusion	2.1% 3/142 • Number of events 3 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Ligament rupture	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Post procedural complication	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Radius fracture	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Road traffic accident	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Tibia fracture	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Abdominal pain	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Intestinal perforation	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Large intestine polyp	0.70% 1/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Lupus pancreatitis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
General disorders Pyrexia	1.4% 2/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
General disorders Oedema peripheral	0.70% 1/142 • Number of events 3 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.4% 2/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Skin ulcer	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Blood and lymphatic system disorders Leukopenia	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Blood and lymphatic system disorders Lymphadenopathy	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Investigations Alanine aminotransferase increased	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Investigations Aspartate aminotransferase increased	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Investigations Protein urine present	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.4% 2/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Nervous system disorders Brain stem infarction	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Nervous system disorders Putamen haemorrhage	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Renal and urinary disorders Acute kidney injury	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Renal and urinary disorders Nephrolithiasis	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Renal and urinary disorders Ureterolithiasis	0.70% 1/142 • Number of events 2 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Cardiac disorders Pericarditis lupus	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Ear and labyrinth disorders Vertigo	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Endocrine disorders Diabetes insipidus	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Eye disorders Cataract	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Metabolism and nutrition disorders Hypoalbuminaemia	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Psychiatric disorders Depression	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Reproductive system and breast disorders Menorrhagia	0.70% 1/142 • Number of events 1 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.

Other adverse events

Other adverse events
Measure	Open-label Belimumab 10 mg/kg n=142 participants at risk Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Infections and infestations Nasopharyngitis	60.6% 86/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Viral upper respiratory tract infection	17.6% 25/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Herpes zoster	16.2% 23/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Upper respiratory tract infection	15.5% 22/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Influenza	14.1% 20/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Gastroenteritis	12.7% 18/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Pharyngitis	9.9% 14/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Bronchitis	9.2% 13/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Cystitis	8.5% 12/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Oral herpes	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Urinary tract infection bacterial	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Hordeolum	6.3% 9/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Infections and infestations Conjunctivitis	5.6% 8/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Abdominal pain upper	16.2% 23/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Nausea	16.2% 23/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Diarrhoea	15.5% 22/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Constipation	12.0% 17/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Abdominal pain	11.3% 16/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Vomiting	11.3% 16/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Dental caries	9.2% 13/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Gastrointestinal disorders Dyspepsia	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Dermatitis contact	9.2% 13/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Rash	8.5% 12/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Eczema	7.0% 10/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Acne	6.3% 9/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Skin and subcutaneous tissue disorders Urticaria	6.3% 9/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Musculoskeletal and connective tissue disorders Back pain	12.7% 18/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Musculoskeletal and connective tissue disorders Arthralgia	11.3% 16/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Musculoskeletal and connective tissue disorders Myalgia	11.3% 16/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Nervous system disorders Headache	28.2% 40/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Nervous system disorders Dizziness	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Respiratory, thoracic and mediastinal disorders Cough	18.3% 26/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.0% 10/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.3% 9/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.3% 9/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Contusion	11.3% 16/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Ligament sprain	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Injury, poisoning and procedural complications Thermal burn	5.6% 8/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
General disorders Pyrexia	13.4% 19/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
General disorders Oedema peripheral	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Psychiatric disorders Insomnia	12.0% 17/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Reproductive system and breast disorders Dysmenorrhoea	5.6% 8/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Vascular disorders Hypertension	7.7% 11/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	5.6% 8/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Ear and labyrinth disorders Vertigo	6.3% 9/142 • Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months. Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.

Additional Information

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GlaxoSmithKline

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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

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