Trial Outcomes & Findings for Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (NCT NCT01649765)

NCT ID: NCT01649765

Last Updated: 2022-11-16

Results Overview

SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of \<0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (\<=12 vs. \>=13). Percentage of participants with SRI response at Week 52 of Part A were reported. Intent-to-Treat Population comprised of all participants who were randomized and treated with at least one dose of study agent in Part A. One participant had missing data at Baseline and therefore, could not be included in the analysis.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 93 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2022-11-16

Participant Flow

A total of 93 pediatric participants with Systemic Lupus Erythematosus (SLE) were enrolled at 29 study centers in 10 different countries. This was a multi-center study to evaluate the safety, efficacy and pharmacokinetics of belimumab plus background standard therapy. The results presented are based on Part A (double blind).

The study consisted of three separate phases: Randomized, placebo-controlled, double-blind 52-week treatment phase (Part A), Long term belimumab open label safety follow up for participants who completed Part A (Part B) and Long term safety follow-up phase for participants who were withdrawn from Part A or Part B at any time (Part C).

Participant milestones

Measure	Placebo Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Study STARTED	40	53
Overall Study COMPLETED	31	45
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Measure	Placebo Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Study Adverse Event	5	3
Overall Study Lack of Efficacy	1	1
Overall Study Physician Decision	0	3
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Baseline characteristics by cohort

Measure	Placebo n=40 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.	Total n=93 Participants Total of all reporting groups
Age, Continuous	14.8 Years STANDARD_DEVIATION 2.17 • n=5 Participants	13.5 Years STANDARD_DEVIATION 2.59 • n=7 Participants	14.0 Years STANDARD_DEVIATION 2.49 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	49 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · White - White/Caucasian/European Heritage	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · Asian	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · African American/African Heritage	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · American Indian or Alaskan Native	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Intent-to-Treat Population

SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=12 vs. >=13). Percentage of participants with SRI response at Week 52 of Part A were reported. Intent-to-Treat Population comprised of all participants who were randomized and treated with at least one dose of study agent in Part A. One participant had missing data at Baseline and therefore, could not be included in the analysis.

Outcome measures

Measure	Placebo n=39 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percentage of Participants With SLE Responder Index (SRI) Response at Week 52	43.6 Percentage of participants	52.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-to-Treat Population

Percentage of participants meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement that is Definition 1: At least 50% improvement in any 2 of 5 endpoints below and no more than 1 of the remaining worsening by more than 30% and Definition 2: At least 30% improvement in 3 of 5 endpoints below and no more than 1 of the remaining worsening more than 30%. Endpoints were: 1. Percent change in Parent's Global Assessment (ParentGA) at Week 52, 2. Percent change in PGA at Week 52, 3. Percent change in SELENA SLEDAI score at Week 52, 4. Percent change in Pediatric Quality of Life Inventory (PedsQL) physical functioning domain at Week 52, 5. Percent change in 24 hour proteinuria at Week 52 (gram/24hour equivalent by spot urine protein to creatinine ratio).

Outcome measures

Measure	Placebo n=40 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2 Definition 1	35.0 Percentage of participants	60.4 Percentage of participants
Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2 Definition 2	27.5 Percentage of participants	52.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: Intent-to-Treat Population

ParentGA assesses the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale (VAS; 0 - very well, 10 - very poorly). Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. Last Observation Carried Forward (LOCF) was used. Eight participants had a score of zero at Baseline and therefore, could not be included in the analysis.

Outcome measures

Measure	Placebo n=38 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=47 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percent Change From Baseline in ParentGA at Week 52	-23.61 Percent change Interval -95.0 to 600.0	-53.85 Percent change Interval -100.0 to 900.0

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: Intent-to-Treat Population

The PGA is a 10 centimeter (cm) visual analogue scale (VAS), anchored at 0 (none) and 3 (severe), designed for the physician to indicate the participant's overall disease activity at a particular visit as part of the validated SELENA SLEDAI index. Primary investigator or a subinvestigator scored the PGA for the participant, and same person evaluated the participant each time. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. LOCF was used.

Outcome measures

Measure	Placebo n=40 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percent Change From Baseline in PGA at Week 52	-48.802 Percent change Standard Deviation 42.0423	-56.525 Percent change Standard Deviation 43.7939

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: Intent-to-Treat Population

The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. One participant had missing data at Baseline and therefore, could not be included in the analysis.

Outcome measures

Measure	Placebo n=39 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percent Change From Baseline in SELENA SLEDAI at Week 52	-38.0 Percent change Standard Deviation 39.50	-43.3 Percent change Standard Deviation 43.73

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: Intent-to-Treat Population

The PedsQL is a generic quality of life scale validated for the pediatric population which consists of 23 items, encompassing 4 health domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). From the raw scores of the 23 items, a total summary score and individual domain scores can be calculated. The total and domain scores are each transformed on a 0 to 100 score with higher scores indicating higher quality of life. For Physical Functioning Domain scale, score was from 0 to 100 where, 0 indicates lower quality of life and 100 indicates greater quality of life. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.

Outcome measures

Measure	Placebo n=40 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52	12.5 Percent change Interval -53.0 to 575.0	10.5 Percent change Interval -100.0 to 280.0

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: Intent-to-Treat Population

Percent change from Baseline in proteinuria was calculated. The percent change from baseline to Week 52 in 24 hour proteinuria was analyzed using summary statistics and 95% confidence intervals, without any adjustment for covariates. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.

Outcome measures

Measure	Placebo n=40 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percent Change From Baseline in Proteinuria at Week 52	7.0920 Percent Change Interval -90.568 to 570.149	-2.1277 Percent Change Interval -85.073 to 1681.884

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Intent-to-Treat Population

Sustained SRI response was defined as having a response on the primary efficacy endpoint at Weeks 44, 48, and 52. Data for percentage of participants with a sustained SRI response was presented. Drop Outs and Treatment Failures were considered Non-Responders. Only those participants with data available at specific time point were analyzed.

Outcome measures

Measure	Placebo n=39 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percentage of Participants With a Sustained SRI Response	41.0 Percentage of participants	43.4 Percentage of participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Intent-to-Treat Population

Sustained ParentGA response was defined as having >0.7 improvement at Weeks 44, 48, and 52 compared at Baseline. Data for percentage of participants with a sustained ParentGA response was presented. Thirteen participants had a score of <=0.7 at Baseline and therefore, could not be included in the analysis.

Outcome measures

Measure	Placebo n=36 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=44 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Percentage of Participants With a Sustained ParentGA Response	33.3 Percentage of Participants	59.1 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: Intent-to-Treat Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the 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, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.

Outcome measures

Measure	Placebo n=40 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg n=53 Participants Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	33 Participants	42 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	14 Participants	9 Participants

SECONDARY outcome

Timeframe: 28-days dosing interval at steady state

Population: PK Population

The pharmacokinetic (PK) population comprised all participants included in the As- Treated population for whom at least one post belimumab treatment PK sample was obtained and analyzed. The PK model was fitted to the observed serum concentration-time data. The maximum (Cmax) and minimum (Cmin) concentrations reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.

Outcome measures

Measure	Placebo n=53 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss) Cmax, ss	315 Micrograms per milliliter Geometric Coefficient of Variation 31.2	—
Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss) Cmin, ss	50 Micrograms per milliliter Geometric Coefficient of Variation 68.3	—

SECONDARY outcome

Timeframe: 28-days dosing interval at steady state

Population: PK Population

The PK model was fitted to the observed serum concentration-time data. The AUC values reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.

Outcome measures

Measure	Placebo n=53 Participants Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.	Belimumab 10 mg/kg Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Area Under Curve of Belimumab at Steady State (AUC, ss)	3012 Micrograms per milliliter Geometric Coefficient of Variation 43.2	—

Adverse Events

Placebo

Serious events: 14 serious events

Other events: 27 other events

Deaths: 1 deaths

Belimumab 10 mg/kg

Serious events: 9 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=40 participants at risk Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care	Belimumab 10 mg/kg n=53 participants at risk Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Infections and infestations Herpes zoster	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Abscess limb	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Epiglottitis	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Gastroenteritis	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Hepatitis A	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Influenza	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Pneumonia	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Vulval abscess	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Renal and urinary disorders Lupus nephritis	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	3.8% 2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Renal and urinary disorders Glomerulonephritis	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Nervous system disorders Headache	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Nervous system disorders Idiopathic intracranial hypertension	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Nervous system disorders Post herpetic neuralgia	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Pancreatitis acute	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Vasculitis gastrointestinal	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Musculoskeletal and connective tissue disorders Osteochondrosis	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Musculoskeletal and connective tissue disorders SLE arthritis	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Psychiatric disorders Major depression	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Psychiatric disorders Suicidal ideation	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Psychiatric disorders Suicide attempt	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Eye disorders Eye swelling	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Eye disorders Retinal vasculitis	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
General disorders Chest pain	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Skin and subcutaneous tissue disorders Rash	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Blood and lymphatic system disorders Anaemia	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Blood and lymphatic system disorders Thrombocytopenia	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Cardiac disorders Pericardial effusion	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Injury, poisoning and procedural complications Ligament sprain	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Metabolism and nutrition disorders Fluid overload	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.

Other adverse events

Measure	Placebo n=40 participants at risk Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care	Belimumab 10 mg/kg n=53 participants at risk Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Infections and infestations Nasopharyngitis	20.0% 8/40 • Number of events 11 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	17.0% 9/53 • Number of events 14 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Upper respiratory tract infection	20.0% 8/40 • Number of events 8 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	11.3% 6/53 • Number of events 8 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Herpes zoster	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	7.5% 4/53 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Pharyngitis	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Gastroenteritis	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	3.8% 2/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Urinary tract infection	10.0% 4/40 • Number of events 8 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Bronchitis	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Conjunctivitis	5.0% 2/40 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Infections and infestations Influenza	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Diarrhoea	7.5% 3/40 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	13.2% 7/53 • Number of events 9 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Nausea	7.5% 3/40 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	9.4% 5/53 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Abdominal pain	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Vomiting	7.5% 3/40 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	3.8% 2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Gastrointestinal disorders Dyspepsia	7.5% 3/40 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Nervous system disorders Headache	25.0% 10/40 • Number of events 17 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	13.2% 7/53 • Number of events 9 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 4/40 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Musculoskeletal and connective tissue disorders Back pain	7.5% 3/40 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	3.8% 2/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	3.8% 2/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Musculoskeletal and connective tissue disorders Joint swelling	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
General disorders Chest pain	10.0% 4/40 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	7.5% 4/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
General disorders Pyrexia	7.5% 3/40 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	3.8% 2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
General disorders Fatigue	5.0% 2/40 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	7.5% 4/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Respiratory, thoracic and mediastinal disorders Cough	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Blood and lymphatic system disorders Leukopenia	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	3.8% 2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Blood and lymphatic system disorders Neutropenia	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Blood and lymphatic system disorders Anaemia	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Investigations Transaminases increased	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Investigations Blood immunoglobulin G decreased	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Psychiatric disorders Insomnia	7.5% 3/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Psychiatric disorders Suicidal ideation	5.0% 2/40 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Reproductive system and breast disorders Menorrhagia	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Reproductive system and breast disorders Dysmenorrhoea	5.0% 2/40 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Skin and subcutaneous tissue disorders Rash	2.5% 1/40 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	5.7% 3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Renal and urinary disorders Lupus nephritis	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	1.9% 1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.
Vascular disorders Hypertension	5.0% 2/40 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks). Intent-to-Treat Population was used to collect adverse events.

Additional Information

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