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Clinical Trial Results:
BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy

Summary
EudraCT number	2012-000385-38
Trial protocol	GB
Global end of trial date	14 Sep 2016

Results information
Results version number	v2(current)
This version publication date	28 Sep 2017
First version publication date	28 May 2015
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

116472

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

10 Apr 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 Sep 2016

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study is: To evaluate whether belimumab can modulate proteinuria in IMGN. To evaluate whether belimumab can modulate anti-PLA2R autoantibodies in participants with detectable baseline levels of these antibodies.

Protection of trial subjects

Not applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Jul 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 14

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Eligible participants were recruited from July 2012 until March 2014, into this 2 part study of a initial treatment phase, a long term treatment phase, and then followed up for a further 6 months. Results have previously been presented for the initial treatment phase, up to the Week 28 and are now presented for the completed study.

Screening details

Screening occurred within 35 days and no less than 14 days before the first scheduled study treatment dose. Total 21 participants were screened; 14 were randomized and entered the initial treatment phase while 11 participants entered the long-term treatment phase. Common reasons for screen failures were insufficient, or improvements in proteinuria.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Belimumab 10 mg/kg IV

Arm description

Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.

Arm type

Experimental

Investigational medicinal product name

Belimumab ((GSK1550188)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Intravenous infusion of Belimumab 10 mg/kg was administered at Day 0, Week 2, Week 4 then ever 4 weeks up to 100 weeks.

Number of subjects in period 1	Belimumab 10 mg/kg IV
Started	14
Completed	8
Not completed	6
Other: Reached stopping criteria	1
Adverse event, non-fatal	1
Other:Treatment stopped due to remission	1
Lack of efficacy	3

Baseline characteristics

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Reporting group title

Belimumab 10 mg/kg IV

Reporting group description

Reporting group values	Belimumab 10 mg/kg IV	Total
Number of subjects	14
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	46.1 ( 13.3 )	-
Gender categorical
Units: Subjects
Female	3	3
Male	11	11
Race/Ethnicity, Customized
Units: Subjects
Asian - Central/South Asian Heritage	4	4
White- White/Caucasian/European Heritage	9	9
Unknown	1	1

End points

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Reporting group title

Belimumab 10 mg/kg IV

Reporting group description

Primary: Change from Baseline in proteinuria levels at Week 28

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End point title

Change from Baseline in proteinuria levels at Week 28 ^[1]

End point description

Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.

End point type

Primary

End point timeframe

Baseline and Week 28

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	11 ^[2]
Units: Ratio
geometric mean (geometric coefficient of variation)
Ratio	0.7552 ( 45 )

Notes
[2] - ITT Population

No statistical analyses for this end point

Primary: Change from Baseline in anti-phospholipase A2 receptor (PLA2R) autoantibody titers at Week 28

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End point title

Change from Baseline in anti-phospholipase A2 receptor (PLA2R) autoantibody titers at Week 28 ^[3]

End point description

PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.

End point type

Primary

End point timeframe

Baseline and Week 28

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	11 ^[4]
Units: Ratio
geometric mean (geometric coefficient of variation)
Ratio	0.2666 ( 171 )

Notes
[4] - ITT Population

No statistical analyses for this end point

Secondary: Proteinuria levels at the indicated time points

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End point title

Proteinuria levels at the indicated time points

End point description

Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[5]
Units: milligrams per millimole (mg/mmol)
geometric mean (geometric coefficient of variation)
Baseline, n=14	724.3157 ( 40.2 )
Week 12, n=13	670.8655 ( 46.9 )
Week 28, n=11	498.1255 ( 40.9 )
Week 52, n=9	356.4209 ( 174.8 )
Week 76, n=8	274.9714 ( 70.4 )
Week 104, n=10	129.9761 ( 186 )
Week 128, n=9	75.2359 ( 136.4 )

Notes
[5] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in proteinuria levels at the indicated time points

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End point title

Change from Baseline in proteinuria levels at the indicated time points

End point description

Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[6]
Units: Ratio
geometric mean (geometric coefficient of variation)
Week 12; n= 13	0.9437 ( 39.3 )
Week 28; n= 11	0.7552 ( 45 )
Week 52; n= 9	0.5297 ( 206.7 )
Week 76; n= 8	0.4177 ( 54.3 )
Week 104; n= 10	0.1874 ( 189.3 )
Week 128; n= 9	0.1118 ( 139.1 )

Notes
[6] - ITT Population

No statistical analyses for this end point

Secondary: Anti-phospholipase A2 receptor (PLA2R) autoantibody levels at indicated time points

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End point title

Anti-phospholipase A2 receptor (PLA2R) autoantibody levels at indicated time points

End point description

Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[7]
Units: relative units per milliliter (RU/mL)
geometric mean (geometric coefficient of variation)
Baseline, n=14	168.3 ( 138.9 )
Week 12, n=13	91 ( 200.4 )
Week 28, n=11	46.4 ( 319.6 )
Week 52, n=9	12.9 ( 358.4 )
Week 76, n=8	7.5 ( 140.4 )
Week 104, n=10	3.7 ( 72.7 )
Week 128, n=8	4.4 ( 112 )

Notes
[7] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in anti-PLA2R autoantibody titers at the indicated time points

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End point title

Change from Baseline in anti-PLA2R autoantibody titers at the indicated time points

End point description

Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128.

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[8]
Units: Ratio
geometric mean (geometric coefficient of variation)
Week 12; n= 13	0.5362 ( 58.1 )
Week 28; n= 11	0.2666 ( 171 )
Week 52; n= 9	0.0737 ( 130.3 )
Week 76; n= 8	0.0436 ( 102.8 )
Week 104; n= 10	0.0212 ( 169.1 )
Week 128; n= 8	0.0284 ( 243.7 )

Notes
[8] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with complete or partial remission

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End point title

Number of participants with complete or partial remission

End point description

Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3grams [g]/24 h) with no worsening in renal function (estimated glomerular filtration rate [eGFR] reduction from Baseline <15 percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[9]
Units: Participants
Week 12; Partial remission; n= 13	0
Week 12; Complete remission; n= 13	0
Week 28; Partial remission; n= 11	1
Week 28; Complete remission; n= 11	0
Week 52; Partial remission; n= 9	2
Week 52; Complete remission; n= 9	1
Week 76; Partial remission; n= 8	3
Week 76; Complete remission; n= 8	0
Week 104; Partial remission; n= 10	6
Week 104; Complete remission; n= 10	1
Week 128; Partial remission; n= 9	6
Week 128; Complete remission; n= 9	1

Notes
[9] - ITT Population

No statistical analyses for this end point

Secondary: Time to complete or partial remission

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End point title

Time to complete or partial remission

End point description

Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15 percent ). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed.

End point type

Secondary

End point timeframe

Baseline and up to Week 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[10]
Units: Weeks
median (confidence interval 95%)
Weeks	68.2 (28 to 93.6)

Notes
[10] - ITT Population

No statistical analyses for this end point

Secondary: Duration of complete or partial remission

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End point title

Duration of complete or partial remission

End point description

Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.

End point type

Secondary

End point timeframe

Baseline and up to Week 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[11]
Units: Days
arithmetic mean (standard deviation)
Complete remission; n= 1	365 ( 99999 )
Partial remission; n= 9	378.6 ( 186.15 )

Notes
[11] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with PLA2R autoantibody remission

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End point title

Number of participants with PLA2R autoantibody remission

End point description

Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[12]
Units: Participants
Week 12; full response; n= 13	1
Week 12; partial response; n= 13	3
Week 28; full response; n= 11	3
Week 28; partial response; n= 11	6
Week 52; full response; n= 9	4
Week 52; partial response; n= 9	5
Week 76; full response; n= 8	4
Week 76; partial response; n= 8	4
Week 104; full response; n= 10	10
Week 104; partial response; n= 10	0
Week 128; Full response; n= 8	8
Week 128; partial response; n= 8	0

Notes
[12] - ITT Population

No statistical analyses for this end point

Secondary: Time to anti-PLA2R autoantibody remission

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End point title

Time to anti-PLA2R autoantibody remission

End point description

Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.

End point type

Secondary

End point timeframe

Baseline and up to Week 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[13]
Units: Weeks
median (confidence interval 95%)
Partial response	16.2 (8 to 24)
Complete response	82 (16 to 92)

Notes
[13] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with anti-PLA2R autoantibody relapse

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End point title

Number of participants with anti-PLA2R autoantibody relapse

End point description

Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[14]
Units: Participants
Week 12; n= 13	0
Week 28; n= 11	0
Week 52; n= 9	0
Week 76; n= 8	0
Week 104; n= 10	0
Week 128; n= 8	0

Notes
[14] - ITT Population

No statistical analyses for this end point

Secondary: eGFR levels at the indicated time points

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End point title

eGFR levels at the indicated time points

End point description

eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[15]
Units: milliliter/minute (mL/min/1.73meter^2)
geometric mean (geometric coefficient of variation)
Baseline; n= 14	69.817 ( 32.9 )
Week 12; n= 13	66.2639 ( 35.4 )
Week 28; n= 11	65.0866 ( 36.1 )
Week 52; n= 7	65.1308 ( 45 )
Week 76; n= 8	61.6732 ( 47.1 )
Week 104; n= 10	69.7692 ( 39.1 )
Week 128; n= 9	64.7984 ( 39.2 )

Notes
[15] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in eGFR levels at the indicated time points

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End point title

Change from Baseline in eGFR levels at the indicated time points

End point description

eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[16]
Units: Ratio
geometric mean (geometric coefficient of variation)
Week 2, n=14	0.9954 ( 10.8 )
Week 4, n= 13	0.919 ( 16.4 )
Week 8, n= 13	0.9035 ( 16.2 )
Week 12, n= 13	0.9339 ( 17.1 )
Week 16, n= 12	0.9521 ( 12.5 )
Week 20, n= 8	0.9819 ( 11.8 )
Week 24, n= 11	0.9274 ( 17.1 )
Week 28, n= 11	0.9694 ( 21.1 )
Week 32, n= 9	1.0099 ( 19.5 )
Week 36, n= 11	0.9692 ( 17.4 )
Week 40, n= 11	0.9425 ( 20.8 )
Week 44, n= 10	0.9531 ( 22.6 )
Week 48, n= 8	0.9929 ( 23.8 )
Week 52, n= 7	0.929 ( 27.7 )
Week 56, n= 9	1.0181 ( 21.9 )
Week 60, n= 9	0.9805 ( 26.8 )
Week 64, n=9	1.0217 ( 23.5 )
Week 68, n=8	1.0233 ( 24.6 )
Week 72, n=8	1.0168 ( 28.3 )
Week 76, n=8	1.0055 ( 33.3 )
Week 80, n=8	1.0431 ( 21.6 )
Week 84, n=8	0.9959 ( 25.3 )
Week 88, n=8	1.0529 ( 16.3 )
Week 92, n=8	1.0052 ( 26.3 )
Week 96, n=8	1.1204 ( 22.1 )
Week 100, n=8	1.1122 ( 24.7 )
Week 104, n=10	1.048 ( 23.3 )
Week 116; n= 8	1.0373 ( 19.8 )
Week 128, n=9	0.9971 ( 35.2 )

Notes
[16] - ITT Population

No statistical analyses for this end point

Secondary: Serum creatinine levels at the indicated time points

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End point title

Serum creatinine levels at the indicated time points

End point description

Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[17]
Units: micromoles/liter (µmol/L)
geometric mean (geometric coefficient of variation)
Baseline; n= 14	97.1658 ( 22.8 )
Week 12; n= 13	100.6421 ( 26.8 )
Week 28; n= 11	99.9535 ( 24.8 )
Week 52; n= 7	96.6583 ( 30.2 )
Week 76; n= 8	103.0265 ( 32.8 )
Week 104; n= 10	92.4547 ( 29.6 )
Week 128; n= 9	97.726 ( 29.7 )

Notes
[17] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in serum creatinine levels at the indicated time points

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End point title

Change from Baseline in serum creatinine levels at the indicated time points

End point description

Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[18]
Units: Ratio
geometric mean (geometric coefficient of variation)
Week 12; n= 13	1.053 ( 14.8 )
Week 28; n= 11	1.0202 ( 18.6 )
Week 52; n= 7	1.0581 ( 23.7 )
Week 76; n= 8	0.9818 ( 28.7 )
Week 104; n= 10	0.9467 ( 20.1 )
Week 128; n= 9	0.9874 ( 30.4 )

Notes
[18] - ITT Population

No statistical analyses for this end point

Secondary: Serum albumin levels at indicated time points

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End point title

Serum albumin levels at indicated time points

End point description

Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[19]
Units: grams per liter (g/L)
geometric mean (geometric coefficient of variation)
Baseline; n= 14	23.3306 ( 22.7 )
Week 12; n= 13	24.4204 ( 27.5 )
Week 28; n= 11	27.8397 ( 23.4 )
Week 52; n= 7	31.9927 ( 18.3 )
Week 76; n= 8	33.9484 ( 10.9 )
Week 104; n= 10	39.1015 ( 7.5 )
Week 128; n= 9	39.2009 ( 8.8 )

Notes
[19] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in levels of serum albumin at the indicated time points

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End point title

Change from Baseline in levels of serum albumin at the indicated time points

End point description

Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[20]
Units: ratio
geometric mean (geometric coefficient of variation)
Week 12; n= 13	1.0324 ( 15 )
Week 28; n= 11	1.1211 ( 16.9 )
Week 52; n= 7	1.2828 ( 28.1 )
Week 76; n= 8	1.3695 ( 23.8 )
Week 104; n= 10	1.5879 ( 19.6 )
Week 128; n= 9	1.5799 ( 24.7 )

Notes
[20] - ITT Population

No statistical analyses for this end point

Secondary: Serum cholesterol levels at indicated time points

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End point title

Serum cholesterol levels at indicated time points

End point description

Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[21]
Units: millimoles per liter (mmol/L)
geometric mean (geometric coefficient of variation)
Baseline; n= 14	7.6423 ( 36 )
Week 12; n= 13	7.2336 ( 31.5 )
Week 28; n= 11	6.274 ( 23.1 )
Week 52; n= 7	5.8724 ( 18.6 )
Week 76; n= 8	5.0211 ( 18.4 )
Week 104; n= 10	4.8001 ( 24.5 )
Week 128; n= 9	4.2407 ( 12.7 )

Notes
[21] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in serum cholesterol at the indicated time points

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End point title

Change from Baseline in serum cholesterol at the indicated time points

End point description

Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[22]
Units: mmol/L
geometric mean (geometric coefficient of variation)
Week 12; n= 13	0.9238 ( 16.8 )
Week 28; n= 11	0.8896 ( 14.3 )
Week 52; n= 7	0.8571 ( 16.7 )
Week 76; n= 8	0.7111 ( 15 )
Week 104; n= 10	0.6851 ( 17.3 )
Week 128; n= 9	0.614 ( 15.7 )

Notes
[22] - ITT Population

No statistical analyses for this end point

Secondary: Serum Immunoglobulin G (IgG) levels at indicated time points

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End point title

Serum Immunoglobulin G (IgG) levels at indicated time points

End point description

Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[23]
Units: g/L
arithmetic mean (standard deviation)
Baseline; n= 14	4.026 ( 1.681 )
Week 12; n= 13	3.871 ( 1.5266 )
Week 28; n= 11	4.405 ( 1.7833 )
Week 52; n= 8	5.823 ( 2.2572 )
Week 76; n= 8	6.05 ( 2.1103 )
Week 104; n= 10	7.611 ( 2.8301 )
Week 128; n= 9	8.609 ( 2.2597 )

Notes
[23] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in serum IgG at the indicated time points

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End point title

Change from Baseline in serum IgG at the indicated time points

End point description

Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[24]
Units: Ratio
arithmetic mean (standard deviation)
Week 12; n= 13	0.055 ( 0.6625 )
Week 28; n= 11	0.469 ( 1.4287 )
Week 52; n= 8	1.525 ( 2.4411 )
Week 76; n= 8	1.619 ( 1.6681 )
Week 104; n= 10	3.613 ( 2.5488 )
Week 128; n= 9	4.334 ( 2.0289 )

Notes
[24] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with edema and edema extending beyond calf

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End point title

Number of participants with edema and edema extending beyond calf

End point description

Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 28, 52, 76, and 104

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[25]
Units: Participants
Week 0; oedema; n= 14	13
Week 0; oedema extending beyond calf; n= 14	5
Week 12; oedema; n= 12	9
Week 12; Oedema extending beyond calf; n= 12	1
Week 28;Oedema; n= 11	7
Week 28; Oedema extending beyond calf; n= 11	1
Week 52; oedema; n= 9	4
Week 52;Oedema extending beyond calf; n= 9	1
Week 76;Oedema; n=8	4
Week 76;Oedema extending beyond calf; n= 8	0
4 Week post final dose (PFD); Oedema; n=10	6
4 Week PFD; Oedema extending beyond calf; n= 10	1
Week 104 withdrawn (WD); Oedema; n= 1	0
Week 104 WD;Oedema extending beyond calf; n=1	0

Notes
[25] - ITT Population

No statistical analyses for this end point

Secondary: Summary of maximum observed serum concentration (Cmax) of belimumab at the indicated time points

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End point title

Summary of maximum observed serum concentration (Cmax) of belimumab at the indicated time points

End point description

The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times.

End point type

Secondary

End point timeframe

Baseline and up to 4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[26]
Units: nanograms per milliliter (ng/mL)
arithmetic mean (standard deviation)
Day 0, 5 minutes; n= 13	267996 ( 70598.02 )
Week 28, 5 minutes; n= 11	312462.2 ( 95171.16 )

Notes
[26] - PK Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed

No statistical analyses for this end point

Secondary: Summary of minimum observed concentration (Cmin) of belimumab at the indicated time points

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End point title

Summary of minimum observed concentration (Cmin) of belimumab at the indicated time points

End point description

Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose.

End point type

Secondary

End point timeframe

Baseline and up to 4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[27]
Units: ng/mL
arithmetic mean (standard deviation)
Pre-infusion; Week 2; n= 14	29940.8 ( 20918.28 )
Pre-infusion; Week 4; n= 12	41220.9 ( 35720.14 )
Pre-infusion; Week 8; n= 13	30350.9 ( 25505.7 )
Pre-infusion; Week 12; n= 11	30913.7 ( 30681.42 )
Pre-infusion; Week 28; n= 11	34904.7 ( 26388.6 )
Pre-infusion; Week 40; n= 10	40800.6 ( 28847.86 )
Pre-infusion; Week 52; n= 9	38375.9 ( 14136.23 )
Pre-infusion; Week 76; n= 8	65655.8 ( 32873.33 )
4 Weeks post last-dose; n= 9	60497.3 ( 28074.37 )

Notes
[27] - PK Population

No statistical analyses for this end point

Secondary: Summary of area under the serum concentration-time curve to the last quantifiable concentration (AUC[0-2])

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End point title

Summary of area under the serum concentration-time curve to the last quantifiable concentration (AUC[0-2])

End point description

The AUC(0-2) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis were collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results will be posted at later date following post hoc analysis.

End point type

Secondary

End point timeframe

Baseline and up to 4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	0 ^[28]
Units: ng/mL
geometric mean (geometric coefficient of variation)
ng/mL	( )

Notes
[28] - PK Population. The results will be posted at later date following post hoc analysis.

No statistical analyses for this end point

Secondary: Summary of total amount of urine excreted Ae(0-24)

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End point title

Summary of total amount of urine excreted Ae(0-24)

End point description

PK parameters from the urine concentration data: urine Ae(0-24) were assessed. 24 h urine collections for PK analysis were collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach was undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis was conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. Several samples were taken pre-dose at Day 0 and some at week 12 incorrectly which affects interpretation.

End point type

Secondary

End point timeframe

Baseline and Up to 4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[29]
Units: ng/hour
arithmetic mean (standard deviation)
Day 0; n= 14	105826.23 ( 178943.857 )
Week 12; n= 12	95188.14 ( 130217.976 )
Week 28; n= 11	92997.94 ( 110142.599 )
Week 52; n= 9	219367.96 ( 391752.377 )
Week 76; n= 8	145645.34 ( 267292.225 )
4 Week post last dose; n= 6	7909.34 ( 16771.559 )

Notes
[29] - PK Population

No statistical analyses for this end point

Secondary: Change from Baseline in short form (SF)-36 v2 Quality of Life (QoL) questionnaire score

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End point title

Change from Baseline in short form (SF)-36 v2 Quality of Life (QoL) questionnaire score

End point description

Health-related quality of life was assessed through participant self-completion of the short form health survey (SF-36 version [v2]), a general health related quality of life metrics. Norm-based Scores (NBS) for physical functioning, role emotional, role physical were assessed. The remaining SF-36 component scores require re-scaling and therefore will be added at a later date. SF-36 was administered prior to any procedures at Weeks 12, 28, 52, 76 and 104/4 week post last dose. Item score were recorded and higher score represented better health status. Baseline is defined as Day 0 pre dose value and change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 104/4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[30]
Units: Scores on a scale
arithmetic mean (standard deviation)
Physical functioning, Week 12; n= 12	-4.034 ( 5.1907 )
Physical functioning, Week 28; n= 11	-0.765 ( 3.678 )
Physical functioning, Week 52; n= 9	0.468 ( 7.3489 )
Physical functioning, Week 76; n= 7	0.601 ( 7.9409 )
Physical functioning 4 Week post final dose;n=11	0.765 ( 11.7275 )
Role emotional, Week 12; n= 12	0 ( 10.4831 )
Role emotional, Week 28; n= 11	1.413 ( 15.1824 )
Role emotional, Week 52; n= 9	3.023 ( 11.4621 )
Role emotional, Week 76; n= 7	3.332 ( 7.2475 )
Role emotional, 4 Week post final dose; n= 11	6.007 ( 10.0413 )
Role physical, Week 12; n= 12	0.816 ( 11.0681 )
Role physical, Week 28; n= 11	3.34 ( 8.4324 )
Role physical, Week 52; n= 9	3.537 ( 9.1726 )
Role physical, Week 76; n= 7	7.697 ( 12.2803 )
Role physical 4 Week post final dose; n= 11	5.789 ( 11.4489 )

Notes
[30] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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End point title

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

End point description

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, is a congenital anomaly/birth defect, may require medical or surgical intervention, is associated with liver injury and impaired liver function.

End point type

Secondary

End point timeframe

Baseline and up to Week 128/6 month follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[31]
Units: Participants
AE	14
SAE	3

Notes
[31] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with abnormal clinical chemistry and hematology values

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End point title

Number of participants with abnormal clinical chemistry and hematology values

End point description

Blood samples were collected from participants for evaluation of clinical chemistry and hematology parameters. The clinical chemistry parameters included albumin, alkaline phosphatase (alk.phosph.), alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin, calcium, cholesterol, chloride, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, lactate dehydrogenase (LD), magnesium, sodium, phosphorus, total protein, blood urea nitrogen (BUN) and uric acid. The hematology parameters included basophils, eosinophil, hemoglobin, hematocrit, lymphocytes, monocytes, total neutrophils, platelets, red blood cells (RBC) count and white blood cells (WBC) count. Participants were counted in the category that their value changes to (low or high) for the specific time points. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 116/16 week follow-up visit

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[32]
Units: Participants
Albumin; Week 12; to high; n= 13	0
Albumin; Week 12; to low; n= 13	0
Albumin; Week 28; to high; n= 11	0
Albumin; Week 28; to low; n= 11	0
Albumin; Week 52; to high; n= 7	0
Albumin; Week 52; to low; n= 7	0
Albumin; Week 76; to high; n= 8	0
Albumin; Week 76; to low; n= 8	0
Albumin; Week 104; to high; n= 10	0
Albumin; Week 104; to low; n= 10	0
Albumin; 16 Week follow up; to high; n= 8	0
Albumin; 16 Week follow up; to low; n= 8	0
Alk.phosph.; Week 12; to high; n= 13	0
Alk.phosph.; Week 12; to low; n= 13	0
Alk.phosph.; Week 28; to high; n= 11	0
Alk.phosph.; Week 28; to low; n= 11	0
Alk.phosph.; Week 52; to high; n= 7	0
Alk.phosph.; Week 52; to low; n= 7	0
Alk.phosph.; Week 76; to high; n= 8	0
Alk.phosph.; Week 76; to low; n= 8	0
Alk.phosph.; Week 104; to high; n= 10	0
Alk.phosph.; Week 104; to low; n= 10	0
Alk.phosph.; 16 Week follow up; to high; n= 8	0
Alk.phosph.; 16 Week follow up; to low; n= 8	0
ALT; Week 12; to high; n= 13	0
ALT; Week 12; to low; n= 13	0
ALT; Week 28; to high; n= 11	0
ALT; Week 28; to low; n= 11	0
ALT; Week 52; to high; n= 7	0
ALT; Week 52; to low; n= 7	0
ALT; Week 76; to high; n= 8	0
ALT; Week 76; to low; n= 8	0
ALT; Week 104; to high; n= 10	0
ALT; Week 104; to low; n= 10	0
ALT; 16 Week follow up; to high; n= 8	0
ALT; 16 Week follow up; to low; n= 8	0
AST; Week 12; to high; n= 13	0
AST; Week 12; to low; n= 13	0
AST; Week 28; to high; n= 11	1
AST; Week 28; to low; n= 11	0
AST; Week 52; to high; n= 7	0
AST; Week 52; to low; n= 7	0
AST; Week 76; to high; n= 8	0
AST; Week 76; to low; n= 8	0
AST; Week 104; to high; n= 10	0
AST; Week 104; to low; n= 10	0
AST; 16 Week follow up; to high; n= 8	0
AST; 16 Week follow up; to low; n= 8	0
Direct bilirubin; Week 12; to high; n= 13	0
Direct bilirubin; Week 12; to low; n= 13	0
Direct bilirubin; Week 28; to high; n= 11	0
Direct bilirubin; Week 28; to low; n= 11	0
Direct bilirubin; Week 52; to high; n= 7	0
Direct bilirubin; Week 52; to low; n= 7	0
Direct bilirubin; Week 76; to high; n= 8	0
Direct bilirubin; Week 76; to low; n= 8	0
Direct bilirubin; Week 104; to high; n= 10	0
Direct bilirubin; Week 104; to low; n= 10	0
Direct bilirubin; 16 Week follow up; to high; n=8	0
Direct bilirubin; 16 Week follow up; to low; n= 8	0
Total bilirubin; Week 12; to high; n= 12	0
Total bilirubin; Week 12; to low; n= 12	0
Total bilirubin; Week 28; to high; n= 11	0
Total bilirubin; Week 28; to low; n= 11	0
Total bilirubin; Week 52; to high; n= 7	0
Total bilirubin; Week 52; to low; n= 7	0
Total bilirubin; Week 76; to high; n= 8	0
Total bilirubin; Week 76; to low; n= 8	0
Total bilirubin; Week 104; to high; n= 10	0
Total bilirubin; Week 104; to low; n= 10	0
Total bilirubin; 16 Week follow up; to high; n= 8	0
Total bilirubin; 16 Week follow up; to low; n= 8	0
Calcium; Week 12; to high; n= 12	0
Calcium; Week 12; to low; n= 12	0
Calcium; Week 28; to high; n= 11	0
Calcium; Week 28; to low; n= 11	0
Calcium; Week 52; to high; n= 7	0
Calcium; Week 52; to low; n= 7	0
Calcium; Week 76; to high; n= 8	0
Calcium; Week 76; to low; n= 8	0
Calcium; Week 104; to high; n= 10	1
Calcium; Week 104; to low; n= 10	1
Calcium; 16 Week follow up; to high; n= 8	0
Calcium; 16 Week follow up; to low; n= 8	0
Cholesterol; Week 12; to high; n= 13	0
Cholesterol; Week 12; to low; n= 13	0
Cholesterol; Week 28; to high; n= 11	0
Cholesterol; Week 28; to low; n= 11	0
Cholesterol; Week 52; to high; n= 7	0
Cholesterol; Week 52; to low; n= 7	0
Cholesterol; Week 76; to high; n= 8	0
Cholesterol; Week 76; to low; n= 8	0
Cholesterol; Week 104; to high; n= 10	0
Cholesterol; Week 104; to low; n= 10	0
Cholesterol; 16 Week follow up; to high; n= 8	0
Cholesterol; 16 Week follow up; to low; n= 8	0
Chloride; Week 12; to high; n= 13	1
Chloride; Week 12; to low; n= 13	0
Chloride; Week 28; to high; n= 11	2
Chloride; Week 28; to low; n= 11	0
Chloride; Week 52; to high; n= 7	0
Chloride; Week 52; to low; n= 7	0
Chloride; Week 76; to high; n= 8	0
Chloride; Week 76; to low; n= 8	0
Chloride; Week 104; to high; n= 10	0
Chloride; Week 104; to low; n= 10	0
Chloride; 16 Week follow up; to high; n= 8	0
Chloride; 16 Week follow up; to low; n= 8	0
Carbon dioxide; Week 12; to high; n= 13	0
Carbon dioxide; Week 12; to low; n= 13	1
Carbon dioxide; Week 28; to high; n= 11	0
Carbon dioxide; Week 28; to low; n= 11	3
Carbon dioxide; Week 52; to high; n= 7	0
Carbon dioxide; Week 52; to low; n= 7	0
Carbon dioxide; Week 76; to high; n= 8	0
Carbon dioxide; Week 76; to low; n= 8	0
Carbon dioxide; Week 104; to high; n= 10	0
Carbon dioxide; Week 104; to low; n= 10	1
Carbon dioxide; 16 Week follow up; to high; n= 8	0
Carbon dioxide; 16 Week follow up; to low; n= 8	0
Creatinine; Week 12; to high; n= 13	2
Creatinine; Week 12; to low; n= 13	0
Creatinine; Week 28; to high; n= 11	0
Creatinine; Week 28; to low; n= 11	0
Creatinine; Week 52; to high; n= 7	0
Creatinine; Week 52; to low; n= 7	0
Creatinine; Week 76; to high; n= 8	2
Creatinine; Week 76; to low; n= 8	1
Creatinine; Week 104; to high; n= 10	0
Creatinine; Week 104; to low; n= 10	0
Creatinine; 16 Week follow up; to high; n= 8	0
Creatinine; 16 Week follow up; to low; n= 8	0
GGT; Week 12; to high; n= 13	0
GGT; Week 12; to low; n= 13	0
GGT; Week 28; to high; n= 11	0
GGT; Week 28; to low; n= 11	0
GGT; Week 52; to high; n= 7	0
GGT; Week 52; to low; n= 7	0
GGT; Week 76; to high; n= 8	0
GGT; Week 76; to low; n= 8	0
GGT; Week 104; to high; n= 10	0
GGT; Week 104; to low; n= 10	0
GGT; 16 Week follow up; to high; n=8	0
GGT; 16 Week follow up; to low; n= 8	0
Glucose; Week 12; to high; n= 13	3
Glucose; Week 12; to low; n= 13	0
Glucose; Week 28; to high; n= 11	4
Glucose; Week 28; to low; n= 11	0
Glucose; Week 52; to high; n= 7	2
Glucose; Week 52; to low; n= 7	0
Glucose; Week 76; to high; n= 8	3
Glucose; Week 76; to low; n= 8	0
Glucose; Week 104; to high; n= 10	1
Glucose; Week 104; to low; n= 10	0
Glucose; 16 Week follow up; to high; n= 8	1
Glucose; 16 Week follow up; to low; n= 8	1
Potassium; Week 12; to high; n= 13	0
Potassium; Week 12; to low; n= 13	0
Potassium; Week 28; to high; n= 11	1
Potassium; Week 28; to low; n= 11	1
Potassium; Week 52; to high; n= 7	0
Potassium; Week 52; to low; n= 7	0
Potassium; Week 76; to high; n= 8	0
Potassium; Week 76; to low; n= 8	0
Potassium; Week 104; to high; n= 10	0
Potassium; Week 104; to low; n= 10	0
Potassium; 16 Week follow up; to high; n= 8	0
Potassium; 16 Week follow up; to low; n= 8	0
LD; Week 12; to high; n= 13	3
LD; Week 12; to low; n= 13	0
LD; Week 28; to high; n= 11	2
LD; Week 28; to low; n= 11	0
LD; Week 52; to high; n= 7	1
LD; Week 52; to low; n= 7	0
LD; Week 76; to high; n= 8	1
LD; Week 76; to low; n= 8	0
LD;Week 104; to high; n= 10	0
LD;Week 104; to low; n= 10	0
LD; 16 week follow-up; to high; n= 8	0
LD; 16 week follow up; to low; n= 8	0
Magnesium; Week 12; to high; n= 13	1
Magnesium; Week 12; to low; n= 13	0
Magnesium; Week 28; to high; n= 11	0
Magnesium; Week 28; to low; n= 11	0
Magnesium; Week 52; to high; n= 7	0
Magnesium; Week 52; to low; n= 7	0
Magnesium; Week 76; to high; n= 8	0
Magnesium; Week 76; to low; n= 8	0
Magnesium; Week 104; to high; n= 10	0
Magnesium; Week 104; to low; n= 10	0
Magnesium; 16 week follow up; to high; n= 8	0
Magnesium; 16 week follow up; to low; n= 8	0
Sodium; Week 12; to high; n= 12	0
Sodium; Week 12; to low; n= 12	0
Sodium; Week 28; to high; n= 11	0
Sodium; Week 28; to low; n= 11	1
Sodium; Week 52; to high; n= 7	0
Sodium; Week 52; to low; n= 7	1
Sodium; Week 76; to high; n= 8	0
Sodium; Week 76; to low; n= 8	1
Sodium; Week 104; to high; n= 10	0
Sodium; Week 104; to low; n= 10	0
Sodium; 16 week follow p; to high; n= 8	0
Sodium; 16 week follow up; to low; n= 8	1
Phosphorus; Week 12; to high; n= 13	1
Phosphorus; Week 12; to low; n= 13	0
Phosphorus; Week 28; to high; n= 11	2
Phosphorus; Week 28; to low; n= 11	0
Phosphorus; Week 52; to high; n= 7	0
Phosphorus; Week 52; to low; n= 7	0
Phosphorus; Week 76; to high; n= 8	0
Phosphorus; Week 76; to low; n= 8	0
Phosphorus;Week 104; to high; n= 10	1
Phosphorus;Week 104; to low; n= 10	1
Phosphorus; 16 week follow up; to high; n= 8	0
Phosphorus; 16 week follow up; to low; n= 8	0
Total protein; Week 12; to high; n= 12	0
Total protein; Week 12; to low; n= 12	0
Total protein; Week 28; to high; n= 11	0
Total protein; Week 28; to low; n= 11	0
Total protein; Week 52; to high; n= 7	0
Total protein; Week 52; to low; n= 7	1
Total protein; Week 76; to high; n= 8	0
Total protein; Week 76; to low; n= 8	0
Total protein; Week 104; to high; n= 10	0
Total protein; Week 104; to low; n= 10	0
Total protein; 16 Week follow up; to high; n= 8	0
Total protein; 16 Week follow up; to low; n= 8	0
BUN; Week 12; to high; n= 13	2
BUN; Week 12; to low; n= 13	0
BUN; Week 28; to high; n= 11	0
BUN; Week 28; to low; n= 11	0
BUN; Week 52; to high; n= 7	2
BUN; Week 52; to low; n= 7	0
BUN; Week 76; to high; n= 8	2
BUN; Week 76; to low; n= 8	0
BUN; Week 104; to high; n= 10	0
BUN; Week 104; to low; n= 10	0
BUN; 16 week follow up; to high; n= 8	0
BUN; 16 week follow up; to low; n= 8	0
Uric acid; Week 12; to high; n= 13	2
Uric acid; Week 12; to low; n= 13	2
Uric acid; Week 28; to high; n= 11	1
Uric acid; Week 28; to low; n= 11	0
Uric acid; Week 52; to high; n= 7	1
Uric acid; Week 52; to low; n= 7	0
Uric acid; Week 76; to high; n= 8	2
Uric acid; Week 76; to low; n= 8	0
Uric acid; Week 104; to high; n= 10	2
Uric acid; Week 104; to low; n= 10	0
Uric acid; 16 week follow up; to high; n= 8	2
Uric acid; 16 week follow up; to low; n= 8	0
Basophils; Week 12; to high; n= 12	0
Basophils; Week 12; to low; n= 12	0
Basophils; Week 28; to high; n= 11	0
Basophils; Week 28; to low; n= 11	0
Basophils; Week 52; to high; n= 9	0
Basophils; Week 52; to low; n= 9	0
Basophils; Week 76; to high; n= 8	0
Basophils; Week 76; to low; n= 8	0
Basophils; Week 104; to high; n= 9	0
Basophils; Week 104; to low; n= 9	0
Basophils; 16 week follow up; to high; n= 9	0
Basophils; 16 week follow up; to low; n= 9	0
Eosinophils; Week 12; to high; n= 12	1
Eosinophils; Week 12; to low; n= 12	0
Eosinophils; Week 28; to high; n= 11	1
Eosinophils; Week 28; to low; n= 11	0
Eosinophils; Week 52; to high; n= 9	0
Eosinophils; Week 52; to low; n= 9	0
Eosinophils; Week 76; to high; n= 8	1
Eosinophils; Week 76; to low; n= 8	0
Eosinophils; Week 104; to high; n= 9	0
Eosinophils; Week 104; to low; n= 9	0
Eosinophils; 16 week follow up; to high; n= 9	0
Eosinophils; 16 week follow up; to low; n= 9	0
Hemoglobin; Week 12; to high; n= 12	0
Hemoglobin; Week 12; to low; n= 12	0
Hemoglobin; Week 28; to high; n= 11	0
Hemoglobin; Week 28; to low; n= 11	0
Hemoglobin; Week 52; to high; n= 9	0
Hemoglobin; Week 52; to low; n= 9	2
Hemoglobin; Week 76; to high; n= 8	0
Hemoglobin; Week 76; to low; n= 8	1
Hemoglobin; Week 104; to high; n= 9	0
Hemoglobin; Week 104; to low; n= 9	1
Hemoglobin; 16 week follow up; to high; n= 9	0
Hemoglobin; 16 week follow up; to low; n= 9	1
Hematocrit; Week 12; to high; n= 12	0
Hematocrit; Week 12; to low; n= 12	0
Hematocrit; Week 28; to high; n= 11	1
Hematocrit; Week 28; to low; n= 11	0
Hematocrit; Week 52; to high; n= 9	0
Hematocrit; Week 52; to low; n= 9	1
Hematocrit; Week 76; to high; n= 8	0
Hematocrit; Week 76; to low; n= 8	0
Hematocrit; Week 104; to high; n= 9	0
Hematocrit; Week 104; to low; n= 9	1
Hematocrit; 16 week follow up; to high; n= 9	0
Hematocrit; 16 week follow up; to low; n= 9	1
Lymphocytes; Week 12; to high; n= 12	0
Lymphocytes; Week 12; to low; n= 12	0
Lymphocytes; Week 28; to high; n= 11	0
Lymphocytes; Week 28; to low; n= 11	0
Lymphocytes; Week 52; to high; n= 9	0
Lymphocytes; Week 52; to low; n= 9	0
Lymphocytes; Week 76; to high; n= 8	0
Lymphocytes; Week 76; to low; n= 8	0
Lymphocytes; Week 104; to high; n= 9	0
Lymphocytes; Week 104; to low; n= 9	0
Lymphocytes; 16 week follow up; to high; n= 9	0
Lymphocytes; 16 week follow up; to low; n= 9	0
Monocytes; Week 12; to high; n= 12	0
Monocytes; Week 12; to low; n= 12	0
Monocytes; Week 28; to high; n= 11	0
Monocytes; Week 28; to low; n= 11	0
Monocytes; Week 52; to high; n= 9	0
Monocytes; Week 52; to low; n= 9	0
Monocytes; Week 76; to high; n= 8	0
Monocytes; Week 76; to low; n= 8	0
Monocytes; Week 104; to high; n= 9	0
Monocytes; Week 104; to low; n= 9	0
Monocytes; 16 week follow up; to high; n= 9	0
Monocytes; 16 week follow up; to low; n= 9	0
Neutrophils; Week 12; to high; n= 12	1
Neutrophils; Week 12; to low; n= 12	0
Neutrophils; Week 28; to high; n= 11	0
Neutrophils; Week 28; to low; n= 11	0
Neutrophils; Week 52; to high; n= 9	0
Neutrophils; Week 52; to low; n= 9	0
Neutrophils; Week 76; to high; n= 8	0
Neutrophils; Week 76; to low; n= 8	0
Neutrophils; Week 104; to high; n= 9	2
Neutrophils; Week 104; to low; n= 9	0
Neutrophils; 16 week follow up; to high; n=9	1
Neutrophils; 16 week follow up; to low; n= 9	0
Platelet count; Week 12; to high; n= 12	3
Platelet count; Week 12; to low; n= 12	0
Platelet count; Week 28; to high; n= 11	2
Platelet count; Week 28; to low; n= 11	0
Platelet count; Week 52; to high; n= 9	0
Platelet count; Week 52; to low; n= 9	0
Platelet count; Week 76; to high; n= 8	0
Platelet count; Week 76; to low; n= 8	0
Platelet count; Week 104; to high; n= 9	1
Platelet count; Week 104; to low; n= 9	0
Platelet count; 16 week follow up; to high; n= 9	0
Platelet count; 16 week follow up; to low; n= 9	0
RBC; Week 12; to high; n= 12	0
RBC; Week 12; to low; n= 12	3
RBC; Week 28; to high; n= 11	0
RBC; Week 28; to low; n= 11	1
RBC; Week 52; to high; n= 9	0
RBC; Week 52; to low; n= 9	1
RBC; Week 76; to high; n= 8	0
RBC; Week 76; to low; n= 8	0
RBC; Week 104; to high; n= 9	0
RBC; Week 104; to low; n= 9	0
RBC; 16 week follow up; to high; n= 9	0
RBC; 16 week follow up; to low; n= 9	1
WBC; Week 12; to high; n= 12	1
WBC; Week 12; to low; n= 12	0
WBC; Week 28; to high; n= 11	0
WBC; Week 28; to low; n= 11	0
WBC; Week 52; to high; n= 9	0
WBC; Week 52; to low; n= 9	0
WBC; Week 76; to high; n= 8	0
WBC; Week 76; to low; n= 8	0
WBC; Week 104; to high; n= 9	2
WBC; Week 104; to low; n= 9	0
WBC; 16 week follow up; to high; n= 9	1
WBC; 16 week follow up; to low; n= 9	0

Notes
[32] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with urinalysis dipstick findings

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End point title

Number of participants with urinalysis dipstick findings

End point description

Urine samples were collected for urinalysis by dipstick method from Baseline up to Week 116/16 months follow up and number of participants with findings were presented for Baseline, Week 12, 28, 52, 76, 104/4 weeks post last-dose and Week 116/16 week follow up (WF). The urinalysis parameters included occult blood, glucose, ketones, protein. The findings were presented as trace or 1/10 g/100 milliliter (dL), trace, negative, 4+, 3+, 3+ or 1 g/dL, 2+ or 1/2 g/dL, 2+, 1+ or 1/4 g/dL and 1+. Only participants present at the specific time points were presented (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 116/16 Week follow up

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[33]
Units: Participants
Week 12; occult blood; Trace or 1/10 g/DL; n= 12	0
Week 12;Occult Blood; Trace; n= 12	1
Week 12; Occult Blood; negative; n= 12	2
Week 12; Occult Blood; 4+; n= 12	0
Week 12; Occult Blood; 3+ OR 1 G/DL; n= 12	0
Week 12; Occult Blood; 3+; n= 12	2
Week 12; Occult Blood; 2+ OR 1/2 G/DL; n= 12	0
Week 12; Occult Blood; 2+ ; n= 12	6
Week 12; Occult Blood;1+ OR 1/4 G/DL; n= 12	0
Week 12; Occult Blood; 1+; n= 12	1
Week 12; glucose; Trace or 1/10 g/DL; n= 12	3
Week 12;glucose; Trace; n= 12	0
Week 12; glucose; negative; n= 12	8
Week 12; glucose; 4+; n= 12	0
Week 12; glucose; 3+ OR 1 G/DL; n= 12	0
Week 12; glucose; 3+; n= 12	0
Week 12; glucose; 2+ OR 1/2 G/DL; n= 12	0
Week 12; glucose; 2+ ; n= 12	0
Week 12; glucose;1+ OR 1/4 G/DL; n= 12	1
Week 12; glucose; 1+; n= 12	0
Week 12; ketones; Trace or 1/10 g/DL; n= 12	0
Week 12; ketones; Trace; n= 12	0
Week 12; ketones; negative; n= 12	12
Week 12; ketones; 4+; n= 12	0
Week 12; ketones; 3+ OR 1 G/DL; n= 12	0
Week 12; ketones; 3+; n= 12	0
Week 12; ketones; 2+ OR 1/2 G/DL; n= 12	0
Week 12; ketones; 2+ ; n= 12	0
Week 12; ketones;1+ OR 1/4 G/DL; n= 12	0
Week 12; ketones; 1+; n= 12	0
Week 12; protein; Trace or 1/10 g/DL; n= 12	0
Week 12; Protein; Trace; n= 12	0
Week 12; Protein; negative; n= 12	0
Week 12; Protein; 4+; n= 12	0
Week 12; Protein; 3+ OR 1 G/DL; n= 12	0
Week 12; Protein; 3+; n= 12	8
Week 12; Protein; 2+ OR 1/2 G/DL; n= 12	0
Week 12; Protein; 2+ ; n= 12	3
Week 12; Protein;1+ OR 1/4 G/DL; n= 12	0
Week 12; Protein; 1+; n= 12	1
Week 28; occult blood; Trace or 1/10 g/DL; n= 11	0
Week 28;Occult Blood; Trace; n= 11	2
Week 28; Occult Blood; negative; n= 11	1
Week 28; Occult Blood; 4+; n= 11	0
Week 28; Occult Blood; 3+ OR 1 G/DL; n= 11	0
Week 28; Occult Blood; 3+; n= 11	0
Week 28; Occult Blood; 2+ OR 1/2 G/DL; n= 11	0
Week 28; Occult Blood; 2+ ; n= 11	4
Week 28; Occult Blood;1+ OR 1/4 G/DL; n= 11	0
Week 28; Occult Blood; 1+; n= 11	4
Week 28; glucose; Trace or 1/10 g/DL; n= 11	1
Week 28;glucose; Trace; n= 11	0
Week 28; glucose; negative; n= 11	9
Week 28; glucose; 4+; n= 11	0
Week 28; glucose; 3+ OR 1 G/DL; n= 11	0
Week 28; glucose; 3+; n= 11	0
Week 28; glucose; 2+ OR 1/2 G/DL; n= 11	0
Week 28; glucose; 2+ ; n= 11	0
Week 28; glucose;1+ OR 1/4 G/DL; n= 11	1
Week 28; glucose; 1+; n= 11	0
Week 28; ketones; Trace or 1/10 g/DL; n= 11	0
Week 28; ketones; Trace; n= 11	0
Week 28; ketones; negative; n= 11	11
Week 28; ketones; 4+; n= 11	0
Week 28; ketones; 3+ OR 1 G/DL; n= 11	0
Week 28; ketones; 3+; n= 11	0
Week 28; ketones; 2+ OR 1/2 G/DL; n= 11	0
Week 28; ketones; 2+ ; n= 11	0
Week 28; ketones;1+ OR 1/4 G/DL; n= 11	0
Week 28; ketones; 1+; n= 11	0
Week 28; protein; Trace or 1/10 g/DL; n= 11	0
Week 28; Protein; Trace; n= 11	0
Week 28; Protein; negative; n= 11	0
Week 28; protein; 4+; n= 11	0
Week 28; Protein; 3+ OR 1 G/DL; n= 11	0
Week 28; Protein; 3+; n= 11	10
Week 28; Protein; 2+ OR 1/2 G/DL; n= 11	0
Week 28; Protein; 2+ ; n= 11	1
Week 28; Protein;1+ OR 1/4 G/DL; n= 11	0
Week 28; Protein; 1+; n= 11	0
Week 52; occult blood; Trace or 1/10 g/DL; n= 9	0
Week 52;Occult Blood; Trace; n= 9	2
Week 52; Occult Blood; negative; n= 9	3
Week 52; Occult Blood; 4+; n= 9	0
Week 52; Occult Blood; 3+ OR 1 G/DL; n= 9	0
Week 52; Occult Blood; 3+; n= 9	0
Week 52; Occult Blood; 2+ OR 1/2 G/DL; n= 9	0
Week 52; Occult Blood; 2+ ; n= 9	4
Week 52; Occult Blood;1+ OR 1/4 G/DL; n= 9	0
Week 52; Occult Blood; 1+; n= 9	0
Week 52; glucose; Trace or 1/10 g/DL; n= 9	2
Week 52;glucose; Trace; n= 9	0
Week 52; glucose; negative; n= 9	7
Week 52; glucose; 4+; n= 9	0
Week 52; glucose; 3+ OR 1 G/DL; n= 9	0
Week 52; glucose; 3+; n= 9	0
Week 52; glucose; 2+ OR 1/2 G/DL; n= 9	0
Week 52; glucose; 2+ ; n= 9	0
Week 52; glucose;1+ OR 1/4 G/DL; n= 9	0
Week 52; glucose; 1+; n= 9	0
Week 52; ketones; Trace or 1/10 g/DL; n= 9	0
Week 52; ketones; Trace; n= 9	0
Week 52; ketones; negative; n= 9	9
Week 52; ketones; 4+; n= 9	0
Week 52; ketones; 3+ OR 1 G/DL; n= 9	0
Week 52; ketones; 3+; n= 9	0
Week 52; ketones; 2+ OR 1/2 G/DL; n= 9	0
Week 52; ketones; 2+ ; n= 9	0
Week 52; ketones;1+ OR 1/4 G/DL; n= 9	0
Week 52; ketones; 1+; n= 9	0
Week 52; protein; Trace or 1/10 g/DL; n= 9	0
Week 52; Protein; Trace; n= 9	0
Week 52; Protein; negative; n= 9	0
Week 52; protein; 4+; n= 9	0
Week 52; Protein; 3+ OR 1 G/DL; n= 9	0
Week 52; Protein; 3+; n= 9	4
Week 52; Protein; 2+ OR 1/2 G/DL; n= 9	0
Week 52; Protein; 2+ ; n= 9	3
Week 52; Protein;1+ OR 1/4 G/DL; n= 9	0
Week 52; Protein; 1+; n= 9	2
Week 76; occult blood; Trace or 1/10 g/DL;n=7	0
Week 76;Occult Blood; Trace; n= 7	3
Week 76; Occult Blood; negative; n= 7	3
Week 76; Occult Blood; 4+; n= 7	0
Week 76; Occult Blood; 3+ OR 1 G/DL; n= 7	0
Week 76; Occult Blood; 3+; n= 7	0
Week 76; Occult Blood; 2+ OR 1/2 G/DL; n= 7	0
Week 76; Occult Blood; 2+ ; n= 7	0
Week 76; Occult Blood;1+ OR 1/4 G/DL; n= 7	0
Week 76; Occult Blood; 1+; n= 7	1
Week 76; glucose; Trace or 1/10 g/DL; n= 7	2
Week 76;glucose; Trace; n= 7	0
Week 76; glucose; negative; n= 7	5
Week 76; glucose; 4+; n= 7	0
Week 76; glucose; 3+ OR 1 G/DL; n= 7	0
Week 76; glucose; 3+; n= 7	0
Week 76; glucose; 2+ OR 1/2 G/DL; n= 7	0
Week 76; glucose; 2+ ; n= 7	0
Week 76; glucose;1+ OR 1/4 G/DL; n= 7	0
Week 76; glucose; 1+; n= 7	0
Week 76; ketones; Trace or 1/10 g/DL; n= 7	0
Week 76; ketones; Trace; n= 7	0
Week 76; ketones; negative; n= 7	7
Week 76; ketones; 4+; n= 7	0
Week 76; ketones; 3+ OR 1 G/DL; n= 7	0
Week 76; ketones; 3+; n= 7	0
Week 76; ketones; 2+ OR 1/2 G/DL; n= 7	0
Week 76; ketones; 2+ ; n= 7	0
Week 76; ketones;1+ OR 1/4 G/DL; n= 7	0
Week 76; ketones; 1+; n= 7	0
Week 76; protein; Trace or 1/10 g/DL; n= 7	0
Week 76; Protein; Trace; n= 7	0
Week 76; Protein; negative; n= 7	1
Week 76; protein; 4+; n= 7	0
Week 76; Protein; 3+ OR 1 G/DL; n= 7	0
Week 76; Protein; 3+; n= 7	1
Week 76; Protein; 2+ OR 1/2 G/DL; n= 7	0
Week 76; Protein; 2+ ; n= 7	4
Week 76; Protein;1+ OR 1/4 G/DL; n= 7	0
Week 76; Protein; 1+; n= 7	1
Week 104; occult blood; Trace or 1/10 g/DL;n=10	0
Week 104;Occult Blood; Trace; n= 10	0
Week 104; Occult Blood; negative; n= 10	8
Week 104; Occult Blood; 4+; n= 10	0
Week 104; Occult Blood; 3+ OR 1 G/DL; n= 10	0
Week 104; Occult Blood; 3+; n= 10	0
Week 104; Occult Blood; 2+ OR 1/2 G/DL; n= 10	0
Week 104; Occult Blood; 2+ ; n=10	1
Week 104; Occult Blood;1+ OR 1/4 G/DL; n= 10	0
Week 104; Occult Blood; 1+; n= 10	1
Week 104; glucose; Trace or 1/10 g/DL; n= 10	2
Week 104 ;glucose; Trace; n= 10	0
Week 104; glucose; negative; n= 10	7
Week 104; glucose; 4+; n= 10	0
Week 104; glucose; 3+ OR 1 G/DL; n= 10	0
Week 104; glucose; 3+; n= 10	0
Week 104; glucose; 2+ OR 1/2 G/DL; n= 10	0
Week 104; glucose; 2+ ; n= 10	0
Week 104; glucose;1+ OR 1/4 G/DL; n= 10	1
Week 104; glucose; 1+; n= 10	0
Week 104; ketones; Trace or 1/10 g/DL; n= 10	0
Week 104; ketones; Trace; n= 10	0
Week 104; ketones; negative; n= 10	10
Week 104; ketones; 4+; n= 10	0
Week 104; ketones; 3+ OR 1 G/DL; n= 10	0
Week 104; ketones; 3+; n= 10	0
Week 104; ketones; 2+ OR 1/2 G/DL; n= 10	0
Week 104; ketones; 2+ ; n= 10	0
Week 104; ketones;1+ OR 1/4 G/DL; n= 10	0
Week 104; ketones; 1+; n= 10	0
Week 104; protein; Trace or 1/10 g/DL; n= 10	0
Week 104; Protein; Trace; n= 10	0
Week 104; Protein; negative; n= 10	1
Week 104; protein; 4+; n= 10	0
Week 104; Protein; 3+ OR 1 G/DL; n= 10	0
Week 104; Protein; 3+; n= 10	3
Week 104; Protein; 2+ OR 1/2 G/DL; n= 10	0
Week 104; Protein; 2+ ; n= 10	6
Week 104; Protein;1+ OR 1/4 G/DL; n= 10	0
Week 104; Protein; 1+; n= 10	0
16 WF; Occult blood; TRACE OR 1/10 G/DL; n= 9	0
16 WF; Occult blood; TRACE; n= 9	2
16 WF; Occult blood; NEGATIVE; n= 9	6
16 WF; Occult blood; 4+; n= 9	0
16 WF; Occult blood; 3+ OR 1 G/DL; n= 9	0
16 WF; Occult blood; 3+; n= 9	0
16 WF; Occult blood; 2+ OR 1/2 G/DL; n= 9	0
16 WF; Occult blood; 2+; n= 9	1
16 WF; Occult blood; 1+ OR 1/4 G/DL; n= 9	0
16 WF; Occult blood; 1+; n= 9	0
16 WF; Glucose; TRACE OR 1/10 G/DL; n= 9	1
16 WF; Glucose; TRACE; n= 9	0
16 WF; Glucose; negative; n= 9	7
16 WF; Glucose; 4+; n= 9	0
16 WF; Glucose; 3+ OR 1 G/DL; n= 9	0
16 WF; Glucose; 3+; n= 9	0
16 WF; Glucose; 2+ OR 1/2 G/DL; n= 9	1
16 WF; Glucose; 2+; n= 9	0
16 WF; Glucose; 1+ OR 1/4 G/DL; n=9	0
16 WF; Glucose; 1+; n=9	0
16 WF; Ketones; TRACE OR 1/10 G/DL; n= 9	0
16 WF; Ketones; TRACE; n= 9	0
16 WF; Ketones; negative; n= 9	9
16 WF; Ketones; 4+; n= 9	0
16 WF; Ketones; 3+ OR 1 G/DL; n= 9	0
16 WF; Ketones; 3+; n= 9	0
16 WF; Ketones; 2+ OR 1/2 G/DL; n= 9	0
16 WF; Ketones; 2+; n= 9	0
16 WF; Ketones; 1+ OR 1/4 G/DL; n= 9	0
16 WF; Ketones; 1+; n= 9	0
16 WF; Protein; TRACE OR 1/10 G/DL; n= 9	0
16 WF; Protein; TRACE; n= 9	1
16 WF; Protein; negative; n= 9	0
16 WF; Protein; 4+; n= 9	0
16 WF; Protein; 3+ OR 1 G/DL; n= 9	0
16 WF; Protein; 3+; n= 9	3
16 WF; Protein; 2+ OR 1/2 G/DL; n= 9	0
16 WF; Protein; 2+; n= 9	4
16 WF; Protein; 1+ OR 1/4 G/DL; n= 9	0
16 WF; Protein; 1+; n= 9	1

Notes
[33] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

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End point title

Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

End point description

SBP and DBP were measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week follow-up visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline and up to week 116/16 week follow-up visit

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[34]
Units: millimeter of mercury (mmHg)
arithmetic mean (standard deviation)
Week 12; SBP; n= 12	-4.2 ( 17.23 )
Week 28; SBP; n= 11	-5.8 ( 18.14 )
Week 52; SBP; n= 9	-1.9 ( 18.66 )
Week 76; SBP; n= 8	-1.3 ( 11.3 )
4 Week post last dose; SBP; n= 10	-12.2 ( 11.78 )
16 Week follow up; SBP; n= 9	-7.4 ( 15.72 )
Week 104 withdrawn visit; SBP; n= 2	-1 ( 5.66 )
Week 12; DBP; n= 12	3.8 ( 12.94 )
Week 28; DBP; n= 11	0.8 ( 10.75 )
Week 52; DBP; n= 9	1.2 ( 11.87 )
Week 76; DBP; n= 8	2.8 ( 9.68 )
4 Week post last dose; DBP; n= 10	-3.3 ( 9.87 )
16 Week follow up; DBP; n= 9	2.4 ( 14.98 )
Week 104 withdrawn visit; DBP; n= 2	5.5 ( 2.12 )

Notes
[34] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in pulse rate

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End point title

Change from Baseline in pulse rate

End point description

Pulse rate was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 116/16 week follow-up visit

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[35]
Units: Beats per minute
arithmetic mean (standard deviation)
Week 12; n= 12	-0.7 ( 11.4 )
Week 28; n= 11	1 ( 7.9 )
Week 52; n= 9	-1.7 ( 13.11 )
Week 76; n= 8	-2.3 ( 15.77 )
4 Week post last dose; n= 10	-2.8 ( 15.33 )
16 Week follow up; n= 9	-0.9 ( 16.72 )
Week 104 withdrawn visit; n= 2	5 ( 7.07 )

Notes
[35] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in temperature

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End point title

Change from Baseline in temperature

End point description

Temperature was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 116/16 week follow-up visit

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[36]
Units: Celsius
arithmetic mean (standard deviation)
Week 12; n= 12	-0.09 ( 0.591 )
Week 28; n= 11	0 ( 0.453 )
Week 52; n= 9	-0.11 ( 0.639 )
Week 76; n= 8	-0.17 ( 0.486 )
4 Week post last dose; n= 8	-0.06 ( 0.604 )
16 Week follow up; n= 6	0.3 ( 0.424 )
Week 104 withdrawn visit; n= 2	0.15 ( 0.353 )

Notes
[36] - ITT Population

No statistical analyses for this end point

Secondary: Number of participants with positive immunogenicity findings

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End point title

Number of participants with positive immunogenicity findings

End point description

Blood samples of participants were collected pre-dose on Weeks 0, 12, 28, 40, 52, 76, 4 week post last dose and 16 week post last dose visit for belimumab immunogenicity assay. No participants showed positive immunogenicity findings.

End point type

Secondary

End point timeframe

Baseline and up to Week 116/16 week follow-up visit

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[37]
Units: Participants
Participants	0

Notes
[37] - ITT Population

No statistical analyses for this end point

Secondary: Urine membrane attack complex (MAC) levels

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End point title

Urine membrane attack complex (MAC) levels

End point description

Urine membrane attack complex was assayed quantitatively by ELISA method. Urine MAC samples were collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results were normalized using urine creatinine concentration to adjust for urine dilution. Endpoint was moved to ‘Exploratory’ in Protocol amendment 5 as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed.

End point type

Secondary

End point timeframe

Baseline and up to 4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	0 ^[38]
Units: Micrograms/micromoles (ug/umol)
geometric mean (geometric coefficient of variation)
Micrograms/micromoles (ug/umol)	( )

Notes
[38] - ITT Population. No assay was subsequently found and samples were not analyzed

No statistical analyses for this end point

Secondary: Change from Baseline in urine membrane attack complex (MAC)

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End point title

Change from Baseline in urine membrane attack complex (MAC)

End point description

Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). Endpoint was changed to 'exploratory' as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed.

End point type

Secondary

End point timeframe

Baseline and up to 4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	0 ^[39]
Units: Ratio
geometric mean (geometric coefficient of variation)
Ratio	( )

Notes
[39] - ITT Population. No assay was subsequently found and samples were not analyzed

No statistical analyses for this end point

Secondary: Change from Baseline in B Cell and T Cell markers concentration

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End point title

Change from Baseline in B Cell and T Cell markers concentration

End point description

B cell Facs panels were used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel were used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

End point type

Secondary

End point timeframe

Baseline and up to Week 128/6 month post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[40]
Units: Ratio
geometric mean (geometric coefficient of variation)
CD19+; Week 8; n= 12	0.7221 ( 82.1 )
CD19+; Week 16; n= 11	0.9209 ( 63.6 )
CD19+; Week 28; n= 10	1.0049 ( 71.6 )
CD19+; Week 104; n= 10	0.5193 ( 156.2 )
CD19+; 6 month follow up; n= 7	0.3828 ( 185.7 )
CD19+ CD24b+ CD38b+ CD27-; Week 8; n= 12	0.2352 ( 340 )
CD19+ CD24b+ CD38b+ CD27-; Week 16; n= 11	0.6228 ( 316.7 )
CD19+ CD24b+ CD38b+ CD27-; Week 28; n= 10	0.6119 ( 656 )
CD19+ CD24b+ CD38b+ CD27-; Week 104; n= 10	0.3582 ( 405.1 )
CD19+ CD24b+ CD38b+ CD27-; 6 month follow up; n= 7	1.6471 ( 534 )
CD19+ CD27- IgD+; Week 8; n= 12	0.349 ( 131.6 )
CD19+ CD27- IgD+; Week 16; n= 11	0.4486 ( 94.7 )
CD19+ CD27- IgD+; Week 28; n= 10	0.4561 ( 82.5 )
CD19+ CD27- IgD+; Week 104; n= 10	0.1808 ( 298.6 )
CD19+ CD27- IgD+; 6 month follow up; n= 7	0.3278 ( 189.2 )
CD19+ CD27-; Week 8; n= 12	0.4074 ( 109.2 )
CD19+ CD27-; Week 16; n= 11	0.5079 ( 88.1 )
CD19+ CD27-; Week 28; n= 10	0.5165 ( 76.5 )
CD19+ CD27-; Week 104; n= 10	0.2602 ( 236.9 )
CD19+ CD27-; 6 month follow up; n= 7	0.3756 ( 186 )
CD19lo CD38hi CD27hi; Week 8; n= 12	0.5982 ( 555.4 )
CD19lo CD38hi CD27hi; Week 16; n= 11	0.4128 ( 1085.7 )
CD19lo CD38hi CD27hi; Week 28; n= 10	0.4481 ( 651.6 )
CD19lo CD38hi CD27hi; Week 104; n= 10	0.2615 ( 238.8 )
CD19lo CD38hi CD27hi; 6 month follow up; n= 7	0.0647 ( 1269.7 )
CD19+ CD24+ CD27+ ; Week 8; n= 12	2.0747 ( 65.3 )
CD19+ CD24+ CD27+ ; Week 16; n= 11	2.4161 ( 61.2 )
CD19+ CD24+ CD27+ ; Week 28; n= 10	3.1294 ( 64.2 )
CD19+ CD24+ CD27+ ; Week 104; n= 10	0.6089 ( 104014.8 )
CD19+ CD24+ CD27+ ; 6 month follow up; n= 7	0.7952 ( 328.6 )
CD19+CD27+; Week 8; n= 12	1.9195 ( 69.9 )
CD19+CD27+; Week 16; n= 11	2.3132 ( 62.7 )
CD19+CD27+; Week 28; n= 10	3.1352 ( 65.6 )
CD19+CD27+; Week 104; n= 10	1.3273 ( 127.7 )
CD19+CD27+; 6 month follow up; n= 7	0.3338 ( 158.2 )
CD19+CD27+IgD; Week 8; n= 12	1.9365 ( 69.6 )
CD19+CD27+IgD; Week 16; n= 11	2.3147 ( 75.1 )
CD19+CD27+IgD; Week 28; n= 10	3.2313 ( 51.1 )
CD19+CD27+IgD; Week 104; n= 10	1.2814 ( 102.3 )
CD19+CD27+IgD; 6 month follow up; n= 7	0.2413 ( 163.9 )
CD19+CD27+IgD-; Week 8; n= 12	1.8846 ( 67.7 )
CD19+CD27+IgD-; Week 16; n= 11	2.2113 ( 70.4 )
CD19+CD27+IgD-; Week 28; n= 10	3.0478 ( 73.2 )
CD19+CD27+IgD-; Week 104; n= 10	1.3051 ( 147.1 )
CD19+CD27+IgD-; 6 month follow up; n= 7	0.344 ( 163.8 )
CD4+ CD25hi CD45RA- IL7Rhi; Week 8; n= 12	0.701 ( 86.7 )
CD4+ CD25hi CD45RA- IL7Rhi; Week 16; n= 10	0.534 ( 221.3 )
CD4+ CD25hi CD45RA- IL7Rhi; Week 28; n= 9	0.5718 ( 669.2 )
CD4+ CD25hi CD45RA- IL7Rhi; Week 104; n= 10	4.1865 ( 509.4 )
CD4+ CD25hi CD45RA- IL7Rh; 6 month follow up; n= 7	1.8067 ( 1456.7 )
CD4+ CD45RA- IL-7Rhi; Week 8; n= 12	1.4174 ( 19513.4 )
CD4+ CD45RA- IL-7Rhi; Week 16; n= 10	1.8613 ( 99527.6 )
CD4+ CD45RA- IL-7Rhi; Week 28; n=9	2.8378 ( 49940.7 )
CD4+ CD45RA- IL-7Rhi; Week 104; n= 10	0.1517 ( 33534.3 )
CD4+ CD45RA- IL-7Rhi; 6 month follow-up; n= 7	0.3532 ( 966.4 )
CD4+ CD25hi xIL-7Rlo; Week 8; n= 12	0.7285 ( 85.7 )
CD4+ CD25hi xIL-7Rlo; Week 16; n= 11	0.6232 ( 317.6 )
CD4+ CD25hi xIL-7Rlo; Week 28; n= 10	0.701 ( 961.5 )
CD4+ CD25hi xIL-7Rlo; Week 104; n= 10	3.1025 ( 932.7 )
CD4+ CD25hi xIL-7Rlo; 6 month follow-up; n= 7	2.0827 ( 832.7 )
CD4+ CD25hi IL-7Rlo; Week 8; 12	2.3001 ( 29702.5 )
CD4+ CD25hi IL-7Rlo; Week 16; n= 10	2.9023 ( 136702.6 )
CD4+ CD25hi IL-7Rlo; Week 28; n= 9	3.3453 ( 35372.4 )
CD4+ CD25hi IL-7Rlo; Week 104; n= 10	0.341 ( 72506.2 )
CD4+ CD25hi IL-7Rlo; 6 month follow up; n= 7	0.9978 ( 32.7 )
CD4+ CD45RA-; Week 8; n= 12	0.7532 ( 44.5 )
CD4+ CD45RA-; Week 16; n= 11	0.7638 ( 55.4 )
CD4+ CD45RA-; Week 28; n= 10	0.9032 ( 71.1 )
CD4+ CD45RA-; 104; n= 10	0.975 ( 95.8 )
CD4+ CD45RA-; 6 month follow up; n= 7	1.0792 ( 90 )

Notes
[40] - ITT Population

No statistical analyses for this end point

Secondary: Change from Baseline in cytokines/chemokine

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End point title

Change from Baseline in cytokines/chemokine

End point description

Cytokine/chemokine associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification were used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Endpoint was moved to ‘Exploratory’ in Protocol amendment 5 as benefits of assessing cytokines was deemed low. Samples were not analyzed.

End point type

Secondary

End point timeframe

Baseline and up to Week 104/4 week post last dose

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	0 ^[41]
Units: Ratio
geometric mean (geometric coefficient of variation)
Ratio	( )

Notes
[41] - ITT Population. Samples were not analyzed.

No statistical analyses for this end point

Secondary: Serum BLys levels

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End point title

Serum BLys levels

End point description

Free BLyS protein were analyzed using an ELISA. Serum samples were collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit.

End point type

Secondary

End point timeframe

Baseline and Week 116/16 week follow-up visit

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	14 ^[42]
Units: pg/mL
geometric mean (geometric coefficient of variation)
Day 0; n= 14	969.9595 ( 16.8 )
16 week follow up; n= 8	12357.5558 ( 123.3 )

Notes
[42] - ITT Population

No statistical analyses for this end point

Secondary: Urine BLys levels as a ratio to creatinine

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End point title

Urine BLys levels as a ratio to creatinine

End point description

B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS: creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. Only raw BLyS values available and unable to be assessed due to lack of comparison to a creatinine as a urine concentration marker.

End point type

Secondary

End point timeframe

Baseline and Week 116/16 week follow-up visit

End point values	Belimumab 10 mg/kg IV
Number of subjects analysed	0 ^[43]
Units: pg/mmol
geometric mean (geometric coefficient of variation)
pg/mmol	( )

Notes
[43] - ITT Population. Only raw BLyS values available and unable to be assessed due to lack of comparison

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study.

Adverse event reporting additional description

On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Belimumab 10 mg/kg IV

Reporting group description

Serious adverse events	Belimumab 10 mg/kg IV
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 14 (21.43%)
number of deaths (all causes)	0
number of deaths resulting from adverse events
Investigations
Weight decreased
subjects affected / exposed	1 / 14 (7.14%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vascular disorders
Embolism
subjects affected / exposed	1 / 14 (7.14%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	1 / 14 (7.14%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Belimumab 10 mg/kg IV
Total subjects affected by non serious adverse events
subjects affected / exposed	14 / 14 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Skin papilloma
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Vascular disorders
Hypertension
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
General disorders and administration site conditions
Malaise
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Chest pain
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Pyrexia
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Chest discomfort
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Immune system disorders
Seasonal allergy
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Oropharyngeal pain
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	3
Epistaxis
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Productive cough
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Psychiatric disorders
Depression
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Insomnia
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Investigations
Eosinophil count increased
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Blood parathyroid hormone increased
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Injury, poisoning and procedural complications
Limb injury
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Cardiac disorders
Angina pectoris
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Palpitations
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	2
Nervous system disorders
Headache
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	7
Dizziness
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	3
Migraine
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Presyncope
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Hypoaesthesia
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Peripheral sensory neuropathy
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Sciatica
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Eye disorders
Periorbital oedema
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	3
Abdominal pain
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Abdominal pain upper
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Ascites
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Dyspepsia
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	3
Irritable bowel syndrome
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Nausea
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Rectal haemorrhage
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Vomiting
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Gingival bleeding
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Haemorrhoids
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Melaena
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Toothache
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	2
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Rash pruritic
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Skin lesion
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Swelling face
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	3
Angioedema
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Renal and urinary disorders
Tubulointerstitial nephritis
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Costovertebral angle tenderness
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Musculoskeletal and connective tissue disorders
Muscle spasms
subjects affected / exposed	4 / 14 (28.57%)
occurrences all number	12
Arthralgia
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Flank pain
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Joint swelling
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Myalgia
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Pain in extremity
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Back pain
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	4
Musculoskeletal discomfort
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Neck pain
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Tendonitis
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	6 / 14 (42.86%)
occurrences all number	10
Cellulitis
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Lower respiratory tract infection
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Oral candidiasis
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Respiratory tract infection
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	4
Rhinitis
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Urinary tract infection
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	2
Viral upper respiratory tract infection
subjects affected / exposed	5 / 14 (35.71%)
occurrences all number	5
Viral infection
subjects affected / exposed	2 / 14 (14.29%)
occurrences all number	2
Influenza
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Labyrinthitis
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Lower respiratory tract infection viral
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 14 (7.14%)
occurrences all number	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

10 May 2012

Clarification of stopping criteria; additional rationale for hypogammaglobulinaemia including stopping criteria and monitoring; removal of Disease-Related Events provision; clarification of SRT.

21 Dec 2012

Addition of Benlysta program generic suicidality monitoring text; extension of biopsy inclusion to 7 years (3 years non-active); extension of time before stopping study treatment when hypogammaglobulinaemia without improvement; removal of requirement for 6 month post dose immunogenicity; addition of aliskiren, ACTH to prohibited medications; minor clarifications and consistency corrections.

10 Jan 2014

Addition of 6 month post treatment follow-up; PML text revision; alternative use of 24h protein excretion instead of uPCR in eligibility and for increased dosing frequency threshold; reduction in rituximab washout; removal NSAID prohibition; removal of change in urine belimumab endpoint; minor clarifications and consistency corrections

06 Mar 2014

Strengthening of discouragement against use of NSAIDs.

22 Jun 2016

Modification and clarification of secondary and exploratory endpoints, due to change in protocol template; clarification of Week 104 withdrawn visit; addition of serum IgG as an efficacy marker; clarification of text defining populations and confirmatory samples.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in proteinuria levels at Week 28

Primary: Change from Baseline in proteinuria levels at Week 28

Primary: Change from Baseline in anti-phospholipase A2 receptor (PLA2R) autoantibody titers at Week 28

Primary: Change from Baseline in anti-phospholipase A2 receptor (PLA2R) autoantibody titers at Week 28

Secondary: Proteinuria levels at the indicated time points

Secondary: Proteinuria levels at the indicated time points

Secondary: Change from Baseline in proteinuria levels at the indicated time points

Secondary: Change from Baseline in proteinuria levels at the indicated time points

Secondary: Anti-phospholipase A2 receptor (PLA2R) autoantibody levels at indicated time points

Secondary: Anti-phospholipase A2 receptor (PLA2R) autoantibody levels at indicated time points

Secondary: Change from Baseline in anti-PLA2R autoantibody titers at the indicated time points

Secondary: Change from Baseline in anti-PLA2R autoantibody titers at the indicated time points

Secondary: Number of participants with complete or partial remission

Secondary: Number of participants with complete or partial remission

Secondary: Time to complete or partial remission

Secondary: Time to complete or partial remission

Secondary: Duration of complete or partial remission

Secondary: Duration of complete or partial remission

Secondary: Number of participants with PLA2R autoantibody remission

Secondary: Number of participants with PLA2R autoantibody remission

Secondary: Time to anti-PLA2R autoantibody remission

Secondary: Time to anti-PLA2R autoantibody remission

Secondary: Number of participants with anti-PLA2R autoantibody relapse

Secondary: Number of participants with anti-PLA2R autoantibody relapse

Secondary: eGFR levels at the indicated time points

Secondary: eGFR levels at the indicated time points

Secondary: Change from Baseline in eGFR levels at the indicated time points

Secondary: Change from Baseline in eGFR levels at the indicated time points

Secondary: Serum creatinine levels at the indicated time points

Secondary: Serum creatinine levels at the indicated time points

Secondary: Change from Baseline in serum creatinine levels at the indicated time points

Secondary: Change from Baseline in serum creatinine levels at the indicated time points

Secondary: Serum albumin levels at indicated time points

Secondary: Serum albumin levels at indicated time points

Secondary: Change from Baseline in levels of serum albumin at the indicated time points

Secondary: Change from Baseline in levels of serum albumin at the indicated time points

Secondary: Serum cholesterol levels at indicated time points

Secondary: Serum cholesterol levels at indicated time points

Secondary: Change from Baseline in serum cholesterol at the indicated time points

Secondary: Change from Baseline in serum cholesterol at the indicated time points

Secondary: Serum Immunoglobulin G (IgG) levels at indicated time points

Secondary: Serum Immunoglobulin G (IgG) levels at indicated time points

Secondary: Change from Baseline in serum IgG at the indicated time points

Secondary: Change from Baseline in serum IgG at the indicated time points

Secondary: Number of participants with edema and edema extending beyond calf

Secondary: Number of participants with edema and edema extending beyond calf

Secondary: Summary of maximum observed serum concentration (Cmax) of belimumab at the indicated time points

Secondary: Summary of maximum observed serum concentration (Cmax) of belimumab at the indicated time points

Secondary: Summary of minimum observed concentration (Cmin) of belimumab at the indicated time points

Secondary: Summary of minimum observed concentration (Cmin) of belimumab at the indicated time points

Secondary: Summary of area under the serum concentration-time curve to the last quantifiable concentration (AUC[0-2])

Secondary: Summary of area under the serum concentration-time curve to the last quantifiable concentration (AUC[0-2])

Secondary: Summary of total amount of urine excreted Ae(0-24)

Secondary: Summary of total amount of urine excreted Ae(0-24)

Secondary: Change from Baseline in short form (SF)-36 v2 Quality of Life (QoL) questionnaire score

Secondary: Change from Baseline in short form (SF)-36 v2 Quality of Life (QoL) questionnaire score

Secondary: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary: Number of participants with abnormal clinical chemistry and hematology values

Secondary: Number of participants with abnormal clinical chemistry and hematology values

Secondary: Number of participants with urinalysis dipstick findings

Secondary: Number of participants with urinalysis dipstick findings

Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Secondary: Change from Baseline in pulse rate

Secondary: Change from Baseline in pulse rate

Secondary: Change from Baseline in temperature

Secondary: Change from Baseline in temperature

Secondary: Number of participants with positive immunogenicity findings

Secondary: Number of participants with positive immunogenicity findings

Clinical Trial Results:
BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy