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    Clinical Trial Results:
    Protocol Title: A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients with Active Systemic Lupus Erythematosus (SLE)

    Summary
    EudraCT number
    		 2025-000106-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2025
    First version publication date
    17 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    213560
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04908865
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of belimumab IV in Chinese pediatric participants with SLE.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 67
    Worldwide total number of subjects
    67
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    16
    Adolescents (12-17 years)
    51
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 67 participants were enrolled in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Belimumab
    Arm description
    		 Participants with active systemic lupus erythematosus (SLE) received belimumab at 10 milligrams per kilogram (mg/kg) body weight by intravenous (IV) infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 milligrams per kilogram (mg/kg) on Days 0, 14, 28, and then every 28 days through Week 48

    Number of subjects in period 1
    		Belimumab
    Started
    67
    Pharmacokinetic (PK) Population
    26 [1]
    Completed
    59
    Not completed
    8
         Adverse event, non-fatal
    2
         Lost to follow-up
    1
         Lack of efficacy
    5
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PK population was added as a milestone because the study contains endpoints based on this population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Belimumab
    Reporting group description
    		 Participants with active systemic lupus erythematosus (SLE) received belimumab at 10 milligrams per kilogram (mg/kg) body weight by intravenous (IV) infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.

    Reporting group values
    		 Belimumab Total
    Number of subjects
    		 67 67
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 16 16
        Adolescents (12-17 years)
    		 51 51
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.0 ( 2.22 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 51 51
        Male
    		 16 16
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 67 67

    End points

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    End points reporting groups
    Reporting group title
    Belimumab
    Reporting group description
    		 Participants with active systemic lupus erythematosus (SLE) received belimumab at 10 milligrams per kilogram (mg/kg) body weight by intravenous (IV) infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.

    Primary: Number of Participants with Adverse Events of Special Interest (AESIs) Through Week 52

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    End point title
    		 Number of Participants with Adverse Events of Special Interest (AESIs) Through Week 52 [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included malignancies, post-infusion systemic or hypersensitivity reactions, infections (including serious infections of special interest), and depression (including mood disorders and anxiety), suicide, or self-injury. Infections of special interest included opportunistic infections (OI), herpes zoster (HZ), tuberculosis (TB), and sepsis. Number of participants with AESIs as identified by custom Medical Dictionary for Regulatory Activities (MedDRA) query has been reported. Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    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: As per the study protocol, no formal hypothesis testing was planned in the study. Hence, no statistical analyses have been specified for this endpoint.
    End point values
    		 Belimumab
    Number of subjects analysed
    67
    Units: Participants
        All malignancies
    0
        Post-infusion systemic reactions (PISR)
    0
        All infections of special interest
    2
        Depression/suicide/self-injury
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Greater than Equal to (>=) 4 Points Reduction from Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score

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    End point title
    		 Number of Participants With Greater than Equal to (>=) 4 Points Reduction from Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score [2]
    End point description
    SELENA-SLEDAI score is cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. Total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). Higher score indicates a more significant degree of disease activity. Baseline was defined as latest pre-dose assessment with non-missing value, including those from unscheduled visits. Number of participants with decrease of >= 4 points in score at Week 52 compared to Baseline is presented. ITT population. One participant with Baseline SELENA-SLEDAI score below (<) 4 was excluded.
    End point type
    Primary
    End point timeframe
    Baseline (Day 0) and Week 52
    Notes
    [2] - 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: As per the study protocol, no formal hypothesis testing was planned in the study. Hence, no statistical analyses have been specified for this endpoint.
    End point values
    		 Belimumab
    Number of subjects analysed
    66
    Units: Participants
    44
    No statistical analyses for this end point

    Secondary: Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52

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    End point title
    		 Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52
    End point description
    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly, or other situations as per the medical or scientific judgment of the investigator. Number of participants with AEs and SAEs has been reported. ITT population consisted of all participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Belimumab
    Number of subjects analysed
    67
    Units: Participants
        AEs
    56
        SAEs
    19
    No statistical analyses for this end point

    Secondary: Percentage of Participants With >=4 Points Reduction from Baseline in SELENA-SLEDAI Score by Each Visit

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    End point title
    		 Percentage of Participants With >=4 Points Reduction from Baseline in SELENA-SLEDAI Score by Each Visit
    End point description
    SELENA-SLEDAI score is used to assess SLE disease activity in participants with SLE. It consists of 24 disease descriptors across 9 organ systems. Each descriptor is assigned a weight (8 descriptors: each weighted 8; 6 descriptors: each weighted 4; 7 descriptors: each weighted 2; 3 descriptors: each weighted 1) which is summed if the descriptor is observed during a visit or within preceding 10 days. Total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present together). Higher score means more significant degree of disease activity. Baseline was the latest pre-dose assessment with non-missing value, including those from unscheduled visits. ITT population. 1 participant with Baseline score < 4 was excluded. All 66 participants served as denominator to calculate percentages at each visit. Due to rounding off at Week 52 (as no data was missing) and use of multiple imputation for missing data for all other visits, percentages may not yield whole participants.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
    End point values
    		 Belimumab
    Number of subjects analysed
    66
    Units: Percentage of Participants
    number (not applicable)
        Week 4
    39.8
        Week 8
    51.8
        Week 12
    68.9
        Week 16
    69.0
        Week 20
    65.4
        Week 24
    68.1
        Week 28
    65.7
        Week 32
    67.7
        Week 36
    69.1
        Week 40
    75.1
        Week 44
    74.2
        Week 48
    71.3
        Week 52
    66.7
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 52 in Physician Global Assessment (PGA)

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    End point title
    		 Change from Baseline to Week 52 in Physician Global Assessment (PGA)
    End point description
    The PGA is used to assess the participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) visual analogue scale. The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. ITT population consisted of all participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Week 52
    End point values
    		 Belimumab
    Number of subjects analysed
    67
    Units: Scores on scale
        arithmetic mean (standard deviation)
    -0.931 ( 0.6046 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 52 in Parent Global Assessment (ParentGA)

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    End point title
    		 Change from Baseline to Week 52 in Parent Global Assessment (ParentGA)
    End point description
    The ParentGA is used to assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale by the parent. The score ranges from 0 (very well) to 10 (very poorly). Higher score indicates worse effect of the illness on the child. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. ITT population consisted of all participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Week 52
    End point values
    		 Belimumab
    Number of subjects analysed
    67
    Units: Scores on scale
        arithmetic mean (standard deviation)
    -2.71 ( 2.713 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Average Daily Prednisone Equivalent Dose at Week 52

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    End point title
    		 Change from Baseline in Average Daily Prednisone Equivalent Dose at Week 52
    End point description
    Average daily prednisone equivalent dose included all steroids taken. All steroid dosages were converted to prednisone equivalent in mg at each visit. Daily prednisone equivalent dose was calculated as follows: dose of steroid in mg multiplied by (*) conversion factor * frequency factor. Baseline was defined as latest pre-dose assessment with non-missing value, including those from unscheduled visits. Baseline average daily prednisone equivalent dose was sum of all prednisone doses over 7 consecutive days up to but not including Day 0 divided by 7. Average daily prednisone dose at Week 52 visit was sum of all prednisone doses over 7 consecutive days up to and including Week 52 visit divided by 7. Average daily prednisone equivalent dose was expressed in mg per day. ITT population included all participants who received at least 1 dose of study treatment. 'Number of Subjects Analyzed' included only those participants who were analyzed (i.e., contributed data reported in table).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Week 52
    End point values
    		 Belimumab
    Number of subjects analysed
    59
    Units: milligrams per day
        arithmetic mean (standard deviation)
    -6.020 ( 9.2970 )
    No statistical analyses for this end point

    Secondary: Time to First Flare Over 52 Weeks

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    End point title
    		 Time to First Flare Over 52 Weeks
    End point description
    SLE flare index (SFI) is used to categorize SLE flares as mild/moderate or severe. Mild/moderate SFI flare: SELENA-SLEDAI score increase of 3 to 12 (higher score - greater disease activity); SLE symptom development; prednisone dose increase (but not above [>] 0.5 milligrams per kilogram per day [mg/kg/day]); non-steroidal anti-inflammatory drugs (NSAIDs)/hydroxychloroquine addition; or PGA score increase by >= 1, but not to > 2.5 (higher score - greater disease activity). Severe SFI flare: SELENA-SLEDAI score increase > 12; onset or worsening of severe SLE symptoms; prednisone dose increase > 0.5 mg/kg/day; introduction of potent immunosuppressants; hospitalization; or PGA score reaching >= 2.5. Time to first SLE flare was number of days from treatment start date until the event. Time to first flare was defined as event date minus treatment start date plus 1. ITT population. 'Number of subjects analyzed' included participants with post-baseline SFI flare over 52 weeks.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Belimumab
    Number of subjects analysed
    50
    Units: days
        median (inter-quartile range (Q1-Q3))
    141.0 (58.0 to 333.0)
    No statistical analyses for this end point

    Secondary: Time to First Severe Flare Over 52 Weeks

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    End point title
    		 Time to First Severe Flare Over 52 Weeks
    End point description
    SFI is used to categorize SLE flares as mild/moderate or severe. Severe SFI flare: SELENA-SLEDAI score increase > 12; onset or worsening of severe SLE symptoms; prednisone dose increase > 0.5 mg/kg/day; introduction of potent immunosuppressants; hospitalization; or PGA score reaching >= 2.5. Time to first SLE flare was number of days from treatment start date until the event. Time to first flare was defined as event date minus treatment start date plus 1. ITT population. 'Number of subjects analyzed' included participants with post-baseline severe SFI flare over 52 weeks. '99999’ indicates that the median time and/or interquartile range could not be estimated due to low number of events in the participants.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Belimumab
    Number of subjects analysed
    18
    Units: days
        median (inter-quartile range (Q1-Q3))
    99999 (289.0 to 99999)
    No statistical analyses for this end point

    Secondary: Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84

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    End point title
    		 Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84
    End point description
    Blood samples were collected at indicated time points for measurement of plasma concentrations of belimumab. Pharmacokinetic (PK) population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. 'Number of subjects analyzed' included only those participants who were analyzed (i.e., contributed data reported in table). 'n' indicates participants evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Micrograms per milliliter
    median (full range (min-max))
        Day 0 (n=24)
    197.1173 (141.9326 to 257.3748)
        Day 7 (n=26)
    71.3616 (35.9532 to 100.5913)
        Day 14 (n=26)
    37.8585 (14.5944 to 74.1679)
        Day 84, pre-infusion (n=25)
    28.2415 (2.3467 to 89.0718)
        Day 84, post-infusion (n=25)
    238.5688 (139.1862 to 357.0316)
    No statistical analyses for this end point

    Secondary: Apparent Total Clearance of Belimumab

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    End point title
    		 Apparent Total Clearance of Belimumab
    End point description
    Blood samples were collected at indicated time points for PK analysis of belimumab. '99999' indicates that data has not been disclosed for apparent total clearance of belimumab, as this analysis integrating data from Study 213560 and other studies, is still under discussion and review to fully understand the PK characteristics. The data for all pre-specified PK parameters will be disclosed by 30 June 2026.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Milliliters per day
        geometric mean (geometric coefficient of variation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Volume of Distribution of Belimumab

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    End point title
    		 Volume of Distribution of Belimumab
    End point description
    Blood samples were collected at indicated time points for PK analysis of belimumab. '99999' indicates that data has not been disclosed for volume of distribution of belimumab, as this analysis integrating data from Study 213560 and other studies, is still under discussion and review to fully understand the PK characteristics. The data for all pre-specified PK parameters will be disclosed by 30 June 2026.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Milliliters
        geometric mean (geometric coefficient of variation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Estimated Maximum Concentration (Cmax) of Belimumab at Steady State

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    End point title
    		 Estimated Maximum Concentration (Cmax) of Belimumab at Steady State
    End point description
    Blood samples were collected at indicated time points for PK analysis of belimumab. '99999' indicates that data has not been disclosed for estimated Cmax of belimumab at steady state, as this analysis integrating data from Study 213560 and other studies, is still under discussion and review to fully understand the PK characteristics. The data for all pre-specified PK parameters will be disclosed by 30 June 2026.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Micrograms per milliliter
        geometric mean (geometric coefficient of variation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Estimated Minimum Concentration (Cmin) of Belimumab at Steady State

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    End point title
    		 Estimated Minimum Concentration (Cmin) of Belimumab at Steady State
    End point description
    Blood samples were collected at indicated time points for PK analysis of belimumab. '99999' indicates that data has not been disclosed for estimated Cmin of belimumab at steady state, as this analysis integrating data from Study 213560 and other studies, is still under discussion and review to fully understand the PK characteristics. The data for all pre-specified PK parameters will be disclosed by 30 June 2026.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Micrograms per milliliter
        geometric mean (geometric coefficient of variation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Terminal Half-life (t1/2) of Belimumab

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    End point title
    		 Terminal Half-life (t1/2) of Belimumab
    End point description
    Blood samples were collected at indicated time points for PK analysis of belimumab. '99999' indicates that data has not been disclosed for t1/2 of belimumab, as this analysis integrating data from Study 213560 and other studies, is still under discussion and review to fully understand the PK characteristics. The data for all pre-specified PK parameters will be disclosed by 30 June 2026.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Days
        median (full range (min-max))
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Estimated Average Concentration (Cavg) of Belimumab at Steady State

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    End point title
    		 Estimated Average Concentration (Cavg) of Belimumab at Steady State
    End point description
    Blood samples were collected at indicated time points for PK analysis of belimumab. '99999' indicates that data has not been disclosed for estimated Cavg of belimumab at steady state, as this analysis integrating data from Study 213560 and other studies, is still under discussion and review to fully understand the PK characteristics. The data for all pre-specified PK parameters will be disclosed by 30 June 2026.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Micrograms per milliliter
        geometric mean (geometric coefficient of variation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Area Under Plasma Concentration-time Curve (AUC) of Belimumab at Steady State

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    End point title
    		 Area Under Plasma Concentration-time Curve (AUC) of Belimumab at Steady State
    End point description
    Blood samples were collected at indicated time points for PK analysis of belimumab. '99999' indicates that data has not been disclosed for AUC of belimumab at steady state, as this analysis integrating data from Study 213560 and other studies, is still under discussion and review to fully understand the PK characteristics. The data for all pre-specified PK parameters will be disclosed by 30 June 2026.
    End point type
    Secondary
    End point timeframe
    Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
    End point values
    		 Belimumab
    Number of subjects analysed
    26
    Units: Micrograms-day per milliliter
        geometric mean (geometric coefficient of variation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64
    Adverse event reporting additional description
    All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Belimumab
    Reporting group description
    		 Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.

    Serious adverse events
    		 Belimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 67 (29.85%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Neuromyelitis optica spectrum disorder
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Belimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 67 (85.07%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Endocrine hypertension
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Venous thrombosis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    7 / 67 (10.45%)
         occurrences all number
    9
    Chest pain
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Face oedema
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypogammaglobulinaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 67 (13.43%)
         occurrences all number
    13
    Productive cough
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences all number
    11
    Lymphocyte count decreased
         subjects affected / exposed
    5 / 67 (7.46%)
         occurrences all number
    9
    Reticulocyte count increased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    CD19 lymphocytes decreased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Bone density decreased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Blood immunoglobulin M decreased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Neutrophil count increased
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    3
    Intraocular pressure increased
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    White blood cell count increased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    2
    Neutrophil count decreased
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hand fracture
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Arthropod bite
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Animal bite
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Pericardial effusion
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Myocardial injury
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Arrhythmia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Seizure
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Polycythaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Eye disorders
    Xerophthalmia
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Eyelid oedema
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Ocular hypertension
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Retinal haemorrhage
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Gastrointestinal disorders
    Mouth ulceration
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Functional gastrointestinal disorder
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Abdominal discomfort
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Anal fissure
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Cheilitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Faeces discoloured
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Pancreatitis acute
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    9 / 67 (13.43%)
         occurrences all number
    13
    Cholestasis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hepatic lesion
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hepatomegaly
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences all number
    4
    Cutaneous vasculitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Dermatitis allergic
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Acne
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Arthritis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Infections and infestations
    Coronavirus pneumonia
         subjects affected / exposed
    11 / 67 (16.42%)
         occurrences all number
    11
    COVID-19
         subjects affected / exposed
    9 / 67 (13.43%)
         occurrences all number
    9
    Upper respiratory tract infection
         subjects affected / exposed
    31 / 67 (46.27%)
         occurrences all number
    63
    Bronchitis
         subjects affected / exposed
    4 / 67 (5.97%)
         occurrences all number
    5
    Gastroenteritis
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Pneumonia
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Oral candidiasis
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Infection
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Conjunctivitis
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Abscess soft tissue
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Tinea versicolour
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    3
    Adenovirus infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Varicella
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Tinea pedis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Sepsis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Rhinovirus infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Mumps
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Herpangina
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    2
    Viral infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypoproteinaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2021
    Protocol Amendment 1
    03 Jun 2022
    Protocol Amendment 2
    02 Jan 2023
    Protocol Amendment 3

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Data for PK parameters derived from population PK analysis has not been disclosed as this analysis, integrating data from Study 213560 and others, is under ongoing review to understand PK characteristics. This data will be disclosed by 30 June 2026.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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