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    Clinical Trial Results:
    A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2014-004632-19
    Trial protocol
    		 LT   BE   ES   CZ   DE   BG  
    Global end of trial date
    06 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Mar 2020
    First version publication date
    21 Mar 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D3461C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02446899
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Forskargatan 18, Sudertalje, Sweden, 151 85
    Public contact
    Global Clinical Lead, AstraZeneca AB, +46 317761000, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca AB, + 46 317761000, ClinicalTrialTransparency@astrazeneca.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effect of anifrolumab 300 mg compared to placebo on disease activity as measured by the difference in the proportion of participants who achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at Week 52.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/GCP, applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 43
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Lithuania: 22
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Brazil: 23
    Country: Number of subjects enrolled
    Mexico: 32
    Country: Number of subjects enrolled
    South Africa: 13
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    United States: 123
    Worldwide total number of subjects
    362
    EEA total number of subjects
    78
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    356
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the trial at 119 sites in 15 countries worldwide.

    Pre-assignment
    Screening details
    		 Participants reported to the clinical study site for screening within 30 days of 1st study drug administration. 649 participants were screened, and 284 participants were screen failures. 365 participants were randomized, with 3 participant not receiving study drug. 362 participants received the study drug and were included in the full analysis set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anifrolumab 300 mg
    Arm description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anifrolumab
    Investigational medicinal product code
    MEDI-546
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg anifrolumab administered via a controlled intravenous infusion (IV) pump into a peripheral vein over at last 30 minutes, every 4 weeks for up to 48 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching placebo administered via a controlled intravenous infusion (IV) pump into a peripheral vein over at least 30 minutes, every 4 weeks for up to 48 weeks.

    Number of subjects in period 1
    		Anifrolumab 300 mg Placebo
    Started
    180
    182
    Completed
    156
    136
    Not completed
    24
    46
         Adverse event, serious fatal
    1
    -
         Severe non-compliance to protocol
    -
    1
         Consent withdrawn by subject
    11
    19
         Adverse event, non-fatal
    2
    7
         Condition under investigation worsened
    1
    4
         Miscellaneous
    5
    4
         Development of study specific withdrawal criteria
    1
    -
         Lost to follow-up
    1
    3
         Lack of efficacy
    2
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anifrolumab 300 mg
    Reporting group description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Reporting group values
    		 Anifrolumab 300 mg Placebo Total
    Number of subjects
    		 180 182 362
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 175 181 356
        From 65-84 years
    		 5 1 6
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.1 ( 11.95 ) 41.1 ( 11.47 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 168 170 338
        Male
    		 12 12 24
    Race
    Units: Subjects
        White
    		 110 107 217
        Black or African American
    		 17 25 42
        Asian
    		 30 30 60
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        American Indian or Alaska Native
    		 4 1 5
        Other
    		 11 11 22
        Missing
    		 8 8 16
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 54 54 108
        Not Hispanic or Latino
    		 118 120 238
        Missing
    		 8 8 16
    Geographic region
    Units: Subjects
        Asia Pacific
    		 27 26 53
        Europe
    		 51 46 97
        Latin America
    		 35 32 67
        United States/Canada
    		 64 68 132
        Rest of World (South Africa)
    		 3 10 13

    End points

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    End points reporting groups
    Reporting group title
    Anifrolumab 300 mg
    Reporting group description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Subject analysis set title
    Anifrolumab 300 mg High IFN Test Results Subgroup
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with high interferon (IFN) test results at baseline.

    Subject analysis set title
    Placebo High IFN Test Results Subgroup
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 cycles). Participants with high interferon (IFN) test results at baseline.

    Subject analysis set title
    Anifrolumab 300 mg Baseline OCS ≥10 mg/day
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with a baseline oral corticosteroid (OCS) dose of ≥10 mg/day.

    Subject analysis set title
    Placebo Baseline OCS ≥10 mg/day
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with a baseline oral corticosteroid (OCS) dose of ≥10 mg/day.

    Subject analysis set title
    Anifrolumab 300 mg CLASI Activity Score ≥10
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score of ≥10 at baseline.

    Subject analysis set title
    Placebo CLASI Activity Score ≥10
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score ≥10 at baseline.

    Subject analysis set title
    Anifrolumab 300 mg ≥6 Swollen and ≥6 Tender Joints at Baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with 6 or more swollen joints and 6 or more tender joints at baseline.

    Subject analysis set title
    Placebo ≥6 Swollen and ≥6 Tender Joints at Baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Participants with 6 or more swollen joints and 6 or more tender joints at baseline.

    Primary: Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52

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    End point title
    		 Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52
    End point description
    Composite endpoint BICLA, was defined by meeting all of the following criteria: • Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B • No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline of >0 points in SLEDAI-2K • No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) • No discontinuation of investigational product • No use of restricted medications beyond the protocol allowed threshold before assessment
    End point type
    Primary
    End point timeframe
    Baseline; Week 52
    End point values
    		 Anifrolumab 300 mg Placebo
    Number of subjects analysed
    180 [1]
    182 [2]
    Units: Participants
    86
    57
    Notes
    [1] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [2] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    Statistical analysis title
    		 Anifrolumab 300 mg vs Placebo
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    362
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0013
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.3
         upper limit
    		 26.3

    Secondary: Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group

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    End point title
    		 Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group
    End point description
    Composite endpoint BICLA, was defined by meeting all of the following criteria: • Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B • No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline to >0 points in SLEDAI-2K • No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) • No discontinuation of investigational product • No use of restricted medications beyond the protocol allowed threshold before assessment
    End point type
    Secondary
    End point timeframe
    Baseline; Week 52
    End point values
    		 Anifrolumab 300 mg High IFN Test Results Subgroup Placebo High IFN Test Results Subgroup
    Number of subjects analysed
    150 [3]
    151 [4]
    Units: Participants
    72
    46
    Notes
    [3] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [4] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    Statistical analysis title
    		 Anifrolumab 300 mg vs Placebo
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg High IFN Test Results Subgroup v Placebo High IFN Test Results Subgroup
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0022 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.5
         upper limit
    		 28.2
    Notes
    [5] - Adjusted p-value.

    Secondary: Number of Participants Who Achieve an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/day at Week 40, Which is Maintained Through to Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/day

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    End point title
    		 Number of Participants Who Achieve an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/day at Week 40, Which is Maintained Through to Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/day
    End point description
    Maintained OCS reduction was defined by meeting all of the following criteria: • Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 • Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 • No discontinuation of investigational product • No use of restricted medications beyond the protocol allowed threshold before assessment
    End point type
    Secondary
    End point timeframe
    Week 40; Week 52
    End point values
    		 Anifrolumab 300 mg Baseline OCS ≥10 mg/day Placebo Baseline OCS ≥10 mg/day
    Number of subjects analysed
    87 [6]
    83 [7]
    Units: Participants
    45
    25
    Notes
    [6] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [7] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    Statistical analysis title
    		 Anifrolumab 300 mg vs Placebo
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg Baseline OCS ≥10 mg/day v Placebo Baseline OCS ≥10 mg/day
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0135 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    21.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.8
         upper limit
    		 35.7
    Notes
    [8] - Adjusted p-value.

    Secondary: Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10

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    End point title
    		 Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10
    End point description
    50% reduction in CLASI activity score compared to baseline was defined by meeting all of the following criteria: • Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline • No discontinuation of investigational product • No use of restricted medications beyond the protocol allowed threshold before assessment
    End point type
    Secondary
    End point timeframe
    Baseline; Week 12
    End point values
    		 Anifrolumab 300 mg CLASI Activity Score ≥10 Placebo CLASI Activity Score ≥10
    Number of subjects analysed
    49 [9]
    40 [10]
    Units: Participants
    24
    10
    Notes
    [9] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [10] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    Statistical analysis title
    		 Anifrolumab 300 mg vs Placebo
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg CLASI Activity Score ≥10 v Placebo CLASI Activity Score ≥10
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0392 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.3
         upper limit
    		 43.6
    Notes
    [11] - Adjusted p-value.

    Secondary: Number of Participants With ≥50% Reduction in Joint Count at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline

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    End point title
    		 Number of Participants With ≥50% Reduction in Joint Count at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline
    End point description
    50% reduction in the number of swollen and tender joints compared to baseline was defined by meeting all of the following criteria: • Achieve ≥50% reduction in the number of swollen and tender joints, separately • No discontinuation of investigational product • No use of restricted medications beyond the protocol allowed threshold before assessment
    End point type
    Secondary
    End point timeframe
    Baseline; Week 52
    End point values
    		 Anifrolumab 300 mg ≥6 Swollen and ≥6 Tender Joints at Baseline Placebo ≥6 Swollen and ≥6 Tender Joints at Baseline
    Number of subjects analysed
    71 [12]
    90 [13]
    Units: Participants
    30
    34
    Notes
    [12] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [13] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    Statistical analysis title
    		 Anifrolumab 300 mg vs Placebo
    Statistical analysis description
    The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
    Comparison groups
    Anifrolumab 300 mg ≥6 Swollen and ≥6 Tender Joints at Baseline v Placebo ≥6 Swollen and ≥6 Tender Joints at Baseline
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5469 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 20
    Notes
    [14] - Adjusted p-value.

    Secondary: Annualised Flare Rate Through 52 Weeks

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    End point title
    		 Annualised Flare Rate Through 52 Weeks
    End point description
    Annualised flare rate was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG) 2004 A or 2 or more new BILAG 2004 B items compared to the previous visit.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Anifrolumab 300 mg Placebo
    Number of subjects analysed
    180 [15]
    182 [16]
    Units: Annualized flare rate ratio
        number (confidence interval 95%)
    0.43 (0.31 to 0.59)
    0.64 (0.47 to 0.86)
    Notes
    [15] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [16] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    Statistical analysis title
    		 Anifrolumab 300 mg vs Placebo
    Statistical analysis description
    Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening [<10 points vs >=10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]). The logarithm of the follow-up time is used as an offset variable.
    Comparison groups
    Anifrolumab 300 mg v Placebo
    Number of subjects included in analysis
    362
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0809 [17]
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.94
    Notes
    [17] - Adjusted p-value.

    Secondary: Number of Participants With One or More Adverse Events (AEs)

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    End point title
    		 Number of Participants With One or More Adverse Events (AEs)
    End point description
    An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs.
    End point type
    Secondary
    End point timeframe
    Baseline to end of trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 300 mg Placebo
    Number of subjects analysed
    180 [18]
    182 [19]
    Units: Participants
    162
    154
    Notes
    [18] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [19] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Number of Participants With One or More Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Participants With One or More Adverse Events of Special Interest (AESIs)
    End point description
    An AESI is an adverse event (AE) of scientific and medical concern specific to understanding biologics. An AESI may be serious or non-serious. AESI are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, tuberculosis (TB) (including latent TB), influenza, vasculitis (non-systemic lupus erythematosus [SLE]), and major adverse cardiovascular events (MACE) (including stroke, myocardial infarction [MI], or cardiovascular death). AESIs were collected throughout the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to end of trial (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 300 mg Placebo
    Number of subjects analysed
    180 [20]
    182 [21]
    Units: Participants
    29
    20
    Notes
    [20] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [21] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Number of Participants with a Potentially Clinically Important Change from Baseline in Vital Sign Measurements

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    End point title
    		 Number of Participants with a Potentially Clinically Important Change from Baseline in Vital Sign Measurements
    End point description
    Vital sign measurements included oral temperature, blood pressure (BP), pulse rate, and respiratory rate. Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to end of study (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 300 mg Placebo
    Number of subjects analysed
    180 [22]
    182 [23]
    Units: Participants
    45
    45
    Notes
    [22] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [23] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Number of Participants with a Potentially Clinically Important Change from Baseline in Clinical Laboratory Tests

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    End point title
    		 Number of Participants with a Potentially Clinically Important Change from Baseline in Clinical Laboratory Tests
    End point description
    Clinical laboratory tests were analyzed in a central clinical laboratory and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
    End point type
    Secondary
    End point timeframe
    Baseline to end of study (Maximum of 60 weeks)
    End point values
    		 Anifrolumab 300 mg Placebo
    Number of subjects analysed
    180 [24]
    182 [25]
    Units: Participants
    72
    87
    Notes
    [24] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    [25] - Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to end of study (Maximum of 60 weeks)
    Adverse event reporting additional description
    TEAEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to study drug discontinuation. Full analysis set: All participants who had received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Anifrolumab 300 mg
    Reporting group description
    		 Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).

    Serious adverse events
    		 Anifrolumab 300 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 180 (8.89%)
    34 / 182 (18.68%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lip squamous cell carcinoma
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal ulceration
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 180 (0.00%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Chilaiditi's syndrome
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 180 (0.56%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 180 (0.56%)
    6 / 182 (3.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 180 (1.11%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 180 (1.67%)
    7 / 182 (3.85%)
         occurrences causally related to treatment / all
    3 / 3
    7 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Anifrolumab 300 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    125 / 180 (69.44%)
    99 / 182 (54.40%)
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    25 / 180 (13.89%)
    14 / 182 (7.69%)
         occurrences all number
    42
    27
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 180 (6.11%)
    18 / 182 (9.89%)
         occurrences all number
    13
    23
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 180 (3.89%)
    10 / 182 (5.49%)
         occurrences all number
    7
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 180 (5.56%)
    7 / 182 (3.85%)
         occurrences all number
    11
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 180 (5.56%)
    6 / 182 (3.30%)
         occurrences all number
    11
    6
    Back pain
         subjects affected / exposed
    11 / 180 (6.11%)
    3 / 182 (1.65%)
         occurrences all number
    12
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    23 / 180 (12.78%)
    8 / 182 (4.40%)
         occurrences all number
    31
    8
    Herpes zoster
         subjects affected / exposed
    12 / 180 (6.67%)
    3 / 182 (1.65%)
         occurrences all number
    12
    3
    Nasopharyngitis
         subjects affected / exposed
    28 / 180 (15.56%)
    23 / 182 (12.64%)
         occurrences all number
    42
    31
    Sinusitis
         subjects affected / exposed
    13 / 180 (7.22%)
    9 / 182 (4.95%)
         occurrences all number
    21
    10
    Upper respiratory tract infection
         subjects affected / exposed
    42 / 180 (23.33%)
    19 / 182 (10.44%)
         occurrences all number
    57
    24
    Urinary tract infection
         subjects affected / exposed
    21 / 180 (11.67%)
    26 / 182 (14.29%)
         occurrences all number
    27
    40

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2016
    Added HIV testing at screening.
    23 Mar 2016
    Updates were made to the restricted medications regarding B-cell depleter, rituximab, and other biologics.
    18 May 2016
    Clarified inclusion/exclusion criteria and clarified long term extension design.
    06 Dec 2018
    Unable to report dates after End of Trial (EOT). Protocol Amendment dated 23 May 2019: British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at Week 52 replaced Systemic Lupus Erythematosus Responder Index ≥4 (SRI[4]) as primary endpoint; rationale for primary endpoint selection updated. Changed 2 key secondary endpoints: 1) SRI(4) response at Week 52 in the interferon (IFN)-high only sub population was replaced with the BICLA response 2) SRI(4) at Week 24 replaced with an organ-specific assessment of joints. Statistical methodology regarding analysis of the primary and key secondary endpoints, the testing strategy, and power estimation updated. Clarified guidance for the use of non-steroidal anti-inflammatory drug (NSAIDs). Added scoring disease activity by modified British Isles Lupus Assessment Group (BILAG) 2004.

    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.
    None reported
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    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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