Systemic Lupus Erythematosus
Conditions
Brief summary
This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.
Interventions
DRUGAnifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
DRUGPlacebo
subcutaneous administration every two weeks from week 0 to week 50
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 through 70 years 2. Diagnosis of paediatric or adult SLE for \> 24 weeks and fulfilling ≥4 of the 11 American College of Rheumatology (ACR) classification criteria with at least one being: * Positive antinuclear antibody (ANA) or * Elevated anti-dsDNA antibodies or * anti-Smith (anti-Sm) antibodies 3. Interferon high test result 4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 5. Currently receiving at least 1 of the following for treatment of SLE: • Oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks prior to randomization • Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization: (i) Azathioprine ≤200 mg/day (ii) Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week (v) Mizoribine ≤150 mg/day 6. Must not have signs of active or latent tuberculosis (TB). 7. Must not be pregnant or breastfeeding.
Exclusion criteria
1. Active severe or unstable neuropsychiatric SLE 2. Active severe SLE-driven renal disease 3. Any severe herpes infection at any time 4. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV infection. 5. Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection 6. Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF 7. History of cancer, apart from: * Squamous or basal cell carcinoma of the skin if successfully treated. * Cervical cancer in situ if successfully treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration of Anifrolumab in Serum After First Dose | Week 0 | Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment. |
| Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab | Week 12 | Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose). |
| 21-gene Type 1 IFN Signature Score (Fold-change) | Week 12 | 21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control. |
| 21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) | Week 12 | 21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)\*100) for the 21 genes. At a population level, the results are presented as mean the above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Vital Signs | Baseline to Week 60 | Change from baseline for vital signs. |
| Change From Baseline for Physical Examination | Baseline to Week 60 | Physical examination is reported as change from baseline in body weight. |
| Change From Baseline for 12-lead ECG | Baseline to Week 52 | The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant \[NCS\]), abnormal (clinically significant \[CS\]), or not done. |
| Value of Haematology Blood Tests to Detect Change From Baseline | Baseline to Week 60 | Change from baseline in haematology blood tests (leucocytes \[particle concentration\], platelets \[particle concentration\]) are reported. |
| Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Baseline to Week 60 | Change from baseline in protein-creatinine ratio urinalysis tests are reported. |
| Value of Haemoglobin Blood Test to Detect Change From Baseline | Baseline to Week 60 | Change from baseline in haemoglobin blood tests are reported. |
| Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Baseline to Week 60 | Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported. |
| Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Baseline to Week 60 | Change from baseline in clinical creatinine chemistry blood tests (serum) are reported. |
| Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | Baseline to Week 60 | Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported. |
| Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | Baseline to Week 60 | Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported. |
| Number of Participants With Positive Hepatitis B Core Antibody Post-baseline. | Baseline to Week 60 | Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening. |
| Value of Total Protein Urinalysis Test to Detect Change From Baseline | Baseline to Week 60 | Change from baseline in total protein urinalysis tests are reported. |
| Number of Participants With Antidrug Antibody (ADA) | Baseline to Week 52 | Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA) |
| Number of Participants With Neutralizing Antibodies (nAb) | Baseline to Week 52 | Incidence of detectable nAb in post-baseline ADA positive participants. |
| Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Baseline to Week 52 | Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section. |
Countries
Hungary, Poland, South Korea, United States
Participant flow
Recruitment details
Participants type I Interferon (IFN) test-high Systemic Lupus Erythematosus (SLE) subjects with active skin manifestations while receiving Standard of Care (SOC) treatment were eligible for the study.
Pre-assignment details
36 patients were randomized, and all received at least one dose of study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Anifrolumab - Lower Dose 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 14 |
| Anifrolumab - Higher Dose 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | 13 |
| Placebo Comparator Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 | 9 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator | Total |
|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 9.1 | 41.5 years STANDARD_DEVIATION 9.2 | 47.8 years STANDARD_DEVIATION 14.2 | 44.9 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 13 Participants | 9 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 9 Participants | 28 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 8 Participants | 32 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 | 0 / 9 |
| other Total, other adverse events | 12 / 14 | 11 / 13 | 7 / 9 |
| serious Total, serious adverse events | 4 / 14 | 2 / 13 | 0 / 9 |
Outcome results
Primary
21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change)
21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)\*100) for the 21 genes. At a population level, the results are presented as mean the above.
Time frame: Week 12
Population: All participants who are 21-gene IFN test high at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anifrolumab - Lower Dose | 21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) | 77.5 percentage neutralization | Standard Deviation 24.16 |
| Anifrolumab - Higher Dose | 21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) | 80.5 percentage neutralization | Standard Deviation 36.65 |
| Placebo Comparator | 21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) | 15.1 percentage neutralization | Standard Deviation 49.63 |
Primary
21-gene Type 1 IFN Signature Score (Fold-change)
21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.
Time frame: Week 12
Population: All participants who are 21-gene IFN test high at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anifrolumab - Lower Dose | 21-gene Type 1 IFN Signature Score (Fold-change) | 3.2 fold change | Standard Deviation 3.69 |
| Anifrolumab - Higher Dose | 21-gene Type 1 IFN Signature Score (Fold-change) | 3.5 fold change | Standard Deviation 5.73 |
| Placebo Comparator | 21-gene Type 1 IFN Signature Score (Fold-change) | 14.3 fold change | Standard Deviation 6.68 |
Primary
Maximum Concentration of Anifrolumab in Serum After First Dose
Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.
Time frame: Week 0
Population: All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Anifrolumab - Lower Dose | Maximum Concentration of Anifrolumab in Serum After First Dose | 14.058 mcg/mL | Geometric Coefficient of Variation 49.8151 |
| Anifrolumab - Higher Dose | Maximum Concentration of Anifrolumab in Serum After First Dose | 28.115 mcg/mL | Geometric Coefficient of Variation 74.4916 |
Primary
Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab
Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).
Time frame: Week 12
Population: All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Anifrolumab - Lower Dose | Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab | 15.618 mcg/mL | Geometric Coefficient of Variation 81.3595 |
| Anifrolumab - Higher Dose | Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab | 16.926 mcg/mL | Geometric Coefficient of Variation 9205.6677 |
Secondary
Change From Baseline for 12-lead ECG
The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant \[NCS\]), abnormal (clinically significant \[CS\]), or not done.
Time frame: Baseline to Week 52
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (NCS) Week 52 | 1 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Not done baseline - Not done Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - not done Week 52 | 2 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Normal baseline - Normal Week 52 | 7 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Not done baseline - Normal Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Not done Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Normal baseline - not done Week 52 | 1 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Normal Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Normal Week 52 | 2 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (NCS) Week 52 | 1 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Lower Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Not done Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - Normal Week 52 | 10 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (NCS) Week 52 | 1 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - not done Week 52 | 2 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Normal Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - not done Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Normal Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Not done Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Normal Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Anifrolumab - Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Not done baseline - Not done Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Normal baseline - Normal Week 52 | 5 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Normal Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Normal Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Normal baseline - not done Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - not done Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Not done baseline - Normal Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Not done Week 52 | 0 Participants |
| Placebo Comparator | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Normal Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Not done Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Normal Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - Normal Week 52 | 3 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Normal Week 52 | 1 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Not done Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - Abnormal (NCS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (NCS) baseline - not done Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Not done baseline - Abnormal (CS) Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Normal baseline - not done Week 52 | 0 Participants |
| Placebo Comparator to Higher Dose | Change From Baseline for 12-lead ECG | Abnormal (CS) baseline - Abnormal (NCS) Week 52 | 0 Participants |
Secondary
Change From Baseline for Physical Examination
Physical examination is reported as change from baseline in body weight.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Change From Baseline for Physical Examination | Week 60 | -1.81 kilograms | Standard Deviation 3.858 |
| Anifrolumab - Lower Dose | Change From Baseline for Physical Examination | Week 12 | -1.81 kilograms | Standard Deviation 2.674 |
| Anifrolumab - Lower Dose | Change From Baseline for Physical Examination | Week 52 | -2.83 kilograms | Standard Deviation 4.683 |
| Anifrolumab - Higher Dose | Change From Baseline for Physical Examination | Week 60 | 2.93 kilograms | Standard Deviation 6.463 |
| Anifrolumab - Higher Dose | Change From Baseline for Physical Examination | Week 12 | 1.37 kilograms | Standard Deviation 3.113 |
| Anifrolumab - Higher Dose | Change From Baseline for Physical Examination | Week 52 | 2.52 kilograms | Standard Deviation 6.495 |
| Placebo Comparator | Change From Baseline for Physical Examination | Week 52 | 0.30 kilograms | Standard Deviation 3.338 |
| Placebo Comparator | Change From Baseline for Physical Examination | Week 12 | 0.7 kilograms | Standard Deviation 1.889 |
| Placebo Comparator | Change From Baseline for Physical Examination | Week 60 | 1.06 kilograms | Standard Deviation 4.02 |
| Placebo Comparator to Higher Dose | Change From Baseline for Physical Examination | Week 12 | 0.98 kilograms | Standard Deviation 2.904 |
| Placebo Comparator to Higher Dose | Change From Baseline for Physical Examination | Week 60 | 3.60 kilograms | Standard Deviation 5.3 |
| Placebo Comparator to Higher Dose | Change From Baseline for Physical Examination | Week 52 | 3.90 kilograms | Standard Deviation 5.608 |
Secondary
Change From Baseline for Vital Signs
Change from baseline for vital signs.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 12 | -4.1 mmHg | Standard Deviation 12.08 |
| Anifrolumab - Lower Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 52 | 2.1 mmHg | Standard Deviation 10.96 |
| Anifrolumab - Lower Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 60 | 4.1 mmHg | Standard Deviation 19.7 |
| Anifrolumab - Lower Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 12 | -2.0 mmHg | Standard Deviation 10.02 |
| Anifrolumab - Lower Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 60 | 3.6 mmHg | Standard Deviation 12.23 |
| Anifrolumab - Lower Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 52 | 0.1 mmHg | Standard Deviation 6.87 |
| Anifrolumab - Higher Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 52 | 2.9 mmHg | Standard Deviation 7.54 |
| Anifrolumab - Higher Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 12 | 2.4 mmHg | Standard Deviation 6.71 |
| Anifrolumab - Higher Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 12 | 3 mmHg | Standard Deviation 6.63 |
| Anifrolumab - Higher Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 60 | -2.8 mmHg | Standard Deviation 14.91 |
| Anifrolumab - Higher Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 52 | -1.7 mmHg | Standard Deviation 12.96 |
| Anifrolumab - Higher Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 60 | -0.8 mmHg | Standard Deviation 6.86 |
| Placebo Comparator | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 52 | -0.4 mmHg | Standard Deviation 7.13 |
| Placebo Comparator | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 60 | 12.2 mmHg | Standard Deviation 8.61 |
| Placebo Comparator | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 12 | -3.8 mmHg | Standard Deviation 6.5 |
| Placebo Comparator | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 52 | 3.4 mmHg | Standard Deviation 8.53 |
| Placebo Comparator | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 12 | -5.8 mmHg | Standard Deviation 13.99 |
| Placebo Comparator | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 60 | -1.0 mmHg | Standard Deviation 8.22 |
| Placebo Comparator to Higher Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 60 | 4.5 mmHg | Standard Deviation 7.14 |
| Placebo Comparator to Higher Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 60 | 8.8 mmHg | Standard Deviation 6.29 |
| Placebo Comparator to Higher Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 52 | 12.5 mmHg | Standard Deviation 19.36 |
| Placebo Comparator to Higher Dose | Change From Baseline for Vital Signs | Systolic Blood Pressure (mmHg) - Week 12 | 7.3 mmHg | Standard Deviation 8.96 |
| Placebo Comparator to Higher Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 52 | 6.8 mmHg | Standard Deviation 5.38 |
| Placebo Comparator to Higher Dose | Change From Baseline for Vital Signs | Diastolic Blood Pressure (mmHg) - Week 12 | 4.3 mmHg | Standard Deviation 4.35 |
Secondary
Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI)
Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.
Time frame: Baseline to Week 52
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anifrolumab - Lower Dose | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any serious adverse event | 4 Participants |
| Anifrolumab - Lower Dose | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any adverse event | 12 Participants |
| Anifrolumab - Lower Dose | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any adverse event of special interest | 5 Participants |
| Anifrolumab - Higher Dose | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any serious adverse event | 2 Participants |
| Anifrolumab - Higher Dose | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any adverse event | 11 Participants |
| Anifrolumab - Higher Dose | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any adverse event of special interest | 1 Participants |
| Placebo Comparator | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any adverse event | 7 Participants |
| Placebo Comparator | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any adverse event of special interest | 1 Participants |
| Placebo Comparator | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) | Any serious adverse event | 0 Participants |
Secondary
Number of Participants With Antidrug Antibody (ADA)
Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)
Time frame: Baseline to Week 52
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anifrolumab - Lower Dose | Number of Participants With Antidrug Antibody (ADA) | 1 Participants |
| Anifrolumab - Higher Dose | Number of Participants With Antidrug Antibody (ADA) | 1 Participants |
| Placebo Comparator | Number of Participants With Antidrug Antibody (ADA) | 0 Participants |
Secondary
Number of Participants With Neutralizing Antibodies (nAb)
Incidence of detectable nAb in post-baseline ADA positive participants.
Time frame: Baseline to Week 52
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anifrolumab - Lower Dose | Number of Participants With Neutralizing Antibodies (nAb) | 0 Participants |
| Anifrolumab - Higher Dose | Number of Participants With Neutralizing Antibodies (nAb) | 0 Participants |
| Placebo Comparator | Number of Participants With Neutralizing Antibodies (nAb) | 0 Participants |
Secondary
Number of Participants With Positive Hepatitis B Core Antibody Post-baseline.
Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). No participants were positive for Hepatitis B at screening, therefore no participants were tested post-baseline.
Secondary
Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline
Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). Only participants with abnormal baseline values are included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 52 | -99.04 IU/mL | Standard Deviation 288.183 |
| Anifrolumab - Lower Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 12 | -42.09 IU/mL | Standard Deviation 256.228 |
| Anifrolumab - Lower Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 60 | 52.67 IU/mL | Standard Deviation 144.22 |
| Anifrolumab - Higher Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 12 | -84.97 IU/mL | Standard Deviation 231.489 |
| Anifrolumab - Higher Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 52 | 8.70 IU/mL | Standard Deviation 27.308 |
| Anifrolumab - Higher Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 60 | 16.53 IU/mL | Standard Deviation 30.528 |
| Placebo Comparator | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 12 | -37.0 IU/mL | Standard Deviation 19.799 |
| Placebo Comparator | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 60 | -21.33 IU/mL | Standard Deviation 54.921 |
| Placebo Comparator | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 52 | -13.0 IU/mL | Standard Deviation 50.229 |
| Placebo Comparator to Higher Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 52 | -76.87 IU/mL | Standard Deviation 127.433 |
| Placebo Comparator to Higher Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 12 | -97.33 IU/mL | Standard Deviation 151.596 |
| Placebo Comparator to Higher Dose | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline | anti-dsDNA - Week 60 | -76.73 IU/mL | Standard Deviation 141.525 |
Secondary
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)
Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 12 | 0.00769 ukat/L | Standard Deviation 0.147479 |
| Anifrolumab - Lower Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 52 | -0.06335 ukat/L | Standard Deviation 0.119642 |
| Anifrolumab - Lower Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 60 | -0.01297 ukat/L | Standard Deviation 0.043131 |
| Anifrolumab - Lower Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 12 | -0.01154 ukat/L | Standard Deviation 0.065765 |
| Anifrolumab - Lower Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 52 | -0.04834 ukat/L | Standard Deviation 0.066424 |
| Anifrolumab - Lower Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 60 | -0.01111 ukat/L | Standard Deviation 0.058937 |
| Anifrolumab - Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 60 | 0.04816 ukat/L | Standard Deviation 0.123752 |
| Anifrolumab - Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 12 | -0.10502 ukat/L | Standard Deviation 0.169099 |
| Anifrolumab - Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 12 | -0.13003 ukat/L | Standard Deviation 0.431764 |
| Anifrolumab - Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 60 | 0.09446 ukat/L | Standard Deviation 0.365981 |
| Anifrolumab - Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 52 | -0.05607 ukat/L | Standard Deviation 0.556152 |
| Anifrolumab - Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 52 | -0.05304 ukat/L | Standard Deviation 0.196369 |
| Placebo Comparator | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 52 | -0.06335 ukat/L | Standard Deviation 0.047735 |
| Placebo Comparator | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 60 | -0.04334 ukat/L | Standard Deviation 0.032495 |
| Placebo Comparator | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 12 | 0.00417 ukat/L | Standard Deviation 0.059911 |
| Placebo Comparator | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 60 | 0 ukat/L | Standard Deviation 0.05001 |
| Placebo Comparator | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 52 | 0.00333 ukat/L | Standard Deviation 0.090847 |
| Placebo Comparator | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 12 | -0.05418 ukat/L | Standard Deviation 0.045905 |
| Placebo Comparator to Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 52 | 0.09169 ukat/L | Standard Deviation 0.100482 |
| Placebo Comparator to Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 60 | -0.02501 ukat/L | Standard Deviation 0.099555 |
| Placebo Comparator to Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 52 | 0.04167 ukat/L | Standard Deviation 0.169182 |
| Placebo Comparator to Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Aspartate Aminotransferase - Week 12 | 0.03334 ukat/L | Standard Deviation 0.10543 |
| Placebo Comparator to Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 12 | 0.02501 ukat/L | Standard Deviation 0.134397 |
| Placebo Comparator to Higher Dose | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Alanine Aminotransferase - Week 60 | -0.01667 ukat/L | Standard Deviation 0.18127 |
Secondary
Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)
Change from baseline in clinical creatinine chemistry blood tests (serum) are reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 12 | 4.385 umol/L | Standard Deviation 8.5799 |
| Anifrolumab - Lower Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 60 | 7.316 umol/L | Standard Deviation 8.7449 |
| Anifrolumab - Lower Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 52 | 12.2 umol/L | Standard Deviation 33.2597 |
| Anifrolumab - Higher Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 12 | -3.6 umol/L | Standard Deviation 11.2467 |
| Anifrolumab - Higher Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 60 | -5.556 umol/L | Standard Deviation 12.8463 |
| Anifrolumab - Higher Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 52 | -7.273 umol/L | Standard Deviation 19.5862 |
| Placebo Comparator | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 52 | 0.2 umol/L | Standard Deviation 13.9714 |
| Placebo Comparator | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 12 | 5.5 umol/L | Standard Deviation 6.3509 |
| Placebo Comparator | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 60 | 5.0 umol/L | Standard Deviation 10.4163 |
| Placebo Comparator to Higher Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 12 | 5.25 umol/L | Standard Deviation 9.8446 |
| Placebo Comparator to Higher Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 60 | 6.5 umol/L | Standard Deviation 12.5033 |
| Placebo Comparator to Higher Dose | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) | Creatinine - Week 52 | 2.5 umol/L | Standard Deviation 5.5076 |
Secondary
Value of Haematology Blood Tests to Detect Change From Baseline
Change from baseline in haematology blood tests (leucocytes \[particle concentration\], platelets \[particle concentration\]) are reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 12 | 0.491 10^9/L | Standard Deviation 1.5806 |
| Anifrolumab - Lower Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 52 | 1.041 10^9/L | Standard Deviation 1.5794 |
| Anifrolumab - Lower Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 60 | -0.012 10^9/L | Standard Deviation 1.5489 |
| Anifrolumab - Lower Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 12 | 7.8 10^9/L | Standard Deviation 65.28 |
| Anifrolumab - Lower Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 52 | 28.0 10^9/L | Standard Deviation 74.28 |
| Anifrolumab - Lower Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 60 | -19.1 10^9/L | Standard Deviation 53.48 |
| Anifrolumab - Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 60 | 39.0 10^9/L | Standard Deviation 60.33 |
| Anifrolumab - Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 12 | 45.2 10^9/L | Standard Deviation 67.41 |
| Anifrolumab - Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 12 | 3.165 10^9/L | Standard Deviation 2.2706 |
| Anifrolumab - Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 60 | 1.474 10^9/L | Standard Deviation 1.649 |
| Anifrolumab - Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 52 | 2.457 10^9/L | Standard Deviation 2.3891 |
| Anifrolumab - Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 52 | 46.1 10^9/L | Standard Deviation 74.91 |
| Placebo Comparator | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 52 | 0.236 10^9/L | Standard Deviation 1.0107 |
| Placebo Comparator | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 60 | 0.776 10^9/L | Standard Deviation 2.1779 |
| Placebo Comparator | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 12 | 10.3 10^9/L | Standard Deviation 24.54 |
| Placebo Comparator | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 60 | 24.4 10^9/L | Standard Deviation 65.73 |
| Placebo Comparator | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 52 | 6.6 10^9/L | Standard Deviation 64.24 |
| Placebo Comparator | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 12 | 0.867 10^9/L | Standard Deviation 1.0999 |
| Placebo Comparator to Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 52 | -2.0 10^9/L | Standard Deviation 33.85 |
| Placebo Comparator to Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 60 | -2.8 10^9/L | Standard Deviation 28.43 |
| Placebo Comparator to Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 52 | 0.080 10^9/L | Standard Deviation 1.4798 |
| Placebo Comparator to Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Platelets - Week 12 | 17.0 10^9/L | Standard Deviation 42.58 |
| Placebo Comparator to Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 12 | 1.96 10^9/L | Standard Deviation 1.9487 |
| Placebo Comparator to Higher Dose | Value of Haematology Blood Tests to Detect Change From Baseline | Leucocytes - Week 60 | 1.23 10^9/L | Standard Deviation 1.6687 |
Secondary
Value of Haemoglobin Blood Test to Detect Change From Baseline
Change from baseline in haemoglobin blood tests are reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 12 | -0.2 g/L | Standard Deviation 9.07 |
| Anifrolumab - Lower Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 60 | 0.8 g/L | Standard Deviation 12.97 |
| Anifrolumab - Lower Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 52 | -1.1 g/L | Standard Deviation 13.92 |
| Anifrolumab - Higher Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 12 | 0.7 g/L | Standard Deviation 7.4 |
| Anifrolumab - Higher Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 60 | 0 g/L | Standard Deviation 10.43 |
| Anifrolumab - Higher Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 52 | 0.1 g/L | Standard Deviation 11.65 |
| Placebo Comparator | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 52 | -4.8 g/L | Standard Deviation 3.83 |
| Placebo Comparator | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 12 | -0.5 g/L | Standard Deviation 7.14 |
| Placebo Comparator | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 60 | -5.4 g/L | Standard Deviation 5.68 |
| Placebo Comparator to Higher Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 12 | 4.8 g/L | Standard Deviation 5.91 |
| Placebo Comparator to Higher Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 60 | 5.8 g/L | Standard Deviation 6.85 |
| Placebo Comparator to Higher Dose | Value of Haemoglobin Blood Test to Detect Change From Baseline | Haemoglobin - Week 52 | 7 g/L | Standard Deviation 5.94 |
Secondary
Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline
Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 52 | 5.6 mm | Standard Deviation 25.58 |
| Anifrolumab - Lower Dose | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 12 | -3.0 mm | Standard Deviation 20.37 |
| Anifrolumab - Lower Dose | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 60 | 14.6 mm | Standard Deviation 38.77 |
| Anifrolumab - Higher Dose | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 52 | -6.7 mm | Standard Deviation 12.25 |
| Anifrolumab - Higher Dose | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 12 | -7.2 mm | Standard Deviation 15.46 |
| Anifrolumab - Higher Dose | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 60 | -1.0 mm | Standard Deviation 21.84 |
| Placebo Comparator | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 12 | -11.9 mm | Standard Deviation 15.36 |
| Placebo Comparator | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 60 | 2.2 mm | Standard Deviation 22.48 |
| Placebo Comparator | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline | ESR - Week 52 | -16.0 mm | Standard Deviation 10.95 |
Secondary
Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline
Change from baseline in protein-creatinine ratio urinalysis tests are reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 12 | 1.37029 g/g | Standard Deviation 5.186672 |
| Anifrolumab - Lower Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 60 | 0.02578 g/g | Standard Deviation 0.119862 |
| Anifrolumab - Lower Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 52 | 0.03756 g/g | Standard Deviation 0.135157 |
| Anifrolumab - Higher Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 12 | -0.13007 g/g | Standard Deviation 1.123807 |
| Anifrolumab - Higher Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 60 | -0.28836 g/g | Standard Deviation 1.185347 |
| Anifrolumab - Higher Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 52 | -0.00465 g/g | Standard Deviation 0.183327 |
| Placebo Comparator | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 52 | -0.00781 g/g | Standard Deviation 0.047671 |
| Placebo Comparator | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 12 | -0.03056 g/g | Standard Deviation 0.056701 |
| Placebo Comparator | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 60 | -0.03501 g/g | Standard Deviation 0.061888 |
| Placebo Comparator to Higher Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 12 | 0.32764 g/g | Standard Deviation 0.337631 |
| Placebo Comparator to Higher Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 60 | 0.46178 g/g | Standard Deviation 0.899886 |
| Placebo Comparator to Higher Dose | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Protein/Creatinine - Week 52 | 0.080930 g/g | Standard Deviation 1.581772 |
Secondary
Value of Total Protein Urinalysis Test to Detect Change From Baseline
Change from baseline in total protein urinalysis tests are reported.
Time frame: Baseline to Week 60
Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Lower Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 12 | 0.7669 g/L | Standard Deviation 2.71221 |
| Anifrolumab - Lower Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 60 | 0.1151 g/L | Standard Deviation 0.12514 |
| Anifrolumab - Lower Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 52 | -0.0029 g/L | Standard Deviation 0.08124 |
| Anifrolumab - Higher Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 12 | -0.0744 g/L | Standard Deviation 0.76445 |
| Anifrolumab - Higher Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 60 | -0.1790 g/L | Standard Deviation 0.83066 |
| Anifrolumab - Higher Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 52 | -0.0011 g/L | Standard Deviation 0.33468 |
| Placebo Comparator | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 52 | 0 g/L | Standard Deviation 0 |
| Placebo Comparator | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 12 | 0 g/L | Standard Deviation 0 |
| Placebo Comparator | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 60 | 0.003 g/L | Standard Deviation 0.00671 |
| Placebo Comparator to Higher Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 12 | 0.3443 g/L | Standard Deviation 0.34301 |
| Placebo Comparator to Higher Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 60 | 0.3975 g/L | Standard Deviation 0.82602 |
| Placebo Comparator to Higher Dose | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Protein, Total - Week 52 | 0.1143 g/L | Standard Deviation 0.24476 |