Lupus Nephritis
Conditions
Keywords
lupus, nephritis, randomized, placebo, anifrolumab, safety, efficacy, adult
Brief summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).
Detailed description
This is a Phase 2, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two intravenous (IV) treatment regimens of anifrolumab versus placebo while taking standard of care (SOC) treatment with mycophenolate mofetil (MMF) and corticosteroids in adult subjects with active proliferative lupus nephritis (LN).
Interventions
BIOLOGICALAnifrolumab
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
DRUGPlacebo
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Sponsors
Parexel
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Age 18 through 70 years at the time of screening 2. Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be: 1. Positive antinuclear antibody (ANA) test (1:40 or higher) or 2. Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the centrallaboratory; or 3. Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory 3. Class III (±Class V) or Class IV (±Class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period: 4. Urine protein to creatinine ratio \>1 gm/gm (113.17 mg/mmol), obtained on a 24-hour urine collection at screening 5. Estimated glomerular filtration rate ≥35 mL/min/1.73 m2 6. Must not have active or latent TB on either chest radiograph or by Quantiferon gold test 7. Women of childbearing potential must have a negative serum beta-hCG test at screening and negative urine pregnancy test prior to the first dose of sponsor-provided MMF. Main
Exclusion criteria
1. Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater 2. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period 3. Known intolerance to ≤1.0 gm/day of MMF 4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment 5. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy 1. Oral corticosteroids \>0.5 mg/kg/day for more than 8 weeks or 2. Oral or IV pulse methylprednisolone \>3.0 gm (cumulative dose) or 3. IV cyclophosphamide \>2 pulses of high-dose (≥0.5 gm/m2) or \>4 doses of low dose (500 mg every 2 weeks) or 4. Average MMF \>2.5 gm/day (\>1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or 5. Tacrolimus \>4 mg/day for more than 8 weeks 6. Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period 7. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF 8. Confirmed positive test for hepatitis B or hepatitis C 9. Any severe herpes infection at any time prior to randomization 10. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization (vaginal, oral and skin candidiasis is not an exclusionreason). 11. History of cancer, apart from: 1. Squamous or basal cell carcinoma of the skin that has been successfully treated 2. Cervical cancer in situ that has been successfully treated 12. Concurrent enrolment in another clinical study with an IP within 4 weeks prior to ICF signing or within 5 half-lives of the IP used in that clinical study, whichever is longer. 13. During screening (within 30 days before Day 1 \[Week 0 visit\]), any of the following: 1. Aspartate transaminase (AST) \>2.5×upper limit of normal (ULN) 2. Alanine transaminase (ALT) \>2.5×ULN 3. Total bilirubin \>ULN (unless due to Gilbert's syndrome \[based on Investigator's judgement\]) 4. Glycosylated haemoglobin (HbA1c) \>8% (or \>0.08) at screening (diabetic subjects only) 5. Neutrophil count \<1x103/μL (or \<1.0 GI/L) 6. Platelet count \<25x103/μL (or \<25 GI/L) 7. Haemoglobin \<8 g/dL (or \<80 g/L).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) | From Week 1 (Baseline) up to Week 52 | To evaluate the efficacy of anifrolumab plus SOC (combination of mycophenolate mofetil and corticosteroids) compared with placebo plus SOC in subjects with active proliferative lupus nephritis (LN). Geometric mean ratio of 24-hour UPCR at week 52 over baseline. Values \<1 indicate improvement from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Week 52 | CRR was defined as meeting all of the following: * Estimated glomerular filtration rate (eGFR) is ≥60 mL/min/1.73 m\^2 or no confirmed decrease of eGFR from baseline of ≥20% * 24-hour UPCR ≤ 0.7 mg/mg * No discontinuation of investigational product (IP) or use of restricted medication beyond the protocol allowed threshold before assessment * eGFR was based on Modification of Diet in Renal Disease (MDRD) formula. Subjects treated with restricted medication beyond the protocol allowed threshold, or discontinuing study treatment for other reasons, were regarded as non-responders. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events | From screening (Day-30 to -1) period until the follow-up period (Week 112) | To assess AEs (non-serious, serious and adverse event of special interest (AESI)) as variables of safety and tolerability of anifrolimab. The AESIs are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, acute coronary syndrome, myocardial infarction, or cardiovascular death). Study period: During treatment and follow-up data are presented. |
| Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, treatment and follow up (an average of 60 weeks) | The C-SSRS was used to assess the suicidal ideation and behavior and suicide attempts on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior. |
| Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Baseline, Week 12, Week 24, Week 36, Week 52, Week 60 | PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms. |
| Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | From baseline up to week 112 | Flare will be defined as any one criterion present in either the Mild/Moderate Flare and/or Severe Flare categories. New or worsened manifestation should only be reported for manifestations of SLE. The SLEDAI-2K score range is 0 to 105 with higher scores representing increased disease activity. Mild/ Moderate flare defined as change in non-renal components of the SLEDAI-2K instrument score of ≥3 but \<7 points compared to previous visit. Severe Flare defined as change in non-renal components of the SLEDAI-2K instrument score by ≥7 points compared to previous visit. The flare rate per subject year is defined as the number of subjects with a respective flare divided by the sum of exposure time in days for all subjects in the analysis set multiplied by 365.25. |
Countries
Argentina, Australia, Belgium, France, Germany, Hungary, Italy, Mexico, Peru, Poland, Russia, Serbia, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Subjects who met all the inclusion and none of the exclusion criteria were randomized at 66 sites in 16 countries. The study was conducted from 04 November 2015 to 18 January 2021.
Pre-assignment details
The screening period was from Day -30 to Day -1. Informed consent form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessment.
Participants by arm
| Arm | Count |
|---|---|
| Anifrolumab - Basic Regimen Subjects were administered with lower dose of Anifrolumab intravenously (IV) every 4 weeks (Q4W) from Week 0 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112. | 45 |
| Anifrolumab - Intensified Regimen Subjects were administered with higher dose of Anifrolumab IV Q4W for first 3 doses followed by lower dose from Week 12 to Week 100, in addition to pre-specified standard of care (SOC) which continued until Week 112. | 51 |
| Placebo Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112. | 49 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 2 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 5 | 7 | 4 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Non-responding completer, Not eligible for extension study, Use of any restricted Medications | 4 | 8 | 9 |
| Overall Study | Patients did not receive IP | 1 | 1 | 0 |
| Overall Study | Physician Decision | 2 | 1 | 2 |
| Overall Study | PROGRESSIVE DISEASE | 1 | 0 | 2 |
| Overall Study | TECHNICAL PROBLEMS | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 6 | 10 |
Baseline characteristics
| Characteristic | Anifrolumab - Basic Regimen | Anifrolumab - Intensified Regimen | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 35.2 years STANDARD_DEVIATION 11.49 | 35.0 years STANDARD_DEVIATION 10.58 | 34.0 years STANDARD_DEVIATION 10.18 | 34.7 years STANDARD_DEVIATION 10.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 23 Participants | 20 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 28 Participants | 29 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 7 Participants | 10 Participants | 28 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 4 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 14 Participants | 14 Participants | 39 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 25 Participants | 24 Participants | 66 Participants |
| Sex: Female, Male Female | 37 Participants | 45 Participants | 38 Participants | 120 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 51 | 0 / 96 | 0 / 49 | 1 / 45 | 0 / 51 | 1 / 96 | 0 / 49 |
| other Total, other adverse events | 31 / 45 | 39 / 51 | 70 / 96 | 33 / 49 | 0 / 45 | 0 / 51 | 0 / 96 | 0 / 49 |
| serious Total, serious adverse events | 10 / 45 | 9 / 51 | 19 / 96 | 8 / 49 | 3 / 45 | 0 / 51 | 3 / 96 | 3 / 49 |
Outcome results
Primary
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)
To evaluate the efficacy of anifrolumab plus SOC (combination of mycophenolate mofetil and corticosteroids) compared with placebo plus SOC in subjects with active proliferative lupus nephritis (LN). Geometric mean ratio of 24-hour UPCR at week 52 over baseline. Values \<1 indicate improvement from baseline.
Time frame: From Week 1 (Baseline) up to Week 52
Population: Full analysis set (FAS): The FAS included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment (mITT principle).~Here, overall number of subjects analyzed signifies the subjects with available data that were analyzed for the outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Anifrolumab - Basic Regimen | Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) | 0.326 milligram/milligram (mg/mg) |
| Anifrolumab - Intensified Regimen | Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) | 0.285 milligram/milligram (mg/mg) |
| All Anifrolumab | Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) | 0.305 milligram/milligram (mg/mg) |
| Placebo | Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) | 0.296 milligram/milligram (mg/mg) |
Comparison: The model includes fixed effects for treatment group, visit, stratification factors, log-transformed 24-hour UPCR at baseline, and treatment-by-visit interaction. All data up to and including the date of discontinuation of study treatment were included in the analysis.p-value: 0.905295% CI: [0.621, 1.713]Mixed Models Analysis
Secondary
Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)
CRR was defined as meeting all of the following: * Estimated glomerular filtration rate (eGFR) is ≥60 mL/min/1.73 m\^2 or no confirmed decrease of eGFR from baseline of ≥20% * 24-hour UPCR ≤ 0.7 mg/mg * No discontinuation of investigational product (IP) or use of restricted medication beyond the protocol allowed threshold before assessment * eGFR was based on Modification of Diet in Renal Disease (MDRD) formula. Subjects treated with restricted medication beyond the protocol allowed threshold, or discontinuing study treatment for other reasons, were regarded as non-responders.
Time frame: Week 52
Population: The FAS included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment (mITT principle). The subjects being analyzed was less than the number of patients in the FAS. Subjects from France and Italy were excluded from the analysis (France EC and Italy HA did not accept CSP amendment 3 (version 4.0)).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anifrolumab - Basic Regimen | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Responder | 16.3 Percentage of subjects |
| Anifrolumab - Basic Regimen | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Non-responder | 83.7 Percentage of subjects |
| Anifrolumab - Intensified Regimen | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Non-responder | 54.5 Percentage of subjects |
| Anifrolumab - Intensified Regimen | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Responder | 45.5 Percentage of subjects |
| All Anifrolumab | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Responder | 31.0 Percentage of subjects |
| All Anifrolumab | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Non-responder | 69.0 Percentage of subjects |
| Placebo | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Responder | 31.1 Percentage of subjects |
| Placebo | Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR) | Non-responder | 68.9 Percentage of subjects |
Comparison: The statistical analysis represents the estimated percentage of responders. The responder/non-responder rates (percentages), the difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach.p-value: 0.992995% CI: [-16.92, 16.76]Cochran-Mantel-Haenszel
Other Pre-specified
Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument
Flare will be defined as any one criterion present in either the Mild/Moderate Flare and/or Severe Flare categories. New or worsened manifestation should only be reported for manifestations of SLE. The SLEDAI-2K score range is 0 to 105 with higher scores representing increased disease activity. Mild/ Moderate flare defined as change in non-renal components of the SLEDAI-2K instrument score of ≥3 but \<7 points compared to previous visit. Severe Flare defined as change in non-renal components of the SLEDAI-2K instrument score by ≥7 points compared to previous visit. The flare rate per subject year is defined as the number of subjects with a respective flare divided by the sum of exposure time in days for all subjects in the analysis set multiplied by 365.25.
Time frame: From baseline up to week 112
Population: Full analysis set (FAS): The FAS included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment (mITT principle).~Here, number analyzed in each row signifies only the subjects with available data that were analyzed for each parameter
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anifrolumab - Basic Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: Off-treatment | 0.002 Flare rate per subject year |
| Anifrolumab - Basic Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: On-treatment | 0.017 Flare rate per subject year |
| Anifrolumab - Basic Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: On-treatment | 0.004 Flare rate per subject year |
| Anifrolumab - Basic Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: All flares | 0.019 Flare rate per subject year |
| Anifrolumab - Basic Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: Off-treatment | 0.003 Flare rate per subject year |
| Anifrolumab - Basic Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: All flares | 0.007 Flare rate per subject year |
| Anifrolumab - Intensified Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: Off-treatment | 0.003 Flare rate per subject year |
| Anifrolumab - Intensified Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: All flares | 0.016 Flare rate per subject year |
| Anifrolumab - Intensified Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: On-treatment | 0.012 Flare rate per subject year |
| Anifrolumab - Intensified Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: Off-treatment | 0.001 Flare rate per subject year |
| Anifrolumab - Intensified Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: All flares | 0.001 Flare rate per subject year |
| Anifrolumab - Intensified Regimen | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: On-treatment | 0.00 Flare rate per subject year |
| All Anifrolumab | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: All flares | 0.017 Flare rate per subject year |
| All Anifrolumab | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: Off-treatment | 0.003 Flare rate per subject year |
| All Anifrolumab | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: Off-treatment | 0.002 Flare rate per subject year |
| All Anifrolumab | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: On-treatment | 0.014 Flare rate per subject year |
| All Anifrolumab | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: All flares | 0.003 Flare rate per subject year |
| All Anifrolumab | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: On-treatment | 0.002 Flare rate per subject year |
| Placebo | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: All flares | 0.016 Flare rate per subject year |
| Placebo | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: Off-treatment | 0.006 Flare rate per subject year |
| Placebo | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: On-treatment | 0.004 Flare rate per subject year |
| Placebo | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: All flares | 0.006 Flare rate per subject year |
| Placebo | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Severe: Off-treatment | 0.002 Flare rate per subject year |
| Placebo | Extra-renal Flares Using Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI 2K) Based Flare Assessment Instrument | Mild/moderate: On-treatment | 0.010 Flare rate per subject year |
Other Pre-specified
Number of Subjects With Adverse Events
To assess AEs (non-serious, serious and adverse event of special interest (AESI)) as variables of safety and tolerability of anifrolimab. The AESIs are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, acute coronary syndrome, myocardial infarction, or cardiovascular death). Study period: During treatment and follow-up data are presented.
Time frame: From screening (Day-30 to -1) period until the follow-up period (Week 112)
Population: Full analysis set (FAS): The FAS included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment (mITT principle).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any other significant AE- During treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- During treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Opportunistic infections- During treatment | 1 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Vasculitis (non-systemic lupus erythematosus)- During treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Influenza- During treatment | 2 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Anaphylaxis- During treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Tuberculosis/LTB- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Tuberculosis/LTB (latent tuberculosis)- During treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Herpes zoster- During treatment | 9 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Malignancy- During treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Herpes zoster- follow-up | 2 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any SAE (including events with- outcome of death)- During treatment | 10 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Subjects with any acute AE- During treatment | 11 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Malignancy- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Anaphylaxis- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AE leading to discontinuation of investigational product- During treatment | 5 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Subjects with any AE- During treatment | 43 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Opportunistic infections- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Non-opportunistic serious infections- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- During treatment | 24 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any other significant AE- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AESI- follow-up | 2 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AE of severe intensity- follow-up | 2 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AE of severe intensity- During treatment | 6 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Vasculitis (non-SLE)- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- follow-up | 2 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any SAE (including events with outcome of death)- follow-up | 3 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AESI- During treatment | 12 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Influenza- follow-up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AE with outcome of death- follow-up | 1 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Subjects with any AE- follow-up | 12 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Non-opportunistic serious infections- During treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Adverse Events | Any AE with outcome of death- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AE leading to discontinuation of investigational product- During treatment | 6 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Subjects with any AE- During treatment | 47 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Subjects with any acute AE- During treatment | 15 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AE with outcome of death- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any SAE (including events with- outcome of death)- During treatment | 9 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- During treatment | 13 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AE of severe intensity- During treatment | 7 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AESI- During treatment | 12 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Non-opportunistic serious infections- During treatment | 1 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Opportunistic infections- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Anaphylaxis- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Malignancy- During treatment | 1 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Herpes zoster- During treatment | 7 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Tuberculosis/LTB (latent tuberculosis)- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Influenza- During treatment | 4 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Vasculitis (non-systemic lupus erythematosus)- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any other significant AE- During treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Subjects with any AE- follow-up | 8 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AE with outcome of death- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any SAE (including events with outcome of death)- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AE of severe intensity- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any AESI- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Non-opportunistic serious infections- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Opportunistic infections- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Anaphylaxis- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Malignancy- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Herpes zoster- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Tuberculosis/LTB- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Influenza- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Vasculitis (non-SLE)- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- follow-up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Adverse Events | Any other significant AE- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AE of severe intensity- During treatment | 13 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any other significant AE- During treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Subjects with any AE- follow-up | 20 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AESI- During treatment | 24 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Subjects with any AE- During treatment | 90 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AE with outcome of death- follow-up | 1 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Influenza- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any SAE (including events with outcome of death)- follow-up | 3 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Non-opportunistic serious infections- During treatment | 1 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- follow-up | 2 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Subjects with any acute AE- During treatment | 26 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AE of severe intensity- follow-up | 2 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- During treatment | 37 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AESI- follow-up | 2 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Vasculitis (non-SLE)- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Non-opportunistic serious infections- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AE leading to discontinuation of investigational product- During treatment | 11 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Opportunistic infections- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Anaphylaxis- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any SAE (including events with- outcome of death)- During treatment | 19 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any other significant AE- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Malignancy- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Malignancy- During treatment | 1 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Herpes zoster- follow-up | 2 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Herpes zoster- During treatment | 16 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Anaphylaxis- During treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Tuberculosis/LTB (latent tuberculosis)- During treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Any AE with outcome of death- During treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Influenza- During treatment | 6 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Opportunistic infections- During treatment | 1 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Vasculitis (non-systemic lupus erythematosus)- During treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Tuberculosis/LTB- follow-up | 0 Participants |
| All Anifrolumab | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- During treatment | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Herpes zoster- During treatment | 4 Participants |
| Placebo | Number of Subjects With Adverse Events | Tuberculosis/LTB- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Opportunistic infections- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Any other significant AE- During treatment | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AESI- During treatment | 8 Participants |
| Placebo | Number of Subjects With Adverse Events | Subjects with any acute AE- During treatment | 14 Participants |
| Placebo | Number of Subjects With Adverse Events | Any SAE (including events with- outcome of death)- During treatment | 8 Participants |
| Placebo | Number of Subjects With Adverse Events | Subjects with any AE- follow-up | 22 Participants |
| Placebo | Number of Subjects With Adverse Events | Subjects with any AE- During treatment | 44 Participants |
| Placebo | Number of Subjects With Adverse Events | Non-opportunistic serious infections- During treatment | 3 Participants |
| Placebo | Number of Subjects With Adverse Events | Anaphylaxis- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AE with outcome of death- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AE of severe intensity- During treatment | 8 Participants |
| Placebo | Number of Subjects With Adverse Events | Herpes zoster- follow-up | 1 Participants |
| Placebo | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Any SAE (including events with outcome of death)- follow-up | 3 Participants |
| Placebo | Number of Subjects With Adverse Events | Tuberculosis/LTB (latent tuberculosis)- During treatment | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Influenza- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Malignancy- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- follow-up | 1 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AE related to investigational product (investigator assessment)- During treatment | 16 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AE with outcome of death- During treatment | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Opportunistic infections- During treatment | 1 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AE of severe intensity- follow-up | 3 Participants |
| Placebo | Number of Subjects With Adverse Events | Major adverse cardiovascular events according to the CV-EAC- During treatment | 1 Participants |
| Placebo | Number of Subjects With Adverse Events | Any other significant AE- follow-up | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Malignancy- During treatment | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AESI- follow-up | 2 Participants |
| Placebo | Number of Subjects With Adverse Events | Any AE leading to discontinuation of investigational product- During treatment | 5 Participants |
| Placebo | Number of Subjects With Adverse Events | Anaphylaxis- During treatment | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Vasculitis (non-systemic lupus erythematosus)- During treatment | 0 Participants |
| Placebo | Number of Subjects With Adverse Events | Non-opportunistic serious infections- follow-up | 1 Participants |
| Placebo | Number of Subjects With Adverse Events | Influenza- During treatment | 1 Participants |
| Placebo | Number of Subjects With Adverse Events | Vasculitis (non-SLE)- follow-up | 0 Participants |
Other Pre-specified
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS was used to assess the suicidal ideation and behavior and suicide attempts on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior.
Time frame: Baseline, treatment and follow up (an average of 60 weeks)
Population: Full analysis set (FAS): The FAS included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment (mITT principle).~Here, number analyzed in each row signifies only the subjects with available data that were analyzed for each parameter/ timeframe.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Baseline | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Follow up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Follow up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Baseline | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Follow up | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Treatment | 0 Participants |
| Anifrolumab - Basic Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Baseline | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Baseline | 2 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Follow up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Baseline | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Follow up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Follow up | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Treatment | 0 Participants |
| Anifrolumab - Intensified Regimen | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Baseline | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Baseline | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Follow up | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Baseline | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Follow up | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Baseline | 2 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Treatment | 0 Participants |
| All Anifrolumab | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Follow up | 0 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Baseline | 4 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Baseline | 0 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Follow up | 0 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Follow up | 0 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation: Treatment | 2 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Treatment | 0 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Follow up | 0 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behaviour: Treatment | 0 Participants |
| Placebo | Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal attempts: Baseline | 0 Participants |
Other Pre-specified
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms.
Time frame: Baseline, Week 12, Week 24, Week 36, Week 52, Week 60
Population: Full analysis set (FAS): The FAS included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment (mITT principle).~Here, number analyzed in each row signifies only the subjects with available data that were analyzed for each timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anifrolumab - Basic Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 52 | 2.3 Score on a scale | Standard Deviation 3.44 |
| Anifrolumab - Basic Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 60 | 3.3 Score on a scale | Standard Deviation 4.8 |
| Anifrolumab - Basic Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 24 | 2.7 Score on a scale | Standard Deviation 2.41 |
| Anifrolumab - Basic Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Baseline | 5.1 Score on a scale | Standard Deviation 4.34 |
| Anifrolumab - Basic Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 12 | 3.4 Score on a scale | Standard Deviation 3.88 |
| Anifrolumab - Basic Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 36 | 3.3 Score on a scale | Standard Deviation 4.04 |
| Anifrolumab - Intensified Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 52 | 3.4 Score on a scale | Standard Deviation 5.24 |
| Anifrolumab - Intensified Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 36 | 2.5 Score on a scale | Standard Deviation 3.22 |
| Anifrolumab - Intensified Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 60 | 5.6 Score on a scale | Standard Deviation 7.01 |
| Anifrolumab - Intensified Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 12 | 3.1 Score on a scale | Standard Deviation 3.56 |
| Anifrolumab - Intensified Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 24 | 2.5 Score on a scale | Standard Deviation 3.18 |
| Anifrolumab - Intensified Regimen | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Baseline | 4.3 Score on a scale | Standard Deviation 4.05 |
| All Anifrolumab | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 12 | 3.2 Score on a scale | Standard Deviation 3.68 |
| All Anifrolumab | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Baseline | 4.6 Score on a scale | Standard Deviation 4.18 |
| All Anifrolumab | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 24 | 2.6 Score on a scale | Standard Deviation 2.86 |
| All Anifrolumab | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 36 | 2.8 Score on a scale | Standard Deviation 3.63 |
| All Anifrolumab | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 52 | 2.9 Score on a scale | Standard Deviation 4.51 |
| All Anifrolumab | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 60 | 4.6 Score on a scale | Standard Deviation 6.06 |
| Placebo | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 60 | 4.6 Score on a scale | Standard Deviation 2.07 |
| Placebo | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 52 | 4.2 Score on a scale | Standard Deviation 3.3 |
| Placebo | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 12 | 5.1 Score on a scale | Standard Deviation 4.84 |
| Placebo | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Baseline | 5.8 Score on a scale | Standard Deviation 4.54 |
| Placebo | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 36 | 3.5 Score on a scale | Standard Deviation 2.73 |
| Placebo | Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8) | Week 24 | 4.9 Score on a scale | Standard Deviation 5.1 |