Trial Outcomes & Findings for Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis (NCT NCT02547922)
NCT ID: NCT02547922
Last Updated: 2021-11-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
From Week 1 (Baseline) up to Week 52
Results posted on
2021-11-24
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
Placebo
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
52
|
49
|
|
Overall Study
FAS (Full Analysis Set)
|
45
|
51
|
49
|
|
Overall Study
COMPLETED
|
18
|
28
|
20
|
|
Overall Study
NOT COMPLETED
|
28
|
24
|
29
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Placebo
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
10
|
|
Overall Study
Adverse Event
|
3
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
5
|
7
|
4
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Non-responding completer, Not eligible for extension study, Use of any restricted Medications
|
4
|
8
|
9
|
|
Overall Study
TECHNICAL PROBLEMS
|
1
|
0
|
0
|
|
Overall Study
PROGRESSIVE DISEASE
|
1
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
2
|
|
Overall Study
Patients did not receive IP
|
1
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
Baseline characteristics by cohort
| Measure |
Anifrolumab - Basic Regimen
n=45 Participants
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.
|
Anifrolumab - Intensified Regimen
n=51 Participants
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.
|
Placebo
n=49 Participants
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 11.49 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 10.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Week 1 (Baseline) up to Week 52Population: 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.
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.
Outcome measures
| Measure |
Anifrolumab - Basic Regimen
n=41 Participants
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.
|
Anifrolumab - Intensified Regimen
n=50 Participants
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.
|
All Anifrolumab
n=91 Participants
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo
n=41 Participants
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|
|
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)
|
0.326 milligram/milligram (mg/mg)
Interval 0.19 to 0.561
|
0.285 milligram/milligram (mg/mg)
Interval 0.177 to 0.457
|
0.305 milligram/milligram (mg/mg)
Interval 0.198 to 0.468
|
0.296 milligram/milligram (mg/mg)
Interval 0.175 to 0.499
|
SECONDARY outcome
Timeframe: Week 52Population: 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)).
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.
Outcome measures
| Measure |
Anifrolumab - Basic Regimen
n=45 Participants
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.
|
Anifrolumab - Intensified Regimen
n=51 Participants
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.
|
All Anifrolumab
n=96 Participants
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo
n=49 Participants
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)
Responder
|
16.3 Percentage of subjects
|
45.5 Percentage of subjects
|
31.0 Percentage of subjects
|
31.1 Percentage of subjects
|
|
Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)
Non-responder
|
83.7 Percentage of subjects
|
54.5 Percentage of subjects
|
69.0 Percentage of subjects
|
68.9 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Anifrolumab - Basic Regimen
n=45 Participants
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.
|
Anifrolumab - Intensified Regimen
n=51 Participants
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.
|
All Anifrolumab
n=96 Participants
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo
n=49 Participants
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|
|
Number of Subjects With Adverse Events
Any SAE (including events with- outcome of death)- During treatment
|
10 Participants
|
9 Participants
|
19 Participants
|
8 Participants
|
|
Number of Subjects With Adverse Events
Any AE leading to discontinuation of investigational product- During treatment
|
5 Participants
|
6 Participants
|
11 Participants
|
5 Participants
|
|
Number of Subjects With Adverse Events
Subjects with any AE- During treatment
|
43 Participants
|
47 Participants
|
90 Participants
|
44 Participants
|
|
Number of Subjects With Adverse Events
Subjects with any acute AE- During treatment
|
11 Participants
|
15 Participants
|
26 Participants
|
14 Participants
|
|
Number of Subjects With Adverse Events
Any AE with outcome of death- During treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Any AE related to investigational product (investigator assessment)- During treatment
|
24 Participants
|
13 Participants
|
37 Participants
|
16 Participants
|
|
Number of Subjects With Adverse Events
Any AE of severe intensity- During treatment
|
6 Participants
|
7 Participants
|
13 Participants
|
8 Participants
|
|
Number of Subjects With Adverse Events
Any AESI- During treatment
|
12 Participants
|
12 Participants
|
24 Participants
|
8 Participants
|
|
Number of Subjects With Adverse Events
Non-opportunistic serious infections- During treatment
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Adverse Events
Opportunistic infections- During treatment
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Adverse Events
Anaphylaxis- During treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Malignancy- During treatment
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Herpes zoster- During treatment
|
9 Participants
|
7 Participants
|
16 Participants
|
4 Participants
|
|
Number of Subjects With Adverse Events
Tuberculosis/LTB (latent tuberculosis)- During treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Influenza- During treatment
|
2 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Adverse Events
Vasculitis (non-systemic lupus erythematosus)- During treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Major adverse cardiovascular events according to the CV-EAC- During treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Adverse Events
Any other significant AE- During treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Subjects with any AE- follow-up
|
12 Participants
|
8 Participants
|
20 Participants
|
22 Participants
|
|
Number of Subjects With Adverse Events
Any AE with outcome of death- follow-up
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Any SAE (including events with outcome of death)- follow-up
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Adverse Events
Any AE related to investigational product (investigator assessment)- follow-up
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Adverse Events
Any AE of severe intensity- follow-up
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Adverse Events
Any AESI- follow-up
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events
Non-opportunistic serious infections- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Adverse Events
Opportunistic infections- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Anaphylaxis- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Malignancy- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Herpes zoster- follow-up
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Adverse Events
Tuberculosis/LTB- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Influenza- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Vasculitis (non-SLE)- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Major adverse cardiovascular events according to the CV-EAC- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Any other significant AE- follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Anifrolumab - Basic Regimen
n=45 Participants
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.
|
Anifrolumab - Intensified Regimen
n=51 Participants
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.
|
All Anifrolumab
n=96 Participants
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo
n=49 Participants
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|
|
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal attempts: Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal attempts: Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal behaviour: Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal behaviour: Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation: Baseline
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation: Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 52, Week 60Population: 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.
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.
Outcome measures
| Measure |
Anifrolumab - Basic Regimen
n=45 Participants
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.
|
Anifrolumab - Intensified Regimen
n=51 Participants
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.
|
All Anifrolumab
n=96 Participants
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo
n=49 Participants
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|
|
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Baseline
|
5.1 Score on a scale
Standard Deviation 4.34
|
4.3 Score on a scale
Standard Deviation 4.05
|
4.6 Score on a scale
Standard Deviation 4.18
|
5.8 Score on a scale
Standard Deviation 4.54
|
|
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Week 12
|
3.4 Score on a scale
Standard Deviation 3.88
|
3.1 Score on a scale
Standard Deviation 3.56
|
3.2 Score on a scale
Standard Deviation 3.68
|
5.1 Score on a scale
Standard Deviation 4.84
|
|
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Week 24
|
2.7 Score on a scale
Standard Deviation 2.41
|
2.5 Score on a scale
Standard Deviation 3.18
|
2.6 Score on a scale
Standard Deviation 2.86
|
4.9 Score on a scale
Standard Deviation 5.10
|
|
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Week 36
|
3.3 Score on a scale
Standard Deviation 4.04
|
2.5 Score on a scale
Standard Deviation 3.22
|
2.8 Score on a scale
Standard Deviation 3.63
|
3.5 Score on a scale
Standard Deviation 2.73
|
|
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Week 52
|
2.3 Score on a scale
Standard Deviation 3.44
|
3.4 Score on a scale
Standard Deviation 5.24
|
2.9 Score on a scale
Standard Deviation 4.51
|
4.2 Score on a scale
Standard Deviation 3.30
|
|
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Week 60
|
3.3 Score on a scale
Standard Deviation 4.80
|
5.6 Score on a scale
Standard Deviation 7.01
|
4.6 Score on a scale
Standard Deviation 6.06
|
4.6 Score on a scale
Standard Deviation 2.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline up to week 112Population: 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
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.
Outcome measures
| Measure |
Anifrolumab - Basic Regimen
n=45 Participants
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.
|
Anifrolumab - Intensified Regimen
n=51 Participants
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.
|
All Anifrolumab
n=96 Participants
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo
n=49 Participants
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|
|
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
|
0.012 Flare rate per subject year
|
0.014 Flare rate per subject year
|
0.010 Flare rate per subject year
|
|
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
|
0.016 Flare rate per subject year
|
0.017 Flare rate per subject year
|
0.016 Flare rate per subject year
|
|
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
|
0.003 Flare rate per subject year
|
0.003 Flare rate per subject year
|
0.006 Flare rate per subject year
|
|
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
|
0.001 Flare rate per subject year
|
0.003 Flare rate per subject year
|
0.006 Flare rate per subject year
|
|
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
|
0.00 Flare rate per subject year
|
0.002 Flare rate per subject year
|
0.004 Flare rate per subject year
|
|
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
|
0.001 Flare rate per subject year
|
0.002 Flare rate per subject year
|
0.002 Flare rate per subject year
|
Adverse Events
Anifrolumab - Basic Regimen- Treatment Period
Serious events: 10 serious events
Other events: 31 other events
Deaths: 0 deaths
Anifrolumab - Intensified Regimen- Treatment Period
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
All Anifrolumab- Treatment Period
Serious events: 19 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo- Treatment Period
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
Anifrolumab - Basic Regimen- Follow up
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Anifrolumab - Intensified Regimen- Follow up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Anifrolumab- Follow up
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Placebo- Follow up
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anifrolumab - Basic Regimen- Treatment Period
n=45 participants at risk
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.
|
Anifrolumab - Intensified Regimen- Treatment Period
n=51 participants at risk
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.
|
All Anifrolumab- Treatment Period
n=96 participants at risk
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo- Treatment Period
n=49 participants at risk
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
Anifrolumab - Basic Regimen- Follow up
n=45 participants at risk
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
|
Anifrolumab - Intensified Regimen- Follow up
n=51 participants at risk
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.
|
All Anifrolumab- Follow up
n=96 participants at risk
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo- Follow up
n=49 participants at risk
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Herpes zoster
|
6.7%
3/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.9%
3/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
6.2%
6/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Influenza
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.1%
2/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Abscess bacterial
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Pyelonephritis acute
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Varicella zoster pneumonia
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Meningitis
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Otitis externa bacterial
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Cardiac disorders
Lupus endocarditis
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Renal and urinary disorders
Lupus nephritis
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.1%
2/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
General disorders
Chest pain
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
General disorders
Malaise
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
General disorders
Pyrexia
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Varicella
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
Other adverse events
| Measure |
Anifrolumab - Basic Regimen- Treatment Period
n=45 participants at risk
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.
|
Anifrolumab - Intensified Regimen- Treatment Period
n=51 participants at risk
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.
|
All Anifrolumab- Treatment Period
n=96 participants at risk
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo- Treatment Period
n=49 participants at risk
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
Anifrolumab - Basic Regimen- Follow up
n=45 participants at risk
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
|
Anifrolumab - Intensified Regimen- Follow up
n=51 participants at risk
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.
|
All Anifrolumab- Follow up
n=96 participants at risk
This arm comprises Anifrolumab - Basic Regimen and Anifrolumab - Intensified Regimen.
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.
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.
|
Placebo- Follow up
n=49 participants at risk
Subjects were administered with placebo every 4 week from Week 0 to Week 100 in addition to SOC which continued until Week 112.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pharyngitis
|
6.7%
3/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.8%
4/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.3%
7/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
4.1%
2/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Oral herpes
|
6.7%
3/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.9%
3/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
6.2%
6/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
4.1%
2/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Herpes simplex
|
6.7%
3/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
3.9%
2/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.2%
5/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
4.1%
2/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Influenza
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.8%
4/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.2%
5/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Psychiatric disorders
Depression
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
6.1%
3/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.9%
3/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.2%
5/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
8.2%
4/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Vascular disorders
Hypertension
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
3.9%
2/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.1%
2/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
6.1%
3/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
4/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.9%
3/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.3%
7/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
8.2%
4/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
1.0%
1/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
6.1%
3/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
3/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.8%
4/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.3%
7/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
20.4%
10/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.8%
4/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.2%
5/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
4.1%
2/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
2/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.1%
2/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
8.2%
4/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.0%
1/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
2.1%
2/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
8.2%
4/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
8.2%
4/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.9%
3/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
4.2%
4/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
1/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
5.9%
3/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
4.2%
4/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Urinary tract infection
|
22.2%
10/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
11.8%
6/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
16.7%
16/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
10.2%
5/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
6/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
17.6%
9/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
15.6%
15/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
18.4%
9/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Upper respiratory tract infection
|
17.8%
8/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
13.7%
7/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
15.6%
15/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
16.3%
8/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Bronchitis
|
8.9%
4/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
13.7%
7/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
11.5%
11/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
12.2%
6/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
|
Infections and infestations
Herpes zoster
|
13.3%
6/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
7.8%
4/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
10.4%
10/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
8.2%
4/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/45 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/51 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/96 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
0.00%
0/49 • From screening (Day-30 to -1) period until follow-up (Week 112).
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The submission/document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER