Trial Outcomes & Findings for A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis (NCT NCT04963270)
NCT ID: NCT04963270
Last Updated: 2025-02-28
Results Overview
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
At Week 24
Results posted on
2025-02-28
Participant Flow
A total of 188 participants with generalized myasthenia gravis (gMG) took part in the study across 76 investigational sites in 17 countries. Of the 188, 2 adolescent participants were randomized after the last adult participant was enrolled in the study and therefore were not part of efficacy analysis.
The study consists of 2 periods: Double-blind (DB) period where participants were randomized in a 1:1 ratio to receive either satralizumab or matching placebo and an open-label extension (OLE) period where all participants who completed the DB period received satralizumab. Participants were on a stable dose of background therapy (for gMG) throughout the DB period and until Week 12 of the OLE period.
Participant milestones
| Measure |
Placebo
Participants received satralizumab matched placebo, subcutaneously (SC), at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter until the end of the DB period.
|
Satralizumab
Participants received satralizumab 120 (milligrams) mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Placebo (DB) to Satralizumab (OLE)
After completion of the DB period, participants entered the OLE period where they received satralizumab, 120 mg or 180 mg, based on body weight, SC at Weeks 0, 2, and 4 (loading doses), and Q4W thereafter (maintenance doses) during the OLE period.
|
Satralizumab (DB) to Satralizumab (OLE)
After completion of the DB period, participants entered the OLE period and continued receiving satralizumab 120 mg or 180 mg, based on body weight, SC until the end of the OLE period. Participants received a placebo injection on Week 2 of OLE to maintain blinding to DB treatment assignment.
|
|---|---|---|---|---|
|
Double-Blind Period (24 Weeks)
STARTED
|
92
|
96
|
0
|
0
|
|
Double-Blind Period (24 Weeks)
COMPLETED
|
88
|
92
|
0
|
0
|
|
Double-Blind Period (24 Weeks)
NOT COMPLETED
|
4
|
4
|
0
|
0
|
|
Open Label Extension Period (92 Weeks)
STARTED
|
0
|
0
|
88
|
92
|
|
Open Label Extension Period (92 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open Label Extension Period (92 Weeks)
NOT COMPLETED
|
0
|
0
|
88
|
92
|
Reasons for withdrawal
| Measure |
Placebo
Participants received satralizumab matched placebo, subcutaneously (SC), at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter until the end of the DB period.
|
Satralizumab
Participants received satralizumab 120 (milligrams) mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Placebo (DB) to Satralizumab (OLE)
After completion of the DB period, participants entered the OLE period where they received satralizumab, 120 mg or 180 mg, based on body weight, SC at Weeks 0, 2, and 4 (loading doses), and Q4W thereafter (maintenance doses) during the OLE period.
|
Satralizumab (DB) to Satralizumab (OLE)
After completion of the DB period, participants entered the OLE period and continued receiving satralizumab 120 mg or 180 mg, based on body weight, SC until the end of the OLE period. Participants received a placebo injection on Week 2 of OLE to maintain blinding to DB treatment assignment.
|
|---|---|---|---|---|
|
Double-Blind Period (24 Weeks)
Adverse Event
|
1
|
2
|
0
|
0
|
|
Double-Blind Period (24 Weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Double-Blind Period (24 Weeks)
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Double-Blind Period (24 Weeks)
Study Terminated by Sponsor
|
2
|
0
|
0
|
0
|
|
Double-Blind Period (24 Weeks)
Reason Not Specified
|
0
|
1
|
0
|
0
|
|
Open Label Extension Period (92 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Open Label Extension Period (92 Weeks)
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
Open Label Extension Period (92 Weeks)
Withdrawal by Subject
|
0
|
0
|
2
|
6
|
|
Open Label Extension Period (92 Weeks)
Physician Decision
|
0
|
0
|
1
|
1
|
|
Open Label Extension Period (92 Weeks)
Pregnancy
|
0
|
0
|
1
|
0
|
|
Open Label Extension Period (92 Weeks)
Study Terminated by Sponsor
|
0
|
0
|
82
|
81
|
|
Open Label Extension Period (92 Weeks)
Reason Not Specified
|
0
|
0
|
0
|
1
|
|
Open Label Extension Period (92 Weeks)
Reason Unknown
|
0
|
0
|
0
|
1
|
|
Open Label Extension Period (92 Weeks)
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Placebo
n=92 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population
|
-2.57 score on a scale
Standard Error 0.35
|
-3.59 score on a scale
Standard Error 0.29
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: Modified intent-to-treat (mIIT) population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Total MG-ADL Score in the Overall Population (OP) at Week 24
|
-2.52 score on a scale
Standard Error 0.32
|
-3.54 score on a scale
Standard Error 0.28
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in AChR+ Population at Week 24
|
58.8 percentage of participants
Interval 47.9 to 69.6
|
70.9 percentage of participants
Interval 61.2 to 80.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in OP at Week 24
|
60.7 percentage of participants
Interval 50.4 to 70.9
|
69.8 percentage of participants
Interval 60.5 to 79.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score in AChR+ Population at Week 24
|
-1.78 score on a scale
Standard Error 0.46
|
-3.41 score on a scale
Standard Error 0.41
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in QMG Score in OP at Week 24
|
-1.74 score on a scale
Standard Error 0.43
|
-3.42 score on a scale
Standard Error 0.39
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items were scored on a scale from 0=Not at all to 2=Very much with the total score ranging from 0 to 30 and higher scores indicate worse health-related quality of life (HRQoL).
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Myasthenia Gravis Quality of Life 15 Scale (Revised) (MG-QOL 15r) Total Score in AChR+ Population at Week 24
|
-4.69 score on a scale
Standard Error 0.71
|
-6.20 score on a scale
Standard Error 0.69
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items are scored on a scale from 0=Not at all to 2=Very much, with the total score ranging from 0 to 30 and higher scores indicate worse HRQoL.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in MG-QOL 15r Total Score in OP at Week 24
|
-4.73 score on a scale
Standard Error 0.65
|
-6.13 score on a scale
Standard Error 0.63
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale Total Score in AChR+ Population at Week 24
|
-3.29 score on a scale
Standard Error 0.90
|
-5.50 score on a scale
Standard Error 0.75
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Neuro-QoL Fatigue Subscale Total Score in OP at Week 24
|
-3.45 score on a scale
Standard Error 0.83
|
-5.56 score on a scale
Standard Error 0.69
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in QMG Score in AChR+ Population at Week 24
|
28.7 percentage of participants
Interval 18.7 to 38.8
|
47.7 percentage of participants
Interval 37.0 to 58.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in QMG Score in OP at Week 24
|
28.1 percentage of participants
Interval 18.7 to 37.5
|
50.0 percentage of participants
Interval 39.9 to 60.1
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Total Myasthenia Gravis Composite (MGC) Score in AChR+ Population at Week 24
|
-4.14 score on a scale
Standard Error 0.62
|
-7.13 score on a scale
Standard Error 0.58
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Mean Change From Baseline in Total MGC Score in OP at Week 24
|
-4.18 score on a scale
Standard Error 0.57
|
-7.18 score on a scale
Standard Error 0.55
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in Total MGC Score in AChR+ Population at Week 24
|
55.0 percentage of participants
Interval 44.0 to 66.0
|
75.6 percentage of participants
Interval 66.4 to 84.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in Total MGC Score in OP at Week 24
|
57.3 percentage of participants
Interval 46.9 to 67.7
|
76.0 percentage of participants
Interval 67.4 to 84.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: AChR+ population included all participants in the study who were AChR+.
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved Minimal Symptom Expression (Total MG-ADL Score of 0 or 1) in AChR+ Population at Week 24
|
12.5 percentage of participants
Interval -4.8 to 29.8
|
14.0 percentage of participants
Interval 6.6 to 21.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants Who Achieved Minimal Symptom Expression (Total MG-ADL Score of 0 or 1) in OP at Week 24
|
12.4 percentage of participants
Interval 4.2 to 20.5
|
15.6 percentage of participants
Interval 8.3 to 22.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: AChR+ population included all participants in the study who were AChR+.
gMG-related exacerbation was defined as one of the following: MG crisis; Substantial symptomatic worsening that requires immediate therapy; or health in jeopardy if rescue therapy is not given.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With at Least One gMG-Related Exacerbation Between Baseline and Week 24 in AChR+ Population
|
17.5 percentage of participants
Interval 9.1 to 25.9
|
9.3 percentage of participants
Interval 3.1 to 15.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
gMG-related exacerbation was defined as one of the following: MG crisis; Substantial symptomatic worsening that requires immediate therapy; or health in jeopardy if rescue therapy is not given.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants With at Least One gMG-Related Exacerbation Between Baseline and Week 24 in OP
|
16.9 percentage of participants
Interval 9.0 to 24.7
|
8.3 percentage of participants
Interval 2.8 to 13.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: AChR+ population included all participants in the study who were AChR+.
The percentage of participants receiving rescue therapy during DBP analyzed the variable that encodes whether a participant received rescue therapy during DBP or not. If a participant stopped the study drug but received rescue therapy during the safety follow-up and this occurred within 24 weeks of baseline then this was counted as having received rescue therapy.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants in AChR+ Population Receiving Rescue Therapy Between Baseline and Week 24
|
13.8 percentage of participants
Interval 5.58 to 21.92
|
7.0 percentage of participants
Interval 1.01 to 12.94
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The percentage of participants receiving rescue therapy during DBP analyzed the variable that encodes whether a participant received rescue therapy during DBP or not. If a participant stopped the study drug but received rescue therapy during the safety follow-up and this occurred within 24 weeks of baseline then this was counted as having received rescue therapy.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Percentage of Participants in OP Receiving Rescue Therapy Between Baseline and Week 24
|
12.4 percentage of participants
Interval 4.96 to 19.76
|
7 percentage of participants
Interval 1.57 to 13.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: AChR+ population included all participants in the study who were AChR+.
The duration was the difference in weeks between the two visits defining the start and end (or Week 24) of reduction from baseline. The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=86 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Duration of Meaningful Improvement, Defined as ≥ 2-Point Reduction From Baseline in Total MG-ADL Score in AChR+ Population
|
7.46 weeks
Standard Error 1.00
|
10.90 weeks
Standard Error 1.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized.
The duration was the difference in weeks between the two visits defining the start and end (or Week 24) of reduction from baseline. The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=96 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Duration of Meaningful Improvement, Defined as ≥ 2-Point Reduction From Baseline in Total MG-ADL Score in OP
|
7.29 weeks
Standard Error 0.95
|
11.02 weeks
Standard Error 0.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 24 weeksPopulation: Safety-evaluable (SE) population included all enrolled participants who received at least one dose of study drug, with participants grouped according to treatment received.
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptoms, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Placebo
n=92 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=87 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
n=9 Participants
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Number of Participants With Adverse Events (AEs)
|
67 Participants
|
78 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24Population: SE Population included all enrolled participants who received at least one dose of study drug, with participants grouped according to treatment received. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=87 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
n=16 Participants
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
n=9 Participants
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Baseline
|
1.97 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 70.7
|
2.19 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 79.3
|
3.65 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 124.3
|
4.87 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 87.7
|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Week 2
|
2.30 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 90.8
|
17.45 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 100.6
|
3.08 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 118.5
|
35.23 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 91.8
|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Week 4
|
2.10 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 81.0
|
20.31 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 119.7
|
2.66 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 63.3
|
46.49 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 87.1
|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Week 8
|
2.37 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 92.3
|
19.40 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 100.8
|
2.46 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 84.5
|
38.59 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 37.9
|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Week 12
|
2.11 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 78.3
|
16.59 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 93.0
|
3.90 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 81.4
|
41.72 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 45.5
|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Week 16
|
2.17 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 91.0
|
18.02 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 100.2
|
2.65 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 71.8
|
30.13 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 67.1
|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Week 20
|
2.24 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 93.4
|
15.50 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 112.7
|
2.96 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 98.7
|
26.10 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 220.1
|
|
DB Period: Serum Levels of Interleukin-6 (IL-6)
Week 24
|
2.18 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 99.5
|
15.75 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 95.7
|
2.26 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 77.1
|
29.57 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 161.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24Population: SE Population included all enrolled participants who received at least one dose of study drug, with participants grouped according to treatment received. Number analyzed is the number of participants with data available for analyses at the specified timepoints.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=87 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
n=16 Participants
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
n=9 Participants
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Week 20
|
34.58 ng/mL
Geometric Coefficient of Variation 24.6
|
637.30 ng/mL
Geometric Coefficient of Variation 23.9
|
33.30 ng/mL
Geometric Coefficient of Variation 24.8
|
430.87 ng/mL
Geometric Coefficient of Variation 124.1
|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Baseline
|
36.39 ng/mL
Geometric Coefficient of Variation 27.3
|
35.95 ng/mL
Geometric Coefficient of Variation 24.8
|
34.52 ng/mL
Geometric Coefficient of Variation 27.9
|
41.90 ng/mL
Geometric Coefficient of Variation 24.4
|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Week 2
|
36.08 ng/mL
Geometric Coefficient of Variation 25.8
|
461.84 ng/mL
Geometric Coefficient of Variation 18.1
|
35.51 ng/mL
Geometric Coefficient of Variation 24.0
|
441.03 ng/mL
Geometric Coefficient of Variation 32.9
|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Week 4
|
34.88 ng/mL
Geometric Coefficient of Variation 26.0
|
608.26 ng/mL
Geometric Coefficient of Variation 18.1
|
35.65 ng/mL
Geometric Coefficient of Variation 23.3
|
558.11 ng/mL
Geometric Coefficient of Variation 27.3
|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Week 8
|
35.26 ng/mL
Geometric Coefficient of Variation 27.9
|
659.47 ng/mL
Geometric Coefficient of Variation 19.4
|
33.04 ng/mL
Geometric Coefficient of Variation 28.1
|
653.33 ng/mL
Geometric Coefficient of Variation 23.6
|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Week 12
|
36.54 ng/mL
Geometric Coefficient of Variation 26.9
|
643.91 ng/mL
Geometric Coefficient of Variation 26.3
|
33.45 ng/mL
Geometric Coefficient of Variation 26.2
|
646.65 ng/mL
Geometric Coefficient of Variation 25.2
|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Week 16
|
35.58 ng/mL
Geometric Coefficient of Variation 25.1
|
646.92 ng/mL
Geometric Coefficient of Variation 25.9
|
35.80 ng/mL
Geometric Coefficient of Variation 29.6
|
600.54 ng/mL
Geometric Coefficient of Variation 40.2
|
|
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
Week 24
|
37.46 ng/mL
Geometric Coefficient of Variation 58.7
|
634.58 ng/mL
Geometric Coefficient of Variation 25.8
|
34.12 ng/mL
Geometric Coefficient of Variation 24.1
|
374.27 ng/mL
Geometric Coefficient of Variation 158.9
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Immunogenicity-analysis population included all participants randomly assigned to study treatment who received any study treatment with at least one post-dose anti-drug antibody (ADA) assessment. Overall number analyzed is the number of participants with data available for analysis.
The percentage of ADA-positive participants after drug administration were determined for participants exposed to satralizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. Participants were considered to be ADA-negative if they were ADA-negative or had missing data at baseline and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that is at least 4-fold (0.60 titer unit) greater than the titer of the baseline sample.
Outcome measures
| Measure |
Placebo
n=94 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab
Participants with ADA postive sample
|
23 Participants
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab
Participants with ADA negative sample
|
71 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20 and 24Population: Pharmacokinetic (PK)-evaluable population included all participants randomly assigned to study treatment who received at least one dose and had sufficient sampling to permit PK evaluation. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
Outcome measures
| Measure |
Placebo
n=87 Participants
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
Satralizumab
n=9 Participants
Participants received satralizumab 120 mg or 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180mg
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Satralizumab 180 mg
Participants received satralizumab 180 mg, based on body weight, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
|---|---|---|---|---|
|
Serum Concentrations of Satralizumab
Week 0
|
NA mg
Standard Deviation NA
Geometric Mean and Geometric Coefficient of Variation was not evaluable as samples were below limit of quantification.
|
NA mg
Standard Deviation NA
Geometric Mean and Geometric Coefficient of Variation was not evaluable as samples were below limit of quantification.
|
—
|
—
|
|
Serum Concentrations of Satralizumab
Week 2
|
9740 mg
Standard Deviation 5270
|
9620 mg
Standard Deviation 5210
|
—
|
—
|
|
Serum Concentrations of Satralizumab
Week 4
|
19000 mg
Standard Deviation 8530
|
18900 mg
Standard Deviation 7290
|
—
|
—
|
|
Serum Concentrations of Satralizumab
Week 8
|
17300 mg
Standard Deviation 9550
|
21700 mg
Standard Deviation 9690
|
—
|
—
|
|
Serum Concentrations of Satralizumab
Week 12
|
15600 mg
Standard Deviation 9030
|
19300 mg
Standard Deviation 13000
|
—
|
—
|
|
Serum Concentrations of Satralizumab
Week 16
|
15800 mg
Standard Deviation 9710
|
14500 mg
Standard Deviation 10100
|
—
|
—
|
|
Serum Concentrations of Satralizumab
Week 20
|
14900 mg
Standard Deviation 9180
|
15100 mg
Standard Deviation 10100
|
—
|
—
|
|
Serum Concentrations of Satralizumab
Week 24
|
14800 mg
Standard Deviation 10100
|
14800 mg
Standard Deviation 10900
|
—
|
—
|
Adverse Events
DB Period: Placebo
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
DB Period: Satralizumab 120mg
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
DB Period: Satralizumab 180mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Overall Satralizumab 120mg
Serious events: 18 serious events
Other events: 95 other events
Deaths: 1 deaths
Overall Satralizumab 180mg
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Period: Placebo
n=92 participants at risk
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
DB Period: Satralizumab 120mg
n=87 participants at risk
Participants received satralizumab 120 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
DB Period: Satralizumab 180mg
n=9 participants at risk
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Overall Satralizumab 120mg
n=159 participants at risk
Participants who received satralizumab 120 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period continued receiving satralizumab 120 mg, Q4W in the OLE period. Participants who received placebo in the DB period received satralizumab, 120 mg at Weeks 0, 2, and 4 (loading doses), and Q4W thereafter (maintenance doses) in the OLE period. Participants continuing satralizumab treatment from the DB period received a placebo injection on Week 2 of OLE to maintain blinding to DB treatment assignment.
|
Overall Satralizumab 180mg
n=25 participants at risk
Participants who received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period continued receiving satralizumab 180 mg, Q4W in the OLE period. Participants who received placebo in the DB period received satralizumab, 180 mg at Weeks 0, 2, and 4 (loading doses), and Q4W thereafter (maintenance doses) in the OLE period. Participants continuing satralizumab treatment from the DB period received a placebo injection on Week 2 of OLE to maintain blinding to DB treatment assignment.
|
|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
General disorders
Chest pain
|
1.1%
1/92 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
COVID-19
|
2.2%
2/92 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.1%
1/92 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Neurological infection
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.1%
1/87 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.3%
2/159 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.1%
1/87 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.1%
1/92 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Investigations
Lipase increased
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.1%
1/87 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/92 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.1%
1/92 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
Other adverse events
| Measure |
DB Period: Placebo
n=92 participants at risk
Participants received satralizumab matched placebo, SC, at Weeks 0, 2, 4, and Q4W thereafter until the end of the DB period.
|
DB Period: Satralizumab 120mg
n=87 participants at risk
Participants received satralizumab 120 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
DB Period: Satralizumab 180mg
n=9 participants at risk
Participants received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period.
|
Overall Satralizumab 120mg
n=159 participants at risk
Participants who received satralizumab 120 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period continued receiving satralizumab 120 mg, Q4W in the OLE period. Participants who received placebo in the DB period received satralizumab, 120 mg at Weeks 0, 2, and 4 (loading doses), and Q4W thereafter (maintenance doses) in the OLE period. Participants continuing satralizumab treatment from the DB period received a placebo injection on Week 2 of OLE to maintain blinding to DB treatment assignment.
|
Overall Satralizumab 180mg
n=25 participants at risk
Participants who received satralizumab 180 mg, SC, at Weeks 0, 2, 4 (loading doses), and Q4W (maintenance doses) thereafter until the end of the DB period continued receiving satralizumab 180 mg, Q4W in the OLE period. Participants who received placebo in the DB period received satralizumab, 180 mg at Weeks 0, 2, and 4 (loading doses), and Q4W thereafter (maintenance doses) in the OLE period. Participants continuing satralizumab treatment from the DB period received a placebo injection on Week 2 of OLE to maintain blinding to DB treatment assignment.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/92 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
2.3%
2/87 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.3%
2/159 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Eye disorders
Diplopia
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Eye disorders
Dry eye
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
22.2%
2/9 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.3%
2/159 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
12.0%
3/25 • Number of events 3 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
2/92 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
5/92 • Number of events 7 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
3.4%
3/87 • Number of events 3 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
6.9%
11/159 • Number of events 11 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.1%
1/87 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.3%
2/159 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/92 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.6%
4/87 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.0%
8/159 • Number of events 9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
COVID-19
|
7.6%
7/92 • Number of events 7 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
12.6%
11/87 • Number of events 11 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
13.8%
22/159 • Number of events 24 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
1/92 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 3 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
4/92 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
6.9%
6/87 • Number of events 6 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.3%
18/159 • Number of events 23 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Pharyngitis
|
2.2%
2/92 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.7%
5/87 • Number of events 5 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.0%
8/159 • Number of events 12 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
8/92 • Number of events 8 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
6.9%
6/87 • Number of events 7 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
14.5%
23/159 • Number of events 34 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
12.0%
3/25 • Number of events 5 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
6/92 • Number of events 6 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.6%
4/87 • Number of events 5 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.2%
13/159 • Number of events 19 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Injury, poisoning and procedural complications
Intercepted medication error
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
2/92 • Number of events 3 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
2.3%
2/87 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
6.3%
10/159 • Number of events 13 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
12.0%
3/25 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Investigations
Platelet count decreased
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.3%
2/159 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Investigations
Weight increased
|
1.1%
1/92 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.6%
4/87 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.0%
8/159 • Number of events 8 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
6/92 • Number of events 7 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
3.4%
3/87 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
22.2%
2/9 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
3.8%
6/159 • Number of events 7 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
16.0%
4/25 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
3/92 • Number of events 3 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
2.3%
2/87 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.7%
9/159 • Number of events 9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
3/92 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
3.4%
3/87 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
3.8%
6/159 • Number of events 7 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Nervous system disorders
Headache
|
9.8%
9/92 • Number of events 17 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
10.3%
9/87 • Number of events 16 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
12.6%
20/159 • Number of events 40 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Psychiatric disorders
Insomnia
|
2.2%
2/92 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
3.4%
3/87 • Number of events 3 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.0%
8/159 • Number of events 8 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Renal and urinary disorders
Haematuria
|
2.2%
2/92 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
1.1%
1/87 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.63%
1/159 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 3 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/87 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/159 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.0%
1/25 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/92 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.6%
4/87 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/9 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.0%
8/159 • Number of events 8 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
0.00%
0/25 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
|
Vascular disorders
Hypertension
|
4.3%
4/92 • Number of events 5 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
4.6%
4/87 • Number of events 4 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
11.1%
1/9 • Number of events 1 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
5.7%
9/159 • Number of events 10 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
8.0%
2/25 • Number of events 2 • DB Period Arms: Day 1 up to approximately 24 weeks; Overall Satralizumab Treatment (OST) Period: Participants receiving Satralizumab in DB: Day 1 in DB up to end of OLE (approximately 116 weeks); Participants receiving Placebo in DB: Day 1 in OLE up to end of OLE (approximately 92 weeks) As placebo has no active drug, all AEs for placebo (matched to 120 mg and 180 mg satralizumab) are reported together.
DB Period: SE Population used; All Treated Participants Set=all participants who received at least 1 dose of satralizumab in DB \& OLE period. As pre-specified in SAP, AEs were reported for DB period \& OST period. OST includes data for all participants from 1st dose of satralizumab (in DB for participants receiving satralizumab \& in OLE for participants receiving placebo in DB) up to 4 weeks after the last dose (if discontinued), or last contact with participant, whatever occurred first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER