Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)
Conditions
Brief summary
The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.
Interventions
DRUGSatralizumab
Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
DRUGPlacebo
Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Sponsors
Chugai Pharmaceutical
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following: 1. NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following 3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three supportive criteria: Contiguous spinal cord lesion identified on a magnetic resonance imaging \[MRI\] scan extending over 3 vertebral segments; Brain MRI not meeting diagnostic criteria for multiple sclerosis \[MS\]; NMO-IgG seropositive status) 2. NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral 2. Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening 3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening 4. Age 18 to 74 years, inclusive at the time of informed consent 5. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
Exclusion criteria
1. Clinical relapse onset (including first attack) within 30 days prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period | Up to Week 216 | TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period | Baseline, Week 24 | The FACIT Fatigue scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. As each of the 13 items of the scale ranges from 0-4, the range of possible scores was computed using FACIT scoring algorithm as 0-52, where 0 is the worst possible score and 52 the best which indicated less fatigue. A positive change from baseline indicates an improvement. |
| Relapse-Free Rate During the DB Period | Up to Week 216 | Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onsets within 30 days of one another, they were counted as 1), and onset date used in analysis was the date of first relapse. |
| Annualized Relapse Rate (ARR) During the DB Period | Up to Week 216 | The ARR is calculated as the total number of participants with adjudicated PDRs experienced divided by the patient-years at risk. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD. Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (2 relapses with onset days in 30 days of one another was counted as 1 relapse), onset date used in analysis was the date of first relapse. |
| Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement. |
| Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The EQ-5D is a participant-answered questionnaire measuring 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 possible response categories: 1) no problems; 2) some problems; 3) severe problems. The scores from 5 dimensions are used as input to generate EQ-5D index score using scoring algorithm. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state. A positive change from baseline indicates an improvement |
| Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The T25W is an assessment of walking ability. The time (in seconds) that the participant took to walk 25 feet was measured. Speed is calculated as 1/Timed 25-Foot Walk where time is measured in seconds. A positive change from baseline indicates an improvement. |
| Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period | Baseline, Week 24 | The VAS is a subjective measure of pain consisting of a 100 mm line with two endpoints representing 0 = no pain and 100 = pain as bad as it could be. Participants rated their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the no pain marker was measured with a ruler giving a pain score out of 100. A higher score indicated more pain and lower scores reflected a better health state. A negative change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and standard error (SE). |
| Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 120 | The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden. A negative change from baseline indicates an improvement. |
| Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The EDSS is an ordinal scale with values from 0 points (normal neurological examination) to 10 points (death) increasing in half-point increments once an EDSS of 1.0 has been reached. Higher scores represent increased disability. A negative change from baseline indicates an improvement. |
| Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline up to Week 216 | Visual acuity was measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). A negative change from baseline indicates an improvement. |
| Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The LCSLC evaluates the visual function and captures the minimum size at which individuals can perceive letters of a particular contrast level. The change in binocular visual acuity, as assessed by the number of letters read correctly from a distance of 2 meters on 100%, 2.5% and 1.25% contrast level Sloan letter charts, was analyzed. The LCSLC is scored on a scale of 0-60. Higher scores indicate better visual function. A positive change from baseline indicates an improvement. |
| Number of Participants With at Least One Adverse Event in the DB Period | Up to Week 216 | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. |
| Number of Participants With at Least One Serious Adverse Event in the DB Period | Up to Week 216 | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above. |
| Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period | Up to Week 216 | Non-serious adverse events of special interest for this study included: 1\) cases of an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, 2) suspected transmission of an infectious agent by the study treatment. |
| Number of Participants With Selected Adverse Events in the DB Period | Up to Week 216 | Selected adverse events for this study included: 1\) all infections, 2) serious infections, 3) potential opportunistic infections, 4) injection-related reactions (IRRs; an AE which occured within 24 hours after study treatment injection except where the event was not considered an allergic reaction), 5) psychiatric disorders and 6) anaphylaxis (an acute allergic/hypersensitivity reaction). |
| Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Baseline and Post-Baseline (up to Week 216) | The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a yes answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates suicidal ideation or behavior. |
| Serum Satralizumab Concentration During the DB Period | Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 204 | — |
| Serum Interleukin-6 (IL-6) Concentration During the DB Period | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216 | — |
| Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216 | — |
| Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216 | — |
| Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period | Up to approximately Week 216 | Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period. |
| Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The mRS is a 7-point disability scale that assesses the degree of disability in participants with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability. A negative change from baseline indicates an improvement. |
Countries
Bulgaria, Canada, Croatia, Georgia, Italy, Malaysia, Philippines, Poland, Puerto Rico, Romania, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
The Double-blind (DB) period lasted up to the primary clinical cut-off date (CCOD: 12 Oct 2018) when the study reached 1.5 years since the date of randomization of the last participant enrolled. The Open Label Period lasted up to clinical cut-off date (31-Jan-2022).
Pre-assignment details
Participants with neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD) were randomized 2:1 to receive either satralizumab 120 mg or matching placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo, Then Satralizumab Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | 32 |
| Satralizumab, Then Satralizumab Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter. | 63 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Period | Adverse Event | 1 | 1 |
| Double-blind Period | Protocol Violation | 0 | 1 |
| Double-blind Period | Refused Treatment/Did Not Cooperate | 0 | 1 |
| Double-blind Period | Switched to another treatment | 1 | 2 |
| Double-blind Period | Withdrawal by Subject | 2 | 2 |
| Open-label Extension Period | Adverse Event | 1 | 0 |
| Open-label Extension Period | Lack of Efficacy | 1 | 0 |
| Open-label Extension Period | Lost to Follow-up | 0 | 4 |
| Open-label Extension Period | Protocol Violation | 0 | 1 |
| Open-label Extension Period | Refused Treatment/Did Not Cooperate | 0 | 1 |
| Open-label Extension Period | Switched to another treatment | 1 | 4 |
| Open-label Extension Period | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Placebo, Then Satralizumab | Satralizumab, Then Satralizumab | Total |
|---|---|---|---|
| Age, Continuous | 40.5 Years STANDARD_DEVIATION 10.5 | 45.3 Years STANDARD_DEVIATION 12 | 43.7 Years STANDARD_DEVIATION 11.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 13 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 28 Participants | 50 Participants | 78 Participants |
| Race/Ethnicity, Customized Not Stated | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 37 Participants | 59 Participants |
| Sex: Female, Male Female | 31 Participants | 46 Participants | 77 Participants |
| Sex: Female, Male Male | 1 Participants | 17 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 63 | 0 / 28 | 0 / 56 |
| other Total, other adverse events | 23 / 32 | 57 / 63 | 23 / 28 | 42 / 56 |
| serious Total, serious adverse events | 5 / 32 | 12 / 63 | 3 / 28 | 7 / 56 |
Outcome results
Primary
Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period
TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse.
Time frame: Up to Week 216
Population: ITT population included all participants randomized to the treatment groups. For participants who had not relapsed, the TFR was censored on the date of end of the DB period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo, Then Satralizumab | Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period | 128.3 weeks |
| Satralizumab, Then Satralizumab | Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period | NA weeks |
Comparison: Stratified by prior therapy (B-cell depleting therapy or immunosuppressants/others) and most recent attack (first attack or relapse).p-value: 0.018495% CI: [0.23, 0.89]Log Rank
Secondary
Annualized Relapse Rate (ARR) During the DB Period
The ARR is calculated as the total number of participants with adjudicated PDRs experienced divided by the patient-years at risk. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD. Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (2 relapses with onset days in 30 days of one another was counted as 1 relapse), onset date used in analysis was the date of first relapse.
Time frame: Up to Week 216
Population: ITT population included all participants randomized to the treatment groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo, Then Satralizumab | Annualized Relapse Rate (ARR) During the DB Period | 0.41 patients w PDRs/patient-years at risk |
| Satralizumab, Then Satralizumab | Annualized Relapse Rate (ARR) During the DB Period | 0.17 patients w PDRs/patient-years at risk |
Secondary
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
The EQ-5D is a participant-answered questionnaire measuring 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 possible response categories: 1) no problems; 2) some problems; 3) severe problems. The scores from 5 dimensions are used as input to generate EQ-5D index score using scoring algorithm. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state. A positive change from baseline indicates an improvement
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Baseline | 0.7153 score on scale | Standard Deviation 0.2253 |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.0031 score on scale | Standard Deviation 0.1602 |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.0016 score on scale | Standard Deviation 0.1176 |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.0582 score on scale | Standard Deviation 0.1498 |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.0447 score on scale | Standard Deviation 0.1508 |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.0288 score on scale | Standard Deviation 0.1908 |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -0.1001 score on scale | Standard Deviation 0.1416 |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.0000 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -0.2002 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -0.2002 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Baseline | 0.6881 score on scale | Standard Deviation 0.204 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 0.0299 score on scale | Standard Deviation 0.0423 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.0188 score on scale | Standard Deviation 0.1812 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.0099 score on scale | Standard Deviation 0.1636 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.0244 score on scale | Standard Deviation 0.1571 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.0261 score on scale | Standard Deviation 0.2532 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.0238 score on scale | Standard Deviation 0.1323 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 0.0063 score on scale | Standard Deviation 0.2299 |
| Satralizumab, Then Satralizumab | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.0460 score on scale | Standard Deviation 0.1067 |
Secondary
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
The EDSS is an ordinal scale with values from 0 points (normal neurological examination) to 10 points (death) increasing in half-point increments once an EDSS of 1.0 has been reached. Higher scores represent increased disability. A negative change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -1.00 score on scale | Standard Deviation 0.71 |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Baseline | 3.66 score on scale | Standard Deviation 1.61 |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.03 score on scale | Standard Deviation 0.38 |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.06 score on scale | Standard Deviation 0.42 |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.21 score on scale | Standard Deviation 0.58 |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.50 score on scale | Standard Deviation 0.76 |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.50 score on scale | Standard Deviation 0.87 |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.50 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 0.00 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -0.50 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 0.18 score on scale | Standard Deviation 0.68 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 0.25 score on scale | Standard Deviation 1.06 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Baseline | 3.92 score on scale | Standard Deviation 1.5 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.03 score on scale | Standard Deviation 0.48 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.24 score on scale | Standard Deviation 0.71 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.15 score on scale | Standard Deviation 1.13 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.32 score on scale | Standard Deviation 0.65 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.22 score on scale | Standard Deviation 0.91 |
| Satralizumab, Then Satralizumab | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -0.29 score on scale | Standard Deviation 0.76 |
Secondary
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
The mRS is a 7-point disability scale that assesses the degree of disability in participants with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability. A negative change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Baseline | 1.66 score on scale | Standard Deviation 1 |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.05 score on scale | Standard Deviation 0.4 |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.00 score on scale | Standard Deviation 0.94 |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -0.08 score on scale | Standard Deviation 1.04 |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.38 score on scale | Standard Deviation 0.74 |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -1.00 score on scale | Standard Deviation 0 |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -1.00 score on scale | Standard Deviation 1.41 |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -1.00 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -1.00 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.42 score on scale | Standard Deviation 0.99 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Baseline | 1.97 score on scale | Standard Deviation 0.98 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.00 score on scale | Standard Deviation 0.67 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.04 score on scale | Standard Deviation 0.64 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.13 score on scale | Standard Deviation 0.81 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.13 score on scale | Standard Deviation 0.78 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -0.50 score on scale | Standard Deviation 2.12 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -0.12 score on scale | Standard Deviation 0.63 |
| Satralizumab, Then Satralizumab | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -0.09 score on scale | Standard Deviation 0.54 |
Secondary
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 6.60 score on scale | Standard Deviation 9.1 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 39.43 score on scale | Standard Deviation 9.5 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 8.72 score on scale | Standard Deviation 13.55 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.85 score on scale | Standard Deviation 9.72 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 5.23 score on scale | Standard Deviation 14.11 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -4.75 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -7.13 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 4.83 score on scale | Standard Deviation 12.41 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -4.75 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.52 score on scale | Standard Deviation 9.96 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.21 score on scale | Standard Deviation 6.57 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 39.72 score on scale | Standard Deviation 10.41 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.49 score on scale | Standard Deviation 6.46 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.01 score on scale | Standard Deviation 7.61 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 5.04 score on scale | Standard Deviation 9.45 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 3.45 score on scale | Standard Deviation 6.42 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.60 score on scale | Standard Deviation 7.02 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.82 score on scale | Standard Deviation 8 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 8.32 score on scale | Standard Deviation 11.77 |
Secondary
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -4.22 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -5.40 score on scale | Standard Deviation 8.41 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 44.03 score on scale | Standard Deviation 13.93 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.28 score on scale | Standard Deviation 11.19 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.09 score on scale | Standard Deviation 8.96 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 1.54 score on scale | Standard Deviation 8.18 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -2.65 score on scale | Standard Deviation 6.05 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -10.65 score on scale | Standard Deviation 11.99 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.61 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -14.38 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 1.03 score on scale | Standard Deviation 12.92 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.17 score on scale | Standard Deviation 7.7 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 1.63 score on scale | Standard Deviation 11.86 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 46.43 score on scale | Standard Deviation 11.55 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.91 score on scale | Standard Deviation 9.32 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.89 score on scale | Standard Deviation 8.96 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.98 score on scale | Standard Deviation 12.99 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.63 score on scale | Standard Deviation 8.04 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -5.88 score on scale | Standard Deviation 7.54 |
Secondary
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 42.86 score on scale | Standard Deviation 12.69 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.79 score on scale | Standard Deviation 9.02 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.58 score on scale | Standard Deviation 7.32 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.62 score on scale | Standard Deviation 6.32 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -3.60 score on scale | Standard Deviation 6.08 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -2.62 score on scale | Standard Deviation 6.92 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 1.31 score on scale | Standard Deviation 1.85 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 5.23 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -13.08 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -2.62 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 46.78 score on scale | Standard Deviation 10.1 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -3.93 score on scale | Standard Deviation 12.95 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.84 score on scale | Standard Deviation 7.05 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.82 score on scale | Standard Deviation 10.32 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.67 score on scale | Standard Deviation 7.89 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 2.62 score on scale | Standard Deviation 8.89 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 1.95 score on scale | Standard Deviation 7.85 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.83 score on scale | Standard Deviation 9.43 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 2.36 score on scale | Standard Deviation 7.38 |
Secondary
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -10.84 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 38.89 score on scale | Standard Deviation 11.2 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.78 score on scale | Standard Deviation 4.99 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 3.57 score on scale | Standard Deviation 4.94 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 5.68 score on scale | Standard Deviation 7.32 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 7.25 score on scale | Standard Deviation 7.08 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 8.95 score on scale | Standard Deviation 8.51 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.18 score on scale | Standard Deviation 10.67 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -1.79 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -2.00 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 4.20 score on scale | Standard Deviation 5.9 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 38.59 score on scale | Standard Deviation 9.68 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 1.83 score on scale | Standard Deviation 10.96 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.05 score on scale | Standard Deviation 6.14 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 2.68 score on scale | Standard Deviation 8.72 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.85 score on scale | Standard Deviation 4.9 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 7.24 score on scale | Standard Deviation 3.35 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.87 score on scale | Standard Deviation 6.8 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.89 score on scale | Standard Deviation 7.11 |
Secondary
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 5.50 score on scale | Standard Deviation 9.62 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.34 score on scale | Standard Deviation 6.9 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 7.01 score on scale | Standard Deviation 8.63 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.20 score on scale | Standard Deviation 4.62 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 4.79 score on scale | Standard Deviation 9.48 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 6.62 score on scale | Standard Deviation 9.71 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 1.91 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -1.92 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -3.83 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 38.70 score on scale | Standard Deviation 12.24 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.99 score on scale | Standard Deviation 6.94 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 4.78 score on scale | Standard Deviation 4.06 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 39.48 score on scale | Standard Deviation 10.99 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.96 score on scale | Standard Deviation 6.12 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 3.33 score on scale | Standard Deviation 6.76 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.96 score on scale | Standard Deviation 8.62 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 3.59 score on scale | Standard Deviation 7.49 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 1.94 score on scale | Standard Deviation 8.05 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.19 score on scale | Standard Deviation 10.87 |
Secondary
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Baseline | 42.24 score on scale | Standard Deviation 13.09 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -1.57 score on scale | Standard Deviation 15.67 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.78 score on scale | Standard Deviation 8.57 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 4.55 score on scale | Standard Deviation 7.96 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 3.05 score on scale | Standard Deviation 11.98 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -12.77 score on scale | Standard Deviation 14.07 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -12.19 score on scale | Standard Deviation 17.23 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.00 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -13.93 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -10.45 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Baseline | 42.07 score on scale | Standard Deviation 13.62 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -3.49 score on scale | Standard Deviation 4.93 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 3.87 score on scale | Standard Deviation 11.27 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 1.31 score on scale | Standard Deviation 14.04 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.73 score on scale | Standard Deviation 10.3 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.35 score on scale | Standard Deviation 11.89 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.89 score on scale | Standard Deviation 9.22 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 1.74 score on scale | Standard Deviation 13.4 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.12 score on scale | Standard Deviation 11.87 |
Secondary
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Baseline | 37.86 score on scale | Standard Deviation 11.28 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 3.14 score on scale | Standard Deviation 9.92 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 4.12 score on scale | Standard Deviation 7.24 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 5.70 score on scale | Standard Deviation 7.65 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 5.62 score on scale | Standard Deviation 6.35 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 2.25 score on scale | Standard Deviation 8.99 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -3.37 score on scale | Standard Deviation 11.12 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.00 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -6.74 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -17.97 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Baseline | 37.43 score on scale | Standard Deviation 11.55 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 4.49 score on scale | Standard Deviation 6.35 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 3.52 score on scale | Standard Deviation 8.38 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.18 score on scale | Standard Deviation 9.46 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 5.01 score on scale | Standard Deviation 8.25 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.00 score on scale | Standard Deviation 9.1 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 4.59 score on scale | Standard Deviation 8.56 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.43 score on scale | Standard Deviation 8.8 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 4.83 score on scale | Standard Deviation 8.31 |
Secondary
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.56 score on scale | Standard Deviation 10.59 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 42.93 score on scale | Standard Deviation 13.22 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.76 score on scale | Standard Deviation 12.42 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.39 score on scale | Standard Deviation 11.66 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.63 score on scale | Standard Deviation 1.77 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -5.01 score on scale | Standard Deviation 13.26 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 7.52 score on scale | Standard Deviation 10.63 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -5.01 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -5.01 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 0.00 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -2.51 score on scale | Standard Deviation 3.54 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 41.01 score on scale | Standard Deviation 11.66 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.31 score on scale | Standard Deviation 8.48 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.42 score on scale | Standard Deviation 9.63 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.62 score on scale | Standard Deviation 8.17 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -1.50 score on scale | Standard Deviation 7.86 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.96 score on scale | Standard Deviation 7.93 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.76 score on scale | Standard Deviation 14.68 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 3.56 score on scale | Standard Deviation 7.89 |
Secondary
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Baseline | 40.72 score on scale | Standard Deviation 11.86 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.49 score on scale | Standard Deviation 10.22 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 4.79 score on scale | Standard Deviation 9.07 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.43 score on scale | Standard Deviation 9.38 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.00 score on scale | Standard Deviation 7.94 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -1.98 score on scale | Standard Deviation 11.24 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -9.41 score on scale | Standard Deviation 7.7 |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -5.94 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -11.88 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -11.88 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Baseline | 46.02 score on scale | Standard Deviation 10.58 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 0.00 score on scale | Standard Deviation 8.4 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.33 score on scale | Standard Deviation 8.29 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.96 score on scale | Standard Deviation 9.94 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 4.15 score on scale | Standard Deviation 7.49 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 5.05 score on scale | Standard Deviation 6.58 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.68 score on scale | Standard Deviation 6.43 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 4.95 score on scale | Standard Deviation 7.95 |
| Satralizumab, Then Satralizumab | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 4.34 score on scale | Standard Deviation 9.39 |
Secondary
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Baseline | 42.86 score on scale | Standard Deviation 11.28 |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.89 score on scale | Standard Deviation 8.35 |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.75 score on scale | Standard Deviation 5.42 |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.19 score on scale | Standard Deviation 8.04 |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 3.43 score on scale | Standard Deviation 5.6 |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.00 score on scale | Standard Deviation 8.07 |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -2.22 score on scale | Standard Deviation 8.84 |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.80 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -8.47 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -12.50 score on scale | — |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Baseline | 43.20 score on scale | Standard Deviation 11.08 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 0 score on scale | Standard Deviation 0 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.13 score on scale | Standard Deviation 8.09 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.53 score on scale | Standard Deviation 6.21 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.36 score on scale | Standard Deviation 8.89 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 4.19 score on scale | Standard Deviation 7.01 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.91 score on scale | Standard Deviation 9.23 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.59 score on scale | Standard Deviation 6.66 |
| Satralizumab, Then Satralizumab | Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 2.38 score on scale | Standard Deviation 7.82 |
Secondary
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
The T25W is an assessment of walking ability. The time (in seconds) that the participant took to walk 25 feet was measured. Speed is calculated as 1/Timed 25-Foot Walk where time is measured in seconds. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Baseline | 0.1442 1/seconds | Standard Deviation 0.0793 |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.0030 1/seconds | Standard Deviation 0.0374 |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.0142 1/seconds | Standard Deviation 0.0493 |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.0205 1/seconds | Standard Deviation 0.0531 |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.0031 1/seconds | Standard Deviation 0.0251 |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.0489 1/seconds | Standard Deviation 0.0301 |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 0.0388 1/seconds | Standard Deviation 0.0572 |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.0656 1/seconds | — |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -0.0812 1/seconds | — |
| Placebo, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -0.0917 1/seconds | — |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Baseline | 0.1355 1/seconds | Standard Deviation 0.0561 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | -0.0304 1/seconds | Standard Deviation 0.036 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.0040 1/seconds | Standard Deviation 0.0225 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.0063 1/seconds | Standard Deviation 0.0386 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.0115 1/seconds | Standard Deviation 0.0306 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.0155 1/seconds | Standard Deviation 0.0379 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.0071 1/seconds | Standard Deviation 0.0257 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 0.0003 1/seconds | Standard Deviation 0.0443 |
| Satralizumab, Then Satralizumab | Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.0081 1/seconds | Standard Deviation 0.0253 |
Secondary
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Visual acuity was measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). A negative change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OD | -0.027 LogMAR units | Standard Deviation 0.142 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OS | 0.050 LogMAR units | Standard Deviation 0.252 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OS | 0.000 LogMAR units | Standard Deviation 0 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OD | -0.058 LogMAR units | Standard Deviation 0.512 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OD | 0.010 LogMAR units | Standard Deviation 0.127 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OD | -0.050 LogMAR units | Standard Deviation 0.14 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OS | 0.000 LogMAR units | Standard Deviation 0 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OS | 0.046 LogMAR units | Standard Deviation 0.242 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: OD | -0.080 LogMAR units | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OS | -0.083 LogMAR units | Standard Deviation 0.595 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: OS | -0.100 LogMAR units | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OS | 0.456 LogMAR units | Standard Deviation 0.811 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: OD | -0.180 LogMAR units | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OD | -0.045 LogMAR units | Standard Deviation 0.099 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: OS | 0.080 LogMAR units | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OD | -0.027 LogMAR units | Standard Deviation 0.097 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 216: OD | -0.180 LogMAR units | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 216: OS | -0.100 LogMAR units | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OS | -0.260 LogMAR units | Standard Deviation 0.707 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OD | 0.560 LogMAR units | Standard Deviation 0.903 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OS | -0.121 LogMAR units | Standard Deviation 0.571 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OD | 0.449 LogMAR units | Standard Deviation 0.712 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OS | 0.545 LogMAR units | Standard Deviation 0.836 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OS | -0.001 LogMAR units | Standard Deviation 0.5 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OD | 0.053 LogMAR units | Standard Deviation 0.434 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OS | -0.006 LogMAR units | Standard Deviation 0.591 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OD | -0.056 LogMAR units | Standard Deviation 0.26 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OS | -0.101 LogMAR units | Standard Deviation 0.492 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OD | -0.081 LogMAR units | Standard Deviation 0.58 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OD | 0.039 LogMAR units | Standard Deviation 0.434 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OD | -0.039 LogMAR units | Standard Deviation 0.637 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OS | -0.229 LogMAR units | Standard Deviation 0.754 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OD | 0.149 LogMAR units | Standard Deviation 0.618 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OS | -0.280 LogMAR units | Standard Deviation 0.846 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: OD | 0.134 LogMAR units | Standard Deviation 0.663 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: OS | -0.320 LogMAR units | Standard Deviation 0.91 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: OD | -0.110 LogMAR units | Standard Deviation 0.156 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: OS | -0.050 LogMAR units | Standard Deviation 0.071 |
Secondary
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
The LCSLC evaluates the visual function and captures the minimum size at which individuals can perceive letters of a particular contrast level. The change in binocular visual acuity, as assessed by the number of letters read correctly from a distance of 2 meters on 100%, 2.5% and 1.25% contrast level Sloan letter charts, was analyzed. The LCSLC is scored on a scale of 0-60. Higher scores indicate better visual function. A positive change from baseline indicates an improvement.
Time frame: Baseline up to Week 216
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Baseline: 1.25% CHART | 17.5 letters | Standard Deviation 15.7 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: 100% CHART | 1.0 letters | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: 1.25% CHART | -7.0 letters | Standard Deviation 7.1 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: 2.5% CHART | -2.8 letters | Standard Deviation 9.1 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: 2.5% CHART | -1.0 letters | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: 1.25% CHART | -4.2 letters | Standard Deviation 11.9 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: 100% CHART | -3.5 letters | Standard Deviation 2.1 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: 100% CHART | -3.4 letters | Standard Deviation 8.7 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: 1.25% CHART | -8.0 letters | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: 2.5% CHART | 1.5 letters | Standard Deviation 6.1 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: 1.25% CHART | -2.0 letters | Standard Deviation 5 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: 1.25% CHART | 1.7 letters | Standard Deviation 11.3 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216: 100% CHART | 0.0 letters | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: 100% CHART | 0.3 letters | Standard Deviation 5.9 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216: 2.5% CHART | -1.0 letters | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: 2.5% CHART | -0.6 letters | Standard Deviation 8.6 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216: 1.25% CHART | -8.0 letters | — |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: 1.25% CHART | -2.4 letters | Standard Deviation 8.3 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Baseline: 100% CHART | 44.3 letters | Standard Deviation 16.1 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: 100% CHART | 3.3 letters | Standard Deviation 13.2 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: 2.5% CHART | 17.5 letters | Standard Deviation 17.7 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: 2.5% CHART | 2.6 letters | Standard Deviation 20.1 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Baseline: 2.5% CHART | 24.6 letters | Standard Deviation 16.2 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: 1.25% CHART | -3.4 letters | Standard Deviation 11.3 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: 2.5% CHART | 3.7 letters | Standard Deviation 4.6 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: 100% CHART | -1.0 letters | Standard Deviation 1 |
| Placebo, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: 100% CHART | 0.5 letters | Standard Deviation 7.1 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: 100% CHART | 1.5 letters | Standard Deviation 10.6 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: 2.5% CHART | 2.1 letters | Standard Deviation 7.3 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: 1.25% CHART | 1.6 letters | Standard Deviation 9.1 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: 100% CHART | 0.4 letters | Standard Deviation 7.7 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: 2.5% CHART | 1.6 letters | Standard Deviation 12 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: 1.25% CHART | 1.4 letters | Standard Deviation 12.2 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: 100% CHART | 2.1 letters | Standard Deviation 6.7 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: 2.5% CHART | 6.2 letters | Standard Deviation 8.2 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: 1.25% CHART | 0.3 letters | Standard Deviation 12.2 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: 100% CHART | -2.5 letters | Standard Deviation 3.5 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: 2.5% CHART | -1.0 letters | Standard Deviation 4.2 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: 1.25% CHART | -4.0 letters | Standard Deviation 7.1 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Baseline: 100% CHART | 44.4 letters | Standard Deviation 16.3 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Baseline: 2.5% CHART | 22.6 letters | Standard Deviation 15.6 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Baseline: 1.25% CHART | 14.9 letters | Standard Deviation 14.8 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: 100% CHART | 2.0 letters | Standard Deviation 5.3 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: 2.5% CHART | 1.7 letters | Standard Deviation 7.1 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: 1.25% CHART | 0.1 letters | Standard Deviation 7.5 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: 100% CHART | 1.3 letters | Standard Deviation 6.1 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: 2.5% CHART | 4.0 letters | Standard Deviation 9.2 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: 1.25% CHART | 4.1 letters | Standard Deviation 9.3 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: 100% CHART | 2.8 letters | Standard Deviation 7.3 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: 2.5% CHART | 2.6 letters | Standard Deviation 7.5 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: 1.25% CHART | 0.4 letters | Standard Deviation 10.6 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: 100% CHART | 2.1 letters | Standard Deviation 12.4 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: 2.5% CHART | 2.3 letters | Standard Deviation 10.8 |
| Satralizumab, Then Satralizumab | Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: 1.25% CHART | -0.5 letters | Standard Deviation 11.3 |
Secondary
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden. A negative change from baseline indicates an improvement.
Time frame: Baseline up to Week 120
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline | 19.43 score on scale | Standard Deviation 12.19 |
| Placebo, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -2.83 score on scale | Standard Deviation 6.11 |
| Placebo, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -5.00 score on scale | Standard Deviation 3 |
| Placebo, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -1.00 score on scale | Standard Deviation 7.07 |
| Placebo, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 4.00 score on scale | — |
| Placebo, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.00 score on scale | Standard Deviation 6.2 |
| Satralizumab, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline | 11.32 score on scale | Standard Deviation 7.2 |
| Satralizumab, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -3.00 score on scale | Standard Deviation 9.9 |
| Satralizumab, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.50 score on scale | Standard Deviation 9.68 |
| Satralizumab, Then Satralizumab | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -13.00 score on scale | — |
Secondary
Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period
The FACIT Fatigue scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. As each of the 13 items of the scale ranges from 0-4, the range of possible scores was computed using FACIT scoring algorithm as 0-52, where 0 is the worst possible score and 52 the best which indicated less fatigue. A positive change from baseline indicates an improvement.
Time frame: Baseline, Week 24
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data was imputed using BOCF method
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period | Baseline | 29.656 score on scale | Standard Error 2.28 |
| Placebo, Then Satralizumab | Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period | Change from Baseline to Week 24 | 3.602 score on scale | Standard Error 1.82 |
| Satralizumab, Then Satralizumab | Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period | Baseline | 30.590 score on scale | Standard Error 1.492 |
| Satralizumab, Then Satralizumab | Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period | Change from Baseline to Week 24 | 5.709 score on scale | Standard Error 1.61 |
p-value: 0.182495% CI: [-1.008, 5.221]ANCOVA
Secondary
Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period
The VAS is a subjective measure of pain consisting of a 100 mm line with two endpoints representing 0 = no pain and 100 = pain as bad as it could be. Participants rated their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the no pain marker was measured with a ruler giving a pain score out of 100. A higher score indicated more pain and lower scores reflected a better health state. A negative change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and standard error (SE).
Time frame: Baseline, Week 24
Population: ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data were imputed by BOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period | Baseline | 27.563 score on scale | Standard Error 5.438 |
| Placebo, Then Satralizumab | Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period | Change from Baseline to Week 24 | -5.949 score on scale | Standard Error 4.832 |
| Satralizumab, Then Satralizumab | Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period | Baseline | 31.661 score on scale | Standard Error 3.665 |
| Satralizumab, Then Satralizumab | Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period | Change from Baseline to Week 24 | -2.735 score on scale | Standard Error 4.26 |
p-value: 0.443695% CI: [-5.086, 11.515]ANCOVA
Secondary
Number of Participants With at Least One Adverse Event in the DB Period
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Up to Week 216
Population: The Safety Analysis Population (SAF) included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo, Then Satralizumab | Number of Participants With at Least One Adverse Event in the DB Period | 24 participants |
| Satralizumab, Then Satralizumab | Number of Participants With at Least One Adverse Event in the DB Period | 58 participants |
Secondary
Number of Participants With at Least One Serious Adverse Event in the DB Period
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time frame: Up to Week 216
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo, Then Satralizumab | Number of Participants With at Least One Serious Adverse Event in the DB Period | 5 participants |
| Satralizumab, Then Satralizumab | Number of Participants With at Least One Serious Adverse Event in the DB Period | 12 participants |
Secondary
Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period
Non-serious adverse events of special interest for this study included: 1\) cases of an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, 2) suspected transmission of an infectious agent by the study treatment.
Time frame: Up to Week 216
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo, Then Satralizumab | Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period | 0 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period | 0 participants |
Secondary
Number of Participants With Selected Adverse Events in the DB Period
Selected adverse events for this study included: 1\) all infections, 2) serious infections, 3) potential opportunistic infections, 4) injection-related reactions (IRRs; an AE which occured within 24 hours after study treatment injection except where the event was not considered an allergic reaction), 5) psychiatric disorders and 6) anaphylaxis (an acute allergic/hypersensitivity reaction).
Time frame: Up to Week 216
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | All Infections | 14 participants |
| Placebo, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Serious Infections | 3 participants |
| Placebo, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Potential Opportunistic Infections | 5 participants |
| Placebo, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Injection-related Reactions | 5 participants |
| Placebo, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Psychiatric Disorders | 4 participants |
| Placebo, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Anaphylaxis | 0 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Psychiatric Disorders | 13 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | All Infections | 34 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Injection-related Reactions | 8 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Serious Infections | 6 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Anaphylaxis | 0 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Selected Adverse Events in the DB Period | Potential Opportunistic Infections | 3 participants |
Secondary
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period
The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a yes answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates suicidal ideation or behavior.
Time frame: Baseline and Post-Baseline (up to Week 216)
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo, Then Satralizumab | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Baseline | 0 participants |
| Placebo, Then Satralizumab | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Post-Baseline | 1 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Baseline | 9 participants |
| Satralizumab, Then Satralizumab | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Post-Baseline | 3 participants |
Secondary
Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.
Time frame: Up to approximately Week 216
Population: Participants from SAF who received satralizumab were evaluated for this outcome measure. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Data was summarized together for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo, Then Satralizumab | Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period | 71.4 percentage of participants |
Secondary
Relapse-Free Rate During the DB Period
Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onsets within 30 days of one another, they were counted as 1), and onset date used in analysis was the date of first relapse.
Time frame: Up to Week 216
Population: ITT population included all participants randomized to the treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 96 | 51.21 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 144 | 34.14 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 24 | 71.61 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 36 | 61.85 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 48 | 61.85 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 72 | 51.21 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 120 | 51.21 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 168 | 34.14 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 192 | 34.14 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 216 | 34.14 percentage of participants |
| Placebo, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 12 | 74.87 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 96 | 72.14 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 120 | 72.14 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 192 | 62.80 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 12 | 88.89 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 72 | 74.40 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 24 | 85.71 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 168 | 62.80 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 36 | 79.37 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 144 | 62.80 percentage of participants |
| Satralizumab, Then Satralizumab | Relapse-Free Rate During the DB Period | Week 48 | 76.13 percentage of participants |
Secondary
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Time frame: Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 176 | 1.30 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 32 | 3.97 mg/L | Standard Deviation 5.2 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 36 | 3.77 mg/L | Standard Deviation 4.4 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 40 | 6.77 mg/L | Standard Deviation 10.92 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 44 | 5.44 mg/L | Standard Deviation 8.72 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 48 | 4.70 mg/L | Standard Deviation 5.43 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 52 | 3.82 mg/L | Standard Deviation 4.75 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 56 | 5.33 mg/L | Standard Deviation 8.87 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 60 | 4.54 mg/L | Standard Deviation 5.6 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 124 | 1.50 mg/L | Standard Deviation 1.04 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 128 | 0.65 mg/L | Standard Deviation 0.64 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 132 | 2.55 mg/L | Standard Deviation 1.77 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 136 | 2.70 mg/L | Standard Deviation 1.27 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 140 | 2.50 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 180 | 1.20 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 184 | 1.10 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 188 | 2.40 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 192 | 1.10 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Baseline | 3.08 mg/L | Standard Deviation 3.77 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 2 | 3.51 mg/L | Standard Deviation 4.55 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 4 | 3.45 mg/L | Standard Deviation 6.24 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 8 | 4.56 mg/L | Standard Deviation 8.97 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 12 | 4.23 mg/L | Standard Deviation 7.23 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 16 | 5.30 mg/L | Standard Deviation 9.17 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 20 | 4.07 mg/L | Standard Deviation 5.2 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 24 | 3.53 mg/L | Standard Deviation 4.08 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 28 | 5.85 mg/L | Standard Deviation 9.99 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 64 | 3.76 mg/L | Standard Deviation 4.62 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 68 | 3.30 mg/L | Standard Deviation 5.11 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 72 | 5.07 mg/L | Standard Deviation 11.87 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 76 | 1.98 mg/L | Standard Deviation 2.12 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 80 | 1.10 mg/L | Standard Deviation 0.72 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 84 | 2.31 mg/L | Standard Deviation 4.66 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 88 | 1.94 mg/L | Standard Deviation 3.38 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 92 | 4.49 mg/L | Standard Deviation 10.18 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 96 | 1.76 mg/L | Standard Deviation 2.47 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 100 | 0.90 mg/L | Standard Deviation 0.87 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 104 | 1.13 mg/L | Standard Deviation 1.01 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 108 | 2.20 mg/L | Standard Deviation 3.16 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 112 | 2.25 mg/L | Standard Deviation 2.68 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 116 | 2.28 mg/L | Standard Deviation 3.41 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 120 | 1.55 mg/L | Standard Deviation 1.63 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 144 | 2.65 mg/L | Standard Deviation 2.19 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 148 | 4.80 mg/L | Standard Deviation 0.99 |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 152 | 1.20 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 156 | 1.80 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 160 | 1.20 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 164 | 1.30 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 168 | 1.30 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 172 | 1.30 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 196 | 2.00 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 200 | 1.10 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 208 | 1.00 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 212 | 1.60 mg/L | — |
| Placebo, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 216 | 1.10 mg/L | — |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 32 | 2.06 mg/L | Standard Deviation 4.28 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 64 | 1.92 mg/L | Standard Deviation 3.55 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 36 | 1.56 mg/L | Standard Deviation 3.36 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 116 | 1.19 mg/L | Standard Deviation 1.93 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 40 | 2.55 mg/L | Standard Deviation 5.53 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 68 | 3.65 mg/L | Standard Deviation 8.52 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 44 | 3.31 mg/L | Standard Deviation 11.31 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 200 | 0.50 mg/L | — |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 48 | 1.79 mg/L | Standard Deviation 3.24 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 72 | 3.33 mg/L | Standard Deviation 7.3 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 52 | 1.90 mg/L | Standard Deviation 3.69 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 140 | 4.54 mg/L | Standard Deviation 9.57 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 56 | 2.32 mg/L | Standard Deviation 5.44 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 76 | 2.79 mg/L | Standard Deviation 6.54 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 120 | 6.05 mg/L | Standard Deviation 14.33 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 164 | 0.54 mg/L | Standard Deviation 0.5 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 124 | 3.24 mg/L | Standard Deviation 8.32 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 80 | 2.83 mg/L | Standard Deviation 7.09 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 128 | 3.09 mg/L | Standard Deviation 7.52 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 144 | 0.96 mg/L | Standard Deviation 1.75 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 132 | 2.66 mg/L | Standard Deviation 5.04 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 84 | 3.81 mg/L | Standard Deviation 10.18 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 136 | 2.85 mg/L | Standard Deviation 7.29 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 196 | 0.15 mg/L | Standard Deviation 0 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 28 | 2.35 mg/L | Standard Deviation 5.61 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 176 | 0.25 mg/L | Standard Deviation 0.17 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 88 | 2.64 mg/L | Standard Deviation 6.56 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 180 | 0.27 mg/L | Standard Deviation 0.16 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 148 | 0.87 mg/L | Standard Deviation 1.44 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 184 | 0.22 mg/L | Standard Deviation 0.11 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 92 | 1.94 mg/L | Standard Deviation 4.11 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 188 | 0.21 mg/L | Standard Deviation 0.13 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 168 | 0.37 mg/L | Standard Deviation 0.22 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 192 | 0.33 mg/L | Standard Deviation 0.25 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 96 | 1.64 mg/L | Standard Deviation 3.37 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Baseline | 4.95 mg/L | Standard Deviation 8.67 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 152 | 0.79 mg/L | Standard Deviation 0.79 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 2 | 0.93 mg/L | Standard Deviation 2.35 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 100 | 1.87 mg/L | Standard Deviation 4.28 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 4 | 0.82 mg/L | Standard Deviation 1.64 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 204 | 0.15 mg/L | — |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 8 | 0.83 mg/L | Standard Deviation 1.99 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 104 | 1.93 mg/L | Standard Deviation 4.43 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 12 | 1.23 mg/L | Standard Deviation 3.19 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 156 | 0.71 mg/L | Standard Deviation 1.17 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 16 | 1.56 mg/L | Standard Deviation 4.53 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 108 | 2.56 mg/L | Standard Deviation 7.4 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 20 | 1.78 mg/L | Standard Deviation 3.72 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 172 | 0.19 mg/L | Standard Deviation 0.09 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 24 | 1.72 mg/L | Standard Deviation 4.05 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 112 | 1.53 mg/L | Standard Deviation 2.86 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 60 | 3.20 mg/L | Standard Deviation 11.86 |
| Satralizumab, Then Satralizumab | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 160 | 0.82 mg/L | Standard Deviation 1.36 |
Secondary
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Time frame: Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 108 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 36 | 3.78 pg/mL | Standard Deviation 3.65 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 112 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 8 | 3.30 pg/mL | Standard Deviation 4.59 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 116 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 40 | 4.82 pg/mL | Standard Deviation 6.45 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 120 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 80 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 124 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 44 | 3.47 pg/mL | Standard Deviation 3.65 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 128 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 12 | 3.40 pg/mL | Standard Deviation 4.21 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 132 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 48 | 4.58 pg/mL | Standard Deviation 4.21 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 136 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Baseline | 3.66 pg/mL | Standard Deviation 6.49 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 140 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 52 | 3.52 pg/mL | Standard Deviation 3.36 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 144 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 16 | 3.72 pg/mL | Standard Deviation 4.54 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 148 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 56 | 4.13 pg/mL | Standard Deviation 5.26 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 152 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 68 | 2.75 pg/mL | Standard Deviation 3.35 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 156 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 60 | 3.28 pg/mL | Standard Deviation 3.65 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 160 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 20 | 2.99 pg/mL | Standard Deviation 2.88 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 164 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 64 | 4.08 pg/mL | Standard Deviation 4.48 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 168 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 2 | 5.90 pg/mL | Standard Deviation 16.31 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 172 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 84 | 2.27 pg/mL | Standard Deviation 1.84 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 176 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 24 | 3.68 pg/mL | Standard Deviation 4.02 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 180 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 88 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 184 | 3.63 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 76 | 2.44 pg/mL | Standard Deviation 3.04 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 188 | 5.21 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 92 | 3.38 pg/mL | Standard Deviation 4.8 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 192 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 28 | 3.88 pg/mL | Standard Deviation 4.24 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 196 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 96 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 200 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 4 | 5.41 pg/mL | Standard Deviation 10.02 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 204 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 100 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 208 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 212 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 216 | 1.57 pg/mL | — |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 32 | 3.43 pg/mL | Standard Deviation 3.2 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 104 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 72 | 2.95 pg/mL | Standard Deviation 4.8 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 128 | 31.20 pg/mL | Standard Deviation 21.29 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 68 | 30.56 pg/mL | Standard Deviation 44.67 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 72 | 23.16 pg/mL | Standard Deviation 17.54 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 76 | 24.08 pg/mL | Standard Deviation 16.78 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Baseline | 3.49 pg/mL | Standard Deviation 5.14 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 2 | 30.14 pg/mL | Standard Deviation 26.07 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 4 | 51.53 pg/mL | Standard Deviation 126.49 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 8 | 30.88 pg/mL | Standard Deviation 25.57 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 12 | 32.02 pg/mL | Standard Deviation 24.91 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 16 | 28.59 pg/mL | Standard Deviation 23.27 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 20 | 24.06 pg/mL | Standard Deviation 19.59 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 24 | 26.27 pg/mL | Standard Deviation 23.19 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 28 | 26.89 pg/mL | Standard Deviation 24.01 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 32 | 33.29 pg/mL | Standard Deviation 37.93 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 36 | 26.03 pg/mL | Standard Deviation 21.75 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 40 | 24.16 pg/mL | Standard Deviation 19.93 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 44 | 26.16 pg/mL | Standard Deviation 20.39 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 48 | 29.61 pg/mL | Standard Deviation 27.37 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 52 | 26.94 pg/mL | Standard Deviation 22.26 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 56 | 33.15 pg/mL | Standard Deviation 40.66 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 60 | 31.34 pg/mL | Standard Deviation 25.38 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 80 | 24.86 pg/mL | Standard Deviation 17.89 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 84 | 27.61 pg/mL | Standard Deviation 23.04 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 88 | 26.51 pg/mL | Standard Deviation 20.07 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 92 | 25.48 pg/mL | Standard Deviation 17.24 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 96 | 24.57 pg/mL | Standard Deviation 15.25 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 100 | 26.31 pg/mL | Standard Deviation 18.74 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 104 | 26.30 pg/mL | Standard Deviation 19.96 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 108 | 27.64 pg/mL | Standard Deviation 23.97 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 112 | 27.39 pg/mL | Standard Deviation 22.72 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 116 | 31.73 pg/mL | Standard Deviation 23.27 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 120 | 55.92 pg/mL | Standard Deviation 68.46 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 124 | 29.46 pg/mL | Standard Deviation 19.49 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 64 | 30.60 pg/mL | Standard Deviation 24.55 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 132 | 33.84 pg/mL | Standard Deviation 34.36 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 136 | 51.83 pg/mL | Standard Deviation 73.68 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 140 | 41.00 pg/mL | Standard Deviation 45.44 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 144 | 28.26 pg/mL | Standard Deviation 25.64 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 148 | 28.76 pg/mL | Standard Deviation 21.52 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 152 | 28.07 pg/mL | Standard Deviation 23.66 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 156 | 27.25 pg/mL | Standard Deviation 19.19 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 160 | 29.60 pg/mL | Standard Deviation 20.3 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 164 | 34.00 pg/mL | Standard Deviation 24.13 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 168 | 26.29 pg/mL | Standard Deviation 20.85 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 172 | 23.57 pg/mL | Standard Deviation 6.59 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 176 | 27.73 pg/mL | Standard Deviation 11.1 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 180 | 24.09 pg/mL | Standard Deviation 9.21 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 184 | 17.34 pg/mL | Standard Deviation 8.47 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 188 | 17.78 pg/mL | Standard Deviation 7.22 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 192 | 16.55 pg/mL | Standard Deviation 3.89 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 196 | 14.45 pg/mL | Standard Deviation 2.76 |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 200 | 36.90 pg/mL | — |
| Satralizumab, Then Satralizumab | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 204 | 12.30 pg/mL | — |
Secondary
Serum Satralizumab Concentration During the DB Period
Time frame: Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 204
Population: Participants from SAF who received satralizumab were evaluated for this outcome measure. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 36 | 16068.58 ng/mL | Standard Deviation 14643.61 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 40 | 15428.04 ng/mL | Standard Deviation 16059.35 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 44 | 16110.00 ng/mL | Standard Deviation 15363.29 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 48 | 16701.16 ng/mL | Standard Deviation 16790.77 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Baseline | 145.13 ng/mL | Standard Deviation 274.87 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 2 | 8099.70 ng/mL | Standard Deviation 4541.66 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 4 | 14602.50 ng/mL | Standard Deviation 8931.85 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 5 | 22564.32 ng/mL | Standard Deviation 12306.09 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 6 | 20991.43 ng/mL | Standard Deviation 12515.82 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 8 | 14864.35 ng/mL | Standard Deviation 9955.41 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 12 | 14760.33 ng/mL | Standard Deviation 10695.11 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 16 | 14613.11 ng/mL | Standard Deviation 11276.95 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 20 | 14136.62 ng/mL | Standard Deviation 12489.83 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 24 | 15634.18 ng/mL | Standard Deviation 13310.22 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 28 | 15538.38 ng/mL | Standard Deviation 13406.73 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 32 | 15111.94 ng/mL | Standard Deviation 13827.06 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 52 | 15300.57 ng/mL | Standard Deviation 14701.05 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 56 | 16390.82 ng/mL | Standard Deviation 16130.69 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 60 | 16050.81 ng/mL | Standard Deviation 14779.35 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 64 | 14385.10 ng/mL | Standard Deviation 14084.24 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 68 | 14010.46 ng/mL | Standard Deviation 13614.03 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 72 | 12895.69 ng/mL | Standard Deviation 13849.12 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 76 | 14139.31 ng/mL | Standard Deviation 14549.71 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 80 | 12709.79 ng/mL | Standard Deviation 14098.26 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 84 | 11725.05 ng/mL | Standard Deviation 13654.04 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 88 | 13733.17 ng/mL | Standard Deviation 13438.07 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 92 | 12928.13 ng/mL | Standard Deviation 13302.53 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 96 | 14036.58 ng/mL | Standard Deviation 12644.16 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 100 | 14186.50 ng/mL | Standard Deviation 12888.23 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 104 | 16647.00 ng/mL | Standard Deviation 15568.61 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 108 | 15970.00 ng/mL | Standard Deviation 13525.53 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 112 | 18657.37 ng/mL | Standard Deviation 17426.82 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 116 | 17677.33 ng/mL | Standard Deviation 16892.59 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 120 | 16615.00 ng/mL | Standard Deviation 16751.13 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 124 | 13734.00 ng/mL | Standard Deviation 12687.75 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 128 | 13738.00 ng/mL | Standard Deviation 16005.33 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 132 | 13311.73 ng/mL | Standard Deviation 15401.04 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 136 | 14208.54 ng/mL | Standard Deviation 15266.48 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 140 | 13404.62 ng/mL | Standard Deviation 12392.48 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 144 | 16138.18 ng/mL | Standard Deviation 13782.26 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 148 | 14044.33 ng/mL | Standard Deviation 12082.37 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 152 | 14644.42 ng/mL | Standard Deviation 13123.67 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 156 | 18856.36 ng/mL | Standard Deviation 20378.31 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 160 | 15238.18 ng/mL | Standard Deviation 11360.62 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 164 | 14760.00 ng/mL | Standard Deviation 11479.99 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 168 | 14199.60 ng/mL | Standard Deviation 9911.22 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 172 | 17971.43 ng/mL | Standard Deviation 16962.78 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 176 | 17922.86 ng/mL | Standard Deviation 12815.57 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 180 | 15981.43 ng/mL | Standard Deviation 9640.78 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 184 | 17911.67 ng/mL | Standard Deviation 15142.19 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 188 | 16442.50 ng/mL | Standard Deviation 13180.44 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 192 | 28750.00 ng/mL | Standard Deviation 22415.28 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 196 | 26850.00 ng/mL | Standard Deviation 20152.54 |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 200 | 45000.00 ng/mL | — |
| Placebo, Then Satralizumab | Serum Satralizumab Concentration During the DB Period | Week 204 | 34500.00 ng/mL | — |
Secondary
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Time frame: Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 44 | 33.97 ng/mL | Standard Deviation 9.05 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 36 | 34.03 ng/mL | Standard Deviation 7.79 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Baseline | 31.88 ng/mL | Standard Deviation 7.5 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 2 | 32.72 ng/mL | Standard Deviation 8.09 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 4 | 44.79 ng/mL | Standard Deviation 64.73 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 8 | 33.23 ng/mL | Standard Deviation 7.21 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 12 | 33.02 ng/mL | Standard Deviation 7.65 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 16 | 31.60 ng/mL | Standard Deviation 8.18 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 20 | 32.99 ng/mL | Standard Deviation 8.14 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 40 | 33.64 ng/mL | Standard Deviation 9.44 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 88 | 32.05 ng/mL | Standard Deviation 7.23 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 24 | 32.47 ng/mL | Standard Deviation 8.69 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 48 | 33.72 ng/mL | Standard Deviation 8.18 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 52 | 33.47 ng/mL | Standard Deviation 7.58 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 56 | 30.34 ng/mL | Standard Deviation 5.21 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 60 | 30.58 ng/mL | Standard Deviation 6.81 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 64 | 32.27 ng/mL | Standard Deviation 7.63 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 68 | 31.19 ng/mL | Standard Deviation 7.23 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 72 | 31.12 ng/mL | Standard Deviation 7.76 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 76 | 30.56 ng/mL | Standard Deviation 7.06 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 80 | 33.36 ng/mL | Standard Deviation 9.91 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 84 | 30.95 ng/mL | Standard Deviation 8.96 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 92 | 28.93 ng/mL | Standard Deviation 5.72 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 96 | 32.88 ng/mL | Standard Deviation 5.62 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 100 | 31.84 ng/mL | Standard Deviation 7.62 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 104 | 31.70 ng/mL | Standard Deviation 8.81 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 108 | 30.55 ng/mL | Standard Deviation 6.94 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 112 | 29.93 ng/mL | Standard Deviation 8.47 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 116 | 34.30 ng/mL | Standard Deviation 13.37 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 120 | 38.20 ng/mL | Standard Deviation 10.96 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 124 | 37.87 ng/mL | Standard Deviation 13.59 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 128 | 44.50 ng/mL | Standard Deviation 2.4 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 132 | 29.80 ng/mL | Standard Deviation 8.63 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 136 | 29.45 ng/mL | Standard Deviation 11.53 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 140 | 37.20 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 144 | 31.10 ng/mL | Standard Deviation 10.18 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 148 | 28.55 ng/mL | Standard Deviation 13.08 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 152 | 33.60 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 156 | 39.90 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 160 | 45.00 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 164 | 43.00 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 168 | 40.60 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 172 | 49.70 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 176 | 45.50 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 180 | 55.60 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 184 | 41.60 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 188 | 40.00 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 192 | 43.40 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 196 | 38.00 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 200 | 35.80 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 204 | 33.70 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 208 | 35.60 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 212 | 30.50 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 216 | 37.60 ng/mL | — |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 28 | 31.83 ng/mL | Standard Deviation 9.71 |
| Placebo, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 32 | 33.33 ng/mL | Standard Deviation 9.97 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 24 | 573.01 ng/mL | Standard Deviation 217.93 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 180 | 702.00 ng/mL | Standard Deviation 75.6 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 28 | 565.29 ng/mL | Standard Deviation 219.88 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 104 | 598.05 ng/mL | Standard Deviation 192.99 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 32 | 564.13 ng/mL | Standard Deviation 215.59 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 156 | 682.82 ng/mL | Standard Deviation 156.88 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 36 | 572.31 ng/mL | Standard Deviation 207.35 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 84 | 552.37 ng/mL | Standard Deviation 226.76 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 108 | 592.06 ng/mL | Standard Deviation 193.2 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Baseline | 33.18 ng/mL | Standard Deviation 7.72 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 200 | 815.00 ng/mL | — |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 2 | 396.49 ng/mL | Standard Deviation 80.09 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 112 | 603.31 ng/mL | Standard Deviation 227.68 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 4 | 509.21 ng/mL | Standard Deviation 121.99 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 160 | 694.18 ng/mL | Standard Deviation 127.92 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 8 | 560.63 ng/mL | Standard Deviation 164.11 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 116 | 609.37 ng/mL | Standard Deviation 198.61 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 12 | 582.36 ng/mL | Standard Deviation 169.71 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 184 | 678.33 ng/mL | Standard Deviation 78.2 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 16 | 582.22 ng/mL | Standard Deviation 204.2 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 120 | 625.15 ng/mL | Standard Deviation 229.67 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 20 | 555.64 ng/mL | Standard Deviation 210.76 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 164 | 696.18 ng/mL | Standard Deviation 106.76 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 40 | 554.90 ng/mL | Standard Deviation 241.34 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 124 | 580.07 ng/mL | Standard Deviation 240.15 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 196 | 630.00 ng/mL | Standard Deviation 141.42 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 44 | 585.62 ng/mL | Standard Deviation 219.45 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 128 | 574.54 ng/mL | Standard Deviation 214.94 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 48 | 591.06 ng/mL | Standard Deviation 213.04 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 168 | 681.00 ng/mL | Standard Deviation 122.6 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 52 | 575.56 ng/mL | Standard Deviation 210.84 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 132 | 575.40 ng/mL | Standard Deviation 213.45 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 56 | 585.40 ng/mL | Standard Deviation 233.38 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 188 | 688.75 ng/mL | Standard Deviation 143.82 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 60 | 586.40 ng/mL | Standard Deviation 226.21 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 136 | 593.92 ng/mL | Standard Deviation 209.84 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 64 | 602.72 ng/mL | Standard Deviation 239.25 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 172 | 672.71 ng/mL | Standard Deviation 107.83 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 68 | 617.80 ng/mL | Standard Deviation 244.63 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 140 | 627.32 ng/mL | Standard Deviation 232.08 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 72 | 543.95 ng/mL | Standard Deviation 224 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 204 | 783.00 ng/mL | — |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 76 | 558.67 ng/mL | Standard Deviation 234.41 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 144 | 693.82 ng/mL | Standard Deviation 239.7 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 80 | 558.73 ng/mL | Standard Deviation 235.6 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 176 | 700.71 ng/mL | Standard Deviation 90.64 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 88 | 547.93 ng/mL | Standard Deviation 211.74 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 148 | 690.83 ng/mL | Standard Deviation 142.94 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 92 | 580.64 ng/mL | Standard Deviation 201.78 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 192 | 668.00 ng/mL | Standard Deviation 192.33 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 96 | 561.64 ng/mL | Standard Deviation 205 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 152 | 626.41 ng/mL | Standard Deviation 229.59 |
| Satralizumab, Then Satralizumab | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 100 | 559.18 ng/mL | Standard Deviation 194.43 |