Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)
Conditions
Brief summary
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment 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).
As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS is also permitted. Change or termination of baseline treatment is only permitted during the open-label extension period.
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
12 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Patients 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 the following Wingerchuk 2007 criteria with anti-AQP4 antibody (Ab) seropositive status at screening (i. Idiopathic single or recurrent events of longitudinally extensive myelitis \[≥3 vertebral segment spinal cord MRI lesion\]; ii. Optic neuritis: recurrent or simultaneous bilateral); For patients aged 12 to 17 years, a minimum of 4 patients should be positive for anti-AQP4Ab status at screening 2. Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening 3. EDSS score from 0 to 6.5 inclusive at screening 4. Age 12 to 74 years, inclusive at the time of informed consent 5. One of the following baseline treatments must be at stable dose as a monotherapy for 8 weeks prior to baseline: Azathioprine; Mycophenolate mofetil; Oral corticosteroids. For participants aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed: Azathioprine + oral corticosteroids; Mycophenolate mofetil + oral corticosteroids 6. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol For adolescents who may be enrolled after the end of the double-blind period, the inclusion criterion 2 is as follows (other criteria are same): Clinical evidence of at least 2 documented relapses (including first attack) prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | Up to Week 224 | 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) as adjudicated by an independent clinical endpoint committee (CEC). 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 at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score 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. ANCOVA was used for analysis to report the adjusted mean and SE. |
| 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 relapses 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 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. |
| Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 168 | 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 Short Form Generic Health Survey (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 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 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 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 at Week 24 in the Visual Analogue Scale (VAS) Score 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 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 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. |
| Serum Satralizumab Concentration During the DB Period | Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 224 | — |
| Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224 | — |
| Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224 | — |
| Serum Interleukin-6 (IL-6) Concentration During the DB Period | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224 | — |
| Number of Participants With at Least One Adverse Event in the DB Period | Up to Week 224 | 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 224 | 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 224 | 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 224 | Selected adverse events for this study included: 1) non-serious infections that required treatments with intravenous (IV) antibiotic, antifungal, antiviral, 2) opportunistic infections that required treatments with oral antibiotics, antifungals, or antivirals, 3) 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), and 4) 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 224) | 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. |
| Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period | Up to approximately Week 224 | Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period. |
| Percentage of Participants With Anti-Drug Antibodies to Satralizumab Overall S237 Period | Up to approximately Week 368 | Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during Overall S237 period. |
| 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. |
Countries
France, Germany, Hungary, Italy, Japan, Poland, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants took part in the double-blind (DB) period up to the primary clinical cut-off date (06 June 2018) and in the Open-label Extension Period until the final clinical cut-off date (23-Dec-2021). All ongoing patients have been offered to transition to the WN42349 study
Participants by arm
| Arm | Count |
|---|---|
| Placebo + Baseline Treatment Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) 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 (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | 42 |
| Satralizumab + Baseline Treatment Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | 42 |
| SA237 - Enrolled in Open-Label In the open-label extension period, the participant received an SC injection of satralizumab at Weeks 0,2, and 4, and Q4W thereafter, in addition to baseline treatment | 1 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-blind Period | Adverse Event | 5 | 3 | 0 |
| Double-blind Period | Eligibility Violation | 1 | 0 | 0 |
| Double-blind Period | Non-Compliance With Study Drug | 2 | 0 | 0 |
| Double-blind Period | Withdrawal by Subject | 2 | 0 | 0 |
| Open-label Extension Period | Adverse Event | 3 | 1 | 0 |
| Open-label Extension Period | Lack of Efficacy | 3 | 0 | 0 |
| Open-label Extension Period | Refused Treatment/Did Not Cooperate | 0 | 1 | 0 |
| Open-label Extension Period | Switched to another treatment option | 3 | 0 | 0 |
| Open-label Extension Period | Withdrawal by Subject | 0 | 6 | 0 |
Baseline characteristics
| Characteristic | Satralizumab + Baseline Treatment | SA237 - Enrolled in Open-Label | Placebo + Baseline Treatment | Total |
|---|---|---|---|---|
| Age, Continuous | 40.2 Years STANDARD_DEVIATION 16.3 | 16 Years | 43.4 Years STANDARD_DEVIATION 12 | 41.5 Years STANDARD_DEVIATION 14.5 |
| Race/Ethnicity, Customized Asian | 18 Participants | 0 Participants | 18 Participants | 36 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 42 Participants | 1 Participants | 40 Participants | 83 Participants |
| Race/Ethnicity, Customized Not Stated | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 0 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Female | 38 Participants | 1 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 | 0 / 32 | 0 / 39 | 0 / 1 |
| other Total, other adverse events | 37 / 42 | 35 / 42 | 30 / 32 | 30 / 39 | 1 / 1 |
| serious Total, serious adverse events | 9 / 42 | 9 / 42 | 5 / 32 | 8 / 39 | 1 / 1 |
Outcome results
Primary
Time to First Protocol-Defined Relapse (TFR) in the Double-Blind 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) as adjudicated by an independent clinical endpoint committee (CEC). 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 224
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 + Baseline Treatment | Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | 120.6 weeks |
| Satralizumab + Baseline Treatment | Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | NA weeks |
Comparison: Stratified by Baseline annualized relapse rate (ARR: 1, \> 1) and geographic region (Asia, EU/Other).p-value: 0.018495% CI: [0.16, 0.88]Log Rank
Secondary
Annualized Relapse Rate (ARR) During the DB Period
The ARR is calculated as the total number of participants with relapses 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 + Baseline Treatment | Annualized Relapse Rate (ARR) During the DB Period | 0.32 patients w relapse/patient-years at risk |
| Satralizumab + Baseline Treatment | Annualized Relapse Rate (ARR) During the DB Period | 0.11 patients w relapse/patient-years at risk |
Secondary
Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score 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. ANCOVA was used for analysis to report the adjusted mean and 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 was imputed using BOCF method
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Baseline Treatment | Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Change from Baseline at Week 24 | 2.234 score on scale | Standard Error 0.943 |
| Placebo + Baseline Treatment | Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Baseline | 33.857 score on scale | Standard Error 1.746 |
| Satralizumab + Baseline Treatment | Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Change from Baseline at Week 24 | 0.145 score on scale | Standard Error 0.963 |
| Satralizumab + Baseline Treatment | Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Baseline | 34.732 score on scale | Standard Error 1.646 |
p-value: 0.122495% CI: [-4.752, 0.574]ANCOVA
Secondary
Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score 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 baseline observation carried forward (BOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Baseline Treatment | Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Baseline | 34.619 score on scale | Standard Error 4.026 |
| Placebo + Baseline Treatment | Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Change from Baseline at Week 24 | -3.505 score on scale | Standard Error 2.357 |
| Satralizumab + Baseline Treatment | Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Baseline | 27.561 score on scale | Standard Error 4.399 |
| Satralizumab + Baseline Treatment | Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Change from Baseline at Week 24 | 2.871 score on scale | Standard Error 2.391 |
p-value: 0.060295% CI: [-0.28, 13.033]ANCOVA
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 + Baseline Treatment | 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 | 0.0336 score on scale | Standard Deviation 0.2111 |
| Placebo + Baseline Treatment | 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 | 0.0846 score on scale | Standard Deviation 0.165 |
| Placebo + Baseline Treatment | 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 | 0.0724 score on scale | Standard Deviation 0.2088 |
| Placebo + Baseline Treatment | 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 | 0.0648 score on scale | Standard Deviation 0.1031 |
| Placebo + Baseline Treatment | 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 | 0.0352 score on scale | Standard Deviation 0.183 |
| Placebo + Baseline Treatment | 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 | 0.0349 score on scale | Standard Deviation 0.1758 |
| Placebo + Baseline Treatment | 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 | 0.0649 score on scale | Standard Deviation 0.1596 |
| Placebo + Baseline Treatment | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Baseline | 0.7297 score on scale | Standard Deviation 0.1863 |
| Satralizumab + Baseline Treatment | 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 | 0.1873 score on scale | Standard Deviation 0.289 |
| Satralizumab + Baseline Treatment | 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 | 0.3322 score on scale | — |
| Satralizumab + Baseline Treatment | 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 | 0.0257 score on scale | Standard Deviation 0.1178 |
| Satralizumab + Baseline Treatment | Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period | Baseline | 0.7634 score on scale | Standard Deviation 0.1811 |
| Satralizumab + Baseline Treatment | 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 | -0.0082 score on scale | Standard Deviation 0.1882 |
| Satralizumab + Baseline Treatment | 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 | 0.0011 score on scale | Standard Deviation 0.1256 |
| Satralizumab + Baseline Treatment | 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 | 0.0241 score on scale | Standard Deviation 0.1084 |
| Satralizumab + Baseline Treatment | 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 | 0.0167 score on scale | Standard Deviation 0.1056 |
| Satralizumab + Baseline Treatment | 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 | 0.0488 score on scale | Standard Deviation 0.1424 |
| Satralizumab + Baseline Treatment | 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 | 0.0307 score on scale | Standard Deviation 0.1335 |
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 + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.19 score on scale | Standard Deviation 0.81 |
| Placebo + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.19 score on scale | Standard Deviation 0.77 |
| Placebo + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.30 score on scale | Standard Deviation 0.79 |
| Placebo + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.17 score on scale | Standard Deviation 0.76 |
| Placebo + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -0.33 score on scale | Standard Deviation 0.83 |
| Placebo + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -0.27 score on scale | Standard Deviation 0.68 |
| Placebo + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Baseline | 3.63 score on scale | Standard Deviation 1.32 |
| Placebo + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.21 score on scale | Standard Deviation 0.68 |
| Satralizumab + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -0.07 score on scale | Standard Deviation 0.62 |
| Satralizumab + Baseline Treatment | 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 | Standard Deviation 0.71 |
| Satralizumab + Baseline Treatment | 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 + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.06 score on scale | Standard Deviation 0.58 |
| Satralizumab + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Baseline | 3.83 score on scale | Standard Deviation 1.57 |
| Satralizumab + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.14 score on scale | Standard Deviation 0.82 |
| Satralizumab + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.19 score on scale | Standard Deviation 0.67 |
| Satralizumab + Baseline Treatment | 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 0.73 |
| Satralizumab + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.19 score on scale | Standard Deviation 0.75 |
| Satralizumab + Baseline Treatment | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.03 score on scale | Standard Deviation 0.57 |
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 + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.67 score on scale | Standard Deviation 0.58 |
| Placebo + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.10 score on scale | Standard Deviation 0.74 |
| Placebo + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Baseline | 1.55 score on scale | Standard Deviation 0.97 |
| Placebo + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.03 score on scale | Standard Deviation 0.42 |
| Placebo + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.13 score on scale | Standard Deviation 0.62 |
| Placebo + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.18 score on scale | Standard Deviation 0.53 |
| Placebo + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -0.11 score on scale | Standard Deviation 0.93 |
| Placebo + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.07 score on scale | Standard Deviation 0.7 |
| Satralizumab + Baseline Treatment | 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 0.71 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Baseline | 1.90 score on scale | Standard Deviation 1.14 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 0.00 score on scale | — |
| Satralizumab + Baseline Treatment | 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 0.45 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.00 score on scale | Standard Deviation 0.52 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -0.19 score on scale | Standard Deviation 0.51 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.05 score on scale | Standard Deviation 0.51 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -0.20 score on scale | Standard Deviation 0.41 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -0.11 score on scale | Standard Deviation 0.33 |
| Satralizumab + Baseline Treatment | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.03 score on scale | Standard Deviation 0.5 |
Secondary
Change From Baseline in 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 + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 2.22 score on scale | Standard Deviation 9.96 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.55 score on scale | Standard Deviation 8.2 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.58 score on scale | Standard Deviation 8.53 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.81 score on scale | Standard Deviation 5.6 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 1.61 score on scale | Standard Deviation 10.58 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.31 score on scale | Standard Deviation 7.13 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.71 score on scale | Standard Deviation 7.06 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Baseline | 43.91 score on scale | Standard Deviation 10.22 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 3.05 score on scale | Standard Deviation 9 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 8.07 score on scale | Standard Deviation 0.57 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 3.63 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Baseline | 45.94 score on scale | Standard Deviation 11.56 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.03 score on scale | Standard Deviation 11.06 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.12 score on scale | Standard Deviation 6.99 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.30 score on scale | Standard Deviation 6.99 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.15 score on scale | Standard Deviation 8.86 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -1.45 score on scale | Standard Deviation 9.13 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.14 score on scale | Standard Deviation 8.18 |
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 + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 39.65 score on scale | Standard Deviation 7.9 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -1.90 score on scale | Standard Deviation 6.17 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.33 score on scale | Standard Deviation 4.03 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.66 score on scale | Standard Deviation 5.53 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -0.95 score on scale | Standard Deviation 5.66 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.84 score on scale | Standard Deviation 5.68 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | -5.23 score on scale | Standard Deviation 7.41 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -0.16 score on scale | Standard Deviation 6.25 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 5.20 score on scale | Standard Deviation 7.11 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.86 score on scale | Standard Deviation 6.12 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 3.06 score on scale | Standard Deviation 6.99 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 1.19 score on scale | Standard Deviation 5.04 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -2.38 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 41.23 score on scale | Standard Deviation 9.29 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -0.60 score on scale | Standard Deviation 7.26 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.27 score on scale | Standard Deviation 6 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.94 score on scale | Standard Deviation 5.57 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.76 score on scale | Standard Deviation 6.72 |
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 + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.14 score on scale | Standard Deviation 7.06 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 5.23 score on scale | Standard Deviation 7.66 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.49 score on scale | Standard Deviation 7.04 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.76 score on scale | Standard Deviation 8.54 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 4.36 score on scale | Standard Deviation 3.02 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 4.09 score on scale | Standard Deviation 8.49 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 5.23 score on scale | Standard Deviation 7.69 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 43.71 score on scale | Standard Deviation 10.92 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 4.07 score on scale | Standard Deviation 10.72 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 13.09 score on scale | Standard Deviation 14.8 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 23.55 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Baseline | 43.59 score on scale | Standard Deviation 10.55 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.99 score on scale | Standard Deviation 10.21 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.11 score on scale | Standard Deviation 10.73 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.18 score on scale | Standard Deviation 9.72 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 2.12 score on scale | Standard Deviation 8.13 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 1.57 score on scale | Standard Deviation 6.76 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 4.88 score on scale | Standard Deviation 8.38 |
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 + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | -1.15 score on scale | Standard Deviation 7.52 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.18 score on scale | Standard Deviation 5.33 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.13 score on scale | Standard Deviation 7.1 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 41.54 score on scale | Standard Deviation 9.11 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 1.78 score on scale | Standard Deviation 5.5 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 1.97 score on scale | Standard Deviation 6.23 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.22 score on scale | Standard Deviation 9.23 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.79 score on scale | Standard Deviation 5.61 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.05 score on scale | Standard Deviation 4.23 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 43.60 score on scale | Standard Deviation 10.47 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | -1.63 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.76 score on scale | Standard Deviation 5.98 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 0.23 score on scale | Standard Deviation 0.55 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.30 score on scale | Standard Deviation 6.01 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.22 score on scale | Standard Deviation 5.77 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 1.16 score on scale | Standard Deviation 4.79 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.88 score on scale | Standard Deviation 5.72 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 2.34 score on scale | Standard Deviation 6.6 |
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 + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | -0.19 score on scale | Standard Deviation 8.39 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.19 score on scale | Standard Deviation 6.54 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.55 score on scale | Standard Deviation 4.06 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.92 score on scale | Standard Deviation 4.3 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 1.92 score on scale | Standard Deviation 5.06 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.84 score on scale | Standard Deviation 6.77 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 3.56 score on scale | Standard Deviation 7.04 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 42.50 score on scale | Standard Deviation 10.53 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.00 score on scale | Standard Deviation 5.5 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 1.91 score on scale | Standard Deviation 2.7 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 1.91 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 43.46 score on scale | Standard Deviation 10.34 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.49 score on scale | Standard Deviation 7.05 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.86 score on scale | Standard Deviation 7.73 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 0.88 score on scale | Standard Deviation 6.52 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 2.37 score on scale | Standard Deviation 7.75 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 2.58 score on scale | Standard Deviation 6.03 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.32 score on scale | Standard Deviation 5.72 |
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 + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.13 score on scale | Standard Deviation 12.44 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 1.39 score on scale | Standard Deviation 9.38 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.09 score on scale | Standard Deviation 9.61 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 3.29 score on scale | Standard Deviation 8.05 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 1.16 score on scale | Standard Deviation 5.32 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 4.13 score on scale | Standard Deviation 14.4 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.24 score on scale | Standard Deviation 10.35 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Baseline | 43.98 score on scale | Standard Deviation 11.46 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 4.64 score on scale | Standard Deviation 9.05 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 12.19 score on scale | Standard Deviation 2.46 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 6.97 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Baseline | 43.01 score on scale | Standard Deviation 10.55 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.36 score on scale | Standard Deviation 10.12 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 0.00 score on scale | Standard Deviation 12.49 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.57 score on scale | Standard Deviation 7.66 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.83 score on scale | Standard Deviation 10.2 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.35 score on scale | Standard Deviation 6.95 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.25 score on scale | Standard Deviation 7.38 |
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 + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 3.93 score on scale | Standard Deviation 9.56 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.99 score on scale | Standard Deviation 6.05 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.37 score on scale | Standard Deviation 7.23 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Baseline | 40.74 score on scale | Standard Deviation 10.12 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.40 score on scale | Standard Deviation 7.94 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 3.74 score on scale | Standard Deviation 10.61 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 0.42 score on scale | Standard Deviation 9.03 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 1.57 score on scale | Standard Deviation 9.47 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.40 score on scale | Standard Deviation 8.66 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.83 score on scale | Standard Deviation 7.81 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.71 score on scale | Standard Deviation 4.6 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.14 score on scale | Standard Deviation 7.44 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.69 score on scale | Standard Deviation 6.8 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 2.25 score on scale | Standard Deviation 6.45 |
| Satralizumab + Baseline Treatment | 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 + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 8.98 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Baseline | 41.88 score on scale | Standard Deviation 11.38 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 3.02 score on scale | Standard Deviation 6.95 |
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 + Baseline Treatment | 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 | 1.51 score on scale | Standard Deviation 13.59 |
| Placebo + Baseline Treatment | 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 | 2.34 score on scale | Standard Deviation 7.78 |
| Placebo + Baseline Treatment | 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 | 0.56 score on scale | Standard Deviation 9.85 |
| Placebo + Baseline Treatment | 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 | 1.12 score on scale | Standard Deviation 7.8 |
| Placebo + Baseline Treatment | 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 | 1.67 score on scale | Standard Deviation 22.61 |
| Placebo + Baseline Treatment | 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 | 2.82 score on scale | Standard Deviation 11.72 |
| Placebo + Baseline Treatment | 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 | 1.73 score on scale | Standard Deviation 7.96 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 41.70 score on scale | Standard Deviation 11.62 |
| Satralizumab + Baseline Treatment | 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 | 0.00 score on scale | Standard Deviation 5.61 |
| Satralizumab + Baseline Treatment | 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 | 0.00 score on scale | Standard Deviation 0 |
| Satralizumab + Baseline Treatment | 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 | -5.01 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period | Baseline | 44.26 score on scale | Standard Deviation 10.92 |
| Satralizumab + Baseline Treatment | 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 | 0.86 score on scale | Standard Deviation 8.69 |
| Satralizumab + Baseline Treatment | 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 | 0.00 score on scale | Standard Deviation 10.24 |
| Satralizumab + Baseline Treatment | 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 | 2.18 score on scale | Standard Deviation 7.22 |
| Satralizumab + Baseline Treatment | 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 | 0.00 score on scale | Standard Deviation 9.38 |
| Satralizumab + Baseline Treatment | 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 | 0.25 score on scale | Standard Deviation 9.13 |
| Satralizumab + Baseline Treatment | 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 | 2.01 score on scale | Standard Deviation 7.29 |
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 + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 2.97 score on scale | Standard Deviation 5.24 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 4.55 score on scale | Standard Deviation 6.91 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.96 score on scale | Standard Deviation 6.12 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.65 score on scale | Standard Deviation 5.6 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 2.97 score on scale | Standard Deviation 2.97 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 4.08 score on scale | Standard Deviation 8.53 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.66 score on scale | Standard Deviation 7.38 |
| Placebo + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Baseline | 45.95 score on scale | Standard Deviation 9.14 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 0.99 score on scale | Standard Deviation 10.82 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 7.43 score on scale | Standard Deviation 10.51 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 11.89 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Baseline | 46.66 score on scale | Standard Deviation 9.65 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 1.74 score on scale | Standard Deviation 8.61 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.25 score on scale | Standard Deviation 8.71 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 1.38 score on scale | Standard Deviation 9.12 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 2.41 score on scale | Standard Deviation 8.28 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 2.67 score on scale | Standard Deviation 8.45 |
| Satralizumab + Baseline Treatment | Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 4.16 score on scale | Standard Deviation 10.03 |
Secondary
Change From Baseline in Short Form Generic Health Survey (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 + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 5.16 score on scale | Standard Deviation 10.52 |
| Placebo + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 2.78 score on scale | Standard Deviation 7.51 |
| Placebo + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.63 score on scale | Standard Deviation 8.62 |
| Placebo + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 2.53 score on scale | Standard Deviation 7.58 |
| Placebo + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 2.83 score on scale | Standard Deviation 8.79 |
| Placebo + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 3.47 score on scale | Standard Deviation 7.13 |
| Placebo + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 2.79 score on scale | Standard Deviation 6.85 |
| Placebo + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 44.77 score on scale | Standard Deviation 11.08 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | 3.82 score on scale | Standard Deviation 7.15 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 3.60 score on scale | Standard Deviation 9.5 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 216 | 14.05 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 192 | 11.60 score on scale | Standard Deviation 7.32 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Baseline | 44.56 score on scale | Standard Deviation 9.75 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | 0.57 score on scale | Standard Deviation 8.99 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | -0.61 score on scale | Standard Deviation 10.97 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.78 score on scale | Standard Deviation 8.13 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 1.06 score on scale | Standard Deviation 7.63 |
| Satralizumab + Baseline Treatment | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.71 score on scale | Standard Deviation 7.23 |
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 + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OS | 0.026 LogMAR units | Standard Deviation 0.096 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OD | 0.030 LogMAR units | Standard Deviation 0.15 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OS | -0.012 LogMAR units | Standard Deviation 0.107 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OS | -0.024 LogMAR units | Standard Deviation 0.15 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OD | -0.001 LogMAR units | Standard Deviation 0.11 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OD | 0.058 LogMAR units | Standard Deviation 0.231 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OD | -0.064 LogMAR units | Standard Deviation 0.197 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OS | -0.016 LogMAR units | Standard Deviation 0.165 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: OD | 0.113 LogMAR units | Standard Deviation 0.306 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OS | -0.001 LogMAR units | Standard Deviation 0.121 |
| Placebo + Baseline Treatment | 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 | Standard Deviation 0.173 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OD | -0.019 LogMAR units | Standard Deviation 0.086 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OD | 0.018 LogMAR units | Standard Deviation 0.174 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OS | 0.526 LogMAR units | Standard Deviation 0.911 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OS | -0.078 LogMAR units | Standard Deviation 0.185 |
| Placebo + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OD | 0.490 LogMAR units | Standard Deviation 0.928 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: OS | -0.024 LogMAR units | Standard Deviation 0.113 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: OD | 0.150 LogMAR units | Standard Deviation 0.099 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 192: OS | 0.000 LogMAR units | Standard Deviation 0 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 216: OD | 0.120 LogMAR units | — |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 216: OS | 0.000 LogMAR units | — |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OD | 0.303 LogMAR units | Standard Deviation 0.593 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OS | -0.028 LogMAR units | Standard Deviation 0.111 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline: OS | 0.597 LogMAR units | Standard Deviation 1.016 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OD | 0.042 LogMAR units | Standard Deviation 0.236 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 24: OS | 0.059 LogMAR units | Standard Deviation 0.319 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OD | 0.008 LogMAR units | Standard Deviation 0.093 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 48: OS | 0.013 LogMAR units | Standard Deviation 0.061 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OD | -0.034 LogMAR units | Standard Deviation 0.111 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 72: OS | -0.019 LogMAR units | Standard Deviation 0.077 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OD | -0.013 LogMAR units | Standard Deviation 0.095 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 96: OS | -0.010 LogMAR units | Standard Deviation 0.073 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OD | 0.011 LogMAR units | Standard Deviation 0.103 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 120: OS | 0.014 LogMAR units | Standard Deviation 0.257 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 144: OD | -0.016 LogMAR units | Standard Deviation 0.12 |
| Satralizumab + Baseline Treatment | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Change from Baseline at Week 168: OD | 0.027 LogMAR units | Standard Deviation 0.199 |
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 168
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 + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | 2.20 score on scale | Standard Deviation 19.64 |
| Placebo + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline | 19.31 score on scale | Standard Deviation 9.31 |
| Placebo + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -3.44 score on scale | Standard Deviation 5.59 |
| Placebo + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.17 score on scale | Standard Deviation 8.26 |
| Placebo + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 3.00 score on scale | Standard Deviation 14.98 |
| Placebo + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 0.00 score on scale | Standard Deviation 3.61 |
| Placebo + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -3.50 score on scale | Standard Deviation 12.02 |
| Placebo + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 2.50 score on scale | Standard Deviation 13.44 |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 168 | 11.00 score on scale | — |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 96 | 4.17 score on scale | Standard Deviation 13.33 |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline | 18.92 score on scale | Standard Deviation 12.82 |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 144 | -3.50 score on scale | Standard Deviation 11.33 |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 24 | -3.57 score on scale | Standard Deviation 7.11 |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 120 | 3.40 score on scale | Standard Deviation 9.29 |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 48 | 1.13 score on scale | Standard Deviation 13.45 |
| Satralizumab + Baseline Treatment | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Change from Baseline at Week 72 | -0.71 score on scale | Standard Deviation 11.6 |
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 224
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Baseline Treatment | Number of Participants With at Least One Adverse Event in the DB Period | 40 participants |
| Satralizumab + Baseline Treatment | Number of Participants With at Least One Adverse Event in the DB Period | 37 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 224
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Baseline Treatment | Number of Participants With at Least One Serious Adverse Event in the DB Period | 9 participants |
| Satralizumab + Baseline Treatment | Number of Participants With at Least One Serious Adverse Event in the DB Period | 7 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 224
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Baseline Treatment | Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period | 0 participants |
| Satralizumab + Baseline Treatment | 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) non-serious infections that required treatments with intravenous (IV) antibiotic, antifungal, antiviral, 2) opportunistic infections that required treatments with oral antibiotics, antifungals, or antivirals, 3) 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), and 4) anaphylaxis (an acute allergic/hypersensitivity reaction).
Time frame: Up to Week 224
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Potential Opportunistic Infections | 5 participants |
| Placebo + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Anaphylaxis | 0 participants |
| Placebo + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Injection Related Reactions | 2 participants |
| Placebo + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Non serious Infections requiring IV treatment | 4 participants |
| Satralizumab + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Injection Related Reactions | 5 participants |
| Satralizumab + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Potential Opportunistic Infections | 4 participants |
| Satralizumab + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Non serious Infections requiring IV treatment | 1 participants |
| Satralizumab + Baseline Treatment | Number of Participants With Selected Adverse Events in the DB Period | Anaphylaxis | 0 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 224)
Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Baseline Treatment | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Baseline | 5 participants |
| Placebo + Baseline Treatment | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Post-Baseline | 2 participants |
| Satralizumab + Baseline Treatment | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period | Baseline | 12 participants |
| Satralizumab + Baseline Treatment | 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 224
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 + Baseline Treatment | Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period | 41.5 percentage |
Secondary
Percentage of Participants With Anti-Drug Antibodies to Satralizumab Overall S237 Period
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during Overall S237 period.
Time frame: Up to approximately Week 368
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Baseline Treatment | Percentage of Participants With Anti-Drug Antibodies to Satralizumab Overall S237 Period | Treatment-Boosted ADA Patients | 2.7 percentage |
| Placebo + Baseline Treatment | Percentage of Participants With Anti-Drug Antibodies to Satralizumab Overall S237 Period | Treatment-Induced ADA Patients | 44.0 percentage |
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 + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 24 | 84.41 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 72 | 58.68 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 12 | 89.86 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 36 | 69.49 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 120 | 54.17 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 144 | 49.24 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 96 | 58.68 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 168 | 43.77 percentage of participants |
| Placebo + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 48 | 66.02 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 96 | 77.58 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 144 | 73.70 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 168 | 73.70 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 120 | 73.70 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 192 | 73.70 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 216 | 73.70 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 12 | 94.99 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 24 | 88.86 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 36 | 88.86 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 48 | 88.86 percentage of participants |
| Satralizumab + Baseline Treatment | Relapse-Free Rate During the DB Period | Week 72 | 81.46 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 224
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 + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 48 | 1.59 mg/L | Standard Deviation 2.07 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 168 | 0.80 mg/L | Standard Deviation 0.26 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 52 | 2.60 mg/L | Standard Deviation 3.87 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 4 | 1.59 mg/L | Standard Deviation 2.27 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 56 | 1.43 mg/L | Standard Deviation 1.58 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 156 | 1.52 mg/L | Standard Deviation 1.42 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 60 | 2.63 mg/L | Standard Deviation 4.34 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 8 | 1.76 mg/L | Standard Deviation 2.25 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 64 | 11.10 mg/L | Standard Deviation 40.09 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 172 | 1.37 mg/L | Standard Deviation 1 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 68 | 1.86 mg/L | Standard Deviation 2.66 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 12 | 1.48 mg/L | Standard Deviation 2.07 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 72 | 3.80 mg/L | Standard Deviation 8.83 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 144 | 0.82 mg/L | Standard Deviation 0.73 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 76 | 5.24 mg/L | Standard Deviation 10.68 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 16 | 1.91 mg/L | Standard Deviation 3.34 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 80 | 2.11 mg/L | Standard Deviation 2.63 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 176 | 0.95 mg/L | Standard Deviation 0.64 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 84 | 2.08 mg/L | Standard Deviation 2.26 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 20 | 1.91 mg/L | Standard Deviation 3.44 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 88 | 5.19 mg/L | Standard Deviation 12.83 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 160 | 0.83 mg/L | Standard Deviation 0.53 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 92 | 2.07 mg/L | Standard Deviation 2.21 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 24 | 2.45 mg/L | Standard Deviation 6.87 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 96 | 2.92 mg/L | Standard Deviation 4.6 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 180 | 30.15 mg/L | Standard Deviation 41.65 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 100 | 2.58 mg/L | Standard Deviation 4.53 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 28 | 1.96 mg/L | Standard Deviation 3.24 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 104 | 1.41 mg/L | Standard Deviation 2.05 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 152 | 1.08 mg/L | Standard Deviation 0.97 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 108 | 1.93 mg/L | Standard Deviation 2.25 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 32 | 2.36 mg/L | Standard Deviation 4.96 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 112 | 1.54 mg/L | Standard Deviation 1.56 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 164 | 3.18 mg/L | Standard Deviation 4.89 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 116 | 2.39 mg/L | Standard Deviation 3.91 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 36 | 2.48 mg/L | Standard Deviation 3.59 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 120 | 1.53 mg/L | Standard Deviation 1.33 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Baseline | 1.48 mg/L | Standard Deviation 2.08 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 124 | 1.43 mg/L | Standard Deviation 1.43 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 40 | 2.49 mg/L | Standard Deviation 4.53 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 128 | 6.00 mg/L | Standard Deviation 16.28 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 148 | 1.29 mg/L | Standard Deviation 1.43 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 132 | 1.08 mg/L | Standard Deviation 0.94 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 44 | 1.41 mg/L | Standard Deviation 1.47 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 136 | 1.43 mg/L | Standard Deviation 1.54 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 2 | 1.65 mg/L | Standard Deviation 2.86 |
| Placebo + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 140 | 1.15 mg/L | Standard Deviation 1.28 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 96 | 0.74 mg/L | Standard Deviation 1.01 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 100 | 0.87 mg/L | Standard Deviation 1.49 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 104 | 0.84 mg/L | Standard Deviation 1.4 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 108 | 0.66 mg/L | Standard Deviation 0.58 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 112 | 0.82 mg/L | Standard Deviation 0.87 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 116 | 0.84 mg/L | Standard Deviation 1.26 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 120 | 0.98 mg/L | Standard Deviation 1.58 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 124 | 0.72 mg/L | Standard Deviation 0.67 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 128 | 0.96 mg/L | Standard Deviation 1.29 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 132 | 0.70 mg/L | Standard Deviation 0.84 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 136 | 0.99 mg/L | Standard Deviation 1.68 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 60 | 1.05 mg/L | Standard Deviation 2.15 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 144 | 0.44 mg/L | Standard Deviation 0.37 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 148 | 0.35 mg/L | Standard Deviation 0.18 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 152 | 0.38 mg/L | Standard Deviation 0.23 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 156 | 0.35 mg/L | Standard Deviation 0.18 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 160 | 0.37 mg/L | Standard Deviation 0.22 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 164 | 0.38 mg/L | Standard Deviation 0.2 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 168 | 0.40 mg/L | Standard Deviation 0.19 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 172 | 0.26 mg/L | Standard Deviation 0.17 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 176 | 0.31 mg/L | Standard Deviation 0.19 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 180 | 0.28 mg/L | Standard Deviation 0.15 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 184 | 0.20 mg/L | Standard Deviation 0.11 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 188 | 0.37 mg/L | Standard Deviation 0.06 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 192 | 0.15 mg/L | Standard Deviation 0 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 196 | 0.23 mg/L | Standard Deviation 0.11 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 200 | 0.23 mg/L | Standard Deviation 0.11 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 204 | 0.23 mg/L | Standard Deviation 0.11 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 208 | 0.30 mg/L | — |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 212 | 0.40 mg/L | — |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 216 | 0.30 mg/L | — |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 220 | 0.40 mg/L | — |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 224 | 0.15 mg/L | — |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Baseline | 1.68 mg/L | Standard Deviation 2.49 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 2 | 0.78 mg/L | Standard Deviation 2.93 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 4 | 0.44 mg/L | Standard Deviation 0.72 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 8 | 0.59 mg/L | Standard Deviation 1.26 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 12 | 0.47 mg/L | Standard Deviation 0.6 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 16 | 0.49 mg/L | Standard Deviation 0.51 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 20 | 0.48 mg/L | Standard Deviation 0.5 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 24 | 0.58 mg/L | Standard Deviation 0.91 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 28 | 0.73 mg/L | Standard Deviation 1.34 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 32 | 0.73 mg/L | Standard Deviation 1.21 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 36 | 0.56 mg/L | Standard Deviation 0.66 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 40 | 1.13 mg/L | Standard Deviation 2.26 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 44 | 0.72 mg/L | Standard Deviation 1.2 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 48 | 0.86 mg/L | Standard Deviation 1.44 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 52 | 0.67 mg/L | Standard Deviation 0.88 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 56 | 0.72 mg/L | Standard Deviation 1.02 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 140 | 1.06 mg/L | Standard Deviation 2.25 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 64 | 0.64 mg/L | Standard Deviation 0.89 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 68 | 0.57 mg/L | Standard Deviation 0.47 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 72 | 0.59 mg/L | Standard Deviation 0.71 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 76 | 0.51 mg/L | Standard Deviation 0.37 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 80 | 0.58 mg/L | Standard Deviation 0.51 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 84 | 0.59 mg/L | Standard Deviation 0.61 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 88 | 0.60 mg/L | Standard Deviation 0.53 |
| Satralizumab + Baseline Treatment | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period | Week 92 | 0.60 mg/L | Standard Deviation 0.7 |
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 224
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 + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 112 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 56 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 116 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 28 | 1.95 pg/mL | Standard Deviation 1.38 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 120 | 1.71 pg/mL | Standard Deviation 0.52 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 60 | 2.27 pg/mL | Standard Deviation 1.46 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 124 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 2 | 1.84 pg/mL | Standard Deviation 0.95 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 128 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 64 | 2.46 pg/mL | Standard Deviation 3.22 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 132 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 32 | 1.74 pg/mL | Standard Deviation 0.84 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 136 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 68 | 1.94 pg/mL | Standard Deviation 1.14 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 140 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 16 | 1.84 pg/mL | Standard Deviation 0.9 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 144 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 72 | 1.93 pg/mL | Standard Deviation 0.97 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 148 | 2.04 pg/mL | Standard Deviation 1.25 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 36 | 2.13 pg/mL | Standard Deviation 1.41 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 152 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 76 | 2.21 pg/mL | Standard Deviation 1.87 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 156 | 2.34 pg/mL | Standard Deviation 1.72 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 8 | 1.69 pg/mL | Standard Deviation 0.55 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 160 | 1.96 pg/mL | Standard Deviation 0.8 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 80 | 2.19 pg/mL | Standard Deviation 2.51 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 164 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 40 | 1.66 pg/mL | Standard Deviation 0.4 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 168 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 84 | 2.66 pg/mL | Standard Deviation 2.36 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 172 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 20 | 2.99 pg/mL | Standard Deviation 5.45 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 176 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 88 | 2.59 pg/mL | Standard Deviation 2.77 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 180 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 44 | 1.57 pg/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 92 | 1.84 pg/mL | Standard Deviation 0.77 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 4 | 2.33 pg/mL | Standard Deviation 2.99 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 96 | 3.06 pg/mL | Standard Deviation 3.19 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 48 | 1.69 pg/mL | Standard Deviation 0.53 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 100 | 2.04 pg/mL | Standard Deviation 1.02 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 24 | 2.02 pg/mL | Standard Deviation 1.52 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 104 | 1.95 pg/mL | Standard Deviation 0.96 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 52 | 2.12 pg/mL | Standard Deviation 1.36 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 108 | 1.76 pg/mL | Standard Deviation 0.7 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 12 | 1.71 pg/mL | Standard Deviation 0.6 |
| Placebo + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Baseline | 1.63 pg/mL | Standard Deviation 0.39 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 180 | 13.34 pg/mL | Standard Deviation 6.68 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 184 | 15.24 pg/mL | Standard Deviation 9.91 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 188 | 13.96 pg/mL | Standard Deviation 9.74 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 192 | 16.71 pg/mL | Standard Deviation 13.15 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 200 | 18.55 pg/mL | Standard Deviation 8.84 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 204 | 18.24 pg/mL | Standard Deviation 12.53 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 208 | 9.95 pg/mL | — |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 212 | 8.02 pg/mL | — |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 216 | 6.45 pg/mL | — |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 220 | 45.80 pg/mL | — |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 224 | 34.30 pg/mL | — |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 196 | 14.34 pg/mL | Standard Deviation 12.81 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Baseline | 1.92 pg/mL | Standard Deviation 1.36 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 2 | 40.12 pg/mL | Standard Deviation 118.83 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 4 | 28.30 pg/mL | Standard Deviation 31.31 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 8 | 32.37 pg/mL | Standard Deviation 77.99 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 12 | 22.95 pg/mL | Standard Deviation 20.55 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 16 | 25.76 pg/mL | Standard Deviation 30.85 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 20 | 23.07 pg/mL | Standard Deviation 15.37 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 24 | 21.53 pg/mL | Standard Deviation 17.91 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 28 | 25.14 pg/mL | Standard Deviation 24.27 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 32 | 23.77 pg/mL | Standard Deviation 18.53 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 36 | 23.08 pg/mL | Standard Deviation 15.56 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 40 | 27.31 pg/mL | Standard Deviation 47.45 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 44 | 17.01 pg/mL | Standard Deviation 15.38 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 48 | 19.45 pg/mL | Standard Deviation 19.36 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 52 | 21.11 pg/mL | Standard Deviation 17.42 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 56 | 21.74 pg/mL | Standard Deviation 20.96 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 60 | 23.25 pg/mL | Standard Deviation 23.36 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 64 | 24.31 pg/mL | Standard Deviation 20.74 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 68 | 31.30 pg/mL | Standard Deviation 53.79 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 72 | 24.69 pg/mL | Standard Deviation 24.45 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 76 | 20.45 pg/mL | Standard Deviation 13.79 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 80 | 23.29 pg/mL | Standard Deviation 19.64 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 84 | 22.71 pg/mL | Standard Deviation 21.49 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 88 | 29.17 pg/mL | Standard Deviation 25.58 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 92 | 24.51 pg/mL | Standard Deviation 32.02 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 96 | 21.52 pg/mL | Standard Deviation 20.2 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 100 | 21.77 pg/mL | Standard Deviation 24.98 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 104 | 22.61 pg/mL | Standard Deviation 26.55 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 108 | 24.18 pg/mL | Standard Deviation 20.55 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 112 | 32.18 pg/mL | Standard Deviation 36.15 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 116 | 22.33 pg/mL | Standard Deviation 22.2 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 120 | 21.86 pg/mL | Standard Deviation 24.54 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 124 | 26.23 pg/mL | Standard Deviation 27.67 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 128 | 25.40 pg/mL | Standard Deviation 31.2 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 132 | 25.48 pg/mL | Standard Deviation 27.38 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 136 | 27.23 pg/mL | Standard Deviation 37.56 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 140 | 20.66 pg/mL | Standard Deviation 18.1 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 144 | 16.82 pg/mL | Standard Deviation 16.16 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 148 | 17.10 pg/mL | Standard Deviation 11.33 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 152 | 16.62 pg/mL | Standard Deviation 13.75 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 156 | 12.67 pg/mL | Standard Deviation 5.73 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 160 | 11.15 pg/mL | Standard Deviation 5.12 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 164 | 12.84 pg/mL | Standard Deviation 6.93 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 168 | 13.30 pg/mL | Standard Deviation 8.89 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 172 | 13.89 pg/mL | Standard Deviation 6.94 |
| Satralizumab + Baseline Treatment | Serum Interleukin-6 (IL-6) Concentration During the DB Period | Week 176 | 15.11 pg/mL | Standard Deviation 7.16 |
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 224
Population: Participants from Safety Analysis Population (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 + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 100 | 27707.14 ng/mL | Standard Deviation 14225.93 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 104 | 26203.81 ng/mL | Standard Deviation 13616.28 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Baseline | 100.00 ng/mL | Standard Deviation 0 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 2 | 11343.66 ng/mL | Standard Deviation 5125.84 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 4 | 22222.63 ng/mL | Standard Deviation 8003.48 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 5 | 28461.00 ng/mL | Standard Deviation 12542.52 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 6 | 28174.50 ng/mL | Standard Deviation 11199 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 8 | 21246.92 ng/mL | Standard Deviation 9045.31 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 12 | 20927.63 ng/mL | Standard Deviation 9536.07 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 16 | 20274.86 ng/mL | Standard Deviation 10694.38 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 20 | 20146.06 ng/mL | Standard Deviation 10740.65 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 24 | 20189.00 ng/mL | Standard Deviation 10140.88 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 28 | 20826.07 ng/mL | Standard Deviation 10995.92 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 32 | 20631.79 ng/mL | Standard Deviation 11110.94 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 108 | 26112.38 ng/mL | Standard Deviation 12521.65 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 36 | 21114.62 ng/mL | Standard Deviation 11190.52 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 40 | 22224.76 ng/mL | Standard Deviation 13389.71 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 44 | 22582.17 ng/mL | Standard Deviation 12031.13 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 48 | 23324.80 ng/mL | Standard Deviation 13979.87 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 52 | 24570.83 ng/mL | Standard Deviation 15798.38 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 56 | 24252.50 ng/mL | Standard Deviation 15433.8 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 60 | 23061.67 ng/mL | Standard Deviation 15777.82 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 64 | 23369.55 ng/mL | Standard Deviation 13447.96 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 68 | 26194.43 ng/mL | Standard Deviation 16836.77 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 72 | 26618.87 ng/mL | Standard Deviation 14999.38 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 76 | 26539.09 ng/mL | Standard Deviation 13736.3 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 80 | 26868.00 ng/mL | Standard Deviation 14005.87 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 84 | 27037.62 ng/mL | Standard Deviation 15460.97 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 88 | 26203.00 ng/mL | Standard Deviation 14309.81 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 92 | 28308.10 ng/mL | Standard Deviation 15111.34 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 96 | 26754.43 ng/mL | Standard Deviation 15146.2 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 112 | 24925.10 ng/mL | Standard Deviation 12181.81 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 116 | 26360.50 ng/mL | Standard Deviation 13885.76 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 120 | 24910.00 ng/mL | Standard Deviation 13217.57 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 124 | 24689.50 ng/mL | Standard Deviation 14352.3 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 128 | 22395.53 ng/mL | Standard Deviation 12954 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 132 | 23804.74 ng/mL | Standard Deviation 14878.32 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 136 | 25856.32 ng/mL | Standard Deviation 15506.85 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 140 | 26118.56 ng/mL | Standard Deviation 15264.89 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 144 | 27975.33 ng/mL | Standard Deviation 11536.28 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 148 | 27935.83 ng/mL | Standard Deviation 11940.9 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 152 | 28967.00 ng/mL | Standard Deviation 10354.22 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 156 | 27990.00 ng/mL | Standard Deviation 10444.75 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 164 | 28903.33 ng/mL | Standard Deviation 10780.69 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 168 | 23683.33 ng/mL | Standard Deviation 11615.4 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 172 | 24498.89 ng/mL | Standard Deviation 11106.23 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 176 | 26300.00 ng/mL | Standard Deviation 11498.48 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 180 | 28300.00 ng/mL | Standard Deviation 9431.86 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 184 | 32380.00 ng/mL | Standard Deviation 9427.19 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 188 | 36600.00 ng/mL | Standard Deviation 8214.62 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 192 | 32650.00 ng/mL | Standard Deviation 7848.89 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 196 | 30800.00 ng/mL | Standard Deviation 4808.33 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 200 | 28400.00 ng/mL | Standard Deviation 3818.38 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 204 | 25300.00 ng/mL | Standard Deviation 3252.69 |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 208 | 25900.00 ng/mL | — |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 212 | 17000.00 ng/mL | — |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 216 | 28600.00 ng/mL | — |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 220 | 31600.00 ng/mL | — |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 224 | 28700.00 ng/mL | — |
| Placebo + Baseline Treatment | Serum Satralizumab Concentration During the DB Period | Week 160 | 28983.33 ng/mL | Standard Deviation 11429.02 |
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 224
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 + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 112 | 32.75 ng/mL | Standard Deviation 7.77 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 56 | 37.00 ng/mL | Standard Deviation 7.42 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 116 | 33.68 ng/mL | Standard Deviation 8.31 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 28 | 33.70 ng/mL | Standard Deviation 8.28 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 120 | 33.73 ng/mL | Standard Deviation 6.2 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 60 | 36.39 ng/mL | Standard Deviation 7.81 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 124 | 33.06 ng/mL | Standard Deviation 9.31 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 2 | 33.82 ng/mL | Standard Deviation 8.3 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 128 | 34.07 ng/mL | Standard Deviation 8.83 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 64 | 35.14 ng/mL | Standard Deviation 8.78 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 132 | 34.28 ng/mL | Standard Deviation 4.95 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 32 | 33.48 ng/mL | Standard Deviation 8.74 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 136 | 32.43 ng/mL | Standard Deviation 8.12 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 68 | 35.35 ng/mL | Standard Deviation 8.68 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 140 | 32.97 ng/mL | Standard Deviation 6.52 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 16 | 32.67 ng/mL | Standard Deviation 9.32 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 144 | 35.37 ng/mL | Standard Deviation 8.91 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 72 | 36.02 ng/mL | Standard Deviation 10.73 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 148 | 37.97 ng/mL | Standard Deviation 12.4 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 36 | 34.39 ng/mL | Standard Deviation 11.01 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 152 | 35.08 ng/mL | Standard Deviation 9.08 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 76 | 36.94 ng/mL | Standard Deviation 9.46 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 156 | 36.92 ng/mL | Standard Deviation 7.77 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 8 | 34.02 ng/mL | Standard Deviation 9.43 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 160 | 40.38 ng/mL | Standard Deviation 7.31 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 80 | 36.45 ng/mL | Standard Deviation 9.5 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 164 | 43.08 ng/mL | Standard Deviation 10.54 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 40 | 33.31 ng/mL | Standard Deviation 7.86 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 168 | 42.30 ng/mL | Standard Deviation 5.92 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 84 | 34.60 ng/mL | Standard Deviation 8.88 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 172 | 42.03 ng/mL | Standard Deviation 5.87 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 20 | 34.22 ng/mL | Standard Deviation 8.15 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 176 | 39.85 ng/mL | Standard Deviation 6.15 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 88 | 31.95 ng/mL | Standard Deviation 8.29 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 180 | 38.85 ng/mL | Standard Deviation 12.09 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 44 | 33.94 ng/mL | Standard Deviation 7.77 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 92 | 34.30 ng/mL | Standard Deviation 9.71 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 4 | 33.13 ng/mL | Standard Deviation 8.52 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 96 | 32.88 ng/mL | Standard Deviation 9.39 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 48 | 34.50 ng/mL | Standard Deviation 9.14 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 100 | 33.78 ng/mL | Standard Deviation 9.04 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 24 | 34.44 ng/mL | Standard Deviation 9.31 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 104 | 31.61 ng/mL | Standard Deviation 9.13 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 52 | 44.01 ng/mL | Standard Deviation 44.26 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 108 | 31.49 ng/mL | Standard Deviation 9.23 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 12 | 32.58 ng/mL | Standard Deviation 8.52 |
| Placebo + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Baseline | 32.52 ng/mL | Standard Deviation 7.78 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 180 | 769.83 ng/mL | Standard Deviation 119.5 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 184 | 736.80 ng/mL | Standard Deviation 152.09 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 188 | 853.67 ng/mL | Standard Deviation 38.02 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 192 | 930.00 ng/mL | Standard Deviation 49.5 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 196 | 887.00 ng/mL | Standard Deviation 91.92 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 200 | 902.50 ng/mL | Standard Deviation 79.9 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 204 | 935.00 ng/mL | Standard Deviation 7.07 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 208 | 941.00 ng/mL | — |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 212 | 971.00 ng/mL | — |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 216 | 896.00 ng/mL | — |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 220 | 901.00 ng/mL | — |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 224 | 831.00 ng/mL | — |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Baseline | 35.13 ng/mL | Standard Deviation 21.52 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 2 | 437.41 ng/mL | Standard Deviation 72.31 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 4 | 572.29 ng/mL | Standard Deviation 94.84 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 8 | 642.92 ng/mL | Standard Deviation 115.51 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 12 | 651.41 ng/mL | Standard Deviation 99.2 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 16 | 640.57 ng/mL | Standard Deviation 97.41 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 20 | 636.64 ng/mL | Standard Deviation 109.75 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 24 | 639.20 ng/mL | Standard Deviation 108.94 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 28 | 649.11 ng/mL | Standard Deviation 131.85 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 32 | 651.82 ng/mL | Standard Deviation 162.04 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 36 | 652.12 ng/mL | Standard Deviation 124.7 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 40 | 664.21 ng/mL | Standard Deviation 158.61 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 44 | 677.13 ng/mL | Standard Deviation 173.99 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 48 | 627.23 ng/mL | Standard Deviation 217.06 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 52 | 656.29 ng/mL | Standard Deviation 173.67 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 56 | 626.83 ng/mL | Standard Deviation 155.56 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 60 | 617.00 ng/mL | Standard Deviation 142.13 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 64 | 621.27 ng/mL | Standard Deviation 152.45 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 68 | 664.91 ng/mL | Standard Deviation 130.58 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 72 | 648.83 ng/mL | Standard Deviation 134.32 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 76 | 643.91 ng/mL | Standard Deviation 118.6 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 80 | 667.24 ng/mL | Standard Deviation 133.49 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 84 | 649.38 ng/mL | Standard Deviation 137.64 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 88 | 651.35 ng/mL | Standard Deviation 150.58 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 92 | 633.43 ng/mL | Standard Deviation 134.36 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 96 | 630.62 ng/mL | Standard Deviation 162.28 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 100 | 651.90 ng/mL | Standard Deviation 162.09 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 104 | 649.57 ng/mL | Standard Deviation 185.99 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 108 | 658.67 ng/mL | Standard Deviation 152.61 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 112 | 683.90 ng/mL | Standard Deviation 135.07 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 116 | 653.98 ng/mL | Standard Deviation 194.92 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 120 | 667.10 ng/mL | Standard Deviation 152.24 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 124 | 696.45 ng/mL | Standard Deviation 138.17 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 128 | 670.05 ng/mL | Standard Deviation 138.28 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 132 | 671.84 ng/mL | Standard Deviation 138.75 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 136 | 674.95 ng/mL | Standard Deviation 170.04 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 140 | 645.72 ng/mL | Standard Deviation 132.32 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 144 | 699.80 ng/mL | Standard Deviation 101.84 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 148 | 672.42 ng/mL | Standard Deviation 107.4 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 152 | 701.60 ng/mL | Standard Deviation 110.27 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 156 | 720.33 ng/mL | Standard Deviation 103.58 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 160 | 704.89 ng/mL | Standard Deviation 109.86 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 164 | 723.67 ng/mL | Standard Deviation 136.2 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 168 | 744.22 ng/mL | Standard Deviation 123.47 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 172 | 706.33 ng/mL | Standard Deviation 127.63 |
| Satralizumab + Baseline Treatment | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period | Week 176 | 730.56 ng/mL | Standard Deviation 121.75 |