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    Clinical Trial Results:
    A Multicenter, Single Arm, Open-label Study to Evaluate the Long-term Safety and Efficacy of Satralizumab in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

    Summary
    EudraCT number
    		 2020-003413-35
    Trial protocol
    		 GB   DE   HU   BG   PL   IT   HR  
    Global end of trial date
    28 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Dec 2024
    First version publication date
    14 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WN42349
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04660539
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4058
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aims to evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optic spectrum disorder (NMOSD). Study WN42349 is not a part of a PIP. However, the parent studies (2013-003752-21 and 2015-005431-41) were a part of a PIP, with an EMA-PIP number of EMEA-001625-PIP01-14.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Georgia: 1
    Country: Number of subjects enrolled
    Croatia: 1
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Türkiye: 1
    Country: Number of subjects enrolled
    Taiwan: 16
    Country: Number of subjects enrolled
    Ukraine: 12
    Country: Number of subjects enrolled
    United States: 47
    Worldwide total number of subjects
    166
    EEA total number of subjects
    51
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    154
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 119 participants from studies BN40898 & BN40900 rolled over in study WN42349 at 53 sites in 17 countries. ‘All Participants-treated population’ is used to report results, which includes 166 participants who received at least one dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in WN42349.

    Pre-assignment
    Screening details
    		 Participants from 2013-003752-21 and 2015-005431-41 enrolled in this study to receive satralizumab treatment. Participants were permitted to use azathioprine (AZA) or mycophenolate mofetil (MMF) or oral corticosteroids during the study as background immunosuppressive treatments.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Satralizumab
    Arm description
    		 Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (Q4W) up to a maximum duration of 3 years in the current study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in the current study are represented here.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Satralizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Satralizumab, 120 mg, as SC injection for up to 3 years.

    Number of subjects in period 1
    		Satralizumab
    Started
    166
    Completed
    106
    Not completed
    60
         Consent withdrawn by subject
    21
         Adverse Event
    10
         Switch To Commercial Satralizumab
    1
         Non-Compliance With Study Drug
    3
         Pregnancy
    2
         Lost to follow-up
    5
         Reason not Specified
    12
         Lack of efficacy
    4
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Satralizumab
    Reporting group description
    		 Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (Q4W) up to a maximum duration of 3 years in the current study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in the current study are represented here.

    Reporting group values
    		 Satralizumab Total
    Number of subjects
    		 166 166
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.7 ( 13.3 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 142 142
        Male
    		 24 24
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 12 12
        Not Hispanic or Latino
    		 147 147
        Unknown or Not Reported
    		 7 7
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 2 2
        Asian
    		 47 47
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 17 17
        White
    		 95 95
        More than one race
    		 0 0
        Other
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Satralizumab
    Reporting group description
    		 Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (Q4W) up to a maximum duration of 3 years in the current study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in the current study are represented here.

    Primary: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    AE=any untoward medical occurrence in a participant administered a medicinal product, regardless of causal relationship with it. AE=unfavorable & unintended sign, symptoms/disease temporally associated with use of medicinal product, whether or not considered related to it. SAE=any significant hazard, contraindication/side effect that is fatal/ life-threatening, requires hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is congenital anomaly, is medically significant/requires intervention. First dosing visit in current study/randomization visit in the parent studies was considered as baseline. All AEs from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population=participants who received at least 1 dose of satralizumab at any time during parent or this study, irrespective of enrollment in current study.
    End point type
    Primary
    End point timeframe
    Baseline up to 523 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistics was planned for this endpoint.
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: participants
        AEs
    162
        SAEs
    44
    No statistical analyses for this end point

    Primary: Number of Participants with Adverse Events of Special Interest (AESIs) and Selected AEs

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    End point title
    		 Number of Participants with Adverse Events of Special Interest (AESIs) and Selected AEs [2]
    End point description
    An AESIs included potential drug induced liver injury & suspected transmission of infectious agent by study drug defined as any organism, virus or infectious particle, pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate infection in participant exposed to medicinal product. Selected AEs included infections that required treatments with IV antibiotics, antifungals or antivirals; opportunistic infections that required treatment with oral antibiotics, antifungals or antivirals and injection related reaction. First dosing visit in current study or randomization visit in parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. All AEs from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least 1 dose of satralizumab at any time during parent or this study.
    End point type
    Primary
    End point timeframe
    Baseline up to 523 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistics was planned for this endpoint.
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: participants
        AESIs
    0
        Selected AEs
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of Participants with Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
    End point description
    C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) and any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior and attempts with actual/potential lethality. Categories have 2 responses(yes/no) & include a-Wish to be Dead; b-Non-specific Active Suicidal Thoughts; c-Active Suicidal Ideation with Any Methods(Not Plan) w/o Intent to Act; d-Active Suicidal Ideation with Some Intent to Act, w/o Specific Plan; e-Active Suicidal Ideation with Specific Plan & Intent, f-Preparatory Acts & Behavior; g-Aborted Attempt; h-Interrupted Attempt; i-Actual Attempt(non-fatal); j-Completed Suicide. Suicidal ideation or behavior is indicated by yes answer to any categories. Score=0 if no suicide risk present. Score≥1=suicidal ideation or behavior. All Participants-treated population. Baseline=1st dosing visit in current study/randomization visit in parent studies.
    End point type
    Secondary
    End point timeframe
    Baseline up to 523 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: participants
        a- Baseline
    7
        a- Post-baseline
    5
        b- Baseline
    5
        b- Post-baseline
    2
        c- Baseline
    1
        c- Post-baseline
    0
        d- Baseline
    1
        d- Post-baseline
    0
        e- Baseline (n=166)
    1
        e- Post-baseline
    0
        f- Baseline
    2
        f- Post-baseline
    0
        i- Baseline
    3
        i- Post-baseline
    1
        j- Baseline
    0
        j- Post-baseline
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Serious Infections and Hepatotoxicity

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    End point title
    		 Number of Participants with Serious Infections and Hepatotoxicity
    End point description
    Hepatotoxicity was defined using the following Medical Dictionary for Regulatory Activities Standardised MedDRA Queries (MedDRA SMQs) - Cholestasis and jaundice of hepatic origin (SMQ narrow) and Drug related hepatic disorders - severe events only (SMQ narrow). The first dosing visit in the current study or randomization visit in the parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. Data for all serious infections and hepatotoxicity from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population=participants who received at least 1 dose of satralizumab at any time during parent or this study, irrespective of enrollment in WN42349 .
    End point type
    Secondary
    End point timeframe
    Baseline up to 523 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: participants
        Serious Infections
    19
        Hepatotoxicity
    8
    No statistical analyses for this end point

    Secondary: Percentage of Relapse-Free Participants

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    End point title
    		 Percentage of Relapse-Free Participants
    End point description
    Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur < 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. All data from the time of randomization in the parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any relapse events are reported here. Percentages have been rounded off to the nearest decimal point. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study.
    End point type
    Secondary
    End point timeframe
    Baseline up to 528 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: percentage of participants
        number (not applicable)
    70.5
    No statistical analyses for this end point

    Secondary: Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR)

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    End point title
    		 Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR)
    End point description
    Time to first relapse (TFR) was defined as the time from randomization in parent studies to the first occurrence of the first iPDR. PDR=occurrence of new or worsening neurological symptoms attributable to NMO/NMOSD. New/worsening neurological symptoms occurring < 31 days following onset of PDR were considered part of same relapse. Time point of relapse onset=time at which participant experienced new/worsening neurological symptoms representing NMOSD clinical relapse(s). For participants who did not relapse at the time of analysis, TFR was censored at clinical cutoff date (CCOD) or at withdrawal from study. Baseline=1st visit in current study/randomization visit in parent studies. TFR data from time of randomization in parent studies to end of this study for satralizumab-treated participants are reported. All Participants-treated population. 99999=insufficient number of events to estimate median and 95% CI.
    End point type
    Secondary
    End point timeframe
    Baseline up to 528 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: weeks
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: iPDR-free Rate up to Week 456

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    End point title
    		 iPDR-free Rate up to Week 456
    End point description
    iPDR free rate was defined as percentage of participants who did not experience a protocol-defined relapse as assessed by the investigator. PDR was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a PDR were considered part of the same relapse. First dosing visit in the current study or randomization visit in parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. All data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Percentages have been rounded off to the nearest decimal point. Kaplan-Meier method was used to estimate the iPDR-free rates. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 456
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: percentage of participants
        number (confidence interval 95%)
    67.11 (58.61 to 74.25)
    No statistical analyses for this end point

    Secondary: Annualized Relapse Rate (ARR)

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    End point title
    		 Annualized Relapse Rate (ARR)
    End point description
    ARR calculated as total number of relapses experienced divided by participant-years of whole study period. Adjusted AAR was calculated using Poisson regression model adjusted by study identifier (BN40898, BN40900). ARR was assessed from randomization in parent studies to 1st occurrence of iPDR. PDR = occurrence of new/worsening neurological symptoms attributable to NMO/NMOSD. New/worsening neurological symptoms occurring < 31 days following onset of PDR were considered part of same relapse. Time point of relapse onset=time at which participant experienced any new/worsening neurological symptoms representing NMOSD clinical relapse(s). Baseline was defined as first dosing visit in current study/randomization visit in parent studies (2013-003752-21/2015-005431-41). All ARR data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants is used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to 528 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: relapses per participant-year
        number (confidence interval 95%)
    0.0788 (0.0633 to 0.0982)
    No statistical analyses for this end point

    Secondary: Change in Expanded Disability Status Scale (EDSS) Score

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    End point title
    		 Change in Expanded Disability Status Scale (EDSS) Score
    End point description
    EDSS=quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. Baseline=last observation on/before the day of first study drug administration in this study/parent studies (2013-003752-21/2015-005431-41). EDSS data from the time of randomization in parent studies to end of this study for satralizumab-treated participants are reported. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Number analyzed=number of participants with data available for analysis. "n"= participants with data available for analysis at the specified timepoint. 99999=standard deviation (SD) was not evaluable as only 1 participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and every 24 weeks (up to 528 weeks)
    End point values
    		 Satralizumab
    Number of subjects analysed
    165
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=165)
    3.80 ( 1.57 )
        Change from Baseline at Week 24 (n=162)
    -0.08 ( 0.77 )
        Change from Baseline at Week 48 (n=151)
    -0.16 ( 0.72 )
        Change from Baseline at Week 72 (n=147)
    -0.14 ( 0.80 )
        Change from Baseline at Week 96 (n=141)
    -0.18 ( 0.86 )
        Change from Baseline at Week 120 (n=135)
    -0.14 ( 0.90 )
        Change from Baseline at Week 144 (n=133)
    -0.09 ( 0.97 )
        Change from Baseline at Week 168 (n=128)
    -0.16 ( 0.90 )
        Change from Baseline at Week 192 (n=129)
    -0.13 ( 0.95 )
        Change from Baseline at Week 216 (n=124)
    -0.22 ( 0.99 )
        Change from Baseline at Week 240 (n=116)
    -0.21 ( 0.95 )
        Change from Baseline at Week 264 (n=114)
    -0.25 ( 0.92 )
        Change from Baseline at Week 288 (n=106)
    -0.34 ( 0.99 )
        Change from Baseline at Week 312 (n=97)
    -0.44 ( 1.02 )
        Change from Baseline at Week 336 (n=87)
    -0.42 ( 1.15 )
        Change from Baseline at Week 360 (n=82)
    -0.51 ( 1.24 )
        Change from Baseline at Week 384 (n=66)
    -0.37 ( 1.22 )
        Change from Baseline at Week 408 (n=52)
    -0.26 ( 1.20 )
        Change from Baseline at Week 432 (n=48)
    -0.31 ( 1.16 )
        Change from Baseline at Week 456 (n=37)
    -0.31 ( 1.23 )
        Change from Baseline at Week 480 (n=16)
    0.00 ( 1.03 )
        Change from Baseline at Week 504 (n=1)
    0.00 ( 99999 )
        Change from Baseline at Week 528 (n=1)
    -0.50 ( 99999 )
    No statistical analyses for this end point

    Secondary: Time to First EDSS Scores Worsening

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    End point title
    		 Time to First EDSS Scores Worsening
    End point description
    EDSS=quantitative measure with values from 0 points (normal neurological examination) to 10 points (death), increasing in increments of 0.5 points. EDSS worsening=(a) worsening of ≥2 points in EDSS score for participants with a baseline score (BS) of 0, (b) worsening of ≥1points in EDSS score for participants with a BS of 1-5, or (c) worsening of ≥0.5 points in EDSS score for participants with a BS of ≥5.5. Participants were censored at date of last EDSS assessment/if no assessment was performed at randomization. Baseline is the last observation on/before day of 1st drug administration in this study/parent studies (2013-003752-21/2015-005431-41). EDSS data from randomization in parent studies to end of this study for satralizumab-treated participants are reported. All Participants-treated population is used. Number analyzed=participants with data available for analysis. 99999=there was an insufficient number of events to estimate median & 95% CI.
    End point type
    Secondary
    End point timeframe
    Baseline up to 528 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    165
    Units: weeks
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart

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    End point title
    		 Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart
    End point description
    VA was measured using Snellen 20-foot wall chart & then converted to logMAR VA scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) & left eye (OS). Scores worse than 20/200 [i.e. CF (counting fingers), HM (hand movement), LP (light perception), or NLP (no LP)] are converted to logMAR 1.85, logMAR 2.00, logMAR 2.70 & logMAR 3.00. LogMAR >= 1 is equivalent to Physically blind. Negative change from baseline =improvement. Baseline=first dosing visit in current study/randomization visit in parent studies. VA data from time of randomization in parent studies to end of study WN42349 for satralizumab-treated participants are reported. All Participants-treated population=participants who received at least one dose of satralizumab any time during the parent studies or this study, irrespective of enrollment in WN42349. "n"=participants with data available for analysis at specified timepoint. 99999=SD was not evaluable as only 1 participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and every 24 weeks (up to 528 weeks)
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: LogMAR units
    arithmetic mean (standard deviation)
        Baseline [OD] (n=166)
    0.438 ( 0.746 )
        Baseline [OS] (n=166)
    0.566 ( 0.899 )
        Change from Baseline at Week 24 [OD] (n=162)
    0.028 ( 0.297 )
        Change from Baseline at Week 24 [OS] (n=161)
    0.009 ( 0.329 )
        Change from Baseline at Week 48 [OD] (n=152)
    0.014 ( 0.363 )
        Change from Baseline at Week 48 [OS] (n=152)
    0.020 ( 0.385 )
        Change from Baseline at Week 72 [OD] (n=148)
    -0.004 ( 0.340 )
        Change from Baseline at Week 72 [OS] (n=147)
    -0.017 ( 0.362 )
        Change from Baseline at Week 96 [OD] (n=141)
    -0.024 ( 0.375 )
        Change from Baseline at Week 96 [OS] (n=141)
    0.030 ( 0.317 )
        Change from Baseline at Week 120 [OD] (n=136)
    0.015 ( 0.404 )
        Change from Baseline at Week 120 [OS] (n=135)
    -0.065 ( 0.404 )
        Change from Baseline at Week 144 [OD] (n=134)
    -0.023 ( 0.379 )
        Change from Baseline at Week 144 [OS] (n=134)
    -0.054 ( 0.355 )
        Change from Baseline at Week 168 [OD] (n=129)
    -0.004 ( 0.338 )
        Change from Baseline at Week 168 [OS] (n=128)
    -0.053 ( 0.324 )
        Change from Baseline at Week 192 [OD] (n=131)
    0.008 ( 0.383 )
        Change from Baseline at Week 192 [OS] (n=130)
    -0.056 ( 0.386 )
        Change from Baseline at Week 216 [OD] (n=124)
    0.019 ( 0.427 )
        Change from Baseline at Week 216 [OS] (n=125)
    -0.069 ( 0.440 )
        Change from Baseline at Week 240 [OD] (n=117)
    0.007 ( 0.465 )
        Change from Baseline at Week 240 [OS] (n=117)
    -0.085 ( 0.490 )
        Change from Baseline at Week 264 [OD] (n=118)
    -0.016 ( 0.421 )
        Change from Baseline at Week 264 [OS] (n=119)
    -0.074 ( 0.472 )
        Change from Baseline at Week 288 [OD] (n=109)
    0.006 ( 0.386 )
        Change from Baseline at Week 288 [OS] (n=110)
    -0.085 ( 0.458 )
        Change from Baseline at Week 312 [OD] (n=98)
    -0.043 ( 0.420 )
        Change from Baseline at Week 312 [OS] (n=99)
    -0.106 ( 0.499 )
        Change from Baseline at Week 336 [OD] (n=92)
    -0.025 ( 0.470 )
        Change from Baseline at Week 336 [OS] (n=91)
    -0.112 ( 0.539 )
        Change from Baseline at Week 360 [OD] (n=87)
    -0.008 ( 0.400 )
        Change from Baseline at Week 360 [OS] (n=86)
    -0.122 ( 0.524 )
        Change from Baseline at Week 384 [OD] (n=72)
    0.002 ( 0.421 )
        Change from Baseline at Week 384 [OS] (n=71)
    -0.086 ( 0.467 )
        Change from Baseline at Week 408 [OD] (n=55)
    0.039 ( 0.466 )
        Change from Baseline at Week 408 [OS] (n=54)
    -0.071 ( 0.572 )
        Change from Baseline at Week 432 [OD] (n=50)
    -0.010 ( 0.427 )
        Change from Baseline at Week 432 [OS] (n=49)
    -0.145 ( 0.509 )
        Change from Baseline at Week 456 [OD] (n=38)
    0.011 ( 0.373 )
        Change from Baseline at Week 456 [OS] (n=38)
    -0.109 ( 0.509 )
        Change from Baseline at Week 480 [OD] (n=18)
    -0.106 ( 0.315 )
        Change from Baseline at Week 480 [OS] (n=17)
    -0.018 ( 0.185 )
        Change from Baseline at Week 504 [OD] (n=2)
    -0.200 ( 0.141 )
        Change from Baseline at Week 504 [OS] (n=2)
    -0.320 ( 0.283 )
        Change from Baseline at Week 528 [OD] (n=1)
    0.220 ( 99999 )
        Change from Baseline at Week 528 [OS] (n=1)
    0.300 ( 99999 )
    No statistical analyses for this end point

    Secondary: Event-free Rate for EDSS Score Worsening up to Week 456

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    End point title
    		 Event-free Rate for EDSS Score Worsening up to Week 456
    End point description
    Event-free rate for EDSS score worsening=percentage of participants who did not experience worsening in their EDSS score from baseline. EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. Participants were censored at the date of the last EDSS assessment or if no EDSS assessment was performed at the randomization date. Baseline=last observation on/before the day of first study drug administration in current study/parent studies (2013-003752-21/2015-005431-41). All EDSS data from the time of randomization in parent studies up to Week 456 for satralizumab-treated participants are reported here. Kaplan-Meier method was used to estimate the event-free rates. All Participants-treated population is used. Number analyzed is number of participants with data available for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 456
    End point values
    		 Satralizumab
    Number of subjects analysed
    165
    Units: percentage of participants
        number (confidence interval 95%)
    57.03 (46.80 to 66.01)
    No statistical analyses for this end point

    Secondary: Percentage of Participants without EDSS Worsening

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    End point title
    		 Percentage of Participants without EDSS Worsening
    End point description
    EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. EDSS worsening=(a) worsening of 2/more points in EDSS score for participants with BS of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1-5, (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). EDSS data from time of randomization in parent studies up to end of study WN42349 for all participants are reported here. All Participants-treated population.Participants from parent studies who did not enroll in the current study are also considered for efficacy analysis. Number analyzed=participants with data available for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to 528 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    165
    Units: percentage of participants
        number (not applicable)
    64.8
    No statistical analyses for this end point

    Secondary: Concentrations of Interleukin-6 (IL-6) in Blood

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    End point title
    		 Concentrations of Interleukin-6 (IL-6) in Blood
    End point description
    Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed is the number of participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528
    End point values
    		 Satralizumab
    Number of subjects analysed
    163
    Units: picograms/millilitre (pg/mL)
    geometric mean (geometric coefficient of variation)
        Baseline (n=163)
    2.07 ( 70.3 )
        Week 2 (n=101)
    21.27 ( 97.0 )
        Week 4 (n=163)
    21.90 ( 108.2 )
        Week 8 (n=159)
    19.35 ( 110.2 )
        Week 12 (n=157)
    18.84 ( 99.9 )
        Week 16 (n=151)
    17.53 ( 108.5 )
        Week 20 (n=157)
    17.16 ( 108.1 )
        Week 24 (n=152)
    17.77 ( 101.9 )
        Week 28 (n=152)
    17.08 ( 109.6 )
        Week 32 (n=151)
    18.32 ( 107.1 )
        Week 36 (n=145)
    18.29 ( 95.7 )
        Week 40 (n=141)
    16.21 ( 95.8 )
        Week 44 (n=145)
    17.59 ( 108.5 )
        Week 48 (n=141)
    18.59 ( 105.5 )
        Week 52 (n=93)
    18.55 ( 101.8 )
        Week 56 (n=91)
    18.78 ( 124.2 )
        Week 60 (n=90)
    20.56 ( 99.8 )
        Week 64 (n=87)
    20.04 ( 98.2 )
        Week 68 (n=83)
    19.70 ( 95.6 )
        Week 72 (n=83)
    18.48 ( 103.7 )
        Week 76 (n=80)
    18.05 ( 89.0 )
        Week 80 (n=71)
    17.93 ( 101.2 )
        Week 84 (n=74)
    18.44 ( 111.1 )
        Week 88 (n=69)
    20.33 ( 89.1 )
        Week 92 (n=68)
    17.12 ( 100.7 )
        Week 96 (n=69)
    19.72 ( 107.8 )
        Week 100 (n=63)
    19.73 ( 111.5 )
        Week 104 (n=66)
    19.34 ( 82.6 )
        Week 108 (n=66)
    19.74 ( 94.9 )
        Week 112 (n=65)
    21.39 ( 95.8 )
        Week 116 (n=60)
    17.98 ( 93.4 )
        Week 120 (n=60)
    19.26 ( 108.0 )
        Week 124 (n=60)
    18.41 ( 98.5 )
        Week 128 (n=59)
    18.17 ( 93.3 )
        Week 132 (n=59)
    17.83 ( 98.6 )
        Week 136 (n=53)
    19.22 ( 100.4 )
        Week 140 (n=51)
    17.62 ( 91.5 )
        Week 144 (n=62)
    16.54 ( 101.1 )
        Week 148 (n=50)
    18.95 ( 82.9 )
        Week 152 (n=44)
    19.71 ( 100.3 )
        Week 156 (n=37)
    20.84 ( 78.5 )
        Week 160 (n=43)
    19.91 ( 81.3 )
        Week 164 (n=38)
    19.76 ( 76.8 )
        Week 168 (n=54)
    22.33 ( 87.4 )
        Week 172 (n=34)
    21.94 ( 82.8 )
        Week 176 (n=32)
    23.31 ( 75.8 )
        Week 180 (n=35)
    21.28 ( 78.4 )
        Week 184 (n=29)
    23.23 ( 98.0 )
        Week 188 (n=35)
    23.52 ( 86.0 )
        Week 192 (n=62)
    22.25 ( 76.4 )
        Week 216 (n=62)
    19.41 ( 102.0 )
        Week 240 (n=66)
    18.22 ( 101.8 )
        Week 264 (n=61)
    18.56 ( 99.6 )
        Week 288 (n=67)
    19.17 ( 94.4 )
        Week 312 (n=68)
    21.70 ( 82.1 )
        Week 336 (n=85)
    17.71 ( 103.0 )
        Week 360 (n=86)
    19.40 ( 77.1 )
        Week 384 (n=68)
    19.68 ( 91.2 )
        Week 408 (n=56)
    18.94 ( 113.3 )
        Week 432 (n=50)
    19.29 ( 124.0 )
        Week 456 (n=36)
    17.90 ( 94.5 )
        Week 480 (n=18)
    20.89 ( 42.5 )
        Week 504 (n=2)
    8.40 ( 32.4 )
        Week 528 (n=1)
    13.50 ( 99999 )
    No statistical analyses for this end point

    Secondary: Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood

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    End point title
    		 Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood
    End point description
    Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed is the number of participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528
    End point values
    		 Satralizumab
    Number of subjects analysed
    164
    Units: nanograms/millilitre (ng/mL)
    geometric mean (geometric coefficient of variation)
        Baseline (n=164)
    32.27 ( 29.0 )
        Week 2 (n=102)
    404.20 ( 22.1 )
        Week 4 (n=163)
    536.46 ( 28.3 )
        Week 8 (n=161)
    566.91 ( 49.4 )
        Week 12 (n=159)
    568.96 ( 53.8 )
        Week 16 (n=152)
    561.69 ( 56.2 )
        Week 20 (n=157)
    543.99 ( 63.3 )
        Week 24 (n=154)
    556.84 ( 60.5 )
        Week 28 (n=154)
    547.77 ( 64.0 )
        Week 32 (n=153)
    574.72 ( 50.9 )
        Week 36 (n=146)
    552.54 ( 61.9 )
        Week 40 (n=142)
    556.08 ( 62.9 )
        Week 44 (n=150)
    569.26 ( 62.3 )
        Week 48 (n=143)
    575.25 ( 58.8 )
        Week 52 (n=93)
    555.92 ( 60.3 )
        Week 56 (n=93)
    523.80 ( 71.6 )
        Week 60 (n=91)
    549.23 ( 58.7 )
        Week 64 (n=88)
    550.61 ( 62.7 )
        Week 68 (n=83)
    581.62 ( 61.5 )
        Week 72 (n=84)
    540.99 ( 66.6 )
        Week 76 (n=81)
    519.20 ( 74.5 )
        Week 80 (n=71)
    535.83 ( 73.9 )
        Week 84 (n=74)
    533.47 ( 66.9 )
        Week 88 (n=69)
    523.64 ( 69.8 )
        Week 92 (n=70)
    515.37 ( 74.5 )
        Week 96 (n=70)
    526.59 ( 70.4 )
        Week 100 (n=64)
    534.72 ( 71.2 )
        Week 104 (n=66)
    583.53 ( 55.1 )
        Week 108 (n=66)
    578.63 ( 57.1 )
        Week 112 (n=65)
    594.60 ( 61.0 )
        Week 116 (n=60)
    571.37 ( 62.0 )
        Week 120 (n=61)
    615.02 ( 42.7 )
        Week 124 (n=61)
    590.17 ( 53.3 )
        Week 128 (n=60)
    559.85 ( 58.7 )
        Week 132 (n=59)
    580.53 ( 45.0 )
        Week 136 (n=55)
    607.27 ( 38.6 )
        Week 140 (n=52)
    592.84 ( 43.8 )
        Week 144 (n=62)
    571.70 ( 61.2 )
        Week 148 (n=50)
    610.47 ( 43.8 )
        Week 152 (n=44)
    565.34 ( 73.3 )
        Week 156 (n=38)
    667.59 ( 22.3 )
        Week 160 (n=43)
    652.90 ( 28.8 )
        Week 164 (n=38)
    636.27 ( 34.9 )
        Week 168 (n=54)
    662.43 ( 29.9 )
        Week 172 (n=34)
    643.84 ( 36.8 )
        Week 176 (n=32)
    670.38 ( 28.3 )
        Week 180 (n=35)
    655.31 ( 35.0 )
        Week 184 (n=30)
    684.07 ( 18.5 )
        Week 188 (n=35)
    666.52 ( 30.8 )
        Week 192 (n=62)
    611.46 ( 67.0 )
        Week 216 (n=63)
    592.12 ( 68.9 )
        Week 240 (n=71)
    587.26 ( 58.7 )
        Week 264 (n=63)
    570.35 ( 45.3 )
        Week 288 (n=67)
    572.20 ( 52.2 )
        Week 312 (n=68)
    608.11 ( 35.0 )
        Week 336 (n=85)
    533.73 ( 71.8 )
        Week 360 (n=87)
    557.05 ( 55.3 )
        Week 384 (n=69)
    549.57 ( 58.0 )
        Week 408 (n=56)
    586.95 ( 62.4 )
        Week 432 (n=50)
    569.09 ( 42.7 )
        Week 456 (n=36)
    561.16 ( 56.8 )
        Week 480 (n=18)
    652.16 ( 18.0 )
        Week 504 (n=2)
    668.04 ( 13.4 )
        Week 528 (n=1)
    910.00 ( 99999 )
    No statistical analyses for this end point

    Secondary: Concentration of C-Reactive Protein (CRP) in Blood

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    End point title
    		 Concentration of C-Reactive Protein (CRP) in Blood
    End point description
    Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed=participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528
    End point values
    		 Satralizumab
    Number of subjects analysed
    165
    Units: milligrams/litre (mg/L)
    geometric mean (geometric coefficient of variation)
        Baseline (n=165)
    1.27 ( 226.6 )
        Week 2 (n=102)
    0.38 ( 118.0 )
        Week 4 (n=162)
    0.36 ( 113.3 )
        Week 8 (n=161)
    0.39 ( 125.9 )
        Week 12 (n=156)
    0.42 ( 144.9 )
        Week 16 (n=152)
    0.42 ( 151.1 )
        Week 20 (n=157)
    0.41 ( 157.8 )
        Week 24 (n=154)
    0.44 ( 161.0 )
        Week 28 (n=155)
    0.41 ( 175.7 )
        Week 32 (n=153)
    0.44 ( 171.4 )
        Week 36 (n=147)
    0.43 ( 185.3 )
        Week 40 (n=146)
    0.48 ( 184.3 )
        Week 44 (n=150)
    0.43 ( 182.3 )
        Week 48 (n=144)
    0.44 ( 167.9 )
        Week 52 (n=91)
    0.50 ( 177.4 )
        Week 56 (n=91)
    0.47 ( 183.8 )
        Week 60 (n=91)
    0.49 ( 183.3 )
        Week 64 (n=88)
    0.47 ( 177.6 )
        Week 68 (n=85)
    0.52 ( 194.3 )
        Week 72 (n=89)
    0.50 ( 223.7 )
        Week 76 (n=81)
    0.51 ( 189.5 )
        Week 80 (n=72)
    0.51 ( 200.4 )
        Week 84 (n=74)
    0.53 ( 227.4 )
        Week 88 (n=69)
    0.51 ( 188.0 )
        Week 92 (n=69)
    0.51 ( 200.4 )
        Week 96 (n=71)
    0.52 ( 183.4 )
        Week 100 (n=64)
    0.52 ( 231.4 )
        Week 104 (n=66)
    0.46 ( 167.3 )
        Week 108 (n=66)
    0.51 ( 161.9 )
        Week 112 (n=66)
    0.48 ( 191.7 )
        Week 116 (n=61)
    0.43 ( 177.0 )
        Week 120 (n=64)
    0.52 ( 227.6 )
        Week 124 (n=61)
    0.56 ( 173.2 )
        Week 128 (n=60)
    0.57 ( 209.1 )
        Week 132 (n=61)
    0.59 ( 234.8 )
        Week 136 (n=59)
    0.54 ( 193.9 )
        Week 140 (n=55)
    0.61 ( 283.9 )
        Week 144 (n=65)
    0.47 ( 205.6 )
        Week 148 (n=51)
    0.47 ( 152.0 )
        Week 152 (n=46)
    0.51 ( 147.8 )
        Week 156 (n=43)
    0.47 ( 129.5 )
        Week 160 (n=45)
    0.48 ( 148.9 )
        Week 164 (n=39)
    0.49 ( 163.7 )
        Week 168 (n=56)
    0.45 ( 148.9 )
        Week 172 (n=32)
    0.45 ( 228.2 )
        Week 176 (n=33)
    0.39 ( 156.7 )
        Week 180 (n=35)
    0.42 ( 156.6 )
        Week 184 (n=33)
    0.38 ( 197.3 )
        Week 188 (n=37)
    0.46 ( 154.0 )
        Week 192 (n=71)
    0.40 ( 188.5 )
        Week 216 (n=62)
    0.30 ( 110.4 )
        Week 240 (n=78)
    0.40 ( 221.9 )
        Week 264 (n=65)
    0.36 ( 178.6 )
        Week 288 (n=68)
    0.36 ( 215.6 )
        Week 312 (n=68)
    0.32 ( 160.2 )
        Week 336 (n=84)
    0.48 ( 302.7 )
        Week 360 (n=89)
    0.39 ( 221.2 )
        Week 384 (n=74)
    0.37 ( 185.9 )
        Week 408 (n=56)
    0.29 ( 195.5 )
        Week 432 (n=51)
    0.35 ( 161.1 )
        Week 456 (n=39)
    0.32 ( 139.8 )
        Week 480 (n=21)
    0.17 ( 33.0 )
        Week 504 (n=3)
    0.15 ( 0.0 )
        Week 528 (n=1)
    0.15 ( 99999 )
    No statistical analyses for this end point

    Secondary: Serum Concentration of Satralizumab at Specified Timepoints

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    End point title
    		 Serum Concentration of Satralizumab at Specified Timepoints
    End point description
    Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed is the number of participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4, Week 5, Week 6; every 4 weeks from Weeks 8 to 192; every 24 weeks from Weeks 216 to 528
    End point values
    		 Satralizumab
    Number of subjects analysed
    164
    Units: nanograms/litre (ng/L)
    geometric mean (geometric coefficient of variation)
        Baseline (n=164)
    103.75 ( 29.7 )
        Week 2 (n=102)
    7489.76 ( 102.8 )
        Week 4 (n=155)
    14631.06 ( 95.9 )
        Week 5 (n=64)
    20068.86 ( 105.6 )
        Week 6 (n=62)
    17495.09 ( 157.7 )
        Week 8 (n=160)
    12673.14 ( 190.9 )
        Week 12 (n=158)
    11031.23 ( 220.8 )
        Week 16 (n=152)
    10588.85 ( 250.6 )
        Week 20 (n=157)
    10065.62 ( 305.1 )
        Week 24 (n=154)
    10605.69 ( 306.1 )
        Week 28 (n=154)
    9730.68 ( 333.9 )
        Week 32 (n=153)
    10686.86 ( 282.5 )
        Week 36 (n=146)
    10036.31 ( 368.4 )
        Week 40 (n=143)
    9508.64 ( 400.1 )
        Week 44 (n=150)
    9891.10 ( 361.9 )
        Week 48 (n=144)
    11282.31 ( 311.3 )
        Week 52 (n=93)
    9585.58 ( 500.8 )
        Week 56 (n=93)
    9209.84 ( 468.2 )
        Week 60 (n=91)
    10090.62 ( 394.0 )
        Week 64 (n=88)
    9186.35 ( 376.7 )
        Week 68 (n=83)
    9951.51 ( 359.5 )
        Week 72 (n=131)
    10737.11 ( 340.8 )
        Week 76 (n=82)
    8414.98 ( 522.7 )
        Week 80 (n=74)
    8557.82 ( 431.6 )
        Week 84 (n=77)
    8208.84 ( 473.6 )
        Week 88 (n=73)
    8457.80 ( 498.3 )
        Week 92 (n=71)
    8316.17 ( 510.7 )
        Week 96 (n=119)
    10560.87 ( 329.6 )
        Week 100 (n=70)
    9841.13 ( 361.2 )
        Week 104 (n=68)
    11256.29 ( 278.2 )
        Week 108 (n=71)
    10521.75 ( 273.5 )
        Week 112 (n=71)
    10362.73 ( 314.0 )
        Week 116 (n=63)
    11219.11 ( 331.1 )
        Week 120 (n=105)
    11619.05 ( 315.4 )
        Week 124 (n=66)
    9680.42 ( 354.6 )
        Week 128 (n=62)
    8727.98 ( 362.3 )
        Week 132 (n=65)
    8378.76 ( 437.7 )
        Week 136 (n=61)
    10182.79 ( 294.2 )
        Week 140 (n=57)
    9731.57 ( 440.3 )
        Week 144 (n=101)
    11206.52 ( 328.4 )
        Week 148 (n=56)
    11605.26 ( 291.6 )
        Week 152 (n=45)
    12065.91 ( 352.8 )
        Week 156 (n=45)
    13017.85 ( 222.9 )
        Week 160 (n=50)
    13952.43 ( 173.1 )
        Week 164 (n=43)
    13869.87 ( 202.0 )
        Week 168 (n=85)
    14256.36 ( 183.0 )
        Week 172 (n=42)
    13018.63 ( 227.2 )
        Week 176 (n=37)
    11989.36 ( 330.9 )
        Week 180 (n=42)
    15333.00 ( 150.7 )
        Week 184 (n=43)
    16449.28 ( 101.1 )
        Week 188 (n=43)
    14519.13 ( 221.7 )
        Week 192 (n=106)
    11926.93 ( 284.9 )
        Week 216 (n=123)
    10582.11 ( 404.7 )
        Week 240 (n=114)
    13683.03 ( 237.7 )
        Week 264 (n=116)
    11576.23 ( 326.0 )
        Week 288 (n=108)
    13169.85 ( 221.9 )
        Week 312 (n=96)
    13007.87 ( 243.1 )
        Week 336 (n=91)
    10522.02 ( 407.6 )
        Week 360 (n=87)
    11604.67 ( 295.8 )
        Week 384 (n=70)
    14508.95 ( 303.3 )
        Week 408 (n=56)
    14652.75 ( 290.3 )
        Week 432 (n=49)
    13287.68 ( 329.1 )
        Week 456 (n=36)
    18532.35 ( 174.8 )
        Week 480 (n=19)
    26688.35 ( 56.3 )
        Week 504 (n=2)
    43917.08 ( 8.7 )
        Week 528 (n=1)
    57800.00 ( 99999 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-Drug Antibodies (ADAs) from the First Dose of Satralizumab in Studies 2013-003752-21 and 2015-005431-41

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    End point title
    		 Number of Participants with Anti-Drug Antibodies (ADAs) from the First Dose of Satralizumab in Studies 2013-003752-21 and 2015-005431-41
    End point description
    Number of ADA-positive participants & ADA-negative participants at baseline (baseline prevalence) & after drug administration (post-baseline incidence) were summarized. Baseline evaluable participants = participants with an ADA assay result at baseline. Post-baseline evaluable participants = participants with an ADA assay from at least one post-baseline sample. Participants positive for ADA= number of participants with positive ADA result. Participants negative for ADA=number of participants with negative or missing baseline ADA result(s) & all negative post-baseline results. Baseline = last observation collected on or before day of first study drug administration in parent studies. All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population is used for analysis. 'n'=number of participants with data available for analysis at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    First dose of satralizumab in parent studies up to 528 weeks
    End point values
    		 Satralizumab
    Number of subjects analysed
    166
    Units: participants
        Baseline|Positive (N=166)
    3
        Post-baseline|Positive (N=164)
    99
        Baseline|Negative (N=166)
    161
        Post-baseline|Negative (N=164)
    67
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 523 weeks
    Adverse event reporting additional description
    All Participants-treated population=all enrolled participants (in current study) who received at least 1 dose of satralizumab at any time either during parent studies or this study. First dosing visit in the current study or first satralizumab dosing visit in parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Satralizumab
    Reporting group description
    		 Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 mg as SC injection, Q4W up to a maximum duration of 3 years in this study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in current study are represented here.

    Serious adverse events
    		 Satralizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    44 / 166 (26.51%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer metastatic
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Rehabilitation therapy
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Mental disorder
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mental status changes
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fracture displacement
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Accidental exposure to product
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Limb fracture
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuromyelitis optica pseudo relapse
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia macrocytic
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cataract
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis E
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atypical mycobacterial infection
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sinusitis fungal
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic endocarditis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 166 (3.01%)
         occurrences causally related to treatment / all
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Satralizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    155 / 166 (93.37%)
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    13 / 166 (7.83%)
         occurrences all number
    30
    Lymphocyte count decreased
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    17
    Complement factor C4 decreased
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    11
    Blood fibrinogen decreased
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    17
    Blood creatine phosphokinase increased
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    12
    Blood cholesterol increased
         subjects affected / exposed
    14 / 166 (8.43%)
         occurrences all number
    23
    Alanine aminotransferase increased
         subjects affected / exposed
    14 / 166 (8.43%)
         occurrences all number
    20
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    11
    Injection related reaction
         subjects affected / exposed
    24 / 166 (14.46%)
         occurrences all number
    57
    Fall
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    21
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    21
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    15 / 166 (9.04%)
         occurrences all number
    24
    Headache
         subjects affected / exposed
    44 / 166 (26.51%)
         occurrences all number
    86
    Dizziness
         subjects affected / exposed
    15 / 166 (9.04%)
         occurrences all number
    20
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    16 / 166 (9.64%)
         occurrences all number
    26
    Leukopenia
         subjects affected / exposed
    18 / 166 (10.84%)
         occurrences all number
    33
    Iron deficiency anaemia
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    12
    Anaemia
         subjects affected / exposed
    15 / 166 (9.04%)
         occurrences all number
    19
    Lymphopenia
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    27
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    12
    Vomiting
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    11
    Toothache
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    14
    Nausea
         subjects affected / exposed
    21 / 166 (12.65%)
         occurrences all number
    27
    Diarrhoea
         subjects affected / exposed
    21 / 166 (12.65%)
         occurrences all number
    42
    Dental caries
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    18 / 166 (10.84%)
         occurrences all number
    23
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    19 / 166 (11.45%)
         occurrences all number
    22
    Oropharyngeal pain
         subjects affected / exposed
    17 / 166 (10.24%)
         occurrences all number
    21
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    17 / 166 (10.24%)
         occurrences all number
    20
    Depression
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    14
    Anxiety
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    11
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    26 / 166 (15.66%)
         occurrences all number
    43
    Myalgia
         subjects affected / exposed
    15 / 166 (9.04%)
         occurrences all number
    16
    Back pain
         subjects affected / exposed
    20 / 166 (12.05%)
         occurrences all number
    31
    Arthralgia
         subjects affected / exposed
    35 / 166 (21.08%)
         occurrences all number
    43
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    16 / 166 (9.64%)
         occurrences all number
    22
    Oral herpes
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    70
    Nasopharyngitis
         subjects affected / exposed
    48 / 166 (28.92%)
         occurrences all number
    132
    Influenza
         subjects affected / exposed
    13 / 166 (7.83%)
         occurrences all number
    14
    Gastroenteritis
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    17
    Ear infection
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    13
    Cystitis
         subjects affected / exposed
    15 / 166 (9.04%)
         occurrences all number
    18
    COVID-19
         subjects affected / exposed
    31 / 166 (18.67%)
         occurrences all number
    33
    Oedema peripheral
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    13
    Fatigue
         subjects affected / exposed
    17 / 166 (10.24%)
         occurrences all number
    22
    Eczema
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    11
    Rash
         subjects affected / exposed
    20 / 166 (12.05%)
         occurrences all number
    27
    Urinary tract infection
         subjects affected / exposed
    40 / 166 (24.10%)
         occurrences all number
    139
    Upper respiratory tract infection
         subjects affected / exposed
    46 / 166 (27.71%)
         occurrences all number
    172
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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