Neuromyelitis Optica Spectrum Disorder
Conditions
Brief summary
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.
Interventions
DRUGsatralizumab
Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years
Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day)
DRUGmycophenolate mofetil (MMF)
Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day
Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF * Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.
Exclusion criteria
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug * Evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency * Known active infection that requires delaying the next satralizumab dose at the time of enrollment * NMOSD relapse at the time of enrollment * Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 523 weeks | AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with it. AE can therefore be any unfavorable & unintended sign, symptoms/disease temporally associated with use of a medicinal (investigational) product, whether or not considered related to it. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. |
| Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | Baseline up to 523 weeks | An AESIs included potential drug induced liver injury and suspected transmission of an infectious agent by study drug defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate an infection in a participant exposed to a 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. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR) | Baseline up to 528 weeks | 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 neurological neuromyelitis optica (NMO) or NMOSD. New or worsening neurological symptoms that occur \< 31 days following onset of PDR were considered part of same relapse. The time point of relapse onset=time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). For participants who did not relapse at the time of analysis, TFR was censored at the clinical cutoff date (CCOD) or at the time of withdrawal from study. The first dosing visit in current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline. All TFR data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. |
| iPDR-free Rate up to Week 456 | Baseline up to Week 456 | iPDR free rate was defined as the percentage of participants who did not experience a protocol-defined relapse as assessed by the investigator. 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 (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. 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. |
| Percentage of Relapse-Free Participants | Baseline up to 528 weeks | 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 (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. 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. |
| Annualized Relapse Rate (ARR) | Baseline up to 528 weeks | ARR was calculated as total number of relapses experienced divided by the participant-years of the whole study period. Adjusted ARR was calculated using Poisson regression model adjusted by study identifier (BN40898, BN40900). ARR was assessed from randomization in parent studies to the first occurrence of the iPDR. PDR=occurrence of new/worsening neurological symptoms attributable to NMO/NMOSD. New or worsening neurological symptoms that occur \< 31 days following onset of a PDR were considered part of the same relapse. Time point of relapse onset=the time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). First dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All ARR data from time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. |
| Change in Expanded Disability Status Scale (EDSS) Score | Baseline and every 24 weeks (up to 528 weeks) | EDSS was a quantitative measure of disability and 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 represent increased disability. Baseline is the last observation on or before the day of first study drug administration in the current study or the parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. |
| Time to First EDSS Scores Worsening | Baseline up to 528 weeks | 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 a baseline score (BS) of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Participants were censored at date of last EDSS assessment or if no EDSS assessment was performed at randomization date. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. |
| Event-free Rate for EDSS Score Worsening up to Week 456 | Baseline up to Week 456 | Event-free rate for EDSS score worsening was defined as the 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 is defined as the last observation on/before the day of the first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Kaplan-Meier method was used to estimate the event-free rates. |
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to 523 weeks | C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include a-Wish to be Dead; b-Non-specific Active Suicidal Thoughts; c-Active Suicidal Ideation with Any Methods(Not Plan) without Intent to Act; d-Active Suicidal Ideation with Some Intent to Act, without 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/behavior is indicated by a yes answer to any of listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. |
| Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Baseline and every 24 weeks (up to 528 weeks) | Visual acuity is 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). Visual acuity scores (Snellen chart) 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, and logMAR 3.00 respectively. LogMAR \>= 1 is equivalent to Physically blind. A negative change from baseline indicates an improvement. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All VA data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. |
| Concentrations of Interleukin-6 (IL-6) in Blood | 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 | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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. |
| Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | 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 | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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. |
| Concentration of C-Reactive Protein (CRP) in Blood | 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 | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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. |
| Serum Concentration of Satralizumab at Specified Timepoints | 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 | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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. |
| Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 | First dose of satralizumab in parent studies up to end of study WN42349 (up to 523 weeks) | The number and percentage of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after drug administration (post-baseline incidence) were summarized. Baseline evaluable participants were participants with an ADA assay result at baseline. Post-baseline evaluable participants were 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) and all negative post-baseline results. Baseline was defined as 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. |
| Percentage of Participants Without EDSS Worsening | Baseline up to 528 weeks | 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 a BS of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (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). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any EDDS worsening events are reported here. Percentages have been rounded off to the nearest decimal point. |
| Number of Participants With Serious Infections and Hepatotoxicity | Baseline up to 523 weeks | 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 (NCT02028884/NCT02073279 ) was considered as baseline for this outcome measure. Data for all serious infections and hepatotoxicity from the time of randomization in the parent studies for satralizumab-treated participants are reported here. |
Countries
Bulgaria, Canada, Croatia, Germany, Hungary, Italy, Japan, Malaysia, Poland, Puerto Rico, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
A total of 119 participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 (NCT02028884) & BN40900 (NCT02073279) rolled over in study WN42349 at 53 sites in 17 countries. 'All Participants-treated population' is used to report results of this study, which includes 166 participants who received at least one dose of satralizumab at any time either during parent studies/this study, irrespective of enrollment in current study.
Pre-assignment details
Participants from NCT02028884 and NCT02073279 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.
Participants by arm
| Arm | Count |
|---|---|
| Satralizumab Participants rolled over from studies NCT02028884 and NCT02073279 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 the parent studies or this study, irrespective of enrollment in current study are represented here. | 166 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Non-Compliance With Study Drug | 3 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Reason not Specified | 12 |
| Overall Study | Switch To Commercial Satralizumab | 1 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | Satralizumab |
|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 47 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized White | 95 Participants |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 166 |
| other Total, other adverse events | 155 / 166 |
| serious Total, serious adverse events | 44 / 166 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with it. AE can therefore be any unfavorable & unintended sign, symptoms/disease temporally associated with use of a medicinal (investigational) product, whether or not considered related to it. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here.
Time frame: Baseline up to 523 weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Satralizumab | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 162 Participants |
| Satralizumab | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 44 Participants |
Primary
Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs
An AESIs included potential drug induced liver injury and suspected transmission of an infectious agent by study drug defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate an infection in a participant exposed to a 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. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here.
Time frame: Baseline up to 523 weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Satralizumab | Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | AESIs | 0 Participants |
| Satralizumab | Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | Selected AEs | 0 Participants |
Secondary
Annualized Relapse Rate (ARR)
ARR was calculated as total number of relapses experienced divided by the participant-years of the whole study period. Adjusted ARR was calculated using Poisson regression model adjusted by study identifier (BN40898, BN40900). ARR was assessed from randomization in parent studies to the first occurrence of the iPDR. PDR=occurrence of new/worsening neurological symptoms attributable to NMO/NMOSD. New or worsening neurological symptoms that occur \< 31 days following onset of a PDR were considered part of the same relapse. Time point of relapse onset=the time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). First dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All ARR data from time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here.
Time frame: Baseline up to 528 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Satralizumab | Annualized Relapse Rate (ARR) | 0.0788 relapses per participant-year |
Secondary
Change in Expanded Disability Status Scale (EDSS) Score
EDSS was a quantitative measure of disability and 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 represent increased disability. Baseline is the last observation on or before the day of first study drug administration in the current study or the parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here.
Time frame: Baseline and every 24 weeks (up to 528 weeks)
Population: 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. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 144 | -0.09 score on a scale | Standard Deviation 0.97 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Baseline | 3.80 score on a scale | Standard Deviation 1.57 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 24 | -0.08 score on a scale | Standard Deviation 0.77 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 120 | -0.14 score on a scale | Standard Deviation 0.9 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 168 | -0.16 score on a scale | Standard Deviation 0.9 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 192 | -0.13 score on a scale | Standard Deviation 0.95 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 216 | -0.22 score on a scale | Standard Deviation 0.99 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 240 | -0.21 score on a scale | Standard Deviation 0.95 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 384 | -0.37 score on a scale | Standard Deviation 1.22 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 408 | -0.26 score on a scale | Standard Deviation 1.2 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 432 | -0.31 score on a scale | Standard Deviation 1.16 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 456 | -0.31 score on a scale | Standard Deviation 1.23 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 480 | 0.00 score on a scale | Standard Deviation 1.03 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 504 | 0.00 score on a scale | — |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 528 | -0.50 score on a scale | — |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 48 | -0.16 score on a scale | Standard Deviation 0.72 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 72 | -0.14 score on a scale | Standard Deviation 0.8 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 96 | -0.18 score on a scale | Standard Deviation 0.86 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 264 | -0.25 score on a scale | Standard Deviation 0.92 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 288 | -0.34 score on a scale | Standard Deviation 0.99 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 312 | -0.44 score on a scale | Standard Deviation 1.02 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 336 | -0.42 score on a scale | Standard Deviation 1.15 |
| Satralizumab | Change in Expanded Disability Status Scale (EDSS) Score | Change from Baseline at Week 360 | -0.51 score on a scale | Standard Deviation 1.24 |
Secondary
Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart
Visual acuity is 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). Visual acuity scores (Snellen chart) 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, and logMAR 3.00 respectively. LogMAR \>= 1 is equivalent to Physically blind. A negative change from baseline indicates an improvement. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All VA data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here.
Time frame: Baseline and every 24 weeks (up to 528 weeks)
Population: 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 is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Baseline [OD] | 0.438 LogMAR units | Standard Deviation 0.746 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 24 [OD] | 0.028 LogMAR units | Standard Deviation 0.297 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 24 [OS] | 0.009 LogMAR units | Standard Deviation 0.329 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 48 [OD] | 0.014 LogMAR units | Standard Deviation 0.363 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 48 [OS] | 0.020 LogMAR units | Standard Deviation 0.385 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 96 [OD] | -0.024 LogMAR units | Standard Deviation 0.375 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 120 [OD] | 0.015 LogMAR units | Standard Deviation 0.404 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 120 [OS] | -0.065 LogMAR units | Standard Deviation 0.404 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 144 [OD] | -0.023 LogMAR units | Standard Deviation 0.379 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 144 [OS] | -0.054 LogMAR units | Standard Deviation 0.355 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 168 [OD] | -0.004 LogMAR units | Standard Deviation 0.338 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 192 [OS] | -0.056 LogMAR units | Standard Deviation 0.386 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 216 [OD] | 0.019 LogMAR units | Standard Deviation 0.427 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 240 [OS] | -0.085 LogMAR units | Standard Deviation 0.49 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 264 [OD] | -0.016 LogMAR units | Standard Deviation 0.421 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 264 [OS] | -0.074 LogMAR units | Standard Deviation 0.472 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 288 [OD] | 0.006 LogMAR units | Standard Deviation 0.386 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 288 [OS] | -0.085 LogMAR units | Standard Deviation 0.458 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 312 [OD] | -0.043 LogMAR units | Standard Deviation 0.42 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 312 [OS] | -0.106 LogMAR units | Standard Deviation 0.499 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 336 [OD] | -0.025 LogMAR units | Standard Deviation 0.47 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 336 [OS] | -0.112 LogMAR units | Standard Deviation 0.539 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 360 [OD] | -0.008 LogMAR units | Standard Deviation 0.4 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 360 [OS] | -0.122 LogMAR units | Standard Deviation 0.524 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 384 [OD] | 0.002 LogMAR units | Standard Deviation 0.421 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 384 [OS] | -0.086 LogMAR units | Standard Deviation 0.467 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 408 [OD] | 0.039 LogMAR units | Standard Deviation 0.466 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 432 [OD] | -0.010 LogMAR units | Standard Deviation 0.427 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 432 [OS] | -0.145 LogMAR units | Standard Deviation 0.509 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 456 [OD] | 0.011 LogMAR units | Standard Deviation 0.373 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 456 [OS] | -0.109 LogMAR units | Standard Deviation 0.509 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 480 [OD] | -0.106 LogMAR units | Standard Deviation 0.315 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 480 [OS] | -0.018 LogMAR units | Standard Deviation 0.185 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 504 [OS] | -0.320 LogMAR units | Standard Deviation 0.283 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 528 [OD] | 0.220 LogMAR units | — |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 528 [OS] | 0.300 LogMAR units | — |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Baseline [OS] | 0.566 LogMAR units | Standard Deviation 0.899 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 72 [OD] | -0.004 LogMAR units | Standard Deviation 0.34 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 72 [OS] | -0.017 LogMAR units | Standard Deviation 0.362 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 96 [OS] | -0.030 LogMAR units | Standard Deviation 0.317 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 168 [OS] | -0.053 LogMAR units | Standard Deviation 0.324 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 192 [OD] | 0.008 LogMAR units | Standard Deviation 0.383 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 216 [OS] | -0.069 LogMAR units | Standard Deviation 0.44 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 240 [OD] | 0.007 LogMAR units | Standard Deviation 0.465 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 408 [OS] | -0.071 LogMAR units | Standard Deviation 0.572 |
| Satralizumab | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Change from Baseline at Week 504 [OD] | -0.200 LogMAR units | Standard Deviation 0.141 |
Secondary
Concentration of C-Reactive Protein (CRP) in Blood
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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.
Time frame: 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
Population: 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. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 12 | 0.42 milligrams/litre (mg/L) | Geometric Coefficient of Variation 144.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 16 | 0.42 milligrams/litre (mg/L) | Geometric Coefficient of Variation 151.1 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 44 | 0.43 milligrams/litre (mg/L) | Geometric Coefficient of Variation 182.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 48 | 0.44 milligrams/litre (mg/L) | Geometric Coefficient of Variation 167.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 84 | 0.53 milligrams/litre (mg/L) | Geometric Coefficient of Variation 227.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 88 | 0.51 milligrams/litre (mg/L) | Geometric Coefficient of Variation 188 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 92 | 0.51 milligrams/litre (mg/L) | Geometric Coefficient of Variation 200.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 96 | 0.52 milligrams/litre (mg/L) | Geometric Coefficient of Variation 183.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 124 | 0.56 milligrams/litre (mg/L) | Geometric Coefficient of Variation 173.2 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 128 | 0.57 milligrams/litre (mg/L) | Geometric Coefficient of Variation 209.1 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 132 | 0.59 milligrams/litre (mg/L) | Geometric Coefficient of Variation 234.8 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 136 | 0.54 milligrams/litre (mg/L) | Geometric Coefficient of Variation 193.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 160 | 0.48 milligrams/litre (mg/L) | Geometric Coefficient of Variation 148.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 164 | 0.49 milligrams/litre (mg/L) | Geometric Coefficient of Variation 163.7 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 168 | 0.45 milligrams/litre (mg/L) | Geometric Coefficient of Variation 148.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 172 | 0.45 milligrams/litre (mg/L) | Geometric Coefficient of Variation 228.2 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 184 | 0.38 milligrams/litre (mg/L) | Geometric Coefficient of Variation 197.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 188 | 0.46 milligrams/litre (mg/L) | Geometric Coefficient of Variation 154 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 192 | 0.40 milligrams/litre (mg/L) | Geometric Coefficient of Variation 188.5 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 216 | 0.30 milligrams/litre (mg/L) | Geometric Coefficient of Variation 110.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 240 | 0.40 milligrams/litre (mg/L) | Geometric Coefficient of Variation 221.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 312 | 0.32 milligrams/litre (mg/L) | Geometric Coefficient of Variation 160.2 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 336 | 0.48 milligrams/litre (mg/L) | Geometric Coefficient of Variation 302.7 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 360 | 0.39 milligrams/litre (mg/L) | Geometric Coefficient of Variation 221.2 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 504 | 0.15 milligrams/litre (mg/L) | Geometric Coefficient of Variation 0 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Baseline | 1.27 milligrams/litre (mg/L) | Geometric Coefficient of Variation 226.6 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 2 | 0.38 milligrams/litre (mg/L) | Geometric Coefficient of Variation 118 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 4 | 0.36 milligrams/litre (mg/L) | Geometric Coefficient of Variation 113.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 8 | 0.39 milligrams/litre (mg/L) | Geometric Coefficient of Variation 125.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 20 | 0.41 milligrams/litre (mg/L) | Geometric Coefficient of Variation 157.8 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 24 | 0.44 milligrams/litre (mg/L) | Geometric Coefficient of Variation 161 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 28 | 0.41 milligrams/litre (mg/L) | Geometric Coefficient of Variation 175.7 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 32 | 0.44 milligrams/litre (mg/L) | Geometric Coefficient of Variation 171.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 36 | 0.43 milligrams/litre (mg/L) | Geometric Coefficient of Variation 185.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 40 | 0.48 milligrams/litre (mg/L) | Geometric Coefficient of Variation 184.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 52 | 0.50 milligrams/litre (mg/L) | Geometric Coefficient of Variation 177.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 56 | 0.47 milligrams/litre (mg/L) | Geometric Coefficient of Variation 183.8 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 60 | 0.49 milligrams/litre (mg/L) | Geometric Coefficient of Variation 183.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 64 | 0.47 milligrams/litre (mg/L) | Geometric Coefficient of Variation 177.6 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 68 | 0.52 milligrams/litre (mg/L) | Geometric Coefficient of Variation 194.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 72 | 0.50 milligrams/litre (mg/L) | Geometric Coefficient of Variation 223.7 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 76 | 0.51 milligrams/litre (mg/L) | Geometric Coefficient of Variation 189.5 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 80 | 0.51 milligrams/litre (mg/L) | Geometric Coefficient of Variation 200.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 100 | 0.52 milligrams/litre (mg/L) | Geometric Coefficient of Variation 231.4 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 104 | 0.46 milligrams/litre (mg/L) | Geometric Coefficient of Variation 167.3 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 108 | 0.51 milligrams/litre (mg/L) | Geometric Coefficient of Variation 161.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 112 | 0.48 milligrams/litre (mg/L) | Geometric Coefficient of Variation 191.7 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 116 | 0.43 milligrams/litre (mg/L) | Geometric Coefficient of Variation 177 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 120 | 0.52 milligrams/litre (mg/L) | Geometric Coefficient of Variation 227.6 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 140 | 0.61 milligrams/litre (mg/L) | Geometric Coefficient of Variation 283.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 144 | 0.47 milligrams/litre (mg/L) | Geometric Coefficient of Variation 205.6 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 148 | 0.47 milligrams/litre (mg/L) | Geometric Coefficient of Variation 152 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 152 | 0.51 milligrams/litre (mg/L) | Geometric Coefficient of Variation 147.8 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 156 | 0.47 milligrams/litre (mg/L) | Geometric Coefficient of Variation 129.5 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 176 | 0.39 milligrams/litre (mg/L) | Geometric Coefficient of Variation 156.7 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 180 | 0.42 milligrams/litre (mg/L) | Geometric Coefficient of Variation 156.6 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 264 | 0.36 milligrams/litre (mg/L) | Geometric Coefficient of Variation 178.6 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 288 | 0.36 milligrams/litre (mg/L) | Geometric Coefficient of Variation 215.6 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 384 | 0.37 milligrams/litre (mg/L) | Geometric Coefficient of Variation 185.9 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 408 | 0.29 milligrams/litre (mg/L) | Geometric Coefficient of Variation 195.5 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 432 | 0.35 milligrams/litre (mg/L) | Geometric Coefficient of Variation 161.1 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 456 | 0.32 milligrams/litre (mg/L) | Geometric Coefficient of Variation 139.8 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 480 | 0.17 milligrams/litre (mg/L) | Geometric Coefficient of Variation 33 |
| Satralizumab | Concentration of C-Reactive Protein (CRP) in Blood | Week 528 | 0.15 milligrams/litre (mg/L) | — |
Secondary
Concentrations of Interleukin-6 (IL-6) in Blood
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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.
Time frame: 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
Population: 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. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 8 | 19.35 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 110.2 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 12 | 18.84 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 99.9 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 16 | 17.53 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 108.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 20 | 17.16 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 108.1 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 24 | 17.77 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 101.9 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 28 | 17.08 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 109.6 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 32 | 18.32 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 107.1 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 36 | 18.29 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 95.7 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 40 | 16.21 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 95.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 44 | 17.59 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 108.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 48 | 18.59 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 105.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 52 | 18.55 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 101.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 56 | 18.78 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 124.2 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 60 | 20.56 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 99.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 64 | 20.04 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 98.2 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 68 | 19.70 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 95.6 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 72 | 18.48 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 103.7 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 120 | 19.26 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 108 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 124 | 18.41 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 98.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 128 | 18.17 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 93.3 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 144 | 16.54 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 101.1 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 148 | 18.95 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 82.9 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 152 | 19.71 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 100.3 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 156 | 20.84 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 78.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 160 | 19.91 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 81.3 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 164 | 19.76 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 76.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 168 | 22.33 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 87.4 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 172 | 21.94 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 82.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 176 | 23.31 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 75.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 180 | 21.28 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 78.4 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 184 | 23.23 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 98 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 312 | 21.70 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 82.1 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 336 | 17.71 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 103 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 360 | 19.40 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 77.1 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 408 | 18.94 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 113.3 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 432 | 19.29 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 124 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 456 | 17.90 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 94.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 480 | 20.89 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 42.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 504 | 8.40 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 32.4 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 528 | 13.50 picograms/millilitre (pg/mL) | — |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Baseline | 2.07 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 70.3 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 2 | 21.27 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 97 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 4 | 21.90 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 108.2 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 76 | 18.05 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 89 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 80 | 17.93 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 101.2 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 84 | 18.44 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 111.1 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 88 | 20.33 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 89.1 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 92 | 17.12 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 100.7 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 96 | 19.72 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 107.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 100 | 19.73 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 111.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 104 | 19.34 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 82.6 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 108 | 19.74 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 94.9 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 112 | 21.39 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 95.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 116 | 17.98 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 93.4 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 132 | 17.83 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 98.6 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 136 | 19.22 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 100.4 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 140 | 17.62 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 91.5 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 188 | 23.52 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 86 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 192 | 22.25 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 76.4 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 216 | 19.41 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 102 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 240 | 18.22 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 101.8 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 264 | 18.56 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 99.6 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 288 | 19.17 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 94.4 |
| Satralizumab | Concentrations of Interleukin-6 (IL-6) in Blood | Week 384 | 19.68 picograms/millilitre (pg/mL) | Geometric Coefficient of Variation 91.2 |
Secondary
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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.
Time frame: 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
Population: 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. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Baseline | 32.27 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 29 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 2 | 404.20 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 22.1 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 60 | 549.23 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 58.7 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 64 | 550.61 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 62.7 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 116 | 571.37 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 62 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 120 | 615.02 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 42.7 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 124 | 590.17 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 53.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 128 | 559.85 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 58.7 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 132 | 580.53 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 45 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 136 | 607.27 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 38.6 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 144 | 571.70 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 61.2 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 148 | 610.47 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 43.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 152 | 565.34 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 73.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 184 | 684.07 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 18.5 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 188 | 666.52 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 30.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 384 | 549.57 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 58 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 408 | 586.95 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 62.4 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 4 | 536.46 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 28.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 8 | 566.91 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 49.4 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 12 | 568.96 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 53.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 16 | 561.69 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 56.2 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 20 | 543.99 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 63.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 24 | 556.84 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 60.5 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 28 | 547.77 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 64 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 32 | 574.72 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 50.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 36 | 552.54 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 61.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 40 | 556.08 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 62.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 44 | 569.26 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 62.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 48 | 575.25 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 58.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 52 | 555.92 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 60.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 56 | 523.80 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 71.6 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 68 | 581.62 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 61.5 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 72 | 540.99 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 66.6 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 76 | 519.20 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 74.5 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 80 | 535.83 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 73.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 84 | 533.47 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 66.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 88 | 523.64 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 69.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 92 | 515.37 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 74.5 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 96 | 526.59 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 70.4 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 100 | 534.72 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 71.2 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 104 | 583.53 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 55.1 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 108 | 578.63 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 57.1 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 112 | 594.60 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 61 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 140 | 592.84 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 43.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 156 | 667.59 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 22.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 160 | 652.90 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 28.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 164 | 636.27 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 34.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 168 | 662.43 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 29.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 172 | 643.84 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 36.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 176 | 670.38 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 28.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 180 | 655.31 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 35 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 192 | 611.46 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 67 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 216 | 592.12 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 68.9 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 240 | 587.26 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 58.7 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 264 | 570.35 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 45.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 288 | 572.20 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 52.2 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 312 | 608.11 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 35 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 336 | 533.73 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 71.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 360 | 557.05 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 55.3 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 432 | 569.09 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 42.7 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 456 | 561.16 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 56.8 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 480 | 652.16 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 18 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 504 | 668.04 nanograms/millilitre (ng/mL) | Geometric Coefficient of Variation 13.4 |
| Satralizumab | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Week 528 | 910.00 nanograms/millilitre (ng/mL) | — |
Secondary
Event-free Rate for EDSS Score Worsening up to Week 456
Event-free rate for EDSS score worsening was defined as the 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 is defined as the last observation on/before the day of the first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Kaplan-Meier method was used to estimate the event-free rates.
Time frame: Baseline up to Week 456
Population: 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. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Satralizumab | Event-free Rate for EDSS Score Worsening up to Week 456 | 57.03 percentage of participants |
Secondary
iPDR-free Rate up to Week 456
iPDR free rate was defined as the percentage of participants who did not experience a protocol-defined relapse as assessed by the investigator. 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 (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. 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.
Time frame: Baseline up to Week 456
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Satralizumab | iPDR-free Rate up to Week 456 | 67.11 percentage of participants |
Secondary
Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279
The number and percentage of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after drug administration (post-baseline incidence) were summarized. Baseline evaluable participants were participants with an ADA assay result at baseline. Post-baseline evaluable participants were 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) and all negative post-baseline results. Baseline was defined as 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.
Time frame: First dose of satralizumab in parent studies up to end of study WN42349 (up to 523 weeks)
Population: 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 at the specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Satralizumab | Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 | Post-baseline | Positive | 99 Participants |
| Satralizumab | Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 | Baseline | Positive | 3 Participants |
| Satralizumab | Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 | Baseline | Negative | 161 Participants |
| Satralizumab | Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 | Post-baseline | Negative | 67 Participants |
Secondary
Number of Participants With Serious Infections and Hepatotoxicity
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 (NCT02028884/NCT02073279 ) was considered as baseline for this outcome measure. Data for all serious infections and hepatotoxicity from the time of randomization in the parent studies for satralizumab-treated participants are reported here.
Time frame: Baseline up to 523 weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Satralizumab | Number of Participants With Serious Infections and Hepatotoxicity | Serious Infections | 19 Participants |
| Satralizumab | Number of Participants With Serious Infections and Hepatotoxicity | Hepatotoxicity | 8 Participants |
Secondary
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include a-Wish to be Dead; b-Non-specific Active Suicidal Thoughts; c-Active Suicidal Ideation with Any Methods(Not Plan) without Intent to Act; d-Active Suicidal Ideation with Some Intent to Act, without 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/behavior is indicated by a yes answer to any of listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
Time frame: Baseline up to 523 weeks
Population: 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. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies for satralizumab-treated participants are reported here.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | a- Baseline | 7 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | a- Post-baseline | 5 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | b- Baseline | 5 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | c- Baseline | 1 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | d- Post-baseline | 0 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | e- Baseline | 1 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | e- Post-baseline | 0 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | f- Post-baseline | 0 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | i- Baseline | 3 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | i- Post-baseline | 1 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | b- Post-baseline | 2 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | c- Post-baseline | 0 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | d- Baseline | 1 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | f- Baseline | 2 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | j- Baseline | 0 Participants |
| Satralizumab | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | j- Post-baseline | 1 Participants |
Secondary
Percentage of Participants Without EDSS Worsening
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 a BS of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (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). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any EDDS worsening events are reported here. Percentages have been rounded off to the nearest decimal point.
Time frame: Baseline up to 528 weeks
Population: 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. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Satralizumab | Percentage of Participants Without EDSS Worsening | 64.8 percentage of participants |
Secondary
Percentage of Relapse-Free Participants
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 (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. 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.
Time frame: Baseline up to 528 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Satralizumab | Percentage of Relapse-Free Participants | 70.5 percentage of participants |
Secondary
Serum Concentration of Satralizumab at Specified Timepoints
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). 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.
Time frame: 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
Population: 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. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Baseline | 103.75 nanograms/litre (ng/L) | Geometric Coefficient of Variation 29.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 6 | 17495.09 nanograms/litre (ng/L) | Geometric Coefficient of Variation 157.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 44 | 9891.10 nanograms/litre (ng/L) | Geometric Coefficient of Variation 361.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 48 | 11282.31 nanograms/litre (ng/L) | Geometric Coefficient of Variation 311.3 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 52 | 9585.58 nanograms/litre (ng/L) | Geometric Coefficient of Variation 500.8 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 56 | 9209.84 nanograms/litre (ng/L) | Geometric Coefficient of Variation 468.2 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 60 | 10090.62 nanograms/litre (ng/L) | Geometric Coefficient of Variation 394 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 84 | 8208.84 nanograms/litre (ng/L) | Geometric Coefficient of Variation 473.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 88 | 8457.80 nanograms/litre (ng/L) | Geometric Coefficient of Variation 498.3 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 92 | 8316.17 nanograms/litre (ng/L) | Geometric Coefficient of Variation 510.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 124 | 9680.42 nanograms/litre (ng/L) | Geometric Coefficient of Variation 354.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 128 | 8727.98 nanograms/litre (ng/L) | Geometric Coefficient of Variation 362.3 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 132 | 8378.76 nanograms/litre (ng/L) | Geometric Coefficient of Variation 437.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 136 | 10182.79 nanograms/litre (ng/L) | Geometric Coefficient of Variation 294.2 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 172 | 13018.63 nanograms/litre (ng/L) | Geometric Coefficient of Variation 227.2 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 176 | 11989.36 nanograms/litre (ng/L) | Geometric Coefficient of Variation 330.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 288 | 13169.85 nanograms/litre (ng/L) | Geometric Coefficient of Variation 221.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 312 | 13007.87 nanograms/litre (ng/L) | Geometric Coefficient of Variation 243.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 456 | 18532.35 nanograms/litre (ng/L) | Geometric Coefficient of Variation 174.8 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 480 | 26688.35 nanograms/litre (ng/L) | Geometric Coefficient of Variation 56.3 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 504 | 43917.08 nanograms/litre (ng/L) | Geometric Coefficient of Variation 8.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 2 | 7489.76 nanograms/litre (ng/L) | Geometric Coefficient of Variation 102.8 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 4 | 14631.06 nanograms/litre (ng/L) | Geometric Coefficient of Variation 95.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 5 | 20068.86 nanograms/litre (ng/L) | Geometric Coefficient of Variation 105.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 8 | 12673.14 nanograms/litre (ng/L) | Geometric Coefficient of Variation 190.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 12 | 11031.23 nanograms/litre (ng/L) | Geometric Coefficient of Variation 220.8 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 16 | 10588.85 nanograms/litre (ng/L) | Geometric Coefficient of Variation 250.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 20 | 10065.62 nanograms/litre (ng/L) | Geometric Coefficient of Variation 305.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 24 | 10605.69 nanograms/litre (ng/L) | Geometric Coefficient of Variation 306.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 28 | 9730.68 nanograms/litre (ng/L) | Geometric Coefficient of Variation 333.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 32 | 10686.86 nanograms/litre (ng/L) | Geometric Coefficient of Variation 282.5 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 36 | 10036.31 nanograms/litre (ng/L) | Geometric Coefficient of Variation 368.4 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 40 | 9508.64 nanograms/litre (ng/L) | Geometric Coefficient of Variation 400.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 64 | 9186.35 nanograms/litre (ng/L) | Geometric Coefficient of Variation 376.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 68 | 9951.51 nanograms/litre (ng/L) | Geometric Coefficient of Variation 359.5 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 72 | 10737.11 nanograms/litre (ng/L) | Geometric Coefficient of Variation 340.8 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 76 | 8414.98 nanograms/litre (ng/L) | Geometric Coefficient of Variation 522.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 80 | 8557.82 nanograms/litre (ng/L) | Geometric Coefficient of Variation 431.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 96 | 10560.87 nanograms/litre (ng/L) | Geometric Coefficient of Variation 329.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 100 | 9841.13 nanograms/litre (ng/L) | Geometric Coefficient of Variation 361.2 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 104 | 11256.29 nanograms/litre (ng/L) | Geometric Coefficient of Variation 278.2 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 108 | 10521.75 nanograms/litre (ng/L) | Geometric Coefficient of Variation 273.5 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 112 | 10362.73 nanograms/litre (ng/L) | Geometric Coefficient of Variation 314 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 116 | 11219.11 nanograms/litre (ng/L) | Geometric Coefficient of Variation 331.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 120 | 11619.05 nanograms/litre (ng/L) | Geometric Coefficient of Variation 315.4 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 140 | 9731.57 nanograms/litre (ng/L) | Geometric Coefficient of Variation 440.3 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 144 | 11206.52 nanograms/litre (ng/L) | Geometric Coefficient of Variation 328.4 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 148 | 11605.26 nanograms/litre (ng/L) | Geometric Coefficient of Variation 291.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 152 | 12065.91 nanograms/litre (ng/L) | Geometric Coefficient of Variation 352.8 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 156 | 13017.85 nanograms/litre (ng/L) | Geometric Coefficient of Variation 222.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 160 | 13952.43 nanograms/litre (ng/L) | Geometric Coefficient of Variation 173.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 164 | 13869.87 nanograms/litre (ng/L) | Geometric Coefficient of Variation 202 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 168 | 14256.36 nanograms/litre (ng/L) | Geometric Coefficient of Variation 183 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 180 | 15333.00 nanograms/litre (ng/L) | Geometric Coefficient of Variation 150.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 184 | 16449.28 nanograms/litre (ng/L) | Geometric Coefficient of Variation 101.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 188 | 14519.13 nanograms/litre (ng/L) | Geometric Coefficient of Variation 221.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 192 | 11926.93 nanograms/litre (ng/L) | Geometric Coefficient of Variation 284.9 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 216 | 10582.11 nanograms/litre (ng/L) | Geometric Coefficient of Variation 404.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 240 | 13683.03 nanograms/litre (ng/L) | Geometric Coefficient of Variation 237.7 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 264 | 11576.23 nanograms/litre (ng/L) | Geometric Coefficient of Variation 326 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 336 | 10522.02 nanograms/litre (ng/L) | Geometric Coefficient of Variation 407.6 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 360 | 11604.67 nanograms/litre (ng/L) | Geometric Coefficient of Variation 295.8 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 384 | 14508.95 nanograms/litre (ng/L) | Geometric Coefficient of Variation 303.3 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 408 | 14652.75 nanograms/litre (ng/L) | Geometric Coefficient of Variation 290.3 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 432 | 13287.68 nanograms/litre (ng/L) | Geometric Coefficient of Variation 329.1 |
| Satralizumab | Serum Concentration of Satralizumab at Specified Timepoints | Week 528 | 57800.00 nanograms/litre (ng/L) | — |
Secondary
Time to First EDSS Scores Worsening
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 a baseline score (BS) of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Participants were censored at date of last EDSS assessment or if no EDSS assessment was performed at randomization date. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here.
Time frame: Baseline up to 528 weeks
Population: 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. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Satralizumab | Time to First EDSS Scores Worsening | NA weeks |
Secondary
Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR)
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 neurological neuromyelitis optica (NMO) or NMOSD. New or worsening neurological symptoms that occur \< 31 days following onset of PDR were considered part of same relapse. The time point of relapse onset=time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). For participants who did not relapse at the time of analysis, TFR was censored at the clinical cutoff date (CCOD) or at the time of withdrawal from study. The first dosing visit in current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline. All TFR data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here.
Time frame: Baseline up to 528 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Satralizumab | Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR) | NA weeks |