Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) (NCT NCT04660539)

Last Updated: 2024-12-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

Baseline up to 523 weeks

Results posted on

2024-12-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Satralizumab Participants rolled over from studies NCT02028884 and NCT02073279 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (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.
Overall Study STARTED	166
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Satralizumab Participants rolled over from studies NCT02028884 and NCT02073279 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (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.
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 Reason not Specified	12
Overall Study Pregnancy	2
Overall Study Protocol Violation	2
Overall Study Switch To Commercial Satralizumab	1
Overall Study Withdrawal by Subject	21

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Satralizumab n=166 Participants 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.
Age, Continuous	42.7 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	147 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	47 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	17 Participants n=5 Participants
Race/Ethnicity, Customized White	95 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 523 weeks

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	162 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	44 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs AESIs	0 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs Selected AEs	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) a- Baseline	7 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) a- Post-baseline	5 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) b- Baseline	5 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) b- Post-baseline	2 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) c- Baseline	1 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) c- Post-baseline	0 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) d- Baseline	1 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) d- Post-baseline	0 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) e- Baseline	1 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) e- Post-baseline	0 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) f- Baseline	2 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) f- Post-baseline	0 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) i- Baseline	3 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) i- Post-baseline	1 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) j- Baseline	0 Participants
Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) j- Post-baseline	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Number of Participants With Serious Infections and Hepatotoxicity Serious Infections	19 Participants
Number of Participants With Serious Infections and Hepatotoxicity Hepatotoxicity	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR)	NA weeks Median and 95% CI was not estimable because there was an insufficient number of participants with events.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
iPDR-free Rate up to Week 456	67.11 percentage of participants Interval 58.61 to 74.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Percentage of Relapse-Free Participants	70.5 percentage of participants Interval 58.61 to 74.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Annualized Relapse Rate (ARR)	0.0788 relapses per participant-year Interval 0.0633 to 0.0982

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=165 Participants 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.
Change in Expanded Disability Status Scale (EDSS) Score Baseline	3.80 score on a scale Standard Deviation 1.57
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 24	-0.08 score on a scale Standard Deviation 0.77
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 48	-0.16 score on a scale Standard Deviation 0.72
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 72	-0.14 score on a scale Standard Deviation 0.80
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 96	-0.18 score on a scale Standard Deviation 0.86
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 120	-0.14 score on a scale Standard Deviation 0.90
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 144	-0.09 score on a scale Standard Deviation 0.97
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 168	-0.16 score on a scale Standard Deviation 0.90
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 192	-0.13 score on a scale Standard Deviation 0.95
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 216	-0.22 score on a scale Standard Deviation 0.99
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 240	-0.21 score on a scale Standard Deviation 0.95
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 264	-0.25 score on a scale Standard Deviation 0.92
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 288	-0.34 score on a scale Standard Deviation 0.99
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 312	-0.44 score on a scale Standard Deviation 1.02
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 336	-0.42 score on a scale Standard Deviation 1.15
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 360	-0.51 score on a scale Standard Deviation 1.24
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 384	-0.37 score on a scale Standard Deviation 1.22
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 408	-0.26 score on a scale Standard Deviation 1.20
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 432	-0.31 score on a scale Standard Deviation 1.16
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 456	-0.31 score on a scale Standard Deviation 1.23
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 480	0.00 score on a scale Standard Deviation 1.03
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 504	0.00 score on a scale Standard Deviation NA Since only 1 participant was analyzed, standard deviation (SD) could not be calculated.
Change in Expanded Disability Status Scale (EDSS) Score Change from Baseline at Week 528	-0.50 score on a scale Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=165 Participants 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.
Time to First EDSS Scores Worsening	NA weeks Interval 398.1 to Median and upper limit of 95% CI was not estimable because there was an insufficient number of participants with events.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=165 Participants 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.
Event-free Rate for EDSS Score Worsening up to Week 456	57.03 percentage of participants Interval 46.8 to 66.01

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Satralizumab n=165 Participants 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.
Percentage of Participants Without EDSS Worsening	64.8 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart Baseline [OD]	0.438 LogMAR units Standard Deviation 0.746
Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart Baseline [OS]	0.566 LogMAR units Standard Deviation 0.899
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
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
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
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
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 0.340
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
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
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
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
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
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
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
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
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
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
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
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
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 0.440
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
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 0.490
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
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
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
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
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 0.420
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
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 0.470
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
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 0.400
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
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
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
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
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
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
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
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
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
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
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
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
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
Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart Change from Baseline at Week 528 [OD]	0.220 LogMAR units Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.
Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart Change from Baseline at Week 528 [OS]	0.300 LogMAR units Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.

SECONDARY outcome

Timeframe: Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528

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.

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=163 Participants 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.
Concentrations of Interleukin-6 (IL-6) in Blood Week 104	19.34 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 82.6
Concentrations of Interleukin-6 (IL-6) in Blood Week 108	19.74 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 94.9
Concentrations of Interleukin-6 (IL-6) in Blood Week 112	21.39 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 95.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 116	17.98 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 93.4
Concentrations of Interleukin-6 (IL-6) in Blood Week 120	19.26 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 108.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 124	18.41 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 98.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 128	18.17 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 93.3
Concentrations of Interleukin-6 (IL-6) in Blood Week 132	17.83 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 98.6
Concentrations of Interleukin-6 (IL-6) in Blood Week 136	19.22 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 100.4
Concentrations of Interleukin-6 (IL-6) in Blood Week 140	17.62 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 91.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 144	16.54 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 101.1
Concentrations of Interleukin-6 (IL-6) in Blood Week 148	18.95 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 82.9
Concentrations of Interleukin-6 (IL-6) in Blood Week 152	19.71 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 100.3
Concentrations of Interleukin-6 (IL-6) in Blood Week 156	20.84 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 78.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 160	19.91 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 81.3
Concentrations of Interleukin-6 (IL-6) in Blood Week 164	19.76 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 76.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 168	22.33 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 87.4
Concentrations of Interleukin-6 (IL-6) in Blood Week 172	21.94 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 82.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 176	23.31 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 75.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 180	21.28 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 78.4
Concentrations of Interleukin-6 (IL-6) in Blood Week 184	23.23 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 98.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 188	23.52 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 86.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 192	22.25 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 76.4
Concentrations of Interleukin-6 (IL-6) in Blood Week 216	19.41 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 102.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 240	18.22 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 101.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 264	18.56 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 99.6
Concentrations of Interleukin-6 (IL-6) in Blood Week 288	19.17 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 94.4
Concentrations of Interleukin-6 (IL-6) in Blood Week 312	21.70 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 82.1
Concentrations of Interleukin-6 (IL-6) in Blood Week 336	17.71 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 103.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 360	19.40 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 77.1
Concentrations of Interleukin-6 (IL-6) in Blood Week 384	19.68 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 91.2
Concentrations of Interleukin-6 (IL-6) in Blood Week 408	18.94 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 113.3
Concentrations of Interleukin-6 (IL-6) in Blood Week 432	19.29 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 124.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 456	17.90 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 94.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 480	20.89 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 42.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 504	8.40 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 32.4
Concentrations of Interleukin-6 (IL-6) in Blood Week 528	13.50 picograms/millilitre (pg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
Concentrations of Interleukin-6 (IL-6) in Blood Baseline	2.07 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 70.3
Concentrations of Interleukin-6 (IL-6) in Blood Week 2	21.27 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 97.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 4	21.90 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 108.2
Concentrations of Interleukin-6 (IL-6) in Blood Week 8	19.35 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 110.2
Concentrations of Interleukin-6 (IL-6) in Blood Week 12	18.84 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 99.9
Concentrations of Interleukin-6 (IL-6) in Blood Week 16	17.53 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 108.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 20	17.16 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 108.1
Concentrations of Interleukin-6 (IL-6) in Blood Week 24	17.77 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 101.9
Concentrations of Interleukin-6 (IL-6) in Blood Week 28	17.08 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 109.6
Concentrations of Interleukin-6 (IL-6) in Blood Week 32	18.32 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 107.1
Concentrations of Interleukin-6 (IL-6) in Blood Week 36	18.29 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 95.7
Concentrations of Interleukin-6 (IL-6) in Blood Week 40	16.21 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 95.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 44	17.59 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 108.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 48	18.59 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 105.5
Concentrations of Interleukin-6 (IL-6) in Blood Week 52	18.55 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 101.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 56	18.78 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 124.2
Concentrations of Interleukin-6 (IL-6) in Blood Week 60	20.56 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 99.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 64	20.04 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 98.2
Concentrations of Interleukin-6 (IL-6) in Blood Week 68	19.70 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 95.6
Concentrations of Interleukin-6 (IL-6) in Blood Week 72	18.48 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 103.7
Concentrations of Interleukin-6 (IL-6) in Blood Week 76	18.05 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 89.0
Concentrations of Interleukin-6 (IL-6) in Blood Week 80	17.93 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 101.2
Concentrations of Interleukin-6 (IL-6) in Blood Week 84	18.44 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 111.1
Concentrations of Interleukin-6 (IL-6) in Blood Week 88	20.33 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 89.1
Concentrations of Interleukin-6 (IL-6) in Blood Week 92	17.12 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 100.7
Concentrations of Interleukin-6 (IL-6) in Blood Week 96	19.72 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 107.8
Concentrations of Interleukin-6 (IL-6) in Blood Week 100	19.73 picograms/millilitre (pg/mL) Geometric Coefficient of Variation 111.5

SECONDARY outcome

Timeframe: Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=164 Participants 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.
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 128	559.85 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 58.7
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 144	571.70 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 61.2
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 264	570.35 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 45.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 288	572.20 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 52.2
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 136	607.27 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 38.6
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 140	592.84 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 43.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 148	610.47 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 43.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 152	565.34 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 73.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 156	667.59 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 22.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 160	652.90 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 28.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 164	636.27 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 34.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 168	662.43 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 29.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 172	643.84 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 36.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 176	670.38 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 28.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 180	655.31 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 35.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 184	684.07 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 18.5
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 188	666.52 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 30.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 192	611.46 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 67.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 216	592.12 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 68.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 240	587.26 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 58.7
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 312	608.11 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 35.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 336	533.73 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 71.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 360	557.05 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 55.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 384	549.57 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 58.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 408	586.95 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 62.4
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 432	569.09 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 42.7
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 456	561.16 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 56.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 480	652.16 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 18.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 504	668.04 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 13.4
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 528	910.00 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Baseline	32.27 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 29.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 2	404.20 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 22.1
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 4	536.46 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 28.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 8	566.91 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 49.4
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 12	568.96 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 53.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 16	561.69 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 56.2
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 20	543.99 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 63.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 24	556.84 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 60.5
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 28	547.77 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 64.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 32	574.72 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 50.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 36	552.54 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 61.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 40	556.08 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 62.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 44	569.26 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 62.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 48	575.25 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 58.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 52	555.92 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 60.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 56	523.80 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 71.6
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 60	549.23 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 58.7
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 64	550.61 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 62.7
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 68	581.62 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 61.5
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 72	540.99 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 66.6
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 76	519.20 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 74.5
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 80	535.83 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 73.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 84	533.47 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 66.9
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 88	523.64 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 69.8
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 92	515.37 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 74.5
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 96	526.59 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 70.4
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 100	534.72 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 71.2
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 104	583.53 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 55.1
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 108	578.63 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 57.1
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 112	594.60 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 61.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 116	571.37 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 62.0
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 120	615.02 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 42.7
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 124	590.17 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 53.3
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood Week 132	580.53 nanograms/millilitre (ng/mL) Geometric Coefficient of Variation 45.0

SECONDARY outcome

Timeframe: Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=165 Participants 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.
Concentration of C-Reactive Protein (CRP) in Blood Week 8	0.39 milligrams/litre (mg/L) Geometric Coefficient of Variation 125.9
Concentration of C-Reactive Protein (CRP) in Blood Week 12	0.42 milligrams/litre (mg/L) Geometric Coefficient of Variation 144.9
Concentration of C-Reactive Protein (CRP) in Blood Week 16	0.42 milligrams/litre (mg/L) Geometric Coefficient of Variation 151.1
Concentration of C-Reactive Protein (CRP) in Blood Week 20	0.41 milligrams/litre (mg/L) Geometric Coefficient of Variation 157.8
Concentration of C-Reactive Protein (CRP) in Blood Week 24	0.44 milligrams/litre (mg/L) Geometric Coefficient of Variation 161.0
Concentration of C-Reactive Protein (CRP) in Blood Week 28	0.41 milligrams/litre (mg/L) Geometric Coefficient of Variation 175.7
Concentration of C-Reactive Protein (CRP) in Blood Week 32	0.44 milligrams/litre (mg/L) Geometric Coefficient of Variation 171.4
Concentration of C-Reactive Protein (CRP) in Blood Week 36	0.43 milligrams/litre (mg/L) Geometric Coefficient of Variation 185.3
Concentration of C-Reactive Protein (CRP) in Blood Week 40	0.48 milligrams/litre (mg/L) Geometric Coefficient of Variation 184.3
Concentration of C-Reactive Protein (CRP) in Blood Week 44	0.43 milligrams/litre (mg/L) Geometric Coefficient of Variation 182.3
Concentration of C-Reactive Protein (CRP) in Blood Week 48	0.44 milligrams/litre (mg/L) Geometric Coefficient of Variation 167.9
Concentration of C-Reactive Protein (CRP) in Blood Week 52	0.50 milligrams/litre (mg/L) Geometric Coefficient of Variation 177.4
Concentration of C-Reactive Protein (CRP) in Blood Week 64	0.47 milligrams/litre (mg/L) Geometric Coefficient of Variation 177.6
Concentration of C-Reactive Protein (CRP) in Blood Week 68	0.52 milligrams/litre (mg/L) Geometric Coefficient of Variation 194.3
Concentration of C-Reactive Protein (CRP) in Blood Week 72	0.50 milligrams/litre (mg/L) Geometric Coefficient of Variation 223.7
Concentration of C-Reactive Protein (CRP) in Blood Week 76	0.51 milligrams/litre (mg/L) Geometric Coefficient of Variation 189.5
Concentration of C-Reactive Protein (CRP) in Blood Week 80	0.51 milligrams/litre (mg/L) Geometric Coefficient of Variation 200.4
Concentration of C-Reactive Protein (CRP) in Blood Week 84	0.53 milligrams/litre (mg/L) Geometric Coefficient of Variation 227.4
Concentration of C-Reactive Protein (CRP) in Blood Week 88	0.51 milligrams/litre (mg/L) Geometric Coefficient of Variation 188.0
Concentration of C-Reactive Protein (CRP) in Blood Week 92	0.51 milligrams/litre (mg/L) Geometric Coefficient of Variation 200.4
Concentration of C-Reactive Protein (CRP) in Blood Week 96	0.52 milligrams/litre (mg/L) Geometric Coefficient of Variation 183.4
Concentration of C-Reactive Protein (CRP) in Blood Week 100	0.52 milligrams/litre (mg/L) Geometric Coefficient of Variation 231.4
Concentration of C-Reactive Protein (CRP) in Blood Week 104	0.46 milligrams/litre (mg/L) Geometric Coefficient of Variation 167.3
Concentration of C-Reactive Protein (CRP) in Blood Week 56	0.47 milligrams/litre (mg/L) Geometric Coefficient of Variation 183.8
Concentration of C-Reactive Protein (CRP) in Blood Week 60	0.49 milligrams/litre (mg/L) Geometric Coefficient of Variation 183.3
Concentration of C-Reactive Protein (CRP) in Blood Baseline	1.27 milligrams/litre (mg/L) Geometric Coefficient of Variation 226.6
Concentration of C-Reactive Protein (CRP) in Blood Week 2	0.38 milligrams/litre (mg/L) Geometric Coefficient of Variation 118.0
Concentration of C-Reactive Protein (CRP) in Blood Week 4	0.36 milligrams/litre (mg/L) Geometric Coefficient of Variation 113.3
Concentration of C-Reactive Protein (CRP) in Blood Week 108	0.51 milligrams/litre (mg/L) Geometric Coefficient of Variation 161.9
Concentration of C-Reactive Protein (CRP) in Blood Week 112	0.48 milligrams/litre (mg/L) Geometric Coefficient of Variation 191.7
Concentration of C-Reactive Protein (CRP) in Blood Week 116	0.43 milligrams/litre (mg/L) Geometric Coefficient of Variation 177.0
Concentration of C-Reactive Protein (CRP) in Blood Week 120	0.52 milligrams/litre (mg/L) Geometric Coefficient of Variation 227.6
Concentration of C-Reactive Protein (CRP) in Blood Week 124	0.56 milligrams/litre (mg/L) Geometric Coefficient of Variation 173.2
Concentration of C-Reactive Protein (CRP) in Blood Week 128	0.57 milligrams/litre (mg/L) Geometric Coefficient of Variation 209.1
Concentration of C-Reactive Protein (CRP) in Blood Week 132	0.59 milligrams/litre (mg/L) Geometric Coefficient of Variation 234.8
Concentration of C-Reactive Protein (CRP) in Blood Week 136	0.54 milligrams/litre (mg/L) Geometric Coefficient of Variation 193.9
Concentration of C-Reactive Protein (CRP) in Blood Week 140	0.61 milligrams/litre (mg/L) Geometric Coefficient of Variation 283.9
Concentration of C-Reactive Protein (CRP) in Blood Week 144	0.47 milligrams/litre (mg/L) Geometric Coefficient of Variation 205.6
Concentration of C-Reactive Protein (CRP) in Blood Week 148	0.47 milligrams/litre (mg/L) Geometric Coefficient of Variation 152.0
Concentration of C-Reactive Protein (CRP) in Blood Week 152	0.51 milligrams/litre (mg/L) Geometric Coefficient of Variation 147.8
Concentration of C-Reactive Protein (CRP) in Blood Week 156	0.47 milligrams/litre (mg/L) Geometric Coefficient of Variation 129.5
Concentration of C-Reactive Protein (CRP) in Blood Week 160	0.48 milligrams/litre (mg/L) Geometric Coefficient of Variation 148.9
Concentration of C-Reactive Protein (CRP) in Blood Week 164	0.49 milligrams/litre (mg/L) Geometric Coefficient of Variation 163.7
Concentration of C-Reactive Protein (CRP) in Blood Week 168	0.45 milligrams/litre (mg/L) Geometric Coefficient of Variation 148.9
Concentration of C-Reactive Protein (CRP) in Blood Week 172	0.45 milligrams/litre (mg/L) Geometric Coefficient of Variation 228.2
Concentration of C-Reactive Protein (CRP) in Blood Week 176	0.39 milligrams/litre (mg/L) Geometric Coefficient of Variation 156.7
Concentration of C-Reactive Protein (CRP) in Blood Week 180	0.42 milligrams/litre (mg/L) Geometric Coefficient of Variation 156.6
Concentration of C-Reactive Protein (CRP) in Blood Week 184	0.38 milligrams/litre (mg/L) Geometric Coefficient of Variation 197.3
Concentration of C-Reactive Protein (CRP) in Blood Week 188	0.46 milligrams/litre (mg/L) Geometric Coefficient of Variation 154.0
Concentration of C-Reactive Protein (CRP) in Blood Week 192	0.40 milligrams/litre (mg/L) Geometric Coefficient of Variation 188.5
Concentration of C-Reactive Protein (CRP) in Blood Week 216	0.30 milligrams/litre (mg/L) Geometric Coefficient of Variation 110.4
Concentration of C-Reactive Protein (CRP) in Blood Week 240	0.40 milligrams/litre (mg/L) Geometric Coefficient of Variation 221.9
Concentration of C-Reactive Protein (CRP) in Blood Week 264	0.36 milligrams/litre (mg/L) Geometric Coefficient of Variation 178.6
Concentration of C-Reactive Protein (CRP) in Blood Week 288	0.36 milligrams/litre (mg/L) Geometric Coefficient of Variation 215.6
Concentration of C-Reactive Protein (CRP) in Blood Week 312	0.32 milligrams/litre (mg/L) Geometric Coefficient of Variation 160.2
Concentration of C-Reactive Protein (CRP) in Blood Week 336	0.48 milligrams/litre (mg/L) Geometric Coefficient of Variation 302.7
Concentration of C-Reactive Protein (CRP) in Blood Week 360	0.39 milligrams/litre (mg/L) Geometric Coefficient of Variation 221.2
Concentration of C-Reactive Protein (CRP) in Blood Week 384	0.37 milligrams/litre (mg/L) Geometric Coefficient of Variation 185.9
Concentration of C-Reactive Protein (CRP) in Blood Week 408	0.29 milligrams/litre (mg/L) Geometric Coefficient of Variation 195.5
Concentration of C-Reactive Protein (CRP) in Blood Week 432	0.35 milligrams/litre (mg/L) Geometric Coefficient of Variation 161.1
Concentration of C-Reactive Protein (CRP) in Blood Week 456	0.32 milligrams/litre (mg/L) Geometric Coefficient of Variation 139.8
Concentration of C-Reactive Protein (CRP) in Blood Week 480	0.17 milligrams/litre (mg/L) Geometric Coefficient of Variation 33.0
Concentration of C-Reactive Protein (CRP) in Blood Week 504	0.15 milligrams/litre (mg/L) Geometric Coefficient of Variation 0.0
Concentration of C-Reactive Protein (CRP) in Blood Week 528	0.15 milligrams/litre (mg/L) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 5, Week 6; every 4 weeks from Weeks 8 to 192; every 24 weeks from Weeks 216 to 528

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=164 Participants 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.
Serum Concentration of Satralizumab at Specified Timepoints Baseline	103.75 nanograms/litre (ng/L) Geometric Coefficient of Variation 29.7
Serum Concentration of Satralizumab at Specified Timepoints Week 2	7489.76 nanograms/litre (ng/L) Geometric Coefficient of Variation 102.8
Serum Concentration of Satralizumab at Specified Timepoints Week 4	14631.06 nanograms/litre (ng/L) Geometric Coefficient of Variation 95.9
Serum Concentration of Satralizumab at Specified Timepoints Week 5	20068.86 nanograms/litre (ng/L) Geometric Coefficient of Variation 105.6
Serum Concentration of Satralizumab at Specified Timepoints Week 6	17495.09 nanograms/litre (ng/L) Geometric Coefficient of Variation 157.7
Serum Concentration of Satralizumab at Specified Timepoints Week 8	12673.14 nanograms/litre (ng/L) Geometric Coefficient of Variation 190.9
Serum Concentration of Satralizumab at Specified Timepoints Week 12	11031.23 nanograms/litre (ng/L) Geometric Coefficient of Variation 220.8
Serum Concentration of Satralizumab at Specified Timepoints Week 16	10588.85 nanograms/litre (ng/L) Geometric Coefficient of Variation 250.6
Serum Concentration of Satralizumab at Specified Timepoints Week 20	10065.62 nanograms/litre (ng/L) Geometric Coefficient of Variation 305.1
Serum Concentration of Satralizumab at Specified Timepoints Week 24	10605.69 nanograms/litre (ng/L) Geometric Coefficient of Variation 306.1
Serum Concentration of Satralizumab at Specified Timepoints Week 28	9730.68 nanograms/litre (ng/L) Geometric Coefficient of Variation 333.9
Serum Concentration of Satralizumab at Specified Timepoints Week 32	10686.86 nanograms/litre (ng/L) Geometric Coefficient of Variation 282.5
Serum Concentration of Satralizumab at Specified Timepoints Week 36	10036.31 nanograms/litre (ng/L) Geometric Coefficient of Variation 368.4
Serum Concentration of Satralizumab at Specified Timepoints Week 40	9508.64 nanograms/litre (ng/L) Geometric Coefficient of Variation 400.1
Serum Concentration of Satralizumab at Specified Timepoints Week 44	9891.10 nanograms/litre (ng/L) Geometric Coefficient of Variation 361.9
Serum Concentration of Satralizumab at Specified Timepoints Week 48	11282.31 nanograms/litre (ng/L) Geometric Coefficient of Variation 311.3
Serum Concentration of Satralizumab at Specified Timepoints Week 52	9585.58 nanograms/litre (ng/L) Geometric Coefficient of Variation 500.8
Serum Concentration of Satralizumab at Specified Timepoints Week 56	9209.84 nanograms/litre (ng/L) Geometric Coefficient of Variation 468.2
Serum Concentration of Satralizumab at Specified Timepoints Week 60	10090.62 nanograms/litre (ng/L) Geometric Coefficient of Variation 394.0
Serum Concentration of Satralizumab at Specified Timepoints Week 64	9186.35 nanograms/litre (ng/L) Geometric Coefficient of Variation 376.7
Serum Concentration of Satralizumab at Specified Timepoints Week 68	9951.51 nanograms/litre (ng/L) Geometric Coefficient of Variation 359.5
Serum Concentration of Satralizumab at Specified Timepoints Week 72	10737.11 nanograms/litre (ng/L) Geometric Coefficient of Variation 340.8
Serum Concentration of Satralizumab at Specified Timepoints Week 76	8414.98 nanograms/litre (ng/L) Geometric Coefficient of Variation 522.7
Serum Concentration of Satralizumab at Specified Timepoints Week 80	8557.82 nanograms/litre (ng/L) Geometric Coefficient of Variation 431.6
Serum Concentration of Satralizumab at Specified Timepoints Week 84	8208.84 nanograms/litre (ng/L) Geometric Coefficient of Variation 473.6
Serum Concentration of Satralizumab at Specified Timepoints Week 88	8457.80 nanograms/litre (ng/L) Geometric Coefficient of Variation 498.3
Serum Concentration of Satralizumab at Specified Timepoints Week 92	8316.17 nanograms/litre (ng/L) Geometric Coefficient of Variation 510.7
Serum Concentration of Satralizumab at Specified Timepoints Week 96	10560.87 nanograms/litre (ng/L) Geometric Coefficient of Variation 329.6
Serum Concentration of Satralizumab at Specified Timepoints Week 100	9841.13 nanograms/litre (ng/L) Geometric Coefficient of Variation 361.2
Serum Concentration of Satralizumab at Specified Timepoints Week 104	11256.29 nanograms/litre (ng/L) Geometric Coefficient of Variation 278.2
Serum Concentration of Satralizumab at Specified Timepoints Week 108	10521.75 nanograms/litre (ng/L) Geometric Coefficient of Variation 273.5
Serum Concentration of Satralizumab at Specified Timepoints Week 112	10362.73 nanograms/litre (ng/L) Geometric Coefficient of Variation 314.0
Serum Concentration of Satralizumab at Specified Timepoints Week 116	11219.11 nanograms/litre (ng/L) Geometric Coefficient of Variation 331.1
Serum Concentration of Satralizumab at Specified Timepoints Week 120	11619.05 nanograms/litre (ng/L) Geometric Coefficient of Variation 315.4
Serum Concentration of Satralizumab at Specified Timepoints Week 124	9680.42 nanograms/litre (ng/L) Geometric Coefficient of Variation 354.6
Serum Concentration of Satralizumab at Specified Timepoints Week 128	8727.98 nanograms/litre (ng/L) Geometric Coefficient of Variation 362.3
Serum Concentration of Satralizumab at Specified Timepoints Week 132	8378.76 nanograms/litre (ng/L) Geometric Coefficient of Variation 437.7
Serum Concentration of Satralizumab at Specified Timepoints Week 136	10182.79 nanograms/litre (ng/L) Geometric Coefficient of Variation 294.2
Serum Concentration of Satralizumab at Specified Timepoints Week 140	9731.57 nanograms/litre (ng/L) Geometric Coefficient of Variation 440.3
Serum Concentration of Satralizumab at Specified Timepoints Week 144	11206.52 nanograms/litre (ng/L) Geometric Coefficient of Variation 328.4
Serum Concentration of Satralizumab at Specified Timepoints Week 148	11605.26 nanograms/litre (ng/L) Geometric Coefficient of Variation 291.6
Serum Concentration of Satralizumab at Specified Timepoints Week 152	12065.91 nanograms/litre (ng/L) Geometric Coefficient of Variation 352.8
Serum Concentration of Satralizumab at Specified Timepoints Week 156	13017.85 nanograms/litre (ng/L) Geometric Coefficient of Variation 222.9
Serum Concentration of Satralizumab at Specified Timepoints Week 160	13952.43 nanograms/litre (ng/L) Geometric Coefficient of Variation 173.1
Serum Concentration of Satralizumab at Specified Timepoints Week 164	13869.87 nanograms/litre (ng/L) Geometric Coefficient of Variation 202.0
Serum Concentration of Satralizumab at Specified Timepoints Week 168	14256.36 nanograms/litre (ng/L) Geometric Coefficient of Variation 183.0
Serum Concentration of Satralizumab at Specified Timepoints Week 172	13018.63 nanograms/litre (ng/L) Geometric Coefficient of Variation 227.2
Serum Concentration of Satralizumab at Specified Timepoints Week 176	11989.36 nanograms/litre (ng/L) Geometric Coefficient of Variation 330.9
Serum Concentration of Satralizumab at Specified Timepoints Week 180	15333.00 nanograms/litre (ng/L) Geometric Coefficient of Variation 150.7
Serum Concentration of Satralizumab at Specified Timepoints Week 184	16449.28 nanograms/litre (ng/L) Geometric Coefficient of Variation 101.1
Serum Concentration of Satralizumab at Specified Timepoints Week 188	14519.13 nanograms/litre (ng/L) Geometric Coefficient of Variation 221.7
Serum Concentration of Satralizumab at Specified Timepoints Week 192	11926.93 nanograms/litre (ng/L) Geometric Coefficient of Variation 284.9
Serum Concentration of Satralizumab at Specified Timepoints Week 216	10582.11 nanograms/litre (ng/L) Geometric Coefficient of Variation 404.7
Serum Concentration of Satralizumab at Specified Timepoints Week 240	13683.03 nanograms/litre (ng/L) Geometric Coefficient of Variation 237.7
Serum Concentration of Satralizumab at Specified Timepoints Week 264	11576.23 nanograms/litre (ng/L) Geometric Coefficient of Variation 326.0
Serum Concentration of Satralizumab at Specified Timepoints Week 288	13169.85 nanograms/litre (ng/L) Geometric Coefficient of Variation 221.9
Serum Concentration of Satralizumab at Specified Timepoints Week 312	13007.87 nanograms/litre (ng/L) Geometric Coefficient of Variation 243.1
Serum Concentration of Satralizumab at Specified Timepoints Week 336	10522.02 nanograms/litre (ng/L) Geometric Coefficient of Variation 407.6
Serum Concentration of Satralizumab at Specified Timepoints Week 360	11604.67 nanograms/litre (ng/L) Geometric Coefficient of Variation 295.8
Serum Concentration of Satralizumab at Specified Timepoints Week 384	14508.95 nanograms/litre (ng/L) Geometric Coefficient of Variation 303.3
Serum Concentration of Satralizumab at Specified Timepoints Week 408	14652.75 nanograms/litre (ng/L) Geometric Coefficient of Variation 290.3
Serum Concentration of Satralizumab at Specified Timepoints Week 432	13287.68 nanograms/litre (ng/L) Geometric Coefficient of Variation 329.1
Serum Concentration of Satralizumab at Specified Timepoints Week 456	18532.35 nanograms/litre (ng/L) Geometric Coefficient of Variation 174.8
Serum Concentration of Satralizumab at Specified Timepoints Week 480	26688.35 nanograms/litre (ng/L) Geometric Coefficient of Variation 56.3
Serum Concentration of Satralizumab at Specified Timepoints Week 504	43917.08 nanograms/litre (ng/L) Geometric Coefficient of Variation 8.7
Serum Concentration of Satralizumab at Specified Timepoints Week 528	57800.00 nanograms/litre (ng/L) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Satralizumab n=166 Participants 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.
Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 Baseline · Positive	3 Participants
Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 Baseline · Negative	161 Participants
Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 Post-baseline · Positive	99 Participants
Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 Post-baseline · Negative	67 Participants

Adverse Events

Satralizumab

Serious events: 44 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Satralizumab n=166 participants at risk 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.
Blood and lymphatic system disorders Anaemia macrocytic	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Cardiac disorders Acute myocardial infarction	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Cardiac disorders Bradycardia	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Eye disorders Cataract	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Eye disorders Glaucoma	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Eye disorders Visual impairment	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Abdominal pain	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Enterocolitis	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Intestinal perforation	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Nausea	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Pancreatitis acute	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Rectal haemorrhage	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
General disorders Hypothermia	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
General disorders Non-cardiac chest pain	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Atypical mycobacterial infection	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Cellulitis	1.2% 2/166 • Number of events 3 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Hepatitis E	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Influenza	1.8% 3/166 • Number of events 3 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Large intestine infection	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Pneumonia	3.0% 5/166 • Number of events 5 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Pulmonary sepsis	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Pyelonephritis	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Pyelonephritis acute	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Septic endocarditis	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Sinusitis fungal	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Urinary tract infection	1.8% 3/166 • Number of events 3 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Urosepsis	1.2% 2/166 • Number of events 2 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Accidental exposure to product	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Accidental overdose	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Femur fracture	0.60% 1/166 • Number of events 2 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Fracture displacement	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Fractured sacrum	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Limb fracture	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Multiple injuries	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Post procedural complication	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Post procedural haematoma	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Radius fracture	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Road traffic accident	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Spinal compression fracture	1.2% 2/166 • Number of events 3 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Metabolism and nutrition disorders Diabetes mellitus	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Metabolism and nutrition disorders Hyperglycaemia	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.8% 3/166 • Number of events 3 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Migraine	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Neuromyelitis optica pseudo relapse	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Parkinsonism	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Seizure	0.60% 1/166 • Number of events 2 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Tension headache	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Pregnancy, puerperium and perinatal conditions Abortion	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Psychiatric disorders Mental disorder	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Psychiatric disorders Mental status changes	1.2% 2/166 • Number of events 2 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Psychiatric disorders Suicide attempt	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Reproductive system and breast disorders Cervical dysplasia	1.2% 2/166 • Number of events 2 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Reproductive system and breast disorders Ovarian cyst	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Respiratory, thoracic and mediastinal disorders Apnoea	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Surgical and medical procedures Rehabilitation therapy	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Vascular disorders Aneurysm	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Vascular disorders Hypertension	0.60% 1/166 • Number of events 1 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.

Other adverse events

Other adverse events
Measure	Satralizumab n=166 participants at risk 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.
Blood and lymphatic system disorders Anaemia	9.0% 15/166 • Number of events 19 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Blood and lymphatic system disorders Iron deficiency anaemia	5.4% 9/166 • Number of events 12 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Blood and lymphatic system disorders Leukopenia	10.8% 18/166 • Number of events 33 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Blood and lymphatic system disorders Lymphopenia	6.0% 10/166 • Number of events 27 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Blood and lymphatic system disorders Neutropenia	9.6% 16/166 • Number of events 26 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Abdominal pain upper	6.6% 11/166 • Number of events 12 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Constipation	10.8% 18/166 • Number of events 23 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Dental caries	6.0% 10/166 • Number of events 10 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Diarrhoea	12.7% 21/166 • Number of events 42 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Nausea	12.7% 21/166 • Number of events 27 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Toothache	6.6% 11/166 • Number of events 14 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Gastrointestinal disorders Vomiting	5.4% 9/166 • Number of events 11 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
General disorders Fatigue	10.2% 17/166 • Number of events 22 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
General disorders Oedema peripheral	6.6% 11/166 • Number of events 13 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations COVID-19	18.7% 31/166 • Number of events 33 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Cystitis	9.0% 15/166 • Number of events 18 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Ear infection	6.0% 10/166 • Number of events 13 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Gastroenteritis	5.4% 9/166 • Number of events 17 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Influenza	7.8% 13/166 • Number of events 14 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Nasopharyngitis	28.9% 48/166 • Number of events 132 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Oral herpes	5.4% 9/166 • Number of events 70 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Sinusitis	9.6% 16/166 • Number of events 22 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Upper respiratory tract infection	27.7% 46/166 • Number of events 172 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Infections and infestations Urinary tract infection	24.1% 40/166 • Number of events 139 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Fall	6.6% 11/166 • Number of events 21 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Injection related reaction	14.5% 24/166 • Number of events 57 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Injury, poisoning and procedural complications Ligament sprain	5.4% 9/166 • Number of events 11 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Investigations Alanine aminotransferase increased	8.4% 14/166 • Number of events 20 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Investigations Blood cholesterol increased	8.4% 14/166 • Number of events 23 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Investigations Blood creatine phosphokinase increased	6.0% 10/166 • Number of events 12 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Investigations Blood fibrinogen decreased	6.0% 10/166 • Number of events 17 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Investigations Complement factor C4 decreased	5.4% 9/166 • Number of events 11 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Investigations Lymphocyte count decreased	6.6% 11/166 • Number of events 17 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Investigations White blood cell count decreased	7.8% 13/166 • Number of events 30 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Metabolism and nutrition disorders Hypercholesterolaemia	5.4% 9/166 • Number of events 19 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Musculoskeletal and connective tissue disorders Arthralgia	21.1% 35/166 • Number of events 43 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Musculoskeletal and connective tissue disorders Back pain	12.0% 20/166 • Number of events 31 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Musculoskeletal and connective tissue disorders Myalgia	9.0% 15/166 • Number of events 16 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Musculoskeletal and connective tissue disorders Pain in extremity	15.7% 26/166 • Number of events 43 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Dizziness	9.0% 15/166 • Number of events 20 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Headache	26.5% 44/166 • Number of events 86 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Nervous system disorders Hypoaesthesia	9.0% 15/166 • Number of events 24 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Psychiatric disorders Anxiety	6.0% 10/166 • Number of events 11 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Psychiatric disorders Depression	6.6% 11/166 • Number of events 14 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Psychiatric disorders Insomnia	10.2% 17/166 • Number of events 20 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Respiratory, thoracic and mediastinal disorders Cough	11.4% 19/166 • Number of events 22 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.2% 17/166 • Number of events 21 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Skin and subcutaneous tissue disorders Eczema	6.0% 10/166 • Number of events 11 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Skin and subcutaneous tissue disorders Rash	12.0% 20/166 • Number of events 27 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Vascular disorders Hypertension	6.6% 11/166 • Number of events 21 • Baseline up to 523 weeks 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. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.

Additional Information

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Hoffmann-La Roche

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Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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