Systemic Lupus Erythematosus
Conditions
Keywords
treatment holiday, PGA, belimumab, Lymphostat-B, rebound, SELENA SLEDAI, Systemic Lupus Erythematosus, immunogenicity
Brief summary
This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.
Detailed description
This study will assess the effect of a 24-week withdrawal of belimumab followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications on immunogenicity, markers of biological activity, efficacy, and safety in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Additionally, this study will assess rebound phenomenon in subjects with any disease level of SLE who have permanently withdrawn from further belimumab treatment
Interventions
DRUGBelimumab
Monthly intravenous infusions dosed as 10 mg/kg body weight
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study. * Be 18 years of age at the Day 0 visit. * Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol. * Able to provide written informed consent to participate. * Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0. * Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.
Exclusion criteria
* Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk. * Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to First SLE Flare Index (SFI) | Up to 52 weeks | SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to \>12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 visit date + 1) in the 52 Week/Holiday phase; (event date - treatment re-start date + 1) in the Re-start Holiday phase. Day 0 visit date is defined as Day 0 from present study. Median time to first SFI flare is reported; estimated using the product-limit method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Complement Levels | Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks | Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value. |
| Median Time to First Severe SFI Flare | Up to 52 weeks | The SLE Flare Index categorizes SLE flare as mild or moderate or severe based on a positive assessment for at least 1 of 5 variables as follows: Change in SELENA SLEDAI score from the most recent assessment to current; Change in signs or symptoms of disease activity; Change in prednisone dosage; Use of new medications for disease activity or hospitalization; Change in Physician's Global Assessment (PGA) score; Hospitalization for SLE activity is an additional category included only for a severe flare. Time to first severe flare is defined as (event date-Day 0 visit date) + 1 for Long-term discontinuation, treatment control groups and holiday phase group. For holiday phase group data censored at last flare assessment by treatment re-start date. Time to first severe flare is defined as (event date-treatment re-start date) + 1 for Re-start treatment holiday group. Median time to first severe SFI flare is reported; estimated using the product-limit method. |
| Number of Participants With Evidence of Rebound | Up to 24 weeks | Rebound is defined as SELENA SLEDAI score during the first 24 weeks that exceeds the Baseline SELENA SLEDAI score in the participant's respective original parent study. Baseline is defined as the Day 0 visit from the parent study. SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Any time during the first 24 weeks of this study has been reported. |
| Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Up to 52 weeks | Immunogenicity assay results were categorized as negative or positive. A persistent positive result was defined as a positive post-Day 0 visit immunogenic response that occurred for at least 2 consecutive assessments or a single result at the final assessment. A transient positive result was defined as a single post-Day 0 visit positive immunogenic response that did not occur at the final assessment. Any time post-Day 0 visit data are reported (or post-Week 24 for Treatment Holiday - Restart phase). Day 0 visit date is defined as Day 0 from present study. |
| Percentage Change From Baseline in Immunoglobulin | Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40, 48 and 52 weeks | Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (value at specified visit minus Baseline value) divided by Baseline value. |
| Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks | Blood samples were collected at indicated time-points for analysis of autoantibodies like dsDNA. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value. |
| Rate of SLE Index Flare Per Subject Year | Up to 52 weeks | Rate per subject year of SFI flare was calculated as total number of flares divided by total subject years in interval. The total subject years for each participant was calculated as (Week 52/ Exit visit date minus Day 0 visit date + 1) for Long-term discontinuation and treatment control groups. For treatment holiday phase group the subject-years for each participant was calculated as (Week 24/Treatment Re-start/Exit visit date minus Day 0 Visit date + 1)/365.25. For re-start treatment holiday phase group the subject-years for each participant was calculated as (Week 52/Exit visit date minus Week 24/Treatment Re-start date + 1)/365.25. Day 0 visit date is defined as Day 0 from present study. |
| Percentage Change From Baseline in B Cell Subsets | Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40 and 52 weeks | Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, cluster of differentiation 20+ (CD20+), Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value. |
| Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Week 24, 32, 40 and 52 weeks | Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, CD20+, Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Percentage change from Week 24 of present study was calculated as 100\*(value at specified visit - Week 24 value) divided by week 24 value. The data below is only reported for the Treatment Holiday Group (Re-start phase). Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. No other groups were measured for this outcome. |
| SELENA SLEDAI Scores Change From Baseline | Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52 weeks | SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Data are reported at the specified time-points from Day 0 (of present study) up to Week 52. Baseline is defined as the Day 0 from parent studies. Change from Baseline is equal to (Value at specified visit minus Baseline value). |
| Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52 | All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase. |
| Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52 | All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase. |
| Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Baseline (Day 0 from parent studies); Day 0 and 24 and 52 weeks | Blood samples were collected at indicated time-points for analysis of autoantibodies like ANA. Only participants who had an ANA value measured in INDEX at the parent studies Baseline were included in this analysis. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value. |
Countries
China, Japan, South Korea, United States
Participant flow
Recruitment details
This was multi-center study to evaluate temporary discontinuation of belimumab 10 milligram(mg)/kilogram(kg) for 24 weeks followed by reintroduction of belimumab 10 mg/kg Intravenous (IV) for 28 weeks, in participants with low Systemic Lupus Erythematosus (SLE) disease activity receiving belimumab plus standard of care.
Pre-assignment details
A total of 80 participants were enrolled for this study. Participants were enrolled across 20 sites in China, Japan, Korea and the United States.
Participants by arm
| Arm | Count |
|---|---|
| Long-term Discontinuation Group Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study. | 39 |
| Treatment Control Group Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4). | 29 |
| Treatment Holiday Group Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4). | 12 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Maintenance (Up to 48 Weeks of Year 2-4) | Study Terminated By Sponsor | 0 | 10 | 7 |
| Treatment Phase (Up to 52 Weeks) | Physician Decision | 1 | 0 | 0 |
| Treatment Phase (Up to 52 Weeks) | Protocol Violation | 1 | 2 | 0 |
| Treatment Phase (Up to 52 Weeks) | Study Terminated By Sponsor | 0 | 0 | 1 |
| Treatment Phase (Up to 52 Weeks) | Withdrawal by Subject | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Long-term Discontinuation Group | Treatment Control Group | Treatment Holiday Group | Total |
|---|---|---|---|---|
| Age, Continuous | 38.9 Years STANDARD_DEVIATION 12.01 | 40.6 Years STANDARD_DEVIATION 9.76 | 38.1 Years STANDARD_DEVIATION 8.04 | 39.4 Years STANDARD_DEVIATION 10.63 |
| Race/Ethnicity, Customized African American/African Heritage | 5 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian: Central/South Asian Heritage | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian: East Asian Heritage | 23 Participants | 27 Participants | 4 Participants | 54 Participants |
| Race/Ethnicity, Customized Asian: Japanese Heritage | 0 Participants | 2 Participants | 8 Participants | 10 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian/European Heritage | 9 Participants | 0 Participants | 0 Participants | 9 Participants |
| Sex: Female, Male Female | 35 Participants | 27 Participants | 9 Participants | 71 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 29 | 0 / 12 | 0 / 11 | 0 / 16 | 0 / 10 |
| other Total, other adverse events | 30 / 39 | 18 / 29 | 7 / 12 | 9 / 11 | 4 / 16 | 8 / 10 |
| serious Total, serious adverse events | 6 / 39 | 2 / 29 | 0 / 12 | 1 / 11 | 0 / 16 | 0 / 10 |
Outcome results
Primary
Median Time to First SLE Flare Index (SFI)
SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to \>12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 visit date + 1) in the 52 Week/Holiday phase; (event date - treatment re-start date + 1) in the Re-start Holiday phase. Day 0 visit date is defined as Day 0 from present study. Median time to first SFI flare is reported; estimated using the product-limit method.
Time frame: Up to 52 weeks
Population: Intent-to-Treat (ITT) Population comprised of all participants who enrolled in the study, excluding screen failures.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long-term Discontinuation Group | Median Time to First SLE Flare Index (SFI) | 183.0 Days |
| Treatment Control Group | Median Time to First SLE Flare Index (SFI) | NA Days |
| Treatment Holiday Group - Holiday Phase | Median Time to First SLE Flare Index (SFI) | NA Days |
| Treatment Holiday Group - Re-start Phase | Median Time to First SLE Flare Index (SFI) | NA Days |
Secondary
Median Time to First Severe SFI Flare
The SLE Flare Index categorizes SLE flare as mild or moderate or severe based on a positive assessment for at least 1 of 5 variables as follows: Change in SELENA SLEDAI score from the most recent assessment to current; Change in signs or symptoms of disease activity; Change in prednisone dosage; Use of new medications for disease activity or hospitalization; Change in Physician's Global Assessment (PGA) score; Hospitalization for SLE activity is an additional category included only for a severe flare. Time to first severe flare is defined as (event date-Day 0 visit date) + 1 for Long-term discontinuation, treatment control groups and holiday phase group. For holiday phase group data censored at last flare assessment by treatment re-start date. Time to first severe flare is defined as (event date-treatment re-start date) + 1 for Re-start treatment holiday group. Median time to first severe SFI flare is reported; estimated using the product-limit method.
Time frame: Up to 52 weeks
Population: ITT Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long-term Discontinuation Group | Median Time to First Severe SFI Flare | NA Days |
| Treatment Control Group | Median Time to First Severe SFI Flare | NA Days |
| Treatment Holiday Group - Holiday Phase | Median Time to First Severe SFI Flare | NA Days |
| Treatment Holiday Group - Re-start Phase | Median Time to First Severe SFI Flare | NA Days |
Secondary
Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study
All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.
Time frame: Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52
Population: ITT Population. Only those participants who met specified criteria (\<=7.5 mg/day and/or decreased by 25%) within specified time period were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Day 0 to Week 52, n=25,19, 6 | 362.0 Days |
| Long-term Discontinuation Group | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Day 0 to Week 24, n=23,19, 6 | 168.0 Days |
| Long-term Discontinuation Group | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Week 24 to Week 52, n=24,18, 5 | 195.0 Days |
| Treatment Control Group | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Day 0 to Week 52, n=25,19, 6 | 364.0 Days |
| Treatment Control Group | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Day 0 to Week 24, n=23,19, 6 | 168.0 Days |
| Treatment Control Group | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Week 24 to Week 52, n=24,18, 5 | 196.0 Days |
| Treatment Holiday Group - Holiday Phase | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Day 0 to Week 24, n=23,19, 6 | 166.0 Days |
| Treatment Holiday Group - Holiday Phase | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Week 24 to Week 52, n=24,18, 5 | 200.0 Days |
| Treatment Holiday Group - Holiday Phase | Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study | Day 0 to Week 52, n=25,19, 6 | 364.0 Days |
Secondary
Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study
All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.
Time frame: Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52
Population: ITT Population. Only those participants who met specified criteria (\>=7.5 mg/day and/or increased by 25%) within specified time period were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Day 0 to Week 52, n=13, 12, 6 | 278.0 Days |
| Long-term Discontinuation Group | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Day 0 to Week 24, n=11, 12, 6 | 143.0 Days |
| Long-term Discontinuation Group | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Week 24 to Week 52, n=10, 9, 5 | 167.5 Days |
| Treatment Control Group | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Day 0 to Week 52, n=13, 12, 6 | 364.0 Days |
| Treatment Control Group | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Day 0 to Week 24, n=11, 12, 6 | 170.0 Days |
| Treatment Control Group | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Week 24 to Week 52, n=10, 9, 5 | 196.0 Days |
| Treatment Holiday Group - Holiday Phase | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Day 0 to Week 24, n=11, 12, 6 | 168.0 Days |
| Treatment Holiday Group - Holiday Phase | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Week 24 to Week 52, n=10, 9, 5 | 196.0 Days |
| Treatment Holiday Group - Holiday Phase | Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study | Day 0 to Week 52, n=13, 12, 6 | 364.0 Days |
Secondary
Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA)
Immunogenicity assay results were categorized as negative or positive. A persistent positive result was defined as a positive post-Day 0 visit immunogenic response that occurred for at least 2 consecutive assessments or a single result at the final assessment. A transient positive result was defined as a single post-Day 0 visit positive immunogenic response that did not occur at the final assessment. Any time post-Day 0 visit data are reported (or post-Week 24 for Treatment Holiday - Restart phase). Day 0 visit date is defined as Day 0 from present study.
Time frame: Up to 52 weeks
Population: ITT Population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Long-term Discontinuation Group | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Transient positive | 0 Participants |
| Long-term Discontinuation Group | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Negative | 39 Participants |
| Long-term Discontinuation Group | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Persistent positive | 0 Participants |
| Treatment Control Group | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Persistent positive | 0 Participants |
| Treatment Control Group | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Negative | 29 Participants |
| Treatment Control Group | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Transient positive | 0 Participants |
| Treatment Holiday Group - Holiday Phase | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Transient positive | 0 Participants |
| Treatment Holiday Group - Holiday Phase | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Negative | 12 Participants |
| Treatment Holiday Group - Holiday Phase | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Persistent positive | 0 Participants |
| Treatment Holiday Group - Re-start Phase | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Persistent positive | 0 Participants |
| Treatment Holiday Group - Re-start Phase | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Negative | 11 Participants |
| Treatment Holiday Group - Re-start Phase | Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) | Transient positive | 0 Participants |
Secondary
Number of Participants With Evidence of Rebound
Rebound is defined as SELENA SLEDAI score during the first 24 weeks that exceeds the Baseline SELENA SLEDAI score in the participant's respective original parent study. Baseline is defined as the Day 0 visit from the parent study. SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Any time during the first 24 weeks of this study has been reported.
Time frame: Up to 24 weeks
Population: ITT Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Long-term Discontinuation Group | Number of Participants With Evidence of Rebound | 2 Participants |
| Treatment Control Group | Number of Participants With Evidence of Rebound | 2 Participants |
| Treatment Holiday Group - Holiday Phase | Number of Participants With Evidence of Rebound | 0 Participants |
Secondary
Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase)
Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, CD20+, Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Percentage change from Week 24 of present study was calculated as 100\*(value at specified visit - Week 24 value) divided by week 24 value. The data below is only reported for the Treatment Holiday Group (Re-start phase). Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. No other groups were measured for this outcome.
Time frame: Week 24, 32, 40 and 52 weeks
Population: ITT Population. Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. The data below is only reported for the Treatment Holiday Group and no other groups were measured.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Memory CD19+CD20+CD27+,Week52 | 66.7 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Memory CD19+CD20+CD27+, Week 32 | 100.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Memory CD19+CD20+CD27+, Week 40 | 83.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Naive CD19+CD20+CD27-,Week 32 | -19.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Naive CD19+CD20+CD27-,Week 40 | -12.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Naive CD19+CD20+CD27-,Week52 | -35.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Plasma CD19+CD20-CD138+,Week32 | -16.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Plasma CD19+CD20-CD138+, Week40 | -59.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Plasma CD19+CD20-CD138+,Week52 | -48.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Plasmacytoid CD19+CD20+CD138+,Week32 | -35.7 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Plasmacytoid CD19+CD20+CD138+,Week40 | -64.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Plasmacytoid CD19+CD20+CD138+,Week52 | -55.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | SLE SubsetCD19+CD38b+CD27b+Lymph,Week32 | -55.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | SLE SubsetCD19+CD38b+CD27b+Lymph,Week40 | -56.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | SLE SubsetCD19+CD38b+CD27b+Lymph,Week52 | -67.2 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | CD20+, Week 32 | -3.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | CD20+, Week 40 | 2.2 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | CD20+, Week 52 | -20.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Activated CD19+CD20+CD69+,Week32 | -28.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Activated CD19+CD20+CD69+,Week40 | -23.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) | Activated CD19+CD20+CD69+,Week52 | -66.7 Percent change |
Secondary
Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA)
Blood samples were collected at indicated time-points for analysis of autoantibodies like dsDNA. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value.
Time frame: Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 16,n=36,27, 11,0 | -78.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 4,n=39,29,12, 0 | -82.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 32,n=34,27,0,11 | -77.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 20,n=34,27, 11,0 | -82.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Day 0,n=39,29,12, 0 | -82.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 28,n=35,27,0,10 | -69.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 24,n=31,27, 11,0 | -82.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 44,n=34,27,0,10 | -62.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 8,n=37,29, 11,0 | -74.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 52,n=33,27,0,10 | -65.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 40,n=34,25,0,11 | -73.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 12,n=38,29, 11,0 | -77.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 48,n=33,27,0,10 | -71.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 36,n=34,27,0,11 | -75.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 44,n=34,27,0,10 | -77.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Day 0,n=39,29,12, 0 | -69.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 4,n=39,29,12, 0 | -65.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 8,n=37,29, 11,0 | -70.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 12,n=38,29, 11,0 | -68.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 16,n=36,27, 11,0 | -72.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 20,n=34,27, 11,0 | -70.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 24,n=31,27, 11,0 | -71.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 28,n=35,27,0,10 | -72.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 32,n=34,27,0,11 | -71.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 36,n=34,27,0,11 | -71.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 40,n=34,25,0,11 | -87.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 52,n=33,27,0,10 | -78.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 48,n=33,27,0,10 | -76.6 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 4,n=39,29,12, 0 | -83.2 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 24,n=31,27, 11,0 | -75.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 20,n=34,27, 11,0 | -79.9 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 8,n=37,29, 11,0 | -81.6 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Day 0,n=39,29,12, 0 | -81.3 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 16,n=36,27, 11,0 | -79.7 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 12,n=38,29, 11,0 | -85.0 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 44,n=34,27,0,10 | -82.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 36,n=34,27,0,11 | -80.8 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 52,n=33,27,0,10 | -79.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 40,n=34,25,0,11 | -79.9 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 48,n=33,27,0,10 | -80.6 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 28,n=35,27,0,10 | -79.9 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) | Week 32,n=34,27,0,11 | -79.6 Percent change |
Secondary
Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA)
Blood samples were collected at indicated time-points for analysis of autoantibodies like ANA. Only participants who had an ANA value measured in INDEX at the parent studies Baseline were included in this analysis. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value.
Time frame: Baseline (Day 0 from parent studies); Day 0 and 24 and 52 weeks
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Week 24,n=20,26, 10,0 | 5.723 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Day 0,n=21,27, 10,0 | -15.044 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Week 52,n=19,26,0,9 | -16.455 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Week 24,n=20,26, 10,0 | -27.434 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Day 0,n=21,27, 10,0 | -24.938 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Week 52,n=19,26,0,9 | -45.961 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Day 0,n=21,27, 10,0 | -32.336 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Week 24,n=20,26, 10,0 | -29.771 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) | Week 52,n=19,26,0,9 | -35.539 Percent change |
Secondary
Percentage Change From Baseline in B Cell Subsets
Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, cluster of differentiation 20+ (CD20+), Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value.
Time frame: Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40 and 52 weeks
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week8, n=10,1,7,0 | -99.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week32,n=9,2,0,7 | -8.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week8,n=10,2,7,0 | -100.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week32,n=12,2,0,7 | -85.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week24,n=9,2,7,0 | 25.2 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+, Week16,n=9,2,7,0 | -97.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week16,n=9,2,7,0 | 21.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week8,n=10,2,7,0 | -30.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week24,n=9,2,7,0 | -88.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week52,n=9,2,0,6 | -75.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week32,n=9,2,0,7 | -76.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Day0, n=11,1,8,0 | -99.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Day0,n=11,2,8,0 | -28.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week40,n=9,2,0,7 | -53.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week40,n=13,2,0,7 | -80.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week 52,n=9,2,0,6 | -96.1 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Week32, n=9,1,0,7 | -98.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week40,n=9,2,0,7 | -93.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Day 0,n=11,2,8,0 | -98.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week52,n=13,2,0,6 | -12.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week32,n=9,2,0,7 | -95.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week8,n=10,2,7,0 | -97.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week24,n=9,2,7,0 | -98.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week16,n=9,2,7,0 | -98.7 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week52,n=13,2,0,6 | -81.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+, Week 8,n=15,2,5,0 | -73.7 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week40,n=13,2,0,7 | -15.2 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Day 0,n=16,2,8,0 | -78.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week52, n=9,1,0,6 | -96.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week32,n=12,2,0,7 | -49.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 8,n=15,2,5,0 | -80.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Week24, n=9,1,7,0 | -99.7 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week24,n=13,2,6,0 | -52.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week16,n=14,2,6,0 | -76.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week16,n=14,2,6,0 | -83.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week16,n=14,2,6,0 | -75.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 24,n=13,2,6,0 | -45.7 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week40, n=9,1,0,7 | -98.1 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | CD20+ Week 8,n=15,2,5,0 | -79.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 32,n=12,2,0,7 | -39.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week16, n=9,1,7,0 | -98.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | CD20+ Day 0,n=16,2,8,0 | -75.2 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 40,n=13,2,0,7 | -6.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week24,n=13,2,6,0 | -86.7 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week52,n=9,2,0,6 | -23.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 52,n=13,2,0,6 | 17.1 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+, Day 0,n=16,2,8,0 | -69.0 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week40,n=9,2,0,7 | -8.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Day0,n=11,2,8,0 | -96.2 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+, Week16,n=9,2,7,0 | 535.2 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week8,n=10,2,7,0 | 14.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week16,n=9,2,7,0 | 226.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+, Day 0,n=16,2,8,0 | -76.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+, Week 8,n=15,2,5,0 | -78.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week16,n=14,2,6,0 | -69.2 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week24,n=13,2,6,0 | -59.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week32,n=12,2,0,7 | -73.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week40,n=13,2,0,7 | -65.6 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week52,n=13,2,0,6 | -78.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Day 0,n=16,2,8,0 | -91.6 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 8,n=15,2,5,0 | -94.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week16,n=14,2,6,0 | -89.6 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 24,n=13,2,6,0 | -92.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 32,n=12,2,0,7 | -92.2 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 40,n=13,2,0,7 | -92.6 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 52,n=13,2,0,6 | -92.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Day0,n=11,2,8,0 | 45.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week8,n=10,2,7,0 | 752.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week24,n=9,2,7,0 | 68.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week32,n=9,2,0,7 | 182.5 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week40,n=9,2,0,7 | -9.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week52,n=9,2,0,6 | -43.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Day 0,n=11,2,8,0 | 118.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week24,n=9,2,7,0 | -16.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week32,n=9,2,0,7 | -24.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week40,n=9,2,0,7 | -31.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week 52,n=9,2,0,6 | 202.5 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Day0,n=11,2,8,0 | -67.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week8,n=10,2,7,0 | -91.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week16,n=9,2,7,0 | -74.2 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week24,n=9,2,7,0 | -64.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week32,n=9,2,0,7 | -37.5 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week40,n=9,2,0,7 | -66.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week52,n=9,2,0,6 | -81.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | CD20+ Day 0,n=16,2,8,0 | -88.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | CD20+ Week 8,n=15,2,5,0 | -91.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week16,n=14,2,6,0 | -84.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week24,n=13,2,6,0 | -87.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week32,n=12,2,0,7 | -87.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week40,n=13,2,0,7 | -86.6 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | CD20+,Week52,n=13,2,0,6 | -89.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Day0, n=11,1,8,0 | -86.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week8, n=10,1,7,0 | -97.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week16, n=9,1,7,0 | -93.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Week24, n=9,1,7,0 | -94.2 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Week32, n=9,1,0,7 | -86.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week40, n=9,1,0,7 | -100.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week52, n=9,1,0,6 | -100.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Day0,n=11,2,8,0 | -56.7 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week16,n=14,2,6,0 | -81.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+, Week 8,n=15,2,5,0 | -50.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | CD20+,Week16,n=14,2,6,0 | -80.4 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 8,n=15,2,5,0 | -83.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | CD20+,Week24,n=13,2,6,0 | -53.4 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Day 0,n=16,2,8,0 | -81.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Week24, n=9,1,7,0 | -50.9 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+, Day 0,n=16,2,8,0 | -43.2 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week16,n=9,2,7,0 | -75.9 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week8,n=10,2,7,0 | -75.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week24,n=9,2,7,0 | -15.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Day 0,n=11,2,8,0 | -75.5 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Day0,n=11,2,8,0 | -66.7 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+, Week16,n=9,2,7,0 | -53.5 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week8,n=10,2,7,0 | -71.9 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week24,n=9,2,7,0 | -79.1 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Day0, n=11,1,8,0 | -65.1 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week16,n=9,2,7,0 | -48.6 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week8,n=10,2,7,0 | -88.6 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week24,n=13,2,6,0 | -65.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week24,n=9,2,7,0 | 152.3 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week8, n=10,1,7,0 | -76.3 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week16,n=14,2,6,0 | -60.7 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | CD20+ Day 0,n=16,2,8,0 | -77.1 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 24,n=13,2,6,0 | -54.2 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week16, n=9,1,7,0 | -72.3 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in B Cell Subsets | CD20+ Week 8,n=15,2,5,0 | -80.9 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week32,n=9,2,0,7 | -4.6 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 52,n=13,2,0,6 | -77.9 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week52,n=13,2,0,6 | -10.0 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 40,n=13,2,0,7 | -68.4 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | CD20+,Week52,n=13,2,0,6 | -71.8 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week52,n=9,2,0,6 | 0.7 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Naive CD19+CD20+CD27-,Week 32,n=12,2,0,7 | -73.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week52, n=9,1,0,6 | -27.4 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week32,n=9,2,0,7 | -41.3 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week32,n=12,2,0,7 | -20.0 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | CD20+,Week40,n=13,2,0,7 | -59.1 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+,Week32, n=9,1,0,7 | -54.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | SLE Subset CD19+CD38b+CD27b+Lymph,Week40,n=9,2,0,7 | -24.6 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Memory CD19+CD20+CD27+,Week40,n=13,2,0,7 | 0.0 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week32,n=9,2,0,7 | -52.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week52,n=9,2,0,6 | -53.8 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Activated CD19+CD20+CD69+, Week40, n=9,1,0,7 | -47.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week 52,n=9,2,0,6 | 32.2 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Plasmacytoid CD19+CD20+CD138+,Week40,n=9,2,0,7 | 2.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | Plasma CD19+CD20-CD138+,Week40,n=9,2,0,7 | -86.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in B Cell Subsets | CD20+,Week32,n=12,2,0,7 | -66.2 Percent change |
Secondary
Percentage Change From Baseline in Complement Levels
Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (Value at specified visit minus Baseline value) divided by Baseline value.
Time frame: Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 52,n=33,27,0,10 | 17.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 20,n=34,27, 11,0 | 32.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 40,n=34,25,0,11 | 12.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3, Day 0,n=39,27,12, 0 | 10.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 16,n=36,27, 11,0 | 35.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 44,n=34,27,0,10 | 14.1 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 16,n=36,27, 11,0 | 15.2 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 12,n=38,29, 11,0 | 27.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 48,n=33,27,0,10 | 15.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 48,n=33,27,0,10 | 31.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 8,n=37,29, 11,0 | 37.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 52,n=33,27,0,10 | 5.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 40,n=34,25,0,11 | 32.1 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4, Week 4,n=39,29,12, 0 | 31.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4, Day 0,n=39,27,12, 0 | 36.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 20,n=34,27, 11,0 | 15.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 8,n=37,29, 11,0 | 13.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 36,n=34,27,0,11 | 29.2 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 24,n=31,27, 11,0 | 17.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3, Week 4,n=39,29,12, 0 | 15.4 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 32,n=34,27,0,11 | 27.6 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 28,n=35,27,0,10 | 15.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 44,n=34,27,0,10 | 20.5 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 28,n=35,27,0,10 | 31.3 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 32,n=34,27,0,11 | 13.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 12,n=38,29, 11,0 | 10.9 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C4,Week 24,n=31,27, 11,0 | 34.8 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Complement Levels | C3,Week 36,n=34,27,0,11 | 9.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 40,n=34,25,0,11 | 73.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3, Day 0,n=39,27,12, 0 | 7.2 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3, Week 4,n=39,29,12, 0 | 16.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 8,n=37,29, 11,0 | 19.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 12,n=38,29, 11,0 | 14.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 16,n=36,27, 11,0 | 20.5 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 20,n=34,27, 11,0 | 13.6 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 24,n=31,27, 11,0 | 19.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 28,n=35,27,0,10 | 15.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 32,n=34,27,0,11 | 21.6 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 36,n=34,27,0,11 | 17.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 40,n=34,25,0,11 | 17.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 44,n=34,27,0,10 | 22.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 48,n=33,27,0,10 | 15.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C3,Week 52,n=33,27,0,10 | 21.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4, Day 0,n=39,27,12, 0 | 27.8 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4, Week 4,n=39,29,12, 0 | 47.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 8,n=37,29, 11,0 | 71.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 12,n=38,29, 11,0 | 68.4 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 16,n=36,27, 11,0 | 50.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 20,n=34,27, 11,0 | 64.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 24,n=31,27, 11,0 | 57.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 28,n=35,27,0,10 | 66.7 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 32,n=34,27,0,11 | 92.9 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 36,n=34,27,0,11 | 50.0 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 44,n=34,27,0,10 | 57.1 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 48,n=33,27,0,10 | 64.3 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Complement Levels | C4,Week 52,n=33,27,0,10 | 63.2 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C4,Week 16,n=36,27, 11,0 | 41.7 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C3, Day 0,n=39,27,12, 0 | 32.1 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C4,Week 20,n=34,27, 11,0 | 58.3 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C4,Week 24,n=31,27, 11,0 | 66.7 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C3, Week 4,n=39,29,12, 0 | 14.8 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C3,Week 24,n=31,27, 11,0 | 44.2 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C3,Week 20,n=34,27, 11,0 | 30.0 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C4, Day 0,n=39,27,12, 0 | 70.8 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C3,Week 16,n=36,27, 11,0 | 32.2 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C4, Week 4,n=39,29,12, 0 | 39.7 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C3,Week 12,n=38,29, 11,0 | 30.4 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C4,Week 8,n=37,29, 11,0 | 58.3 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C4,Week 12,n=38,29, 11,0 | 64.3 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Complement Levels | C3,Week 8,n=37,29, 11,0 | 31.4 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C4,Week 48,n=33,27,0,10 | 34.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C3,Week 36,n=34,27,0,11 | 26.0 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C4,Week 36,n=34,27,0,11 | 58.3 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C4,Week 40,n=34,25,0,11 | 58.3 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C3,Week 32,n=34,27,0,11 | 31.6 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C4,Week 44,n=34,27,0,10 | 60.7 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C3,Week 52,n=33,27,0,10 | 36.5 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C3,Week 28,n=35,27,0,10 | 31.3 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C3,Week 40,n=34,25,0,11 | 41.8 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C4,Week 28,n=35,27,0,10 | 50.6 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C3,Week 44,n=34,27,0,10 | 38.9 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C4,Week 52,n=33,27,0,10 | 58.3 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C4,Week 32,n=34,27,0,11 | 58.3 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Complement Levels | C3,Week 48,n=33,27,0,10 | 30.4 Percent change |
Secondary
Percentage Change From Baseline in Immunoglobulin
Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\* (value at specified visit minus Baseline value) divided by Baseline value.
Time frame: Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40, 48 and 52 weeks
Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 32,n=34,27,0,10 | -34.887 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM,Week 8,n=37,29, 11,0 | -49.174 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 16,n=36,27, 11,0 | -50.077 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 24,n=31,27, 11,0 | -20.570 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 24,n=31,27, 11,0 | -39.496 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA,Day 0,n=31,29, 12,0 | -19.205 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 32,n=34,27,0,10 | -11.243 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 40,n=33,25,0,11 | -10.769 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 52,n=33,27,0,10 | -30.921 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 48,n=33,27,0,10 | -16.000 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 52,n=33,27,0,10 | -14.859 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 48,n=33,27,0,10 | -31.707 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG,Day 0,n=39,29, 12,0 | -13.939 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA,Week 8,n=37,29, 11,0 | -21.028 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG,Week 8,n=37,29, 11,0 | -19.169 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 16,n=36,27, 11,0 | -16.169 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 24,n=31,27, 11,0 | -17.982 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 16,n=36,27, 11,0 | -22.052 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 32,n=34,27,0,10 | -9.798 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 40,n=34,25,0,11 | -6.955 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 40,n=34,25,0,11 | -37.870 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 48,n=33,27,0,10 | -14.063 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 52,n=33,27,0,10 | -11.258 Percent change |
| Long-term Discontinuation Group | Percentage Change From Baseline in Immunoglobulin | IgM,Day 0,n=31,29, 12,0 | -47.059 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 52,n=33,27,0,10 | -23.596 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM,Day 0,n=31,29, 12,0 | -53.608 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 16,n=36,27, 11,0 | -31.016 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG,Day 0,n=39,29, 12,0 | -29.524 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM,Week 8,n=37,29, 11,0 | -53.659 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 52,n=33,27,0,10 | -30.698 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 32,n=34,27,0,10 | -23.288 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 16,n=36,27, 11,0 | -54.945 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 40,n=34,25,0,11 | -52.381 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG,Week 8,n=37,29, 11,0 | -29.048 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 24,n=31,27, 11,0 | -50.909 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 24,n=31,27, 11,0 | -28.000 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA,Week 8,n=37,29, 11,0 | -31.455 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 48,n=33,27,0,10 | -25.133 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 32,n=34,27,0,10 | -29.703 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 52,n=33,27,0,10 | -51.648 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 16,n=36,27, 11,0 | -29.818 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 40,n=33,25,0,11 | -30.617 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA,Day 0,n=31,29, 12,0 | -25.909 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 40,n=34,25,0,11 | -25.532 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgA, Week 48,n=33,27,0,10 | -34.091 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 48,n=33,27,0,10 | -53.636 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgG, Week 24,n=31,27, 11,0 | -26.241 Percent change |
| Treatment Control Group | Percentage Change From Baseline in Immunoglobulin | IgM, Week 32,n=34,27,0,10 | -52.577 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgA, Week 16,n=36,27, 11,0 | -20.202 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgA,Day 0,n=31,29, 12,0 | -22.193 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgA,Week 8,n=37,29, 11,0 | -24.242 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgA, Week 24,n=31,27, 11,0 | -21.711 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgG,Day 0,n=39,29, 12,0 | -19.481 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgG,Week 8,n=37,29, 11,0 | -25.571 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgG, Week 16,n=36,27, 11,0 | -21.642 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgG, Week 24,n=31,27, 11,0 | -17.886 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgM,Day 0,n=31,29, 12,0 | -44.326 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgM,Week 8,n=37,29, 11,0 | -50.943 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgM, Week 16,n=36,27, 11,0 | -45.926 Percent change |
| Treatment Holiday Group - Holiday Phase | Percentage Change From Baseline in Immunoglobulin | IgM, Week 24,n=31,27, 11,0 | -45.161 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgG, Week 52,n=33,27,0,10 | -23.754 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgG, Week 48,n=33,27,0,10 | -20.596 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgM, Week 32,n=34,27,0,10 | -46.548 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgG, Week 40,n=34,25,0,11 | -26.484 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgG, Week 32,n=34,27,0,10 | -18.611 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgM, Week 40,n=34,25,0,11 | -48.889 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgA, Week 52,n=33,27,0,10 | -31.663 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgA, Week 48,n=33,27,0,10 | -33.936 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgM, Week 48,n=33,27,0,10 | -48.268 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgA, Week 40,n=33,25,0,11 | -24.579 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgA, Week 32,n=34,27,0,10 | -23.363 Percent change |
| Treatment Holiday Group - Re-start Phase | Percentage Change From Baseline in Immunoglobulin | IgM, Week 52,n=33,27,0,10 | -57.966 Percent change |
Secondary
Rate of SLE Index Flare Per Subject Year
Rate per subject year of SFI flare was calculated as total number of flares divided by total subject years in interval. The total subject years for each participant was calculated as (Week 52/ Exit visit date minus Day 0 visit date + 1) for Long-term discontinuation and treatment control groups. For treatment holiday phase group the subject-years for each participant was calculated as (Week 24/Treatment Re-start/Exit visit date minus Day 0 Visit date + 1)/365.25. For re-start treatment holiday phase group the subject-years for each participant was calculated as (Week 52/Exit visit date minus Week 24/Treatment Re-start date + 1)/365.25. Day 0 visit date is defined as Day 0 from present study.
Time frame: Up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Long-term Discontinuation Group | Rate of SLE Index Flare Per Subject Year | 2.1 Flares per Subject-year |
| Treatment Control Group | Rate of SLE Index Flare Per Subject Year | 0.6 Flares per Subject-year |
| Treatment Holiday Group - Holiday Phase | Rate of SLE Index Flare Per Subject Year | 1.0 Flares per Subject-year |
| Treatment Holiday Group - Re-start Phase | Rate of SLE Index Flare Per Subject Year | 0.3 Flares per Subject-year |
Secondary
SELENA SLEDAI Scores Change From Baseline
SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Data are reported at the specified time-points from Day 0 (of present study) up to Week 52. Baseline is defined as the Day 0 from parent studies. Change from Baseline is equal to (Value at specified visit minus Baseline value).
Time frame: Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52 weeks
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 36,n=34,27,0,11 | -5.0 Scores on a scale | Standard Deviation 4.42 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 20,n=36,27, 11,0 | -6.9 Scores on a scale | Standard Deviation 4.17 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Day 0,n=39,29,12, 0 | -6.2 Scores on a scale | Standard Deviation 4.12 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 32,n=34,27,0,11 | -5.7 Scores on a scale | Standard Deviation 4.59 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 24,n=36,27, 11,0 | -6.4 Scores on a scale | Standard Deviation 4.45 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 48,n=33,27,0,11 | -5.7 Scores on a scale | Standard Deviation 4.3 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 28,n=35,27,0,10 | -5.8 Scores on a scale | Standard Deviation 4.22 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 8,n=38,29, 11,0 | -6.4 Scores on a scale | Standard Deviation 4.18 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 52,n=33,27,0,11 | -5.0 Scores on a scale | Standard Deviation 4.39 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 44,n=34,27,0,11 | -5.8 Scores on a scale | Standard Deviation 4.15 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 12,n=38,29, 11,0 | -6.1 Scores on a scale | Standard Deviation 4.28 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 40,n=34,27,0,11 | -5.2 Scores on a scale | Standard Deviation 4.3 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 16,n=36,27, 11,0 | -6.4 Scores on a scale | Standard Deviation 5.21 |
| Long-term Discontinuation Group | SELENA SLEDAI Scores Change From Baseline | Week 4,n=39,29,12, 0 | -5.9 Scores on a scale | Standard Deviation 5.07 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 40,n=34,27,0,11 | -7.2 Scores on a scale | Standard Deviation 3.37 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Day 0,n=39,29,12, 0 | -6.9 Scores on a scale | Standard Deviation 3.62 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 4,n=39,29,12, 0 | -6.6 Scores on a scale | Standard Deviation 3.44 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 8,n=38,29, 11,0 | -7.0 Scores on a scale | Standard Deviation 3.73 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 16,n=36,27, 11,0 | -6.8 Scores on a scale | Standard Deviation 4.05 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 20,n=36,27, 11,0 | -6.9 Scores on a scale | Standard Deviation 3.23 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 24,n=36,27, 11,0 | -6.7 Scores on a scale | Standard Deviation 3.45 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 28,n=35,27,0,10 | -7.0 Scores on a scale | Standard Deviation 3.32 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 32,n=34,27,0,11 | -7.1 Scores on a scale | Standard Deviation 3.38 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 36,n=34,27,0,11 | -6.7 Scores on a scale | Standard Deviation 3.59 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 12,n=38,29, 11,0 | -7.0 Scores on a scale | Standard Deviation 3.75 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 44,n=34,27,0,11 | -7.3 Scores on a scale | Standard Deviation 3.49 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 48,n=33,27,0,11 | -7.3 Scores on a scale | Standard Deviation 3.28 |
| Treatment Control Group | SELENA SLEDAI Scores Change From Baseline | Week 52,n=33,27,0,11 | -6.9 Scores on a scale | Standard Deviation 3.69 |
| Treatment Holiday Group - Holiday Phase | SELENA SLEDAI Scores Change From Baseline | Week 16,n=36,27, 11,0 | -6.1 Scores on a scale | Standard Deviation 3.96 |
| Treatment Holiday Group - Holiday Phase | SELENA SLEDAI Scores Change From Baseline | Week 12,n=38,29, 11,0 | -6.3 Scores on a scale | Standard Deviation 3.95 |
| Treatment Holiday Group - Holiday Phase | SELENA SLEDAI Scores Change From Baseline | Week 8,n=38,29, 11,0 | -5.9 Scores on a scale | Standard Deviation 4.16 |
| Treatment Holiday Group - Holiday Phase | SELENA SLEDAI Scores Change From Baseline | Day 0,n=39,29,12, 0 | -6.3 Scores on a scale | Standard Deviation 4.31 |
| Treatment Holiday Group - Holiday Phase | SELENA SLEDAI Scores Change From Baseline | Week 24,n=36,27, 11,0 | -5.4 Scores on a scale | Standard Deviation 4.01 |
| Treatment Holiday Group - Holiday Phase | SELENA SLEDAI Scores Change From Baseline | Week 20,n=36,27, 11,0 | -6.1 Scores on a scale | Standard Deviation 3.96 |
| Treatment Holiday Group - Holiday Phase | SELENA SLEDAI Scores Change From Baseline | Week 4,n=39,29,12, 0 | -6.1 Scores on a scale | Standard Deviation 4.01 |
| Treatment Holiday Group - Re-start Phase | SELENA SLEDAI Scores Change From Baseline | Week 52,n=33,27,0,11 | -5.5 Scores on a scale | Standard Deviation 4.08 |
| Treatment Holiday Group - Re-start Phase | SELENA SLEDAI Scores Change From Baseline | Week 36,n=34,27,0,11 | -5.9 Scores on a scale | Standard Deviation 4.01 |
| Treatment Holiday Group - Re-start Phase | SELENA SLEDAI Scores Change From Baseline | Week 44,n=34,27,0,11 | -6.3 Scores on a scale | Standard Deviation 4.65 |
| Treatment Holiday Group - Re-start Phase | SELENA SLEDAI Scores Change From Baseline | Week 48,n=33,27,0,11 | -6.1 Scores on a scale | Standard Deviation 3.91 |
| Treatment Holiday Group - Re-start Phase | SELENA SLEDAI Scores Change From Baseline | Week 40,n=34,27,0,11 | -6.6 Scores on a scale | Standard Deviation 4.3 |
| Treatment Holiday Group - Re-start Phase | SELENA SLEDAI Scores Change From Baseline | Week 28,n=35,27,0,10 | -5.5 Scores on a scale | Standard Deviation 5.36 |
| Treatment Holiday Group - Re-start Phase | SELENA SLEDAI Scores Change From Baseline | Week 32,n=34,27,0,11 | -6.1 Scores on a scale | Standard Deviation 4.01 |