Trial Outcomes & Findings for Rituximab and Belimumab for Lupus Nephritis (NCT NCT02260934)

Last Updated: 2020-12-01

Results Overview

The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those: * with an onset date on or after the first dose of study medication, * with onset before first dose but that worsened in severity after first dose, and * for which the start of the AE in relation to the start of study medication could not be established. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Week 0 to Week 96

Results posted on

2020-12-01

Participant Flow

Of the 59 participants screened, 43 were enrolled at 14 sites in the US from July 9, 2015 to May 22, 2017.

Prior to randomization, enrolled participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper. Participants were randomized at Week 4.

Participant milestones

Participant milestones
Measure	Rituximab/Cyclophosphamide (RC) Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Overall Study STARTED	22	21
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab/Cyclophosphamide (RC) Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	0	2
Overall Study Participant Relocated	1	0
Overall Study Site error	0	1

Baseline Characteristics

Participants who signed informed consent and were enrolled in the study. Reported baseline measurements are the most recent measurements for a participant taken between the screening visit and Week 0.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.	Total n=43 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 11.4 • n=22 Participants	34.5 years STANDARD_DEVIATION 9.1 • n=21 Participants	33.4 years STANDARD_DEVIATION 10.3 • n=43 Participants
Sex: Female, Male Female	18 Participants n=22 Participants	19 Participants n=21 Participants	37 Participants n=43 Participants
Sex: Female, Male Male	4 Participants n=22 Participants	2 Participants n=21 Participants	6 Participants n=43 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=22 Participants	5 Participants n=21 Participants	15 Participants n=43 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=22 Participants	16 Participants n=21 Participants	28 Participants n=43 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=43 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Asian	3 Participants n=22 Participants	2 Participants n=21 Participants	5 Participants n=43 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Black or African American	9 Participants n=22 Participants	8 Participants n=21 Participants	17 Participants n=43 Participants
Race (NIH/OMB) White	7 Participants n=22 Participants	9 Participants n=21 Participants	16 Participants n=43 Participants
Race (NIH/OMB) More than one race	1 Participants n=22 Participants	1 Participants n=21 Participants	2 Participants n=43 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=22 Participants	1 Participants n=21 Participants	3 Participants n=43 Participants
Region of Enrollment United States	22 Participants n=22 Participants	21 Participants n=21 Participants	43 Participants n=43 Participants
Urine Protein-to-Creatinine Ratio (UPCR) from 24 Hour Collection	3.4 Ratio STANDARD_DEVIATION 1.5 • n=22 Participants	3.3 Ratio STANDARD_DEVIATION 2.5 • n=21 Participants	3.4 Ratio STANDARD_DEVIATION 2.0 • n=43 Participants
Elevated Urine Protein-to-Creatinine Ratio (UPCR)	14 Participants n=22 Participants	8 Participants n=21 Participants	22 Participants n=43 Participants
Serum Creatinine	1.0 mg/dL STANDARD_DEVIATION 0.4 • n=22 Participants	1.0 mg/dL STANDARD_DEVIATION 0.5 • n=21 Participants	1.0 mg/dL STANDARD_DEVIATION 0.4 • n=43 Participants
Estimated glomerular filtration rate (eGFR)	92.7 mL/min/1.73m^2 STANDARD_DEVIATION 36.0 • n=22 Participants	89.1 mL/min/1.73m^2 STANDARD_DEVIATION 33.9 • n=21 Participants	90.9 mL/min/1.73m^2 STANDARD_DEVIATION 34.6 • n=43 Participants
Serum Albumin	3.0 g/dL STANDARD_DEVIATION 0.5 • n=22 Participants	2.9 g/dL STANDARD_DEVIATION 0.6 • n=21 Participants	2.9 g/dL STANDARD_DEVIATION 0.6 • n=43 Participants
B Cell Count	160.5 cells/µL STANDARD_DEVIATION 157.4 • n=18 Participants • Participants who signed informed consent and were enrolled in the study. Reported baseline measurements are the most recent measurements for a participant taken between the screening visit and Week 0.	216.0 cells/µL STANDARD_DEVIATION 207.3 • n=18 Participants • Participants who signed informed consent and were enrolled in the study. Reported baseline measurements are the most recent measurements for a participant taken between the screening visit and Week 0.	188.3 cells/µL STANDARD_DEVIATION 183.6 • n=36 Participants • Participants who signed informed consent and were enrolled in the study. Reported baseline measurements are the most recent measurements for a participant taken between the screening visit and Week 0.
Immunoglobulin G (IgG) Level	1044.9 mg/dL STANDARD_DEVIATION 408.9 • n=22 Participants	1057.1 mg/dL STANDARD_DEVIATION 589.5 • n=21 Participants	1050.8 mg/dL STANDARD_DEVIATION 499.1 • n=43 Participants
Hypogammaglobulinemia	2 Participants n=22 Participants	4 Participants n=21 Participants	6 Participants n=43 Participants
Anti-Double Stranded DNA (Anti-dsDNA) Positive	20 Participants n=22 Participants	19 Participants n=21 Participants	39 Participants n=43 Participants
Hypocomplementemic for C3	18 Participants n=22 Participants	16 Participants n=21 Participants	34 Participants n=43 Participants
Hypocomplementemic for C4	10 Participants n=22 Participants	8 Participants n=21 Participants	18 Participants n=43 Participants
Weight	69.7 kg STANDARD_DEVIATION 18.0 • n=22 Participants	75.4 kg STANDARD_DEVIATION 26.0 • n=21 Participants	72.5 kg STANDARD_DEVIATION 22.2 • n=43 Participants
Duration of Lupus Nephritis	4.8 Years STANDARD_DEVIATION 4.5 • n=22 Participants	6.8 Years STANDARD_DEVIATION 6.6 • n=21 Participants	5.8 Years STANDARD_DEVIATION 5.7 • n=43 Participants
Duration of Lupus Nephritis More Than One Year > 1 year	18 Participants n=22 Participants	18 Participants n=21 Participants	36 Participants n=43 Participants
Duration of Lupus Nephritis More Than One Year ≤ 1 year	4 Participants n=22 Participants	3 Participants n=21 Participants	7 Participants n=43 Participants

PRIMARY outcome

Timeframe: Week 0 to Week 96

Population: The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab. Confidence intervals were calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96 Week 0 to Week 24	9.1 percentage of participants Interval 1.1 to 29.2	4.8 percentage of participants Interval 0.1 to 23.8
Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96 Week 0 to Week 48	22.7 percentage of participants Interval 7.8 to 45.4	9.5 percentage of participants Interval 1.2 to 30.4
Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96 Week 0 to Week 96	27.3 percentage of participants Interval 10.7 to 50.2	9.5 percentage of participants Interval 1.2 to 30.4

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide. Normal peripheral blood B Cell count: 107 to 698 cells/µL.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96 Week 96	40.0 Percentage of Participants Interval 16.3 to 67.7	30.8 Percentage of Participants Interval 9.1 to 61.4
Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96 Week 24	31.3 Percentage of Participants Interval 11.0 to 58.7	6.3 Percentage of Participants Interval 0.2 to 30.2
Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96 Week 48	35.7 Percentage of Participants Interval 12.8 to 64.9	11.8 Percentage of Participants Interval 1.5 to 36.4

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level \< 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010).

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96 Week 0 to Week 24	0 percentage of participants Interval 0.0 to 15.4	0 percentage of participants Interval 0.0 to 16.1
Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96 Week 0 to Week 48	0 percentage of participants Interval 0.0 to 15.4	0 percentage of participants Interval 0.0 to 16.1
Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96 Week 0 to Week 96	0 percentage of participants Interval 0.0 to 15.4	0 percentage of participants Interval 0.0 to 16.1

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who achieved a complete response, defined as meeting all of the following criteria: 1. Urine protein-to-creatinine ratio (UPCR) \< 0.5, based on a 24-hour collection; 2. Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m\^2 calculated by the CKD-EPI formula or, if \< 120 ml/min/1.73 m\^2, then \> 80% of eGFR at entry; and 3. Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96 Week 24	23.8 percentage of participants Interval 8.2 to 47.2	30.0 percentage of participants Interval 11.9 to 54.3
Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96 Week 48	35.0 percentage of participants Interval 15.4 to 59.2	42.1 percentage of participants Interval 20.3 to 66.5
Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96 Week 96	33.3 percentage of participants Interval 11.8 to 61.6	42.9 percentage of participants Interval 17.7 to 71.1

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who achieved an overall response, defined as meeting all of the following criteria: 1. \>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection; 2. Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m\^2 calculated by the CKD-EPI formula or, if \< 120 ml/min/1.73 m\^2, then \> 80% of eGFR at entry; and 3. Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96 Week 24	46.7 percentage of participants Interval 25.7 to 70.2	55.0 percentage of participants Interval 31.5 to 76.9
Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96 Week 48	60.0 percentage of participants Interval 36.1 to 80.9	73.7 percentage of participants Interval 48.8 to 90.9
Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96 Week 96	53.3 percentage of participants Interval 26.6 to 78.7	71.4 percentage of participants Interval 41.9 to 91.6

SECONDARY outcome

Timeframe: Week 48, Week 96

The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96. Complete response was defined as meeting all of the following criteria: 1. Urine protein-to-creatinine ratio (UPCR) \< 0.5, based on a 24-hour collection; 2. Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m\^2 calculated by the CKD-EPI formula or, if \< 120 ml/min/1.73 m\^2, then \> 80% of eGFR at entry; and 3. Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With a Sustained Complete Response	26.7 percentage of participants Interval 7.8 to 55.1	28.6 percentage of participants Interval 8.4 to 58.1

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96 Week 0 to Week 24	18.2 percentage of participants Interval 5.2 to 40.3	14.3 percentage of participants Interval 3.1 to 36.3
Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96 Week 0 to Week 48	45.5 percentage of participants Interval 24.4 to 67.8	28.6 percentage of participants Interval 11.3 to 52.2
Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96 Week 0 to Week 96	63.6 percentage of participants Interval 40.7 to 82.8	47.6 percentage of participants Interval 25.7 to 70.2

SECONDARY outcome

Timeframe: Week 24

Count of participants who experienced non-renal flares, defined as any new "A" finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG "A" finding represents a significant increase in, or a new manifestation of, disease activity.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Count of Participants: Frequency of Non-renal Flares by Week 24 0 Non-renal flares	21 Participants	20 Participants
Count of Participants: Frequency of Non-renal Flares by Week 24 1 Non-renal flare	1 Participants	0 Participants
Count of Participants: Frequency of Non-renal Flares by Week 24 2 Non-renal flares	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Count of Participants: Frequency of Non-renal Flares by Week 48 0 Non-renal flares	20 Participants	20 Participants
Count of Participants: Frequency of Non-renal Flares by Week 48 1 Non-renal flares	2 Participants	0 Participants
Count of Participants: Frequency of Non-renal Flares by Week 48 2 Non-renal flare	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 96

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Count of Participants: Frequency of Non-renal Flares by Week 96 0 Non-renal flares	18 Participants	19 Participants
Count of Participants: Frequency of Non-renal Flares by Week 96 1 Non-renal flare	4 Participants	1 Participants
Count of Participants: Frequency of Non-renal Flares by Week 96 2 Non-renal flares	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels \<30 IU/mL. Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96 Week 24	14.3 percentage of participants Interval 3.1 to 36.3	15.8 percentage of participants Interval 3.4 to 39.6
Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96 Week 48	20.0 percentage of participants Interval 5.7 to 43.7	30.0 percentage of participants Interval 11.9 to 54.3
Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96 Week 96	0.0 percentage of participants Interval 0.0 to 19.5	27.8 percentage of participants Interval 9.7 to 53.5

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level \<90 mg/dL. Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96 Week 24	57.1 percentage of participants Interval 34.0 to 78.2	30.0 percentage of participants Interval 11.9 to 54.3
Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96 Week 48	55.0 percentage of participants Interval 31.5 to 76.9	30.0 percentage of participants Interval 11.9 to 54.3
Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96 Week 96	61.1 percentage of participants Interval 35.8 to 82.7	27.8 percentage of participants Interval 9.7 to 53.5

SECONDARY outcome

Timeframe: Week 24, Week 48 and Week 96

The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level \<10 mg/dL. Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96 Week 24	19.0 percentage of participants Interval 5.5 to 41.9	5.0 percentage of participants Interval 0.1 to 24.9
Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96 Week 48	15.0 percentage of participants Interval 3.2 to 37.9	15.0 percentage of participants Interval 3.2 to 37.9
Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96 Week 96	16.7 percentage of participants Interval 3.6 to 41.4	11.1 percentage of participants Interval 1.4 to 34.7

SECONDARY outcome

Timeframe: Week 96

Population: The safety population includes all participants who received at least one dose of study treatment.

Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs. Treatment-emergent AEs are those: * with an onset date on or after the first dose of study medication, * with onset before first dose but that worsened in severity after first dose, and * for which the start of the AE in relation to the start of study medication could not be established. The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Frequency of Specific Adverse Events of Interest By Event by Week 96 Any event leading to death	0 Events	0 Events
Frequency of Specific Adverse Events of Interest By Event by Week 96 ≥Grade 2 leukopenia or thrombocytopenia	13 Events	16 Events
Frequency of Specific Adverse Events of Interest By Event by Week 96 Premature ovarian failure	0 Events	0 Events
Frequency of Specific Adverse Events of Interest By Event by Week 96 Malignancy	0 Events	0 Events
Frequency of Specific Adverse Events of Interest By Event by Week 96 Venous thromboembolic event	3 Events	0 Events

SECONDARY outcome

Timeframe: Week 96

Population: The safety population includes all participants who received at least one dose of study treatment.

Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs. Treatment-emergent AEs are those: * with an onset date on or after the first dose of study medication, * with onset before first dose but that worsened in severity after first dose, and * for which the start of the AE in relation to the start of study medication could not be established. The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.

Outcome measures

Outcome measures
Measure	Rituximab/Cyclophosphamide (RC) n=22 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.	Rituximab/Cyclophosphamide/Belimumab (RCB) n=21 Participants Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Frequency of Specific Adverse Events of Interest By Participant, By Week 96 Any event leading to death	0 Participants	0 Participants
Frequency of Specific Adverse Events of Interest By Participant, By Week 96 ≥Grade 2 leukopenia or thrombocytopenia	6 Participants	6 Participants
Frequency of Specific Adverse Events of Interest By Participant, By Week 96 Premature ovarian failure	0 Participants	0 Participants
Frequency of Specific Adverse Events of Interest By Participant, By Week 96 Malignancy	0 Participants	0 Participants
Frequency of Specific Adverse Events of Interest By Participant, By Week 96 Venous thromboembolic event	2 Participants	0 Participants

Adverse Events

RC Group on Treatment

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

RCB Group on Treatment

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

RC Group After Treatment Discontinuation

Serious events: 8 serious events

Other events: 11 other events

Deaths: 0 deaths

RCB Group After Treatment Discontinuation

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	RC Group on Treatment n=22 participants at risk Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96.	RCB Group on Treatment n=21 participants at risk Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.	RC Group After Treatment Discontinuation n=22 participants at risk Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96.	RCB Group After Treatment Discontinuation n=21 participants at risk Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Blood and lymphatic system disorders Anaemia	45.5% 10/22 • Number of events 17 • 1 year, 8 months (96 Weeks)	61.9% 13/21 • Number of events 20 • 1 year, 8 months (96 Weeks)	13.6% 3/22 • Number of events 3 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
Blood and lymphatic system disorders Leukopenia	22.7% 5/22 • Number of events 10 • 1 year, 8 months (96 Weeks)	28.6% 6/21 • Number of events 15 • 1 year, 8 months (96 Weeks)	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Blood and lymphatic system disorders Lymphopenia	77.3% 17/22 • Number of events 33 • 1 year, 8 months (96 Weeks)	52.4% 11/21 • Number of events 19 • 1 year, 8 months (96 Weeks)	40.9% 9/22 • Number of events 11 • 1 year, 8 months (96 Weeks)	14.3% 3/21 • Number of events 4 • 1 year, 8 months (96 Weeks)
Blood and lymphatic system disorders Neutropenia	13.6% 3/22 • Number of events 5 • 1 year, 8 months (96 Weeks)	23.8% 5/21 • Number of events 8 • 1 year, 8 months (96 Weeks)	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Endocrine disorders Cushingoid	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Gastrointestinal disorders Diarrhoea	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 3 • 1 year, 8 months (96 Weeks)	4.5% 1/22 • Number of events 1 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
Gastrointestinal disorders Dyspepsia	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Gastrointestinal disorders Nausea	22.7% 5/22 • Number of events 6 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Gastrointestinal disorders Vomiting	0.00% 0/22 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 3 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
General disorders Fatigue	9.1% 2/22 • Number of events 4 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
General disorders Local swelling	0.00% 0/22 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
General disorders Oedema peripheral	13.6% 3/22 • Number of events 3 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	4.5% 1/22 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Immune system disorders Hypogammaglobulinaemia	40.9% 9/22 • Number of events 12 • 1 year, 8 months (96 Weeks)	52.4% 11/21 • Number of events 18 • 1 year, 8 months (96 Weeks)	18.2% 4/22 • Number of events 5 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Infections and infestations Herpes zoster	0.00% 0/22 • 1 year, 8 months (96 Weeks)	14.3% 3/21 • Number of events 3 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Infections and infestations Nasopharyngitis	0.00% 0/22 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 3 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
Infections and infestations Oral candidiasis	9.1% 2/22 • Number of events 3 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 3 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Infections and infestations Upper respiratory tract infection	13.6% 3/22 • Number of events 6 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 4 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
Infections and infestations Urinary tract infection	13.6% 3/22 • Number of events 7 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Infections and infestations Viral upper respiratory tract infection	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Injury, poisoning and procedural complications Infusion related reaction	4.5% 1/22 • Number of events 1 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Injury, poisoning and procedural complications Maternal exposure during pregnancy	0.00% 0/22 • 1 year, 8 months (96 Weeks)	14.3% 3/21 • Number of events 4 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Investigations Blood creatinine increased	27.3% 6/22 • Number of events 9 • 1 year, 8 months (96 Weeks)	38.1% 8/21 • Number of events 11 • 1 year, 8 months (96 Weeks)	4.5% 1/22 • Number of events 1 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 2 • 1 year, 8 months (96 Weeks)
Metabolism and nutrition disorders Hypoalbuminaemia	45.5% 10/22 • Number of events 15 • 1 year, 8 months (96 Weeks)	38.1% 8/21 • Number of events 10 • 1 year, 8 months (96 Weeks)	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 2 • 1 year, 8 months (96 Weeks)
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Musculoskeletal and connective tissue disorders Back pain	13.6% 3/22 • Number of events 3 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
Nervous system disorders Headache	0.00% 0/22 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 2 • 1 year, 8 months (96 Weeks)	4.5% 1/22 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Psychiatric disorders Insomnia	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Renal and urinary disorders Lupus nephritis	18.2% 4/22 • Number of events 4 • 1 year, 8 months (96 Weeks)	28.6% 6/21 • Number of events 6 • 1 year, 8 months (96 Weeks)	4.5% 1/22 • Number of events 1 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
Renal and urinary disorders Proteinuria	31.8% 7/22 • Number of events 7 • 1 year, 8 months (96 Weeks)	28.6% 6/21 • Number of events 8 • 1 year, 8 months (96 Weeks)	13.6% 3/22 • Number of events 3 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)
Respiratory, thoracic and mediastinal disorders Cough	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	9.5% 2/21 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Skin and subcutaneous tissue disorders Alopecia	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)	0.00% 0/22 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)
Vascular disorders Hypertension	9.1% 2/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	4.8% 1/21 • Number of events 1 • 1 year, 8 months (96 Weeks)	4.5% 1/22 • Number of events 2 • 1 year, 8 months (96 Weeks)	0.00% 0/21 • 1 year, 8 months (96 Weeks)

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place