Trial Outcomes & Findings for Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (NCT NCT03597464)

Last Updated: 2022-12-14

Results Overview

Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

216 participants

Primary outcome timeframe

Month 12 (AURORA 2 baseline) to Month 36

Results posted on

2022-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Voclosporin Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil + corticosteroid	Placebo Oral Capsule Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil + corticosteroid
Overall Study STARTED	116	100
Overall Study COMPLETED	101	85
Overall Study NOT COMPLETED	15	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Voclosporin Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil + corticosteroid	Placebo Oral Capsule Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil + corticosteroid
Overall Study Withdrawal by Subject	4	5
Overall Study Lost to Follow-up	3	1
Overall Study Pregnancy	3	1
Overall Study Lack of Efficacy	2	0
Overall Study Physician Decision	2	2
Overall Study Protocol Violation	1	1
Overall Study Adverse Event	0	2
Overall Study Death	0	3

Baseline Characteristics

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Total n=216 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 10.31 • n=5 Participants	35.4 years STANDARD_DEVIATION 11.64 • n=7 Participants	33.7 years STANDARD_DEVIATION 11.03 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	88 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=5 Participants	33 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	67 Participants n=7 Participants	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	40 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	9 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment Southeast Asia	29 participants n=5 Participants	27 participants n=7 Participants	56 participants n=5 Participants
Region of Enrollment Europe	38 participants n=5 Participants	37 participants n=7 Participants	75 participants n=5 Participants
Region of Enrollment South America	34 participants n=5 Participants	27 participants n=7 Participants	61 participants n=5 Participants
Lupus Nephritis (LN) history Years since diagnosis of systemic lupus erythematosus (SLE)	6.6 years STANDARD_DEVIATION 6.66 • n=5 Participants	7.3 years STANDARD_DEVIATION 6.85 • n=7 Participants	6.9 years STANDARD_DEVIATION 6.75 • n=5 Participants
Lupus Nephritis (LN) history Years since diagnosis of lupus nephritis (LN)	4.8 years STANDARD_DEVIATION 5.27 • n=5 Participants	5.0 years STANDARD_DEVIATION 5.23 • n=7 Participants	4.9 years STANDARD_DEVIATION 5.24 • n=5 Participants
Lupus Nephritis (LN) history Years since first instance of significant proteinuria (>500 mg/day)	5.0 years STANDARD_DEVIATION 5.15 • n=5 Participants	4.7 years STANDARD_DEVIATION 4.49 • n=7 Participants	4.8 years STANDARD_DEVIATION 4.85 • n=5 Participants
Baseline Urine Protein Creatinine Ratio (UPCR)	3.941 mg/mg STANDARD_DEVIATION 2.5766 • n=5 Participants	3.868 mg/mg STANDARD_DEVIATION 2.4764 • n=7 Participants	3.907 mg/mg STANDARD_DEVIATION 2.5251 • n=5 Participants
Baseline estimated glomerular filtration rate (eGFR)	94.1 mL/min/1.73 m^2 STANDARD_DEVIATION 31.36 • n=5 Participants	92.0 mL/min/1.73 m^2 STANDARD_DEVIATION 28.04 • n=7 Participants	93.2 mL/min/1.73 m^2 STANDARD_DEVIATION 29.82 • n=5 Participants

PRIMARY outcome

Timeframe: Month 12 (AURORA 2 baseline) to Month 36

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. Any treatment-emergent adverse event (TEAE)	100 Participants	80 Participants
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. Treatment-related TEAE	28 Participants	21 Participants
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. Serious TEAE	21 Participants	23 Participants
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. TEAE leading to study drug discontinuation	11 Participants	17 Participants
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. TEAE leading to death	0 Participants	3 Participants
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. Treatment-related TEAE leading to death	0 Participants	0 Participants
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. Disease-related TEAE	50 Participants	34 Participants
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. Disease-related serious TEAE	7 Participants	11 Participants

SECONDARY outcome

Timeframe: Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36

Proportion of subjects in renal response defined as: * urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg * estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m\^2 or no confirmed decrease from baseline in eGFR of \>20% * Received no rescue medication for LN * Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during the 8 weeks prior to the renal response assessment.

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Number (and Percent) of Subjects in Renal Response Renal Response - Month 30	69 Participants	42 Participants
Number (and Percent) of Subjects in Renal Response Renal Response - Month 12	61 Participants	34 Participants
Number (and Percent) of Subjects in Renal Response Renal Response - Month 18	74 Participants	46 Participants
Number (and Percent) of Subjects in Renal Response Renal Response - Month 24	65 Participants	43 Participants
Number (and Percent) of Subjects in Renal Response Renal Response - Month 36	59 Participants	39 Participants

SECONDARY outcome

Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR).

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Number (and Percent) of Subjects in Partial Renal Response Partial Renal Response - Month 12	104 Participants	70 Participants
Number (and Percent) of Subjects in Partial Renal Response Partial Renal Response - Month 30	85 Participants	61 Participants
Number (and Percent) of Subjects in Partial Renal Response Partial Renal Response - Month 36	86 Participants	69 Participants
Number (and Percent) of Subjects in Partial Renal Response Partial Renal Response - Month 18	96 Participants	68 Participants
Number (and Percent) of Subjects in Partial Renal Response Partial Renal Response - Month 24	90 Participants	58 Participants

SECONDARY outcome

Timeframe: Month 12 (AURORA 2 baseline) to Month 36

A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria: * A reproducible increase to UPCR \>1 mg/mg from a post-response baseline of \<0.2 mg/mg or * an increase to UPCR \>2 mg/mg from a post-response baseline between 0.2 to 1.0 mg/mg or * a doubling of UPCR for baseline values of UPCR \>1 mg/mg

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC). Subjects without adequate response or with flares	39 Participants	46 Participants
Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC). Subjects with adequate response and wothout flares	77 Participants	54 Participants

SECONDARY outcome

Timeframe: Months 18, 24 and 36

Population: The number of subjects analyzed may not be aligned with overall number analyzed due to subjects withdrawing from study and missed study visits

Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of \<2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity.

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Month 18	-6.4 Scores on a scale Interval -7.4 to -5.4	-5.6 Scores on a scale Interval -6.6 to -4.5
Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Month 24	-6.8 Scores on a scale Interval -7.7 to -5.9	-6.1 Scores on a scale Interval -7.0 to -5.1
Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Month 36	-6.8 Scores on a scale Interval -7.7 to -5.9	-6.1 Scores on a scale Interval -7.1 to -5.2

SECONDARY outcome

Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Population: The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) Month 18	-3.05 mg/mg Standard Error 0.216	-2.42 mg/mg Standard Error 0.232
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) Month 24	-3.18 mg/mg Standard Error 0.188	-2.41 mg/mg Standard Error 0.202
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) Month 12 (AURORA 2 baseline)	-3.17 mg/mg Standard Error 0.164	-2.52 mg/mg Standard Error 0.175
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) Month 30	-3.12 mg/mg Standard Error 0.219	-2.21 mg/mg Standard Error 0.235
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) Month 36	-3.00 mg/mg Standard Error 0.222	-2.52 mg/mg Standard Error 0.236

SECONDARY outcome

Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Population: The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) Month 12 (AURORA 2 baseline)	1.8 mL/min/1.73 m^2 Standard Error 1.08	4.4 mL/min/1.73 m^2 Standard Error 1.15
Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) Month 18	-0.2 mL/min/1.73 m^2 Standard Error 1.31	1.6 mL/min/1.73 m^2 Standard Error 1.40
Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) Month 24	-1.3 mL/min/1.73 m^2 Standard Error 1.48	0.9 mL/min/1.73 m^2 Standard Error 1.60
Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) Month 30	0.2 mL/min/1.73 m^2 Standard Error 1.56	-0.8 mL/min/1.73 m^2 Standard Error 1.67
Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) Month 36	-0.2 mL/min/1.73 m^2 Standard Error 1.69	-2.0 mL/min/1.73 m^2 Standard Error 1.81

SECONDARY outcome

Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Population: The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein Month 12 (AURORA 2 baseline)	-302.4 mg/dL Standard Error 16.91	-234.6 mg/dL Standard Error 18.05
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein Month 18	-297.8 mg/dL Standard Error 23.41	-210.1 mg/dL Standard Error 25.15
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein Month 24	-295.8 mg/dL Standard Error 17.10	-248.8 mg/dL Standard Error 18.51
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein Month 30	-304.7 mg/dL Standard Error 19.23	-231.6 mg/dL Standard Error 20.67
Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein Month 36	-280.7 mg/dL Standard Error 22.66	-261.7 mg/dL Standard Error 24.01

SECONDARY outcome

Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Population: The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid	Placebo Oral Capsule n=100 Participants Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid
Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) Month 18	0.078 mg/dL Standard Error 0.0300	0.027 mg/dL Standard Error 0.0323
Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) Month 36	0.119 mg/dL Standard Error 0.0597	0.197 mg/dL Standard Error 0.0644
Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) Month 12 (AURORA 2 baseline)	0.051 mg/dL Standard Error 0.0207	-0.034 mg/dL Standard Error 0.0221
Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) Month 24	0.117 mg/dL Standard Error 0.0429	0.060 mg/dL Standard Error 0.0466
Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) Month 30	0.094 mg/dL Standard Error 0.0494	0.129 mg/dL Standard Error 0.0534

Adverse Events

Voclosporin

Serious events: 21 serious events

Other events: 84 other events

Deaths: 0 deaths

Placebo Oral Capsule

Serious events: 23 serious events

Other events: 60 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials Information

Aurinia Pharmaceuticals

Phone: 1 (250) 744-2487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Voclosporin n=116 participants at risk Voclosporin Voclosporin: Calcineurin inhibitor, oral, 23.7 mg BID	Placebo Oral Capsule n=100 participants at risk Placebo Placebo Oral Capsule: Voclosporin placebo, oral, 3 capsules BID
Infections and infestations Urinary tract infection	12.1% 14/116 • Number of events 22 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	8.0% 8/100 • Number of events 10 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Infections and infestations Upper respiratory tract infection	8.6% 10/116 • Number of events 11 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	3.0% 3/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Infections and infestations Viral upper respiratory tract infection	8.6% 10/116 • Number of events 10 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	4.0% 4/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Infections and infestations Bronchitis	4.3% 5/116 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	4.0% 4/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Infections and infestations Corona virus infection	4.3% 5/116 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	8.0% 8/100 • Number of events 9 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Infections and infestations Gastroenteritis	4.3% 5/116 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	2.0% 2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Infections and infestations Herpes zoster	3.4% 4/116 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	7.0% 7/100 • Number of events 7 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Blood and lymphatic system disorders Anaemia	6.0% 7/116 • Number of events 7 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	0.00% 0/100 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Blood and lymphatic system disorders Neutropenia	5.2% 6/116 • Number of events 8 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	5.0% 5/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 7/116 • Number of events 7 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	3.0% 3/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	4.3% 5/116 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	7.0% 7/100 • Number of events 9 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Musculoskeletal and connective tissue disorders Arthritis	3.4% 4/116 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	2.0% 2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Gastrointestinal disorders Diarrhoea	8.6% 10/116 • Number of events 15 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	5.0% 5/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Gastrointestinal disorders Nausea	2.6% 3/116 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	5.0% 5/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Renal and urinary disorders Lupus nephritis	6.9% 8/116 • Number of events 9 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	1.0% 1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Renal and urinary disorders Renal impairment	3.4% 4/116 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	2.0% 2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Renal and urinary disorders Proteinuria	3.4% 4/116 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	1.0% 1/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Nervous system disorders Headache	6.9% 8/116 • Number of events 12 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	5.0% 5/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Vascular disorders Hypertension	8.6% 10/116 • Number of events 10 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	6.0% 6/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Skin and subcutaneous tissue disorders Alopecia	4.3% 5/116 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	2.0% 2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Skin and subcutaneous tissue disorders Rash	2.6% 3/116 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	2.0% 2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Investigations Glomerular filtration rate decreased	9.5% 11/116 • Number of events 14 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	5.0% 5/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Investigations Neutrophil count decreased	1.7% 2/116 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	3.0% 3/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
General disorders Oedema peripheral	3.4% 4/116 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	8.0% 8/100 • Number of events 9 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Injury, poisoning and procedural complications Ligament sprain	3.4% 4/116 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	1.0% 1/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Eye disorders Dry eye	3.4% 4/116 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	1.0% 1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 3/116 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.	4.0% 4/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37). Subjects are counted once within a system organ class and once for each unique preferred term.