Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress
Aurinia Pharmaceuticals presented significant findings on LUPKYNIS (voclosporin) at the 59th European Renal Association Congress in May 2022, demonstrating its long-term safety and efficacy for treating lupus nephritis (LN).
In the AURORA 2 study, LUPKYNIS showed a clinically relevant preservation of kidney function over three years, with no new safety signals. The study found comparable serious adverse event rates between voclosporin and control, indicating its well-tolerated profile. Additionally, early treatment responses were observed across various biopsy classes, reinforcing voclosporin's role in managing LN effectively.
- LUPKYNIS demonstrated long-term safety and tolerability over three years.
- Clinically relevant preservation of kidney function was observed in LN patients.
- Significant differences in eGFR slope favored voclosporin compared to control.
- No new safety signals reported; overall serious adverse event rates were similar between voclosporin and control.
- None.
Use of LUPKYNIS was safe and well tolerated in patients for up to three years of treatment, with no new safety signals
In AURORA 2, long-term treatment with LUPKYNIS led to a clinically relevant preservation of kidney function in LN patients
A pooled analysis from the AURA-LV and AURORA 1 studies, also presented at ERA, showed early treatment response to LUPKYNIS with reductions in proteinuria across lupus nephritis biopsy classes
The AURORA 2 study assessed long-term safety and tolerability of voclosporin compared to placebo (both taken in combination with mycophenolate mofetil (MMF) and low-dose oral steroids) in patients with LN receiving treatment for an additional 24 months following completion of one year on treatment in the AURORA 1 study. The primary endpoint was safety and included assessments of adverse events, deaths, and hematological assessments. Secondary endpoints include renal response, renal flare, renal outcomes, and changes in urine protein to creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR).
“Lupus nephritis is a severe complication of lupus that will occur in up to half of patients diagnosed with SLE,” said
Voclosporin was well tolerated during the study period with a similar safety profile to control and no unexpected safety signals. Specific findings included:
-
Overall rates of serious adverse events were similar in both the control (
28.0% ) and voclosporin (26.0% ) arms and there was no increase in infectious events. -
Generally adverse events were low and decreased over time on treatment.
- Significant and meaningful reductions in proteinuria achieved in AURORA 1 were maintained.
- In AURORA 2, there was a significant difference in eGFR slope in favor of voclosporin (-0.2 mL/min/1.73 m2) compared to control arm (-5.4 mL/min/1.73 m2).
- There was a small, expected, and early decrease in mean eGFR in the first four weeks of treatment in AURORA 1, after which eGFR remained stable through the end of AURORA 2.
- The mean UPCR was lower in the voclosporin-treated groups at all time points during the three years.
- There were four deaths in the active control group during AURORA 2, while none in the voclosporin-treated group.
“When treating patients with lupus nephritis, the ultimate goal is to preserve kidney function,'' said
A post-hoc analysis of pooled data from the AURA-LV and AURORA 1 studies was also presented during an oral session at the
“The breadth of the AURORA clinical program provides important insights demonstrating the efficacy of voclosporin for the treatment of lupus nephritis across varying patient types," said
AURORA 2 Study Design
AURORA 2 (NCT03597464) is a Phase 3 randomized, double-blind, placebo-controlled clinical trial to assess the long-term safety and tolerability of voclosporin, in addition to MMF/steroids. Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2 continuation study with the same randomized treatment of voclosporin at 23.7 mg twice daily or placebo, in combination with MMF at 1 g twice daily with low-dose oral steroids, for up to an additional 24 months. A total of 216 LN patients continued into AURORA 2, with 116 patients in the voclosporin-treated group and 100 patients in the active control group.
About AURORA 1
The AURORA 1 study was a 52-week study designed to evaluate the efficacy and safety of LUPKYNIS (23.7 mg twice daily) when added to background therapy of MMF and corticosteroids tapered to a low dose, compared to background therapy alone in an ethnically and racially diverse patient population with active LN. Three hundred fifty-seven patients with a diagnosis of SLE and LN according to the
About AURA-LV
The AURA–LV study (Aurinia Urinary protein Reduction in Active Lupus with Voclosporin) was a 48-week study comparing the efficacy of two doses of voclosporin added to current standard of care of MMF against standard of care with placebo in achieving CR in patients with active LN. All arms also received low doses of steroids as background therapy. 265 patients were enrolled at centers in 20 countries worldwide. On entry to the study, patients were required to have a diagnosis of LN according to established diagnostic criteria (
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the
About LUPKYNIS
LUPKYNIS™ is the first FDA-approved oral medicine for the treatment of adult patients with active LN. LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia’s proprietary personalized eGFR-based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.
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INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
CONTRAINDICATIONS
LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.
ADVERSE REACTIONS
The most common adverse reactions (>
SPECIFIC POPULATIONS
Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS
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Corporate Communications, Aurinia
dlynch@auriniapharma.com
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