First study to assess histologic changes in the
kidneys of patients with lupus nephritis treated with LUPKYNIS®
(voclosporin)
Treatment was not associated with chronic
injury, with the average chronicity index remaining stable in both
treatment arms from baseline to follow-up
Activity scores decreased in conjunction with
improvements in urine protein creatinine ratio (UPCR) in both
treatment arms
Data further reinforces differentiation of
LUPKYNIS from first generation calcineurin inhibitors (CNIs)
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today announced data from the kidney biopsy sub-study of
the AURORA clinical trial program (AURORA 1 and AURORA 2 Extension
Study) was presented at the Congress of Clinical Rheumatology East
Conference May 4 – 7, 2023.
The addition of LUPKYNIS to standard of care MMF and low-dose
steroids in Aurinia’s Phase 3 AURORA program led to significantly
earlier and greater reductions in proteinuria while maintaining
stable renal function, as evidenced by a stable estimated
glomerular filtration rate (eGFR) slope over time.
To further characterize the long-term impact of LUPKYNIS on the
kidney at the histologic level, repeat biopsies were collected from
patients participating in the sub-study. Specifically, repeat renal
biopsies were obtained from 16 patients in the LUPKYNIS arm and 10
patients in the active control arm over 18 months from study entry.
Baseline and follow-up activity scores, a measure of active
inflammation in LN, and chronicity scores, a measure of
irreversible kidney injury, were obtained using a validated
assessment tool.
“We are encouraged by these results,” said Dr. Greg Keenan,
Chief Medical Officer of Aurinia. “Seeing similar improvement in
the activity scores and absence of change in the chronicity scores
with the LUPKYNIS treated patients as compared to those on MMF and
low dose steroids alone, without histologic findings of chronic CNI
nephrotoxicity, strengthens the totality of the evidence supporting
the long-term efficacy and safety of LUPKYNIS and further
differentiates the safety of this second-generation treatment from
the legacy, first generation CNIs.”
Higher rates of both complete renal response (CRR) and partial
renal response (PRR) were observed in LUPKYNIS treated patients at
month 36, consistent with the overall Aurora 2, LUPKYNIS treated
population. The patients in the LUPKYNIS treatment arm demonstrated
histologic activity improvement with stable chronicity scores
similar to the active control arm of MMF and low dose steroids
alone over the 18-months average treatment period at the time of
repeat biopsy.
Control
/ Standard of Care
n=10
LUPKYNIS
(voclosporin)
n=16
Baseline*
Follow-up
Baseline
Follow-up
Activity Index, mean (SD)
2.8 (3.2)
0.4 (1.0)
1.8 (3.0)
0.4 (1.0)
Chronicity Index, mean (SD)
2.9 (2.3)
2.8 (2.7)
3.8 (3.5)
4.1 (3.3)
Baseline
Month 36
Baseline
Month 36
UPCR, mean (SD), mg/mg
4.71 (2.6)
2.1 (4.6)
4.59 (2.5)
0.99 (1.4)
eGFR, mean (SD), mL/min/1.73m2
82.6 (12.3)
85.8 (13.3)
80.3 (16.4)
82.7 (15.4)
CRR, % (n/n)
-
40.0 (4/10)
-
62.5 (10/16)
PRR, % (n/n)
-
70.0 (7/10)
-
81.3 (13/16)
*Data from pre-treatment baseline of
AURORA 1.
There were no unexpected adverse events in patients treated with
LUPKYNIS, and the safety profile was consistent with the overall
AURORA 2 population.
LUPKYNIS is a novel calcineurin inhibitor (CNI) approved in the
United States, European Union, and Great Britain for the treatment
of adults with lupus nephritis (LN)1. It has two complementary
mechanisms of action relevant to the treatment of LN and the
inhibition of calcineurin1: it reduces activation of T-cells and
stabilizes podocytes, reducing proteinuria. LUPKYNIS has a
consistent dose-concentration relationship, eliminating the need
for therapeutic drug monitoring1,2 but unlike other CNIs, LUPKYNIS
has shown no increased safety signal for diabetes or dyslipidemia,
and has no drug-drug interaction with mycophenolate mofetil
(MMF)3-8.
The clinical poster presented at CCR East can be found by
accessing the Aurinia corporate website contained within the
Investor Relations tab and Presentation section of the site.
About Lupus Nephritis
Lupus Nephritis is a serious manifestation of systemic lupus
erythematosus (SLE), a chronic and complex autoimmune disease.
About 200,000-300,000 people live with SLE in the U.S. and about
one-third of these people are diagnosed with lupus nephritis at the
time of their SLE diagnosis. About 50 percent of all people with
SLE may develop lupus nephritis. If poorly controlled, lupus
nephritis can lead to permanent and irreversible tissue damage
within the kidney. Black and Asian people with SLE are four times
more likely to develop lupus nephritis and Hispanic people are
approximately twice as likely to develop the disease compared to
White people with SLE. Black and Hispanic people with SLE also tend
to develop lupus nephritis earlier and have poorer outcomes,
compared to White people with SLE.
About LUPKYNIS
LUPKYNIS® is the first U.S. FDA- and EC-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.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical
company focused on delivering therapies to treat targeted patient
populations with a high unmet medical need that are impacted by
autoimmune, kidney and rare diseases. In January 2021, the Company
introduced LUPKYNIS® (voclosporin), the first FDA-approved oral
therapy dedicated to the treatment of adult patients with active
lupus nephritis. The Company’s head office is in Edmonton, Alberta,
its U.S. commercial office is in Rockville, Maryland. The Company
focuses its development efforts globally.
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 (>3%) were glomerular
filtration rate decreased, hypertension, diarrhea, headache,
anemia, cough, urinary tract infection, abdominal pain upper,
dyspepsia, alopecia, renal impairment, abdominal pain, mouth
ulceration, fatigue, tremor, acute kidney injury, and decreased
appetite.
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.
1. LUPKYNIS® [package insert]. Rockville, MD : Aurinia Pharma
U.S., Inc., 2021. 2. van Gelder T et al. J Am Soc Nephrol.
2020;31:594. 3. Busque S et al. Am J Transplant.
2011;11(12):2675-2684. 4. Kolic J et al. Endocrinology.
2020;(161)11. 5. van Gelder T et al. Nephrol Dial Transplant.
2021;gfab022. 6. Ardoin S et al. Kidney Int Rep. 2022;7:S99. 7.
Rovin BH et al. Lancet. 2021 ;397(10289):2070-2080. 8. van Gelder T
et al. Nephrol Dial Transplant. 2022 ;37(5):917-922. 9. Teng YKO et
al. Nephrol Dial Transplant. 2022 ;37(3):gfac108.002. 10. Bajema IM
et al. Kidney Int. 2018;93(4):789-796.
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Investor/Media: Aurinia@westwicke.com
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