- Patients treated with LUPKYNISⓇ in a repeat kidney biopsy
sub-study achieved improvement in histologic activity with stable
chronicity scores and no evidence of chronic injury.
- A propensity analysis of AURORA 1 suggested that LUPKYNISⓇ plus
standard of care improved safety and demonstrated earlier
reductions in proteinuria when compared to a conventional regimen
consisting of higher doses of both glucocorticoids and
mycophenolate mofetil.
- A post-hoc analysis showed Black patients experienced improved
outcomes and better renal response when using LUPKYNISⓇ.
- Additional poster presentations provided insights into ongoing
pre-clinical research, biomarkers, and other important areas to
improve care for LN patients.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company), announced today the presentation of nine studies (one
oral and eight posters) at the annual American Society of
Nephrology Kidney Week 2023 Convergence taking place in
Philadelphia, PA, November 2-5. The data reinforce previous
findings on the safety and effectiveness of LUPKYNISⓇ
(voclosporin), a second generation calcineurin inhibitor (CNI), for
the treatment of adult patients with active LN, as shown in the
AURORA Clinical Program, comprised of the Phase 3 AURORA 1 clinical
trial and the Phase 3 AURORA 2 extension study.
Results from an analysis of kidney biopsy samples collected from
patients participating in the AURORA Clinical Program were
presented in an oral session. To characterize the long-term renal
impact of LUPKYNISⓇ at the histologic level, researchers analyzed
repeat kidney biopsies from a subset of patients who completed one
year of treatment in the AURORA 1 clinical trial, including 16
patients in the active treatment arm who received LUPKYNISⓇ in
combination with mycophenolate mofetil (MMF) and low-dose
glucocorticoids and 10 patients in the control arm treated with MMF
and low-dose glucocorticoids alone.
Histologic changes from baseline to approximately 18 months
post-treatment were assessed using the modified National Institutes
of Health (NIH) activity and chronicity indices, wherein the
activity index provides a measure of active inflammation in LN, and
the chronicity index provides a measure of irreversible kidney
injury. Activity scores for both arms improved to a similar degree,
while the chronicity scores remained stable in both arms. These
results confirmed the safety profile of LUPKYNISⓇ showing no
associated chronic injury with use. Importantly, LUPKYNISⓇ -treated
patients in the overall AURORA 2 cohort maintained stable renal
function over the last two years of the study, as measured by eGFR
analysis and experienced numerically greater mean reductions in
urine protein creatinine ratio (UPCR), compared to patients in the
control arm.
“These findings from a small subset of patients further
strengthen the overall evidence supporting the long-term safety of
LUPKYNISⓇ in LN patients. The addition of LUPKYNISⓇ to MMF and
low-dose glucocorticoids to treat LN can lead to significantly
earlier and greater reductions in proteinuria while allowing
patients to maintain stable renal function. This is a critical
aspect to consider for patients with LN, as proteinuria is
associated with a major decline in kidney function and, in some
cases, kidney failure. This increased understanding of the
long-term safety and efficacy profile of LUPKYNISⓇ will contribute
to improving outcomes over time for this patient population,” said
Samir V. Parikh, M.D., nephrologist at the Ohio State University
Wexner Medical Center and lead study author.
A propensity analysis of the Aspreva Lupus Management Study
(ALMS) and AURORA 1 study suggested that LUPKYNISⓇ plus standard of
care may reduce patient exposure to toxicities associated with
taking mycophenolate mofetil (MMF) and glucocorticoids alone and
demonstrated earlier reductions in proteinuria. Safety and efficacy
outcomes for propensity-matched patients with active LN from the
ALMS and AURORA 1 study were assessed at three and six months. The
data showed an improved safety profile over the first six months of
treatment with LUPKYNISⓇ in combination with low-dose
glucocorticoids and lower-dose MMF without compromising efficacy.
Patients who received the LUPKYNISⓇ -based regimen experienced
reductions in exposure to glucocorticoids and MMF and earlier
reductions in proteinuria compared to patients treated with higher
doses of glucocorticoids and MMF.
In a subset analysis of three years of data from the AURORA
Clinical Program, 44.4% of Black patients treated with LUPKYNISⓇ
experienced an improvement in complete renal response at 36 months
(n=18) compared to 14.3% of Black patients who achieved complete
renal response when treated with MMF and glucocorticoids alone (n=
7). These findings among Black patients, a population that often
experiences worse outcomes and lower responses to LN treatment, are
consistent with the treatment response seen across all racial and
ethnic groups treated with LUPKYNISⓇ in the AURORA Clinical
Program.
“These data contribute to our growing body of evidence that
LUPKYNISⓇ enables positive long-term kidney outcomes for people
living with LN, a debilitating, yet common complication that occurs
in about half of people with lupus,” said Dr. Greg Keenan, Chief
Medical Officer of Aurinia. “The results presented at ASN this week
demonstrate important clinical and mechanistic findings associated
with LUPKYNISⓇ treatment. We remain deeply committed to improving
the lives of people living with autoimmune diseases, by advancing
transformative treatment options that are not only safe, but
clinically meaningful, for long-term use.”
Additional poster presentations provided a view into current,
new, and upcoming research.
Following is the complete guide to Aurinia’s presentations at
ASN 2023:
Title: Repeat kidney biopsies from
the AURORA 2 study of voclosporin in active lupus nephritis
Authors: Samir V. Parikh, Clint Abner, Ernie Yap, Krista
Piper, Rob Huizinga, Henry Leher Date: Thursday, November 2,
2023 Time: 5:42 p.m. – 5:51 p.m. ET Oral Session:
Glomerular Diseases - Clinical and Translational Studies
Location: Room 103
Title: Urinary extracellular
vesicles reveal distinct biological effects of voclosporin in the
treatment of lupus nephritis Authors: Martijn H. van
Heugten, Kuang-Yu Wei, Hester van Willigenburg, Faith Demir, Linda
M. Rehaume, John Viel, Markus M. Rinschen, Ewout J. Hoorn
Date: Thursday, November 2, 2023 Time: 10:00 a.m. –
12:00 p.m. ET Location: Poster Hall, #TH-PO550
Title: Registry of US adult
patients treated with LUPKYNIS for lupus nephritis
Authors: Lily Cipolla, Victoria Bal, Henry Leher
Date: Friday, November 3, 2023 Time: 10:00 a.m. –
12:00 p.m. ET Location: Poster Hall, #INFO16-FR
Title: Voclosporin treatment in
adolescents with lupus nephritis (VOCAL) Authors:
Nicola Waddingham, Amber Rosales, Gigi Cheung, Blake Potter, Mary
Palmen (Presented by Ernie Yap) Date: Friday, November 3,
2023 Time: 10:00 a.m. – 12:00 p.m. ET Location:
Poster Hall, #INFO17-FR
Title: Long-term safety and
efficacy of voclosporin in Black patients with lupus
nephritis Authors: Gabriel Contreras, Matt Baker,
Lucy Hodge, Ernie Yap Date: Saturday, November 4, 2023
Time: 10:00 a.m. – 12:00 p.m. ET Location: Poster
Hall, #SA-PO876
Title: Comparison of
dual-immunosuppressive therapy and a voclosporin-based,
triple-immunosuppressive regimen for lupus nephritis: a propensity
analysis of ALMS and AURORA 1 studies Authors: Ernie
Yap, Maria Dall’Era, Matt Truman, Lucy S. Hodge, Neil Solomons
Date: Saturday, November 4, 2023 Time: 10:00 a.m. –
12:00 p.m. ET Location: Poster Hall, #SA-PO877
Title: Comparative effects of
cyclosporine and voclosporin on primary human proximal tubular
epithelial (PTEC) gene expression Authors: Theresa
Aliwarga, Linda M. Rehaume, Catherine K. Yeung, Jonathan
Himmelfarb, Edward J. Kelly Date: Saturday, November 4, 2023
Time: 10:00 a.m. – 12:00 p.m. ET Location: Poster
Hall, #TH-PO103
Title: Voclosporin ameliorates both
proteinuria and dyslipidemia in a model of non-inflammatory
glomerular disease Authors: Yu Kamigaki, Julie
Dougherty, Amanda P. Waller, Linda M. Rehaume, Katelyn Wolfgang,
Eman Abdelghani, Bryce A. Kerlin, William E. Smoyer Date:
Saturday, November 4, 2023 Time: 10:00 a.m. – 12:00 p.m. ET
Location: Poster Hall, #SA-PO975
Title: Integrative systems analysis
of calcineurin inhibitor action on podocytes and proximal tubular
epithelial cells Authors: Anthony Mendoza, Maria
Paola Santini, Jenny Wong, Linda M. Rehaume, John Viel, Kirk N.
Campbell, Evren U. Azeloglu Date: Saturday, November 4, 2023
Time: 10:00 a.m. – 12:00 p.m. ET Location: Poster
Hall, #SA-PO010
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 worse outcomes,
compared to White people with SLE.
About LUPKYNIS®
LUPKYNIS® is the first U.S. Food and Drug Administration and
European Commission-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 high unmet medical needs 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
INDICATION
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.
References
- Parikh S. et al. Repeat kidney biopsies from the AURORA 2 study
of voclosporin in active lupus nephritis. Presented at the American
Society of Nephrology Conference, 2023, Philadelphia, PA.
- Yap E. et al. Comparison of dual-immunosuppressive therapy and
a voclosporin-based, triple-immunosuppressive regimen for lupus
nephritis: a propensity analysis of ALMS and AURORA 1 studies.
Presented at the American Society of Nephrology Conference, 2023,
Philadelphia, PA.
- Contreras G. et al. Long-term Safety and Efficacy of
Voclosporin in Black Patients with Lupus Nephritis: Results from
the AURORA 1 and AURORA 2 Studies. Presented at the American
Society of Nephrology Conference, 2023, Philadelphia,
PA.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102353965/en/
Media Inquiries: Andrea Christopher, Corporate
Communications Director, Aurinia achristopher@auriniapharma.com
Investor Inquiries: ir@auriniapharma.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
過去 株価チャート
から 10 2024 まで 11 2024
Aurinia Pharmaceuticals (NASDAQ:AUPH)
過去 株価チャート
から 11 2023 まで 11 2024
