- A propensity analysis of ALMS, AURA-LV, and AURORA 1 suggested
that initial therapy with LUPKYNIS plus standard of care reduced
exposure to potential toxicities and demonstrated earlier
reductions in proteinuria when compared to a conventional regimen
consisting of higher doses of both mycophenolate mofetil and
glucocorticoids alone.
- A post-hoc analysis showed Black patients experienced improved
outcomes and better renal response when using LUPKYNIS.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company), today announced the presentation of two studies at the
annual Congress of Clinical Rheumatology (CCR) East 2024 taking
place in Destin, FL, May 9-12. The data reinforce previous findings
on the safety and effectiveness of LUPKYNIS (voclosporin), a second
generation calcineurin inhibitor (CNI), in combination with MMF and
steroids, for the treatment of adult patients with active lupus
nephritis (LN), as shown in the AURORA Clinical Program.
A propensity analysis of the Aspreva Lupus Management Study
(ALMS), AURA-LV, and AURORA 1 studies suggested that LUPKYNIS plus
standard of care demonstrated superior reductions in proteinuria
and reduced patient exposure to toxicities compared with higher
doses of mycophenolate mofetil (MMF) and glucocorticoids or
cyclophosphamide and glucocorticoids alone. Safety and efficacy
outcomes for propensity-matched patients with active LN from the
AURA-LV plus AURORA 1 studies were assessed at three and six
months. Patients who received the LUPKYNIS-based regimen
experienced reductions in exposure to glucocorticoids and more
patients achieved a >50% urine protein creatinine ratio
reduction from baseline compared to their propensity-matched
counterparts in ALMS.
“Early reduction in proteinuria after initial treatment has been
associated with improved long-term kidney outcomes in lupus
nephritis,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.
“These data provide further support for use of LUPKYNIS plus
standard of care as an initial treatment option for appropriate
patients with active LN, consistent with the updated 2023 EULAR
guidelines. These insights should help rheumatologists implement
more effective treatment plans for their LN patients.”
In a subset analysis of three years of data from the AURORA
Clinical Program, 44.4% of Black patients treated with LUPKYNIS,
MMF, and steroids 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 OR: 4.17 (CI 0.41, >9.99), p=0.22).
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 the addition of LUPKYNIS to the standard
of care in the AURORA Clinical Program.
Following is the complete guide to Aurinia’s presentations at
CCR East 2024:
Title: Comparison of a
Voclosporin-based, Triple Immunotherapy Regimen to High-dose
Glucocorticoid-based Immunosuppressive Therapy: A Propensity
Analysis of the AURA-LV plus AURORA 1 Studies and ALMS
Authors: Maria Dall’Era, Kenneth Kalunian, Anca Askanase,
Neil Solomons, Matt Truman, Lucy S. Hodge, Ernie Yap Date:
Friday, May 10, 2024 Time: 2:45 p.m. – 5:00 p.m. CT
Title: Long-term Safety and
Efficacy of Voclosporin in Black Patients with Lupus
Nephritis Authors: Gabriel Contreras, Matthew G.
Baker, Lucy S. Hodge, Ernie Yap Date: Friday, May 10, 2024
Time: 2:45 p.m. – 5:00 p.m. CT
About LUPKYNIS LUPKYNIS (voclosporin) is the first U.S.
Food and Drug Administration and European Commission approved oral
medicine for the treatment of adult patients with active lupus
nephritis (LN). LUPKYNIS is a second generation 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 AURORA Clinical Program, comprised of the AURORA 1 pivotal
trial and AURORA 2 extension trial, demonstrated the importance of
LUPKYNIS plus standard of care to preserve kidney health in
patients with active LN without reliance on chronic high-dose
glucocorticoids. It is the only clinical program to include three
years of LN treatment and follow-up with mycophenolate mofetil
(MMF) and steroids.
About Lupus Nephritis Lupus Nephritis (LN) is a serious
manifestation of systemic lupus erythematosus (SLE), a chronic and
complex autoimmune disease. LN affects approximately 120,000 people
in the U.S. and disproportionately affects women and people of
color. People living with LN have high unmet needs and often face
significant barriers to optimal care. If poorly controlled, LN can
lead to permanent and irreversible tissue damage within the kidney.
Medical guidelines recommend that all SLE patients receive routine
LN screenings at every visit. Guidelines also note that delaying LN
diagnosis has profound prognostic repercussions. Yet, research
shows that approximately 50% of SLE patients are not screened for
LN and 77% of people with LN go untreated. Aurinia is committed to
improving health outcomes for people living with LN by educating
patients and providers on the critical need for routine screening
and transformative therapies that can help improve health
outcomes.
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. This
may lead to serious, even fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other calcineurin
inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity.
The risk is increased if administered with drugs associated with
nephrotoxicity. Monitor eGFR regularly.
Hypertension: Hypertension is a common adverse reaction
of LUPKYNIS therapy that may require antihypertensive therapy.
Monitor blood pressure regularly.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause
neurotoxicities that if severe can include posterior reversible
encephalopathy syndrome, delirium, seizure, and coma; others
include tremor, paresthesia, headache, and changes in mental status
and/or motor and sensory functions. Monitor for neurologic
symptoms.
Hyperkalemia: Hyperkalemia, which may be serious and
require treatment, has been reported. Concomitant use of agents
associated with hyperkalemia may increase the risk for
hyperkalemia. Monitor serum potassium periodically.
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
have been reported in patients treated with another CNI. If PRCA is
diagnosed, consider discontinuation of LUPKYNIS.
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.
Drug-Drug Interactions: Avoid co-administration of
LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate
CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4
inhibitors is contraindicated. Reduce LUPKYNIS dosage when
co-administered with moderate CYP3A4 inhibitors. Avoid use of
LUPKYNIS with strong or moderate CYP3A4 inducers.
SPECIFIC POPULATIONS
Pregnancy: Avoid use of LUPKYNIS.
Lactation: Consider the benefits and risks of LUPKYNIS
and possible risks to the fetus when prescribing LUPKYNIS to a
lactating woman.
Renal Impairment: LUPKYNIS is not recommended in patients
with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk.
If used in this population, reduce LUPKYNIS dose.
Hepatic Impairment: For mild or moderate hepatic
impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic
impairment.
Please see Prescribing Information, including Boxed Warning, and
Medication Guide for LUPKYNIS.
References
- Dall’Era M. et al. Comparison of a Voclosporin-based, Triple
Immunotherapy Regimen to High-dose Glucocorticoid-based
Immunosuppressive Therapy: A Propensity Analysis of the AURA-LV
plus AURORA 1 Studies and ALMS. Presented at the Congress of
Clinical Rheumatology East, 2024, Destin, FL.
- Contreras G. et al. Long-term Safety and Efficacy of
Voclosporin in Black Patients with Lupus Nephritis. Presented at
the Congress of Clinical Rheumatology East, 2024, Destin, FL.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240509369105/en/
Media and Investor Inquiries: Andrea Christopher
Corporate Communications & Investor Relations
achristopher@auriniapharma.com ir@auriniapharma.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
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