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Now approved for the treatment of adults with active lupus nephritis...

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Strong First Line

See The Data

With LUPKYNIS (voclosporin) in combination with MMF and steroids, you can transform expectations for the journey ahead. LUPKYNIS offers significantly greater complete renal response rates and faster proteinuria reductions vs standard of care alone while reducing steroid use.1,a

aComplete renal response was achieved in 40.8% of patients with LUPKYNIS and 22.5% with control. Proteinuria reductions (UPCR ≤0.5 mg/mg) were achieved at a median time of 169 days with LUPKYNIS vs 372 days with control.1

MMF=mycophenolate mofetil; UPCR=urine protein/creatinine ratio.

Reference: 1. LUPKYNIS [package insert]. Rockville, MD: Aurinia Pharma U.S., Inc., 2021.

First-line treatment with MMF + steroids may not be doing enough to reach treatment goals in lupus nephritis1-3

Many patients don’t respond
to MMF + steroids1-3

Early response to treatment
is critical4

Reliance on high-dose steroids
may be putting patients at risk5

MMF=mycophenolate mofetil.

References: 1. Appel GB, Contreras G, Dooley MA, et al; Aspreva Lupus Management Study Group. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009;20(5):1103-1112. 2. Ginzler EM, Dooley MA, Aranow C, et al. Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis. N Engl J Med. 2005;353(21):2219-2228. 3. Isenberg D, Appel GB, Contreras G, et al. Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study. Rheumatology (Oxford). 2010;49(1):128-140. 4. Tamirou F, D’Cruz D, Sangle S, et al; MAINTAIN Nephritis Trial Group. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis. Ann Rheum Dis. 2016;75(3):526-531. 5. Lightstone L, Doria A, Wilson H, et al. Can we manage lupus nephritis without chronic corticosteroids administration? Autoimmun Rev. 2018;17(1):4-10.

LUPKYNIS is a novel, structurally modified CNI with a dual mechanism of action1,2

Calcineurin inhibition

Podocytes

Podocyte stability

Promotes podocyte stability leading to increased integrity in the glomeruli1

T cells

Immunosuppression

Acts as an immunosuppressant through inhibition of T-cell activation and cytokine production1

NO drug level monitoring is required with LUPKYNIS

Mechanism of voclosporin suppression of calcineurin has not been fully established1

CNI=calcineurin-inhibitor.

References: 1. LUPKYNIS [package insert]. Rockville, MD: Aurinia Pharma U.S., Inc., 2021. 2. Kuglstatter A, Mueller F, Kusznir E, et al. Structural basis for the cyclophilin A binding affinity and immunosuppressive potency of E-ISA247 (voclosporin). Acta Crystallogr D Biol Crystallogr. 2011;67(pt 2):119-123.

Superior results with LUPKYNIS vs standard of care alone—patients were 2.7x more likely to respond (OR: 2.7)1

Primary endpoint: complete renal response at Week 52

Significantly greater complete renal response rate with LUPKYNIS (P<0.001)1

The AURORA trial included a scheduled steroid taper from 20-25 mg/day at Week 1 to 2.5 mg/day by Week 161,2,a,b

  • Demonstrated efficacy even with a substantial steroid taper to low sustained doses (≤2.5 mg/day)1,c

Primary endpoint had strict criteria for complete renal response1:

  • UPCR of ≤0.5 mg/mg
  • eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20% or no treatment- or disease-related eGFR-associated event at the time of assessment
  • Presence of sustained, low-dose steroids from Weeks 44-52d
  • No administration of rescue medications

The AURORA Phase 3 trial was a randomized, double-blind, placebo-controlled trial of LUPKYNIS 23.7 mg BID in combination with MMF and corticosteroids (n=179) vs placebo BID in combination with MMF and corticosteroids (n=178) in adults with class III or IV (alone or in combination with class V) or class V lupus nephritis. Efficacy was established on the basis of complete renal response at Week 52. Key secondary endpoints included complete renal response at Week 24, partial renal response (50% reduction in UPCR from baseline) at Weeks 24 and 52, time to UPCR ≤0.5 mg/mg, and time to 50% reduction in UPCR.1,3

aInitial treatment with intravenous (IV) methylprednisolone on Day 1 and Day 2 at a dose of 500 mg/day (body weight ≥45 kg) or 250 mg/day (body weight <45 kg). The starting dose of oral prednisone was 20 mg/day for patients with a body weight of <45 kg and 25 mg/day for patients ≥45 kg. The dose of oral corticosteroid was tapered down to achieve a target dose of 2.5 mg/day by the end of Week 16. The timing of the titration to that dose was at the discretion of the investigator. When clinically indicated, patients were allowed to be completely titrated off oral corticosteroids.1,2

bPatients with a lack of response were allowed one 4-week interval without dose reduction or 1 dose escalation to the previous dose for 2 weeks at any time during the study. Lack of response was defined as no or minimal change in UPCR per investigator judgment over 3 visits or deterioration in UPCR not meeting the criteria for withdrawal.2

cThe protocol required steroid taper to 2.5 mg/day of prednisone by Week 16.1

dPatients did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44-52.1

Secondary endpoints

Demonstrated significantly greater renal response vs control as early as Week 241-3,e

Complete renal response at Week 24

(OR: 2.2; 95% CI: 1.3, 3.7)

Partial renal response at Week 24
(50% reduction in UPCR from baseline)

(OR: 2.4; 95% CI: 1.6, 3.8)

ePrimary endpoint of complete renal response, as previously described, was assessed at Week 52.

Secondary endpoints

Reduced proteinuria 2x faster than standard of care alone1,f

Median time to UPCR ≤0.5 mg/mg1,2,g

Median time to 50% UPCR reduction2

fPrimary endpoint of complete renal response, as previously described, was assessed at Week 52.

gAll patients were followed for 4 weeks after the last visit at Week 52.2

In a post hoc analysis, LUPKYNIS demonstrated consistent efficacy across racial and ethnic subgroups4,h

The study was not powered to detect differences in the treatment effect between these subgroups; therefore, results from this post hoc analysis should be interpreted with caution

hPrimary endpoint of complete renal response, as previously described, was assessed at Week 52.

BID=twice daily; eGFR=estimated glomerular filtration rate; HR=hazard ratio; MMF=mycophenolate mofetil; NC=not calculated; OR=odds ratio; UPCR=urine protein/creatinine ratio.

References: 1. LUPKYNIS [package insert]. Rockville, MD: Aurinia Pharma U.S., Inc., 2021. 2. Aurinia Pharma U.S., Inc. Data on file. 3. Gibson K, Parikh S, Saxena A, et al; AURORA Study Group. AURORA phase 3 study demonstrates voclosporin statistical superiority over standard of care in lupus nephritis. Presented at: National Kidney Foundation virtual 2020 Spring Clinical Meetings; March 26-29, 2020. 4. Arriens C, Polyakova S, Adzerikho I, et al; AURORA Study Group. AURORA phase 3 study demonstrates voclosporin statistical superiority over standard of care in lupus nephritis. Presented at: EULAR European E-Congress of Rheumatology 2020; June 3-Sept 1, 2020.

View the published pivotal Phase 3 trial results in The Lancet

READ NOW

Safety profile assessed in clinical trials with LUPKYNIS1

Most common adverse events (≥3% incidence and ≥2% vs control) from Phase 2 and 3 trials (integrated safety data)1
Adverse Reaction LUPKYNIS
23.7 mg BID
(n=267)
Control
(n=266)
Glomerular filtration rate decreaseda 26% 9%
Hypertension 19% 9%
Diarrhea 19% 13%
Headache 15% 8%
Anemia 12% 6%
Cough 11% 2%
Urinary tract infection 10% 6%
Abdominal pain upper 7% 2%
Dyspepsia 6% 3%
Alopecia 6% 3%
Renal impairmenta 6% 3%
Abdominal pain 5% 2%
Mouth ulceration 4% 1%
Fatigue 4% 1%
Tremor 3% 1%
Acute kidney injurya 3% 1%
Decreased appetite 3% 1%

aGFR decreased was the most frequently reported renal adverse reaction. Other renal adverse reactions were renal impairment, acute kidney injury, blood creatinine increased, azotemia, renal failure, oliguria, and proteinuria.1

BID=twice daily.

Reference: 1. LUPKYNIS [package insert]. Rockville, MD: Aurinia Pharma U.S., Inc., 2021.

Recommended starting dose is 3 capsules BID1

  • LUPKYNIS should be taken on an empty stomach1
  • Capsules should be swallowed whole and not opened, crushed, or divided1
  • LUPKYNIS is not recommended to be used in combination with cyclophosphamide1
  • If the patient has not experienced therapeutic benefit by 24 weeks, consider discontinuing LUPKYNIS1
  • The safety and efficacy of LUPKYNIS have not been established beyond 1 year1

Straightforward eGFR-based dosing recommendations1

≥60 mL/min/1.73 m2

NO dose adjustments necessary

<60 mL/min/1.73 m2

>20% and <30% from baseline

  • Reduce dose by 1 capsule (7.9 mg) BID
  • Reassess eGFR within 2 weeks; if eGFR is still reduced from baseline by >20%, reduce the dose again by 1 capsule (7.9 mg) BID

≥30% from baseline

  • Discontinue LUPKYNIS. Reassess eGFR within 2 weeks
  • Consider reinitiating LUPKYNIS at a lower dose (7.9 mg BID) only if eGFR has returned to ≥80% of baseline

  • Dose adjustments may be required for patients with eGFR reductions, renal impairment, hepatic impairment, or drug interactions with moderate CYP3A4 inhibitors1
  • Monitor blood pressure every 2 weeks for the first month of treatment, and as clinically indicated thereafter1
    • For blood pressure >165/105 mmHg, discontinue LUPKYNIS and initiate antihypertensive therapy
  • Please see the Prescribing Information for specific dose adjustment recommendations

BID=twice daily; eGFR=estimated glomerular filtration rate.

Reference: 1. LUPKYNIS [package insert]. Rockville, MD: Aurinia Pharma U.S., Inc., 2021.

Interested in prescribing LUPKYNIS for appropriate patients? Get started with Aurinia Alliance

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Indications

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (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 calcineurin inhibitors (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. 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.

Indications

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (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 calcineurin inhibitors (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. 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.