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Triple Immunotherapy and Dual Steroid-Based Immunotherapy for Lupus Nephritis: A Comparative Analysis

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Dive into the results from an analysis comparing a triple immunosuppressive therapy vs dual high-dose MMF and steroid immunotherapy for lupus nephritis.

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  • Overview

    A propensity analysis recently compared the voclosporin-based triple immunosuppressive therapy utilized in the AURA-LV/AURORA 1 studies with the dual regimen of high-dose mycophenolate mofetil (MMF) or intravenous cyclophosphamide (IVC), and high-dose glucocorticoid-based therapy used in the landmark ALMS trial. Patients who received the voclosporin-based triple immunosuppressive group had earlier and greater reductions in proteinuria compared with patients in the dual immunosuppressive group. This is important because proteinuria is a key outcome measure in lupus nephritis and is predictive of long-term kidney health. Joining Dr. Charles Turck to share more of the findings from this propensity analysis and their implications for lupus nephritis care is abstract author Dr. Maria Dall’Era.

    © 2024 Aurinia Pharma U.S., Inc. All Rights Reserved. US-LUP-2400272 10/24

  • INDICATION

    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 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.
    Monitor eGFR regularly.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly.

    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. Monitor for neurologic symptoms.

    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.
    Monitor serum potassium levels 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 (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. 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.

    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: Avoid use of LUPKYNIS.

    Lactation: Consider the mother’s clinical need of LUPKYNIS and any potential adverse effects to the breastfed infant 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 full Prescribing Information including Boxed Warning for additional Important Safety Information about LUPKYNIS at LUPKYNISpro.com.

Schedule9 Dec 2024