Aurinia Pharmaceuticals, a biopharmaceutical company dedicated to revolutionizing autoimmune disease treatments, has announced exciting new data on their groundbreaking medication, LUPKYNIS®. The data will be presented at two major medical conferences: the American Society of Nephrology (ASN) Kidney Week 2023 and the American College of Rheumatology Convergence (ACR) 2023.
These presentations, led by leading experts in nephrology and rheumatology, will reinforce the long-term safety and efficacy profile of LUPKYNIS® for adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). Aurinia’s commitment to ongoing research in autoimmune diseases, particularly lupus, is evident in this robust set of data.
The abstracts for these conferences can be accessed online at the respective websites. Aurinia will also issue full data press releases during the meetings for more comprehensive information.
Lupus Nephritis is a severe manifestation of SLE, a complex and chronic autoimmune disease. Approximately 200,000-300,000 individuals in the United States live with SLE, and around one-third of them are diagnosed with lupus nephritis at the time of their SLE diagnosis. It is estimated that 50 percent of people with SLE may develop lupus nephritis, which, if left uncontrolled, can lead to irreversible tissue damage in the kidneys. Alarmingly, Black and Asian individuals with SLE are four times more likely to develop lupus nephritis, while Hispanic individuals are twice as likely compared to their White counterparts. Additionally, Black and Hispanic people with SLE experience earlier onset and worse outcomes when they develop lupus nephritis.
LUPKYNIS® is the first oral medicine for adult patients with active LN that has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission. This revolutionary medication is a structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action. It acts as an immunosuppressant by inhibiting T-cell activation and cytokine production, while also promoting podocyte stability in the kidneys. The recommended starting dose of LUPKYNIS is three capsules twice daily, without requiring serum drug monitoring. Aurinia has developed a personalized eGFR-based dosing protocol for LUPKYNIS, allowing for dose modifications as needed. The warnings and precautions for LUPKYNIS are consistent with other CNI-immunosuppressive treatments.
Aurinia Pharmaceuticals operates as a fully integrated biopharmaceutical company, focusing on developing therapies to address the unmet medical needs of patients affected by autoimmune, kidney, and rare diseases. Their launch of LUPKYNIS®, the first FDA-approved oral therapy for active lupus nephritis in adults, demonstrates their commitment to improving patient outcomes. Aurinia is headquartered in Edmonton, Alberta, with its U.S. commercial office based in Rockville, Maryland. The company’s development efforts extend globally.
LUPKYNIS® is indicated for use in combination with a background immunosuppressive therapy regimen for adult patients with active LN. However, it should not be taken in combination with cyclophosphamide, as its safety and efficacy in this combination have not been established.
The important safety information for LUPKYNIS® highlights two significant risks: an increased likelihood of developing malignancies and serious infections. These risks apply to LUPKYNIS as well as other immunosuppressive treatments, which could result in hospitalization or even death.
LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors due to the heightened risk of acute and/or chronic nephrotoxicity. It is also contraindicated in patients who have had a serious or severe hypersensitivity reaction to LUPKYNIS or its excipients.
Numerous warnings and precautions accompany the use of LUPKYNIS. Immunosuppressants, including LUPKYNIS, elevate the risk of developing lymphomas and other malignancies, particularly those affecting the skin. The risk is correlated with the duration and dosage of immunosuppression rather than attributable to a specific agent. Additionally, LUPKYNIS can increase the likelihood of bacterial, viral, fungal, and protozoal infections, including opportunistic infections, which may lead to severe, even fatal, consequences.
Nephrotoxicity is another potential concern, as LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. This risk escalates when CNIs are administered concurrently with drugs linked to nephrotoxicity. Hypertension, neurotoxicity, hyperkalemia, and QTc prolongation are additional risks associated with LUPKYNIS use.
There are also precautions regarding immunizations. It is advised to avoid using live attenuated vaccines while undergoing treatment with LUPKYNIS. Although certain inactivated vaccines are considered safe, they may not be sufficiently immunogenic during LUPKYNIS treatment. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant, and discontinuation of LUPKYNIS should be considered if PRCA is diagnosed.
Finally, LUPKYNIS has known drug-drug interactions that should be carefully managed. Co-administration with strong CYP3A4 inhibitors or inducers is to be avoided, and dosage adjustments are necessary when LUPKYNIS is used with moderate CYP3A4 inhibitors. Certain P-gp substrates with narrow therapeutic windows may require reduced dosages when co-administered with LUPKYNIS.
Clinical trials have identified the most common adverse reactions to LUPKYNIS, which include decreased glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, upper abdominal pain, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
In conclusion, Aurinia Pharmaceuticals’ presentation of groundbreaking data on LUPKYNIS® at the upcoming ASN Kidney Week 2023 and ACR 2023 conferences highlights their commitment to transforming treatment options for individuals with active lupus nephritis. The long-term safety and efficacy profile of LUPKYNIS underscore its potential to improve patient outcomes. As a fully integrated biopharmaceutical company, Aurinia is focused on addressing the unmet medical needs of patients affected by autoimmune, kidney, and rare diseases. LUPKYNIS, the first FDA-approved oral therapy for adult patients with active lupus nephritis, represents a significant advancement in the field. While LUPKYNIS has some important precautions and potential risks, it presents a significant opportunity to enhance the lives of those living with lupus nephritis.
