Lupkynis (voclosporin) / Aurinia Pharma, Otsuka - LARVOL DELTA

Childhood-onset lupus nephritis: unique aspects and challenges in management. (PubMed, Kidney Int) - "Novel treatments have become available for adults in the last decade, notably belimumab, obinutuzumab and voclosporin. In this mini review, we will highlight several unique aspects in managing childhood-onset LN (cLN), including the optimal definition of disease remission, prevention of relapse, the delicate balance between treatment efficacy and side-effects, and monogenic forms of lupus nephritis. We will also discuss how treatment adherence and dedicated transition care can affect treatment outcomes."

Journal • Chronic Kidney Disease • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease • Systemic Lupus Erythematosus

Efficacy and safety of Belimumab, Rituximab and Voclosporin in the treatment of lupus nephritis based on registered clinical trials: A systematic review and network meta-analysis. (PubMed, Lupus) - "Voclosporin had significantly better clinical efficacy than Rituximab during 1-year treatment period. Increasing the dose of Voclosporin did not significantly improve the efficacy, but it will increase the safety risk of adverse events."

Clinical • Journal • Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Influenza and COVID-19 Vaccination Uptake Among Women with Systemic Rheumatic Diseases in New York City Assessed Between 2022 and 2024 (ACR Convergence 2025) - "Includes Abatacept, Adalimumab, Anakinra, Anifrolumab, Belimumab, Canakinumab, Certolizumab, Denosumab, Etanercept, Golimumab, Guselkumab, Infliximab, Ixekizumab, Mepolizumab, Rilonacept, Risakizumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Ustekinumab, Azathioprine, Cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate, sulfasalazine, tacrolimus, thalidomide, voclosporin, baricitinib, tofacitinib, upadicitinib; 3. Influenza and COVID-19 vaccination uptake was overall high in this cohort of women with SRDs, with notable associations between black race, immunosuppressive medication use, and frequency of PCP visits with vaccination status. Factors associated with COVID-19 vaccination should be interpreted cautiously due to few unvaccinated women in the current study. Addressing concerns about side effects and improving access to routine care may further optimize vaccination uptake."

Clinical • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Influenza • Myositis • Novel Coronavirus Disease • Respiratory Diseases • Rheumatology • Scleroderma • Seronegative Spondyloarthropathies • Spondylarthritis • Systemic Sclerosis

Anifrolumab In Systemic Lupus Erythematosus With Renal Involvement: National Multicenter Registry In Clinical Practice (ACR Convergence 2025) - "The standard ANI regimen was 300 mg every 4 weeks, except in two patients who received loading doses (900 mg/4 weeks for 3 months, then 300 mg/4 weeks).In addition to corticosteroids, ANI was administered concomitantly with antimalarials (n=16), mycophenolate mofetil (n=11), tacrolimus (n=4), azathioprine (n=2), methotrexate (n=1), and voclosporin (n=1)...The prednisone dose was decreased from 9.2±7.9 mg/day to 3.3±2 mg/day (p= 0.1)...Abbreviations in alphabetical order: ANI: anifrolumab; AZA: azathioprine; BLM: belimumab; CYM: cyclophosp-hamide; MMF: mycophenolate mofetil; MP: methylprednisolone; MTX: methotrexate; LN: lupus nephritis; RTX: rituximab Figure 1... To our knowledge, this is the first real-life study of ANI in LN. In refractory patients to multiple immunosuppressive therapies, we observed a rapid and maintained effectiveness in SLE activity and renal manifestations, with a good safety profile. These preliminary data should be confirmed in clinical..."

Clinical • Dermatology • Glomerulonephritis • Herpes Zoster • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • Varicella Zoster

Evaluating the Neuroprotective and Acetylcholinesterase Inhibitory Properties of Four Calcineurin Inhibitor Drugs: Tacrolimus, Pimecrolimus, Cyclosporin A, and Voclosporin. (PubMed, Mol Neurobiol) - "Voc demonstrated superior in vitro AChE inhibition, surpassing galantamine at low concentrations. Moreover, Voc markedly restored cell viability and reduced neuronal degeneration in H2O2-treated cells. These findings suggest CNIs, especially Voc, as promising candidates for ND treatment, targeting AChE overactivity and oxidative stress."

Journal • Alzheimer's Disease • CNS Disorders • Pain • ACHE • CASP3

Blood pressure remains elevated in patients initiating voclosporin with low baseline blood pressure: evidence from patients in routine clinical care (ACR Convergence 2025) - ">50% of patients using voclosporin had a MCID in the first year of use. Increases tend to occur in the first 3 months of use and on average were larger for patients with normal baseline BPs. In contrast to findings reported from RCTs, BP increases for patients with normal baseline BPs were persistent over 12 months."

Clinical • Cardiovascular • Glomerulonephritis • Hypertension • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology

Voclosporin in Lupus Nephritis: Meta-Analysis of 6-Month and 1-Year Efficacy with 1-Year Safety Outcomes (ACR Convergence 2025) - "Standard therapies—high-dose corticosteroids combined with mycophenolate mofetil or cyclophosphamide—achieve complete renal remission in a limited subset of patients and carry substantial toxicity. Voclosporin significantly improves CRR at 6 months and 1 year in patients with LN, with an overall safety profile comparable to placebo. However, gastrointestinal and neurological adverse events were more common. Further studies are needed to assess long-term outcomes, define steroid-sparing protocols, optimize dosing, and evaluate efficacy across diverse populations to determine voclosporin's definitive role in LN treatment."

Retrospective data • Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

Real-world Effectiveness and Usage of Voclosporin: Data from the Enlight-LN Registry (ACR Convergence 2025) - P | "During clinical trials, voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, led to significant reductions in proteinuria with stable estimated glomerular filtration rate (eGFR) with up to 3 years of exposure compared to MMF and glucocorticoids alone. Patients in the Enlight-LN registry reflect the larger LN population in the US, including high percentages of Black and Hispanic and/or Latino patients. The outcomes data from this initial analysis are consistent with the findings from the voclosporin clinical trials, with substantial reductions in proteinuria observed over the first few months of treatment, with no new safety signals. These real-world data support the recent updates to the ACR guidelines recommending use of triple immunosuppressive therapy first-line in patients with active LN."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Rheumatology

Tacrolimus Versus Voclosporin for Active Lupus Nephritis: A Comparative Meta-analysis of Renal Response (ACR Convergence 2025) - "The approach to active class III and IV LN involves glucocorticoids and mycophenolate mofetil (MMF), with the addition of calcineurin inhibitors (CNIs) based on patient characteristics...Three trials compared TAC with conventional induction regimens (cyclophosphamide or MMF; n = 777)... Based on this meta-analysis, both calcineurin inhibitors improve short-term renal response in active lupus nephritis when added to standard care. Voclosporin shows a larger and more consistent benefit across trials (RR 1.78), whereas tacrolimus exhibits greater between-study variability. Nevertheless, the indirect Bucher comparison does not establish the clear superiority of either drug."

Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • IL2

Use of Voclosporin in Pediatric Patients: A Summary of Available Data from Post-marketing Reports (ACR Convergence 2025) - P3 | "Due to the limited number of reports and incomplete nature of spontaneous reporting, the emerging safety profile of voclosporin in pediatric patients requires further investigation, although no new safety signals were detected. Additional research is needed to better characterize the use of voclosporin in this population.1. Wenderfer SE, et al."

Clinical • P4 data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease • Systemic Lupus Erythematosus

Belimumab Is Associated with Lower Risk of Progression to LN Compared with Standard of Care in Patients with SLE (ACR Convergence 2025) - "Index was defined as the date of initiation of belimumab or SOC (immunosuppressant [IS, except for use in LN initial therapy], intravenous glucocorticoids [GCs], or oral GC escalation to ≥20 mg/day prednisone-equivalent) between Jan 1, 2017, and Mar 31, 2023...Initiation of LN induction therapy served as a proxy for incident LN and was defined as earliest use of: subcutaneous belimumab 400 mg once-weekly for four doses; voclosporin; cyclophosphamide (either monotherapy or combined with MMF or azathioprine); high-dose MMF... Belimumab use was associated with a lower risk of initiating LN induction therapy versus SOC among patients with SLE, suggesting a potential renal protective effect through which belimumab may prevent progression to LN.Funding: GSK Table. Select ATT-weighted baseline characteristics. *Imbalanced after ATT weighting; †the most recent eGFR measurement prior to the index date was used; if multiple measurements were available on the same day, the median..."

Clinical • Chronic Kidney Disease • Infectious Disease • Inflammatory Arthritis • Nephrology • Renal Disease

Retrospective Chart Audit Reveals Gaps in Steroid Tapering and Use of ACR Guideline-Recommended Regimens in LN (ACR Convergence 2025) - "Notably, since the previous guidelines update in 2012, the FDA has approved belimumab and voclosporin for the treatment of LN... ACR strongly recommends that patients with Class III, IV, or V LN be treated with hydroxychloroquine (HCQ), unless contraindicated...Our analysis shows that 69.3% of these patients are on RAAS-I therapy, most commonly ACE inhibitors such as lisinopril and enalapril...Only 51.5% of patients who are on oral steroid dosages exceeding 5mg per day are currently on a regimen consisting of belimumab or a calcineurin inhibitor (CNI), which have been demonstrated to be effective steroid-sparing agents.3,4 Fourth, for patients with Class III or IV ± V LN, ACR recommends a triple therapy regimen of steroids, MMF or cyclophosphamide (CYC), and either a CNI or belimumab... Currently, rheumatologists frequently prescribe HCQ and RAAS-I therapies to their LN patients, in line with the updated ACR guidelines. However, many patients remain on high-dose..."

Retrospective data • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

Investigating Canadians' information needs related to lupus: A Google Trends analysis of online search query data (ACR Convergence 2025) - "Additional peaks were observed across Canada in July 2009 (RV=0.58), September 2016 (RV=0.69), and September 2017 (RV=0.78), all of which were correlated with milestones in the development and eventual approval of belimumab for SLE. Similarly, a peak in August 2016 (RV=0.66) was associated with positive Phase II trials for voclosporin... An understanding of the information needs of the general public related to SLE, and how they vary spatially, is critical for designing and implementing targeted and effective patient education interventions. To this end, these research results will be shared and triangulated with the knowledge needs of advocacy organizations and the realities of lived SLE experience, through a deliberative dialogue with key stakeholders from across Canada. This research and deliberative dialogue will set a foundation for the design and implementation of relevant interventions to effectively reduce SLE-related health disparities and improve SLE-related..."

Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Novel Coronavirus Disease

Analysis of Medicare and Medicaid Utilization and Expenditure of Newly Approved Biologics for Systemic Lupus Erythematosus Patients in the United States (ACR Convergence 2025) - "Background/Purpose: Hydroxychloroquine is a cornerstone in the treatment of Systemic Lupus Erythematosus (SLE), while corticosteroids and immunosuppressive agents are employed for moderate to severe disease [1]. The introduction of targeted biologic agents such as Belimumab for active SLE and lupus nephritis (LN), Anifrolumab for moderate to severe active SLE and Voclosporin for active LN, has expanded the therapeutic armamentarium... The rapid growth in spending reflects expanded utilization of biologics (Figure 1). Although average spending per claim showed only modest changes, the substantial rise in spending per beneficiary highlights increased reliance on these newly approved therapies (Figure 2). Patients with severe SLE exhibit elevated rates of inpatient admissions and emergency department utilization, significantly contributing to increased healthcare expenditures [3]."

Clinical • Medicaid • Medicare • Reimbursement • US reimbursement • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Real-World Immunosuppressant Treatment Patterns in Lupus Nephritis: A Retrospective Claims Database Analysis in the United States (ACR Convergence 2025) - "We aimed to characterize real-world treatment patterns in newly diagnosed patients with LN within the United States (US), focusing on use of immunosuppressants (ISTs) and advanced therapies including belimumab and voclosporin...Of these, 946 patients (48%) received an IST as their first LoT, primarily mycophenolate mofetil (MMF, 66%), azathioprine (AZA, 10%) and/or belimumab (6%)... This health insurance claims-based study identified diverse treatment use in newly diagnosed patients with LN, with nearly half receiving an IST in the first LoT. Variability in treatment duration and regimens reflects dynamic patient needs and treatment practices. Understanding these patterns is essential for optimizing LN care and informing future monitoring of treatment changes following practice guideline updates and availability of newer therapies."

Claims database • Real-world • Real-world evidence • Retrospective data • Glomerulonephritis • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Cell Carcinoma • Renal Disease • Respiratory Diseases • Tuberculosis

Mesenchymal Stroma Cells (MSC) in Autoimmune Diseases: Clinical Application in Systemic Sclerosis and in Systemic Lupus Erythematosus (ICBMT 2025) - "Despite the recent regulatory approval of several drugs (belimumab, anifrolumab, and voclosporin) as add-on to standard of care, more effective and safe treatments are needed for a large number of patients with SLE. 2024 Dec 17:S2665-9913(24)00298 5) Lindsay D et al Mesenchymal stromal cells, autoimmune disease, immunomodulation, standardization, clinical trial design, data reporting. Cytotherapy 2025"

Clinical • Stroma • Acute Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Lupus • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 - 2024). (PubMed, Int J Clin Pharmacol Ther) - "Our findings are consistent with AEs reported in previous clinical trials and outlined in the drug's labeling. The study results further confirm the reliability of the adverse reactions listed in the prescribing information."

Journal • P4 data • Cardiovascular • Glomerulonephritis • Hypertension • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pain

LUPKYNIS Drug-use Results Survey (clinicaltrials.gov) - P=N/A | N=400 | Not yet recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd.

New trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

LUPKYNIS Drug-use Results Survey (clinicaltrials.gov) - P=N/A | N=400 | Recruiting | Sponsor: Otsuka Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Effective management of lupus nephritis using a novel combination therapy with low-dose steroids: a case report. (PubMed, J Nephrol) - "The patient tolerated the combination of volcosporin and belimumab well for nine months. She did not report any specific side effects during this time and was in clinical remission with no signs of systemic flare-up based on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). This case highlights the potential of combining belimumab, voclosporin, mycophenolate mofetil (MMF), and low-dose steroids in selected patients."

Journal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

Aurinia Pharmaceuticals Reports Financial Results for the Three and Six Months Ended June 30, 2025 (Aurinia Pharmaceuticals Press Release) - "Net Product Sales: For the three and six months ended June 30, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $66.6 million and $126.5 million, up 21% and 23%, respectively, from $55.0 million and $103.1 million, respectively, for the same periods of 2024....'We look forward to initiating clinical studies in at least two autoimmune diseases in the second half of this year.'"

New trial • Sales • Immunology • Lupus Nephritis

Clinical adverse events to voclosporin: a real-world drug safety study based on FDA Adverse Event Reporting System. (PubMed, Clin Exp Rheumatol) - "The present research provides a significant assessment of the postmarketing safety profile of voclosporin. However, additional studies are needed to corroborate and solidify these observations. Clinicians are advised to remain highly vigilant about the potential AEs associated with voclosporin and to carefully consider the appropriate dosing regimens when utilising this medication in clinical practice."

Adverse events • Journal • Real-world evidence • Cardiovascular • Dermatology • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Precision Editing of Cyclophilin A Generates Cyclosporine and Voclosporin Resistant Cellular Therapies. (PubMed, bioRxiv) - "This report of site-specific CypA modification offers a promising avenue for developing next-generation IECs that should function effectively in patients receiving CsA/VCS and thus expand applications for adoptive cell therapies in multiple clinical settings. CRISPR editing of the last exon of PPIA retains CypA expression but with an altered C-terminus that disrupts CsA and VCS interactions PPIA Δ C immune effector cells demonstrate retained proliferation and function in the presence of CsA and VCS."

IO biomarker • Journal • Immunology • Transplantation • PPIA

Management of Refractory Lupus Nephritis Based on New Guideline: Glomerular and Tubulointerstitial Disorders (KSN 2025) - "Promising options include obinutuzumab, anifrolumab, belimumab, and voclosporin. In this lecture, we will review the key updates in the 2024 KDIGO lupus nephritis guidelines and examine the clinical evidence supporting these changes. We will also explore real-world cases of refractory lupus nephritis and discuss practical examples of how the aforementioned therapies are being applied in clinical practice."

Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Development and Application of a Senolytic Predictor for Discovery of Novel Senolytic Compounds and Herbs. (PubMed, Molecules) - "In an experimental screening of predicted compounds, panaxatriol was found to exhibit senolytic activity on the etoposide-induced senescence of the IMR-90 cell line. Additionally, voclosporin was found to extend the lifespan of C. elegans more effectively than metformin, demonstrating the value of our model for drug repurposing. This study not only provides an efficient framework for discovering novel senolytic agents, but also highlights the predicted novel senolytic compounds and herbs as valuable starting points for future research into senolytic drug development."

Journal