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

Early antiproteinuric effect of voclosporin in patients with lupus nephritis in a real-life setting: preliminary results from the VoRLiSS (Voclosporin in Real Life Setting Study) experience. (PubMed, Rheumatology (Oxford)) - "Voclosporin may provide a valuable therapeutic option in LN management, achieving early 24 h-proteinuria response consistent with clinical trial data."

Journal • Cardiovascular • Glomerulonephritis • Hypertension • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pulmonary Arterial Hypertension • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

Systemic Lupus Erythematosus: Ophthalmological Safety Considerations of Emerging and Conventional Therapeutic Agents. (PubMed, Int J Mol Sci) - "With the advent of targeted immunomodulatory agents, the therapeutic landscape of SLE has expanded beyond conventional drugs such as hydroxychloroquine and corticosteroids toward biologics and small molecules designed to interfere with specific immunological pathways...In contrast, recently approved or investigational therapies-such as belimumab, anifrolumab, voclosporin, dual BAFF/APRIL inhibitors, rituximab, JAK inhibitors, CD40/CD40L blockade, CD38 inhibition, and mesenchymal stromal cell-based strategies-have limited but evolving safety data, with potential ocular adverse events spanning inflammatory, vascular, neuro-ophthalmic, and structural domains...These findings highlight the need for systematic ophthalmological surveillance in patients receiving immunomodulatory therapies for SLE. Early recognition and timely management of ocular toxicity are crucial to safeguarding visual function and optimizing long-term therapeutic outcomes in this vulnerable patient..."

Journal • Review • Cataract • Glaucoma • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Ophthalmology • Retinal Disorders • Systemic Lupus Erythematosus • CD40LG

Diagnostic Complexities and Challenging Therapeutics in Patients with Systemic Lupus Erythematosus and Thrombotic Microangiopathy (KIDNEY WEEK 2025) - "First biopsy done 6 months before admission revealed class I lupus nephritis with TMA, and she was treated with rituximab, mycophenolate, voclosporin, corticosteroids, and hydroxychloroquine. Due to the patient's choice, given she had an episode of upper gastrointestinal bleeding, she decided to stop warfarin and was on apixaban...This case underscores the importance of high clinical suspicion, early complement testing, and potential consideration of complement inhibition (e.g., eculizumab). Genetic analysis may help confirm the diagnosis and guide therapy."

Clinical • Acute Kidney Injury • Anemia • Atypical Hemolytic Uremic Syndrome • Chronic Kidney Disease • Complement-mediated Rare Disorders • Gastroenterology • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • Thrombocytopenia

Refractory Lupus Nephritis in a Woman With Systemic Lupus Erythematosus on Immunosuppressive Therapy: A Case Report. (PubMed, Cureus) - "She was treated initially with steroids and azathioprine; however, over time her lupus flared and her kidney function worsened despite treatment with mycophenolate, steroids, and eventually voclosporin. To date, she has had several lupus flares while on treatment and appears to have progressed toward CKD stage IIIb."

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

Calcineurin Inhibitors: Current Role, Toxicity Management, and Future Frontiers in Immunosuppression. (PubMed, Mol Neurobiol) - "Cyclosporine, tacrolimus, pimecrolimus and newer derivatives of cyclosporine such as voclosporin are calcineurin inhibitors (CNIs), have a potent immunosuppressant effect...This necessitates the need of continuous monitoring of drug concentrations and management of cardiovascular and metabolic risk factors. This narrative review summarizes the mechanism(s), the current clinical application(s), the safety concern(s), and the future direction(s) of the safer and targeted use of CNIs."

Adverse events • Journal • Review • Atopic Dermatitis • Cardiovascular • Dermatitis • Dermatology • Glomerulonephritis • Hypertension • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Metabolic Disorders • Nephrology • Transplantation • IL2 • NFATC1

A Case of Novel Combination Therapy for Refractory Lupus Nephritis (KIDNEY WEEK 2025) - "She was treated with mycophenolate mofetil (MMF), hydroxychloroquine, and prednisone but required frequent steroids for persistent symptoms and serologic activity. She had an allergic reaction to rituximab and no response to 14 months of belimumab...She received six months of cyclophosphamide, with ocrelizumab later added due to poor response...Discussion In patients with LN who have suboptimal response to MMF/cyclophosphamide and prednisone, current literature recommends addition of voclosporin if high proteinuria or belimumab if prior flares...Belimumab therapy is known to have good serological and extrarenal outcomes (BLISS-LN). Our patient did not respond to either therapies individually with MMF and steroid; however, the novel combination of both achieved both clinical and serological remission for the first time in her 10 years of complicated SLE and LN history."

Clinical • Combination therapy • Acute Kidney Injury • Cardiovascular • Glomerulonephritis • Hypertension • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • Vasculitis

Effect of Cyclosporine- vs. Voclosporin-Based Regimen in a Patient with Class V Lupus Nephritis (KIDNEY WEEK 2025) - "She was started on Plaquenil (hydroxychloroquine) 300 mg daily...She was initially treated with Benlysta (Belimumab) with no response. In Feb 2023, she was started on multiple-targeted therapy with prednisone, mycophenolate mofetil and cyclosporine...Further studies are needed to distinguish if this is an isolated phenomenon or not. Cyclosporine vs Voclosporin in Class V Lupus Nephritis"

Clinical • Alopecia • Dyslipidemia • Fatigue • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Renal Disease

"A Change is Gonna Come" to Treatment of Lupus Nephritis: A Review. (PubMed, Am J Kidney Dis) - "Glucocorticoids with cytotoxic agents or mycophenolate mofetil (MMF) remain the standard of care, but newer therapies targeting B cells (e.g., belimumab, obinutuzumab) and T cells (e.g., voclosporin) have proven efficacy as add-on treatments. Novel therapies such as complement and cytokine inhibitors are being evaluated in preclinical and clinical trials. While maintenance therapy with MMF remains the standard, the distinction between sequential induction and maintenance therapy has increasingly blurred, and new strategies to reduce long term disease and pharmacologic toxicity to improve remission and relapse rates are emerging."

Journal • Review • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Voclosporin Distribution and Clearance from the Kidneys and Cellular Location Following Coadministration with Ketoconazole or Rifampin (KIDNEY WEEK 2025) - "As VCS demonstrates non-equilibrium disposition following IV and PO administration, drug interaction with KCZ or RIF elevated VCS kidney exposure differentiated from the altered VCS plasma exposure. VCS is rapidly cleared from the kidney and although its retention is modified with CYP inhibition or induction, VCS does not accumulate within the glomeruli or podocytes, with transient flow observed through the cortex, medulla and pelvic regions."

Glomerulonephritis • Renal Disease

Cyclosporine and Voclosporin Resistant Immune Effector Cells to Improve Outcomes after Stem Cell Transplantation (ASH 2023) - "Tacrolimus and sirolimus interact with a distinct immunophilin, FKBP12. KO of PPIA is an effective strategy for engineering resistance to CsA and VCS in cellular therapies. Our results demonstrate that PPIA KO conventional T cells, VSTs, and CAR-T cells were markedly resistant to the otherwise suppressive effects on T cell proliferation that are hallmarks of both CsA and VCS. Engineering CNI-resistance into IECs will enhance the ability to deploy these cells early after transplant to prevent or treat both malignant relapse and viral reactivation."

Glomerulonephritis • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Solid Organ Transplantation • Transplantation • CD4 • CD8

Voclosporin in a Complex Lupus Nephritis Population: Real-Life Outcomes Beyond Clinical Trials (KIDNEY WEEK 2025) - "Table 1. Baseline Clinical Characteristics and Voclosporin Treatment Details Abbreviations: PS (prednisone), CNIs (Calcineurin Inhibitors), MMF (Mycophenolate mofetil), HSCT (Autologous hematopoietic stem cell transplantation)"

Clinical • Bone Marrow Transplantation • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Movement Disorders • Nephrology • Renal Disease

Nonequilibrium Voclosporin Disposition Following IV and Oral (PO) Administration: Tissue Levels in Kidney, Liver, Pancreas, and Heart Distinct from Plasma Drug Levels and Dependent on Route of Administration (KIDNEY WEEK 2025) - "Compared to IV administration, oral administration was associated with lower plasma concentrations with significantly higher hepatic uptake/retention and lower pancreatic and cardiac uptake/retention. Consistent with non-equilibrium disposition dependent on route of administration and blood flow, VCS demonstrates distinct tissue distribution not directly correlated with plasma drug levels."

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

Real-World Data on Voclosporin for the Treatment of Lupus Nephritis, Including Use of Concomitant Biologic Therapies: Analysis of the Enlight-LN Registry (KIDNEY WEEK 2025) - P | "There were 83 (36.2%) patients on voclosporin who concomitantly received treatment with a biologic including belimumab (28.4%), rituximab (4.8%), anifrolumab (3.9%) and obinutuzumab (1.3%). This is notable given the unique and possibly synergistic effects of these agents on the immune system. Additional analysis of the registry data will provide further clinical and mechanistic insights into the use of these multi-targeted therapeutic approaches."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

Voclosporin for Induction Treatment of Lupus Nephritis in a Predominantly Black Patient Population: A Case Series (KIDNEY WEEK 2025) - "Its efficacy and safety were demonstrated in the AURORA-1 trial in combination with mycophenolate mofetil and steroids for induction of lupus nephritis and long-term maintenance in the AURORA-2 trial, showing a 32% complete renal response (CRR) at 24 weeks. Voclosporin was well-tolerated, with only one patient discontinuing therapy. These findings suggest voclosporin may be particularly beneficial for LN patients with nephrotic-range proteinuria and in pure class V. Further evaluation of 52-week outcomes and long-term maintenance is warranted."

Clinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

Real-World Use of Voclosporin in Lupus Nephritis (KIDNEY WEEK 2025) - "Used in combination with mycophenolate mofetil it allowed for the rapid taper of steroids and significantly increased the number of patients achieving complete renal response (CRR) when compared to mycophenolate mofetil and steroids alone. The other person discontinued voclosporin for a short period time due to a respiratory tract infection and has since re-instated voclosporin. In our experience, those who have good secretory renal function but are heavily proteinuric benefit from voclosporin add-on therapy in LN."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Respiratory Diseases

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: NephroNet, Inc.

New P4 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

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

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

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"

Clinical • 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. 1,017 moderate-to-severe (M/S) adult SLE patient records were collected in collaboration with 176 US rheumatologists via an online survey platform from January through March 2025...These patients also had to exhibit active, new-onset, or flaring renal disease, defined as an LN diagnosis within the past five years, a flare within the past six months, or active renal involvement at their most recent rheumatology visit. 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..."

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

Anifrolumab in Systemic Lupus Erythematosus with Renal Involvement: National Multicenter Registry in Clinical Practice (ACR Convergence 2025) - "All of them had received belimumab, and 15 mycophenolate mofetil. 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). To our knowledge, this is the first real-life study of ANI in LN. 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 trials."

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

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

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

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

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