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

Cost-effectiveness analysis of voclosporin vs mycophenolate or belimumab in the treatment of patients with lupus nephritis from the Spanish National Healthcare System perspective (ERA 2025) - No abstract available

Clinical • Cost effectiveness • HEOR • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Real-world effectiveness and safety of voclosporin in the treatment of lupus nephritis with poor prognostic clinical and histological factors (ERA 2025) - No abstract available

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

Beneficial effects of voclosporin on reducing proteinuria in lupus nephritis and extrarenal effects in SLE: insights form a small cohort with limited follow-up (ERA 2025) - No abstract available

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

ISS1.11 Multi-target treatments and a multidisciplinary approach: How they can improve care for patients with lupus nephritis (ERA 2025) - "The approval of belimumab and voclosporin represents a milestone in the management, and other substances such as obinutuzumab have met the primary endpoint of their approval trial and will likely be marketed soon...Management issues encountered by other specialities such as rheumatologists or dermatologists will be outlined and specific therapies approved for non-renal SLE, such as anifrolumab, will be discussed in this context.Besides treatment of active disease ("remission induction"), long-term prescription of immunosuppression is reality...While such an approach is invasive and often disregarded by affected patients, our symposium will outline that this is an essential point moving forward in the individualisation of therapy.In summary, relevant points for nephrologists are tackled from different perspectives in our symposium. These include the implementation of novel therapies in the management of SLE and LN, when referral to other specialities needs to be..."

Clinical • Chronic Kidney Disease • Dermatology • Fatigue • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin. (PubMed, Front Nephrol) - P3 | "Samples were analyzed from a cohort of patients in AURORA 1 treated with voclosporin (23.7 mg twice daily, n=57) or placebo (n=59) in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, including in a subgroup of patients that experienced a ≥30% decline from baseline in estimated glomerular filtration rate (voclosporin, n=26; placebo, n=20). These findings further support the safety of voclosporin for the treatment of LN in adult patients. ClinicalTrials.gov , identifier NCT03021499; EudraCT, identifier 2016-004045-81."

Biomarker • Journal • Fibrosis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • KIM1 • TGFB1

Achievement of Proteinuria Targets ≤0.4 g/g in Lupus Nephritis: A Post Hoc Analysis of the AURORA 1 Study of Voclosporin (EULAR 2025) - No abstract available

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

Kidney transplantation in Lupus Nephritis: a comprehensive review of challenges and strategies. (PubMed, BMC Surg) - "RECENT FINDINGS: Advancements in immunosuppressive therapies, including calcineurin inhibitors, Voclosporin, and biologic agents such as belimumab, have significantly improved LN management. Current guidelines emphasize the importance of achieving disease quiescence before transplantation, while new evidence supports the benefits of preemptive transplantation and personalized immunosuppressive regimens in improving patient and graft survival. This review highlights the latest evidence and strategies for optimizing kidney transplantation outcomes in LN patients, focusing on timing, immunosuppression, and disease monitoring."

Journal • Review • Chronic Kidney Disease • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus • Transplantation

Baseline Demographics, Clinical Characteristics, and Medical History of an Initial Cohort of Patients Receiving Voclosporin for Lupus Nephritis in the Enlight-LN Registry (NKF-SCM 2025) - "Common antihypertensives used at baseline included calcium channel blockers (21.1%), diuretics (20.3%), and beta blocking agents (13.8%); 15.4% of patients were on a lipid-modifying agent.Conclusion Baseline data on this initial cohort of patients are reflective of the larger LN population in the US and provide an initial understanding of the use of voclosporin in the real-world. Enrollment of additional patients and ongoing data collection will provide further valuable insight into the real-world utilization of voclosporin."

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

A focused report on IFN-1 targeted therapies for lupus erythematosus. (PubMed, Expert Opin Investig Drugs) - "Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA...This review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial...Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • TYK2

Aurinia Pharmaceuticals Reports Financial Results for the Three and Twelve Months Ended December 31, 2024 and Provides Update on Recent Corporate Progress (Businesswire) - "For the three months ended December 31, 2024, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $57.6 million, up 36% from $42.3 million in the same period of 2023...For the twelve months ended December 31, 2024, net product sales were $216.2 million, up 36% from $158.5 million in 2023...Aurinia expects to report initial results from its Phase 1 study of AUR200 in the second quarter of 2025."

New P1 trial • Sales • Immunology • Lupus Nephritis

Advances in Targeted Therapy for Systemic Lupus Erythematosus: Current Treatments and Novel Approaches. (PubMed, Int J Mol Sci) - "This review examines the current evidence for biological therapies in SLE, including the anti-B cell activating factor antibody belimumab; the type I interferon receptor antagonist anifrolumab; the novel calcineurin inhibitor voclosporin; and rituximab, which targets CD20 on B cells. Recent advances in biomarker research, including interferon signatures and transcriptomic profiles, may facilitate patient stratification and treatment selection. This review offers insights into current and future treatment strategies for patients with SLE by analyzing clinical trial results and recent immunological findings."

Journal • Review • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IFNAR2

Ten tips in lupus nephritis management. (PubMed, Clin Kidney J) - "Effective therapeutic options continue to increase, such as belimumab (a monoclonal antibody that inhibits B-cell activating factor, BAFF) and voclosporin (a calcineurin inhibitor) which have obtained regulatory approval in U.S.A. Ironically, the increasing therapeutic options have resulted in uncertainties in deciding which medication, and which treatment regimen, is best for a patient. In this context, one needs to take into consideration the distinct characteristics and the risk profile of each patient, and adopt a holistic and long-term perspective, so that treatment can be personalized to achieve favourable clinical outcomes."

Journal • Review • Acute Kidney Injury • Chronic Kidney Disease • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

The Role of Sodium-Glucose Co-Transporter-2 (SGLT-2) Inhibitors in Treating Lupus Nephritis: A Systematic Review. (PubMed, Cureus) - "Currently, the medications that are being utilized for the treatment of lupus nephritis (LN), include azathioprine, hydroxychloroquine, cyclophosphamide, belimumab, voclosporin, tacrolimus, mycophenylate, and rituximab...SGLT-2 inhibitors show potential benefits beyond glycemic control. However, due to the novelty of this treatment and the limited studies completed, further testing is required to analyze its true effectiveness in LN."

Journal • Review • Chronic Kidney Disease • Fatigue • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

New Treatment Regimens, New Drugs, and New Treatment Goals for Lupus Nephritis. (PubMed, J Clin Med) - "With the introduction of cyclophosphamide and mycophenolate mofetil, outcomes have dramatically improved...These agents include belimumab, voclosporin, and obinutuzumab, among others...However, determining which patients would benefit the most from novel agents or combined drug regimens and whether these drugs might serve as an alternative to current remission-induction drug regimens rather than as add-on therapies remain unresolved issues. In this review, we will explore the current evidence regarding the efficacy of novel agents."

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

Exploring potential drug targets for SLE through Mendelian randomization and network pharmacology. (PubMed, PLoS One) - "Our integrative analysis suggested that levels of circulating PPP3CA; PPP3R1 had causal effects on SLE risk and served as potential treatment targets. Moreover, this study provides new evidence for Voclosporin as an SLE treatment through Mendelian randomization and Network pharmacology, and warrants further clinical investigation."

Journal • Observational data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • ICAM1 • PACERR • PPP3CA • PPP3R1 • PTGS2 • SIRT1

Novel therapies in SLE treatment: A literature review. (PubMed, Adv Clin Exp Med) - "For a long time, European Alliance of Associations for Rheumatology (EULAR) recommended only 2 biological agents in the treatment of SLE: belimumab and rituximab. However, in 2023, anifrolumab, an interferon (IFN) receptor inhibitor, and voclosporin, a novel calcineurin inhibitor, appeared in new SLE treatment guidelines. In addition, several biological agents are targeting different cells or cytokines that are being evaluated in phase II and III clinical trials. Apart from that, experimental therapies such as targeting of plasma cells, chimeric antigen receptor T-cell therapy (CAR-T) or stem cell transplantation appear promising in the treatment of the severe forms of SLE."

Journal • Review • Bone Marrow Transplantation • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Rheumatology • Systemic Lupus Erythematosus • Transplantation

Dried blood spot LC-MS/MS quantification of voclosporin in renal transplant recipients using volumetric dried blood spot sampling. (PubMed, J Pharm Biomed Anal) - "Method development was based on previously developed assays for the quantification of tacrolimus, everolimus, sirolimus, cyclosporin, mycophenolic acid, creatinine and iohexol in DBS and voclosporin in whole blood using LC-MS/MS. The cross-validation against the whole blood method shows that the quantified voclosporin results are promising. This developed dried blood spot LC-MS/MS method was successfully validated and provides an easy, efficient workflow for therapeutic drug monitoring in kidney transplant patients or remote pharmacokinetic studies in lupus nephritis patients treated with voclosporin."

Journal • Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Novel Coronavirus Disease • Respiratory Diseases • Transplantation

Navigating complexities in male paediatric-onset lupus: From macrophage activation syndrome and refractory lupus nephritis to CAR-T cell therapy (BSR-CBC 2024) - "He had multiple medications over the years, which were not well-tolerated: mycophenolate mophetil (gastrointestinal disturbance), azathioprine (low white cell count), and hydroxychloroquine (significant diarroea)...In the same year, while being on methotrexate, he developed class IV lupus nephritis (LN)...In May 2024, the patient was on mycophenolic acid 180 mg bd (maximum tolerated dose), Prednisolone 10 mg od, and Voclosporin 23.7 mg twice a day, and had 6-monthly Rituximab (last dose in February 2024)...Adding immunosuppresive medications, such as belimumab, or trying CAR-T cell therapy (phase I for LN) was offered...During the conference, we are looking forward to hearing from both paediatric and adult colleagues how they would manage this patient. We are also hoping the patient to have started on CAR-T cell therapy by the start of the conference, so we can present our experience with CAR-T cell therapy and in any case, to raise awareness about this new novel..."

CAR T-Cell Therapy • Gastrointestinal Disorder • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Pediatrics • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

Obinutuzumab for Treatment of Refractory Lupus Nephritis (KIDNEY WEEK 2024) - "Obinutuzumab has shown efficacy in addition to mycophenolate mofetil (MMF) in LN...All patients were on angiotensin convertase inhibitor (ACE-i) or angiotensin receptor blocker (ARB), and 87.5% of patients were on MMF and hydroxychloroquine, 62% were on tacrolimus, and 12.5% on azathioprine. Among this cohort, 75% had been on cyclophosphamide, 50% had been on rituximab, 50% on voclosporin and 37.5% had been on belimumab... Obinutuzumab therapy along with MMF, HCQ and ACE-i was associated with significant improvement in proteinuria, serum albumin and serum C4 levels in patients with refractory LN. Obinutuzumab could be considered as a treatment option for refractory LN."

Glomerulonephritis • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Varicella Zoster

Not yet on Track: Retrospective Chart Analysis Reveals Physician's Treatment Approaches in SLE Fall Short of New EULAR Guidance (ACR Convergence 2024) - "Notably, since the previous guidelines update in 2019, anifrolumab received approval for treatment of SLE, and belimumab and voclosporin for LN. 1,263 moderate-to-severe (M/S) adult SLE patient records were collected in collaboration with 256 EU5 rheumatologists via an online survey platform from March through April 2024...That said, the proportion of patients in the US on the recommended lower dose increased by 13 percentage points between 2022 and 2023, without change in EU5.Third, EULAR guidelines recommend rheumatologists should consider adding traditional DMARDs (methotrexate, azathioprine, or mycophenolate mofetil) and/or biologics to patients who fail to respond to HCQ or those who fail to taper to maintenance GC doses of ≤ 5mg... While SLE management practices in the US and EU5 share similarities, there are notable differences, particularly in HCQ. Importantly, both regions show increasing adoption of biologics, especially for steroid-dependent patients. Future..."

Retrospective data • Inflammatory Arthritis • Rheumatology

Prescribing Trends for Novel Treatments in Systemic Lupus from 2017 to 2022 (ACR Convergence 2024) - "Belimumab, anifrolumab and voclosporin exhibited an increase in claims from 2017-2022, with belimumab having a nearly 600% increase over the time-period, reflecting increased physician uptake of these medications. Our data suggests that Southern states have greater prescription rates of these medications, which, among other factors, may reflect regional variations in SLE prevalence. Interestingly, all claims for anifrolumab in 2021 came from the West, which may reflect factors such as different rates of marketing, information dissemination, etc."

Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology • Systemic Lupus Erythematosus

Navigating Lupus Nephritis: A Comprehensive Review of the Current Treatment Trends. (PubMed, Cureus) - "Key themes include the intricate pathogenesis involving immune complex deposition and the advancing treatment landscape, which encompasses both traditional immunosuppressants such as mycophenolate mofetil (MMF) and cyclophosphamide and newer biologics like belimumab and voclosporin. The evaluation of bias risk was performed according to established protocols. This systematic approach provided a comprehensive analysis of recent developments in lupus nephritis therapy."

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

Characteristics and Treatment Patterns of Patients with Lupus Nephritis: A Retrospective Claims Database Study in the USA (ACR Convergence 2024) - "Among patients who had a record of ≥1 LN treatment following index diagnosis (n=1878), the initial treatment regimen included ≥1 of the following: oral/intravenous corticosteroids (n=1106; 58.9%), antimalarials (n=900; 47.9%), immunosuppressants including mycophenolate mofetil (n=807; 43.0%), antihypertensives (n=699; 37.2%), B-cell therapies including belimumab (n=128; 6.8%), calcineurin inhibitors including voclosporin (n=52; 2.8%) and sodium-glucose cotransporter-2 inhibitors (n=9; 0.5%). Time from index LN diagnosis to treatment was shorter for patients diagnosed on/after January 1, 2021, than those diagnosed before, suggesting a potential movement toward earlier treatment in recent years. This will be explored for specific treatments in future analyses. Further work will investigate LN treatment patterns beyond the initial regimen including line of therapy and switching, as well as treatment in relation to the updated KDIGO 2024 guidelines and by patients'..."

Claims database • Retrospective data • Glomerulonephritis • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Renal Disease • Respiratory Diseases • Tuberculosis

Precision Editing of Cyclophilin a to Engineer Cyclosporine- and Voclosporin- Resistant Human CAR-T Cells (ACR Convergence 2024) - "We edited PPIA to produce CAR-T cells resistant to CsA and VCS. This genetic modification may enable allogeneic CAR-T cells to be compatible with CNIs, a benefit for patients such as those with lupus nephritis being treated with CNIs, and as part of a strategy to help evade allogeneic CAR-T cell rejection. Engineering allogeneic products to function in the setting of different background immunomodulating therapies has the potential to expand the clinical scenarios in which CAR-T cells can be used in patients with autoimmune disease."

CAR T-Cell Therapy • IO biomarker • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • CD4 • PPIA

Rates of Sustained Complete Renal Response with Long-term Use of Voclosporin in AURORA 2 (ACR Convergence 2024) - "SCRR is a novel endpoint that can be leveraged to illustrate disease trajectory of LN and treatment efficacy. Consistent with using CRR as an efficacy endpoint in AURORA 1, more VCS- than control-treated patients achieved SCRR, despite nearly 40% of the analyzed study population being ineligible due to the voluntary nature of AURORA 2 participation. The stringency and potential utility of this new endpoint require further exploration.This work was funded by Aurinia Pharmaceuticals Inc."

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