Lupkynis (voclosporin) News

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|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Baseline Demographics, Clinical Characteristics, and Medical History of an Initial Cohort of Patients Receiving Voclosporin for Lupus Nephritis in the Enlight-LN Registry () - Mar 13, 2025 - Abstract #NKFSCM2025NKF_SCM_897;
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.

|||||||||| Journal: A focused report on IFN-1 targeted therapies for lupus erythematosus. (Pubmed Central) - Mar 6, 2025
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.

|||||||||| Review, Journal: Advances in Targeted Therapy for Systemic Lupus Erythematosus: Current Treatments and Novel Approaches. (Pubmed Central) - Feb 13, 2025
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.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma
Review, Journal: Ten tips in lupus nephritis management. (Pubmed Central) - Jan 28, 2025
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.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Observational data, Journal: Exploring potential drug targets for SLE through Mendelian randomization and network pharmacology. (Pubmed Central) - Jan 18, 2025
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.

|||||||||| Review, Journal: Novel therapies in SLE treatment: A literature review. (Pubmed Central) - Jan 16, 2025
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.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Journal: Calcineurin inhibitor effects on kidney electrolyte handling and blood pressure: tacrolimus versus voclosporin. (Pubmed Central) - Dec 20, 2024
In contrast to tacrolimus, voclosporin does not cause hypercalciuria and hypomagnesaemia, but similarly causes hypertension. Our data reveal differences between the distal tubular effects of tacrolimus and voclosporin and provide a pathophysiological basis for the clinically observed differences between the two CNIs.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
PK/PD data, Journal: Understanding mechanisms of negative food effect for voclosporin using physiologically based pharmacokinetic modeling. (Pubmed Central) - Dec 14, 2024
These results suggest that a possible cause of the negative food effect of voclosporin is the adsorption of voclosporin to food in gastrointestinal tract. These approaches could facilitate understanding of the mechanisms responsible for oral absorption of cyclic peptides.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma
Review, Journal: Navigating Lupus Nephritis: A Comprehensive Review of the Current Treatment Trends. (Pubmed Central) - Nov 29, 2024
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.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Rituxan (rituximab) / Roche
Navigating complexities in male paediatric-onset lupus: From macrophage activation syndrome and refractory lupus nephritis to CAR-T cell therapy () - Nov 8, 2024 - Abstract #BSRCBC2024BSR_CBC_33;
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 treatment which has the potential to revolutianise the treatment of rheumatic diseases.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Saphnelo (anifrolumab-fnia) / AstraZeneca
Review, Journal: Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations. (Pubmed Central) - Oct 21, 2024
In patients achieving these targets, GC and immunosuppressive therapy may gradually be tapered. Cite Now.

||||||||||  Lupkynis (voclosporin) / Aurinia Pharma
Trial completion:  VOCOVID: Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients (clinicaltrials.gov) -  Oct 17, 2024
P2, N=20, Completed,  Sponsor: Leiden University Medical Center
Cite Now. Recruiting --> Completed

|||||||||| Review, Journal: JAK inhibitors in systemic lupus erythematosus: Translating pathogenesis into therapy. (Pubmed Central) - Oct 9, 2024
The efforts of the drug development programme in lupus have led to considerable growth in the last decade, owing to the approval of belimumab, anifrolumab, and voclosporin...Multiple JAKis are currently being investigated in SLE. This paper aims to summarize existing data coming from both clinical trials and case reports regarding the use of JAK inhibitors in SLE.

|||||||||| Biomarker, Journal: Prognostic Factors for Mortality in Patients With Autoimmune Diseases Complicated by Pneumocystis Pneumonia. (Pubmed Central) - Sep 25, 2024
Additionally, the risk of mortality for PCP under the administration of new biological agents, such as anifrolumab, belimumab, and rituximab, or immunosuppressants, such as mycophenolate mofetil and voclosporin, should be evaluated. These findings can contribute to improving PCP prevention and treatment strategies in patients with autoimmune diseases, ultimately leading to better patient outcomes.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Voclosporin Ameliorates Proteinuria and Directly Protects Podocytes in a Model of Noninflammatory Glomerular Disease (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4196;
Rats received 50 mg/kg puromycin aminonucleoside (PAN) or saline via tail vein injection and were gavaged twice daily with vehicle (VEH, vitamin E-TPGS, MCT oil, Tween 40, and 95% ethanol 4:2:2:1, by weight), VCS (4 mg/kg/dose), or cyclosporine (CsA, 10mg/kg/dose) as clinically relevant doses. Compared to CsA, a clinically relevant dose of VCS more effectively ameliorated PAN-induced proteinuria, hypercoagulopathy, NS-associated dyslipidemia, and tubular injury in rats, as well as cell viability and actin cytoskeleton of cultured podocytes.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Integrative Systems Analyses Reveal Calcineurin Inhibitor-Mediated Control of Human Podocyte Biophysics and Physiology (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4036;
Funding: Commercial Support - Aurinia Pharmaceuticals Background: Calcineurin inhibitors (CNIs), such as cyclosporine A (CsA), tacrolimus (TAC), and voclosporin (VCS), have been used to regulate the immune response in a number of conditions, including kidney transplantation, lupus nephritis and other autoimmune disorders. Based on these findings, our study contributes significantly to the understanding of the role of CNIs in podocyte function, independently from other cell biological impacts, and it represents an integrative cellular and molecular atlas to guide the discovery of novel drug-induced modulators of glomerulopathies and evaluate the effect of new CNIs on podocyte biophysical and biomechanical features.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Immunologic Changes over Time in Repeat Kidney Biopsies from the AURORA Studies of Voclosporin in Lupus Nephritis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_3105;
The lack of difference within each treatment group may indicate a lack of concordance between clinical response and immunological landscape but may also be reflective of the small sample size. The potential utility of CD34 and Ki67 as biomarkers of response requires further investigation.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1701;
Baseline data on this initial cohort of patients are reflective of the larger LN population in the US, including high percentages of Black and Hispanic and/or Latino patients. Enrollment of additional patients and ongoing data collection will provide valuable insight into the real-world utilization of voclosporin.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Rituxan (rituximab) / Roche
Early Adoption of Advanced Systemic Therapies in Lupus Nephritis: A Retrospective Analysis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1696;
These results underscore a growing emphasis on initiating systemic treatments earlier in the treatment trajectory, yet high doses of steroids remain prevalent. Despite the earlier adoption of advanced systemic therapies, there persists an unmet need for steroid-sparing agents to mitigate the continued reliance on high-dose steroids.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Disease Targeting Properties of Voclosporin in Kidney Transplant and Lupus Nephritis Patients (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1688;
This is consistent with immunosuppressive activity of VCS in targeted organs relative to blood circulation. The low blood levels of VCS are consistent with the safety profile of VCS compared to other calcineurin inhibitors.

|||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Obinutuzumab for Treatment of Refractory Lupus Nephritis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1686;
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.

||||||||||  Lupkynis (voclosporin) / Aurinia Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  DIVERT: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus (clinicaltrials.gov) -  Sep 19, 2024
P2, N=9, Terminated,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Obinutuzumab could be considered as a treatment option for refractory LN. N=120 --> 9 | Trial completion date: Jun 2026 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Apr 2024; The study was closed due to slow enrollment.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Gazyva (obinutuzumab) / Roche, Biogen
Clinical, Retrospective data, Review, Journal: Efficacy and safety of biologics, multitarget therapy, and standard therapy for lupus nephritis: a systematic review and network meta-analysis. (Pubmed Central) - Sep 1, 2024
Multitarget therapy may be the most effective approach for treating lupus nephritis. However, since the study population consists exclusively of Asian patients, further research is needed to verify the efficacy of multitarget therapy in lupus nephritis patients of non-Asian descent.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma
Biomarker, Review, Journal: Lupus Nephritis from Pathogenesis to New Therapies: An Update. (Pubmed Central) - Aug 31, 2024
Integrating these therapeutic areas requires an effort towards a holistic and multidisciplinary approach. At the same time, the availability of an increasingly wider armamentarium may translate into improvements in patient's renal outcomes over the next decades.

||||||||||  Lupkynis (voclosporin) / Aurinia Pharma
Enrollment open:  VOCAL-EXT: Long-Term Voclosporin Treatment in Adolescent Subjects with Lupus Nephritis (clinicaltrials.gov) -  Aug 30, 2024
P3, N=40, Enrolling by invitation,  Sponsor: Aurinia Pharmaceuticals Inc.
At the same time, the availability of an increasingly wider armamentarium may translate into improvements in patient's renal outcomes over the next decades. Not yet recruiting --> Enrolling by invitation

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Gazyva (obinutuzumab) / Roche, Biogen
Review, Journal: Evidence based treatment for lupus nephritis: present perspectives and challenges. (Pubmed Central) - Aug 21, 2024
Immunosuppressive therapy, particularly glucocorticoids combined with cyclophosphamide or mycophenolate mofetil, has been the mainstay of treatment for many years, while rates of complete remission have not changed dramatically...Emerging therapies including belimumab, voclosporin, and obinutuzumab offer promising results in improving renal outcomes, especially in refractory or relapsing disease...Supportive measures including lifestyle modifications and non-immunosuppressive pharmacological interventions are nowadays also essential in managing LN. This review emphasizes recent advances of therapy and challenges regarding treatment optimization with strategies to improve long-term outcomes.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Evaluating the cost-effectiveness of voclosporin for the treatment of lupus nephritis in the United States. (Pubmed Central) - Aug 1, 2024
For a subpopulation of Black, Hispanic, and Latino patients, the incremental cost of voclosporin per QALY was $77,435 and per evLYG was $67,828. Following the inclusion of updated data in the cost-effectiveness analysis, voclosporin remains a cost-effective therapy for the treatment of active LN including in a Black, Hispanic, and Latino subpopulation, substantially below the ICER willingness-to-pay threshold of $150,000/QALY.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Saphnelo (anifrolumab-fnia) / AstraZeneca
Review, Journal: EULAR recommendations 2023 on the treatment of systemic lupus erythematosus (Pubmed Central) - Jul 22, 2024
If the target of remission or low disease activity is not reached, methotrexate, azathioprine, mycophenolate and/or belimumab or anifrolumab should be used. For lupus nephritis, Euro-Lupus cyclophosphamide or mycophenolate are options for induction therapy and mycophenolate or azathioprine for maintenance...It is important that treatment should be continued for at least 3

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Saphnelo (anifrolumab) / AstraZeneca
Review, Journal: Systemic lupus erythematosus. (Pubmed Central) - May 26, 2024
In the last decade, there have been a few major breakthroughs in approved treatments for SLE and lupus nephritis, such as belimumab, anifrolumab, and voclosporin...Comorbidities due to both disease activity and treatment adverse effects, especially infections, osteoporosis, and cardiovascular disease, necessitate vigilant prevention and management strategies. Tailoring treatment options to achieve remission, while balancing treatment-related comorbidities, are priority areas of SLE management.

||||||||||  Lupkynis (voclosporin) / Aurinia Pharma
Trial completion date:  A Prospective Observational Registry of Patients Treated With LUPKYNIS (clinicaltrials.gov) -  May 22, 2024
P=N/A, N=300, Recruiting,  Sponsor: Aurinia Pharmaceuticals Inc.
Tailoring treatment options to achieve remission, while balancing treatment-related comorbidities, are priority areas of SLE management. Trial completion date: Feb 2027 --> Jun 2030

||||||||||  Lupkynis (voclosporin) / Aurinia Pharma
New P3 trial:  A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis (clinicaltrials.gov) -  May 9, 2024
P3, N=270, Recruiting,  Sponsor: Qilu Pharmaceutical Co., Ltd.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Saphnelo (anifrolumab) / AstraZeneca
Review, Journal: Systemic Lupus Erythematosus: A Review. (Pubmed Central) - May 7, 2024
Hydroxychloroquine is first-line therapy and reduces disease activity, morbidity, and mortality. When needed, additional immunosuppressive and biologic therapies include azathioprine, mycophenolate mofetil, cyclophosphamide, belimumab, voclosporin, and anifrolumab.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
An update to the ICER lupus nephritis model evaluating the cost-effectiveness of voclosporin for the treatment of lupus nephritis in the United States () - Apr 9, 2024 - Abstract #AMCP2024AMCP_64;
Following the inclusion of updated data in the model, VCS was found to be cost-effective, substantially below the ICER published willingness to pay threshold of $150,000/QALY. These results are consistent with the original ICER evaluation with VCS continuing to be a cost-effective treatment for LN.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Saphnelo (anifrolumab) / AstraZeneca
NOT YET ON TRACK: RETROSPECTIVE CHART ANALYSIS REVEALS PHYSICIAN'S TREATMENT APPOACHES IN SLE FALL SHORT OF NEW EULAR GUIDANCE (Poster View) - Mar 29, 2024 - Abstract #EULAR2024EULAR_2362;
Importantly, both regions show increasing adoption of biologics, especially for steroid-dependent patients, partially bridging the gap in adherence to the new EULAR recommendations. Future research is needed to understand the drivers of these geographical differences and how physicians globally may optimize their SLE management strategies to better adhere to the new EULAR recommendations.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
VOCLOSPORIN-BASED, TRIPLE-IMMUNOSUPPRESSIVE REGIMEN VERSUS HIGH-DOSE GLUCOCORTICOID AND MYCOPHENOLATE MOFETIL-BASED THERAPY FOR LUPUS NEPHRITIS: A PROPENSITY ANALYSIS OF THE ALMS, AURA-LV AND AURORA 1 STUDIES (C8) - Mar 29, 2024 - Abstract #EULAR2024EULAR_932;
Participants treated with voclosporin in combination with low-dose GCs and MMF 2g/day demonstrated an improved safety profile and earlier reductions in proteinuria compared to participants treated with high-dose GCs and MMF up to 3 g/day or IVC. These findings support the recommendation that a voclosporin-based, triple-immunosuppressive regimen should be considered as an initial therapy in patients with active LN.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
What's new in Lupus Nephritis: from guidelines to real-world practices (Stolz 1) - Mar 29, 2024 - Abstract #EULAR2024EULAR_659;
3. To share real-world experiences with voclosporin treating LN patients in Europe.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
A propensity analysis of AURA-LV plus AURORA 1 vs ALMS to compare a voclosporin-based, triple immunotherapy regimen to high-dose glucocorticoid-based immunosuppressive therapy () - Mar 23, 2024 - Abstract #NKFSCM2024NKF_SCM_847;
Treatment with the VCS-based triple immunosuppressive regimen resulted in an overall lower incidence of AEs and improved efficacy. These data further support the use of VCS-based triple therapy as initial treatment in patients with active LN and the need to re-evaluate the conventional high-dose 'dual' therapies.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Evaluating the Cost-effectiveness of Voclosporin in the United States for the Treatment of Lupus Nephritis () - Mar 23, 2024 - Abstract #NKFSCM2024NKF_SCM_837;
Moreover, cost-effectiveness was found in a smaller subgroup analysis of Black, Hispanic, and Latino patients, a population disproportionately affected by LN, on par with other interventions for diabetes, blood pressure, and hyperlipidemia. These results are consistent with the original evaluation by ICER demonstrating that VCS continues to be a cost-effective treatment for LN.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States () - Mar 23, 2024 - Abstract #NKFSCM2024NKF_SCM_833;
P
Baseline data on this initial cohort of patients are reflective of the larger LN population in the US. Enrollment of additional patients and ongoing data collection will provide valuable insight into the real-world utilization of voclosporin.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma
Successful Treatment of Lupus Nephritis with Belimumab and Voclosporin: A Rare Case () - Mar 23, 2024 - Abstract #NKFSCM2024NKF_SCM_520;
This case highlights the significant positive response achieved through the combination of Belimumab and Voclosporin, along with low-dose steroids, without any significant adverse effects. Further research is warranted to assess the safety and efficacy of combining Belimumab and Voclosporin in the management of LN.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma
Comparison of a voclosporin-based, triple immunotherapy regimen to high-dose glucocorticoid-based immunosuppressive therapy: A propensity analysis of the AURA-LV plus AURORA 1 studies and ALMS () - Feb 25, 2024 - Abstract #LUPUS2024LUPUS_268;
Triple therapy is also superior in achieving early proteinuria milestones. These data provide further support for use of combination therapy as initial treatment in patients with active LN and to minimizing patient exposure to GCs, as proposed by the 2023 EULAR guidelines

||||||||||  Lupkynis (voclosporin) / Aurinia Pharma
Trial initiation date:  VOCAL-EXT: Long-Term Voclosporin Treatment in Adolescent Subjects with Lupus Nephritis (clinicaltrials.gov) -  Feb 15, 2024
P3, N=40, Not yet recruiting,  Sponsor: Aurinia Pharmaceuticals Inc.
These data provide further support for use of combination therapy as initial treatment in patients with active LN and to minimizing patient exposure to GCs, as proposed by the 2023 EULAR guidelines Initiation date: Dec 2023 --> Mar 2024

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka
Review, Journal: Evolution of diagnosis and treatment for lupus nephritis in Spain. (Pubmed Central) - Jan 21, 2024
Regarding LN treatment, standard strategy consists of an induction phase and a maintenance phase. However, as new drugs have been released, a new paradigm of treatment in a single, continuing and personalized phase has been proposed.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma, Otsuka
Review, Journal: Systemic calcineurin inhibitors tacrolimus and voclosporin: a review of off-label dermatologic uses. (Pubmed Central) - Jan 15, 2024
Voclosporin has only been utilized in psoriasis currently, and clinical trials in psoriasis show voclosporin's efficacy. Voclosporin can be considered for patients with lupus nephritis.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma, Otsuka
Journal: Voclosporin and the Antiviral Effect Against SARS-CoV-2 in Immunocompromised Kidney Patients. (Pubmed Central) - Dec 18, 2023
This proof-of-concept study shows a potential positive risk-benefit profile for voclosporin in immunocompromised patients with SARS-CoV-2 infection. These results warrant further investigations on voclosporin to establish an equipoise between infection and maintenance immunosuppression.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka
Retrospective data, Review, Journal: The efficacy of immunosuppressive drugs induction therapy for lupus nephritis: a systematic review and network meta-analysis. (Pubmed Central) - Dec 17, 2023
This study was to assess the safety and effectiveness of immunosuppressive agents, specifically Voclosporin, when used in conjunction with mycophenolate mofetil (MMF) induction therapy for the management of lupus nephritis (LN)...On the other hand, TAC not only showed efficacy but also had a lower risk of infection and serious infection, making it a favorable option in terms of safety. This study did' not include results on other adverse events.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma, Otsuka
Cyclosporine and Voclosporin Resistant Immune Effector Cells to Improve Outcomes after Stem Cell Transplantation (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4391;
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.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma, Otsuka
Review, Journal: Voclosporin: Unique Chemistry, Pharmacology and Toxicity Profile, and Possible Options for Implementation into the Management of Lupus Nephritis. (Pubmed Central) - Oct 31, 2023
However, the traditional CNI, cyclosporine A and tacrolimus, have a narrow therapeutic range, need monitoring of drug levels, and their use is associated with nephrotoxicity and metabolic alterations...Here, we review the unique chemistry, pharmacology, and toxicity profile of VOC, summarize the efficacy and safety data from the AURA-LV and AURORA-1 trials, and discuss the following four possible options to implement VOC into the management of lupus nephritis, namely regarding B cell-targeting therapy with belimumab (BEL)...VOC-BEL sequential therapy, or 4. alternative options for the rapid antiproteinuric effect of VOC.

|||||||||| Lupkynis (voclosporin) / Aurinia Pharma, Otsuka, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Retrospective data, Review: Efficacy and safety of immunosuppressive agents for adults with lupus nephritis: a systematic review and network meta-analysis. (Pubmed Central) - Oct 30, 2023
This study showed that a combination of TAC, MMF and GC was the best regimen for improving the total remission rate. The optimal regimen for specific outcomes should be highlighted for high-risk patients.

|||||||||| Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Lupus Nephritis in Children: Novel Perspectives. (Pubmed Central) - Oct 28, 2023
Moreover, current literature often lacks pediatric-specific data, leading clinicians to rely exclusively on adult therapeutic approaches. This review aims to describe pediatric lupus nephritis and provide an overview of the novel perspectives on the pathogenetic mechanisms, histopathological classification, therapeutic approach, novel biomarkers, and follow-up targets in children and adolescents with lupus nephritis.



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